CFR 2024 Title42 Vol5

Title 42
Public Health
Part 482 to End
Revised as of October 1, 2024
Containing a codification of documents

of general applicability and future effect
As of October 1, 2024
Published by the Office of the Federal Register

National Archives and Records Administration
as a Special Edition of the Federal Register
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Table of Contents
Page
Explanation ................................................................................................ v
Title 42:
Chapter IV—Centers for Medicare & Medicaid Services, Depart-

ment of Health and Human Services (Continued) ........................ 3
Chapter V—Office of Inspector General-Health Care, Department

of Health and Human Services .................................................... 1115
Finding Aids:
Table of CFR Titles and Chapters ....................................................... 1249
Alphabetical List of Agencies Appearing in the CFR ......................... 1269
List of CFR Sections Affected ............................................................. 1279
iii
Cite this Code: CFR
To cite the regulations in

this volume use title,
part and section num-
ber. Thus, 42 CFR 482.1
refers to title 42, part
482, section 1.
iv
Explanation
The Code of Federal Regulations is a codification of the general and permanent
rules published in the Federal Register by the Executive departments and agen-
cies of the Federal Government. The Code is divided into 50 titles which represent
broad areas subject to Federal regulation. Each title is divided into chapters
which usually bear the name of the issuing agency. Each chapter is further sub-
divided into parts covering specific regulatory areas.
Each volume of the Code is revised at least once each calendar year and issued
on a quarterly basis approximately as follows:
Title 1 through Title 16..............................................................as of January 1
Title 17 through Title 27 .................................................................as of April 1
Title 28 through Title 41 ..................................................................as of July 1
Title 42 through Title 50 .............................................................as of October 1
The appropriate revision date is printed on the cover of each volume.
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v
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vi
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OLIVER A. POTTS,
Director,
Office of the Federal Register
October 1, 2024
vii
THIS TITLE
Title 42—PUBLIC HEALTH is composed of five volumes. The parts in these vol-
umes are arranged in the following order: Parts 1–399, parts 400–413, parts 414–
429, parts 430 to 481, and part 482 to end. The first volume (parts 1–399) contains
current regulations issued under Chapter I—Public Health Service (HHS). The
second, third, and fourth volumes (parts 400–413, parts 414–429, and parts 430 to
481) include regulations issued under Chapter IV—Centers for Medicare & Med-
icaid Services (HHS) and the fifth volume (part 482 to end) contains the remaining
regulations in chapter IV and the regulations issued under chapter V by the Of-
fice of Inspector General-Health Care (HHS). The contents of these volumes rep-
resent all current regulations codified under this title of the CFR as of October
1, 2024.
For this volume, Gabrielle E. Burns was Chief Editor. The Code of Federal
Regulations publication program is under the direction of John Hyrum Martinez,
assisted by Stephen J. Frattini.
ix
Title 42—Public Health
(This book contains part 482 to end)
Part
CHAPTER IV—Centers for Medicare & Medicaid Services, De-

partment of Health and Human Services (Continued) ....... 482
CHAPTER V—Office of Inspector General-Health Care, De-
partment of Health and Human Services ........................... 1000
1
CHAPTER IV—CENTERS FOR MEDICARE &
MEDICAID SERVICES, DEPARTMENT OF HEALTH
AND HUMAN SERVICES (CONTINUED)
EDITORIAL NOTE: Nomenclature changes to chapter IV appear at 66 FR 39452, July 31, 2001;
67 FR 36540, May 24, 2002; 69 FR 18803, Apr. 9, 2004; and 77 FR 29028, May 16, 2012.
SUBCHAPTER G—STANDARDS AND CERTIFICATION
Part Page
482 Conditions of participation for hospitals ................ 5
483 Requirements for States and long term care facili-
ties ....................................................................... 53
484 Home health services .............................................. 158
485 Conditions of participation: Specialized providers 200
486 Conditions for coverage of specialized services fur-
nished by suppliers ............................................... 284
488 Survey, certification, and enforcement procedures 308
489 Provider agreements and supplier approval ............ 643
491 Certification of certain health facilities ................. 677
493 Laboratory requirements ........................................ 685
494 Conditions for coverage for end-stage renal disease
facilities ............................................................... 820
495 Standards for the Electronic Health Record Tech-
nology Incentive Program .................................... 840
498 Appeals procedures for determinations that affect
participation in the Medicare program and for
determinations that affect the participation of
ICFs/IID and certain NFs in the Medicaid pro-
gram ..................................................................... 942
SUBCHAPTER H—HEALTH CARE INFRASTRUCTURE AND MODEL
PROGRAMS
505 Establishment of the health care infrastructure

improvement program .......................................... 961
510 Comprehensive care for joint replacement model ... 964
3
42 CFR Ch. IV (10–1–24 Edition)
Part Page
512 Standard provisions for innovation center models
and specific provisions for certain models ........... 1005
SUBCHAPTER I—BASIC HEALTH PROGRAM
600 Administration, eligibility, essential health bene-

fits, performance standards, service delivery re-
quirements, premium and cost sharing, allot-
ments, and reconciliation .................................... 1091
601–699 [Reserved]
4
SUBCHAPTER G—STANDARDS AND CERTIFICATION
PART 482—CONDITIONS OF 482.55 Condition of participation: Emer-

gency services.
PARTICIPATION FOR HOSPITALS 482.56 Condition of participation: Rehabili-
tation services.
Subpart A—General Provisions 482.57 Condition of participation: Res-
piratory care services.
Sec. 482.58 Special requirements for hospital pro-
482.1 Basis and scope. viders of long-term care services
482.2 Provision of emergency services by (‘‘swing-beds’’).
nonparticipating hospitals.
Subpart E—Requirements for Specialty
Subpart B—Administration Hospitals
482.11 Condition of participation: Compli- 482.60 Special provisions applying to psy-
ance with Federal, State and local laws. chiatric hospitals.
482.12 Condition of participation: Governing 482.61 Condition of participation: Special
body. medical record requirements for psy-
482.13 Condition of participation: Patient’s chiatric hospitals.
rights. 482.62 Condition of participation: Special
482.15 Condition of participation: Emer- staff requirements for psychiatric hos-
gency preparedness. pitals.
482.68 Special requirements for transplant
Subpart C—Basic Hospital Functions programs.
482.70 Definitions.
482.21 Condition of participation: Quality
assessment and performance improve- GENERAL REQUIREMENTS FOR TRANSPLANT
ment program. CENTERS
482.22 Condition of participation: Medical
staff. 482.72 Condition of participation: OPTN
482.23 Condition of participation: Nursing Membership.
services. 482.74 Condition of participation: Notifica-
482.24 Condition of participation: Medical tion to CMS.
record services. 482.76 Condition of participation: Pediatric
482.25 Condition of participation: Pharma- Transplants.
ceutical services. 482.78 Condition of participation: Emer-
gency preparedness for transplant pro-
482.26 Condition of participation:
grams.
Radiologic services.
482.27 Condition of participation: Labora- TRANSPLANT CENTER DATA SUBMISSION, CLIN-
tory services. ICAL EXPERIENCE, AND OUTCOME REQUIRE-
482.28 Condition of participation: Food and MENTS
dietetic services.
482.30 Condition of participation: Utiliza- 482.80 Condition of participation: Data sub-
tion review. mission, clinical experience, and out-
482.41 Condition of participation: Physical come requirements for initial approval of
environment. transplant programs.
482.42 Condition of participation: Infection TRANSPLANT PROGRAM PROCESS
prevention and control and antibiotic REQUIREMENTS
stewardship programs.
482.43 Condition of participation: Discharge 482.90 Condition of participation: Patient
planning. and living donor selection.
482.45 Condition of participation: Organ, tis- 482.92 Condition of participation: Organ re-
sue, and eye procurement. covery and receipt.
482.94 Condition of participation: Patient
Subpart D—Optional Hospital Services and living donor management.
482.96 Condition of participation: Quality
482.51 Condition of participation: Surgical assessment and performance improve-
services. ment (QAPI).
482.52 Condition of participation: Anes- 482.98 Condition of participation: Human re-
thesia services. sources.
482.53 Condition of participation: Nuclear 482.100 Condition of participation: Organ
medicine services. procurement.
482.54 Condition of participation: Out- 482.102 Condition of participation: Patient
patient services. and living donor rights.
5
§ 482.1 42 CFR Ch. IV (10–1–24 Edition)
482.104 Condition of participation: Addi- preting those provisions specify that
tional requirements for kidney trans- hospitals receiving payment under
plant programs. Medicaid must meet the requirements
AUTHORITY: 42 U.S.C. 1302, 1395hh, and for participation in Medicare (except in
1395rr, unless otherwise noted. the case of medical supervision of
SOURCE: 51 FR 22042, June 17, 1986, unless nurse-midwife services. See §§ 440.10 and
otherwise noted. 440.165 of this chapter.).
(b) Scope. Except as provided in sub-
Subpart A—General Provisions part A of part 488 of this chapter, the
provisions of this part serve as the
§ 482.1 Basis and scope. basis of survey activities for the pur-
(a) Statutory basis. (1) Section 1861(e) pose of determining whether a hospital
of the Act provides that— qualifies for a provider agreement
(i) Hospitals participating in Medi- under Medicare and Medicaid.
care must meet certain specified re- [51 FR 22042, June 17, 1986, as amended at 60
quirements; and FR 50442, Sept. 29, 1995]
(ii) The Secretary may impose addi-
tional requirements if they are found § 482.2 Provision of emergency serv-
necessary in the interest of the health ices by nonparticipating hospitals.
and safety of the individuals who are
(a) The services of an institution that
furnished services in hospitals.
does not have an agreement to partici-
(2) Section 1861(f) of the Act provides
pate in the Medicare program may,
that an institution participating in
Medicare as a psychiatric hospital nevertheless, be reimbursed under the
must meet certain specified require- program if—
ments imposed on hospitals under sec- (1) The services are emergency serv-
tion 1861(e), must be primarily engaged ices; and
in providing, by or under the super- (2) The institution meets the require-
vision of a physician, psychiatric serv- ments of section 1861(e) (1) through (5)
ices for the diagnosis and treatment of and (7) of the Act. Rules applicable to
mentally ill persons, must maintain emergency services furnished by non-
clinical records and other records that participating hospitals are set forth in
the Secretary finds necessary, and subpart G of part 424 of this chapter.
must meet staffing requirements that (b) Section 440.170(e) of this chapter
the Secretary finds necessary to carry defines emergency hospital services for
out an active program of treatment for purposes of Medicaid reimbursement.
individuals who are furnished services [51 FR 22042, June 17, 1986, as amended at 53
in the hospital. A distinct part of an FR 6648, Mar. 2, 1988]
institution can participate as a psy-
chiatric hospital if the institution
meets the specified 1861(e) require- Subpart B—Administration
ments and is primarily engaged in pro- § 482.11 Condition of participation:
viding psychiatric services, and if the Compliance with Federal, State and
distinct part meets the records and local laws.
staffing requirements that the Sec-
retary finds necessary. (a) The hospital must be in compli-
(3) Sections 1861(k) and 1902(a)(30) of ance with applicable Federal laws re-
the Act provide that hospitals partici- lated to the health and safety of pa-
pating in Medicare and Medicaid must tients.
have a utilization review plan that (b) The hospital must be—
meets specified requirements. (1) Licensed; or
(4) Section 1883 of the Act sets forth (2) Approved as meeting standards for
the requirements for hospitals that licensing established by the agency of
provide long term care under an agree- the State or locality responsible for li-
ment with the Secretary. censing hospitals.
(5) Section 1905(a) of the Act provides (c) The hospital must assure that
that ‘‘medical assistance’’ (Medicaid) personnel are licensed or meet other
payments may be applied to various applicable standards that are required
hospital services. Regulations inter- by State or local laws.
6
Centers for Medicare & Medicaid Services, HHS § 482.12
§ 482.12 Condition of participation: (9) Ensure that when telemedicine

Governing body. services are furnished to the hospital’s
There must be an effective governing patients through an agreement with a
body that is legally responsible for the distant-site telemedicine entity, the
conduct of the hospital. If a hospital written agreement specifies that the
does not have an organized governing distant-site telemedicine entity is a
body, the persons legally responsible contractor of services to the hospital
for the conduct of the hospital must and as such, in accordance with
carry out the functions specified in § 482.12(e), furnishes the contracted
this part that pertain to the governing services in a manner that permits the
body. hospital to comply with all applicable
(a) Standard: Medical staff. The gov- conditions of participation for the con-
erning body must: tracted services, including, but not
(1) Determine, in accordance with limited to, the requirements in para-
State law, which categories of practi- graphs (a)(1) through (a)(7) of this sec-
tioners are eligible candidates for ap- tion with regard to the distant-site
pointment to the medical staff; telemedicine entity’s physicians and
(2) Appoint members of the medical practitioners providing telemedicine
staff after considering the rec- services. The governing body of the
ommendations of the existing members hospital whose patients are receiving
of the medical staff; the telemedicine services may, in ac-
(3) Assure that the medical staff has cordance with § 482.22(a)(4) of this part,
bylaws; grant privileges to physicians and prac-
(4) Approve medical staff bylaws and titioners employed by the distant-site
other medical staff rules and regula- telemedicine entity based on such hos-
tions; pital’s medical staff recommendations;
(5) Ensure that the medical staff is such staff recommendations may rely
accountable to the governing body for on information provided by the dis-
the quality of care provided to pa- tant-site telemedicine entity.
tients; (10) Consult directly with the indi-
(6) Ensure the criteria for selection vidual assigned the responsibility for
are individual character, competence, the organization and conduct of the
training, experience, and judgment; hospital’s medical staff, or his or her
and
designee. At a minimum, this direct
(7) Ensure that under no cir-
consultation must occur periodically
cumstances is the accordance of staff
throughout the fiscal or calendar year
membership or professional privileges
and include discussion of matters re-
in the hospital dependent solely upon
lated to the quality of medical care
certification, fellowship, or member-
provided to patients of the hospital.
ship in a specialty body or society.
(8) Ensure that, when telemedicine For a multi-hospital system using a
services are furnished to the hospital’s single governing body, the single
patients through an agreement with a multi-hospital system governing body
distant-site hospital, the agreement is must consult directly with the indi-
written and that it specifies that it is vidual responsible for the organized
the responsibility of the governing medical staff (or his or her designee) of
body of the distant-site hospital to each hospital within its system in addi-
meet the requirements in paragraphs tion to the other requirements of this
(a)(1) through (a)(7) of this section with paragraph (a).
regard to the distant-site hospital’s (b) Standard: Chief executive officer.
physicians and practitioners providing The governing body must appoint a
telemedicine services. The governing chief executive officer who is respon-
body of the hospital whose patients are sible for managing the hospital.
receiving the telemedicine services (c) Standard: Care of patients. In ac-
may, in accordance with § 482.22(a)(3) of cordance with hospital policy, the gov-
this part, grant privileges based on its erning body must ensure that the fol-
medical staff recommendations that lowing requirements are met:
rely on information provided by the (1) Every Medicare patient is under
distant-site hospital. the care of:
7
§ 482.12 42 CFR Ch. IV (10–1–24 Edition)
(i) A doctor of medicine or osteop- (C) Limited, under paragraph (c)(1)(v)

athy (This provision is not to be con- of this section, with respect to chiro-
strued to limit the authority of a doc- practors.
tor of medicine or osteopathy to dele- (d) Standard: Institutional plan and
gate tasks to other qualified health budget. The institution must have an
care personnel to the extent recognized overall institutional plan that meets
under State law or a State’s regulatory the following conditions:
mechanism.); (1) The plan must include an annual
(ii) A doctor of dental surgery or den- operating budget that is prepared ac-
tal medicine who is legally authorized cording to generally accepted account-
to practice dentistry by the State and ing principles.
who is acting within the scope of his or (2) The budget must include all an-
her license; ticipated income and expenses. This
(iii) A doctor of podiatric medicine, provision does not require that the
but only with respect to functions budget identify item by item the com-
which he or she is legally authorized by ponents of each anticipated income or
the State to perform; expense.
(iv) A doctor of optometry who is le-
(3) The plan must provide for capital
gally authorized to practice optometry
expenditures for at least a 3-year pe-
by the State in which he or she prac-
riod, including the year in which the
tices;
operating budget specified in para-
(v) A chiropractor who is licensed by
graph (d)(2) of this section is applica-
the State or legally authorized to per-
ble.
form the services of a chiropractor, but
only with respect to treatment by (4) The plan must include and iden-
means of manual manipulation of the tify in detail the objective of, and the
spine to correct a subluxation dem- anticipated sources of financing for,
onstrated by x-ray to exist; and each anticipated capital expenditure in
(vi) A clinical psychologist as defined excess of $600,000 (or a lesser amount
in § 410.71 of this chapter, but only with that is established, in accordance with
respect to clinical psychologist serv- section 1122(g)(1) of the Act, by the
ices as defined in § 410.71 of this chapter State in which the hospital is located)
and only to the extent permitted by that relates to any of the following:
State law. (i) Acquisition of land;
(2) Patients are admitted to the hos- (ii) Improvement of land, buildings,
pital only on the recommendation of a and equipment; or
licensed practitioner permitted by the (iii) The replacement, modernization,
State to admit patients to a hospital. and expansion of buildings and equip-
If a Medicare patient is admitted by a ment.
practitioner not specified in paragraph (5) The plan must be submitted for
(c)(1) of this section, that patient is review to the planning agency des-
under the care of a doctor of medicine ignated in accordance with section
or osteopathy. 1122(b) of the Act, or if an agency is not
(3) A doctor of medicine or osteop- designated, to the appropriate health
athy is on duty or on call at all times. planning agency in the State. (See part
(4) A doctor of medicine or osteop- 100 of this title.) A capital expenditure
athy is responsible for the care of each is not subject to section 1122 review if
Medicare patient with respect to any 75 percent of the health care facility’s
medical or psychiatric problem that— patients who are expected to use the
(i) is present on admission or devel- service for which the capital expendi-
ops during hospitalization; and ture is made are individuals enrolled in
(ii) Is not specifically within the a health maintenance organization
scope of practice of a doctor of dental (HMO) or competitive medical plan
surgery, dental medicine, podiatric (CMP) that meets the requirements of
medicine, or optometry; a chiro- section 1876(b) of the Act, and if the
practor; or clinical psychologist, as Department determines that the cap-
that scope is— ital expenditure is for services and fa-
(A) Defined by the medical staff; cilities that are needed by the HMO or
(B) Permitted by State law; and CMP in order to operate efficiently and
8
economically and that are not other- one or more off-campus departments of
wise readily accessible to the HMO or the hospital, the governing body of the
CMP because— hospital must assure that the medical
(i) The facilities do not provide com- staff has written policies and proce-
mon services at the same site; dures in effect with respect to the off-
(ii) The facilities are not available campus department(s) for appraisal of
under a contract of reasonable dura- emergencies and referral when appro-
tion; priate.
(iii) Full and equal medical staff [51 FR 22042, June 17, 1986; 51 FR 27847, Aug.
privileges in the facilities are not 4, 1986, as amended at 53 FR 6549, Mar. 1, 1988;
available; 53 FR 18987, May 26, 1988; 56 FR 8852, Mar. 1,
(iv) Arrangements with these facili- 1991; 56 FR 23022, May 20, 1991; 59 FR 46514,
ties are not administratively feasible; Sept. 8, 1994; 63 FR 20130, Apr. 23, 1998; 63 FR
or 33874, June 22, 1998; 68 FR 53262, Sept. 9, 2003;
(v) The purchase of these services is 76 FR 25562, May 5, 2011; 77 FR 29074, May 16,
2012; 79 FR 27154, May 12, 2014]
more costly than if the HMO or CMP
provided the services directly. § 482.13 Condition of participation: Pa-
(6) The plan must be reviewed and up- tient’s rights.
dated annually. A hospital must protect and promote
(7) The plan must be prepared— each patient’s rights.
(i) Under the direction of the gov- (a) Standard: Notice of rights. (1) A
erning body; and hospital must inform each patient, or
(ii) By a committee consisting of rep- when appropriate, the patient’s rep-
resentatives of the governing body, the resentative (as allowed under State
administrative staff, and the medical law), of the patient’s rights, in advance
staff of the institution. of furnishing or discontinuing patient
(e) Standard: Contracted services. The care whenever possible.
governing body must be responsible for (2) The hospital must establish a
services furnished in the hospital process for prompt resolution of pa-
whether or not they are furnished tient grievances and must inform each
under contracts. The governing body patient whom to contact to file a griev-
must ensure that a contractor of serv- ance. The hospital’s governing body
ices (including one for shared services must approve and be responsible for
and joint ventures) furnishes services the effective operation of the grievance
that permit the hospital to comply process and must review and resolve
with all applicable conditions of par- grievances, unless it delegates the re-
ticipation and standards for the con- sponsibility in writing to a grievance
tracted services. committee. The grievance process
(1) The governing body must ensure must include a mechanism for timely
that the services performed under a referral of patient concerns regarding
contract are provided in a safe and ef- quality of care or premature discharge
fective manner. to the appropriate Utilization and
(2) The hospital must maintain a list Quality Control Quality Improvement
of all contracted services, including Organization. At a minimum:
the scope and nature of the services (i) The hospital must establish a
provided. clearly explained procedure for the
(f) Standard: Emergency services. (1) If submission of a patient’s written or
emergency services are provided at the verbal grievance to the hospital.
hospital, the hospital must comply (ii) The grievance process must speci-
with the requirements of § 482.55. fy time frames for review of the griev-
(2) If emergency services are not pro- ance and the provision of a response.
vided at the hospital, the governing (iii) In its resolution of the griev-
body must assure that the medical ance, the hospital must provide the pa-
staff has written policies and proce- tient with written notice of its decision
dures for appraisal of emergencies, ini- that contains the name of the hospital
tial treatment, and referral when ap- contact person, the steps taken on be-
propriate. half of the patient to investigate the
(3) If emergency services are provided grievance, the results of the grievance
at the hospital but are not provided at process, and the date of completion.
9
§ 482.13 42 CFR Ch. IV (10–1–24 Edition)
(b) Standard: Exercise of rights. (1) The and must actively seek to meet these
patient has the right to participate in requests as quickly as its record keep-
the development and implementation ing system permits.
of his or her plan of care. (e) Standard: Restraint or seclusion. All
(2) The patient or his or her rep- patients have the right to be free from
resentative (as allowed under State physical or mental abuse, and corporal
law) has the right to make informed punishment. All patients have the
decisions regarding his or her care. The right to be free from restraint or seclu-
patient’s rights include being informed sion, of any form, imposed as a means
of his or her health status, being in- of coercion, discipline, convenience, or
volved in care planning and treatment, retaliation by staff. Restraint or seclu-
and being able to request or refuse sion may only be imposed to ensure the
treatment. This right must not be con- immediate physical safety of the pa-
strued as a mechanism to demand the tient, a staff member, or others and
provision of treatment or services must be discontinued at the earliest
deemed medically unnecessary or inap- possible time.
propriate. (1) Definitions. (i) A restraint is—
(3) The patient has the right to for- (A) Any manual method, physical or
mulate advance directives and to have mechanical device, material, or equip-
hospital staff and practitioners who ment that immobilizes or reduces the
provide care in the hospital comply ability of a patient to move his or her
with these directives, in accordance arms, legs, body, or head freely; or
with § 489.100 of this part (Definition), (B) A drug or medication when it is
§ 489.102 of this part (Requirements for used as a restriction to manage the pa-
providers), and § 489.104 of this part (Ef- tient’s behavior or restrict the pa-
fective dates). tient’s freedom of movement and is not
(4) The patient has the right to have a standard treatment or dosage for the
a family member or representative of patient’s condition.
his or her choice and his or her own (C) A restraint does not include de-
physician notified promptly of his or vices, such as orthopedically prescribed
her admission to the hospital. devices, surgical dressings or bandages,
(c) Standard: Privacy and safety. (1) protective helmets, or other methods
The patient has the right to personal that involve the physical holding of a
privacy. patient for the purpose of conducting
(2) The patient has the right to re- routine physical examinations or tests,
ceive care in a safe setting. or to protect the patient from falling
(3) The patient has the right to be out of bed, or to permit the patient to
free from all forms of abuse or harass- participate in activities without the
ment. risk of physical harm (this does not in-
(d) Standard: Confidentiality of patient clude a physical escort).
records. (1) The patient has the right to (ii) Seclusion is the involuntary con-
the confidentiality of his or her clin- finement of a patient alone in a room
ical records. or area from which the patient is phys-
(2) The patient has the right to ac- ically prevented from leaving. Seclu-
cess their medical records, including sion may only be used for the manage-
current medical records, upon an oral ment of violent or self-destructive be-
or written request, in the form and for- havior.
mat requested by the individual, if it is (2) Restraint or seclusion may only
readily producible in such form and be used when less restrictive interven-
format (including in an electronic form tions have been determined to be inef-
or format when such medical records fective to protect the patient a staff
are maintained electronically); or, if member or others from harm.
not, in a readable hard copy form or (3) The type or technique of restraint
such other form and format as agreed or seclusion used must be the least re-
to by the facility and the individual, strictive intervention that will be ef-
and within a reasonable time frame. fective to protect the patient, a staff
The hospital must not frustrate the le- member, or others from harm.
gitimate efforts of individuals to gain (4) The use of restraint or seclusion
access to their own medical records must be—
10
(i) In accordance with a written (10) The condition of the patient who
modification to the patient’s plan of is restrained or secluded must be mon-
care; and itored by a physician, other licensed
(ii) Implemented in accordance with practitioner, or trained staff that have
safe and appropriate restraint and se- completed the training criteria speci-
clusion techniques as determined by fied in paragraph (f) of this section at
hospital policy in accordance with an interval determined by hospital pol-
State law. icy.
(5) The use of restraint or seclusion (11) Physician and other licensed
must be in accordance with the order practitioner training requirements
of a physician or other licensed practi- must be specified in hospital policy. At
tioner who is responsible for the care of a minimum, physicians and other li-
the patient and authorized to order re- censed practitioners authorized to
straint or seclusion by hospital policy order restraint or seclusion by hospital
in accordance with State law.
policy in accordance with State law
(6) Orders for the use of restraint or
must have a working knowledge of hos-
seclusion must never be written as a
pital policy regarding the use of re-
standing order or on an as needed basis
straint or seclusion.
(PRN).
(12) When restraint or seclusion is
(7) The attending physician must be
consulted as soon as possible if the at- used for the management of violent or
tending physician did not order the re- self-destructive behavior that jeopard-
straint or seclusion. izes the immediate physical safety of
(8) Unless superseded by State law the patient, a staff member, or others,
that is more restrictive— the patient must be seen face-to-face
(i) Each order for restraint or seclu- within 1 hour after the initiation of the
sion used for the management of vio- intervention—
lent or self-destructive behavior that (i) By a—
jeopardizes the immediate physical (A) Physician or other licensed prac-
safety of the patient, a staff member, titioner.
or others may only be renewed in ac- (B) Registered nurse who has been
cordance with the following limits for trained in accordance with the require-
up to a total of 24 hours: ments specified in paragraph (f) of this
(A) 4 hours for adults 18 years of age section.
or older; (ii) To evaluate—
(B) 2 hours for children and adoles- (A) The patient’s immediate situa-
cents 9 to 17 years of age; or tion;
(C) 1 hour for children under 9 years (B) The patient’s reaction to the
of age; and intervention;
(ii) After 24 hours, before writing a (C) The patient’s medical and behav-
new order for the use of restraint or se- ioral condition; and
clusion for the management of violent (D) The need to continue or termi-
or self-destructive behavior, a physi- nate the restraint or seclusion.
cian or other licensed practitioner who
(13) States are free to have require-
is responsible for the care of the pa-
ments by statute or regulation that are
tient and authorized to order restraint
or seclusion by hospital policy in ac- more restrictive than those contained
cordance with State law must see and in paragraph (e)(12)(i) of this section.
assess the patient. (14) If the face-to-face evaluation
(iii) Each order for restraint used to specified in paragraph (e)(12) of this
ensure the physical safety of the non- section is conducted by a trained reg-
violent or non-self-destructive patient istered nurse, the trained registered
may be renewed as authorized by hos- nurse must consult the attending phy-
pital policy. sician or other licensed practitioner
(9) Restraint or seclusion must be who is responsible for the care of the
discontinued at the earliest possible patient as soon as possible after the
time, regardless of the length of time completion of the 1-hour face-to-face
identified in the order. evaluation.
11
§ 482.13 42 CFR Ch. IV (10–1–24 Edition)
(15) All requirements specified under (ii) The use of nonphysical interven-
this paragraph are applicable to the sition skills.
multaneous use of restraint and seclu- (iii) Choosing the least restrictive
sion. Simultaneous restraint and seclu- intervention based on an individualized
sion use is only permitted if the pa- assessment of the patient’s medical, or
tient is continually monitored— behavioral status or condition.
(i) Face-to-face by an assigned, (iv) The safe application and use of
trained staff member; or all types of restraint or seclusion used
(ii) By trained staff using both video in the hospital, including training in
and audio equipment. This monitoring how to recognize and respond to signs
must be in close proximity to the pa- of physical and psychological distress
tient. (for example, positional asphyxia);
(16) When restraint or seclusion is (v) Clinical identification of specific
used, there must be documentation in behavioral changes that indicate that
the patient’s medical record of the fol- restraint or seclusion is no longer nec-
lowing: essary.
(i) The 1-hour face-to-face medical (vi) Monitoring the physical and psy-
and behavioral evaluation if restraint chological well-being of the patient
or seclusion is used to manage violent who is restrained or secluded, including
or self-destructive behavior; but not limited to, respiratory and cir-
(ii) A description of the patient’s be- culatory status, skin integrity, vital
havior and the intervention used; signs, and any special requirements
(iii) Alternatives or other less re- specified by hospital policy associated
strictive interventions attempted (as with the 1-hour face-to-face evaluation.
applicable); (vii) The use of first aid techniques
(iv) The patient’s condition or symp- and certification in the use of
tom(s) that warranted the use of the cardiopulmonary resuscitation, includ-
restraint or seclusion; and ing required periodic recertification.
(v) The patient’s response to the
(3) Trainer requirements. Individuals
intervention(s) used, including the ra-
providing staff training must be quali-
tionale for continued use of the inter-
fied as evidenced by education, train-
vention.
ing, and experience in techniques used
(f) Standard: Restraint or seclusion:
to address patients’ behaviors.
Staff training requirements. The patient
has the right to safe implementation of (4) Training documentation. The hos-
restraint or seclusion by trained staff. pital must document in the staff per-
(1) Training intervals. Staff must be sonnel records that the training and
trained and able to demonstrate com- demonstration of competency were suc-
petency in the application of re- cessfully completed.
straints, implementation of seclusion, (g) Standard: Death reporting require-
monitoring, assessment, and providing ments: Hospitals must report deaths as-
care for a patient in restraint or seclu- sociated with the use of seclusion or re-
sion— straint.
(i) Before performing any of the ac- (1) With the exception of deaths de-
tions specified in this paragraph; scribed under paragraph (g)(2) of this
(ii) As part of orientation; and section, the hospital must report the
(iii) Subsequently on a periodic basis following information to CMS by tele-
consistent with hospital policy. phone, facsimile, or electronically, as
(2) Training content. The hospital determined by CMS, no later than the
must require appropriate staff to have close of business on the next business
education, training, and demonstrated day following knowledge of the pa-
knowledge based on the specific needs tient’s death:
of the patient population in at least (i) Each death that occurs while a pa-
the following: tient is in restraint or seclusion.
(i) Techniques to identify staff and (ii) Each death that occurs within 24
patient behaviors, events, and environ- hours after the patient has been re-
mental factors that may trigger cir- moved from restraint or seclusion.
cumstances that require the use of a (iii) Each death known to the hos-
restraint or seclusion. pital that occurs within 1 week after
12
restraint or seclusion where it is rea- that the hospital may need to place on
sonable to assume that use of restraint such rights and the reasons for the
or placement in seclusion contributed clinical restriction or limitation. A
directly or indirectly to a patient’s hospital must meet the following re-
death, regardless of the type(s) of requirements:
straint used on the patient during this (1) Inform each patient (or support
time. ‘‘Reasonable to assume’’ in this person, where appropriate) of his or her
context includes, but is not limited to, visitation rights, including any clinical
deaths related to restrictions of move- restriction or limitation on such
ment for prolonged periods of time, or rights, when he or she is informed of
death related to chest compression, re- his or her other rights under this sec-
striction of breathing, or asphyxiation. tion.
(2) When no seclusion has been used (2) Inform each patient (or support
and when the only restraints used on person, where appropriate) of the right,
the patient are those applied exclu- subject to his or her consent, to receive
sively to the patient’s wrist(s), and the visitors whom he or she designates,
which are composed solely of soft, non- including, but not limited to, a spouse,
rigid, cloth-like materials, the hospital a domestic partner (including a same-
staff must record in an internal log or sex domestic partner), another family
other system, the following informa- member, or a friend, and his or her
tion: right to withdraw or deny such consent
(i) Any death that occurs while a pa- at any time.
tient is in such restraints. (3) Not restrict, limit, or otherwise
(ii) Any death that occurs within 24 deny visitation privileges on the basis
hours after a patient has been removed of race, color, national origin, religion,
from such restraints. sex, gender identity, sexual orienta-
(3) The staff must document in the tion, or disability.
patient’s medical record the date and (4) Ensure that all visitors enjoy full
time the death was: and equal visitation privileges con-
(i) Reported to CMS for deaths de- sistent with patient preferences.
scribed in paragraph (g)(1) of this sec- [71 FR 71426, Dec. 8, 2006, as amended at 75
tion; or FR 70844, Nov. 19, 2010; 77 FR 29074, May 16,
(ii) Recorded in the internal log or 2012; 84 FR 51817, 51882, Sept. 30, 2019]
other system for deaths described in
paragraph (g)(2) of this section. § 482.15 Condition of participation:
(4) For deaths described in paragraph Emergency preparedness.
(g)(2) of this section, entries into the The hospital must comply with all
internal log or other system must be applicable Federal, State, and local
documented as follows: emergency preparedness requirements.
(i) Each entry must be made not The hospital must develop and main-
later than seven days after the date of tain a comprehensive emergency pre-
death of the patient. paredness program that meets the re-
(ii) Each entry must document the quirements of this section, utilizing an
patient’s name, date of birth, date of all-hazards approach. The emergency
death, name of attending physician or preparedness program must include,
other licensed practitioner who is re- but not be limited to, the following ele-
sponsible for the care of the patient, ments:
medical record number, and primary (a) Emergency plan. The hospital must
diagnosis(es). develop and maintain an emergency
(iii) The information must be made preparedness plan that must be re-
available in either written or elec- viewed, and updated at least every 2
tronic form to CMS immediately upon years. The plan must do the following:
request. (1) Be based on and include a docu-
(h) Standard: Patient visitation rights. mented, facility-based and community-
A hospital must have written policies based risk assessment, utilizing an all-
and procedures regarding the visitation hazards approach.
rights of patients, including those set- (2) Include strategies for addressing
ting forth any clinically necessary or emergency events identified by the
reasonable restriction or limitation risk assessment.
13
§ 482.15 42 CFR Ch. IV (10–1–24 Edition)
(3) Address patient population, in- (4) A means to shelter in place for pa-
cluding, but not limited to, persons at- tients, staff, and volunteers who re-
risk; the type of services the hospital main in the facility.
has the ability to provide in an emer- (5) A system of medical documenta-
gency; and continuity of operations, in- tion that preserves patient informa-
cluding delegations of authority and tion, protects confidentiality of patient
succession plans. information, and secures and main-
(4) Include a process for cooperation tains the availability of records.
and collaboration with local, tribal, re- (6) The use of volunteers in an emer-
gional, State, and Federal emergency gency and other emergency staffing
preparedness officials’ efforts to main- strategies, including the process and
tain an integrated response during a role for integration of State and Feder-
disaster or emergency situation. ally designated health care profes-
(b) Policies and procedures. The hos- sionals to address surge needs during
pital must develop and implement an emergency.
emergency preparedness policies and (7) The development of arrangements
procedures, based on the emergency with other hospitals and other pro-
plan set forth in paragraph (a) of this viders to receive patients in the event
section, risk assessment at paragraph of limitations or cessation of oper-
(a)(1) of this section, and the commu- ations to maintain the continuity of
nication plan at paragraph (c) of this services to hospital patients.
section. The policies and procedures
(8) The role of the hospital under a
must be reviewed and updated at least
waiver declared by the Secretary, in
every 2 years. At a minimum, the poli-
accordance with section 1135 of the
cies and procedures must address the
Act, in the provision of care and treat-
following:
ment at an alternate care site identi-
(1) The provision of subsistence needs
fied by emergency management offi-
for staff and patients, whether they
cials.
evacuate or shelter in place, include,
but are not limited to the following: (c) Communication plan. The hospital
must develop and maintain an emer-
(i) Food, water, medical, and pharma-
gency preparedness communication
ceutical supplies.
plan that complies with Federal, State,
(ii) Alternate sources of energy to
and local laws and must be reviewed
maintain the following:
and updated at least every 2 years. The
(A) Temperatures to protect patient
communication plan must include all
health and safety and for the safe and
of the following:
sanitary storage of provisions.
(1) Names and contact information
(B) Emergency lighting.
for the following:
(C) Fire detection, extinguishing, and
(i) Staff.
alarm systems.
(ii) Entities providing services under
(D) Sewage and waste disposal.
arrangement.
(2) A system to track the location of
(iii) Patients’ physicians.
on-duty staff and sheltered patients in
(iv) Other hospitals and CAHs
the hospital’s care during an emer-
gency. If on-duty staff and sheltered (v) Volunteers.
patients are relocated during the emer- (2) Contact information for the fol-
gency, the hospital must document the lowing:
specific name and location of the re- (i) Federal, State, tribal, regional,
ceiving facility or other location. and local emergency preparedness
(3) Safe evacuation from the hospital, staff.
which includes consideration of care (ii) Other sources of assistance.
and treatment needs of evacuees; staff (3) Primary and alternate means for
responsibilities; transportation; identi- communicating with the following:
fication of evacuation location(s); and (i) Hospital’s staff.
primary and alternate means of com- (ii) Federal, State, tribal, regional,
munication with external sources of as- and local emergency management
sistance. agencies.
14
(4) A method for sharing information nual individual, facility-based func-

and medical documentation for pational exercise; or.
tients under the hospital’s care, as nec- (B) If the hospital experiences an ac-
essary, with other health care pro- tual natural or man-made emergency
viders to maintain the continuity of that requires activation of the emer-
care. gency plan, the hospital is exempt from
(5) A means, in the event of an evacu- engaging in its next required full-scale
ation, to release patient information as community-based exercise or indi-
permitted under 45 CFR 164.510(b)(1)(ii). vidual, facility-based functional exer-
(6) A means of providing information cise following the onset of the emer-
about the general condition and loca- gency event.
tion of patients under the facility’s (ii) Conduct an additional annual ex-
care as permitted under 45 CFR ercise that may include, but is not lim-
164.510(b)(4). ited to the following:
(7) A means of providing information (A) A second full-scale exercise that
about the hospital’s occupancy, needs, is community-based or an individual,
and its ability to provide assistance, to facility-based functional exercise; or
the authority having jurisdiction, the (B) A mock disaster drill; or
Incident Command Center, or designee. (C) A tabletop exercise or workshop
(d) Training and testing. The hospital that is led by a facilitator and includes
must develop and maintain an emer- a group discussion, using a narrated,
gency preparedness training and test- clinically-relevant emergency scenario,
ing program that is based on the emer- and a set of problem statements, di-
gency plan set forth in paragraph (a) of rected messages, or prepared questions
this section, risk assessment at para- designed to challenge an emergency
graph (a)(1) of this section, policies and plan.
procedures at paragraph (b) of this sec- (iii) Analyze the hospital’s response
tion, and the communication plan at to and maintain documentation of all
paragraph (c) of this section. The train- drills, tabletop exercises, and emer-
ing and testing program must be re- gency events, and revise the hospital’s
viewed and updated at least every 2 emergency plan, as needed.
years. (e) Emergency and standby power sys-
(1) Training program. The hospital tems. The hospital must implement
must do all of the following: emergency and standby power systems
(i) Initial training in emergency pre- based on the emergency plan set forth
paredness policies and procedures to all in paragraph (a) of this section and in
new and existing staff, individuals pro- the policies and procedures plan set
viding services under arrangement, and forth in paragraphs (b)(1)(i) and (ii) of
volunteers, consistent with their ex- this section.
pected role. (1) Emergency generator location. The
(ii) Provide emergency preparedness generator must be located in accord-
training at least every 2 years. ance with the location requirements
(iii) Maintain documentation of the found in the Health Care Facilities
training. Code (NFPA 99 and Tentative Interim
(iv) Demonstrate staff knowledge of Amendments TIA 12–2, TIA 12–3, TIA
emergency procedures. 12–4, TIA 12–5, and TIA 12–6), Life Safe-
(v) If the emergency preparedness ty Code (NFPA 101 and Tentative In-
policies and procedures are signifi- terim Amendments TIA 12–1, TIA 12–2,
cantly updated, the hospital must con- TIA 12–3, and TIA 12–4), and NFPA 110,
duct training on the updated policies when a new structure is built or when
and procedures. an existing structure or building is ren-
(2) Testing. The hospital must con- ovated.
duct exercises to test the emergency (2) Emergency generator inspection and
plan at least twice per year. The hos- testing. The hospital must implement
pital must do all of the following: the emergency power system inspec-
(i) Participate in an annual full-scale tion, testing, and maintenance require-
exercise that is community-based; or ments found in the Health Care Facili-
(A) When a community-based exer- ties Code, NFPA 110, and Life Safety
cise is not accessible, conduct an an- Code.
15
§ 482.15 42 CFR Ch. IV (10–1–24 Edition)
(3) Emergency generator fuel. Hospitals development and maintenance of the

that maintain an onsite fuel source to hospital’s emergency preparedness pro-
power emergency generators must have gram; and
a plan for how it will keep emergency (2) The hospital must develop and
power systems operational during the maintain mutually agreed upon proto-
emergency, unless it evacuates. cols that address the duties and respon-
(f) Integrated healthcare systems. If a sibilities of the hospital, each trans-
hospital is part of a healthcare system plant program, and the OPO for the
consisting of multiple separately cer- DSA where the hospital is situated, un-
tified healthcare facilities that elects less the hospital has been granted a
to have a unified and integrated emer- waiver to work with another OPO, dur-
gency preparedness program, the hos- ing an emergency.
pital may choose to participate in the (h) The standards incorporated by
healthcare system’s coordinated emer- reference in this section are approved
gency preparedness program. If elected, for incorporation by reference by the
the unified and integrated emergency Director of the Office of the Federal
preparedness program must— Register in accordance with 5 U.S.C.
(1) Demonstrate that each separately 552(a) and 1 CFR part 51. You may ob-
certified facility within the system ac- tain the material from the sources list-
tively participated in the development ed below. You may inspect a copy at
of the unified and integrated emer- the CMS Information Resource Center,
gency preparedness program. 7500 Security Boulevard, Baltimore,
(2) Be developed and maintained in a MD or at the National Archives and
manner that takes into account each Records Administration (NARA). For
separately certified facility’s unique information on the availability of this
circumstances, patient populations, material at NARA, call 202–741–6030, or
and services offered. go to: http://www.archives.gov/fed-
(3) Demonstrate that each separately eral_register/code_of_federal_regulations/
certified facility is capable of actively ibr_locations.html. If any changes in this
using the unified and integrated emer- edition of the Code are incorporated by
gency preparedness program and is in reference, CMS will publish a docu-
compliance with the program. ment in the FEDERAL REGISTER to an-
(4) Include a unified and integrated nounce the changes.
emergency plan that meets the require- (1) National Fire Protection Associa-
ments of paragraphs (a)(2), (3), and (4) tion, 1 Batterymarch Park, Quincy,
of this section. The unified and inte- MA 02169, www.nfpa.org, 1.617.770.3000.
grated emergency plan must also be (i) NFPA 99, Health Care Facilities
based on and include the following: Code, 2012 edition, issued August 11,
(i) A documented community-based 2011.
risk assessment, utilizing an all-haz- (ii) Technical interim amendment
ards approach. (TIA) 12–2 to NFPA 99, issued August
(ii) A documented individual facility- 11, 2011.
based risk assessment for each sepa-
(iii) TIA 12–3 to NFPA 99, issued Au-
rately certified facility within the
gust 9, 2012.
health system, utilizing an all-hazards
(iv) TIA 12–4 to NFPA 99, issued
approach.
March 7, 2013.
(5) Include integrated policies and
procedures that meet the requirements (v) TIA 12–5 to NFPA 99, issued Au-
set forth in paragraph (b) of this sec- gust 1, 2013.
tion, a coordinated communication (vi) TIA 12–6 to NFPA 99, issued
plan and training and testing programs March 3, 2014.
that meet the requirements of para- (vii) NFPA 101, Life Safety Code, 2012
graphs (c) and (d) of this section, re- edition, issued August 11, 2011.
spectively. (viii) TIA 12–1 to NFPA 101, issued
(g) Transplant hospitals. If a hospital August 11, 2011.
has one or more transplant programs (ix) TIA 12–2 to NFPA 101, issued Oc-
(as defined in § 482.70)— tober 30, 2012.
(1) A representative from each trans- (x) TIA 12–3 to NFPA 101, issued Oc-
plant program must be included in the tober 22, 2013.
16
(xi) TIA 12–4 to NFPA 101, issued Oc- (i) Monitor the effectiveness and
tober 22, 2013. safety of services and quality of care;
(xii) NFPA 110, Standard for Emer- and
gency and Standby Power Systems, (ii) Identify opportunities for im-
2010 edition, including TIAs to chapter provement and changes that will lead
7, issued August 6, 2009. to improvement.
(2) [Reserved] (3) The frequency and detail of data
[81 FR 64028, Sept. 16, 2016; 81 FR 80594, Nov.
collection must be specified by the hos-
16, 2016; 84 FR 51817, Sept. 30, 2019] pital’s governing body.
(c) Standard: Program activities. (1)
The hospital must set priorities for its
Subpart C—Basic Hospital performance improvement activities
Functions that—
§ 482.21 Condition of participation: (i) Focus on high-risk, high-volume,
Quality assessment and perform- or problem-prone areas;
ance improvement program. (ii) Consider the incidence, preva-
The hospital must develop, imple- lence, and severity of problems in those
ment, and maintain an effective, ongo- areas; and
ing, hospital-wide, data-driven quality (iii) Affect health outcomes, patient
assessment and performance improve- safety, and quality of care.
ment program. The hospital’s gov- (2) Performance improvement activi-
erning body must ensure that the pro- ties must track medical errors and ad-
gram reflects the complexity of the verse patient events, analyze their
hospital’s organization and services; causes, and implement preventive ac-
involves all hospital departments and tions and mechanisms that include
services (including those services fur- feedback and learning throughout the
nished under contract or arrangement); hospital.
and focuses on indicators related to im- (3) The hospital must take actions
proved health outcomes and the pre- aimed at performance improvement
vention and reduction of medical er- and, after implementing those actions,
rors. The hospital must maintain and the hospital must measure its success,
demonstrate evidence of its QAPI pro- and track performance to ensure that
gram for review by CMS. improvements are sustained.
(a) Standard: Program scope. (1) The (d) Standard: Performance improvement
program must include, but not be lim- projects. As part of its quality assess-
ited to, an ongoing program that shows ment and performance improvement
measurable improvement in indicators program, the hospital must conduct
for which there is evidence that it will performance improvement projects.
improve health outcomes and identify (1) The number and scope of distinct
and reduce medical errors. improvement projects conducted annu-
(2) The hospital must measure, ana- ally must be proportional to the scope
lyze, and track quality indicators, in- and complexity of the hospital’s serv-
cluding adverse patient events, and ices and operations.
other aspects of performance that as- (2) A hospital may, as one of its
sess processes of care, hospital service projects, develop and implement an in-
and operations. formation technology system explic-
(b) Standard: Program data. (1) The itly designed to improve patient safety
program must incorporate quality indi- and quality of care. This project, in its
cator data including patient care data, initial stage of development, does not
and other relevant data such as data need to demonstrate measurable im-
submitted to or received from Medicare provement in indicators related to
quality reporting and quality perform- health outcomes.
ance programs, including but not lim- (3) The hospital must document what
ited to data related to hospital re- quality improvement projects are
admissions and hospital-acquired con- being conducted, the reasons for con-
ditions. ducting these projects, and the measur-
(2) The hospital must use the data able progress achieved on these
collected to— projects.
17
§ 482.22 42 CFR Ch. IV (10–1–24 Edition)
(4) A hospital is not required to par- (2) The unified and integrated QAPI
ticipate in a QIO cooperative project, program establishes and implements
but its own projects are required to be policies and procedures to ensure that
of comparable effort. the needs and concerns of each of its
(e) Standard: Executive responsibilities. separately certified hospitals, regard-
The hospital’s governing body (or orga- less of practice or location, are given
nized group or individual who assumes due consideration, and that the unified
full legal authority and responsibility and integrated QAPI program has
for operations of the hospital), medical mechanisms in place to ensure that
staff, and administrative officials are issues localized to particular hospitals
responsible and accountable for ensur- are duly considered and addressed.
ing the following: [68 FR 3454, Jan. 24, 2003, as amended at 84
(1) That an ongoing program for qual- FR 51818, Sept. 30, 2019]
ity improvement and patient safety,
including the reduction of medical er- § 482.22 Condition of participation:
rors, is defined, implemented, and Medical staff.
maintained. The hospital must have an organized
(2) That the hospital-wide quality as- medical staff that operates under by-
sessment and performance improve- laws approved by the governing body,
ment efforts address priorities for im- and which is responsible for the quality
proved quality of care and patient safe- of medical care provided to patients by
ty; and that all improvement actions the hospital.
are evaluated. (a) Standard: Eligibility and process for
(3) That clear expectations for safety appointment to medical staff. The med-
are established. ical staff must be composed of doctors
(4) That adequate resources are allo- of medicine or osteopathy. In accord-
cated for measuring, assessing, improv- ance with State law, including scope-
ing, and sustaining the hospital’s per- of-practice laws, the medical staff may
formance and reducing risk to patients. also include other categories of physi-
(5) That the determination of the cians (as listed at § 482.12(c)(1)) and
number of distinct improvement non-physician practitioners who are
projects is conducted annually. determined to be eligible for appoint-
(f) Standard: Unified and integrated ment by the governing body.
QAPI program for multi-hospital systems. (1) The medical staff must periodi-
If a hospital is part of a hospital sys- cally conduct appraisals of its mem-
tem consisting of multiple separately bers.
certified hospitals using a system gov- (2) The medical staff must examine
erning body that is legally responsible the credentials of all eligible can-
for the conduct of two or more hos- didates for medical staff membership
pitals, the system governing body can and make recommendations to the gov-
elect to have a unified and integrated erning body on the appointment of
QAPI program for all of its member these candidates in accordance with
hospitals after determining that such a State law, including scope-of-practice
decision is in accordance with all appli- laws, and the medical staff bylaws,
cable State and local laws. The system rules, and regulations. A candidate who
governing body is responsible and ac- has been recommended by the medical
countable for ensuring that each of its staff and who has been appointed by
separately certified hospitals meets all the governing body is subject to all
of the requirements of this section. medical staff bylaws, rules, and regula-
Each separately certified hospital sub- tions, in addition to the requirements
ject to the system governing body contained in this section.
must demonstrate that: (3) When telemedicine services are
(1) The unified and integrated QAPI furnished to the hospital’s patients
program is established in a manner through an agreement with a distant-
that takes into account each member site hospital, the governing body of the
hospital’s unique circumstances and hospital whose patients are receiving
any significant differences in patient the telemedicine services may choose,
populations and services offered in in lieu of the requirements in para-
each hospital; and graphs (a)(1) and (a)(2) of this section,
18
to have its medical staff rely upon the ommendations on privileges for the in-
credentialing and privileging decisions dividual distant-site physicians and
made by the distant-site hospital when practitioners providing such services, if
making recommendations on privileges the hospital’s governing body ensures,
for the individual distant-site physi- through its written agreement with the
cians and practitioners providing such distant-site telemedicine entity, that
services, if the hospital’s governing the distant-site telemedicine entity
body ensures, through its written furnishes services that, in accordance
agreement with the distant-site hos- with § 482.12(e), permit the hospital to
pital, that all of the following provi- comply with all applicable conditions
sions are met: of participation for the contracted
(i) The distant-site hospital providing services. The hospital’s governing body
the telemedicine services is a Medi- must also ensure, through its written
care-participating hospital. agreement with the distant-site tele-
(ii) The individual distant-site physi- medicine entity, that all of the fol-
cian or practitioner is privileged at the lowing provisions are met:
distant-site hospital providing the tele- (i) The distant-site telemedicine enti-
medicine services, which provides a ty’s medical staff credentialing and
current list of the distant-site physi- privileging process and standards at
cian’s or practitioner’s privileges at least meet the standards at § 482.12(a)(1)
the distant-site hospital. through (a)(7) and § 482.22(a)(1) through
(iii) The individual distant-site phy- (a)(2).
sician or practitioner holds a license (ii) The individual distant-site physi-
issued or recognized by the State in cian or practitioner is privileged at the
which the hospital whose patients are distant-site telemedicine entity pro-
receiving the telemedicine services is viding the telemedicine services, which
located. provides the hospital with a current
(iv) With respect to a distant-site
list of the distant-site physician’s or
physician or practitioner, who holds
practitioner’s privileges at the distant-
current privileges at the hospital
site telemedicine entity.
whose patients are receiving the tele-
medicine services, the hospital has evi- (iii) The individual distant-site phy-
dence of an internal review of the dis- sician or practitioner holds a license
tant-site physician’s or practitioner’s issued or recognized by the State in
performance of these privileges and which the hospital whose patients are
sends the distant-site hospital such receiving such telemedicine services is
performance information for use in the located.
periodic appraisal of the distant-site (iv) With respect to a distant-site
physician or practitioner. At a min- physician or practitioner, who holds
imum, this information must include current privileges at the hospital
all adverse events that result from the whose patients are receiving the tele-
telemedicine services provided by the medicine services, the hospital has evi-
distant-site physician or practitioner dence of an internal review of the dis-
to the hospital’s patients and all com- tant-site physician’s or practitioner’s
plaints the hospital has received about performance of these privileges and
the distant-site physician or practi- sends the distant-site telemedicine en-
tioner. tity such performance information for
(4) When telemedicine services are use in the periodic appraisal of the dis-
furnished to the hospital’s patients tant-site physician or practitioner. At
through an agreement with a distant- a minimum, this information must in-
site telemedicine entity, the governing clude all adverse events that result
body of the hospital whose patients are from the telemedicine services pro-
receiving the telemedicine services vided by the distant-site physician or
may choose, in lieu of the requirements practitioner to the hospital’s patients,
in paragraphs (a)(1) and (a)(2) of this and all complaints the hospital has re-
section, to have its medical staff rely ceived about the distant-site physician
upon the credentialing and privileging or practitioner.
decisions made by the distant-site tele- (b) Standard: Medical staff organiza-
medicine entity when making rection and accountability. The medical
19
§ 482.22 42 CFR Ch. IV (10–1–24 Edition)
staff must be well organized and ac- medical staff structure after a major-
countable to the governing body for ity vote by the members to maintain a
the quality of the medical care pro- separate and distinct medical staff for
vided to patients. their hospital;
(1) The medical staff must be orga- (iii) The unified and integrated med-
nized in a manner approved by the gov- ical staff is established in a manner
erning body. that takes into account each member
(2) If the medical staff has an execu- hospital’s unique circumstances and
tive committee, a majority of the any significant differences in patient
members of the committee must be populations and services offered in
doctors of medicine or osteopathy. each hospital; and
(3) The responsibility for organiza- (iv) The unified and integrated med-
tion and conduct of the medical staff ical staff establishes and implements
must be assigned only to one of the fol- policies and procedures to ensure that
lowing: the needs and concerns expressed by
(i) An individual doctor of medicine members of the medical staff, at each
or osteopathy. of its separately certified hospitals, re-
(ii) A doctor of dental surgery or den- gardless of practice or location, are
tal medicine, when permitted by State given due consideration, and that the
law of the State in which the hospital unified and integrated medical staff
is located. has mechanisms in place to ensure that
(iii) A doctor of podiatric medicine, issues localized to particular hospitals
when permitted by State law of the are duly considered and addressed.
State in which the hospital is located. (c) Standard: Medical staff bylaws. The
(4) If a hospital is part of a hospital medical staff must adopt and enforce
system consisting of multiple sepa- bylaws to carry out its responsibilities.
rately certified hospitals and the sys- The bylaws must:
tem elects to have a unified and inte- (1) Be approved by the governing
grated medical staff for its member body.
hospitals, after determining that such (2) Include a statement of the duties
a decision is in accordance with all ap- and privileges of each category of med-
plicable State and local laws, each sep- ical staff (e.g., active, courtesy, etc.)
arately certified hospital must dem- (3) Describe the organization of the
onstrate that: medical staff.
(i) The medical staff members of each (4) Describe the qualifications to be
separately certified hospital in the sys- met by a candidate in order for the
tem (that is, all medical staff members medical staff to recommend that the
who hold specific privileges to practice candidate be appointed by the gov-
at that hospital) have voted by major- erning body.
ity, in accordance with medical staff (5) Include a requirement that—
bylaws, either to accept a unified and (i) A medical history and physical ex-
integrated medical staff structure or to amination be completed and docu-
opt out of such a structure and to mented for each patient no more than
maintain a separate and distinct med- 30 days before or 24 hours after admis-
ical staff for their respective hospital; sion or registration, but prior to sur-
(ii) The unified and integrated med- gery or a procedure requiring anes-
ical staff has bylaws, rules, and re- thesia services, and except as provided
quirements that describe its processes under paragraph (c)(5)(iii) of this sec-
for self-governance, appointment, tion. The medical history and physical
credentialing, privileging, and over- examination must be completed and
sight, as well as its peer review policies documented by a physician (as defined
and due process rights guarantees, and in section 1861(r) of the Act), an oral
which include a process for the mem- and maxillofacial surgeon, or other
bers of the medical staff of each sepa- qualified licensed individual in accord-
rately certified hospital (that is, all ance with State law and hospital pol-
medical staff members who hold spe- icy.
cific privileges to practice at that hos- (ii) An updated examination of the
pital) to be advised of their rights to patient, including any changes in the
opt out of the unified and integrated patient’s condition, be completed and
20
documented within 24 hours after ad- those patients receiving specific out-
mission or registration, but prior to patient surgical or procedural services
surgery or a procedure requiring anes- as well as evidence that the policy is
thesia services, when the medical his- based on:
tory and physical examination are (A) Patient age, diagnoses, the type
completed within 30 days before admis- and number of surgeries and procedures
sion or registration, and except as pro- scheduled to be performed,
vided under paragraph (c)(5)(iii) of this comorbidities, and the level of anes-
section. The updated examination of thesia required for the surgery or pro-
the patient, including any changes in cedure.
the patient’s condition, must be com- (B) Nationally recognized guidelines
pleted and documented by a physician
and standards of practice for assess-
(as defined in section 1861(r) of the
ment of specific types of patients prior
Act), an oral and maxillofacial sur-
to specific outpatient surgeries and
geon, or other qualified licensed indi-
vidual in accordance with State law procedures.
and hospital policy. (C) Applicable state and local health
(iii) An assessment of the patient (in and safety laws.
lieu of the requirements of paragraphs (6) Include criteria for determining
(c)(5)(i) and (ii) of this section) be com- the privileges to be granted to indi-
pleted and documented after registra- vidual practitioners and a procedure
tion, but prior to surgery or a proce- for applying the criteria to individuals
dure requiring anesthesia services, requesting privileges. For distant-site
when the patient is receiving specific physicians and practitioners requesting
outpatient surgical or procedural serv- privileges to furnish telemedicine serv-
ices and when the medical staff has ices under an agreement with the hos-
chosen to develop and maintain a pol- pital, the criteria for determining
icy that identifies, in accordance with privileges and the procedure for apply-
the requirements at paragraph (c)(5)(v) ing the criteria are also subject to the
of this section, specific patients as not requirements in § 482.12(a)(8) and (a)(9),
requiring a comprehensive medical his- and § 482.22(a)(3) and (a)(4).
tory and physical examination, or any
update to it, prior to specific out- [51 FR 22042, June 17, 1986, as amended at 59
FR 64152, Dec. 13, 1994; 71 FR 68694, Nov. 27,
patient surgical or procedural services. 2006; 72 FR 66933, Nov. 27, 2007; 76 FR 25563,
The assessment must be completed and May 5, 2011; 77 FR 29074, May 16, 2012; 79 FR
documented by a physician (as defined 27154, May 12, 2014; 84 FR 51818, Sept. 30, 2019]
in section 1861(r) of the Act), an oral
and maxillofacial surgeon, or other § 482.23 Condition of participation:
qualified licensed individual in accord- Nursing services.
ance with State law and hospital pol-
The hospital must have an organized
icy.
nursing service that provides 24-hour
(iv) The medical staff develop and
nursing services. The nursing services
maintain a policy that identifies those
must be furnished or supervised by a
patients for whom the assessment re-
registered nurse.
quirements of paragraph (c)(5)(iii) of
this section would apply. The provi- (a) Standard: Organization. The hos-
sions of paragraphs (c)(5)(iii), (iv), and pital must have a well-organized serv-
(v) of this section do not apply to a ice with a plan of administrative au-
medical staff that chooses to maintain thority and delineation of responsibil-
a policy that adheres to the require- ities for patient care. The director of
ments of paragraphs of (c)(5)(i) and (ii) the nursing service must be a licensed
of this section for all patients. registered nurse. He or she is respon-
(v) The medical staff, if it chooses to sible for the operation of the service,
develop and maintain a policy for the including determining the types and
identification of specific patients to numbers of nursing personnel and staff
whom the assessment requirements in necessary to provide nursing care for
paragraph (c)(5)(iii) of this section all areas of the hospital.
would apply, must demonstrate evi- (b) Standard: Staffing and delivery of
dence that the policy applies only to care. The nursing service must have
21
§ 482.23 42 CFR Ch. IV (10–1–24 Edition)
adequate numbers of licensed reg- (i) Establish the criteria such out-
istered nurses, licensed practical (voca- patient departments must meet, taking
tional) nurses, and other personnel to into account the types of services de-
provide nursing care to all patients as livered, the general level of acuity of
needed. There must be supervisory and patients served by the department, and
staff personnel for each department or the established standards of practice
nursing unit to ensure, when needed, for the services delivered;
the immediate availability of a reg- (ii) Establish alternative staffing
istered nurse for the care of any pa- plans;
tient. (iii) Be approved by the director of
(1) The hospital must provide 24-hour nursing;
nursing services furnished or super- (iv) Be reviewed at least once every 3
vised by a registered nurse, and have a years.
licensed practical nurse or registered (c) Standard: Preparation and adminis-
nurse on duty at all times, except for tration of drugs. (1) Drugs and
rural hospitals that have in effect a 24- biologicals must be prepared and ad-
hour nursing waiver granted under ministered in accordance with Federal
§ 488.54(c) of this chapter. and State laws, the orders of the prac-
(2) The nursing service must have a titioner or practitioners responsible for
procedure to ensure that hospital nurs- the patient’s care, and accepted stand-
ing personnel for whom licensure is re- ards of practice.
quired have valid and current licen- (i) Drugs and biologicals may be pre-
sure. pared and administered on the orders
(3) A registered nurse must supervise of other practitioners not specified
and evaluate the nursing care for each under § 482.12(c) only if such practi-
patient. tioners are acting in accordance with
(4) The hospital must ensure that the State law, including scope-of-practice
nursing staff develops and keeps cur- laws, hospital policies, and medical
rent a nursing care plan for each pa- staff bylaws, rules, and regulations.
tient that reflects the patient’s goals (ii) Drugs and biologicals may be pre-
and the nursing care to be provided to pared and administered on the orders
meet the patient’s needs. The nursing contained within pre-printed and elec-
care plan may be part of an inter- tronic standing orders, order sets, and
disciplinary care plan. protocols for patient orders only if
(5) A registered nurse must assign such orders meet the requirements of
the nursing care of each patient to § 482.24(c)(3).
other nursing personnel in accordance (2) All drugs and biologicals must be
with the patient’s needs and the spe- administered by, or under supervision
cialized qualifications and competence of, nursing or other personnel in ac-
of the nursing staff available. cordance with Federal and State laws
(6) All licensed nurses who provide and regulations, including applicable
services in the hospital must adhere to licensing requirements, and in accord-
the policies and procedures of the hos- ance with the approved medical staff
pital. The director of nursing service policies and procedures.
must provide for the adequate super- (3) With the exception of influenza
vision and evaluation of the clinical and pneumococcal vaccines, which may
activities of all nursing personnel be administered per physician-ap-
which occur within the responsibility proved hospital policy after an assess-
of the nursing service, regardless of the ment of contraindications, orders for
mechanism through which those per- drugs and biologicals must be docu-
sonnel are providing services (that is, mented and signed by a practitioner
hospital employee, contract, lease, who is authorized to write orders in ac-
other agreement, or volunteer). cordance with State law and hospital
(7) The hospital must have policies policy, and who is responsible for the
and procedures in place establishing care of the patient.
which outpatient departments, if any, (i) If verbal orders are used, they are
are not required under hospital policy to be used infrequently.
to have a registered nurse present. The (ii) When verbal orders are used, they
policies and procedures must: must only be accepted by persons who
22
are authorized to do so by hospital pol- (A) Ensure that a practitioner re-

icy and procedures consistent with sponsible for the care of the patient
Federal and State law. has issued an order, consistent with
(iii) Orders for drugs and biologicals hospital policy, permitting self-admin-
may be documented and signed by istration of medications the patient
other practitioners only if such practi- brought into the hospital.
tioners are acting in accordance with (B) Assess the capacity of the patient
State law, including scope-of-practice (or the patient’s caregiver/support per-
laws, hospital policies, and medical son where appropriate) to self-admin-
staff bylaws, rules, and regulations. ister the specified medication(s), and
(4) Blood transfusions and intra- also determine if the patient (or the
venous medications must be adminis- patient’s caregiver/support person
tered in accordance with State law and where appropriate) needs instruction in
approved medical staff policies and the safe and accurate administration of
procedures. the specified medication(s).
(5) There must be a hospital proce- (C) Identify the specified medica-
dure for reporting transfusion reaction(s) and visually evaluate the medi-
tions, adverse drug reactions, and er- cation(s) for integrity.
rors in administration of drugs. (D) Address the security of the medi-
(6) The hospital may allow a patient cation(s) for each patient.
(or his or her caregiver/support person (E) Document the administration of
where appropriate) to self-administer each medication, as reported by the pa-
both hospital-issued medications and tient (or the patient’s caregiver/sup-
the patient’s own medications brought port person where appropriate), in the
into the hospital, as defined and speci- patient’s medical record.
fied in the hospital’s policies and pro-
cedures. [51 FR 22042, June 17, 1986, as amended at 67
FR 61814, Oct. 2, 2002; 71 FR 68694, Nov. 27,
(i) If the hospital allows a patient to 2006; 72 FR 66933, Nov. 27, 2007; 77 FR 29074,
self-administer specific hospital-issued May 16, 2012; 78 FR 50970, Aug. 19, 2013; 79 FR
medications, then the hospital must 44129, July 30, 2014; 84 FR 51819, Sept. 30, 2019]
have policies and procedures in place
to: § 482.24 Condition of participation:
(A) Ensure that a practitioner re- Medical record services.
sponsible for the care of the patient The hospital must have a medical
has issued an order, consistent with record service that has administrative
hospital policy, permitting self-admin- responsibility for medical records. A
istration. medical record must be maintained for
(B) Assess the capacity of the patient every individual evaluated or treated
(or the patient’s caregiver/support per- in the hospital.
son where appropriate) to self-admin- (a) Standard: Organization and staff-
ister the specified medication(s). ing. The organization of the medical
(C) Instruct the patient (or the pa- record service must be appropriate to
tient’s caregiver/support person where the scope and complexity of the serv-
appropriate) in the safe and accurate ices performed. The hospital must em-
administration of the specified medica- ploy adequate personnel to ensure
tion(s). prompt completion, filing, and re-
(D) Address the security of the medi- trieval of records.
cation(s) for each patient. (b) Standard: Form and retention of
(E) Document the administration of record. The hospital must maintain a
each medication, as reported by the pa- medical record for each inpatient and
tient (or the patient’s caregiver/sup- outpatient. Medical records must be
port person where appropriate), in the accurately written, promptly com-
patient’s medical record. pleted, properly filed and retained, and
(ii) If the hospital allows a patient to accessible. The hospital must use a sys-
self-administer his or her own specific tem of author identification and record
medications brought into the hospital, maintenance that ensures the integrity
then the hospital must have policies of the authentification and protects
and procedures in place to: the security of all record entries.
23
§ 482.24 42 CFR Ch. IV (10–1–24 Edition)
(1) Medical records must be retained tocols is conducted by the medical

in their original or legally reproduced staff and the hospital’s nursing and
form for a period of at least 5 years. pharmacy leadership to determine the
(2) The hospital must have a system continuing usefulness and safety of the
of coding and indexing medical records. orders and protocols; and
The system must allow for timely re- (iv) Ensures that such orders and pro-
trieval by diagnosis and procedure, in tocols are dated, timed, and authenti-
order to support medical care evalua- cated promptly in the patient’s med-
tion studies. ical record by the ordering practitioner
(3) The hospital must have a proce- or by another practitioner responsible
dure for ensuring the confidentiality of for the care of the patient only if such
patient records. In-formation from or a practitioner is acting in accordance
copies of records may be released only with State law, including scope-of-
to authorized individuals, and the hos- practice laws, hospital policies, and
pital must ensure that unauthorized medical staff bylaws, rules, and regula-
individuals cannot gain access to or tions.
alter patient records. Original medical (4) All records must document the
records must be released by the hos- following, as appropriate:
pital only in accordance with Federal (i) Evidence of—
or State laws, court orders, or sub- (A) A medical history and physical
poenas. examination completed and docu-
(c) Standard: Content of record. The mented no more than 30 days before or
medical record must contain informa- 24 hours after admission or registra-
tion to justify admission and continued tion, but prior to surgery or a proce-
hospitalization, support the diagnosis, dure requiring anesthesia services, and
and describe the patient’s progress and except as provided under paragraph
response to medications and services. (c)(4)(i)(C) of this section. The medical
(1) All patient medical record entries history and physical examination must
must be legible, complete, dated, be placed in the patient’s medical
timed, and authenticated in written or record within 24 hours after admission
electronic form by the person respon- or registration, but prior to surgery or
sible for providing or evaluating the a procedure requiring anesthesia serv-
service provided, consistent with hos- ices.
pital policies and procedures. (B) An updated examination of the
(2) All orders, including verbal or- patient, including any changes in the
ders, must be dated, timed, and authen- patient’s condition, when the medical
ticated promptly by the ordering prac- history and physical examination are
titioner or by another practitioner who completed within 30 days before admis-
is responsible for the care of the pa- sion or registration, and except as pro-
tient only if such a practitioner is act- vided under paragraph (c)(4)(i)(C) of
ing in accordance with State law, in- this section. Documentation of the up-
cluding scope-of-practice laws, hospital dated examination must be placed in
policies, and medical staff bylaws, the patient’s medical record within 24
rules, and regulations. hours after admission or registration,
(3) Hospitals may use pre-printed and but prior to surgery or a procedure re-
electronic standing orders, order sets, quiring anesthesia services.
and protocols for patient orders only if (C) An assessment of the patient (in
the hospital: lieu of the requirements of paragraphs
(i) Establishes that such orders and (c)(4)(i)(A) and (B) of this section) com-
protocols have been reviewed and ap- pleted and documented after registra-
proved by the medical staff and the tion, but prior to surgery or a proce-
hospital’s nursing and pharmacy lead- dure requiring anesthesia services,
ership; when the patient is receiving specific
(ii) Demonstrates that such orders outpatient surgical or procedural serv-
and protocols are consistent with na- ices and when the medical staff has
tionally recognized and evidence-based chosen to develop and maintain a pol-
guidelines; icy that identifies, in accordance with
(iii) Ensures that the periodic and the requirements at § 482.22(c)(5)(v),
regular review of such orders and pro- specific patients as not requiring a
24
comprehensive medical history and (ii) The patient’s admission to the

physical examination, or any update to hospital’s inpatient services (if applica-
it, prior to specific outpatient surgical ble).
or procedural services. (4) To the extent permissible under
(ii) Admitting diagnosis. applicable federal and state law and
(iii) Results of all consultative eval- regulations and not inconsistent with
uations of the patient and appropriate the patient’s expressed privacy pref-
findings by clinical and other staff in- erences, the system sends notifications
volved in the care of the patient. directly, or through an intermediary
(iv) Documentation of complications, that facilitates exchange of health in-
hospital acquired infections, and unfa- formation, either immediately prior to,
vorable reactions to drugs and anes- or at the time of:
thesia. (i) The patient’s discharge or transfer
(v) Properly executed informed con- from the hospital’s emergency depart-
sent forms for procedures and treatment (if applicable).
ments specified by the medical staff, or (ii) The patient’s discharge or trans-
by Federal or State law if applicable, fer from the hospital’s inpatient serv-
to require written patient consent. ices (if applicable).
(vi) All practitioners’ orders, nursing (5) The hospital has made a reason-
notes, reports of treatment, medication able effort to ensure that the system
records, radiology, and laboratory re- sends the notifications to all applicable
ports, and vital signs and other infor- post-acute care services providers and
mation necessary to monitor the pa- suppliers, as well as to any of the fol-
tient’s condition. lowing practitioners and entities,
(vii) Discharge summary with out- which need to receive notification of
come of hospitalization, disposition of the patient’s status for treatment, care
case, and provisions for follow-up care. coordination, or quality improvement
(viii) Final diagnosis with comple- purposes:
tion of medical records within 30 days (i) The patient’s established primary
following discharge. care practitioner;
(d) Standard: Electronic notifications. If (ii) The patient’s established primary
the hospital utilizes an electronic med- care practice group or entity; or
ical records system or other electronic
(iii) Other practitioner, or other
administrative system, which is
practice group or entity, identified by
conformant with the content exchange
the patient as the practitioner, or prac-
standard at 45 CFR 170.205(d)(2), then
tice group or entity, primarily respon-
the hospital must demonstrate that—
sible for his or her care.
(1) The system’s notification capac-
ity is fully operational and the hospital [51 FR 22042, June 17, 1986, as amended at 71
uses it in accordance with all State and FR 68694, Nov. 27, 2006; 72 FR 66933, Nov. 27,
Federal statutes and regulations appli- 2007; 77 FR 29074, May 16, 2012; 84 FR 51819,
cable to the hospital’s exchange of pa- Sept. 30, 2019; 85 FR 25637, May 1, 2020]
tient health information.
§ 482.25 Condition of participation:
(2) The system sends notifications
Pharmaceutical services.
that must include at least patient
name, treating practitioner name, and The hospital must have pharma-
sending institution name. ceutical services that meet the needs
(3) To the extent permissible under of the patients. The institution must
applicable federal and state law and have a pharmacy directed by a reg-
regulations, and not inconsistent with istered pharmacist or a drug storage
the patient’s expressed privacy pref- area under competent supervision. The
erences, the system sends notifications medical staff is responsible for devel-
directly, or through an intermediary oping policies and procedures that min-
that facilitates exchange of health in- imize drug errors. This function may
formation, at the time of: be delegated to the hospital’s organized
(i) The patient’s registration in the pharmaceutical service.
hospital’s emergency department (if (a) Standard: Pharmacy management
applicable). and administration. The pharmacy or
25
§ 482.26 42 CFR Ch. IV (10–1–24 Edition)
drug storage area must be adminis- (7) Abuses and losses of controlled
tered in accordance with accepted pro- substances must be reported, in accord-
fessional principles. ance with applicable Federal and State
(1) A full-time, part-time, or con- laws, to the individual responsible for
sulting pharmacist must be responsible the pharmaceutical service, and to the
for developing, supervising, and coordi- chief executive officer, as appropriate.
nating all the activities of the phar- (8) Information relating to drug
macy services. interactions and information of drug
(2) The pharmaceutical service must therapy, side effects, toxicology, dos-
have an adequate number of personnel age, indications for use, and routes of
to ensure quality pharmaceutical serv- administration must be available to
ices, including emergency services. the professional staff.
(3) Current and accurate records (9) A formulary system must be es-
must be kept of the receipt and disposi- tablished by the medical staff to assure
tion of all scheduled drugs. quality pharmaceuticals at reasonable
(b) Standard: Delivery of services. In costs.
order to provide patient safety, drugs
and biologicals must be controlled and [51 FR 22042, June 17, 1986; 51 FR 27848, Aug.
4, 1986; 71 FR 68694, Nov. 27, 2006; 77 FR 29075,
distributed in accordance with applica-
May 16, 2012]
ble standards of practice, consistent
with Federal and State law. § 482.26 Condition of participation:
(1) All compounding, packaging, and Radiologic services.
dispensing of drugs and biologicals
must be under the supervision of a The hospital must maintain, or have
pharmacist and performed consistent available, diagnostic radiologic serv-
with State and Federal laws. ices. If therapeutic services are also
provided, they, as well as the diag-
(2)(i) All drugs and biologicals must
be kept in a secure area, and locked nostic services, must meet profes-
when appropriate. sionally approved standards for safety
and personnel qualifications.
(ii) Drugs listed in Schedules II, III,
IV, and V of the Comprehensive Drug (a) Standard: Radiologic services. The
Abuse Prevention and Control Act of hospital must maintain, or have avail-
1970 must be kept locked within a se- able, radiologic services according to
cure area. needs of the patients.
(iii) Only authorized personnel may (b) Standard: Safety for patients and
have access to locked areas. personnel. The radiologic services, par-
(3) Outdated, mislabeled, or other- ticularly ionizing radiology proce-
wise unusable drugs and biologicals dures, must be free from hazards for
must not be available for patient use. patients and personnel.
(4) When a pharmacist is not avail- (1) Proper safety precutions must be
able, drugs and biologicals must be re- maintained against radiation hazards.
moved from the pharmacy or storage This includes adequate shielding for
area only by personnel designated in patients, personnel, and facilities, as
the policies of the medical staff and well as appropriate storage, use, and
pharmaceutical service, in accordance disposal of radioactive materials.
with Federal and State law. (2) Periodic inspection of equipment
(5) Drugs and biologicals not specifi- must be made and hazards identified
cally prescribed as to time or number must be promptly corrected.
of doses must automatically be stopped (3) Radiation workers must be
after a reasonable time that is pre- checked periodically, by the use of ex-
determined by the medical staff. posure meters or badge tests, for
(6) Drug administration errors, ad- amount of radiation exposure.
verse drug reactions, and incompati- (4) Radiologic services must be pro-
bilities must be immediately reported vided only on the order of practitioners
to the attending physician and, if ap- with clinical privileges or, consistent
propriate, to the hospital’s quality as- with State law, of other practitioners
sessment and performance improve- authorized by the medical staff and the
ment program. governing body to order the services.
26
(c) Standard: Personnel. (1) A qualified roscopic and microscopic examina-

full-time, part-time, or consulting ra- tions.
diologist must supervise the ionizing (b) Standard: Potentially infectious
radiology services and must interpret blood and blood components—(1) Poten-
only those radiologic tests that are de- tially human immunodeficiency virus
termined by the medical staff to re- (HIV) infectious blood and blood compo-
quire a radiologist’s specialized knowl- nents. Potentially HIV infectious blood
edge. For purposes of this section, a ra- and blood components are prior collec-
diologist is a doctor of medicine or os- tions from a donor—
teopathy who is qualified by education (i) Who tested negative at the time of
and experience in radiology. donation but tests reactive for evi-
(2) Only personnel designated as dence of HIV infection on a later dona-
qualified by the medical staff may use tion;
the radiologic equipment and admin- (ii) Who tests positive on the supple-
ister procedures. mental (additional, more specific) test
(d) Standard: Records. Records of
or other follow-up testing required by
radiologic services must be main-
FDA; and
tained.
(iii) For whom the timing of
(1) The radiologist or other practi-
seroconversion cannot be precisely es-
tioner who performs radiology services
timated.
must sign reports of his or her inter-
pretations. (2) Potentially hepatitis C virus (HCV)
(2) The hospital must maintain the infectious blood and blood components.
following for at least 5 years: Potentially HCV infectious blood and
(i) Copies of reports and printouts. blood components are the blood and
(ii) Films, scans, and other image blood components identified in 21 CFR
records, as appropriate. 610.47.
(3) Services furnished by an outside
[51 FR 22042, June 17, 1986; 51 FR 27848, Aug. blood collecting establishment. If a hos-
4, 1986]
pital regularly uses the services of an
§ 482.27 Condition of participation: outside blood collecting establishment,
Laboratory services. it must have an agreement with the
blood collecting establishment that
The hospital must maintain, or have
governs the procurement, transfer, and
available, adequate laboratory services
availability of blood and blood compo-
to meet the needs of its patients. The
nents. The agreement must require
hospital must ensure that all labora-
that the blood collecting establishment
tory services provided to its patients
notify the hospital—
are performed in a facility certified in
accordance with part 493 of this chap- (i) Within 3 calendar days if the blood
ter. collecting establishment supplied blood
(a) Standard: Adequacy of laboratory and blood components collected from a
services. The hospital must have labora- donor who tested negative at the time
tory services available, either directly of donation but tests reactive for evi-
or through a contractual agreement dence of HIV or HCV infection on a
with a certified laboratory that meets later donation or who is determined to
requirements of part 493 of this chap- be at increased risk for transmitting
ter. HIV or HCV infection;
(1) Emergency laboratory services (ii) Within 45 days of the test, of the
must be available 24 hours a day. results of the supplemental (additional,
(2) A written description of services more specific) test for HIV or HCV, as
provided must be available to the med- relevant, or other follow-up testing re-
ical staff. quired by FDA; and
(3) The laboratory must make provi- (iii) Within 3 calendar days after the
sion for proper receipt and reporting of blood collecting establishment supplied
tissue specimens. blood and blood components collected
(4) The medical staff and a patholo- from an infectious donor, whenever
gist must determine which tissue speci- records are available.
mens require a macroscopic (gross) ex- (4) Quarantine and disposition of blood
amination and which require both mac- and blood components pending completion
27
§ 482.27 42 CFR Ch. IV (10–1–24 Edition)
of testing. If the blood collecting estab- (i) Make reasonable attempts to no-
lishment (either internal or under an tify the patient, or to notify the at-
agreement) notifies the hospital of the tending physician or the physician who
reactive HIV or HCV screening test re- ordered the blood or blood component
sults, the hospital must determine the and ask the physician to notify the pa-
disposition of the blood or blood prod- tient, or other individual as permitted
uct and quarantine all blood and blood under paragraph (b)(10) of this section,
components from previous donations in that potentially HIV or HCV infectious
inventory. blood or blood components were trans-
(i) If the blood collecting establish- fused to the patient and that there
ment notifies the hospital that the re- may be a need for HIV or HCV testing
sult of the supplemental (additional, and counseling.
more specific) test or other follow-up (ii) If the physician is unavailable or
testing required by FDA is negative, declines to make the notification,
absent other informative test results, make reasonable attempts to give this
the hospital may release the blood and notification to the patient, legal guard-
blood components from quarantine. ian, or relative.
(ii) If the blood collecting establish- (iii) Document in the patient’s med-
ment notifies the hospital that the re- ical record the notification or attempts
sult of the supplemental, (additional, to give the required notification.
more specific) test or other follow-up (7) Timeframe for notification—For do-
testing required by FDA is positive, nors tested on or after February 20,
the hospital must— 2008. For notifications resulting from
donors tested on or after February 20,
(A) Dispose of the blood and blood
2008 as set forth at 21 CFR 610.46 and
components; and
610.47 the notification effort begins
(B) Notify the transfusion bene- when the blood collecting establish-
ficiaries as set forth in paragraph (b)(6) ment notifies the hospital that it re-
of this section. ceived potentially HIV or HCV infec-
(iii) If the blood collecting establish- tious blood and blood components. The
ment notifies the hospital that the re- hospital must make reasonable at-
sult of the supplemental, (additional, tempts to give notification over a pe-
more specific) test or other follow-up riod of 12 weeks unless—
testing required by FDA is indetermi- (i) The patient is located and noti-
nate, the hospital must destroy or fied; or
label prior collections of blood or blood (ii) The hospital is unable to locate
components held in quarantine as set the patient and documents in the pa-
forth at 21 CFR 610.46(b)(2) and tient’s medical record the extenuating
610.47(b)(2). circumstances beyond the hospital’s
(5) Recordkeeping by the hospital. The control that caused the notification
hospital must maintain— timeframe to exceed 12 weeks.
(i) Records of the source and disposi- (8) Content of notification. The notifi-
tion of all units of blood and blood cation must include the following in-
components for at least 10 years from formation:
the date of disposition in a manner (i) A basic explanation of the need for
that permits prompt retrieval; and HIV or HCV testing and counseling;
(ii) A fully funded plan to transfer (ii) Enough oral or written informa-
these records to another hospital or tion so that an informed decision can
other entity if such hospital ceases op- be made about whether to obtain HIV
eration for any reason. or HCV testing and counseling; and
(6) Patient notification. If the hospital (iii) A list of programs or places
has administered potentially HIV or where the person can obtain HIV or
HCV infectious blood or blood compo- HCV testing and counseling, including
nents (either directly through its own any requirements or restrictions the
blood collecting establishment or program may impose.
under an agreement) or released such (9) Policies and procedures. The hos-
blood or blood components to another pital must establish policies and proce-
entity or individual, the hospital must dures for notification and documenta-
take the following actions: tion that conform to Federal, State,
28
and local laws, including requirements (a) Standard: Organization. (1) The
for the confidentiality of medical hospital must have a full-time em-
records and other patient information. ployee who—
(10) Notification to legal representative (i) Serves as director of the food and
or relative. If the patient has been ad- dietetic service;
judged incompetent by a State court, (ii) Is responsible for the daily man-
the physician or hospital must notify a agement of the dietary services; and
legal representative designated in ac- (iii) Is qualified by experience or
cordance with State law. If the patient training.
is competent, but State law permits a (2) There must be a qualified dieti-
legal representative or relative to re- tian, full-time, part-time, or on a con-
ceive the information on the patient’s sultant basis.
behalf, the physician or hospital must (3) There must be administrative and
notify the patient or his or her legal technical personnel competent in their
representative or relative. For possible respective duties.
HIV infectious transfusion bene- (b) Standard: Diets. Menus must meet
ficiaries that are deceased, the physi- the needs of the patients.
cian or hospital must inform the de-
(1) Individual patient nutritional
ceased patient’s legal representative or
needs must be met in accordance with
relative. If the patient is a minor, the
recognized dietary practices.
parents or legal guardian must be noti-
(2) All patient diets, including thera-
fied.
peutic diets, must be ordered by a prac-
(c) General blood safety issues. For
titioner responsible for the care of the
lookback activities only related to new
patient, or by a qualified dietitian or
blood safety issues that are identified
qualified nutrition professional as au-
after August 24, 2007, hospitals must
thorized by the medical staff and in ac-
comply with FDA regulations as they
cordance with State law governing di-
pertain to blood safety issues in the
etitians and nutrition professionals.
following areas:
(3) A current therapeutic diet manual
(1) Appropriate testing and quaran-
approved by the dietitian and medical
tining of infectious blood and blood
staff must be readily available to all
components.
medical, nursing, and food service per-
(2) Notification and counseling of sonnel.
beneficiaries that may have received
infectious blood and blood components. [51 FR 22042, June 17, 1986, as amended at 79
FR 27154, May 12, 2014]
[57 FR 7136, Feb. 28, 1992, as amended at 61
FR 47433, Sept. 9, 1996; 72 FR 48573, Aug. 24, § 482.30 Condition of participation:
2007; 84 FR 51819, Sept. 30, 2019; 85 FR 72909, Utilization review.
Nov. 16, 2020]
The hospital must have in effect a
§ 482.28 Condition of participation: utilization review (UR) plan that pro-
Food and dietetic services. vides for review of services furnished
The hospital must have organized di- by the institution and by members of
etary services that are directed and the medical staff to patients entitled
staffed by adequate qualified per- to benefits under the Medicare and
sonnel. However, a hospital that has a Medicaid programs.
contract with an outside food manage- (a) Applicability. The provisions of
ment company may be found to meet this section apply except in either of
this Condition of participation if the the following circumstances:
company has a dietitian who serves the (1) A Utilization and Quality Control
hospital on a full-time, part-time, or Quality Improvement Organization
consultant basis, and if the company (QIO) has assumed binding review for
maintains at least the minimum stand- the hospital.
ards specified in this section and pro- (2) CMS has determined that the UR
vides for constant liaison with the hos- procedures established by the State
pital medical staff for recommenda- under title XIX of the Act are superior
tions on dietetic policies affecting pa- to the procedures required in this sec-
tient treatment. tion, and has required hospitals in that
29
§ 482.30 42 CFR Ch. IV (10–1–24 Edition)
State to meet the UR plan require- review of duration of stays and review
ments under §§ 456.50 through 456.245 of of professional services as follows:
this chapter. (i) For duration of stays, these hos-
(b) Standard: Composition of utilization pitals need review only cases that they
review committee. A UR committee con- reasonably assume to be outlier cases
sisting of two or more practitioners based on extended length of stay, as de-
must carry out the UR function. At scribed in § 412.80(a)(1)(i) of this chap-
least two of the members of the com- ter; and
mittee must be doctors of medicine or (ii) For professional services, these
osteopathy. The other members may be hospitals need review only cases that
any of the other types of practitioners they reasonably assume to be outlier
specified in § 482.12(c)(1). cases based on extraordinarily high
(1) Except as specified in paragraphs costs, as described in § 412.80(a)(1)(ii) of
(b) (2) and (3) of this section, the UR this chapter.
committee must be one of the fol- (d) Standard: Determination regarding
lowing: admissions or continued stays. (1) The de-
(i) A staff committee of the institu- termination that an admission or con-
tion; tinued stay is not medically nec-
(ii) A group outside the institution— essary—
(A) Established by the local medical (i) May be made by one member of
society and some or all of the hospitals the UR committee if the practitioner
in the locality; or or practitioners responsible for the
(B) Established in a manner approved care of the patient, as specified of
by CMS. § 482.12(c), concur with the determina-
tion or fail to present their views when
(2) If, because of the small size of the
afforded the opportunity; and
institution, it is impracticable to have
(ii) Must be made by at least two
a properly functioning staff com-
members of the UR committee in all
mittee, the UR committee must be es-
other cases.
tablished as specified in paragraph
(2) Before making a determination
(b)(1)(ii) of this section.
that an admission or continued stay is
(3) The committee’s or group’s re-
not medically necessary, the UR com-
views may not be conducted by any in-
mittee must consult the practitioner
dividual who—
or practitioners responsible for the
(i) Has a direct financial interest (for care of the patient, as specified in
example, an ownership interest) in that § 482.12(c), and afford the practitioner
hospital; or or practitioners the opportunity to
(ii) Was professionally involved in present their views.
the care of the patient whose case is (3) If the committee decides that ad-
being reviewed. mission to or continued stay in the
(c) Standard: Scope and frequency of hospital is not medically necessary,
review. (1) The UR plan must provide written notification must be given, no
for review for Medicare and Medicaid later than 2 days after the determina-
patients with respect to the medical tion, to the hospital, the patient, and
necessity of— the practitioner or practitioners re-
(i) Admissions to the institution; sponsible for the care of the patient, as
(ii) The duration of stays; and specified in § 482.12(c);
(iii) Professional services furnished, (e) Standard: Extended stay review. (1)
including drugs and biologicals. In hospitals that are not paid under the
(2) Review of admissions may be per- prospective payment system, the UR
formed before, at, or after hospital ad- committee must make a periodic re-
mission. view, as specified in the UR plan, of
(3) Except as specified in paragraph each current inpatient receiving hos-
(e) of this section, reviews may be con- pital services during a continuous pe-
ducted on a sample basis. riod of extended duration. The sched-
(4) Hospitals that are paid for inpa- uling of the periodic reviews may—
tient hospital services under the pro- (i) Be the same for all cases; or
spective payment system set forth in (ii) Differ for different classes of
part 412 of this chapter must conduct cases.
30
(2) In hospitals paid under the pro- and doors to rooms containing flam-
spective payment system, the UR com- mable or combustible materials must
mittee must review all cases reason- be provided with positive latching
ably assumed by the hospital to be hardware. Roller latches are prohibited
outlier cases because the extended on such doors.
length of stay exceeds the threshold (2) In consideration of a rec-
criteria for the diagnosis, as described ommendation by the State survey
in § 412.80(a)(1)(i). The hospital is not agency or Accrediting Organization or
required to review an extended stay at the discretion of the Secretary, may
that does not exceed the outlier thresh- waive, for periods deemed appropriate,
old for the diagnosis. specific provisions of the Life Safety
(3) The UR committee must make the Code, which would result in unreason-
periodic review no later than 7 days able hardship upon a hospital, but only
after the day required in the UR plan. if the waiver will not adversely affect
(f) Standard: Review of professional the health and safety of the patients.
services. The committee must review (3) The provisions of the Life Safety
professional services provided, to de- Code do not apply in a State where
termine medical necessity and to pro- CMS finds that a fire and safety code
mote the most efficient use of avail- imposed by State law adequately pro-
able health facilities and services. tects patients in hospitals.
(4) The hospital must have proce-
Physical environment. dures for the proper routine storage
and prompt disposal of trash.
The hospital must be constructed, ar- (5) The hospital must have written
ranged, and maintained to ensure the fire control plans that contain provi-
safety of the patient, and to provide fa- sions for prompt reporting of fires; ex-
cilities for diagnosis and treatment and tinguishing fires; protection of pa-
for special hospital services appro- tients, personnel and guests; evacu-
priate to the needs of the community. ation; and cooperation with fire fight-
(a) Standard: Buildings. The condition ing authorities.
of the physical plant and the overall
(6) The hospital must maintain writ-
hospital environment must be devel-
ten evidence of regular inspection and
oped and maintained in such a manner
approval by State or local fire control
that the safety and well-being of pa-
agencies.
tients are assured.
(1) There must be emergency power (7) A hospital may install alcohol-
and lighting in at least the operating, based hand rub dispensers in its facil-
ity if the dispensers are installed in a
recovery, intensive care, and emer-
manner that adequately protects
gency rooms, and stairwells. In all
against inappropriate access;
other areas not serviced by the emer-
gency supply source, battery lamps and (8) When a sprinkler system is shut
flashlights must be available. down for more than 10 hours, the hos-
(2) There must be facilities for emer- pital must:
gency gas and water supply. (i) Evacuate the building or portion
(b) Standard: Life safety from fire. (1) of the building affected by the system
Except as otherwise provided in this outage until the system is back in
section— service, or
(i) The hospital must meet the appli- (ii) Establish a fire watch until the
cable provisions and must proceed in system is back in service.
accordance with the Life Safety Code (9) Buildings must have an outside
(NFPA 101 and Tentative Interim window or outside door in every sleep-
Amendments TIA 12–1, TIA 12–2, TIA ing room, and for any building con-
12–3, and TIA 12–4.) Outpatient surgical structed after July 5, 2016 the sill
departments must meet the provisions height must not exceed 36 inches above
applicable to Ambulatory Health Care the floor. Windows in atrium walls are
Occupancies, regardless of the number considered outside windows for the pur-
of patients served. poses of this requirement.
(ii) Notwithstanding paragraph (i) The sill height requirement does
(b)(1)(i) of this section, corridor doors not apply to newborn nurseries and
31
§ 482.42 42 CFR Ch. IV (10–1–24 Edition)
rooms intended for occupancy for less ment in the FEDERAL REGISTER to an-
than 24 hours. nounce the changes.
(ii) The sill height in special nursing (1) National Fire Protection Associa-
care areas of new occupancies must not tion, 1 Batterymarch Park, Quincy,
exceed 60 inches. MA 02169, www.nfpa.org, 1.617.770.3000.
(c) Standard: Building safety. Except (i) NFPA 99, Standards for Health
as otherwise provided in this section, Care Facilities Code of the National
the hospital must meet the applicable Fire Protection Association 99, 2012
provisions and must proceed in accord- edition, issued August 11, 2011.
ance with the Health Care Facilities (ii) TIA 12–2 to NFPA 99, issued Au-
Code (NFPA 99 and Tentative Interim gust 11, 2011.
Amendments TIA 12–2, TIA 12–3, TIA (iii) TIA 12–3 to NFPA 99, issued Au-
12–4, TIA 12–5 and TIA 12–6). gust 9, 2012.
(1) Chapters 7, 8, 12, and 13 of the (iv) TIA 12–4 to NFPA 99, issued
adopted Health Care Facilities Code do March 7, 2013.
not apply to a hospital. (v) TIA 12–5 to NFPA 99, issued Au-
(2) If application of the Health Care gust 1, 2013.
Facilities Code required under para- (vi) TIA 12–6 to NFPA 99, issued
graph (c) of this section would result in March 3, 2014.
unreasonable hardship for the hospital, (vii) NFPA 101, Life Safety Code, 2012
CMS may waive specific provisions of edition, issued August 11, 2011;
the Health Care Facilities Code, but (viii) TIA 12–1 to NFPA 101, issued
only if the waiver does not adversely August 11, 2011.
affect the health and safety of patients. (ix) TIA 12–2 to NFPA 101, issued Oc-
tober 30, 2012.
(d) Standard: Facilities. The hospital
(x) TIA 12–3 to NFPA 101, issued Oc-
must maintain adequate facilities for
tober 22, 2013.
its services.
(xi) TIA 12–4 to NFPA 101, issued Oc-
(1) Diagnostic and therapeutic facili-
tober 22, 2013.
ties must be located for the safety of
(2) [Reserved]
patients.
(2) Facilities, supplies, and equip- [51 FR 22042, June 17, 1986, as amended at 53
ment must be maintained to ensure an FR 11509, Apr. 7, 1988; 68 FR 1386, Jan. 10,
2003; 69 FR 49267, Aug. 11, 2004; 70 FR 15238,
acceptable level of safety and quality.
Mar. 25, 2005; 71 FR 55340, Sept. 22, 2006; 81 FR
(3) The extent and complexity of fa- 26899, May 4, 2016; 81 FR 42548, June 30, 2016]
cilities must be determined by the
services offered. § 482.42 Condition of participation: In-
(4) There must be proper ventilation, fection prevention and control and
light, and temperature controls in antibiotic stewardship programs.
pharmaceutical, food preparation, and The hospital must have active hos-
other appropriate areas. pital-wide programs for the surveil-
(e) The standards incorporated by lance, prevention, and control of HAIs
reference in this section are approved and other infectious diseases, and for
for incorporation by reference by the the optimization of antibiotic use
Director of the Office of the Federal through stewardship. The programs
Register in accordance with 5 U.S.C. must demonstrate adherence to nation-
552(a) and 1 CFR part 51. You may in- ally recognized infection prevention
spect a copy at the CMS Information and control guidelines, as well as to
Resource Center, 7500 Security Boule- best practices for improving antibiotic
vard, Baltimore, MD or at the National use where applicable, and for reducing
Archives and Records Administration the development and transmission of
(NARA). For information on the avail- HAIs and antibiotic-resistant orga-
ability of this material at NARA, call nisms. Infection prevention and control
202–741–6030, or go to: http:// problems and antibiotic use issues
www.archives.gov/federal_register/ identified in the programs must be ad-
code_of_federal_regulations/ dressed in collaboration with the hos-
ibr_locations.html. If any changes in this pital-wide quality assessment and per-
edition of the Code are incorporated by formance improvement (QAPI) pro-
reference, CMS will publish a docu- gram.
32
(a) Standard: Infection prevention and (ii) Documents the evidence-based

control program organization and policies. use of antibiotics in all departments
The hospital must demonstrate that: and services of the hospital; and
(1) An individual (or individuals), (iii) Documents any improvements,
who is qualified through education, including sustained improvements, in
training, experience, or certification in proper antibiotic use;
infection prevention and control, is ap- (3) The antibiotic stewardship pro-
pointed by the governing body as the gram adheres to nationally recognized
infection preventionist(s)/infection guidelines, as well as best practices, for
control professional(s) responsible for improving antibiotic use; and
the infection prevention and control (4) The antibiotic stewardship pro-
program and that the appointment is gram reflects the scope and complexity
based on the recommendations of med- of the hospital services provided.
ical staff leadership and nursing lead- (c) Standard: Leadership responsibil-
ership; ities. (1) The governing body must en-
(2) The hospital infection prevention sure all of the following:
and control program, as documented in (i) Systems are in place and oper-
its policies and procedures, employs ational for the tracking of all infection
methods for preventing and controlling surveillance, prevention, and control,
the transmission of infections within and antibiotic use activities, in order
the hospital and between the hospital to demonstrate the implementation,
and other institutions and settings; success, and sustainability of such ac-
tivities.
(3) The infection prevention and con-
trol program includes surveillance, (ii) All HAIs and other infectious dis-
prevention, and control of HAIs, in- eases identified by the infection pre-
vention and control program as well as
cluding maintaining a clean and sani-
antibiotic use issues identified by the
tary environment to avoid sources and
antibiotic stewardship program are ad-
transmission of infection, and address-
dressed in collaboration with hospital
es any infection control issues identi-
QAPI leadership.
fied by public health authorities; and
(2) The infection preventionist(s)/in-
(4) The infection prevention and con-
fection control professional(s) is re-
trol program reflects the scope and sponsible for:
complexity of the hospital services pro-
(i) The development and implementa-
vided.
tion of hospital-wide infection surveil-
(b) Standard: Antibiotic stewardship lance, prevention, and control policies
program organization and policies. The and procedures that adhere to nation-
hospital must demonstrate that: ally recognized guidelines.
(1) An individual (or individuals), (ii) All documentation, written or
who is qualified through education, electronic, of the infection prevention
training, or experience in infectious and control program and its surveil-
diseases and/or antibiotic stewardship, lance, prevention, and control activi-
is appointed by the governing body as ties.
the leader(s) of the antibiotic steward- (iii) Communication and collabora-
ship program and that the appointment tion with the hospital’s QAPI program
is based on the recommendations of on infection prevention and control
medical staff leadership and pharmacy issues.
leadership; (iv) Competency-based training and
(2) The hospital-wide antibiotic stew- education of hospital personnel and
ardship program: staff, including medical staff, and, as
(i) Demonstrates coordination among applicable, personnel providing con-
all components of the hospital respon- tracted services in the hospital, on the
sible for antibiotic use and resistance, practical applications of infection pre-
including, but not limited to, the infec- vention and control guidelines, poli-
tion prevention and control program, cies, and procedures.
the QAPI program, the medical staff, (v) The prevention and control of
nursing services, and pharmacy serv- HAIs, including auditing of adherence
ices; to infection prevention and control
33
§ 482.42 42 CFR Ch. IV (10–1–24 Edition)
policies and procedures by hospital per- ferences in patient populations and

sonnel. services offered in each hospital;
(vi) Communication and collabora- (2) The unified and integrated infec-
tion with the antibiotic stewardship tion prevention and control and anti-
program. biotic stewardship programs establish
(3) The leader(s) of the antibiotic and implement policies and procedures
stewardship program is responsible for: to ensure that the needs and concerns
(i) The development and implementa- of each of its separately certified hos-
tion of a hospital-wide antibiotic stew- pitals, regardless of practice or loca-
ardship program, based on nationally tion, are given due consideration;
recognized guidelines, to monitor and (3) The unified and integrated infec-
improve the use of antibiotics. tion prevention and control and anti-
biotic stewardship programs have
(ii) All documentation, written or
mechanisms in place to ensure that
electronic, of antibiotic stewardship
issues localized to particular hospitals
program activities.
are duly considered and addressed; and
(iii) Communication and collabora- (4) A qualified individual (or individ-
tion with medical staff, nursing, and uals) with expertise in infection pre-
pharmacy leadership, as well as with vention and control and in antibiotic
the hospital’s infection prevention and stewardship has been designated at the
control and QAPI programs, on anti- hospital as responsible for commu-
biotic use issues. nicating with the unified infection pre-
(iv) Competency-based training and vention and control and antibiotic
education of hospital personnel and stewardship programs, for imple-
staff, including medical staff, and, as menting and maintaining the policies
applicable, personnel providing con- and procedures governing infection
tracted services in the hospital, on the prevention and control and antibiotic
practical applications of antibiotic stewardship as directed by the unified
stewardship guidelines, policies, and infection prevention and control and
procedures. antibiotic stewardship programs, and
(d) Standard: Unified and integrated infor providing education and training on
fection prevention and control and anti- the practical applications of infection
biotic stewardship programs for multi-hos- prevention and control and antibiotic
pital systems. If a hospital is part of a stewardship to hospital staff.
hospital system consisting of multiple (e) COVID–19 reporting. (1) During the
separately certified hospitals using a Public Health Emergency, as defined in
system governing body that is legally § 400.200 of this chapter, the hospital
responsible for the conduct of two or must report information in accordance
more hospitals, the system governing with a frequency as specified by the
body can elect to have unified and inte- Secretary on COVID–19 in a standard-
grated infection prevention and control ized format specified by the Secretary.
and antibiotic stewardship programs This report must include, but not be
for all of its member hospitals after de- limited to, the following data ele-
termining that such a decision is in ac- ments:
cordance with all applicable State and (i) The hospital’s current inventory
local laws. The system governing body supplies of any COVID–19-related
is responsible and accountable for en- therapeutics that have been distributed
suring that each of its separately cer- and delivered to the hospital under the
tified hospitals meets all of the re- authority and direction of the Sec-
quirements of this section. Each sepa- retary.
rately certified hospital subject to the (ii) The hospital’s current usage rate
system governing body must dem- for any COVID–19-related therapeutics
onstrate that: that have been distributed and deliv-
(1) The unified and integrated infec- ered to the hospital under the author-
tion prevention and control and anti- ity and direction of the Secretary.
biotic stewardship programs are estab- (2) Beginning at the conclusion of the
lished in a manner that takes into ac- COVID–19 Public Health Emergency, as
count each member hospital’s unique defined in § 400.200 of this chapter, and
circumstances and any significant dif- continuing until April 30, 2024, except
34
when the Secretary specifies an earlier (iii) Confirmed co-morbid influenza

end date for the requirements of this and COVID–19 infections among pa-
paragraph (e)(2), the hospital must tients.
electronically report information [84 FR 51820, Sept. 30, 2019, as amended at 85
about COVID–19 in a standardized for- FR 54872, Sept. 2, 2020; 85 FR 86303, Dec. 29,
mat specified by the Secretary. To the 2020; 86 FR 61619, Nov. 5, 2021; 87 FR 49409,
extent as required by the Secretary, Aug. 10, 2022; 87 FR 66575, Nov. 4, 2022; 88 FR
36510, June 5, 2023]
this report must include the following
data elements: EDITORIAL NOTE: At 85 FR 86303, Dec. 29,
(i) Confirmed COVID–19 infections 2020, this section was amended, effective Dec.
4, 2020; however, due to a publication error,
among patients. the amendments were codified at 86 FR 33902,
(ii) Total deaths among patients. June 28, 2021.
(iii) Personal protective equipment EFFECTIVE DATE NOTE: At 89 FR 69913, Aug.
and testing supplies. 28, 2024, § 482.42 was amended by revising
(iv) Ventilator use, capacity, and paragraph (e) and removing paragraph (f), ef-
supplies. fective Nov. 1, 2024. For the convenience of
(v) Total bed and intensive care unit the user, the revised text is set forth as fol-
lows:
bed census and capacity.
(vi) Staffing shortages. § 482.42 Condition of participation: Infec-
tion prevention and control and anti-
(vii) COVID–19 vaccine administra- biotic stewardship programs.
tion data of patients and staff.
(viii) Relevant therapeutic inven- * * * * *
tories or usage, or both.
(e) Respiratory illness reporting—(1) Ongoing
(f) Standard: Reporting of acute res-
reporting. The hospital must electronically
piratory illness, including seasonal influ- report information on acute respiratory ill-
enza virus, influenza-like illness, and se- nesses, including influenza, SARS-CoV–2/
vere acute respiratory infection. (1) Dur- COVID–19, and RSV.
ing the Public Health Emergency, as (i) The report must be in a standardized
defined in § 400.200 of this chapter, the format and frequency specified by the Sec-
retary.
hospital must report information, in (ii) To the extent as required by the Sec-
accordance with a frequency as speci- retary, this report must include all of the
fied by the Secretary, on Acute Res- following data elements:
piratory Illness (including, but not lim- (A) Confirmed infections for a limited set
ited to, Seasonal Influenza Virus, Influ- of respiratory illnesses, including but not
limited to influenza, SARS-CoV–2/COVID–19,
enza-like Illness, and Severe Acute and RSV, among newly admitted and hos-
Respiratory Infection) in a standard- pitalized patients.
ized format specified by the Secretary. (B) Total bed census and capacity, includ-
(2) Beginning at the conclusion of the ing for critical hospital units and age groups.
COVID–19 Public Health Emergency, as (C) Limited patient demographic informa-
tion, including but not limited to age.
defined in § 400.200 of this chapter, and (2) Public health emergency (PHE) reporting.
continuing until April 30, 2024, except In the event that the Secretary has declared
when the Secretary specifies an earlier a national, State, or local PHE for an acute
end date for the requirements of this infectious illness, the hospital must also
paragraph (f)(2), the hospital must electronically report the following data ele-
ments in a standardized format and fre-
electronically report information quency specified by the Secretary:
about seasonal influenza in a standard- (i) Supply inventory shortages.
ized format specified by the Secretary. (ii) Staffing shortages.
To the extent as required by the Sec- (iii) Relevant medical countermeasures
retary, this report must include the and therapeutic inventories, usage, or both.
(iv) Facility structure and operating sta-
following data elements: tus, including hospital/ED diversion status.
(i) Confirmed influenza infections
among patients. § 482.43 Condition of participation:
(ii) Total deaths among patients. Discharge planning.
The hospital must have an effective
discharge planning process that focuses
on the patient’s goals and treatment
35
§ 482.43 42 CFR Ch. IV (10–1–24 Edition)
preferences and includes the patient istered nurse, social worker, or other
and his or her caregivers/support per- appropriately qualified personnel.
son(s) as active partners in the dis- (6) The hospital’s discharge planning
charge planning for post-discharge process must require regular re-evalua-
care. The discharge planning process tion of the patient’s condition to iden-
and the discharge plan must be con- tify changes that require modification
sistent with the patient’s goals for care of the discharge plan. The discharge
and his or her treatment preferences, plan must be updated, as needed, to re-
ensure an effective transition of the pa- flect these changes.
tient from hospital to post-discharge (7) The hospital must assess its dis-
care, and reduce the factors leading to charge planning process on a regular
preventable hospital readmissions. basis. The assessment must include on-
(a) Standard: Discharge planning proc- going, periodic review of a representa-
ess. The hospital’s discharge planning tive sample of discharge plans, includ-
process must identify, at an early stage ing those patients who were readmitted
of hospitalization, those patients who within 30 days of a previous admission,
are likely to suffer adverse health con- to ensure that the plans are responsive
sequences upon discharge in the ab- to patient post-discharge needs.
sence of adequate discharge planning (8) The hospital must assist patients,
and must provide a discharge planning their families, or the patient’s rep-
evaluation for those patients so identi- resentative in selecting a post-acute
fied as well as for other patients upon care provider by using and sharing data
the request of the patient, patient’s that includes, but is not limited to,
representative, or patient’s physician. HHA, SNF, IRF, or LTCH data on qual-
(1) Any discharge planning evalua- ity measures and data on resource use
tion must be made on a timely basis to measures. The hospital must ensure
ensure that appropriate arrangements that the post-acute care data on qual-
ity measures and data on resource use
for post-hospital care will be made be-
measures is relevant and applicable to
fore discharge and to avoid unneces-
the patient’s goals of care and treat-
sary delays in discharge.
ment preferences.
(2) A discharge planning evaluation (b) Standard: Discharge of the patient
must include an evaluation of a pa- and provision and transmission of the pa-
tient’s likely need for appropriate post- tient’s necessary medical information.
hospital services, including, but not The hospital must discharge the pa-
limited to, hospice care services, post- tient, and also transfer or refer the pa-
hospital extended care services, home tient where applicable, along with all
health services, and non-health care necessary medical information per-
services and community based care taining to the patient’s current course
providers, and must also include a de- of illness and treatment, post-dis-
termination of the availability of the charge goals of care, and treatment
appropriate services as well as of the preferences, at the time of discharge,
patient’s access to those services. to the appropriate post-acute care serv-
(3) The discharge planning evaluation ice providers and suppliers, facilities,
must be included in the patient’s med- agencies, and other outpatient service
ical record for use in establishing an providers and practitioners responsible
appropriate discharge plan and the re- for the patient’s follow-up or ancillary
sults of the evaluation must be dis- care.
cussed with the patient (or the pa- (c) Standard: Requirements related to
tient’s representative). post-acute care services. For those pa-
(4) Upon the request of a patient’s tients discharged home and referred for
physician, the hospital must arrange HHA services, or for those patients
for the development and initial imple- transferred to a SNF for post-hospital
mentation of a discharge plan for the extended care services, or transferred
patient. to an IRF or LTCH for specialized hos-
(5) Any discharge planning evalua- pital services, the following require-
tion or discharge plan required under ments apply, in addition to those set
this paragraph must be developed by, out at paragraphs (a) and (b) of this
or under the supervision of, a reg- section:
36
(1) The hospital must include in the cordance with the provisions of part
discharge plan a list of HHAs, SNFs, 420, subpart C, of this chapter.
IRFs, or LTCHs that are available to [84 FR 51882, Sept. 30, 2019]
the patient, that are participating in
the Medicare program, and that serve § 482.45 Condition of participation:
the geographic area (as defined by the Organ, tissue, and eye procurement.
HHA) in which the patient resides, or (a) Standard: Organ procurement re-
in the case of a SNF, IRF, or LTCH, in sponsibilities. The hospital must have
the geographic area requested by the and implement written protocols that:
patient. HHAs must request to be list- (1) Incorporate an agreement with an
ed by the hospital as available. OPO designated under part 486 of this
(i) This list must only be presented chapter, under which it must notify, in
to patients for whom home health care a timely manner, the OPO or a third
post-hospital extended care services, party designated by the OPO of individ-
SNF, IRF, or LTCH services are indi- uals whose death is imminent or who
cated and appropriate as determined by have died in the hospital. The OPO de-
the discharge planning evaluation. termines medical suitability for organ
donation and, in the absence of alter-
(ii) For patients enrolled in managed
native arrangements by the hospital,
care organizations, the hospital must
the OPO determines medical suit-
make the patient aware of the need to ability for tissue and eye donation,
verify with their managed care organi- using the definition of potential tissue
zation which practitioners, providers and eye donor and the notification pro-
or certified suppliers are in the man- tocol developed in consultation with
aged care organization’s network. If the tissue and eye banks identified by
the hospital has information on which the hospital for this purpose;
practitioners, providers or certified (2) Incorporate an agreement with at
supplies are in the network of the pa- least one tissue bank and at least one
tient’s managed care organization, it eye bank to cooperate in the retrieval,
must share this with the patient or the processing, preservation, storage and
patient’s representative. distribution of tissues and eyes, as may
(iii) The hospital must document in be appropriate to assure that all usable
the patient’s medical record that the tissues and eyes are obtained from po-
list was presented to the patient or to tential donors, insofar as such an
the patient’s representative. agreement does not interfere with
(2) The hospital, as part of the dis- organ procurement;
charge planning process, must inform (3) Ensure, in collaboration with the
the patient or the patient’s representa- designated OPO, that the family of
tive of their freedom to choose among each potential donor is informed of its
options to donate organs, tissues, or
participating Medicare providers and
eyes or to decline to donate. The indi-
suppliers of post-discharge services and
vidual designated by the hospital to
must, when possible, respect the pa-
initiate the request to the family must
tient’s or the patient’s representative’s
be an organ procurement representa-
goals of care and treatment pref- tive or a designated requestor. A des-
erences, as well as other preferences ignated requestor is an individual who
they express. The hospital must not has completed a course offered or ap-
specify or otherwise limit the qualified proved by the OPO and designed in con-
providers or suppliers that are avail- junction with the tissue and eye bank
able to the patient. community in the methodology for ap-
(3) The discharge plan must identify proaching potential donor families and
any HHA or SNF to which the patient requesting organ or tissue donation;
is referred in which the hospital has a (4) Encourage discretion and sensi-
disclosable financial interest, as speci- tivity with respect to the cir-
fied by the Secretary, and any HHA or cumstances, views, and beliefs of the
SNF that has a disclosable financial in- families of potential donors;
terest in a hospital under Medicare. Fi- (5) Ensure that the hospital works
nancial interests that are disclosable cooperatively with the designated OPO,
under Medicare are determined in ac- tissue bank and eye bank in educating
37
§ 482.51 42 CFR Ch. IV (10–1–24 Edition)
staff on donation issues, reviewing (1) The operating rooms must be su-
death records to improve identification pervised by an experienced registered
of potential donors, and maintaining nurse or a doctor of medicine or oste-
potential donors while necessary test- opathy.
ing and placement of potential donated (2) Licensed practical nurses (LPNs)
organs, tissues, and eyes take place. and surgical technologists (operating
(b) Standard: Organ transplantation re- room technicians) may serve as ‘‘scrub
sponsibilities. (1) A hospital in which nurses’’ under the supervision of a reg-
organ transplants are performed must istered nurse.
be a member of the Organ Procurement (3) Qualified registered nurses may
and Transplantation Network (OPTN) perform circulating duties in the oper-
established and operated in accordance ating room. In accordance with appli-
with section 372 of the Public Health cable State laws and approved medical
Service (PHS) Act (42 U.S.C. 274) and staff policies and procedures, LPNs and
abide by its rules. The term ‘‘rules of surgical technologists may assist in
the OPTN’’ means those rules provided circulatory duties under the
for in regulations issued by the Sec- surpervision of a qualified registered
retary in accordance with section 372 of nurse who is immediately available to
the PHS Act which are enforceable respond to emergencies.
under 42 CFR 121.10. No hospital is con- (4) Surgical privileges must be delin-
sidered to be out of compliance with eated for all practitioners performing
section 1138(a)(1)(B) of the Act, or with surgery in accordance with the com-
the requirements of this paragraph, un- petencies of each practitioner. The sur-
less the Secretary has given the OPTN gical service must maintain a roster of
formal notice that he or she approves practitioners specifying the surgical
the decision to exclude the hospital privileges of each practitioner.
from the OPTN and has notified the (b) Standard: Delivery of service. Sur-
hospital in writing. gical services must be consistent with
(2) For purposes of these standards, needs and resources. Policies governing
the term ‘‘organ’’ means a human kid- surgical care must be designed to as-
ney, liver, heart, lung, or pancreas. sure the achievement and maintenance
(3) If a hospital performs any type of of high standards of medical practice
transplants, it must provide organ- and patient care.
transplant-related data, as requested (1) Prior to surgery or a procedure re-
by the OPTN, the Scientific Registry, quiring anesthesia services and except
and the OPOs. The hospital must also in the case of emergencies:
provide such data directly to the De- (i) A medical history and physical ex-
partment when requested by the Sec- amination must be completed and doc-
retary. umented no more than 30 days before
or 24 hours after admission or registra-
[63 FR 33875, June 22, 1998]
tion, and except as provided under
paragraph (b)(1)(iii) of this section.
Subpart D—Optional Hospital (ii) An updated examination of the
Services patient, including any changes in the
patient’s condition, must be completed
§ 482.51 Condition of participation: and documented within 24 hours after
Surgical services. admission or registration when the
If the hospital provides surgical serv- medical history and physical examina-
ices, the services must be well orga- tion are completed within 30 days be-
nized and provided in accordance with fore admission or registration, and ex-
acceptable standards of practice. If cept as provided under paragraph
outpatient surgical services are offered (b)(1)(iii) of this section.
the services must be consistent in qual- (iii) An assessment of the patient
ity with inpatient care in accordance must be completed and documented
with the complexity of services offered. after registration (in lieu of the re-
(a) Standard: Organization and staff- quirements of paragraphs (b)(1)(i) and
ing. The organization of the surgical (ii) of this section) when the patient is
services must be appropriate to the receiving specific outpatient surgical
scope of the services offered. or procedural services and when the
38
medical staff has chosen to develop and (5) An anesthesiologist’s assistant, as

maintain a policy that identifies, in ac- defined in § 410.69(b) of this chapter,
cordance with the requirements at who is under the supervision of an an-
§ 482.22(c)(5)(v), specific patients as not esthesiologist who is immediately
requiring a comprehensive medical his- available if needed.
tory and physical examination, or any (b) Standard: Delivery of services. An-
update to it, prior to specific out- esthesia services must be consistent
patient surgical or procedural services. with needs and resources. Policies on
(2) A properly executed informed con- anesthesia procedures must include the
sent form for the operation must be in delineation of preanesthesia and post
the patient’s chart before surgery, ex- anesthesia responsibilities. The poli-
cept in emergencies. cies must ensure that the following are
(3) The following equipment must be provided for each patient:
available to the operating room suites: (1) A preanesthesia evaluation com-
call-in-system, cardiac monitor, resus- pleted and documented by an indi-
citator, defibrillator, aspirator, and vidual qualified to administer anes-
tracheotomy set. thesia, as specified in paragraph (a) of
(4) There must be adequate provi- this section, performed within 48 hours
sions for immediate post-operative prior to surgery or a procedure requir-
care. ing anesthesia services.
(5) The operating room register must (2) An intraoperative anesthesia
be complete and up-to-date. record.
(6) An operative report describing (3) A postanesthesia evaluation com-
techniques, findings, and tissues re- pleted and documented by an indi-
moved or altered must be written or vidual qualified to administer anes-
dictated immediately following sur- thesia, as specified in paragraph (a) of
gery and signed by the surgeon. this section, no later than 48 hours
[51 FR 22042, June 17, 1986, as amended at 72 after surgery or a procedure requiring
FR 66933, Nov. 27, 2007; 84 FR 51821, Sept. 30, anesthesia services. The postanesthesia
2019] evaluation for anesthesia recovery
must be completed in accordance with
§ 482.52 Condition of participation: An- State law and with hospital policies
esthesia services. and procedures that have been ap-
If the hospital furnishes anesthesia proved by the medical staff and that
services, they must be provided in a reflect current standards of anesthesia
well-organized manner under the direc- care.
tion of a qualified doctor of medicine (c) Standard: State exemption. (1) A
or osteopathy. The service is respon- hospital may be exempted from the re-
sible for all anesthesia administered in quirement for physician supervision of
the hospital. CRNAs as described in paragraph (a)(4)
(a) Standard: Organization and staff- of this section, if the State in which
ing. The organization of anesthesia the hospital is located submits a letter
services must be appropriate to the to CMS signed by the Governor, fol-
scope of the services offered. Anes- lowing consultation with the State’s
thesia must be administered only by— Boards of Medicine and Nursing, re-
(1) A qualified anesthesiologist; questing exemption from physician su-
(2) A doctor of medicine or osteop- pervision of CRNAs. The letter from
athy (other than an anesthesiologist); the Governor must attest that he or
(3) A dentist, oral surgeon, or podia- she has consulted with State Boards of
trist who is qualified to administer an- Medicine and Nursing about issues re-
esthesia under State law; lated to access to and the quality of
(4) A certified registered nurse anes- anesthesia services in the State and
thetist (CRNA), as defined in § 410.69(b) has concluded that it is in the best in-
of this chapter, who, unless exempted terests of the State’s citizens to opt-
in accordance with paragraph (c)of this out of the current physician super-
section, is under the supervision of the vision requirement, and that the opt-
operating practitioner or of an anes- out is consistent with State law.
thesiologist who is immediately avail- (2) The request for exemption and
able if needed; or recognition of State laws, and the
39
§ 482.53 42 CFR Ch. IV (10–1–24 Edition)
withdrawal of the request may be sub- (1) The hospital must maintain cop-
mitted at any time, and are effective ies of nuclear medicine reports for at
upon submission. least 5 years.
(2) The practitioner approved by the
[51 FR 22042, June 17, 1986, as amended at 57
FR 33900, July 31, 1992; 66 FR 56769, Nov. 13, medical staff to interpret diagnostic
2001; 71 FR 68694, Nov. 27, 2006; 72 FR 66934, procedures must sign and date the in-
Nov. 27, 2007] terpretation of these tests.
(3) The hospital must maintain
§ 482.53 Condition of participation: records of the receipt and disposition of
Nuclear medicine services. radiopharmaceuticals.
If the hospital provides nuclear medi- (4) Nuclear medicine services must be
cine services, those services must meet ordered only by practitioner whose
the needs of the patients in accordance scope of Federal or State licensure and
with acceptable standards of practice. whose defined staff privileges allow
(a) Standard: Organization and staff- such referrals.
ing. The organization of the nuclear [51 FR 22042, June 17, 1986, as amended at 57
medicine service must be appropriate FR 7136, Feb. 28, 1992; 79 FR 27154, May 12,
to the scope and complexity of the 2014]
services offered.
(1) There must be a director who is a § 482.54 Condition of participation:
doctor of medicine or osteopathy quali- Outpatient services.
fied in nuclear medicine. If the hospital provides outpatient
(2) The qualifications, training, func- services, the services must meet the
tions, and responsibilities of nuclear needs of the patients in accordance
medicine personnel must be specified with acceptable standards of practice.
by the service director and approved by (a) Standard: Organization. Outpatient
the medical staff. services must be appropriately orga-
(b) Standard: Delivery of service. Ra- nized and integrated with inpatient
dioactive materials must be prepared, services.
labeled, used, transported, stored, and (b) Standard: Personnel. The hospital
disposed of in accordance with accept- must—
able standards of practice. (1) Assign one or more individuals to
(1) In-house preparation of radio- be responsible for outpatient services.
pharmaceuticals is by, or under the su- (2) Have appropriate professional and
pervision of, an appropriately trained nonprofessional personnel available at
registered pharmacist or a doctor of each location where outpatient serv-
medicine or osteopathy. ices are offered, based on the scope and
(2) There is proper storage and dis- complexity of outpatient services.
posal of radioactive material. (c) Standard: Orders for outpatient
(3) If laboratory tests are performed services. Outpatient services must be
in the nuclear medicine service, the ordered by a practitioner who meets
service must meet the applicable re- the following conditions:
quirement for laboratory services spec- (1) Is responsible for the care of the
ified in § 482.27. patient.
(c) Standard: Facilities. Equipment (2) Is licensed in the State where he
and supplies must be appropriate for or she provides care to the patient.
the types of nuclear medicine services (3) Is acting within his or her scope of
offered and must be maintained for safe practice under State law.
and efficient performance. The equip- (4) Is authorized in accordance with
ment must be— State law and policies adopted by the
(1) Maintained in safe operating con- medical staff, and approved by the gov-
dition; and erning body, to order the applicable
(2) Inspected, tested, and calibrated outpatient services. This applies to the
at least annually by qualified per- following:
sonnel. (i) All practitioners who are ap-
(d) Standard: Records. The hospital pointed to the hospital’s medical staff
must maintain signed and dated re- and who have been granted privileges
ports of nuclear medicine interpreta- to order the applicable outpatient serv-
tions, consultations, and procedures. ices.
40
(ii) All practitioners not appointed to therapy assistants, speech-language pa-

the medical staff, but who satisfy the thologists, or audiologists as defined in
above criteria for authorization by the part 484 of this chapter.
medical staff and the hospital for or- (b) Standard: Delivery of services. Serv-
dering the applicable outpatient services must only be provided under the
ices for their patients. orders of a qualified and licensed prac-
[51 FR 22042, June 17, 1986, as amended at 77 titioner who is responsible for the care
FR 29075, May 16, 2012; 79 FR 27154, May 12, of the patient, acting within his or her
2014] scope of practice under State law, and
who is authorized by the hospital’s
§ 482.55 Condition of participation: medical staff to order the services in
Emergency services. accordance with hospital policies and
The hospital must meet the emer- procedures and State laws.
gency needs of patients in accordance (1) All rehabilitation services orders
with acceptable standards of practice. must be documented in the patient’s
(a) Standard: Organization and direc- medical record in accordance with the
tion. If emergency services are provided requirements at § 482.24.
at the hospital— (2) The provision of care and the per-
(1) The services must be organized sonnel qualifications must be in ac-
under the direction of a qualified mem- cordance with national acceptable
ber of the medical staff; standards of practice and must also
(2) The services must be integrated meet the requirements of § 409.17 of this
with other departments of the hospital; chapter.
(3) The policies and procedures gov-
erning medical care provided in the [51 FR 22042, June 17, 1986, as amended at 72
FR 66406, Nov. 27, 2007; 75 FR 50418, Aug. 16,
emergency service or department are
2010]
established by and are a continuing re-
sponsibility of the medical staff. § 482.57 Condition of participation:
(b) Standard: Personnel. (1) The emer- Respiratory care services.
gency services must be supervised by a
qualified member of the medical staff. The hospital must meet the needs of
(2) There must be adequate medical the patients in accordance with accept-
and nursing personnel qualified in able standards of practice. The fol-
emergency care to meet the written lowing requirements apply if the hos-
emergency procedures and needs an- pital provides respiratory care service.
ticipated by the facility. (a) Standard: Organization and Staff-
ing. The organization of the respiratory
§ 482.56 Condition of participation: Re- care services must be appropriate to
habilitation services. the scope and complexity of the serv-
If the hospital provides rehabilita- ices offered.
tion, physical therapy, occupational (1) There must be a director of res-
therapy, audiology, or speech pathol- piratory care services who is a doctor
ogy services, the services must be orga- of medicine or osteopathy with the
nized and staffed to ensure the health knowledge experience, and capabilities
and safety of patients. to supervise and administer the service
(a) Standard: Organization and staff- properly. The director may serve on ei-
ing. The organization of the service ther a full-time or part-time basis.
must be appropriate to the scope of the (2) There must be adequate numbers
services offered. of respiratory therapists, respiratory
(1) The director of the services must therapy technicians, and other per-
have the necessary knowledge, experi- sonnel who meet the qualifications
ence, and capabilities to properly su- specified by the medical staff, con-
pervise and administer the services. sistent with State law.
(2) Physical therapy, occupational (b) Standard: Delivery of Services.
therapy, speech-language pathology or Services must be delivered in accord-
audiology services, if provided, must be ance with medical staff directives.
provided by qualified physical thera- (1) Personnel qualified to perform
pists, physical therapist assistants, oc- specific procedures and the amount of
cupational therapists, occupational supervision required for personnel to
41
§ 482.58 42 CFR Ch. IV (10–1–24 Edition)
carry out specific procedures must be cility requirements contained in sub-

designated in writing. part B of part 483 of this chapter.
(2) If blood gases or other laboratory (1) Resident rights (§ 483.10(b)(7),
tests are performed in the respiratory (c)(1), (c)(2)(iii), (c)(6), (d), (e)(2) and (4),
care unit, the unit must meet the ap- (f)(4)(ii) and (iii), (h), (g)(8) and (17), and
plicable requirements for laboratory (g)(18) introductory text of this chap-
services specified in § 482.27. ter).
(3) Services must only be provided (2) Admission, transfer, and discharge
under the orders of a qualified and li-
rights (§ 483.5 definition of transfer and
censed practitioner who is responsible
discharge, § 483.15(c)(1), (c)(2)(i),
for the care of the patient, acting with-
(c)(2)(ii), (c)(3), (c)(4), (c)(5), and (c)(7)).
in his or her scope of practice under
State law, and who is authorized by the (3) Freedom from abuse, neglect, and
hospital’s medical staff to order the exploitation (§ 483.12(a)(1), (a)(2),
services in accordance with hospital (a)(3)(i), (a)(3)(ii), (a)(4), (b)(1), (b)(2),
policies and procedures and State laws. (c)).
(4) All respiratory care services or- (4) Social services (§ 483.40(d) of this
ders must be documented in the pa- chapter).
tient’s medical record in accordance (5) Discharge summary (§ 483.20(l)).
with the requirements at § 482.24. (6) Specialized rehabilitative services
[51 FR 22042, June 17, 1986; 51 FR 27848, Aug. (§ 483.65).
4, 1986, as amended at 57 FR 7136, Feb. 28, (7) Dental services (§ 483.55(a)(2), (3),
1992; 75 FR 50418, Aug. 16, 2010] (4), and (5) and (b) of this chapter).
§ 482.58 Special requirements for hos- [72 FR 60788, Oct. 26, 2007. Redesignated at 79
pital providers of long-term care FR 27155, May 12, 2014, as amended at 81 FR
services (‘‘swing-beds’’). 68847, Oct. 4, 2016; 82 FR 32258, July 13, 2017;
84 FR 51821, Sept. 30, 2019]
A hospital that has a Medicare pro-
vider agreement must meet the fol-
lowing requirements in order to be Subpart E—Requirements for
granted an approval from CMS to pro- Specialty Hospitals
vide post-hospital extended care serv-
ices, as specified in § 409.30 of this chap- SOURCE: 72 FR 15273, Mar. 30, 2007, unless
ter, and be reimbursed as a swing-bed otherwise noted.
hospital, as specified in § 413.114 of this
chapter: § 482.60 Special provisions applying to
(a) Eligibility. A hospital must meet psychiatric hospitals.
the following eligibility requirements:
Psychiatric hospital must—
(1) The facility has fewer than 100
hospital beds, excluding beds for (a) Be primarily engaged in pro-
newborns and beds in intensive care viding, by or under the supervision of a
type inpatient units (for eligibility of doctor of medicine or osteopathy, psy-
hospitals with distinct parts electing chiatric services for the diagnosis and
the optional reimbursement method, treatment of mentally ill persons;
see § 413.24(d)(5) of this chapter). (b) Meet the conditions of participa-
(2) The hospital is located in a rural tion specified in §§ 482.1 through 482.23
area. This includes all areas not delin- and §§ 482.25 through 482.57;
eated as ‘‘urbanized’’ areas by the Cen- (c) Maintain clinical records on all
sus Bureau, based on the most recent patients, including records sufficient to
census. permit CMS to determine the degree
(3) The hospital does not have in ef- and intensity of treatment furnished to
fect a 24-hour nursing waiver granted Medicare beneficiaries, as specified in
under § 488.54(c) of this chapter. § 482.61; and
(4) The hospital has not had a swing- (d) Meet the staffing requirements
bed approval terminated within the specified in § 482.62.
two years previous to application.
(b) Skilled nursing facility services. The [72 FR 60788, Oct. 26, 2007]
facility is substantially in compliance
with the following skilled nursing fa-
42
§ 482.61 Condition of participation: tient’s strengths and disabilities. The

Special medical record require- written plan must include—
ments for psychiatric hospitals. (i) A substantiated diagnosis;
The medical records maintained by a (ii) Short-term and long-range goals;
psychiatric hospital must permit deter- (iii) The specific treatment modali-
mination of the degree and intensity of ties utilized;
the treatment provided to individuals (iv) The responsibilities of each mem-
who are furnished services in the insti- ber of the treatment team; and
tution. (v) Adequate documentation to jus-
(a) Standard: Development of assess- tify the diagnosis and the treatment
ment/diagnostic data. Medical records and rehabilitation activities carried
must stress the psychiatric compo- out.
nents of the record, including history (2) The treatment received by the pa-
of findings and treatment provided for tient must be documented in such a
the psychiatric condition for which the way to assure that all active thera-
patient is hospitalized. peutic efforts are included.
(1) The identification data must in- (d) Standard: Recording progress.
clude the patient’s legal status. Progress notes for the patient must be
(2) A provisional or admitting diag- documented, in accordance with appli-
nosis must be made on every patient at cable State scope-of-practice laws and
the time of admission, and must in- hospital policies, by the following
clude the diagnoses of intercurrent disqualified practitioners: Doctor(s) of
eases as well as the psychiatric diag- medicine or osteopathy, or other li-
noses. censed practitioner(s), who is respon-
(3) The reasons for admission must be sible for the care of the patient;
clearly documented as stated by the nurse(s) and social worker(s) (or social
patient and/or others significantly in- service staff) involved in the care of
volved. the patient; and, when appropriate,
(4) The social service records, includ- others significantly involved in the pa-
ing reports of interviews with patients, tient’s active treatment modalities.
family members, and others, must pro- The frequency of progress notes is de-
vide an assessment of home plans and termined by the condition of the pa-
family attitudes, and community re- tient but must be recorded at least
source contacts as well as a social his- weekly for the first 2 months and at
tory. least once a month thereafter and must
(5) When indicated, a complete neuro- contain recommendations for revisions
logical examination must be recorded in the treatment plan as indicated, as
at the time of the admission physical well as precise assessment of the pa-
examination. tient’s progress in accordance with the
(b) Standard: Psychiatric evaluation. original or revised treatment plan.
Each patient must receive a psy- (e) Standard: Discharge planning and
chiatric evaluation that must— discharge summary. The record of each
(1) Be completed within 60 hours of patient who has been discharged must
admission; have a discharge summary that in-
(2) Include a medical history; cludes a recapitulation of the patient’s
(3) Contain a record of mental status; hospitalization and recommendations
(4) Note the onset of illness and the from appropriate services concerning
circumstances leading to admission; follow-up or aftercare as well as a brief
(5) Describe attitudes and behavior; summary of the patient’s condition on
(6) Estimate intellectual functioning, discharge.
memory functioning, and orientation; (f) Standard: Electronic notifications. If
and the hospital utilizes an electronic med-
(7) Include an inventory of the pa- ical records system or other electronic
tient’s assets in descriptive, not inter- administrative system, which is
pretative, fashion. conformant with the content exchange
(c) Standard: Treatment plan. (1) Each standard at 45 CFR 170.205(d)(2), then
patient must have an individual com- the hospital must demonstrate that—
prehensive treatment plan that must (1) The system’s notification capac-
be based on an inventory of the pa- ity is fully operational and the hospital
43
§ 482.62 42 CFR Ch. IV (10–1–24 Edition)
uses it in accordance with all State and § 482.62 Condition of participation:

Federal statutes and regulations appli- Special staff requirements for psy-
cable to the hospital’s exchange of pa- chiatric hospitals.
tient health information. The hospital must have adequate
(2) The system sends notifications numbers of qualified professional and
that must include at least patient supportive staff to evaluate patients,
name, treating practitioner name, and formulate written, individualized com-
sending institution name. prehensive treatment plans, provide ac-
(3) To the extent permissible under tive treatment measures, and engage in
applicable federal and state law and discharge planning.
regulations, and not inconsistent with (a) Standard: Personnel. The hospital
the patient’s expressed privacy pref- must employ or undertake to provide
erences, the system sends notifications adequate numbers of qualified profes-
directly, or through an intermediary sional, technical, and consultative per-
that facilitates exchange of health in- sonnel to:
formation, at the time of: (1) Evaluate patients;
(i) The patient’s registration in the (2) Formulate written individualized,
hospital’s emergency department (if comprehensive treatment plans;
applicable). (3) Provide active treatment meas-
(ii) The patient’s admission to the ures; and
hospital’s inpatient services (if applica- (4) Engage in discharge planning.
ble). (b) Standard: Director of inpatient psy-
(4) To the extent permissible under chiatric services; medical staff. Inpatient
applicable federal and state law and psychiatric services must be under the
regulations, and not inconsistent with supervision of a clinical director, serv-
the patient’s expressed privacy pref- ice chief, or equivalent who is qualified
erences, the system sends notifications to provide the leadership required for
directly, or through an intermediary an intensive treatment program. The
that facilitates exchange of health in- number and qualifications of doctors of
formation, either immediately prior to, medicine and osteopathy must be ade-
or at the time of: quate to provide essential psychiatric
(i) The patient’s discharge or transfer services.
from the hospital’s emergency depart- (1) The clinical director, service
ment (if applicable). chief, or equivalent must meet the
(ii) The patient’s discharge or trans- training and experience requirements
fer from the hospital’s inpatient serv- for examination by the American
ices (if applicable). Board of Psychiatry and Neurology or
(5) The hospital has made a reason- the American Osteopathic Board of
able effort to ensure that the system Neurology and Psychiatry.
sends the notifications to all applicable (2) The director must monitor and
post-acute care services providers and evaluate the quality and appropriate-
suppliers, as well as to any of the fol- ness of services and treatment provided
lowing practitioners and entities, by the medical staff.
which need to receive notification of (c) Standard: Availability of medical
the patient’s status for treatment, care personnel. Doctors of medicine or oste-
coordination, or quality improvement opathy and other appropriate profes-
purposes: sional personnel must be available to
(i) The patient’s established primary provide necessary medical and surgical
care practitioner; diagnostic and treatment services. If
(ii) The patient’s established primary medical and surgical diagnostic and
care practice group or entity; or treatment services are not available
(iii) Other practitioner, or other within the institution, the institution
practice group or entity, identified by must have an agreement with an out-
the patient as the practitioner, or prac- side source of these services to ensure
tice group or entity, primarily respon- that they are immediately available or
sible for his or her care. a satisfactory agreement must be es-
[72 FR 60788, Oct. 26, 2007, as amended at 84 tablished for transferring patients to a
FR 51821, Sept. 30, 2019; 85 FR 19292, Apr. 6, general hospital that participates in
2020; 85 FR 25637, May 1, 2020] the Medicare program.
44
(d) Standard: Nursing services. The arranging for follow-up care, and devel-
hospital must have a qualified director oping mechanisms for exchange of ap-
of psychiatric nursing services. In addi- propriate, information with sources
tion to the director of nursing, there outside the hospital.
must be adequate numbers of reg- (g) Standard: Therapeutic activities.
istered nurses, licensed practical The hospital must provide a thera-
nurses, and mental health workers to peutic activities program.
provide nursing care necessary under (1) The program must be appropriate
each patient’s active treatment pro- to the needs and interests of patients
gram and to maintain progress notes
and be directed toward restoring and
on each patient.
maintaining optimal levels of physical
(1) The director of psychiatric nurs-
ing services must be a registered nurse and psychosocial functioning.
who has a master’s degree in psy- (2) The number of qualified thera-
chiatric or mental health nursing, or pists, support personnel, and consult-
its equivalent from a school of nursing ants must be adequate to provide com-
accredited by the National League for prehensive therapeutic activities con-
Nursing, or be qualified by education sistent with each patient’s active
and experience in the care of the men- treatment program.
tally ill. The director must dem- [72 FR 60788, Oct. 26, 2007]
onstrate competence to participate in
interdisciplinary formulation of indi- § 482.68 Special requirement for trans-
vidual treatment plans; to give skilled plant programs.
nursing care and therapy; and to di-
rect, monitor, and evaluate the nursing A transplant program located within
care furnished. a hospital that has a Medicare provider
(2) The staffing pattern must insure agreement must meet the conditions of
the availability of a registered profes- participation specified in §§ 482.72
sional nurse 24 hours each day. There through 482.104 in order to be granted
must be adequate numbers of reg- approval from CMS to provide trans-
istered nurses, licensed practical plant services.
nurses, and mental health workers to (a) Unless specified otherwise, the
provide the nursing care necessary conditions of participation at §§ 482.72
under each patient’s active treatment through 482.104 apply to heart, heart-
program. lung, intestine, kidney, liver, lung, and
(e) Standard: Psychological services. pancreas centers.
The hospital must provide or have (b) In addition to meeting the condi-
available psychological services to tions of participation specified in
meet the needs of the patients. §§ 482.72 through 482.104, a transplant
(f) Standard: Social services. There program must also meet the conditions
must be a director of social services
of participation in §§ 482.1 through
who monitors and evaluates the qual-
482.57, except for § 482.15.
ity and appropriateness of social serv-
ices furnished. The services must be [81 FR 64030, Sept. 16, 2016, as amended at 84
furnished in accordance with accepted FR 51821, Sept. 30, 2019]
standards of practice and established
policies and procedures. § 482.70 Definitions.
(1) The director of the social work de- As used in this subpart, the following
partment or service must have a mas- definitions apply:
ter’s degree from an accredited school Adverse event means an untoward, un-
of social work or must be qualified by desirable, and usually unanticipated
education and experience in the social
event that causes death or serious in-
services needs of the mentally ill. If
jury, or the risk thereof. As applied to
the director does not hold a masters
transplant programs, examples of ad-
degree in social work, at least one staff
member must have this qualification. verse events include (but are not lim-
(2) Social service staff responsibil- ited to) serious medical complications
ities must include, but are not limited or death caused by living donation; un-
to, participating in discharge planning, intentional transplantation of organs
45
§ 482.72 42 CFR Ch. IV (10–1–24 Edition)
of mismatched blood types; transplan- cordance with section 372 of the Public
tation of organs to unintended bene- Health Service (PHS) Act (42 U.S.C.
ficiaries; and unintended transmission 274). The term ‘‘rules and requirements
of infectious disease to a beneficiary. of the OPTN’’ means those rules and
End-Stage Renal Disease (ESRD) requirements approved by the Sec-
means that stage of renal impairment retary pursuant to § 121.4 of this title.
that appears irreversible and perma- No hospital that provides transplan-
nent, and requires a regular course of tation services shall be deemed to be
dialysis or kidney transplantation to out of compliance with section
maintain life. 1138(a)(1)(B) of the Act or this section
ESRD Network means all Medicare-
unless the Secretary has given the
approved ESRD facilities in a des-
OPTN formal notice that he or she ap-
ignated geographic area specified by
proves the decision to exclude the
CMS.
Heart-Lung transplant program means transplant hospital from the OPTN and
a transplant program that is located in also has notified the transplant hos-
a hospital with an existing Medicare- pital in writing.
approved heart transplant program and [51 FR 22042, June 17, 1986, as amended at 84
an existing Medicare-approved lung FR 51822, Sept. 30, 2019]
program that performs combined
heart-lung transplants. § 482.74 Condition of participation: No-
Intestine transplant program means a tification to CMS.
Medicare-approved liver transplant (a) A transplant program must notify
program that performs intestine trans- CMS immediately of any significant
plants, combined liver-intestine trans-
changes related to the hospital’s trans-
plants, or multivisceral transplants.
plant program or changes that could
Network organization means the ad-
ministrative governing body to the affect its compliance with the condi-
network and liaison to the Federal gov- tions of participation. Instances in
ernment. which CMS should receive information
Pancreas transplant program means a for follow up, as appropriate, include,
Medicare-approved kidney transplant but are not limited to:
program that performs pancreas trans- (1) Change in key staff members of
plants alone or subsequent to a kidney the transplant team, such as a change
transplant as well as kidney-pancreas in the individual the transplant pro-
transplants. gram designated to the OPTN as the
Transplant hospital means a hospital program’s ‘‘primary transplant sur-
that furnishes organ transplants and geon’’ or ‘‘primary transplant physi-
other medical and surgical specialty cian;’
services required for the care of trans- (2) Termination of an agreement be-
plant patients. tween the hospital in which the trans-
Transplant program means an organ- plant program is located and an OPO
specific transplant program within a for the recovery and receipt of organs
transplant hospital (as defined in this as required by section 482.100; and
section).
(3) Inactivation of the transplant pro-
[51 FR 22042, June 17, 1986, as amended at 84 gram.
FR 51821, Sept. 30, 2019] (b) Upon receiving notification of sig-
GENERAL REQUIREMENTS FOR nificant changes, CMS will follow up
TRANSPLANT CENTERS with the transplant program as appro-
priate, including (but not limited to):
§ 482.72 Condition of participation: (1) Requesting additional informa-
OPTN membership. tion;
A transplant program must be lo- (2) Analyzing the information; or
cated in a transplant hospital that is a (3) Conducting an on-site review.
member of and abides by the rules and
[72 FR 15273, Mar. 30, 2007, as amended at 79
requirements of the Organ Procure-
FR 27155, May 12, 2014; 84 FR 51822, Sept. 30,
ment and Transplantation Network 2019]
(OPTN) established and operated in ac-
46
§ 482.76 Condition of participation: Pe- (d) Instead of meeting all conditions

diatric Transplants. of participation at §§ 482.72 through
A transplant center that seeks Medi- 482.74 and §§ 482.80 through 482.104, a
care approval to provide transplan- heart transplant center that wishes to
tation services to pediatric patients provide transplantation services to pe-
must submit to CMS a request specifi- diatric heart patients may be approved
cally for Medicare approval to perform to perform pediatric heart transplants
pediatric transplants using the proce- by meeting the Omnibus Budget Rec-
dures described at § 488.61 of this chap- onciliation Act of 1987 criteria in sec-
ter. tion 4009(b) (Pub. L. 100–203), as follows:
(a) Except as specified in paragraph (1) The center’s pediatric transplant
(d) of this section, a center requesting program must be operated jointly by
Medicare approval to perform pediatric the hospital and another facility that
transplants must meet all the condi- is Medicare-approved;
tions of participation at §§ 482.72 (2) The unified program shares the
through 482.74 and §§ 482.80 through same transplant surgeons and quality
482.104 with respect to its pediatric pa- improvement program (including over-
tients. sight committee, patient protocol, and
(b) A center that performs 50 percent patient selection criteria); and
or more of its transplants in a 12- (3) The center demonstrates to the
month period on adult patients must satisfaction of the Secretary that it is
be approved to perform adult trans- able to provide the specialized facili-
plants in order to be approved to per- ties, services, and personnel that are
form pediatric transplants. required by pediatric heart transplant
(1) Loss of Medicare approval to per- patients.
form adult transplants, whether vol-
untary or involuntary, will result in § 482.78 Condition of participation:
Emergency preparedness for trans-
loss of the center’s approval to perform plant programs.
pediatric transplants.
(2) Loss of Medicare approval to per- A transplant program must be in-
form pediatric transplants, whether cluded in the emergency preparedness
voluntary or involuntary, may trigger planning and the emergency prepared-
a review of the center’s Medicare ap- ness program as set forth in § 482.15 for
proval to perform adult transplants. the hospital in which it is located.
(c) A center that performs 50 percent However, a transplant program is not
or more of its transplants in a 12- individually responsible for the emer-
month period on pediatric patients gency preparedness requirements set
must be approved to perform pediatric forth in § 482.15.
transplants in order to be approved to (a) Standard: Policies and procedures.
perform adult transplants. A transplant program must have poli-
(1) Loss of Medicare approval to per- cies and procedures that address emer-
form pediatric transplants, whether gency preparedness. These policies and
voluntary or involuntary, will result in procedures must be included in the hos-
loss of the center’s approval to perform pital’s emergency preparedness pro-
adult transplants. gram.
(2) Loss of Medicare approval to per- (b) Standard: Protocols with hospital
form adult transplants, whether vol- and OPO. A transplant program must
untary or involuntary, may trigger a develop and maintain mutually agreed
review of the center’s Medicare ap- upon protocols that address the duties
proval to perform pediatric trans- and responsibilities of the transplant
plants. program, the hospital in which the
(3) A center that performs 50 percent transplant program is operated, and
or more of its transplants on pediatric the OPO designated by the Secretary,
patients in a 12-month period is not re- unless the hospital has an approved
quired to meet the clinical experience waiver to work with another OPO, dur-
requirements prior to its request for ing an emergency.
approval as a pediatric transplant cen- [81 FR 64030, Sept. 16, 2016, as amended at 84
ter. FR 51822, Sept. 30, 2019]
47
§ 482.80 42 CFR Ch. IV (10–1–24 Edition)
TRANSPLANT CENTER DATA SUBMISSION, (ii) All three of the following thresh-
CLINICAL EXPERIENCE, AND OUTCOME olds are crossed over:
REQUIREMENTS (A) The one-sided p-value is less than
0.05,
§ 482.80 Condition of participation: (B) The number of observed events
Data submission, clinical experi-
ence, and outcome requirements for (patient deaths or graft failures) minus
initial approval of transplant pro- the number of expected events is great-
grams. er than 3, and
Except as specified in paragraph (d) (C) The number of observed events di-
of this section, and § 488.61 of this chap- vided by the number of expected events
ter, transplant programs must meet all is greater than 1.85.
data submission, clinical experience, (d) Exceptions. (1) A heart-lung trans-
and outcome requirements to be grant- plant program is not required to com-
ed initial approval by CMS. ply with the clinical experience re-
(a) Standard: Data submission. No quirements in paragraph (b) of this sec-
later than 90 days after the due date es- tion or the outcome requirements in
tablished by the OPTN, a transplant paragraph (c) of this section for heart-
program must submit to the OPTN at lung transplants performed at the pro-
least 95 percent of required data on all gram.
transplants (deceased and living donor) (2) An intestine transplant program
it has performed. Required data sub- is not required to comply with the out-
missions include, but are not limited come performance requirements in
to, submission of the appropriate paragraph (c) of this section for intes-
OPTN forms for transplant candidate tine, combined liver-intestine or multi-
registration, transplant recipient reg- visceral transplants performed at the
istration and follow-up, and living program.
donor registration and follow-up. (3) A pancreas transplant program is
(b) Standard: Clinical experience. To be not required to comply with the clin-
considered for initial approval, an ical experience requirements in para-
organ-specific transplant program graph (b) of this section or the outcome
must generally perform 10 transplants requirements in paragraph (c) of this
over a 12-month period. section for pancreas transplants per-
(c) Standard: Outcome requirements. formed at the program.
CMS will review outcomes for all (4) A program that is requesting ini-
transplants performed at a program, tial Medicare approval to perform pedi-
including outcomes for living donor atric transplants is not required to
transplants, if applicable. CMS will re- comply with the clinical experience re-
view adult and pediatric outcomes sep- quirements in paragraph (b) of this sec-
arately when a program requests Medi- tion prior to its request for approval as
care approval to perform both adult a pediatric transplant program.
and pediatric transplants.
(5) A kidney transplant program that
(1) CMS will compare each transplant
is not Medicare-approved on the effec-
program’s observed number of patient
deaths and graft failures 1-year post- tive date of this rule is required to per-
transplant to the center’s expected form at least 3 transplants over a 12-
number of patient deaths and graft month period prior to its request for
failures 1-year post-transplant using initial approval.
the data contained in the most recent [72 FR 15273, Mar. 30, 2007, as amended at 79
Scientific Registry of Transplant Re- FR 27155, May 12, 2014; 81 FR 79880, Nov. 14,
cipients (SRTR) program-specific re- 2016; 84 FR 51822, Sept. 30, 2019]
port.
(2) CMS will not consider a program’s TRANSPLANT PROGRAM PROCESS
patient and graft survival rates to be REQUIREMENTS
acceptable if:
(i) A program’s observed patient sur- § 482.90 Condition of participation: Pa-
vival rate or observed graft survival tient and living donor selection.
rate is lower than its expected patient The transplant program must use
survival rate or expected graft survival written patient selection criteria in de-
rate; and termining a patient’s suitability for
48
placement on the waiting list or a pa- medical suitability of donor organs for
tient’s suitability for transplantation. transplantation into the intended re-
If a program performs living donor cipient.
transplants, the program also must use (a) Standard: Organ receipt. After an
written donor selection criteria in de- organ arrives at a transplant program,
termining the suitability of candidates prior to transplantation, the trans-
for donation. planting surgeon and another licensed
(a) Standard: Patient selection. Patient health care professional must verify
selection criteria must ensure fair and that the donor’s blood type and other
non-discriminatory distribution of or- vital data are compatible with trans-
gans. plantation of the intended recipient.
(1) Prior to placement on the pro- (b) Standard: Living donor transplan-
gram’s waiting list, a prospective tation. If a program performs living
transplant candidate must receive a donor transplants, the transplanting
psychosocial evaluation, if possible. surgeon and another licensed health
(2) Before a transplant program care professional at the program must
places a transplant candidate on its verify that the living donor’s blood
waiting list, the candidate’s medical type and other vital data are compat-
record must contain documentation ible with transplantation of the in-
that the candidate’s blood type has tended recipient immediately before
been determined. the removal of the donor organ(s) and,
(3) When a patient is placed on a pro- if applicable, prior to the removal of
gram’s waiting list or is selected to re- the recipient’s organ(s).
ceive a transplant, the center must
document in the patient’s medical [51 FR 22042, June 17, 1986, as amended at 77
record the patient selection criteria FR 29076, May 16, 2012; 84 FR 51822, Sept. 30,
used. 2019]
(4) A transplant program must pro-
§ 482.94 Condition of participation: Pa-
vide a copy of its patient selection cri- tient and living donor management.
teria to a transplant patient, or a di-
alysis facility, as requested by a pa- Transplant programs must have writ-
tient or a dialysis facility. ten patient management policies for
(b) Standard: Living donor selection. the transplant and discharge phases of
The living donor selection criteria transplantation. If a transplant pro-
must be consistent with the general gram performs living donor trans-
principles of medical ethics. Trans- plants, the program also must have
plant programs must: written donor management policies for
(1) Ensure that a prospective living the donor evaluation, donation, and
donor receives a medical and psycho- discharge phases of living organ dona-
social evaluation prior to donation, tion.
(2) Document in the living donor’s (a) Standard: Patient and living donor
medical records the living donor’s suit- care. The transplant program’s patient
ability for donation, and and donor management policies must
(3) Document that the living donor ensure that:
has given informed consent, as required (1) Each transplant patient is under
under § 482.102. the care of a multidisciplinary patient
[72 FR 15273, Mar. 30, 2007, as amended at 84 care team coordinated by a physician
FR 51822, Sept. 30, 2019] throughout the transplant and dis-
charge phases of transplantation; and
§ 482.92 Condition of participation: (2) If a program performs living donor
Organ recovery and receipt. transplants, each living donor is under
Transplant programs must have writ- the care of a multidisciplinary patient
ten protocols for validation of donor- care team coordinated by a physician
recipient blood type and other vital throughout the donor evaluation, dona-
data for the deceased organ recovery, tion, and discharge phases of donation.
organ receipt, and living donor organ (b) Standard: Waiting list management.
transplantation processes. The trans- Transplant programs must keep their
planting surgeon at the transplant pro- waiting lists up to date on an ongoing
gram is responsible for ensuring the basis, including:
49
§ 482.96 42 CFR Ch. IV (10–1–24 Edition)
(1) Updating of waiting list patients’ tients, living donors, and their fami-
clinical information; lies. A qualified social worker is an in-
(2) Removing patients from the pro- dividual who meets licensing require-
gram’s waiting list if a patient receives ments in the State in which he or she
a transplant or dies, or if there is any practices; and
other reason the patient should no (1) Completed a course of study with
longer be on a program’s waiting list; specialization in clinical practice and
and holds a master’s degree from a grad-
(3) Notifying the OPTN no later than uate school of social work accredited
24 hours after a patient’s removal from by the Council on Social Work Edu-
the program’s waiting list. cation; or
(c) Standard: Patient records. Trans- (2) Is working as a social worker in a
plant programs must maintain up-to- transplant program as of the effective
date and accurate patient management date of this final rule and has served
records for each patient who receives for at least 2 years as a social worker,
an evaluation for placement on a pro- 1 year of which was in a transplan-
gram’s waiting list and who is admit- tation program, and has established a
ted for organ transplantation. consultative relationship with a social
(1) For each patient who receives an worker who is qualified under (d)(1) of
evaluation for placement on a pro- this paragraph.
gram’s waiting list, the program must (e) Standard: Nutritional services.
document in the patient’s record that Transplant programs must make nutri-
the patient (and in the case of a kidney tional assessments and diet counseling
patient, the patient’s usual dialysis fa- services, furnished by a qualified dieti-
cility) has been informed of his or her tian, available to all transplant pa-
transplant status, including notifica- tients and living donors. A qualified di-
tion of: etitian is an individual who meets
(i) The patient’s placement on the practice requirements in the State in
program’s waiting list; which he or she practices and is a reg-
(ii) The program’s decision not to istered dietitian with the Commission
place the patient on its waiting list; or on Dietetic Registration.
(iii) The program’s inability to make [72 FR 15273, Mar. 30, 2007, as amended at 84
a determination regarding the pa- FR 51822, Sept. 30, 2019]
tient’s placement on its waiting list be-
cause further clinical testing or docu- § 482.96 Condition of participation:
mentation is needed. Quality assessment and perform-
(2) If a patient on the waiting list is ance improvement (QAPI).
removed from the waiting list for any Transplant programs must develop,
reason other than death or transplan- implement, and maintain a written,
tation, the transplant program must comprehensive, data-driven QAPI pro-
document in the patient’s record that gram designed to monitor and evaluate
the patient (and in the case of a kidney performance of all transplantation
patient, the patient’s usual dialysis fa- services, including services provided
cility) was notified no later than 10 under contract or arrangement.
days after the date the patient was re- (a) Standard: Components of a QAPI
moved from the waiting list. program. The transplant program’s
(3) In the case of patients admitted QAPI program must use objective
for organ transplants, transplant pro- measures to evaluate the center’s per-
grams must maintain written records formance with regard to transplan-
of: tation activities and outcomes. Out-
(i) Multidisciplinary patient care come measures may include, but are
planning during the transplant period; not limited to, patient and donor selec-
and tion criteria, accuracy of the waiting
(ii) Multidisciplinary discharge plan- list in accordance with the OPTN wait-
ning for post-transplant care. ing list requirements, accuracy of
(d) Standard: Social services. The donor and recipient matching, patient
transplant program must make social and donor management, techniques for
services available, furnished by quali- organ recovery, consent practices, pa-
fied social workers, to transplant patient education, patient satisfaction,
50
and patient rights. The transplant pro- (3) Ensuring that transplantation
gram must take actions that result in surgery is performed by, or under the
performance improvements and track direct supervision of, a qualified trans-
performance to ensure that improve- plant surgeon in accordance with
ments are sustained. § 482.98(b).
(b) Standard: Adverse events. A trans- (b) Standard: Transplant surgeon and
plant program must establish and im- physician. The transplant program
plement written policies to address and must identify to the OPTN a primary
document adverse events that occur transplant surgeon and a transplant
during any phase of an organ trans- physician with the appropriate train-
plantation case. ing and experience to provide trans-
(1) The policies must address, at a plantation services, who are imme-
minimum, the process for the identi- diately available to provide transplan-
fication, reporting, analysis, and pretation services when an organ is of-
vention of adverse events. fered for transplantation.
(2) The transplant program must con- (1) The transplant surgeon is respon-
duct a thorough analysis of and docu- sible for providing surgical services re-
ment any adverse event and must uti- lated to transplantation.
lize the analysis to effect changes in (2) The transplant physician is re-
the transplant program’s policies and sponsible for providing and coordi-
practices to prevent repeat incidents. nating transplantation care.
[72 FR 15273, Mar. 30, 2007, as amended at 84 (c) Standard: Clinical transplant coor-
FR 51822, Sept. 30, 2019] dinator. The transplant program must
have a clinical transplant coordinator
§ 482.98 Condition of participation: to ensure the continuity of care of pa-
Human resources. tients and living donors during the pre-
The transplant program must ensure transplant, transplant, and discharge
that all individuals who provide serv- phases of transplantation and the
ices and/or supervise services at the donor evaluation, donation, and dis-
program, including individuals fur- charge phases of donation. The clinical
nishing services under contract or ar- transplant coordinator must be a reg-
rangement, are qualified to provide or istered nurse or clinician licensed by
supervise such services. the State in which the clinical trans-
(a) Standard: Director of a transplant plant coordinator practices, who has
program. The transplant program must experience and knowledge of transplan-
be under the general supervision of a tation and living donation issues. The
qualified transplant surgeon or a quali- clinical transplant coordinator’s re-
fied physician-director. The director of sponsibilities must include, but are not
a transplant program need not serve limited to, the following:
full-time and may also serve as a pro- (1) Ensuring the coordination of the
gram’s primary transplant surgeon or clinical aspects of transplant patient
transplant physician in accordance and living donor care; and
with § 482.98(b). The director is respon- (2) Acting as a liaison between a kid-
sible for planning, organizing, con- ney transplant program and dialysis fa-
ducting, and directing the transplant cilities, as applicable.
program and must devote sufficient (d) Standard: Independent living donor
time to carry out these responsibil- advocate or independent living donor ad-
ities, which include but are not limited vocate team. The transplant program
to the following: that performs living donor transplan-
(1) Coordinating with the hospital in tation must identify either an inde-
which the transplant program is lo- pendent living donor advocate or an
cated to ensure adequate training of independent living donor advocate
nursing staff and clinical transplant team to ensure protection of the rights
coordinators in the care of transplant of living donors and prospective living
patients and living donors. donors.
(2) Ensuring that tissue typing and (1) The independent living donor ad-
organ procurement services are avail- vocate or independent living donor ad-
able. vocate team must not be involved in
51
§ 482.100 42 CFR Ch. IV (10–1–24 Edition)
transplantation activities on a routine § 482.102 Condition of participation:

basis. Patient and living donor rights.
(2) The independent living donor ad- In addition to meeting the condition
vocate or independent living donor ad- of participation ‘‘Patients rights’’ re-
vocate team must demonstrate: quirements at § 482.13, the transplant
(i) Knowledge of living organ dona- program must protect and promote
tion, transplantation, medical ethics, each transplant patient’s and living do-
and informed consent; and nor’s rights.
(ii) Understanding of the potential (a) Standard: Informed consent for
impact of family and other external transplant patients. Transplant pro-
pressures on the prospective living do- grams must implement written trans-
nor’s decision whether to donate and plant patient informed consent policies
the ability to discuss these issues with that inform each patient of:
the donor. (1) The evaluation process;
(3) The independent living donor ad- (2) The surgical procedure;
vocate or independent living donor ad- (3) Alternative treatments;
vocate team is responsible for: (4) Potential medical or psychosocial
(i) Representing and advising the risks;
donor; (5) National and transplant program-
(ii) Protecting and promoting the in- specific outcomes, from the most re-
terests of the donor; and cent SRTR program-specific report, in-
(iii) Respecting the donor’s decision cluding (but not limited to) the trans-
and ensuring that the donor’s decision plant program’s observed and expected
is informed and free from coercion. 1-year patient and graft survival, and
(e) Standard: Transplant team. The
national 1-year patient and graft sur-
transplant program must identify a
vival;
multidisciplinary transplant team and
(6) Organ donor risk factors that
describe the responsibilities of each
could affect the success of the graft or
member of the team. The team must be
the health of the patient, including,
composed of individuals with the ap-
but not limited to, the donor’s history,
propriate qualifications, training, and
condition or age of the organs used, or
experience in the relevant areas of
the patient’s potential risk of con-
medicine, nursing, nutrition, social
tracting the human immunodeficiency
services, transplant coordination, and
pharmacology. virus and other infectious diseases if
(f) Standard: Resource commitment. the disease cannot be detected in an in-
The transplant program must dem- fected donor;
onstrate availability of expertise in in- (7) His or her right to refuse trans-
ternal medicine, surgery, anesthesi- plantation; and
ology, immunology, infectious disease (8) The fact that if his or her trans-
control, pathology, radiology, blood plant is not provided in a Medicare-ap-
banking, and patient education as re- proved transplant program it could af-
lated to the provision of transplan- fect the transplant recipient’s ability
tation services. to have his or her immunosuppressive
drugs paid for under Medicare Part B.
[72 FR 15273, Mar. 30, 2007, as amended at 84 (b) Standard: Informed consent for liv-
FR 51822, Sept. 30, 2019] ing donors. Transplant programs must
implement written living donor in-
Organ procurement. formed consent policies that inform
the prospective living donor of all as-
The transplant program must ensure pects of, and potential outcomes from,
that the hospital in which it operates living donation. Transplant programs
has a written agreement for the receipt must ensure that the prospective living
of organs with an OPO designated by donor is fully informed about the fol-
the Secretary that identifies specific lowing:
responsibilities for the hospital and for (1) The fact that communication be-
the OPO with respect to organ recovery tween the donor and the transplant
and organ allocation. program will remain confidential, in
[72 FR 15273, Mar. 30, 2007, as amended at 84 accordance with the requirements at 45
FR 51822, Sept. 30, 2019] CFR parts 160 and 164.
52
Centers for Medicare & Medicaid Services, HHS Pt. 483
(2) The evaluation process; (ii) Inform Medicare recipients on the

(3) The surgical procedure, including program’s waiting list that Medicare
post-operative treatment; will no longer pay for transplants per-
(4) The availability of alternative formed at the program after the effec-
treatments for the transplant recipi- tive date of the program’s termination
ent; of approval.
(5) The potential medical or psycho- (3) As soon as possible prior to a
social risks to the donor; transplant program’s voluntary inac-
(6) The national and transplant pro- tivation, the program must inform pa-
gram-specific outcomes for recipients, tients on the program’s waiting list
and the national and transplant-spe- and, as directed by the Secretary, pro-
cific outcomes for living donors, as vide assistance to waiting list patients
data are available; who choose to transfer to the waiting
(7) The possibility that future health list of another Medicare-approved
problems related to the donation may transplant program without loss of
not be covered by the donor’s insurance time accrued on the waiting list.
and that the donor’s ability to obtain [72 FR 15273, Mar. 30, 2007, as amended at 84
health, disability, or life insurance FR 51822, 51824, Sept. 30, 2019]
may be affected;
(8) The donor’s right to opt out of do- § 482.104 Condition of participation:
Additional requirements for kidney
nation at any time during the donation transplant programs.
process; and
(9) The fact that if a transplant is not (a) Standard: End stage renal disease
provided in a Medicare-approved trans- (ESRD) services. Kidney transplant pro-
plant program it could affect the trans- grams must directly furnish transplan-
plant recipient’s ability to have his or tation and other medical and surgical
her immunosuppressive drugs paid for specialty services required for the care
under Medicare Part B. of ESRD patients. A kidney transplant
(c) Standard: Notification to patients. program must have written policies
Transplant programs must notify pa- and procedures for ongoing commu-
tients placed on the program’s waiting nications with dialysis patients’ local
list of information about the program dialysis facilities.
that could impact the patient’s ability (b) Standard: Dialysis services. Kidney
to receive a transplant should an organ transplant programs must furnish in-
become available, and what procedures patient dialysis services directly or
are in place to ensure the availability under arrangement.
of a transplant team. (c) Standard: Participation in network
activities. Kidney transplant programs
(1) A transplant program served by a
must cooperate with the ESRD Net-
single transplant surgeon or physician
work designated for their geographic
must inform patients placed on the
area, in fulfilling the terms of the Net-
program’s waiting list of:
work’s current statement of work.
(i) The potential unavailability of
the transplant surgeon or physician; [72 FR 15273, Mar. 30, 2007, as amended at 84
and FR 51824, Sept. 30, 2019]
(ii) Whether the center has a mecha-
nism to provide an alternate trans-
plant surgeon or transplant physician. PART 483—REQUIREMENTS FOR
(2) At least 30 days before a pro- STATES AND LONG TERM CARE
gram’s Medicare approval is termi- FACILITIES
nated, whether voluntarily or involun-
tarily, the center must: Subpart A [Reserved]
(i) Inform patients on the program’s
waiting list and provide assistance to Subpart B—Requirements for Long Term
waiting list patients who choose to Care Facilities
transfer to the waiting list of another Sec.
Medicare-approved transplant program 483.1 Basis and scope.
without loss of time accrued on the 483.5 Definitions.
waiting list; and 483.10 Resident rights.
53
Pt. 483 42 CFR Ch. IV (10–1–24 Edition)
483.12 Freedom from abuse, neglect, and ex- 483.138 Maintenance of services and avail-
ploitation. ability of FFP.
483.15 Admission, transfer, and discharge
rights. Subpart D—Requirements That Must Be Met
483.20 Resident assessment. by States and State Agencies: Nurse
483.21 Comprehensive person-centered care Aide Training and Competency Eval-
planning. uation; and Paid Feeding Assistants
483.24 Quality of life.
483.150 Statutory basis; Deemed meeting or
483.25 Quality of care.
waiver of requirements.
483.30 Physician services.
483.151 State review and approval of nurse
483.35 Nursing services. aide training and competency evaluation
483.40 Behavioral health services. programs.
483.45 Pharmacy services. 483.152 Requirements for approval of a nurse
483.50 Laboratory, radiology, and other di- aide training and competency evaluation
agnostic services. program.
483.55 Dental services. 483.154 Nurse aide competency evaluation.
483.60 Food and nutrition services. 483.156 Registry of nurse aides.
483.65 Specialized rehabilitative services. 483.158 FFP for nurse aide training and
483.70 Administration. competency evaluation.
483.71 Facility assessment. 483.160 Requirements for training of paid
483.73 Emergency preparedness. feeding assistants.
483.75 Quality assurance and performance
improvement.
Subpart E—Appeals of Discharges, Trans-
483.80 Infection control.
fers, and Preadmission Screening and
483.85 Compliance and ethics program. Annual Resident Review (PASARR) De-
483.90 Physical environment. terminations
483.95 Training requirements. 483.200 Statutory basis.
483.202 Definitions.
Subpart C—Preadmission Screening and 483.204 Provision of a hearing and appeal
Annual Review of Mentally Ill and system.
Mentally Retarded Individuals 483.206 Transfers, discharges and reloca-
tions subject to appeal.
483.100 Basis.
483.102 Applicability and definitions. Subpart F—Requirements That Must Be Met
483.104 State plan requirement. by States and State Agencies, Resi-
483.106 Basic rule. dent Assessment
483.108 Relationship of PASARR to other
Medicaid processes. 483.315 Specification of resident assessment
483.110 Out-of-State arrangements. instrument.
483.112 Preadmission screening of applicants
for admission to NFs. Subpart G—Condition of Participation for
483.114 Annual review of NF residents. the Use of Restraint or Seclusion in Psy-
483.116 Residents and applicants determined chiatric Residential Treatment Facilities
to require NF level of services. Providing Inpatient Psychiatric Services
483.118 Residents and applicants determined for Individuals Under Age 21
not to require NF level of services.
483.350 Basis and scope.
483.120 Specialized services. 483.352 Definitions.
483.122 FFP for NF services. 483.354 General requirements for psychiatric
483.124 FFP for specialized services. residential treatment facilities.
483.126 Appropriate placement. 483.356 Protection of residents.
483.128 PASARR evaluation criteria. 483.358 Orders for the use of restraint or se-
483.130 PASARR determination criteria. clusion.
483.132 Evaluating the need for NF services 483.360 Consultation with treatment team
and NF level of care (PASARR/NF). physician.
483.134 Evaluating whether an individual 483.362 Monitoring of the resident in and
with mental illness requires specialized immediately after restraint.
services (PASARR/MI). 483.364 Monitoring of the resident in and
483.136 Evaluating whether an individual immediately after seclusion.
with intellectual disability requires spe- 483.366 Notification of parent(s) or legal
guardian(s).
cialized services (PASARR/IID).
483.368 Application of time out.
483.370 Postintervention debriefings.
54
483.372 Medical treatment for injuries re- (3) Sections 1919(a), (b), (c), (d), and
sulting from an emergency safety inter- (f) of the Act provide that nursing fa-
vention. cilities participating in Medicaid must
483.374 Facility reporting.
meet certain specific requirements.
483.376 Education and training.
(4) Sections 1128I(b) and (c) require
Subpart H [Reserved] that—
(i) Skilled nursing facilities or nurs-
Subpart I—Conditions of Participation for ing facility have in operation a compli-
Intermediate Care Facilities for Individ- ance and ethics program that is effec-
uals with Intellectual Disabilities tive in preventing and detecting crimi-
nal, civil, and administrative viola-
483.400 Basis and purpose. tions.
483.405 Relationship to other HHS regula-
tions.
(ii) The Secretary establish and im-
483.410 Condition of participation: Gov- plement a quality assurance and per-
erning body and management. formance improvement program for fa-
483.420 Condition of participation: Client cilities, including multi-unit chains of
protections. facilities.
483.430 Condition of participation: Facility (5) Section 1150B establishes require-
staffing. ments for reporting to law enforcement
483.440 Condition of participation: Active crimes occurring in federally funded
treatment services.
LTC facilities.
483.450 Condition of participation: Client
behavior and facility practices. (b) Scope. The provisions of this part
483.460 Condition of participation: Health contain the requirements that an insti-
care services. tution must meet in order to qualify to
483.470 Condition of participation: Physical participate as a Skilled Nursing Facil-
environment. ity in the Medicare program, and as a
483.475 Condition of participation: Emer- nursing facility in the Medicaid pro-
gency preparedness. gram. They serve as the basis for sur-
483.480 Condition of participation: Dietetic
vey activities for the purpose of deter-
services.
mining whether a facility meets the re-
AUTHORITY: 42 U.S.C. 1302, 1320a–7, 1395i, quirements for participation in Medi-
1395hh and 1396r. care and Medicaid.
[56 FR 48867, Sept. 26, 1991, as amended at 57
Subpart A [Reserved] FR 43924, Sept. 23, 1992; 60 FR 50443, Sept. 29,
1995; 81 FR 68848, Oct. 4, 2016]
§ 483.5 Definitions.
Subpart B—Requirements for Long As used in this subpart, the following
Term Care Facilities definitions apply:
Abuse. Abuse is the willful infliction
SOURCE: 54 FR 5359, Feb. 2, 1989, unless oth- of injury, unreasonable confinement,
erwise noted. intimidation, or punishment with re-
sulting physical harm, pain or mental
§ 483.1 Basis and scope. anguish. Abuse also includes the depri-
(a) Statutory basis. (1) Sections vation by an individual, including a
1819(a), (b), (c), (d), and (f) of the Act caretaker, of goods or services that are
provide that— necessary to attain or maintain phys-
(i) Skilled nursing facilities partici- ical, mental, and psychosocial well-
pating in Medicare must meet certain being. Instances of abuse of all resi-
specified requirements; and dents, irrespective of any mental or
(ii) The Secretary may impose addi- physical condition, cause physical
tional requirements (see section harm, pain or mental anguish. It in-
1819(d)(4)(B)) if they are necessary for cludes verbal abuse, sexual abuse,
the health and safety of individuals to physical abuse, and mental abuse in-
whom services are furnished in the fa- cluding abuse facilitated or enabled
cilities. through the use of technology. Willful,
(2) Section 1861(l) of the Act requires as used in this definition of abuse,
the facility to have in effect a transfer means the individual must have acted
agreement with a hospital. deliberately, not that the individual
55
§ 483.5 42 CFR Ch. IV (10–1–24 Edition)
must have intended to inflict injury or ments for participation independently

harm. in each location.
Adverse event. An adverse event is an (v) Use of composite distinct parts to
untoward, undesirable, and usually un- segregate residents by payment source
anticipated event that causes death or or on a basis other than care needs is
serious injury, or the risk thereof. prohibited.
Common area. Common areas are Distinct part—(1) Definition. A distinct
areas in the facility where residents part SNF or NF is physically distin-
may gather together with other resi- guishable from the larger institution
dents, visitors, and staff or engage in or institutional complex that houses it,
individual pursuits, apart from their meets the requirements of this para-
residential rooms. This includes but is graph and of paragraph (2) of this defi-
not limited to living rooms, dining nition, and meets the applicable statu-
rooms, activity rooms, outdoor areas, tory requirements for SNFs or NFs in
and meeting rooms where residents are sections 1819 or 1919 of the Act, respec-
located on a regular basis. tively. A distinct part SNF or NF may
Composite distinct part—(1) Definition. comprise one or more buildings or des-
A composite distinct part is a distinct ignated parts of buildings (that is,
part consisting of two or more non- wings, wards, or floors) that are: In the
contiguous components that are not lo- same physical area immediately adja-
cent to the institution’s main build-
cated within the same campus, as de-
ings; other areas and structures that
fined in § 413.65(a)(2) of this chapter.
are not strictly contiguous with the
(2) Requirements. In addition to meet-
main buildings but are located within
ing the requirements of specified in the close proximity to the main buildings;
definition of ‘‘distinct part’’ of this sec- and any other areas that CMS deter-
tion, a composite distinct part must mines on an individual basis, to be part
meet all of the following requirements: of the institution’s campus. A distinct
(i) A SNF or NF that is a composite part must include all of the beds within
of more than one location will be treat- the designated area, and cannot consist
ed as a single distinct part of the insti- of a random collection of individual
tution of which it is a distinct part. As rooms or beds that are scattered
such, the composite distinct part will throughout the physical plant. The
have only one provider agreement and term ‘‘distinct part’’ also includes a
only one provider number. composite distinct part that meets the
(ii) If two or more institutions (each additional requirements specified in
with a distinct part SNF or NF) under- the definition of ‘‘composite distinct
go a change of ownership, CMS must part’’ of this section.
approve the existing SNFs or NFs as (2) Requirements. In addition to meet-
meeting the requirements before they ing the participation requirements for
are considered a composite distinct long-term care facilities set forth else-
part of a single institution. In making where in this subpart, a distinct part
such a determination, CMS considers SNF or NF must meet all of the fol-
whether its approval or disapproval of lowing requirements:
a composite distinct part promotes the (i) The SNF or NF must be operated
effective and efficient use of public under common ownership and control
monies without sacrificing the quality (that is, common governance) by the
of care. institution of which it is a distinct
(iii) If there is a change of ownership part, as evidenced by the following:
of a composite distinct part SNF or (A) The SNF or NF is wholly owned
NF, the assignment of the provider by the institution of which it is a dis-
agreement to the new owner will apply tinct part.
to all of the approved locations that (B) The SNF or NF is subject to the
comprise the composite distinct part by-laws and operating decisions of a
SNF or NF. common governing body.
(iv) To ensure quality of care and (C) The institution of which the SNF
quality of life for all residents, the var- or NF is a distinct part has final re-
ious components of a composite dis- sponsibility for the distinct part’s ad-
tinct part must meet all of the require- ministrative decisions and personnel
56
policies, and final approval for the dis- an institution (as defined in paragraph
tinct part’s personnel actions. (b) of this section and specified in
(D) The SNF or NF functions as an § 440.40 and § 440.155 of this chapter), but
integral and subordinate part of the in- does not include an institution for indi-
stitution of which it is a distinct part, viduals with intellectual disabilities or
with significant common resource persons with related conditions de-
usage of buildings, equipment, per- scribed in § 440.150 of this chapter. For
sonnel, and services. Medicare and Medicaid purposes (in-
(ii) The administrator of the SNF or cluding eligibility, coverage, certifi-
NF reports to and is directly account- cation, and payment), the ‘‘facility’’ is
able to the management of the institu- always the entity that participates in
tion of which the SNF or NF is a dis- the program, whether that entity is
tinct part. comprised of all of, or a distinct part
(iii) The SNF or NF must have a des- of, a larger institution. For Medicare,
ignated medical director who is respon- an SNF (see section 1819(a)(1) of the
sible for implementing care policies Act), and for Medicaid, an NF (see sec-
and coordinating medical care, and tion 1919(a)(1) of the Act) may not be
who is directly accountable to the an institution for mental diseases as
management of the institution of defined in § 435.1010 of this chapter.
which it is a distinct part. Fully sprinklered. A fully sprinklered
(iv) The SNF or NF is financially in- long term care facility is one that has
tegrated with the institution of which all areas sprinklered in accordance
it is a distinct part, as evidenced by with National Fire Protection Associa-
the sharing of income and expenses tion 13 ‘‘Standard for the Installation
with that institution, and the report- of Sprinkler Systems’’ without the use
ing of its costs on that institution’s of waivers or the Fire Safety Evalua-
cost report. tion System.
(v) A single institution can have a Hours per resident day. Staffing hours
maximum of only one distinct part per resident per day is the total num-
SNF and one distinct part NF. ber of hours worked by each type of
(vi) (A) An institution cannot des- staff divided by the total number of
ignate a distinct part SNF or NF, but residents as calculated by CMS.
instead must submit a written request Licensed health professional. A li-
with documentation that demonstrates censed health professional is a physi-
it meets the criteria set forth above to cian; physician assistant; nurse practi-
CMS to determine if it may be consid- tioner; physical, speech, or occupa-
ered a distinct part. tional therapist; physical or occupa-
(B) The effective date of approval of tional therapy assistant; registered
a distinct part is the date that CMS de- professional nurse; licensed practical
termines all requirements (including nurse; or licensed or certified social
enrollment with the fiscal inter- worker; or registered respiratory ther-
mediary (FI)) are met for approval, and apist or certified respiratory therapy
cannot be made retroactive. technician.
(C) The institution must request ap- Major modification means the modi-
proval from CMS for all proposed fication of more than 50 percent, or
changes in the number of beds in the more than 4,500 square feet, of the
approved distinct part. smoke compartment.
Exploitation. Exploitation means tak- Misappropriation of resident property
ing advantage of a resident for personal means the deliberate misplacement,
gain through the use of manipulation, exploitation, or wrongful, temporary,
intimidation, threats, or coercion. or permanent use of a resident’s be-
Facility. For purposes of this subpart, longings or money without the resi-
facility means a skilled nursing facility dent’s consent.
(SNF) that meets the requirements of Mistreatment means inappropriate
sections 1819(a), (b), (c), and (d) of the treatment or exploitation of a resident.
Act, or a nursing facility (NF) that Neglect is the failure of the facility,
meets the requirements of sections its employees or service providers to
1919(a), (b), (c), and (d) of the Act. ‘‘Fa- provide goods and services to a resident
cility’’ may include a distinct part of that are necessary to avoid physical
57
§ 483.10 42 CFR Ch. IV (10–1–24 Edition)
harm, pain, mental anguish, or emo- resident, State or Federal law, or a

tional distress. court of competent jurisdiction.
Nurse aide. A nurse aide is any indi- Sexual abuse is non-consensual sexual
vidual providing nursing or nursing-re- contact of any type with a resident.
lated services to residents in a facility. Transfer and discharge includes move-
This term may also include an indi- ment of a resident to a bed outside of
vidual who provides these services the certified facility whether that bed
through an agency or under a contract is in the same physical plant or not.
with the facility, but is not a licensed Transfer and discharge does not refer
health professional, a registered dieti- to movement of a resident to a bed
tian, or someone who volunteers to within the same certified facility.
provide such services without pay. [68 FR 46071, Aug. 4, 2003, as amended at 71
Nurse aides do not include those indi- FR 39229, July 12, 2006; 71 FR 55340, Sept. 22,
viduals who furnish services to resi- 2006; 79 FR 27155, May 12, 2014; 81 FR 68848,
dents only as paid feeding assistants as Oct. 4, 2016; 82 FR 32259, July 13, 2017; 89 FR
defined in § 488.301 of this chapter. 40996, May 10, 2024]
Person-centered care. For purposes of
this subpart, person-centered care § 483.10 Resident rights.
means to focus on the resident as the (a) Residents rights. The resident has a
locus of control and support the resi- right to a dignified existence, self-de-
dent in making their own choices and termination, and communication with
having control over their daily lives. and access to persons and services in-
Representative of direct care employees. side and outside the facility, including
A representative of direct care employ- those specified in this section.
ees is an employee of the facility or a (1) A facility must treat each resi-
third party authorized by direct care dent with respect and dignity and care
employees at the facility to provide ex- for each resident in a manner and in an
pertise and input on behalf of the em- environment that promotes mainte-
ployees for the purposes of informing a nance or enhancement of his or her
facility assessment. quality of life, recognizing each resi-
Resident representative. For purposes dent’s individuality. The facility must
of this subpart, the term resident rep- protect and promote the rights of the
resentative means any of the following: resident.
(1) An individual chosen by the resi- (2) The facility must provide equal
dent to act on behalf of the resident in access to quality care regardless of di-
order to support the resident in deci- agnosis, severity of condition, or pay-
sion-making; access medical, social or ment source. A facility must establish
other personal information of the resi- and maintain identical policies and
dent; manage financial matters; or re- practices regarding transfer, discharge,
ceive notifications; and the provision of services under the
(2) A person authorized by State or State plan for all residents regardless
Federal law (including but not limited of payment source.
to agents under power of attorney, rep- (b) Exercise of rights. The resident has
resentative payees, and other fidu- the right to exercise his or her rights
ciaries) to act on behalf of the resident as a resident of the facility and as a
in order to support the resident in deci- citizen or resident of the United
sion-making; access medical, social or States.
other personal information of the resi- (1) The facility must ensure that the
dent; manage financial matters; or re- resident can exercise his or her rights
ceive notifications; without interference, coercion, dis-
(3) Legal representative, as used in crimination, or reprisal from the facil-
section 712 of the Older Americans Act; ity
or. (2) The resident has the right to be
(4) The court-appointed guardian or free of interference, coercion, discrimi-
conservator of a resident. nation, and reprisal from the facility in
(5) Nothing in this rule is intended to exercising his or her rights and to be
expand the scope of authority of any supported by the facility in the exer-
resident representative beyond that au- cise of his or her rights as required
thority specifically authorized by the under this subpart.
58
(3) In the case of a resident who has right to make those decision outside
not been adjudged incompetent by the the representative’s authority.
state court, the resident has the right (ii) The resident’s wishes and pref-
to designate a representative, in ac- erences must be considered in the exer-
cordance with State law and any legal cise of rights by the representative.
surrogate so designated may exercise (iii) To the extent practicable, the
the resident’s rights to the extent pro- resident must be provided with oppor-
vided by state law. The same-sex tunities to participate in the care plan-
spouse of a resident must be afforded ning process.
treatment equal to that afforded to an (c) Planning and implementing care.
opposite-sex spouse if the marriage was The resident has the right to be in-
valid in the jurisdiction in which it was formed of, and participate in, his or her
celebrated. treatment, including:
(i) The resident representative has (1) The right to be fully informed in
the right to exercise the resident’s language that he or she can understand
rights to the extent those rights are of his or her total health status, in-
delegated to the resident representa- cluding but not limited to, his or her
tive. medical condition.
(ii) The resident retains the right to (2) The right to participate in the de-
exercise those rights not delegated to a velopment and implementation of his
resident representative, including the or her person-centered plan of care, in-
right to revoke a delegation of rights, cluding but not limited to:
except as limited by State law. (i) The right to participate in the
planning process, including the right to
(4) The facility must treat the deci-
identify individuals or roles to be in-
sions of a resident representative as
cluded in the planning process, the
the decisions of the resident to the ex-
right to request meetings and the right
tent required by the court or delegated
to request revisions to the person-cen-
by the resident, in accordance with ap-
tered plan of care.
plicable law.
(ii) The right to participate in estab-
(5) The facility shall not extend the lishing the expected goals and out-
resident representative the right to comes of care, the type, amount, fre-
make decisions on behalf of the resi- quency, and duration of care, and any
dent beyond the extent required by the other factors related to the effective-
court or delegated by the resident, in ness of the plan of care.
accordance with applicable law. (iii) The right to be informed, in ad-
(6) If the facility has reason to be- vance, of changes to the plan of care.
lieve that a resident representative is (iv) The right to receive the services
making decisions or taking actions and/or items included in the plan of
that are not in the best interests of a care.
resident, the facility shall report such (v) The right to see the care plan, in-
concerns in the manner required under cluding the right to sign after signifi-
State law. cant changes to the plan of care.
(7) In the case of a resident adjudged (3) The facility shall inform the resi-
incompetent under the laws of a State dent of the right to participate in his
by a court of competent jurisdiction, or her treatment and shall support the
the rights of the resident devolve to resident in this right. The planning
and are exercised by the resident rep- process must—
resentative appointed under State law (i) Facilitate the inclusion of the
to act on the resident’s behalf. The resident and/or resident representative.
court-appointed resident representa- (ii) Include an assessment of the resi-
tive exercises the resident’s rights to dent’s strengths and needs.
the extent judged necessary by a court (iii) Incorporate the resident’s per-
of competent jurisdiction, in accord- sonal and cultural preferences in devel-
ance with State law oping goals of care.
(i) In the case of a resident represent- (4) The right to be informed, in ad-
ative whose decision-making authority vance, of the care to be furnished and
is limited by State law or court ap- the type of care giver or professional
pointment, the resident retains the that will furnish care.
59
§ 483.10 42 CFR Ch. IV (10–1–24 Edition)
(5) The right to be informed in ad- (e) Respect and dignity. The resident
vance, by the physician or other practi- has a right to be treated with respect
tioner or professional, of the risks and and dignity, including:
benefits of proposed care, of treatment (1) The right to be free from any
and treatment alternatives or treat- physical or chemical restraints im-
ment options and to choose the alter- posed for purposes of discipline or con-
native or option he or she prefers. venience, and not required to treat the
(6) The right to request, refuse, and/ resident’s medical symptoms, con-
or discontinue treatment, to partici- sistent with § 483.12(a)(2).
pate in or refuse to participate in ex- (2) The right to retain and use per-
perimental research, and to formulate sonal possessions, including fur-
an advance directive. nishings, and clothing, as space per-
(7) The right to self-administer medi- mits, unless to do so would infringe
cations if the interdisciplinary team, upon the rights or health and safety of
as defined by § 483.21(b)(2)(ii), has deter- other residents.
mined that this practice is clinically (3) The right to reside and receive
appropriate. services in the facility with reasonable
(8) Nothing in this paragraph should accommodation of resident needs and
be construed as the right of the resi- preferences except when to do so would
dent to receive the provision of med- endanger the health or safety of the
ical treatment or medical services resident or other residents.
deemed medically unnecessary or inap- (4) The right to share a room with his
propriate. or her spouse when married residents
(d) Choice of attending physician. The live in the same facility and both
resident has the right to choose his or spouses consent to the arrangement.
her attending physician. (5) The right to share a room with his
(1) The physician must be licensed to or her roommate of choice when prac-
practice, and ticable, when both residents live in the
(2) If the physician chosen by the same facility and both residents con-
resident refuses to or does not meet resent to the arrangement.
quirements specified in this part, the
(6) The right to receive written no-
facility may seek alternate physician
tice, including the reason for the
participation as specified in paragraphs
change, before the resident’s room or
(d)(4) and (5) of this section to assure
roommate in the facility is changed.
provision of appropriate and adequate
care and treatment. (7) The right to refuse to transfer to
(3) The facility must ensure that another room in the facility, if the pur-
each resident remains informed of the pose of the transfer is:
name, specialty, and way of contacting (i) To relocate a resident of a SNF
the physician and other primary care from the distinct part of the institu-
professionals responsible for his or her tion that is a SNF to a part of the in-
care. stitution that is not a SNF, or
(4) The facility must inform the resi- (ii) to relocate a resident of a NF
dent if the facility determines that the from the distinct part of the institu-
physician chosen by the resident is un- tion that is a NF to a distinct part of
able or unwilling to meet requirements the institution that is a SNF.
specified in this part and the facility (iii) solely for the convenience of
seeks alternate physician participation staff.
to assure provision of appropriate and (8) A resident’s exercise of the right
adequate care and treatment. The fa- to refuse transfer does not affect the
cility must discuss the alternative phy- resident’s eligibility or entitlement to
sician participation with the resident Medicare or Medicaid benefits.
and honor the resident’s preferences, if (f) Self-determination. The resident
any, among options. has the right to and the facility must
(5) If the resident subsequently se- promote and facilitate resident self-de-
lects another attending physician who termination through support of resi-
meets the requirements specified in dent choice, including but not limited
this part, the facility must honor that to the rights specified in paragraphs
choice. (f)(1) through (11) of this section.
60
(1) The resident has a right to choose resident’s right to deny or withdraw
activities, schedules (including sleep- consent at any time;
ing and waking times), health care and (iv) The facility must provide reason-
providers of health care services con- able access to a resident by any entity
sistent with his or her interests, assess- or individual that provides health, so-
ments, plan of care and other applica- cial, legal, or other services to the resi-
ble provisions of this part. dent, subject to the resident’s right to
(2) The resident has the right to deny or withdraw consent at any time;
make choices about aspects of his or and
her life in the facility that are signifi- (v) The facility must have written
cant to the resident. policies and procedures regarding the
(3) The resident has a right to inter- visitation rights of residents, including
act with members of the community those setting forth any clinically nec-
and participate in community activi- essary or reasonable restriction or lim-
ties both inside and outside the facil- itation or safety restriction or limita-
ity. tion, when such limitations may apply
(4) The resident has a right to receive consistent with the requirements of
visitors of his or her choosing at the this subpart, that the facility may
time of his or her choosing, subject to need to place on such rights and the
the resident’s right to deny visitation reasons for the clinical or safety re-
when applicable, and in a manner that striction or limitation.
does not impose on the rights of an- (vi) A facility must meet the fol-
other resident. lowing requirements:
(i) The facility must provide imme- (A) Inform each resident (or resident
diate access to any resident by— representative, where appropriate) of
(A) Any representative of the Sec- his or her visitation rights and related
retary, facility policy and procedures, includ-
(B) Any representative of the State, ing any clinical or safety restriction or
(C) Any representative of the Office limitation on such rights, consistent
of the State long term care ombuds- with the requirements of this subpart,
man, (established under section 712 of the reasons for the restriction or limi-
the Older Americans Act of 1965, as tation, and to whom the restrictions
amended 2016 (42 U.S.C. 3001 et seq.), apply, when he or she is informed of his
(D) The resident’s individual physi- or her other rights under this section.
cian, (B) Inform each resident of the right,
(E) Any representative of the protec- subject to his or her consent, to receive
tion and advocacy systems, as des- the visitors whom he or she designates,
ignated by the state, and as established including, but not limited to, a spouse
under the Developmental Disabilities (including a same-sex spouse), a domes-
Assistance and Bill of Rights Act of tic partner (including a same-sex do-
2000 (42 U.S.C. 15001 et seq.), mestic partner), another family mem-
(F) Any representative of the agency ber, or a friend, and his or her right to
responsible for the protection and ad- withdraw or deny such consent at any
vocacy system for individuals with a time.
mental disorder (established under the (C) Not restrict, limit, or otherwise
Protection and Advocacy for Mentally deny visitation privileges on the basis
Ill Individuals Act of 2000 (42 U.S.C. of race, color, national origin, religion,
10801 et seq.), and sex, gender identity, sexual orienta-
(G) The resident representative. tion, or disability.
(ii) The facility must provide imme- (D) Ensure that all visitors enjoy full
diate access to a resident by immediate and equal visitation privileges con-
family and other relatives of the resi- sistent with resident preferences.
dent, subject to the resident’s right to (5) The resident has a right to orga-
deny or withdraw consent at any time; nize and participate in resident groups
(iii) The facility must provide imme- in the facility.
diate access to a resident by others (i) The facility must provide a resi-
who are visiting with the consent of dent or family group, if one exists,
the resident, subject to reasonable clin- with private space; and take reasonable
ical and safety restrictions and the steps, with the approval of the group,
61
§ 483.10 42 CFR Ch. IV (10–1–24 Edition)
to make residents and family members (10) The resident has a right to man-
aware of upcoming meetings in a time- age his or her financial affairs. This in-
ly manner. cludes the right to know, in advance,
(ii) Staff, visitors, or other guests what charges a facility may impose
may attend resident group or family against a resident’s personal funds.
group meetings only at the respective (i) The facility must not require resi-
group’s invitation. dents to deposit their personal funds
(iii) The facility must provide a des- with the facility. If a resident chooses
ignated staff person who is approved by to deposit personal funds with the fa-
the resident or family group and the facility, upon written authorization of a
cility and who is responsible for pro- resident, the facility must act as a fi-
viding assistance and responding to duciary of the resident’s funds and
written requests that result from group hold, safeguard, manage, and account
meetings. for the personal funds of the resident
(iv) The facility must consider the deposited with the facility, as specified
views of a resident or family group and in this section.
act promptly upon the grievances and (ii) Deposit of funds. (A) In general:
recommendations of such groups con- Except as set out in paragraph
cerning issues of resident care and life (f)(10)(ii)(B) of this section, the facility
in the facility. must deposit any residents’ personal
(A) The facility must be able to dem- funds in excess of $100 in an interest
onstrate their response and rationale bearing account (or accounts) that is
for such response. separate from any of the facility’s op-
(B) This should not be construed to erating accounts, and that credits all
mean that the facility must implement interest earned on resident’s funds to
as recommended every request of the that account. (In pooled accounts,
resident or family group. there must be a separate accounting
(6) The resident has a right to par- for each resident’s share.) The facility
ticipate in family groups. must maintain a resident’s personal
(7) The resident has a right to have funds that do not exceed $100 in a non-
family member(s) or other resident interest bearing account, interest-bear-
representative(s) meet in the facility ing account, or petty cash fund.
with the families or resident represent- (B) Residents whose care is funded by
ative(s) of other residents in the facil- Medicaid: The facility must deposit the
ity. residents’ personal funds in excess of
(8) The resident has a right to par- $50 in an interest bearing account (or
ticipate in other activities, including accounts) that is separate from any of
social, religious, and community ac- the facility’s operating accounts, and
tivities that do not interfere with the that credits all interest earned on resi-
rights of other residents in the facility. dent’s funds to that account. (In pooled
(9) The resident has a right to choose accounts, there must be a separate ac-
to or refuse to perform services for the counting for each resident’s share.) The
facility and the facility must not re- facility must maintain personal funds
quire a resident to perform services for that do not exceed $50 in a non-interest
the facility. The resident may perform bearing account, interest-bearing ac-
services for the facility, if he or she count, or petty cash fund.
chooses, when— (iii) Accounting and records. (A) The
(i) The facility has documented the facility must establish and maintain a
resident’s need or desire for work in system that assures a full and com-
the plan of care; plete and separate accounting, accord-
(ii) The plan specifies the nature of ing to generally accepted accounting
the services performed and whether the principles, of each resident’s personal
services are voluntary or paid; funds entrusted to the facility on the
(iii) Compensation for paid services is resident’s behalf.
at or above prevailing rates; and (B) The system must preclude any
(iv) The resident agrees to the work commingling of resident funds with fa-
arrangement described in the plan of cility funds or with the funds of any
care. person other than another resident.
62
(C) The individual financial record for the following categories of items
must be available to the resident and services:
through quarterly statements and upon (A) Nursing services as required at
request. § 483.35.
(iv) Notice of certain balances. The fa- (B) Food and Nutrition services as re-
cility must notify each resident that quired at § 483.60.
receives Medicaid benefits— (C) An activities program as required
(A) When the amount in the resi- at § 483.24(c).
dent’s account reaches $200 less than (D) Room/bed maintenance services.
the SSI resource limit for one person, (E) Routine personal hygiene items
specified in section 1611(a)(3)(B) of the and services as required to meet the
Act; and needs of residents, including, but not
(B) That, if the amount in the ac- limited to, hair hygiene supplies,
count, in addition to the value of the comb, brush, bath soap, disinfecting
resident’s other nonexempt resources, soaps or specialized cleansing agents
reaches the SSI resource limit for one when indicated to treat special skin
person, the resident may lose eligi- problems or to fight infection, razor,
bility for Medicaid or SSI. shaving cream, toothbrush, toothpaste,
(v) Conveyance upon discharge, evic- denture adhesive, denture cleaner, den-
tion, or death. Upon the discharge, tal floss, moisturizing lotion, tissues,
eviction, or death of a resident with a cotton balls, cotton swabs, deodorant,
personal fund deposited with the facil- incontinence care and supplies, sani-
ity, the facility must convey within 30 tary napkins and related supplies, tow-
days the resident’s funds, and a final els, washcloths, hospital gowns, over
accounting of those funds, to the resi- the counter drugs, hair and nail hy-
dent, or in the case of death, the indi- giene services, bathing assistance, and
vidual or probate jurisdiction admin- basic personal laundry.
istering the resident’s estate, in ac- (F) Medically-related social services
cordance with State law. as required at § 483.40(d).
(vi) Assurance of financial security. (G) Hospice services elected by the
The facility must purchase a surety resident and paid for under the Medi-
bond, or otherwise provide assurance care Hospice Benefit or paid for by
satisfactory to the Secretary, to assure Medicaid under a state plan.
the security of all personal funds of (ii) Items and services that may be
residents deposited with the facility. charged to residents’ funds. Paragraphs
(11) The facility must not impose a (f)(11)(ii)(A) through (L) of this section
charge against the personal funds of a are general categories and examples of
resident for any item or service for items and services that the facility
which payment is made under Medicaid may charge to residents’ funds if they
or Medicare (except for applicable de- are requested by a resident, if they are
ductible and coinsurance amounts). not required to achieve the goals stat-
The facility may charge the resident ed in the resident’s care plan, if the fa-
for requested services that are more ex- cility informs the resident that there
pensive than or in excess of covered will be a charge, and if payment is not
services in accordance with § 489.32 of made by Medicare or Medicaid:
this chapter. (This does not affect the (A) Telephone, including a cellular
prohibition on facility charges for phone.
items and services for which Medicaid (B) Television/radio, personal com-
has paid. See § 447.15 of this chapter, puter or other electronic device for
which limits participation in the Med- personal use.
icaid program to providers who accept, (C) Personal comfort items, including
as payment in full, Medicaid payment smoking materials, notions and nov-
plus any deductible, coinsurance, or co- elties, and confections.
payment required by the plan to be (D) Cosmetic and grooming items and
paid by the individual.) services in excess of those for which
(i) Services included in Medicare or payment is made under Medicaid or
Medicaid payment. During the course Medicare.
of a covered Medicare or Medicaid stay, (E) Personal clothing.
facilities must not charge a resident (F) Personal reading matter.
63
§ 483.10 42 CFR Ch. IV (10–1–24 Edition)
(G) Gifts purchased on behalf of a ical records pertaining to him or her-

resident. self, upon an oral or written request, in
(H) Flowers and plants. the form and format requested by the
(I) Cost to participate in social individual, if it is readily producible in
events and entertainment outside the such form and format (including in an
scope of the activities program, pro- electronic form or format when such
vided under § 483.24(c). records are maintained electronically);
(J) Non-covered special care services or, if not, in a readable hard copy form
such as privately hired nurses or aides. or such other form and format as
(K) Private room, except when thera- agreed to by the facility and the indi-
peutically required (for example, isola- vidual, within 24 hours (excluding
tion for infection control). weekends and holidays); and
(L) Except as provided in (ii) The facility must allow the resi-
(e)(11)(ii)(L)(1) and (2) of this section, dent to obtain a copy of the records or
specially prepared or alternative food any portions thereof (including in an
requested instead of the food and meals electronic form or format when such
generally prepared by the facility, as records are maintained electronically)
required by § 483.60. upon request and 2 working days ad-
(1) The facility may not charge for vance notice to the facility. The facil-
special foods and meals, including ity may impose a reasonable, cost-
medically prescribed dietary supple- based fee on the provision of copies,
ments, ordered by the resident’s physi- provided that the fee includes only the
cian, physician assistant, nurse practi- cost of:
tioner, or clinical nurse specialist, as (A) Labor for copying the records re-
these are included in accordance with quested by the individual, whether in
§ 483.60. paper or electronic form;
(2) In accordance with § 483.60(c) (B) Supplies for creating the paper
through (f), when preparing foods and copy or electronic media if the indi-
meals, a facility must take into consid- vidual requests that the electronic
eration residents’ needs and pref- copy be provided on portable media;
erences and the overall cultural and re- and
ligious make-up of the facility’s popu- (C) Postage, when the individual has
lation. requested the copy be mailed.
(iii) Requests for items and services. (A) (3) With the exception of information
The facility can only charge a resident described in paragraphs (g)(2) and
for any non-covered item or service if (g)(11) of this section, the facility must
such item or service is specifically re- ensure that information is provided to
quested by the resident. each resident in a form and manner the
(B) The facility must not require a resident can access and understand, in-
resident to request any item or service cluding in an alternative format or in a
as a condition of admission or contin- language that the resident can under-
ued stay. stand. Summaries that translate infor-
(C) The facility must inform, orally mation described in paragraph (g)(2) of
and in writing, the resident requesting this section may be made available to
an item or service for which a charge the patient at their request and ex-
will be made that there will be a pense in accordance with applicable
charge for the item or service and what law.
the charge will be. (4) The resident has the right to re-
(g) Information and communication. (1) ceive notices orally (meaning spoken)
The resident has the right to be in- and in writing (including Braille) in a
formed of his or her rights and of all format and a language he or she under-
rules and regulations governing resi- stands, including;
dent conduct and responsibilities dur- (i) Required notices as specified in this
ing his or her stay in the facility. section. The facility must furnish to
(2) The resident has the right to ac- each resident a written description of
cess personal and medical records per- legal rights which includes—
taining to him or herself. (A) A description of the manner of
(i) The facility must provide the resi- protecting personal funds, under para-
dent with access to personal and med- graph (f)(10) of this section;
64
(B) A description of the requirements to resident abuse, neglect, exploi-

and procedures for establishing eligi- tation, misappropriation of resident
bility for Medicaid, including the right property in the facility, non-compli-
to request an assessment of resources ance with the advance directives re-
under section 1924(c) of the Social Se- quirements and requests for informa-
curity Act. tion regarding returning to the com-
(C) A list of names, addresses (mail- munity.
ing and email), and telephone numbers (5) The facility must post, in a form
of all pertinent State regulatory and and manner accessible and understand-
informational agencies, resident advo- able to residents, and resident rep-
cacy groups such as the State Survey resentatives:
Agency, the State licensure office, the (i) A list of names, addresses (mailing
State Long-Term Care Ombudsman and email), and telephone numbers of
program, the protection and advocacy all pertinent State agencies and advo-
agency, adult protective services where cacy groups, such as the State Survey
state law provides for jurisdiction in Agency, the State licensure office,
long-term care facilities, the local con- adult protective services where state
tact agency for information about re- law provides for jurisdiction in long-
turning to the community and the term care facilities, the Office of the
Medicaid Fraud Control Unit; and State Long-Term Care Ombudsman
(D) A statement that the resident program, the protection and advocacy
may file a complaint with the State network, home and community based
Survey Agency concerning any sus- service programs, and the Medicaid
pected violation of state or federal Fraud Control Unit; and
nursing facility regulations, including (ii) A statement that the resident
but not limited to resident abuse, ne- may file a complaint with the State
glect, exploitation, misappropriation of Survey Agency concerning any sus-
resident property in the facility, non- pected violation of state or federal
compliance with the advance directives nursing facility regulations, including
requirements and requests for informa- but not limited to resident abuse, ne-
tion regarding returning to the com- glect, exploitation, misappropriation of
munity. resident property in the facility, non-
(ii) Information and contact informa- compliance with the advance directives
tion for State and local advocacy orga- requirements (42 CFR part 489 subpart
nizations, including but not limited to I) and requests for information regard-
the State Survey Agency, the State ing returning to the community.
Long-Term Care Ombudsman program (6) The resident has the right to have
(established under section 712 of the reasonable access to the use of a tele-
Older Americans Act of 1965, as amend- phone, including TTY and TDD serv-
ed 2016 (42 U.S.C. 3001 et seq.) and the ices, and a place in the facility where
protection and advocacy system (as calls can be made without being over-
designated by the state, and as estab- heard. This includes the right to retain
lished under the Developmental Dis- and use a cellular phone at the resi-
abilities Assistance and Bill of Rights dent’s own expense.
Act of 2000 (42 U.S.C. 15001 et seq.); (7) The facility must protect and fa-
(iii) Information regarding Medicare cilitate that resident’s right to com-
and Medicaid eligibility and coverage; municate with individuals and entities
(iv) Contact information for the within and external to the facility, in-
Aging and Disability Resource Center cluding reasonable access to:
(established under Section (i) A telephone, including TTY and
202(a)(20)(B)(iii) of the Older Americans TDD services;
Act); or other No Wrong Door Program (ii) The internet, to the extent avail-
(v) Contact information for the Med- able to the facility; and
icaid Fraud Control Unit; and (iii) Stationery, postage, writing im-
(vi) Information and contact infor- plements and the ability to send mail.
mation for filing grievances or com- (8) The resident has the right to send
plaints concerning any suspected viola- and receive mail, and to receive let-
tion of state or federal nursing facility ters, packages and other materials de-
regulations, including but not limited livered to the facility for the resident
65
§ 483.10 42 CFR Ch. IV (10–1–24 Edition)
through a means other than a postal the resident’s option, formulate an ad-
service, including the right to: vance directive.
(i) Privacy of such communications (ii) This includes a written descrip-
consistent with this section; and tion of the facility’s policies to imple-
(ii) Access to stationery, postage, and ment advance directives and applicable
writing implements at the resident’s State law.
own expense. (iii) Facilities are permitted to con-
(9) The resident has the right to have tract with other entities to furnish this
reasonable access to and privacy in information but are still legally re-
their use of electronic communications sponsible for ensuring that the require-
such as email and video communica- ments of this section are met.
tions and for Internet research.
(iv) If an adult individual is incapaci-
(i) If the access is available to the fa-
cility tated at the time of admission and is
(ii) At the resident’s expense, if any unable to receive information or ar-
additional expense is incurred by the ticulate whether or not he or she has
facility to provide such access to the executed an advance directive, the fa-
resident. cility may give advance directive infor-
(iii) Such use must comply with state mation to the individual’s resident rep-
and federal law. resentative in accordance with State
(10) The resident has the right to— law.
(i) Examine the results of the most (v) The facility is not relieved of its
recent survey of the facility conducted obligation to provide this information
by Federal or State surveyors and any to the individual once he or she is able
plan of correction in effect with re- to receive such information. Follow-up
spect to the facility; and procedures must be in place to provide
(ii) Receive information from agen- the information to the individual di-
cies acting as client advocates, and be rectly at the appropriate time.
afforded the opportunity to contact (13) The facility must display in the
these agencies. facility written information, and pro-
(11) The facility must— vide to residents and applicants for ad-
(i) Post in a place readily accessible mission, oral and written information
to residents, and family members and about how to apply for and use Medi-
legal representatives of residents, the care and Medicaid benefits, and how to
results of the most recent survey of the receive refunds for previous payments
facility. covered by such benefits.
(ii) Have reports with respect to any (14) Notification of changes. (i) A facil-
surveys, certifications, and complaint ity must immediately inform the resi-
investigations made respecting the fa- dent; consult with the resident’s physi-
cility during the 3 preceding years, and cian; and notify, consistent with his or
any plan of correction in effect with re- her authority, the resident representa-
spect to the facility, available for any tive(s), when there is—
individual to review upon request; and
(A) An accident involving the resi-
(iii) Post notice of the availability of
dent which results in injury and has
such reports in areas of the facility
that are prominent and accessible to the potential for requiring physician
the public. intervention;
(iv) The facility shall not make (B) A significant change in the resi-
available identifying information dent’s physical, mental, or psycho-
about complainants or residents. social status (that is, a deterioration in
(12) The facility must comply with health, mental, or psychosocial status
the requirements specified in 42 CFR in either life-threatening conditions or
part 489, subpart I (Advance Direc- clinical complications);
tives). (C) A need to alter treatment signifi-
(i) These requirements include provi- cantly (that is, a need to discontinue
sions to inform and provide written in- or change an existing form of treat-
formation to all adult residents con- ment due to adverse consequences, or
cerning the right to accept or refuse to commence a new form of treatment);
medical or surgical treatment and, at or
66
(D) A decision to transfer or dis- under the State plan and for which the
charge the resident from the facility as resident may not be charged;
specified in § 483.15(c)(1)(ii). (B) Those other items and services
(ii) When making notification under that the facility offers and for which
paragraph (g)(14)(i) of this section, the the resident may be charged, and the
facility must ensure that all pertinent amount of charges for those services;
information specified in § 483.15(c)(2) is and
available and provided upon request to (ii) Inform each Medicaid-eligible
the physician. resident when changes are made to the
(iii) The facility must also promptly items and services specified in
notify the resident and the resident § 483.10(g)(17)(i)(A) and (B) of this sec-
representative, if any, when there is— tion.
(A) A change in room or roommate (18) The facility must inform each
assignment as specified in § 483.10(e)(6); resident before, or at the time of ad-
or mission, and periodically during the
(B) A change in resident rights under resident’s stay, of services available in
Federal or State law or regulations as the facility and of charges for those
specified in paragraph (e)(10) of this services, including any charges for
section. services not covered under Medicare/
(iv) The facility must record and pe- Medicaid or by the facility’s per diem
riodically update the address (mailing
rate.
and email) and phone number of the
(i) Where changes in coverage are
resident representative(s).
made to items and services covered by
(15) Admission to a composite distinct
Medicare and/or by the Medicaid State
part. A facility that is a composite dis-
plan, the facility must provide notice
tinct part (as defined in § 483.5 must
to residents of the change as soon as is
disclose in its admission agreement its
reasonably possible.
physical configuration, including the
various locations that comprise the (ii) Where changes are made to
composite distinct part, and must charges for other items and services
specify the policies that apply to room that the facility offers, the facility
changes between its different locations must inform the resident in writing at
under § 483.15(c)(9). least 60 days prior to implementation
(16) The facility must provide a no- of the change.
tice of rights and services to the resi- (iii) If a resident dies or is hospital-
dent prior to or upon admission and ized or is transferred and does not re-
during the resident’s stay. turn to the facility, the facility must
(i) The facility must inform the resi- refund to the resident, resident rep-
dent both orally and in writing in a resentative, or estate, as applicable,
language that the resident understands any deposit or charges already paid,
of his or her rights and all rules and less the facility’s per diem rate, for the
regulations governing resident conduct days the resident actually resided or
and responsibilities during the stay in reserved or retained a bed in the facil-
the facility. ity, regardless of any minimum stay or
(ii) The facility must also provide the discharge notice requirements.
resident with the State-developed no- (iv) The facility must refund to the
tice of Medicaid rights and obligations, resident or resident representative any
if any. and all refunds due the resident within
(iii) Receipt of such information, and 30 days from the resident’s date of dis-
any amendments to it, must be ac- charge from the facility.
knowledged in writing; (v) The terms of an admission con-
(17) The facility must— tract by or on behalf of an individual
(i) Inform each Medicaid-eligible seeking admission to the facility must
resident, in writing, at the time of ad- not conflict with the requirements of
mission to the nursing facility and these regulations.
when the resident becomes eligible for (h) Privacy and confidentiality. The
Medicaid of— resident has a right to personal privacy
(A) The items and services that are and confidentiality of his or her per-
included in nursing facility services sonal and medical records.
67
§ 483.10 42 CFR Ch. IV (10–1–24 Edition)
(1) Personal privacy includes accom- (5) Adequate and comfortable light-
modations, medical treatment, written ing levels in all areas;
and telephone communications, per- (6) Comfortable and safe temperature
sonal care, visits, and meetings of fam- levels. Facilities initially certified
ily and resident groups, but this does after October 1, 1990 must maintain a
not require the facility to provide a temperature range of 71 to 81 °F; and
private room for each resident. (7) For the maintenance of com-
(2) The facility must respect the resi- fortable sound levels.
dents right to personal privacy, includ- (j) Grievances. (1) The resident has the
ing the right to privacy in his or her right to voice grievances to the facility
oral (that is, spoken), written, and or other agency or entity that hears
electronic communications, including grievances without discrimination or
the right to send and promptly receive reprisal and without fear of discrimina-
unopened mail and other letters, pack- tion or reprisal. Such grievances in-
ages and other materials delivered to clude those with respect to care and
the facility for the resident, including treatment which has been furnished as
those delivered through a means other well as that which has not been fur-
than a postal service. nished, the behavior of staff and of
(3) The resident has a right to secure other residents; and other concerns re-
and confidential personal and medical garding their LTC facility stay.
records.
(2) The resident has the right to and
(i) The resident has the right to
the facility must make prompt efforts
refuse the release of personal and med-
by the facility to resolve grievances
ical records except as provided at
§ 483.70(h)(2) or other applicable Federal the resident may have, in accordance
or State laws. with this paragraph.
(ii) The facility must allow rep- (3) The facility must make informa-
resentatives of the Office of the State tion on how to file a grievance or com-
Long-Term Care Ombudsman to exam- plaint available to the resident.
ine a resident’s medical, social, and ad- (4) The facility must establish a
ministrative records in accordance grievance policy to ensure the prompt
with State law. resolution of all grievances regarding
(i) Safe environment. The resident has the residents’ rights contained in this
a right to a safe, clean, comfortable paragraph. Upon request, the provider
and homelike environment, including must give a copy of the grievance pol-
but not limited to receiving treatment icy to the resident. The grievance pol-
and supports for daily living safely. icy must include:
The facility must provide— (i) Notifying resident individually or
(1) A safe, clean, comfortable, and through postings in prominent loca-
homelike environment, allowing the tions throughout the facility of the
resident to use his or her personal be- right to file grievances orally (meaning
longings to the extent possible. spoken) or in writing; the right to file
(i) This includes ensuring that the grievances anonymously; the contact
resident can receive care and services information of the grievance official
safely and that the physical layout of with whom a grievance can be filed,
the facility maximizes resident inde- that is, his or her name, business ad-
pendence and does not pose a safety dress (mailing and email) and business
risk. phone number; a reasonable expected
(ii) The facility shall exercise reason- time frame for completing the review
able care for the protection of the resi- of the grievance; the right to obtain a
dent’s property from loss or theft. written decision regarding his or her
(2) Housekeeping and maintenance grievance; and the contact information
services necessary to maintain a sani- of independent entities with whom
tary, orderly, and comfortable interior; grievances may be filed, that is, the
(3) Clean bed and bath linens that are pertinent State agency, Quality Im-
in good condition; provement Organization, State Survey
(4) Private closet space in each resi- Agency and State Long-Term Care Om-
dent room, as specified in budsman program or protection and ad-
§ 483.90(e)(2)(iv); vocacy system;
68
(ii) Identifying a Grievance Official ficials, including, but not limited to,
who is responsible for overseeing the federal and state surveyors, other fed-
grievance process, receiving and track- eral or state health department em-
ing grievances through to their conclu- ployees, including representatives of
sion; leading any necessary investiga- the Office of the State Long-Term Care
tions by the facility; maintaining the Ombudsman, and any representative of
confidentiality of all information asso- the agency responsible for the protec-
ciated with grievances, for example, tion and advocacy system for individ-
the identity of the resident for those uals with mental disorder (established
grievances submitted anonymously; under the Protection and Advocacy for
issuing written grievance decisions to Mentally Ill Individuals Act of 2000 (42
the resident; and coordinating with U.S.C. 10801 et seq.), regarding any mat-
state and federal agencies as necessary ter, whether or not subject to arbitra-
in light of specific allegations; tion or any other type of judicial or
(iii) As necessary, taking immediate regulatory action.
action to prevent further potential vio- [81 FR 68849, Oct. 4, 2016, as amended at 82 FR
lations of any resident right while the 32259, July 13, 2017; 89 FR 40996, May 10, 2024]
alleged violation is being investigated;
(iv) Consistent with § 483.12(c)(1), im- § 483.12 Freedom from abuse, neglect,
mediately reporting all alleged viola- and exploitation.
tions involving neglect, abuse, includ- The resident has the right to be free
ing injuries of unknown source, and/or from abuse, neglect, misappropriation
misappropriation of resident property, of resident property, and exploitation
by anyone furnishing services on behalf as defined in this subpart. This in-
of the provider, to the administrator of cludes but is not limited to freedom
the provider; and as required by State from corporal punishment, involuntary
law; seclusion and any physical or chemical
(v) Ensuring that all written griev- restraint not required to treat the resi-
ance decisions include the date the dent’s medical symptoms.
grievance was received, a summary (a) The facility must—
statement of the resident’s grievance, (1) Not use verbal, mental, sexual, or
the steps taken to investigate the physical abuse, corporal punishment,
grievance, a summary of the pertinent or involuntary seclusion;
findings or conclusions regarding the (2) Ensure that the resident is free
resident’s concern(s), a statement as to from physical or chemical restraints
whether the grievance was confirmed imposed for purposes of discipline or
or not confirmed, any corrective action convenience and that are not required
taken or to be taken by the facility as to treat the resident’s medical symp-
a result of the grievance, and the date toms. When the use of restraints is in-
the written decision was issued; dicated, the facility must use the least
(vi) Taking appropriate corrective restrictive alternative for the least
action in accordance with State law if amount of time and document ongoing
the alleged violation of the residents’ re-evaluation of the need for restraints.
rights is confirmed by the facility or if (3) Not employ or otherwise engage
an outside entity having jurisdiction, individuals who—
such as the State Survey Agency, Qual- (i) Have been found guilty of abuse,
ity Improvement Organization, or local neglect, exploitation, misappropriation
law enforcement agency confirms a of property, or mistreatment by a
violation of any of these residents’ court of law;
rights within its area of responsibility; (ii) Have had a finding entered into
and the State nurse aide registry con-
(vii) Maintaining evidence dem- cerning abuse, neglect, exploitation,
onstrating the results of all grievances mistreatment of residents or misappro-
for a period of no less than 3 years from priation of their property; or
the issuance of the grievance decision. (iii) Have a disciplinary action in ef-
(k) Contact with external entities. A fa- fect against his or her professional li-
cility must not prohibit or in any way cense by a state licensure body as a re-
discourage a resident from commu- sult of a finding of abuse, neglect, ex-
nicating with federal, state, or local of- ploitation, mistreatment of residents
69
§ 483.15 42 CFR Ch. IV (10–1–24 Edition)
or misappropriation of resident prop- or mistreatment, including injuries of

erty. unknown source and misappropriation
(4) Report to the State nurse aide of resident property, are reported im-
registry or licensing authorities any mediately, but not later than 2 hours
knowledge it has of actions by a court after the allegation is made, if the
of law against an employee, which events that cause the allegation in-
would indicate unfitness for service as volve abuse or result in serious bodily
a nurse aide or other facility staff. injury, or not later than 24 hours if the
(b) The facility must develop and im- events that cause the allegation do not
plement written policies and proce- involve abuse and do not result in seri-
dures that: ous bodily injury, to the administrator
(1) Prohibit and prevent abuse, ne- of the facility and to other officials (in-
glect, and exploitation of residents and cluding to the State Survey Agency
misappropriation of resident property, and adult protective services where
(2) Establish policies and procedures state law provides for jurisdiction in
to investigate any such allegations, long-term care facilities) in accordance
and with State law through established
(3) Include training as required at procedures.
paragraph § 483.95. (2) Have evidence that all alleged vio-
(4) Establish coordination with the lations are thoroughly investigated.
QAPI program required under § 483.75. (3) Prevent further potential abuse,
(5) Ensure reporting of crimes occur- neglect, exploitation, or mistreatment
ring in federally-funded long-term care while the investigation is in progress.
facilities in accordance with section (4) Report the results of all investiga-
1150B of the Act. The policies and pro- tions to the administrator or his or her
cedures must include but are not lim- designated representative and to other
ited to the following elements. officials in accordance with State law,
(i) Annually notifying covered indi- including to the State Survey Agency,
viduals, as defined at section within 5 working days of the incident,
1150B(a)(3) of the Act, of that individ- and if the alleged violation is verified
ual’s obligation to comply with the fol- appropriate corrective action must be
lowing reporting requirements. taken.
(A) Each covered individual shall re- [81 FR 68855, Oct. 4, 2016]
port to the State Agency and one or
more law enforcement entities for the § 483.15 Admission, transfer, and dis-
political subdivision in which the facil- charge rights.
ity is located any reasonable suspicion (a) Admissions policy. (1) The facility
of a crime against any individual who must establish and implement an ad-
is a resident of, or is receiving care missions policy.
from, the facility. (2) The facility must—
(B) Each covered individual shall re- (i) Not request or require residents or
port immediately, but not later than 2 potential residents to waive their
hours after forming the suspicion, if rights as set forth in this subpart and
the events that cause the suspicion rein applicable state, federal or local li-
sult in serious bodily injury, or not censing or certification laws, including
later than 24 hours if the events that but not limited to their rights to Medi-
cause the suspicion do not result in se- care or Medicaid; and
rious bodily injury. (ii) Not request or require oral or
(ii) Posting a conspicuous notice of written assurance that residents or po-
employee rights, as defined at section tential residents are not eligible for, or
1150B(d)(3) of the Act. will not apply for, Medicare or Med-
(iii) Prohibiting and preventing re- icaid benefits.
taliation, as defined at section (iii) Not request or require residents
1150B(d)(1) and (2) of the Act. or potential residents to waive poten-
(c) In response to allegations of tial facility liability for losses of per-
abuse, neglect, exploitation, or mis- sonal property
treatment, the facility must: (3) The facility must not request or
(1) Ensure that all alleged violations require a third party guarantee of pay-
involving abuse, neglect, exploitation ment to the facility as a condition of
70
admission or expedited admission, or must specify the policies that apply to

continued stay in the facility. How- room changes between its different lo-
ever, the facility may request and re- cations under paragraph (c)(9) of this
quire a resident representative who has section.
legal access to a resident’s income or (b) Equal access to quality care. (1) A
resources available to pay for facility facility must establish, maintain and
care to sign a contract, without incur- implement identical policies and prac-
ring personal financial liability, to pro- tices regarding transfer and discharge,
vide facility payment from the resi- as defined in § 483.5 and the provision of
dent’s income or resources. services for all individuals regardless
(4) In the case of a person eligible for of source of payment, consistent with
Medicaid, a nursing facility must not § 483.10(a)(2);
charge, solicit, accept, or receive, in (2) The facility may charge any
addition to any amount otherwise re- amount for services furnished to non-
quired to be paid under the State plan, Medicaid residents unless otherwise
any gift, money, donation, or other limited by state law and consistent
consideration as a precondition of ad- with the notice requirement in
mission, expedited admission or con- § 483.10(g)(18)(i) and (g)(4)(i) describing
tinued stay in the facility. However,— the charges; and
(i) A nursing facility may charge a (3) The State is not required to offer
resident who is eligible for Medicaid additional services on behalf of a resi-
for items and services the resident has dent other than services provided in
requested and received, and that are the State plan.
not specified in the State plan as in- (c) Transfer and discharge—(1) Facility
cluded in the term ‘‘nursing facility requirements—(i) The facility must per-
services’’ so long as the facility gives mit each resident to remain in the fa-
proper notice of the availability and cility, and not transfer or discharge
cost of these services to residents and the resident from the facility unless—
does not condition the resident’s ad- (A) The transfer or discharge is nec-
mission or continued stay on the re- essary for the resident’s welfare and
quest for and receipt of such additional the resident’s needs cannot be met in
services; and the facility;
(ii) A nursing facility may solicit, ac- (B) The transfer or discharge is ap-
cept, or receive a charitable, religious, propriate because the resident’s health
or philanthropic contribution from an has improved sufficiently so the resi-
organization or from a person unre- dent no longer needs the services pro-
lated to a Medicaid eligible resident or vided by the facility;
potential resident, but only to the ex- (C) The safety of individuals in the
tent that the contribution is not a con- facility is endangered due to the clin-
dition of admission, expedited admis- ical or behavioral status of the resi-
sion, or continued stay in the facility dent;
for a Medicaid eligible resident. (D) The health of individuals in the
(5) States or political subdivisions facility would otherwise be endangered;
may apply stricter admissions stand- (E) The resident has failed, after rea-
ards under State or local laws than are sonable and appropriate notice, to pay
specified in this section, to prohibit for (or to have paid under Medicare or
discrimination against individuals en- Medicaid) a stay at the facility. Non-
titled to Medicaid. payment applies if the resident does
(6) A nursing facility must disclose not submit the necessary paperwork
and provide to a resident or potential for third party payment or after the
resident prior to time of admission, no- third party, including Medicare or
tice of special characteristics or serv- Medicaid, denies the claim and the
ice limitations of the facility. resident refuses to pay for his or her
(7) A nursing facility that is a com- stay. For a resident who becomes eligi-
posite distinct part as defined in § 483.5 ble for Medicaid after admission to a
must disclose in its admission agree- facility, the facility may charge a resi-
ment its physical configuration, in- dent only allowable charges under Med-
cluding the various locations that com- icaid; or
prise the composite distinct part, and (F) The facility ceases to operate.
71
§ 483.15 42 CFR Ch. IV (10–1–24 Edition)
(ii) The facility may not transfer or § 483.21(c)(2), as applicable, and any
discharge the resident while the appeal other documentation, as applicable, to
is pending, pursuant to § 431.230 of this ensure a safe and effective transition of
chapter, when a resident exercises his care.
or her right to appeal a transfer or dis- (3) Notice before transfer. Before a fa-
charge notice from the facility pursu- cility transfers or discharges a resi-
ant to § 431.220(a)(3) of this chapter, un- dent, the facility must—
less the failure to discharge or transfer (i) Notify the resident and the resi-
would endanger the health or safety of dent’s representative(s) of the transfer
the resident or other individuals in the or discharge and the reasons for the
facility. The facility must document move in writing and in a language and
the danger that failure to transfer or manner they understand. The facility
discharge would pose. must send a copy of the notice to a rep-
(2) Documentation. When the facility resentative of the Office of the State
transfers or discharges a resident under Long-Term Care Ombudsman.
any of the circumstances specified in (ii) Record the reasons for the trans-
paragraphs (c)(1)(i)(A) through (F) of fer or discharge in the resident’s med-
this section, the facility must ensure ical record in accordance with para-
that the transfer or discharge is docu- graph (c)(2) of this section; and
mented in the resident’s medical (iii) Include in the notice the items
record and appropriate information is described in paragraph (c)(5) of this
communicated to the receiving health section.
care institution or provider. (4) Timing of the notice. (i) Except as
(i) Documentation in the resident’s specified in paragraphs (c)(4)(ii) and (8)
medical record must include: of this section, the notice of transfer or
(A) The basis for the transfer per discharge required under this section
paragraph (c)(1)(i) of this section. must be made by the facility at least 30
(B) In the case of paragraph days before the resident is transferred
(c)(1)(i)(A) of this section, the specific or discharged.
resident need(s) that cannot be met, fa- (ii) Notice must be made as soon as
cility attempts to meet the resident practicable before transfer or discharge
needs, and the service available at the when—
receiving facility to meet the need(s).
(A) The safety of individuals in the
(ii) The documentation required by
facility would be endangered under
paragraph (c)(2)(i) of this section must
paragraph (c)(1)(i)(C) of this section;
be made by—
(B) The health of individuals in the
(A) The resident’s physician when
facility would be endangered, under
transfer or discharge is necessary
paragraph (c)(1)(i)(D) of this section;
under paragraph (c)(1)(A) or (B) of this
section; and (C) The resident’s health improves
(B) A physician when transfer or dis- sufficiently to allow a more immediate
charge is necessary under paragraph transfer or discharge, under paragraph
(c)(1)(i)(C) or (D) of this section. (c)(1)(i)(B) of this section;
(iii) Information provided to the re- (D) An immediate transfer or dis-
ceiving provider must include a min- charge is required by the resident’s ur-
imum of the following: gent medical needs, under paragraph
(A) Contact information of the prac- (c)(1)(i)(A) of this section; or
titioner responsible for the care of the (E) A resident has not resided in the
resident facility for 30 days.
(B) Resident representative informa- (5) Contents of the notice. The written
tion including contact information. notice specified in paragraph (c)(3) of
(C) Advance Directive information. this section must include the fol-
(D) All special instructions or pre- lowing:
cautions for ongoing care, as appro- (i) The reason for transfer or dis-
priate. charge;
(E) Comprehensive care plan goals, (ii) The effective date of transfer or
(F) All other necessary information, discharge;
including a copy of the resident’s dis- (iii) The location to which the resi-
charge summary, consistent with dent is transferred or discharged;
72
(iv) A statement of the resident’s ap- cation of the residents, as required at

peal rights, including the name, ad- § 483.70(k).
dress (mailing and email), and tele- (9) Room changes in a composite dis-
phone number of the entity which re- tinct part. Room changes in a facility
ceives such requests; and information that is a composite distinct part (as de-
on how to obtain an appeal form and fined in § 483.5) are subject to the re-
assistance in completing the form and quirements of § 483.10(e)(7) and must be
submitting the appeal hearing request; limited to moves within the particular
(v) The name, address (mailing and building in which the resident resides,
email) and telephone number of the Of- unless the resident voluntarily agrees
fice of the State Long-Term Care Om- to move to another of the composite
budsman; distinct part’s locations.
(vi) For nursing facility residents (d) Notice of bed-hold policy and re-
with intellectual and developmental turn—(1) Notice before transfer. Before a
disabilities or related disabilities, the nursing facility transfers a resident to
mailing and email address and tele- a hospital or the resident goes on
phone number of the agency respon- therapeutic leave, the nursing facility
sible for the protection and advocacy of must provide written information to
individuals with developmental disabil- the resident or resident representative
ities established under Part C of the that specifies—
Developmental Disabilities Assistance (i) The duration of the state bed-hold
and Bill of Rights Act of 2000 (Pub. L. policy, if any, during which the resi-
106–402, codified at 42 U.S.C. 15001 et dent is permitted to return and resume
seq.); and residence in the nursing facility;
(ii) The reserve bed payment policy
(vii) For nursing facility residents
in the state plan, under § 447.40 of this
with a mental disorder or related dis-
chapter, if any;
abilities, the mailing and email address
(iii) The nursing facility’s policies re-
and telephone number of the agency re-
garding bed-hold periods, which must
sponsible for the protection and advo-
be consistent with paragraph (e)(1) of
cacy of individuals with a mental dis-
this section, permitting a resident to
order established under the Protection return; and
and Advocacy for Mentally Ill Individ- (iv) The information specified in
uals Act. paragraph (e)(1) of this section.
(6) Changes to the notice. If the infor- (2) Bed-hold notice upon transfer. At
mation in the notice changes prior to the time of transfer of a resident for
effecting the transfer or discharge, the hospitalization or therapeutic leave, a
facility must update the recipients of nursing facility must provide to the
the notice as soon as practicable once resident and the resident representa-
the updated information becomes tive written notice which specifies the
available. duration of the bed-hold policy de-
(7) Orientation for transfer or dis- scribed in paragraph (d)(1) of this sec-
charge. A facility must provide and tion.
document sufficient preparation and (e)(1) Permitting residents to return to
orientation to residents to ensure safe facility. A facility must establish and
and orderly transfer or discharge from follow a written policy on permitting
the facility. This orientation must be residents to return to the facility after
provided in a form and manner that the they are hospitalized or placed on
resident can understand. therapeutic leave. The policy must pro-
(8) Notice in advance of facility closure. vide for the following.
In the case of facility closure, the indi- (i) A resident, whose hospitalization
vidual who is the administrator of the or therapeutic leave exceeds the bed-
facility must provide written notifica- hold period under the State plan, re-
tion prior to the impending closure to turns to the facility to their previous
the State Survey Agency, the Office of room if available or immediately upon
the State Long-Term Care Ombuds- the first availability of a bed in a semi-
man, residents of the facility, and the private room if the resident
resident representatives, as well as the (A) Requires the services provided by
plan for the transfer and adequate relo- the facility; and
73
§ 483.20 42 CFR Ch. IV (10–1–24 Edition)
(B) Is eligible for Medicare skilled (xii) Skin condition.

nursing facility services or Medicaid (xiii) Activity pursuit.
nursing facility services. (xiv) Medications.
(ii) If the facility that determines (xv) Special treatments and proce-
that a resident who was transferred dures.
with an expectation of returning to the (xvi) Discharge planning.
facility cannot return to the facility,
(xvii) Documentation of summary in-
the facility must comply with the re-
formation regarding the additional as-
quirements of paragraph (c) as they
sessment performed on the care areas
apply to discharges.
(2) Readmission to a composite distinct triggered by the completion of the
part. When the facility to which a resi- Minimum Data Set (MDS).
dent returns is a composite distinct (xviii) Documentation of participa-
part (as defined in § 483.5), the resident tion in assessment. The assessment
must be permitted to return to an process must include direct observa-
available bed in the particular location tion and communication with the resi-
of the composite distinct part in which dent, as well as communication with li-
he or she resided previously. If a bed is censed and nonlicensed direct care
not available in that location at the staff members on all shifts.
time of return, the resident must be (2) When required. Subject to the
given the option to return to that loca- timeframes prescribed in § 413.343(b) of
tion upon the first availability of a bed this chapter, a facility must conduct a
there. comprehensive assessment of a resident
in accordance with the timeframes
[81 FR 68855, Oct. 4, 2016, as amended at 82 FR specified in paragraphs (b)(2) (i)
32259, July 13, 2017; 89 FR 40996, May 10, 2024]
through (iii) of this section. The time-
§ 483.20 Resident assessment. frames prescribed in § 413.343(b) of this
chapter do not apply to CAHs.
The facility must conduct initially
(i) Within 14 calendar days after ad-
and periodically a comprehensive, ac-
mission, excluding readmissions in
curate, standardized, reproducible as-
which there is no significant change in
sessment of each resident’s functional
the resident’s physical or mental con-
capacity.
dition. (For purposes of this section,
(a) Admission orders. At the time each
‘‘readmission’’ means a return to the
resident is admitted, the facility must
facility following a temporary absence
have physician orders for the resident’s
for hospitalization or for therapeutic
immediate care.
leave.)
(b) Comprehensive assessments—(1)
Resident assessment instrument. A facil- (ii) Within 14 calendar days after the
ity must make a comprehensive assess- facility determines, or should have de-
ment of a resident’s needs, strengths, termined, that there has been a signifi-
goals, life history and preferences, cant change in the resident’s physical
using the resident assessment instru- or mental condition. (For purposes of
ment (RAI) specified by CMS. The as- this section, a ‘‘significant change’’
sessment must include at least the fol- means a major decline or improvement
lowing: in the resident’s status that will not
(i) Identification and demographic in- normally resolve itself without further
formation. intervention by staff or by imple-
(ii) Customary routine. menting standard disease-related clin-
(iii) Cognitive patterns. ical interventions, that has an impact
(iv) Communication. on more than one area of the resident’s
(v) Vision. health status, and requires inter-
(vi) Mood and behavior patterns. disciplinary review or revision of the
(vii) Psychosocial well-being. care plan, or both.)
(viii) Physical functioning and struc- (iii) Not less often than once every 12
tural problems. months.
(ix) Continence. (c) Quarterly review assessment. A fa-
(x) Disease diagnoses and health con- cility must assess a resident using the
ditions. quarterly review instrument specified
(xi) Dental and nutritional status. by the State and approved by CMS not
74
less frequently than once every 3 and complete MDS data to the CMS
months. System, including the following:
(d) Use. A facility must maintain all (i) Admission assessment.
resident assessments completed within (ii) Annual assessment.
the previous 15 months in the resi- (iii) Significant change in status as-
dent’s active record and use the results sessment.
of the assessments to develop, review, (iv) Significant correction of prior
and revise the resident’s comprehen- full assessment.
sive plan of care. (v) Significant correction of prior
(e) Coordination. A facility must co- quarterly assessment.
ordinate assessments with the (vi) Quarterly review.
preadmission screening and resident re- (vii) A subset of items upon a resi-
view (PASARR) program under Med- dent’s transfer, reentry, discharge, and
icaid in subpart C of this part to the death.
maximum extent practicable to avoid
(viii) Background (face-sheet) infor-
duplicative testing and effort. Coordi-
mation, for an initial transmission of
nation includes—
MDS data on a resident that does not
(1) Incorporating the recommenda-
have an admission assessment.
tions from the PASARR level II deter-
(4) Data format. The facility must
mination and the PASARR evaluation
transmit data in the format specified
report into a resident’s assessment,
by CMS or, for a State which has an al-
care planning, and transitions of care.
ternate RAI approved by CMS, in the
(2) Referring all level II residents and
format specified by the State and ap-
all residents with newly evident or pos-
proved by CMS.
sible serious mental disorder, intellec-
tual disability, or a related condition (5) Resident-identifiable information. (i)
for level II resident review upon a sig- A facility may not release information
nificant change in status assessment. that is resident-identifiable to the pub-
(f) Automated data processing require- lic.
ment—(1) Encoding data. Within 7 days (ii) The facility may release informa-
after a facility completes a resident’s tion that is resident-identifiable to an
assessment, a facility must encode the agent only in accordance with a con-
following information for each resident tract under which the agent agrees not
in the facility: to use or disclose the information ex-
(i) Admission assessment. cept to the extent the facility itself is
(ii) Annual assessment updates. permitted to do so.
(iii) Significant change in status as- (g) Accuracy of assessments. The as-
sessments. sessment must accurately reflect the
(iv) Quarterly review assessments. resident’s status.
(v) A subset of items upon a resi- (h) Coordination. A registered nurse
dent’s transfer, reentry, discharge, and must conduct or coordinate each as-
death. sessment with the appropriate partici-
(vi) Background (face-sheet) informa- pation of health professionals.
tion, if there is no admission assess- (i) Certification. (1) A registered nurse
ment. must sign and certify that the assess-
(2) Transmitting data. Within 7 days ment is completed.
after a facility completes a resident’s (2) Each individual who completes a
assessment, a facility must be capable portion of the assessment must sign
of transmitting to the CMS System in- and certify the accuracy of that por-
formation for each resident contained tion of the assessment.
in the MDS in a format that conforms (j) Penalty for falsification. (1) Under
to standard record layouts and data Medicare and Medicaid, an individual
dictionaries, and that passes standard- who willfully and knowingly—
ized edits defined by CMS and the (i) Certifies a material and false
State. statement in a resident assessment is
(3) Transmittal requirements. Within 14 subject to a civil money penalty of not
days after a facility completes a resi- more than $1,000 as adjusted annually
dent’s assessment, a facility must elec- under 45 CFR part 102 for each assess-
tronically transmit encoded, accurate, ment; or
75
§ 483.21 42 CFR Ch. IV (10–1–24 Edition)
(ii) Causes another individual to cer- (A) Who is admitted to the facility
tify a material and false statement in a directly from a hospital after receiving
resident assessment is subject to a civil acute inpatient care at the hospital,
money penalty of not more than $5,000 (B) Who requires nursing facility
as adjusted annually under 45 CFR part services for the condition for which the
102 for each assessment. individual received care in the hos-
(2) Clinical disagreement does not pital, and
constitute a material and false state- (C) Whose attending physician has
ment. certified, before admission to the facil-
(k) Preadmission screening for individ- ity that the individual is likely to re-
uals with a mental disorder and individ- quire less than 30 days of nursing facil-
uals with intellectual disability. (1) A ity services.
nursing facility must not admit, on or (3) Definition. For purposes of this
after January 1, 1989, any new resident section—
with— (i) An individual is considered to
have a mental disorder if the indi-
(i) Mental disorder as defined in para-
vidual has a serious mental disorder as
graph (k)(3)(i) of this section, unless
defined in § 483.102(b)(1).
the State mental health authority has
(ii) An individual is considered to
determined, based on an independent
have an intellectual disability if the
physical and mental evaluation per- individual has an intellectual dis-
formed by a person or entity other ability as defined in § 483.102(b)(3) or is
than the State mental health author- a person with a related condition as de-
ity, prior to admission, scribed in § 435.1010 of this chapter.
(A) That, because of the physical and (4) A nursing facility must notify the
mental condition of the individual, the state mental health authority or state
individual requires the level of services intellectual disability authority, as ap-
provided by a nursing facility; and plicable, promptly after a significant
(B) If the individual requires such change in the mental or physical condi-
level of services, whether the indi- tion of a resident who has a mental dis-
vidual requires specialized services; or order or intellectual disability for resi-
(ii) Intellectual disability, as defined dent review.
in paragraph (k)(3)(ii) of this section,
unless the State intellectual disability FR 43924, Sept. 23, 1992; 62 FR 67211, Dec. 23,
or developmental disability authority 1997; 63 FR 53307, Oct. 5, 1998; 64 FR 41543,
has determined prior to admission— July 30, 1999; 68 FR 46072, Aug. 4, 2003; 71 FR
(A) That, because of the physical and 39229, July 12, 2006; 74 FR 40363, Aug. 11, 2009;
mental condition of the individual, the 81 FR 61563, Sept. 6, 2016; 81 FR 68857, Oct. 4,
individual requires the level of services 2016]
provided by a nursing facility; and § 483.21 Comprehensive person-cen-
(B) If the individual requires such tered care planning.
level of services, whether the indi-
(a) Baseline care plans. (1) The facility
vidual requires specialized services for
must develop and implement a baseline
intellectual disability.
care plan for each resident that in-
(2) Exceptions. For purposes of this cludes the instructions needed to pro-
section— vide effective and person-centered care
(i) The preadmission screening proof the resident that meet professional
gram under paragraph (k)(1) of this sec- standards of quality care. The baseline
tion need not provide for determina- care plan must—
tions in the case of the readmission to (i) Be developed within 48 hours of a
a nursing facility of an individual who, resident’s admission.
after being admitted to the nursing fa- (ii) Include the minimum healthcare
cility, was transferred for care in a information necessary to properly care
hospital. for a resident including, but not lim-
(ii) The State may choose not to ited to:
apply the preadmission screening pro- (A) Initial goals based on admission
gram under paragraph (k)(1) of this sec- orders.
tion to the admission to a nursing fa- (B) Physician orders.
cility of an individual— (C) Dietary orders.
76
(D) Therapy services. (iv) In consultation with the resident

(E) Social services. and the resident’s representative(s)—
(F) PASARR recommendation, if ap- (A) The resident’s goals for admission
plicable. and desired outcomes.
(2) The facility may develop a com- (B) The resident’s preference and po-
prehensive care plan in place of the tential for future discharge. Facilities
baseline care plan if the comprehensive must document whether the resident’s
care plan— desire to return to the community was
(i) Is developed within 48 hours of the assessed and any referrals to local con-
resident’s admission. tact agencies and/or other appropriate
(ii) Meets the requirements set forth entities, for this purpose.
in paragraph (b) of this section (except- (C) Discharge plans in the com-
ing paragraph (b)(2)(i) of this section). prehensive care plan, as appropriate, in
(3) The facility must provide the resi- accordance with the requirements set
dent and their representative with a forth in paragraph (c) of this section.
summary of the baseline care plan that (2) A comprehensive care plan must
includes but is not limited to: be—
(i) The initial goals of the resident. (i) Developed within 7 days after
(ii) A summary of the resident’s completion of the comprehensive as-
medications and dietary instructions. sessment.
(iii) Any services and treatments to (ii) Prepared by an interdisciplinary
be administered by the facility and team, that includes but is not limited
personnel acting on behalf of the facil- to—
ity. (A) The attending physician.
(iv) Any updated information based
(B) A registered nurse with responsi-
on the details of the comprehensive
bility for the resident.
care plan, as necessary.
(C) A nurse aide with responsibility
(b) Comprehensive care plans. (1) The
for the resident.
facility must develop and implement a
comprehensive person-centered care (D) A member of food and nutrition
plan for each resident, consistent with services staff.
the resident rights set forth at (E) To the extent practicable, the
§ 483.10(c)(2) and § 483.10(c)(3), that in- participation of the resident and the
cludes measurable objectives and time- resident’s representative(s). An expla-
frames to meet a resident’s medical, nation must be included in a resident’s
nursing, and mental and psychosocial medical record if the participation of
needs that are identified in the com- the resident and their resident rep-
prehensive assessment. The com- resentative is determined not prac-
prehensive care plan must describe the ticable for the development of the resi-
following: dent’s care plan.
(i) The services that are to be fur- (F) Other appropriate staff or profes-
nished to attain or maintain the resi- sionals in disciplines as determined by
dent’s highest practicable physical, the resident’s needs or as requested by
mental, and psychosocial well-being as the resident.
required under § 483.24, § 483.25, or (iii) Reviewed and revised by the
§ 483.40; and interdisciplinary team after each as-
(ii) Any services that would other- sessment, including both the com-
wise be required under § 483.24, § 483.25, prehensive and quarterly review assess-
or § 483.40 but are not provided due to ments.
the resident’s exercise of rights under (3) The services provided or arranged
§ 483.10, including the right to refuse by the facility, as outlined by the com-
treatment under § 483.10(c)(6). prehensive care plan, must—
(iii) Any specialized services or spe- (i) Meet professional standards of
cialized rehabilitative services the quality.
nursing facility will provide as a result (ii) Be provided by qualified persons
of PASARR recommendations. If a fa- in accordance with each resident’s
cility disagrees with the findings of the written plan of care.
PASARR, it must indicate its rationale (iii) Be culturally-competent and
in the resident’s medical record. trauma–informed.
77
§ 483.21 42 CFR Ch. IV (10–1–24 Edition)
(c) Discharge planning—(1) Discharge ity must document who made the de-
planning process. The facility must determination and why.
velop and implement an effective dis- (viii) For residents who are trans-
charge planning process that focuses ferred to another SNF or who are dis-
on the resident’s discharge goals, the charged to a HHA, IRF, or LTCH, assist
preparation of residents to be active residents and their resident representa-
partners and effectively transition tives in selecting a post-acute care pro-
them to post-discharge care, and the vider by using data that includes, but
reduction of factors leading to prevent- is not limited to SNF, HHA, IRF, or
able readmissions. The facility’s dis- LTCH standardized patient assessment
charge planning process must be con- data, data on quality measures, and
sistent with the discharge rights set data on resource use to the extent the
forth at § 483.15(b) as applicable and— data is available. The facility must en-
(i) Ensure that the discharge needs of sure that the post-acute care standard-
each resident are identified and result ized patient assessment data, data on
in the development of a discharge plan quality measures, and data on resource
for each resident. use is relevant and applicable to the
(ii) Include regular re-evaluation of resident’s goals of care and treatment
residents to identify changes that re- preferences.
quire modification of the discharge (ix) Document, complete on a timely
plan. The discharge plan must be up- basis based on the resident’s needs, and
dated, as needed, to reflect these include in the clinical record, the eval-
changes. uation of the resident’s discharge needs
(iii) Involve the interdisciplinary and discharge plan. The results of the
team, as defined by § 483.21(b)(2)(ii), in evaluation must be discussed with the
the ongoing process of developing the resident or resident’s representative.
discharge plan. All relevant resident information must
be incorporated into the discharge plan
(iv) Consider caregiver/support per-
to facilitate its implementation and to
son availability and the resident’s or
avoid unnecessary delays in the resi-
caregiver’s/support person(s) capacity
dent’s discharge or transfer.
and capability to perform required
(2) Discharge summary. When the fa-
care, as part of the identification of
cility anticipates discharge a resident
discharge needs.
must have a discharge summary that
(v) Involve the resident and resident
includes, but is not limited to, the fol-
representative in the development of
lowing:
the discharge plan and inform the resi-
(i) A recapitulation of the resident’s
dent and resident representative of the
stay that includes, but is not limited
final plan.
to, diagnoses, course of illness/treat-
(vi) Address the resident’s goals of ment or therapy, and pertinent lab, ra-
care and treatment preferences. diology, and consultation results.
(vii) Document that a resident has (ii) A final summary of the resident’s
been asked about their interest in re- status to include items in paragraph
ceiving information regarding return- (b)(1) of § 483.20, at the time of the dis-
ing to the community. charge that is available for release to
(A) If the resident indicates an inter- authorized persons and agencies, with
est in returning to the community, the the consent of the resident or resi-
facility must document any referrals dent’s representative.
to local contact agencies or other ap- (iii) Reconciliation of all pre-dis-
propriate entities made for this pur- charge medications with the resident’s
pose. post-discharge medications (both pre-
(B) Facilities must update a resi- scribed and over-the-counter).
dent’s comprehensive care plan and dis- (iv) A post-discharge plan of care
charge plan, as appropriate, in response that is developed with the participa-
to information received from referrals tion of the resident and, with the resi-
to local contact agencies or other ap- dent’s consent, the resident representa-
propriate entities. tive(s), which will assist the resident to
(C) If discharge to the community is adjust to his or her new living environ-
determined to not be feasible, the facil- ment. The post-discharge plan of care
78
must indicate where the individual (5) Communication, including

plans to reside, any arrangements that (i) Speech,
have been made for the resident’s fol- (ii) Language,
low up care and any post-discharge (iii) Other functional communication
medical and non-medical services. systems.
[81 FR 68858, Oct. 4, 2016] (c) Activities. (1) The facility must
provide, based on the comprehensive
§ 483.24 Quality of life. assessment and care plan and the pref-
Quality of life is a fundamental prin- erences of each resident, an ongoing
ciple that applies to all care and serv- program to support residents in their
ices provided to facility residents. choice of activities, both facility-spon-
Each resident must receive and the fa- sored group and individual activities
cility must provide the necessary care and independent activities, designed to
and services to attain or maintain the meet the interests of and support the
highest practicable physical, mental, physical, mental, and psychosocial
and psychosocial well-being, consistent well-being of each resident, encour-
with the resident’s comprehensive as- aging both independence and inter-
sessment and plan of care. action in the community.
(a) Based on the comprehensive as- (2) The activities program must be
sessment of a resident and consistent directed by a qualified professional
with the resident’s needs and choices, who is a qualified therapeutic recre-
the facility must provide the necessary ation specialist or an activities profes-
care and services to ensure that a resi- sional who—
dent’s abilities in activities of daily (i) Is licensed or registered, if appli-
living do not diminish unless cir- cable, by the State in which practicing;
cumstances of the individual’s clinical and
condition demonstrate that such dimi- (ii) Is:
nution was unavoidable. This includes (A) Eligible for certification as a
the facility ensuring that: therapeutic recreation specialist or as
(1) A resident is given the appro- an activities professional by a recog-
priate treatment and services to main- nized accrediting body on or after Oc-
tain or improve his or her ability to tober 1, 1990; or
carry out the activities of daily living, (B) Has 2 years of experience in a so-
including those specified in paragraph cial or recreational program within the
(b) of this section, last 5 years, one of which was full-time
(2) A resident who is unable to carry in a therapeutic activities program; or
out activities of daily living receives (C) Is a qualified occupational thera-
the necessary services to maintain pist or occupational therapy assistant;
good nutrition, grooming, and personal or
and oral hygiene, and (D) Has completed a training course
(3) Personnel provide basic life sup- approved by the State.
port, including CPR, to a resident re-
quiring such emergency care prior to [81 FR 68859, Oct. 4, 2016]
the arrival of emergency medical per-
§ 483.25 Quality of care.
sonnel and subject to related physician
orders and the resident’s advance direc- Quality of care is a fundamental
tives. principle that applies to all treatment
(b) Activities of daily living. The facil- and care provided to facility residents.
ity must provide care and services in Based on the comprehensive assess-
accordance with paragraph (a) of this ment of a resident, the facility must
section for the following activities of ensure that residents receive treat-
daily living: ment and care in accordance with pro-
(1) Hygiene—bathing, dressing, fessional standards of practice, the
grooming, and oral care, comprehensive person-centered care
(2) Mobility—transfer and ambula- plan, and the resident’s choices, includ-
tion, including walking, ing but not limited to the following:
(3) Elimination—toileting, (a) Vision and hearing. To ensure that
(4) Dining—eating, including meals residents receive proper treatment and
and snacks, assistive devices to maintain vision
79
§ 483.25 42 CFR Ch. IV (10–1–24 Edition)
and hearing abilities, the facility must, duction in mobility is demonstrably

if necessary, assist the resident— unavoidable.
(1) In making appointments, and (d) Accidents.The facility must ensure
(2) By arranging for transportation that—
to and from the office of a practitioner (1) The resident environment remains
specializing in the treatment of vision as free of accident hazards as is pos-
or hearing impairment or the office of sible; and
a professional specializing in the provi- (2) Each resident receives adequate
sion of vision or hearing assistive de- supervision and assistance devices to
vices. prevent accidents.
(b) Skin integrity—(1) Pressure ulcers. (e) Incontinence. (1) The facility must
Based on the comprehensive assess- ensure that a resident who is continent
ment of a resident, the facility must of bladder and bowel on admission re-
ensure that— ceives services and assistance to main-
(i) A resident receives care, contain continence unless his or her clin-
sistent with professional standards of ical condition is or becomes such that
practice, to prevent pressure ulcers and continence is not possible to maintain.
does not develop pressure ulcers unless (2) For a resident with urinary incon-
the individual’s clinical condition dem- tinence, based on the resident’s com-
onstrates that they were unavoidable; prehensive assessment, the facility
and must ensure that—
(i) A resident who enters the facility
(ii) A resident with pressure ulcers
without an indwelling catheter is not
receives necessary treatment and serv-
catheterized unless the resident’s clin-
ices, consistent with professional
ical condition demonstrates that cath-
standards of practice, to promote heal-
eterization was necessary;
ing, prevent infection and prevent new
(ii) A resident who enters the facility
ulcers from developing.
with an indwelling catheter or subse-
(2) Foot care. To ensure that residents quently receives one is assessed for re-
receive proper treatment and care to moval of the catheter as soon as pos-
maintain mobility and good foot sible unless the resident’s clinical con-
health, the facility must— dition demonstrates that catheteriza-
(i) Provide foot care and treatment, tion is necessary, and
in accordance with professional stand- (iii) A resident who is incontinent of
ards of practice, including to prevent bladder receives appropriate treatment
complications from the resident’s med- and services to prevent urinary tract
ical condition(s) and infections and to restore continence to
(ii) If necessary, assist the resident in the extent possible.
making appointments with a qualified (3) For a resident with fecal inconti-
person, and arranging for transpor- nence, based on the resident’s com-
tation to and from such appointments. prehensive assessment, the facility
(c) Mobility. (1) The facility must en- must ensure that a resident who is in-
sure that a resident who enters the fa- continent of bowel receives appropriate
cility without limited range of motion treatment and services to restore as
does not experience reduction in range much normal bowel function as pos-
of motion unless the resident’s clinical sible.
condition demonstrates that a reduc- (f) Colostomy, urostomy, or ileostomy
tion in range of motion is unavoidable; care. The facility must ensure that
and residents who require colostomy,
(2) A resident with limited range of urostomy, or ileostomy services, re-
motion receives appropriate treatment ceive such care consistent with profes-
and services to increase range of mo- sional standards of practice, the com-
tion and/or to prevent further decrease prehensive person-centered care plan,
in range of motion. and the residents’ goals and pref-
(3) A resident with limited mobility erences.
receives appropriate services, equip- (g) Assisted nutrition and hydration.
ment, and assistance to maintain or (Includes naso-gastric and gastrostomy
improve mobility with the maximum tubes, both percutaneous endoscopic
practicable independence unless a re- gastrostomy and percutaneous
80
endoscopic jejunostomy, and enteral goals and preferences, to wear and be

fluids). Based on a resident’s com- able to use the prosthetic device.
prehensive assessment, the facility (k) Pain management. The facility
must ensure that a resident— must ensure that pain management is
(1) Maintains acceptable parameters provided to residents who require such
of nutritional status, such as usual services, consistent with professional
body weight or desirable body weight standards of practice, the comprehen-
range and electrolyte balance, unless sive person-centered care plan, and the
the resident’s clinical condition dem- residents’ goals and preferences.
onstrates that this is not possible or (l) Dialysis. The facility must ensure
resident preferences indicate other- that residents who require dialysis re-
wise; ceive such services, consistent with
(2) Is offered sufficient fluid intake to professional standards of practice, the
maintain proper hydration and health; comprehensive person-centered care
and plan, and the residents’ goals and pref-
(3) Is offered a therapeutic diet when erences.
there is a nutritional problem and the (m) Trauma-informed care. The facil-
health care provider orders a thera- ity must ensure that residents who are
peutic diet. trauma survivors receive culturally-
(4) A resident who has been able to competent, trauma-informed care in
eat enough alone or with assistance is accordance with professional standards
not fed by enteral methods unless the of practice and accounting for resi-
resident’s clinical condition dem- dents’ experiences and preferences in
onstrates that enteral feeding was order to eliminate or mitigate triggers
clinically indicated and consented to that may cause re-traumatization of
by the resident; and the resident.
(5) A resident who is fed by enteral (n) Bed rails. The facility must at-
means receives the appropriate treat- tempt to use appropriate alternatives
ment and services to restore, if pos- prior to installing a side or bed rail. If
sible, oral eating skills and to prevent a bed or side rail is used, the facility
complications of enteral feeding in- must ensure correct installation, use,
cluding but not limited to aspiration and maintenance of bed rails, including
pneumonia, diarrhea, vomiting, dehy- but not limited to the following ele-
dration, metabolic abnormalities, and ments.
nasal-pharyngeal ulcers. (1) Assess the resident for risk of en-
(h) Parenteral fluids. Parenteral fluids trapment from bed rails prior to instal-
must be administered consistent with lation.
(2) Review the risks and benefits of
professional standards of practice and
bed rails with the resident or resident
in accordance with physician orders,
representative and obtain informed
the comprehensive person-centered
consent prior to installation.
care plan, and the resident’s goals and
(3) Ensure that the bed’s dimensions
preferences.
are appropriate for the resident’s size
(i) Respiratory care, including trache-
and weight.
ostomy care and tracheal suctioning. The
(4) Follow the manufacturers’ rec-
facility must ensure that a resident
ommendations and specifications for
who needs respiratory care, including
installing and maintaining bed rails.
tracheostomy care and tracheal
suctioning, is provided such care, con- [81 FR 68860, Oct. 4, 2016]
sistent with professional standards of
practice, the comprehensive person- § 483.30 Physician services.
centered care plan, the residents’ goals A physician must personally approve
and preferences, and § 483.65 of this sub- in writing a recommendation that an
part. individual be admitted to a facility.
(j) Prostheses. The facility must en- Each resident must remain under the
sure that a resident who has a pros- care of a physician. A physician, physi-
thesis is provided care and assistance, cian assistant, nurse practitioner, or
consistent with professional standards clinical nurse specialist must provide
of practice, the comprehensive person- orders for the resident’s immediate
centered care plan, and the residents’ care and needs.
81
§ 483.35 42 CFR Ch. IV (10–1–24 Edition)
(a) Physician supervision. The facility (iii) Is under the supervision of the
must ensure that— physician.
(1) The medical care of each resident (2) A resident’s attending physician
is supervised by a physician; and may delegate the task of writing die-
(2) Another physician supervises the tary orders, consistent with § 483.60, to
medical care of residents when their a qualified dietitian or other clinically
attending physician is unavailable. qualified nutrition professional who—
(b) Physician visits. The physician (i) Is acting within the scope of prac-
must— tice as defined by State law; and
(1) Review the resident’s total pro- (ii) Is under the supervision of the
gram of care, including medications physician.
and treatments, at each visit required (3) A resident’s attending physician
by paragraph (c) of this section; may delegate the task of writing ther-
(2) Write, sign, and date progress apy orders, consistent with § 483.65, to a
notes at each visit; and qualified therapist who—
(3) Sign and date all orders with the (i) Is acting within the scope of prac-
exception of influenza and pneumo- tice as defined by State law; and
coccal vaccines, which may be adminis- (ii) Is under the supervision of the
tered per physician-approved facility physician.
policy after an assessment for contra- (4) A physician may not delegate a
indications. task when the regulations specify that
(c) Frequency of physician visits. (1) the physician must perform it person-
The resident must be seen by a physi- ally, or when the delegation is prohib-
cian at least once every 30 days for the ited under State law or by the facili-
first 90 days after admission, and at ty’s own policies.
least once every 60 days thereafter.
(f) Performance of physician tasks in
(2) A physician visit is considered NFs. At the option of the State, any re-
timely if it occurs not later than 10
quired physician task in a NF (includ-
days after the date the visit was re-
ing tasks which the regulations specify
quired.
must be performed personally by the
(3) Except as provided in paragraphs physician) may also be satisfied when
(c)(4) and (f) of this section, all re- performed by a nurse practitioner, clin-
quired physician visits must be made ical nurse specialist, or physician as-
by the physician personally.
sistant who is not an employee of the
(4) At the option of the physician, re- facility but who is working in collabo-
quired visits in SNFs after the initial ration with a physician.
visit may alternate between personal
visits by the physician and visits by a [56 FR 48875, Sept. 26, 1991, as amended at 67
physician assistant, nurse practitioner, FR 61814, Oct. 2, 2002. Redesignated and
or clinical nurse specialist in accord- amended at 81 FR 68861, Oct. 4, 2016]
ance with paragraph (e) of this section.
§ 483.35 Nursing services.
(d) Availability of physicians for emer-
gency care. The facility must provide or The facility must have sufficient
arrange for the provision of physician nursing staff with the appropriate com-
services 24 hours a day, in case of an petencies and skills sets to provide
emergency. nursing and related services to assure
(e) Physician delegation of tasks in resident safety and attain or maintain
SNFs. (1) Except as specified in para- the highest practicable physical, men-
graph (e)(4) of this section, a physician tal, and psychosocial well-being of each
may delegate tasks to a physician as- resident, as determined by resident as-
sistant, nurse practitioner, or clinical sessments and individual plans of care
nurse specialist who— and considering the number, acuity,
(i) Meets the applicable definition in and diagnoses of the facility’s resident
§ 491.2 of this chapter or, in the case of population in accordance with the fa-
a clinical nurse specialist, is licensed cility assessment required at § 483.71.
as such by the State; (a) Sufficient staff. (1) The facility
(ii) Is acting within the scope of prac- must provide services by sufficient
tice as defined by State law; and numbers of each of the following types
82
of personnel on a 24-hour basis to pro- (c) Registered nurse. (1) Except when
vide nursing care to all residents in ac- waived or exempted under paragraph
cordance with resident care plans: (f), (g), or (h) of this section, the facil-
(i) Except when waived under para- ity must have a registered nurse (RN)
graph (f) of this section, licensed onsite 24 hours per day, for 7 days a
nurses; and week that is available to provide direct
(ii) Other nursing personnel, includ- resident care.
ing but not limited to nurse aides. (2) For any periods when the onsite
(2) Except when waived under para- RN requirements in paragraph (c)(1) of
graph (f) of this section, the facility this section are exempted under para-
must designate a licensed nurse to graph (h) of this section, facilities
serve as a charge nurse on each tour of must have a registered nurse, nurse
duty. practitioner, physician assistant, or
physician available to respond imme-
(3) The facility must ensure that li-
diately to telephone calls from the fa-
censed nurses have the specific com-
cility.
petencies and skill sets necessary to
(3) Except when waived under para-
care for residents’ needs, as identified
graph (f) or (g) of this section, the fa-
through resident assessments, and de-
cility must designate a registered
scribed in the plan of care.
nurse to serve as the director of nurs-
(4) Providing care includes but is not ing on a full time basis.
limited to assessing, evaluating, plan- (4) The director of nursing may serve
ning, and implementing resident care as a charge nurse only when the facil-
plans and responding to resident’s ity has an average daily occupancy of
needs. 60 or fewer residents.
(b) Total nurse staffing (licensed nurses (d) Proficiency of nurse aides. The fa-
and nurse aides). (1) The facility must cility must ensure that nurse aides are
meet or exceed a minimum of 3.48 able to demonstrate competency in
hours per resident day for total nurse skills and techniques necessary to care
staffing including but not limited to— for residents’ needs, as identified
(i) A minimum of 0.55 hours per resi- through resident assessments, and de-
dent day for registered nurses; and scribed in the plan of care.
(ii) A minimum of 2.45 hours per resi- (e) Requirements for facility hiring and
dent day for nurse aides. use of nursing aides—(1) General rule. A
(2) One or more of the hours per resi- facility must not use any individual
dent day requirements at paragraph working in the facility as a nurse aide
(b)(1) of this section may be exempted for more than 4 months, on a full-time
for facilities found non-compliant and basis, unless—
who meet the eligibility criteria de- (i) That individual is competent to
fined at paragraph (h) of this section as provide nursing and nursing related
determined by the Secretary. services; and
(3) Compliance with minimum total (ii)(A) That individual has completed
nurse staffing hours per resident day as a training and competency evaluation
set forth in one or more of the hours program, or a competency evaluation
per resident day requirements of para- program approved by the State as
graph (b)(1) of this section should not meeting the requirements of §§ 483.151
be construed as approval for a facility through 483.154; or
to staff only to these numerical stand- (B) That individual has been deemed
ards. Facilities must ensure there are a or determined competent as provided
sufficient number of staff with the ap- in § 483.150(a) and (b).
propriate competencies and skills sets (2) Non-permanent employees. A facil-
necessary to assure resident safety and ity must not use on a temporary, per
to attain or maintain the highest prac- diem, leased, or any basis other than a
ticable physical, mental, and psycho- permanent employee any individual
social well-being of each resident, as who does not meet the requirements in
determined by resident assessments, paragraphs (e)(1)(i) and (ii) of this sec-
acuity and diagnoses of the facility’s tion.
resident population in accordance with (3) Minimum competency. A facility
the facility assessment at § 483.71. must not use any individual who has
83
§ 483.35 42 CFR Ch. IV (10–1–24 Edition)
worked less than 4 months as a nurse training must comply with the require-
aide in that facility unless the indi- ments of § 483.95(g).
vidual— (f) Nursing facilities: Waiver of require-
(i) Is a full-time employee in a State- ment to provide licensed nurses and a reg-
approved training and competency istered nurse on a 24-hour basis. To the
evaluation program; extent that a facility is unable to meet
(ii) Has demonstrated competence the requirements of paragraphs (a)(1),
through satisfactory participation in a (b)(1)(i), and (c)(1) of this section, a
State-approved nurse aide training and State may waive such requirements
competency evaluation program or with respect to the facility if—
competency evaluation program; or (1) The facility demonstrates to the
(iii) Has been deemed or determined satisfaction of the State that the facil-
competent as provided in § 483.150(a) ity has been unable, despite diligent ef-
and (b). forts (including offering wages at the
(4) Registry verification. Before allow- community prevailing rate for nursing
ing an individual to serve as a nurse facilities), to recruit appropriate per-
aide, a facility must receive registry sonnel;
verification that the individual has (2) The State determines that a waiv-
met competency evaluation require- er of the requirement will not endanger
ments unless— the health or safety of individuals
(i) The individual is a full-time em- staying in the facility;
ployee in a training and competency (3) The State finds that, for any peri-
evaluation program approved by the ods in which licensed nursing services
State; or are not available, a registered nurse or
(ii) The individual can prove that he a physician is obligated to respond im-
or she has recently successfully com- mediately to telephone calls from the
pleted a training and competency eval- facility;
uation program or competency evalua- (4) A waiver granted under the condi-
tion program approved by the State tions listed in this paragraph (f) is sub-
and has not yet been included in the ject to annual State review;
registry. Facilities must follow up to (5) In granting or renewing a waiver,
ensure that such an individual actually a facility may be required by the State
becomes registered. to use other qualified, licensed per-
(5) Multi-State registry verification. Be- sonnel;
fore allowing an individual to serve as (6) The State agency granting a waiv-
a nurse aide, a facility must seek infor- er of such requirements provides notice
mation from every State registry es- of the waiver to the Office of the State
tablished under section 1819(e)(2)(A) or Long-Term Care Ombudsman (estab-
1919(e)(2)(A) of the Act that the facility lished under section 712 of the Older
believes will include information on Americans Act of 1965) and the protec-
the individual. tion and advocacy system in the State
(6) Required retraining. If, since an infor individuals with a mental disorder
dividual’s most recent completion of a who are eligible for such services as
training and competency evaluation provided by the protection and advo-
program, there has been a continuous cacy agency; and
period of 24 consecutive months during (7) The nursing facility that is grant-
none of which the individual provided ed such a waiver by a State notifies
nursing or nursing-related services for residents of the facility and their resi-
monetary compensation, the individual dent representatives of the waiver.
must complete a new training and com- (g) SNFs: Waiver of the requirement to
petency evaluation program or a new provide services of a registered nurse for
competency evaluation program. at least 112 hours a week. (1) The Sec-
(7) Regular in-service education. The retary may waive the requirement that
facility must complete a performance a SNF provide the services of a reg-
review of every nurse aide at least once istered nurse for more than 40 hours a
every 12 months, and must provide reg- week, including a director of nursing
ular in-service education based on the specified in paragraph (c) of this sec-
outcome of these reviews. In-service tion, if the Secretary finds that—
84
(i) The facility is located in a rural force that is a minimum of 20 percent

area and the supply of skilled nursing below the national average, as cal-
facility services in the area is not suffi- culated by CMS, by using data from
cient to meet the needs of individuals the Bureau of Labor Statistics and
residing in the area; Census Bureau.
(ii) The facility has one full-time reg- (i) The facility may receive an ex-
istered nurse who is regularly on duty emption from the total nurse staffing
at the facility 40 hours a week; and requirement of 3.48 hours per resident
(iii) The facility either— day at paragraph (b)(1) of this section
(A) Has only patients whose physi- if the combined licensed nurse, which
cians have indicated (through physi- includes both RNs and licensed voca-
cians’ orders or admission notes) that tional nurses (LVN)/licensed practical
they do not require the services of a nurses (LPNs) and nurse aide to popu-
registered nurse or a physician for a 48- lation ratio in its area is a minimum of
hours period; or 20 percent below the national average.
(B) Has made arrangements for a reg- (ii) The facility may receive an ex-
istered nurse or a physician to spend emption from the 0.55 registered nurse
time at the facility, as determined nec- hours per resident day requirement at
essary by the physician, to provide nec- paragraph (b)(1)(i) of this section and
essary skilled nursing services on days an exemption of 8 hours a day from the
when the regular full-time registered registered nurse on site 24 hours per
nurse is not on duty; day, for 7 days a week requirement at
(iv) The Secretary provides notice of paragraph (c)(1) of this section if the
the waiver to the Office of the State registered nurse to population ratio in
Long-Term Care Ombudsman (estab- its area is a minimum of 20 percent
lished under section 712 of the Older below the national average.
Americans Act of 1965) and the protec- (iii) The facility may receive an ex-
tion and advocacy system in the State emption from the 2.45 nurse aide hours
for individuals with developmental dis- per resident day requirement at para-
abilities or mental disorders; and graph (b)(1)(ii) of this section if the
(v) The facility that is granted such a nurse aide to population ratio in its
waiver notifies residents of the facility area is a minimum of 20 percent below
and their resident representatives of the national average.
the waiver. (2) Good faith efforts to hire. The facil-
(2) A waiver of the registered nurse ity demonstrates that it has been un-
requirement under paragraph (g)(1) of able, despite diligent efforts, including
this section is subject to annual re- offering at least prevailing wages, to
newal by the Secretary. recruit and retain appropriate per-
(h) Hardship exemptions from the min- sonnel. The information is verified
imum hours per resident day and reg- through:
istered nurse onsite 24 hours per day, for (i) Job listings in commonly used re-
7 days a week requirements. A facility cruitment forums found online at
may be exempted by the Secretary American Job Centers (coordinated by
from one or more of the requirements the U.S. Department of Labor’s Em-
of paragraphs (b)(1) and (c)(1) of this ployment and Training Administra-
section if a verifiable hardship exists tion), and other forums as appropriate;
that prohibits the facility from achiev- (ii) Documented job vacancies includ-
ing or maintaining compliance. The fa- ing the number and duration of the va-
cility must meet the four following cri- cancies and documentation of offers
teria to qualify for and receive a hard- made, including that they were made
ship exemption: at least at prevailing wages;
(1) Location. The facility is located in (iii) Data on the average wages in the
an area where the supply of applicable Metropolitan Statistical Area in which
healthcare staff (RN, nurse aide (NA), the facility is located and vacancies by
or total nurse staffing, as indicated in industry as reported by the Bureau of
paragraphs (h)(1)(i), (ii), and/or (iii) of Labor Statistics or by the State’s De-
this section) is not sufficient to meet partment of Labor; and
area needs as evidenced by a provider (iv) The facility’s staffing plan in ac-
to population ratio for nursing work- cordance with § 483.71(c)(4); and
85
§ 483.35 42 CFR Ch. IV (10–1–24 Edition)
(3) Demonstrated financial commitment. (7) Timeframe. The term for a hard-
The facility demonstrates through doc- ship exemption is from grant of exemp-
umentation the amount of financial re- tion until the next standard recertifi-
sources that the facility expends on cation survey, unless the facility be-
nurse staffing relative to revenue. comes a Special Focus Facility, is
(4) Disclosure of exemption status. The cited for widespread insufficient staff-
facility: ing with resultant resident actual
(i) Posts, in a prominent location in harm or a pattern of insufficient staff-
the facility, and in a form and manner ing with resultant resident actual
accessible and understandable to resi- harm, or is cited at the immediate
dents, and resident representatives, a jeopardy level of severity with respect
notice of the facility’s exemption sta- to insufficient staffing as determined
tus, the extent to which the facility by CMS, or fails to submit Payroll
does not meet the minimum staffing Based Journal data in accordance with
requirements, and the timeframe dur- § 483.70(p). A hardship exemption may
ing which the exemption applies; and be extended on each standard recertifi-
(ii) Provides to each resident or resi- cation survey, after the initial period,
dent representative, and to each pro- if the facility continues to meet the ex-
spective resident or resident represent- emption criteria in paragraphs (h)(1)
ative, a notice of the facility’s exemp- through (5) of this section, as deter-
mined by the Secretary.
tion status, including the extent to
(i) Nurse staffing information—(1) Data
which the facility does not meet the
requirements. The facility must post the
staffing requirements, the timeframe
following information on a daily basis:
during which the exemption applies,
(i) Facility name.
and a statement reminding residents of
(ii) The current date.
their rights to contact advocacy and
(iii) The total number and the actual
oversight entities, as provided in the
hours worked by the following cat-
notice provided to them under
egories of licensed and unlicensed nurs-
§ 483.10(g)(4); and
ing staff directly responsible for resi-
(iii) Sends a copy of the notice to a dent care per shift:
representative of the Office of the (A) Registered nurses.
State Long-Term Care Ombudsman. (B) Licensed practical nurses or li-
(5) Exclusions. Facilities must not: censed vocational nurses (as defined
(i) Be a Special Focus Facility, pur- under State law).
suant to the Special Focus Facility (C) Certified nurse aides.
Program established under sections (iv) Resident census.
1819(f)(8) and 1919(f)(10) of the Act; or (2) Posting requirements. (i) The facil-
(ii) Have been cited for having wide- ity must post the nurse staffing data
spread insufficient staffing with result- specified in paragraph (i)(1) of this sec-
ant resident actual harm or a pattern tion on a daily basis at the beginning
of insufficient staffing with resultant of each shift.
resident actual harm, or cited at the (ii) Data must be posted as follows:
immediate jeopardy level of severity (A) Clear and readable format.
with respect to insufficient staffing as (B) In a prominent place readily ac-
determined by CMS, within the 12 cessible to residents, staff, and visitors.
months preceding the survey during (3) Public access to posted nurse staff-
which the facility’s non-compliance is ing data. The facility must, upon oral
identified; or or written request, make nurse staffing
(iii) Have failed to submit Payroll data available to the public for review
Based Journal data in accordance with at a cost not to exceed the community
§ 483.70(p). standard.
(6) Determination of eligibility. The (4) Facility data retention requirements.
Secretary, through CMS or the State, The facility must maintain the posted
will determine eligibility for an exemp- daily nurse staffing data for a min-
tion based on the criteria in para- imum of 18 months, or as required by
graphs (h)(1) through (5) of this section. State law, whichever is greater.
The facility must provide supporting [89 FR 40996, May 10, 2024; 89 FR 52396, June
documentation when requested. 24, 2024]
86
§ 483.40 Behavioral health services. and/or increased withdrawn, angry, or

Each resident must receive and the depressive behaviors, unless the resi-
facility must provide the necessary be- dent’s clinical condition demonstrates
havioral health care and services to at- that development of such a pattern was
tain or maintain the highest prac- unavoidable; and
ticable physical, mental, and psycho- (3) A resident who displays or is diag-
social well-being, in accordance with nosed with dementia, receives the ap-
the comprehensive assessment and plan propriate treatment and services to at-
of care. Behavioral health encompasses tain or maintain his or her highest
a resident’s whole emotional and men- practicable physical, mental, and psy-
tal well-being, which includes, but is chosocial well-being.
(c) If rehabilitative services such as
not limited to, the prevention and
but not limited to physical therapy,
treatment of mental and substance use
speech-language pathology, occupa-
disorders.
(a) The facility must have sufficient tional therapy, and rehabilitative serv-
staff who provide direct services to ices for mental disorders and intellec-
residents with the appropriate com- tual disability, are required in the resi-
petencies and skills sets to provide dent’s comprehensive plan of care, the
nursing and related services to assure facility must—
(1) Provide the required services, in-
resident safety and attain or maintain
the highest practicable physical, men- cluding specialized rehabilitation serv-
tal and psychosocial well-being of each ices as required in § 483.65; or
resident, as determined by resident as- (2) Obtain the required services from
sessments and individual plans of care an outside resource (in accordance with
and considering the number, acuity § 483.70(f)) from a Medicare and/or Med-
and diagnoses of the facility’s resident icaid provider of specialized rehabilita-
population in accordance with § 483.71. tive services.
These competencies and skills sets in- (d) The facility must provide medi-
clude, but are not limited to, knowl- cally-related social services to attain
edge of and appropriate training and or maintain the highest practicable
supervision for: physical, mental and psychosocial
(1) Caring for residents with mental well-being of each resident.
and psychosocial disorders, as well as [81 FR 68862, Oct. 4, 2016, as amended at 89 FR
residents with a history of trauma and/ 40999, May 10, 2024]
or post-traumatic stress disorder, that
have been identified in the facility as- § 483.45 Pharmacy services.
sessment conducted pursuant to The facility must provide routine and
§ 483.71; and emergency drugs and biologicals to its
(2) Implementing non-pharma- residents, or obtain them under an
cological interventions. agreement described in § 483.70(f). The
(b) Based on the comprehensive as- facility may permit unlicensed per-
sessment of a resident, the facility sonnel to administer drugs if State law
must ensure that— permits, but only under the general su-
(1) A resident who displays or is diag- pervision of a licensed nurse.
nosed with mental disorder or psycho- (a) Procedures. A facility must pro-
social adjustment difficulty, or who vide pharmaceutical services (includ-
has a history of trauma and/or posting procedures that assure the accurate
traumatic stress disorder, receives ap- acquiring, receiving, dispensing, and
propriate treatment and services to administering of all drugs and
correct the assessed problem or to at- biologicals) to meet the needs of each
tain the highest practicable mental resident.
and psychosocial well-being; (b) Service consultation. The facility
(2) A resident whose assessment did must employ or obtain the services of a
not reveal or who does not have a diag- licensed pharmacist who—
nosis of a mental or psychosocial ad- (1) Provides consultation on all as-
justment difficulty or a documented pects of the provision of pharmacy
history of trauma and/or post-trau- services in the facility;
matic stress disorder does not display a (2) Establishes a system of records of
pattern of decreased social interaction receipt and disposition of all controlled
87
§ 483.45 42 CFR Ch. IV (10–1–24 Edition)
drugs in sufficient detail to enable an (d) Unnecessary drugs—General. Each

accurate reconciliation; and resident’s drug regimen must be free
(3) Determines that drug records are from unnecessary drugs. An unneces-
in order and that an account of all con- sary drug is any drug when used—
trolled drugs is maintained and peri- (1) In excessive dose (including dupli-
odically reconciled. cate drug therapy); or
(c) Drug regimen review. (1) The drug (2) For excessive duration; or
regimen of each resident must be re- (3) Without adequate monitoring; or
viewed at least once a month by a li- (4) Without adequate indications for
censed pharmacist. its use; or
(2) This review must include a review (5) In the presence of adverse con-
of the resident’s medical chart. sequences which indicate the dose
(3) A psychotropic drug is any drug should be reduced or discontinued; or
that affects brain activities associated (6) Any combinations of the reasons
with mental processes and behavior. stated in paragraphs (d)(1) through (5)
These drugs include, but are not lim- of this section.
ited to, drugs in the following cat- (e) Psychotropic drugs. Based on a
egories: comprehensive assessment of a resi-
(i) Anti-psychotic; dent, the facility must ensure that—
(ii) Anti-depressant; (1) Residents who have not used psy-
(iii) Anti-anxiety; and chotropic drugs are not given these
(iv) Hypnotic. drugs unless the medication is nec-
(4) The pharmacist must report any essary to treat a specific condition as
irregularities to the attending physi- diagnosed and documented in the clin-
cian and the facility’s medical director ical record;
and director of nursing, and these re- (2) Residents who use psychotropic
ports must be acted upon. drugs receive gradual dose reductions,
(i) Irregularities include, but are not and behavioral interventions, unless
limited to, any drug that meets the cri- clinically contraindicated, in an effort
teria set forth in paragraph (d) of this to discontinue these drugs;
section for an unnecessary drug. (3) Residents do not receive psycho-
(ii) Any irregularities noted by the tropic drugs pursuant to a PRN order
pharmacist during this review must be unless that medication is necessary to
documented on a separate, written re- treat a diagnosed specific condition
port that is sent to the attending phy- that is documented in the clinical
sician and the facility’s medical direc- record; and
tor and director of nursing and lists, at (4) PRN orders for psychotropic drugs
a minimum, the resident’s name, the are limited to 14 days. Except as pro-
relevant drug, and the irregularity the vided in § 483.45(e)(5), if the attending
pharmacist identified. physician or prescribing practitioner
(iii) The attending physician must believes that it is appropriate for the
document in the resident’s medical PRN order to be extended beyond 14
record that the identified irregularity days, he or she should document their
has been reviewed and what, if any, ac- rationale in the resident’s medical
tion has been taken to address it. If record and indicate the duration for
there is to be no change in the medica- the PRN order.
tion, the attending physician should (5) PRN orders for anti-psychotic
document his or her rationale in the drugs are limited to 14 days and cannot
resident’s medical record. be renewed unless the attending physi-
(5) The facility must develop and cian or prescribing practitioner evalu-
maintain policies and procedures for ates the resident for the appropriate-
the monthly drug regimen review that ness of that medication.
include, but are not limited to, time (f) Medication errors. The facility
frames for the different steps in the must ensure that its—
process and steps the pharmacist must (1) Medication error rates are not 5
take when he or she identifies an irreg- percent or greater; and
ularity that requires urgent action to (2) Residents are free of any signifi-
protect the resident. cant medication errors.
88
(g) Labeling of drugs and biologicals. services from a laboratory that meets
Drugs and biologicals used in the facil- the applicable requirements of part 493
ity must be labeled in accordance with of this chapter.
currently accepted professional prin- (2) The facility must:
ciples, and include the appropriate ac- (i) Provide or obtain laboratory serv-
cessory and cautionary instructions, ices only when ordered by a physician;
and the expiration date when applica- physician assistant; nurse practitioner
ble. or clinical nurse specialist in accord-
(h) Storage of drugs and biologicals. (1) ance with State law, including scope of
In accordance with State and Federal practice laws.
laws, the facility must store all drugs (ii) Promptly notify the ordering
and biologicals in locked compart- physician, physician assistant, nurse
ments under proper temperature con- practitioner, or clinical nurse spe-
trols, and permit only authorized per- cialist of laboratory results that fall
sonnel to have access to the keys. outside of clinical reference ranges in
(2) The facility must provide sepa- accordance with facility policies and
rately locked, permanently affixed procedures for notification of a practi-
compartments for storage of controlled tioner or per the ordering physician’s
drugs listed in Schedule II of the Com- orders.
prehensive Drug Abuse Prevention and (iii) Assist the resident in making
Control Act of 1976 and other drugs transportation arrangements to and
subject to abuse, except when the facil- from the source of service, if the resi-
ity uses single unit package drug dis- dent needs assistance; and
tribution systems in which the quan- (iv) File in the resident’s clinical
tity stored is minimal and a missing record laboratory reports that are
dose can be readily detected. dated and contain the name and ad-
dress of the testing laboratory.
FR 43925, Sept. 23, 1992. Redesignated and (b) Radiology and other diagnostic serv-
amended at 81 FR 68861, 68863, Oct. 4, 2016; 82 ices. (1) The facility must provide or ob-
FR 32259, July 13, 2017; 89 FR 40999, May 10, tain radiology and other diagnostic
2024] services to meet the needs of its resi-
dents. The facility is responsible for
§ 483.50 Laboratory, radiology, and the quality and timeliness of the serv-
other diagnostic services. ices.
(a) Laboratory services. (1) The facility (i) If the facility provides its own di-
must provide or obtain laboratory serv- agnostic services, the services must
ices to meet the needs of its residents. meet the applicable conditions of par-
The facility is responsible for the qual- ticipation for hospitals contained in
ity and timeliness of the services. § 482.26 of this subchapter.
(i) If the facility provides its own lab- (ii) If the facility does not provide its
oratory services, the services must own diagnostic services, it must have
meet the applicable requirements for an agreement to obtain these services
laboratories specified in part 493 of this from a provider or supplier that is ap-
chapter. proved to provide these services under
(ii) If the facility provides blood bank Medicare.
and transfusion services, it must meet (2) The facility must:
the applicable requirements for labora- (i) Provide or obtain radiology and
tories specified in part 493 of this chap- other diagnostic services only when or-
ter. dered by a physician; physician assist-
(iii) If the laboratory chooses to refer ant; nurse practitioner or clinical
specimens for testing to another lab- nurse specialist in accordance with
oratory, the referral laboratory must State law, including scope of practice
be certified in the appropriate special- laws.
ties and subspecialties of services in (ii) Promptly notify the ordering
accordance with the requirements of physician, physician assistant, nurse
part 493 of this chapter. practitioner, or clinical nurse spe-
(iv) If the facility does not provide cialist of results that fall outside of
laboratory services on site, it must clinical reference ranges in accordance
have an agreement to obtain these with facility policies and procedures
89
§ 483.55 42 CFR Ch. IV (10–1–24 Edition)
for notification of a practitioner or per (i) In making appointments; and

the ordering physician’s orders. (ii) By arranging for transportation
(iii) Assist the resident in making to and from the dental services loca-
transportation arrangements to and tions;
from the source of service, if the resi- (3) Must promptly, within 3 days,
dent needs assistance; and refer residents with lost or damaged
(iv) File in the resident’s clinical dentures for dental services. If a refer-
record signed and dated reports of x- ral does not occur within 3 days, the fa-
ray and other diagnostic services. cility must provide documentation of
[81 FR 68863, Oct. 4, 2016, as amended at 82 FR what they did to ensure the resident
32259, July 13, 2017] could still eat and drink adequately
while awaiting dental services and the
§ 483.55 Dental services. extenuating circumstances that led to
The facility must assist residents in the delay;
obtaining routine and 24-hour emer- (4) Must have a policy identifying
gency dental care. those circumstances when the loss or
(a) Skilled nursing facilities. A facility: damage of dentures is the facility’s re-
(1) Must provide or obtain from an sponsibility and may not charge a resi-
outside resource, in accordance with dent for the loss or damage of dentures
§ 483.70(f), routine and emergency den- determined in accordance with facility
tal services to meet the needs of each policy to be the facility’s responsi-
resident; bility; and
(2) May charge a Medicare resident (5) Must assist residents who are eli-
an additional amount for routine and gible and wish to participate to apply
emergency dental services; for reimbursement of dental services as
(3) Must have a policy identifying an incurred medical expense under the
those circumstances when the loss or State plan.
damage of dentures is the facility’s re-
sponsibility and may not charge a resi-
FR 68864, Oct. 4, 2016; 89 FR 40999, May 10,
dent for the loss or damage of dentures 2024]
determined in accordance with facility
policy to be the facility’s responsi- § 483.60 Food and nutrition services.
bility;
(4) Must if necessary or if requested, The facility must provide each resi-
assist the resident— dent with a nourishing, palatable, well-
(i) In making appointments; and balanced diet that meets his or her
(ii) By arranging for transportation daily nutritional and special dietary
to and from the dental services loca- needs, taking into consideration the
tion; and preferences of each resident.
(5) Must promptly, within 3 days, (a) Staffing. The facility must employ
refer residents with lost or damaged sufficient staff with the appropriate
dentures for dental services. If a refer- competencies and skills sets to carry
ral does not occur within 3 days, the fa- out the functions of the food and nutri-
cility must provide documentation of tion service, taking into consideration
what they did to ensure the resident resident assessments, individual plans
could still eat and drink adequately of care and the number, acuity and di-
while awaiting dental services and the agnoses of the facility’s resident popu-
extenuating circumstances that led to lation in accordance with the facility
the delay. assessment required at § 483.71. This in-
(b) Nursing facilities. The facility: cludes:
(1) Must provide or obtain from an (1) A qualified dietitian or other
outside resource, in accordance with clinically qualified nutrition profes-
§ 483.70(f), the following dental services sional either full-time, part-time, or on
to meet the needs of each resident: a consultant basis. A qualified dieti-
(i) Routine dental services (to the ex- tian or other clinically qualified nutri-
tent covered under the State plan); and tion professional is one who—
(ii) Emergency dental services; (i) Holds a bachelor’s or higher de-
(2) Must, if necessary or if requested, gree granted by a regionally accredited
assist the resident— college or university in the United
90
States (or an equivalent foreign de- (ii) In States that have established
gree) with completion of the academic standards for food service managers or
requirements of a program in nutrition dietary managers, meets State require-
or dietetics accredited by an appro- ments for food service managers or die-
priate national accreditation organiza- tary managers, and
tion recognized for this purpose. (iii) Receives frequently scheduled
(ii) Has completed at least 900 hours consultations from a qualified dietitian
of supervised dietetics practice under or other clinically qualified nutrition
the supervision of a registered dietitian professional.
or nutrition professional. (3) Support staff. The facility must
(iii) Is licensed or certified as a dieti- provide sufficient support personnel to
tian or nutrition professional by the safely and effectively carry out the
State in which the services are per- functions of the food and nutrition
formed. In a state that does not pro- service.
vide for licensure or certification, the (b) A member of the Food and Nutri-
individual will be deemed to have met tion Services staff must participate on
this requirement if he or she is recog- the interdisciplinary team as required
nized as a ‘‘registered dietitian’’ by the in § 483.21(b)(2)(ii).
Commission on Dietetic Registration (c) Menus and nutritional adequacy.
or its successor organization, or meets Menus must—
the requirements of paragraphs (a)(1)(i) (1) Meet the nutritional needs of resi-
and (ii) of this section. dents in accordance with established
(iv) For dietitians hired or con- national guidelines.;
tracted with prior to November 28, 2016, (2) Be prepared in advance;
meets these requirements no later than (3) Be followed;
5 years after November 28, 2016 or as re- (4) Reflect, based on a facility’s rea-
quired by state law. sonable efforts, the religious, cultural,
(2) If a qualified dietitian or other and ethnic needs of the resident popu-
clinically qualified nutrition profes- lation, as well as input received from
sional is not employed full-time, the residents and resident groups;
facility must designate a person to (5) Be updated periodically;
serve as the director of food and nutri- (6) Be reviewed by the facility’s dieti-
tion services. tian or other clinically qualified nutri-
(i) The director of food and nutrition tion professional for nutritional ade-
services must at a minimum meet one quacy; and
of the following qualifications— (7) Nothing in this paragraph should
(A) A certified dietary manager; or be construed to limit the resident’s
(B) A certified food service manager, right to make personal dietary choices.
or (d) Food and drink. Each resident re-
(C) Has similar national certification ceives and the facility provides—
for food service management and safe- (1) Food prepared by methods that
ty from a national certifying body; conserve nutritive value, flavor, and
(D) Has an associate’s or higher de- appearance;
gree in food service management or in (2) Food and drink that is palatable,
hospitality, if the course study in- attractive, and at a safe and appetizing
cludes food service or restaurant man- temperature;
agement, from an accredited institu- (3) Food prepared in a form designed
tion of higher learning; or to meet individual needs;
(E) Has 2 or more years of experience (4) Food that accommodates resident
in the position of director of food and allergies, intolerances, and preferences;
nutrition services in a nursing facility (5) Appealing options of similar nu-
setting and has completed a course of tritive value to residents who choose
study in food safety and management, not to eat food that is initially served
by no later than October 1, 2023, that or who request a different meal choice;
includes topics integral to managing and
dietary operations including, but not (6) Drinks, including water and other
limited to, foodborne illness, sanita- liquids consistent with resident needs
tion procedures, and food purchasing/ and preferences and sufficient to main-
receiving; and tain resident hydration.
91
§ 483.65 42 CFR Ch. IV (10–1–24 Edition)
(e) Therapeutic diets. (1) Therapeutic for residents who have no complicated
diets must be prescribed by the attend- feeding problems.
ing physician. (ii) Complicated feeding problems in-
(2) The attending physician may dele- clude, but are not limited to, difficulty
gate to a registered or licensed dieti- swallowing, recurrent lung aspirations,
tian the task of prescribing a resident’s and tube or parenteral/IV feedings.
diet, including a therapeutic diet, to (iii) The facility must base resident
the extent allowed by State law. selection on the interdisciplinary
(f) Frequency of meals. (1) Each resi- team’s assessment and the resident’s
dent must receive and the facility must latest assessment and plan of care. Ap-
provide at least three meals daily, at propriateness for this program should
regular times comparable to normal be reflected in the comprehensive care
mealtimes in the community or in ac- plan.
cordance with resident needs, pref- (i) Food safety requirements. The facil-
erences, requests, and plan of care. ity must—
(2) There must be no more than 14 (1) Procure food from sources ap-
hours between a substantial evening proved or considered satisfactory by
meal and breakfast the following day, federal, state, or local authorities;
except when a nourishing snack is (i) This may include food items ob-
served at bedtime, up to 16 hours may tained directly from local producers,
elapse between a substantial evening subject to applicable State and local
meal and breakfast the following day if laws or regulations.
a resident group agrees to this meal (ii) This provision does not prohibit
span. or prevent facilities from using
(3) Suitable, nourishing alternative produce grown in facility gardens, sub-
meals and snacks must be provided to ject to compliance with applicable safe
residents who want to eat at non-tradi- growing and food-handling practices.
tional times or outside of scheduled
(iii) This provision does not preclude
meal service times, consistent with the
residents from consuming foods not
resident plan of care.
procured by the facility.
(g) Assistive devices. The facility must
(2) Store, prepare, distribute, and
provide special eating equipment and
serve food in accordance with profes-
utensils for residents who need them
sional standards for food service safety.
and appropriate assistance to ensure
that the resident can use the assistive (3) Have a policy regarding use and
devices when consuming meals and storage of foods brought to residents
snacks. by family and other visitors to ensure
safe and sanitary storage, handling,
(h) Paid feeding assistants—(1) State-
approved training course. A facility may and consumption, and
use a paid feeding assistant, as defined (4) Dispose of garbage and refuse
in § 488.301 of this chapter, if— properly.
(i) The feeding assistant has success- [81 FR 68864, Oct. 4, 2016, as amended at 87 FR
fully completed a State-approved 47618, Aug. 3, 2022; 89 FR 40999, May 10, 2024]
training course that meets the require-
ments of § 483.160 before feeding resi- § 483.65 Specialized rehabilitative
dents; and services.
(ii) The use of feeding assistants is (a) Provision of services. If specialized
consistent with State law. rehabilitative services such as but not
(2) Supervision. (i) A feeding assistant limited to physical therapy, speech-
must work under the supervision of a language pathology, occupational ther-
registered nurse (RN) or licensed prac- apy, respiratory therapy, and rehabili-
tical nurse (LPN). tative services for a mental disorder
(ii) In an emergency, a feeding assist- and intellectual disability or services
ant must call a supervisory nurse for of a lesser intensity as set forth at
help. § 483.120(c), are required in the resi-
(3) Resident selection criteria. (i) A fa- dent’s comprehensive plan of care, the
cility must ensure that a feeding as- facility must—
sistant provides dining assistance only (1) Provide the required services; or
92
(2) In accordance with § 483.70(f), ob- (d) Governing body. (1) The facility
tain the required services from an out- must have a governing body, or des-
side resource that is a provider of spe- ignated persons functioning as a gov-
cialized rehabilitative services and is erning body, that is legally responsible
not excluded from participating in any for establishing and implementing poli-
Federal or State health care programs cies regarding the management and op-
pursuant to section 1128 and 1156 of the eration of the facility; and
Act. (2) The governing body appoints the
(b) Qualifications. Specialized reha- administrator who is—
bilitative services must be provided (i) Licensed by the State, where li-
under the written order of a physician censing is required;
by qualified personnel. (ii) Responsible for management of
[56 FR 48875, Sept. 26, 1991, as amended at 57 the facility; and
FR 43925, Sept. 23, 1992. Redesignated and (iii) Reports to and is accountable to
amended at 81 FR 68861, 68865, Oct. 4, 2016; 89 the governing body.
FR 40999, May 10, 2024] (3) The governing body is responsible
and accountable for the QAPI program,
§ 483.70 Administration. in accordance with § 483.75(f).
A facility must be administered in a (e) Staff qualifications. (1) The facility
manner that enables it to use its re- must employ on a full-time, part-time
sources effectively and efficiently to or consultant basis those professionals
attain or maintain the highest prac- necessary to carry out the provisions
ticable physical, mental, and psycho- of these requirements.
social well-being of each resident. (2) Professional staff must be li-
(a) Licensure. A facility must be licensed, certified, or registered in ac-
censed under applicable State and local cordance with applicable State laws.
law. (f) Use of outside resources. (1) If the
(b) Compliance with Federal, State, and facility does not employ a qualified
local laws and professional standards. professional person to furnish a specific
The facility must operate and provide service to be provided by the facility,
services in compliance with all applica- the facility must have that service fur-
ble Federal, State, and local laws, reg- nished to residents by a person or agen-
ulations, and codes, and with accepted cy outside the facility under an ar-
professional standards and principles rangement described in section 1861(w)
that apply to professionals providing of the Act or (with respect to services
services in such a facility. furnished to NF residents and dental
(c) Relationship to other HHS regula- services furnished to SNF residents) an
tions. In addition to compliance with agreement described in paragraph (g)(2)
the regulations set forth in this sub- of this section.
part, facilities are obliged to meet the (2) Arrangements as described in sec-
applicable provisions of other HHS reg- tion 1861(w) of the Act or agreements
ulations, including but not limited to pertaining to services furnished by out-
those pertaining to nondiscrimination side resources must specify in writing
on the basis of race, color, or national that the facility assumes responsibility
origin (45 CFR part 80); nondiscrimina- for—
tion on the basis of disability (45 CFR (i) Obtaining services that meet pro-
part 84); nondiscrimination on the fessional standards and principles that
basis of age (45 CFR part 91); non- apply to professionals providing serv-
discrimination on the basis of race, ices in such a facility; and
color, national origin, sex, age, or dis- (ii) The timeliness of the services.
ability (45 CFR part 92); protection of (g) Medical director. (1) The facility
human subjects of research (45 CFR must designate a physician to serve as
part 46); and fraud and abuse (42 CFR medical director.
part 455) and protection of individually (2) The medical director is respon-
identifiable health information (45 CFR sible for—
parts 160 and 164). Violations of such (i) Implementation of resident care
other provisions may result in a find- policies; and
ing of non-compliance with this para- (ii) The coordination of medical care
graph. in the facility.
93
§ 483.70 42 CFR Ch. IV (10–1–24 Edition)
(h) Medical records. (1) In accordance (vi) Laboratory, radiology and other
with accepted professional standards diagnostic services reports as required
and practices, the facility must main- under § 483.50.
tain medical records on each resident (i) Transfer agreement. (1) In accord-
that are— ance with section 1861(l) of the Act, the
(i) Complete; facility (other than a nursing facility
(ii) Accurately documented; which is located in a State on an In-
(iii) Readily accessible; and dian reservation) must have in effect a
(iv) Systematically organized. written transfer agreement with one or
(2) The facility must keep confiden- more hospitals approved for participa-
tial all information contained in the tion under the Medicare and Medicaid
resident’s records, regardless of the programs that reasonably assures
form or storage method of the records, that—
except when release is— (i) Residents will be transferred from
(i) To the individual, or their resi- the facility to the hospital, and en-
dent representative where permitted by sured of timely admission to the hos-
applicable law; pital when transfer is medically appro-
(ii) Required by law; priate as determined by the attending
(iii) For treatment, payment, or physician or, in an emergency situa-
health care operations, as permitted by tion, by another practitioner in accord-
and in compliance with 45 CFR 164.506; ance with facility policy and consistent
(iv) For public health activities, re- with state law; and
porting of abuse, neglect, or domestic (ii) Medical and other information
violence, health oversight activities, needed for care and treatment of resi-
judicial and administrative pro- dents and, when the transferring facil-
ceedings, law enforcement purposes, ity deems it appropriate, for deter-
organ donation purposes, research pur- mining whether such residents can re-
poses, or to coroners, medical exam- ceive appropriate services or receive
iners, funeral directors, and to avert a services in a less restrictive setting
serious threat to health or safety as than either the facility or the hospital,
permitted by and in compliance with 45 or reintegrated into the community,
CFR 164.512. will be exchanged between the pro-
(3) The facility must safeguard med- viders, including but not limited to the
ical record information against loss, information required under
destruction, or unauthorized use; § 483.15(c)(2)(iii).
(4) Medical records must be retained (2) The facility is considered to have
for— a transfer agreement in effect if the fa-
(i) The period of time required by cility has attempted in good faith to
State law; or enter into an agreement with a hos-
(ii) Five years from the date of dis- pital sufficiently close to the facility
charge when there is no requirement in to make transfer feasible.
State law; or (j) Disclosure of ownership. (1) The fa-
(iii) For a minor, 3 years after a resi- cility must comply with the disclosure
dent reaches legal age under State law. requirements of §§ 420.206 and 455.104 of
(5) The medical record must con- this chapter.
tain— (2) The facility must provide written
(i) Sufficient information to identify notice to the State agency responsible
the resident; for licensing the facility at the time of
(ii) A record of the resident’s assess- change, if a change occurs in—
ments; (i) Persons with an ownership or con-
(iii) The comprehensive plan of care trol interest, as defined in §§ 420.201 and
and services provided; 455.101 of this chapter;
(iv) The results of any preadmission (ii) The officers, directors, agents, or
screening and resident review evalua- managing employees;
tions and determinations conducted by (iii) The corporation, association, or
the State; other company responsible for the
(v) Physician’s, nurse’s, and other li- management of the facility; or
censed professional’s progress notes; (iv) The facility’s administrator or
and director of nursing.
94
(3) The notice specified in paragraph admission to, or as a requirement to

(k)(2) of this section must include the continue to receive care at, the facil-
identity of each new individual or com- ity.
pany. (2) The facility must ensure that:
(k) Facility closure-Administrator. Any (i) The agreement is explained to the
individual who is the administrator of resident and his or her representative
the facility must: in a form and manner that he or she
(1) Submit to the State Survey Agen- understands, including in a language
cy, the State LTC ombudsman, resi- the resident and his or her representa-
dents of the facility, and the legal rep- tive understands;
resentatives of such residents or other (ii) The resident or his or her rep-
responsible parties, written notifica- resentative acknowledges that he or
tion of an impending closure: she understands the agreement;
(i) At least 60 days prior to the date (iii) The agreement provides for the
of closure; or selection of a neutral arbitrator agreed
(ii) In the case of a facility where the upon by both parties; and
Secretary or a State terminates the fa-
(iv) The agreement provides for the
cility’s participation in the Medicare
selection of a venue that is convenient
and/or Medicaid programs, not later
to both parties.
than the date that the Secretary deter-
(3) The agreement must explicitly
mines appropriate;
grant the resident or his or her rep-
(2) Ensure that the facility does not
resentative the right to rescind the
admit any new residents on or after the
agreement within 30 calendar days of
date on which such written notifica-
signing it.
tion is submitted; and
(3) Include in the notice the plan, (4) The agreement must explicitly
that has been approved by the State, state that neither the resident nor his
for the transfer and adequate reloca- or her representative is required to
tion of the residents of the facility by sign an agreement for binding arbitra-
a date that would be specified by the tion as a condition of admission to, or
State prior to closure, including assur- as a requirement to continue to receive
ances that the residents would be care at, the facility.
transferred to the most appropriate fa- (5) The agreement may not contain
cility or other setting in terms of qual- any language that prohibits or discour-
ity, services, and location, taking into ages the resident or anyone else from
consideration the needs, choice, and communicating with federal, state, or
best interests of each resident. local officials, including but not lim-
(l) Facility closure. The facility must ited to, federal and state surveyors,
have in place policies and procedures other federal or state health depart-
to ensure that the administrator’s du- ment employees, and representatives of
ties and responsibilities involve pro- the Office of the State Long-Term Care
viding the appropriate notices in the Ombudsman, in accordance with
event of a facility closure, as required § 483.10(k).
at paragraph (l) of this section. (6) When the facility and a resident
(m) Binding arbitration agreements. If resolve a dispute through arbitration, a
a facility chooses to ask a resident or copy of the signed agreement for bind-
his or her representative to enter into ing arbitration and the arbitrator’s
an agreement for binding arbitration, final decision must be retained by the
the facility must comply with all of facility for 5 years after the resolution
the requirements in this section. of that dispute on and be available for
(1) The facility must not require any inspection upon request by CMS or its
resident or his or her representative to designee.
sign an agreement for binding arbitra- (n) Hospice services. (1) A long-term
tion as a condition of admission to, or care (LTC) facility may do either of
as a requirement to continue to receive the following:
care at, the facility and must explicitly (i) Arrange for the provision of hos-
inform the resident or his or her rep- pice services through an agreement
resentative of his or her right not to with one or more Medicare-certified
sign the agreement as a condition of hospices.
95
§ 483.70 42 CFR Ch. IV (10–1–24 Edition)
(ii) Not arrange for the provision of (G) An agreement that it is the LTC
hospice services at the facility through facility’s responsibility to furnish 24-
an agreement with a Medicare-certified hour room and board care, meet the
hospice and assist the resident in resident’s personal care and nursing
transferring to a facility that will ar- needs in coordination with the hospice
range for the provision of hospice serv- representative, and ensure that the
ices when a resident requests a trans- level of care provided is appropriately
fer. based on the individual resident’s
(2) If hospice care is furnished in an needs.
LTC facility through an agreement as (H) A delineation of the hospice’s re-
specified in paragraph (o)(1)(i) of this sponsibilities, including but not lim-
section with a hospice, the LTC facility ited to, providing medical direction
must meet the following requirements: and management of the patient; nurs-
(i) Ensure that the hospice services ing; counseling (including spiritual, di-
meet professional standards and prin- etary, and bereavement); social work;
ciples that apply to individuals pro- providing medical supplies, durable
viding services in the facility, and to medical equipment, and drugs nec-
the timeliness of the services. essary for the palliation of pain and
(ii) Have a written agreement with symptoms associated with the terminal
the hospice that is signed by an au- illness and related conditions; and all
thorized representative of the hospice other hospice services that are nec-
and an authorized representative of the essary for the care of the resident’s ter-
LTC facility before hospice care is fur- minal illness and related conditions.
nished to any resident. The written (I) A provision that when the LTC fa-
agreement must set out at least the cility personnel are responsible for the
following: administration of prescribed therapies,
(A) The services the hospice will pro- including those therapies determined
vide. appropriate by the hospice and delin-
(B) The hospice’s responsibilities for eated in the hospice plan of care, the
determining the appropriate hospice LTC facility personnel may administer
plan of care as specified in § 418.112 (d) the therapies where permitted by State
of this chapter. law and as specified by the LTC facil-
(C) The services the LTC facility will ity.
continue to provide, based on each resi- (J) A provision stating that the LTC
dent’s plan of care. facility must report all alleged viola-
(D) A communication process, includ- tions involving mistreatment, neglect,
ing how the communication will be or verbal, mental, sexual, and physical
documented between the LTC facility abuse, including injuries of unknown
and the hospice provider, to ensure source, and misappropriation of patient
that the needs of the resident are ad- property by hospice personnel, to the
dressed and met 24 hours per day. hospice administrator immediately
(E) A provision that the LTC facility when the LTC facility becomes aware
immediately notifies the hospice about of the alleged violation.
the following: (K) A delineation of the responsibil-
(1) A significant change in the resi- ities of the hospice and the LTC facil-
dent’s physical, mental, social, or emo- ity to provide bereavement services to
tional status. LTC facility staff.
(2) Clinical complications that sug- (3) Each LTC facility arranging for
gest a need to alter the plan of care. the provision of hospice care under a
(3) A need to transfer the resident written agreement must designate a
from the facility for any condition. member of the facility’s interdiscipli-
(4) The resident’s death. nary team who is responsible for work-
(F) A provision stating that the hos- ing with hospice representatives to co-
pice assumes responsibility for deter- ordinate care to the resident provided
mining the appropriate course of hos- by the LTC facility staff and hospice
pice care, including the determination staff. The interdisciplinary team mem-
to change the level of services pro- ber must have a clinical background,
vided. function within their State scope of
96
practice act, and have the ability to as- ical, mental, and psychosocial well-
sess the resident or have access to being, as required at § 483.25.
someone that has the skills and capa- (o) Social worker. Any facility with
bilities to assess the resident. The des- more than 120 beds must employ a
ignated interdisciplinary team member qualified social worker on a full-time
is responsible for the following: basis. A qualified social worker is:
(i) Collaborating with hospice rep- (1) An individual with a minimum of
resentatives and coordinating LTC fa- a bachelor’s degree in social work or a
cility staff participation in the hospice bachelor’s degree in a human services
care planning process for those resi- field including, but not limited to, so-
dents receiving these services. ciology, gerontology, special edu-
(ii) Communicating with hospice rep- cation, rehabilitation counseling, and
resentatives and other healthcare pro- psychology; and
viders participating in the provision of (2) One year of supervised social work
care for the terminal illness, related experience in a health care setting
conditions, and other conditions, to en- working directly with individuals.
sure quality of care for the patient and
(p) Mandatory submission of staffing
family.
information based on payroll data in a
(iii) Ensuring that the LTC facility
uniform format. Long-term care facili-
communicates with the hospice med-
ties must electronically submit to CMS
ical director, the patient’s attending
complete and accurate direct care
physician, and other practitioners par-
staffing information, including infor-
ticipating in the provision of care to
mation for agency and contract staff,
the patient as needed to coordinate the
based on payroll and other verifiable
hospice care with the medical care pro-
and auditable data in a uniform format
vided by other physicians.
according to specifications established
(iv) Obtaining the following informa-
by CMS.
tion from the hospice:
(A) The most recent hospice plan of (1) Direct Care Staff. Direct Care Staff
care specific to each patient. are those individuals who, through
(B) Hospice election form. interpersonal contact with residents or
(C) Physician certification and recer- resident care management, provide
tification of the terminal illness spe- care and services to allow residents to
cific to each patient. attain or maintain the highest prac-
(D) Names and contact information ticable physical, mental, and psycho-
for hospice personnel involved in hos- social well-being. Direct care staff does
pice care of each patient. not include individuals whose primary
(E) Instructions on how to access the duty is maintaining the physical envi-
hospice’s 24-hour on-call system. ronment of the long term care facility
(F) Hospice medication information (for example, housekeeping).
specific to each patient. (2) Submission requirements. The facil-
(G) Hospice physician and attending ity must electronically submit to CMS
physician (if any) orders specific to complete and accurate direct care
each patient. staffing information, including the fol-
(v) Ensuring that the LTC facility lowing:
staff provides orientation in the poli- (i) The category of work for each per-
cies and procedures of the facility, in- son on direct care staff (including, but
cluding patient rights, appropriate not limited to, whether the individual
forms, and record keeping require- is a registered nurse, licensed practical
ments, to hospice staff furnishing care nurse, licensed vocational nurse, cer-
to LTC residents. tified nursing assistant, therapist, or
(4) Each LTC facility providing hos- other type of medical personnel as
pice care under a written agreement specified by CMS);
must ensure that each resident’s writ- (ii) Resident census data; and
ten plan of care includes both the most (iii) Information on direct care staff
recent hospice plan of care and a de- turnover and tenure, and on the hours
scription of the services furnished by of care provided by each category of
the LTC facility to attain or maintain staff per resident per day (including,
the resident’s highest practicable phys- but not limited to, start date, end date
97
§ 483.71 42 CFR Ch. IV (10–1–24 Edition)
(as applicable), and hours worked for level and types of care needed for the
each individual). resident population;
(3) Distinguishing employee from agen- (iv) The physical environment, equip-
cy and contract staff. When reporting in- ment, services, and other physical
formation about direct care staff, the plant considerations that are necessary
facility must specify whether the indi- to care for this population; and
vidual is an employee of the facility, or (v) Any ethnic, cultural, or religious
is engaged by the facility under con- factors that may potentially affect the
tract or through an agency. care provided by the facility, includ-
(4) Data format. The facility must ing, but not limited to, activities and
submit direct care staffing information food and nutrition services.
in the uniform format specified by (2) The facility’s resources, including
CMS. but not limited to the following:
(5) Submission schedule. The facility (i) All buildings and/or other physical
must submit direct care staffing infor- structures and vehicles;
mation on the schedule specified by
(ii) Equipment (medical and non-
CMS, but no less frequently than quar-
medical);
terly.
(iii) Services provided, such as phys-
[56 FR 48877, Sept. 26, 1991. Redesignated at ical therapy, pharmacy, behavioral
81 FR 68861, Oct. 4, 2016] health, and specific rehabilitation
EDITORIAL NOTE: For FEDERAL REGISTER ci- therapies;
tations affecting § 483.70, see the List of CFR (iv) All personnel, including man-
Sections Affected, which appears in the agers, nursing and other direct care
Finding Aids section of the printed volume staff (both employees and those who
and at www.govinfo.gov.
provide services under contract), and
§ 483.71 Facility assessment. volunteers, as well as their education
and/or training and any competencies
The facility must conduct and docu- related to resident care;
ment a facility-wide assessment to de- (v) Contracts, memorandums of un-
termine what resources are necessary derstanding, or other agreements with
to care for its residents competently third parties to provide services or
during both day-to-day operations (in- equipment to the facility during both
cluding nights and weekends) and normal operations and emergencies;
emergencies. The facility must review and
and update that assessment, as nec-
(vi) Health information technology
essary, and at least annually. The fa-
resources, such as systems for elec-
cility must also review and update this
tronically managing patient records
assessment whenever there is, or the
and electronically sharing information
facility plans for, any change that
with other organizations.
would require a substantial modifica-
(3) A facility-based and community-
tion to any part of this assessment.
(a) The facility assessment must ad- based risk assessment, utilizing an all-
dress or include the following: hazards approach as required in
(1) The facility’s resident population, § 483.73(a)(1).
including, but not limited to: (b) In conducting the facility assess-
(i) Both the number of residents and ment, the facility must ensure:
the facility’s resident capacity; (1) Active involvement of the fol-
(ii) The care required by the resident lowing participants in the process:
population, using evidence-based, data- (i) Nursing home leadership and man-
driven methods that consider the types agement, including but not limited to,
of diseases, conditions, physical and be- a member of the governing body, the
havioral health needs, cognitive dis- medical director, an administrator, and
abilities, overall acuity, and other per- the director of nursing; and
tinent facts that are present within (ii) Direct care staff, including but
that population, consistent with and not limited to, RNs, LPNs/LVNs, NAs,
informed by individual resident assess- and representatives of the direct care
ments as required under § 483.20; staff, if applicable.
(iii) The staff competencies and skill (iii) The facility must also solicit and
sets that are necessary to provide the consider input received from residents,
98
resident representatives, and family (3) Address resident population, in-

members. cluding, but not limited to, persons at-
(2) [Reserved] risk; the type of services the LTC facil-
(c) The facility must use this facility ity has the ability to provide in an
assessment to: emergency; and continuity of oper-
(1) Inform staffing decisions to en- ations, including delegations of author-
sure that there are a sufficient number ity and succession plans.
of staff with the appropriate com- (4) Include a process for cooperation
petencies and skill sets necessary to and collaboration with local, tribal, re-
care for its residents’ needs as identi- gional, State, or Federal emergency
fied through resident assessments and preparedness officials’ efforts to main-
plans of care as required in tain an integrated response during a
§ 483.35(a)(3). disaster or emergency situation.
(2) Consider specific staffing needs (b) Policies and procedures. The LTC
for each resident unit in the facility facility must develop and implement
and adjust as necessary based on emergency preparedness policies and
changes to its resident population. procedures, based on the emergency
(3) Consider specific staffing needs plan set forth in paragraph (a) of this
for each shift, such as day, evening,
section, risk assessment at paragraph
night, and adjust as necessary based on
(a)(1) of this section, and the commu-
any changes to its resident population.
nication plan at paragraph (c) of this
(4) Develop and maintain a plan to
section. The policies and procedures
maximize recruitment and retention of
must be reviewed and updated at least
direct care staff.
annually. At a minimum, the policies
(5) Inform contingency planning for
and procedures must address the fol-
events that do not require activation of
the facility’s emergency plan, but do lowing:
have the potential to affect resident (1) The provision of subsistence needs
care, such as, but not limited to, the for staff and residents, whether they
availability of direct care nurse staff- evacuate or shelter in place, include,
ing or other resources needed for resi- but are not limited to the following:
dent care. (i) Food, water, medical, and pharma-
ceutical supplies.
[89 FR 40999, May 10, 2024]
(ii) Alternate sources of energy to
§ 483.73 Emergency preparedness. maintain—
(A) Temperatures to protect resident
The LTC facility must comply with
health and safety and for the safe and
all applicable Federal, State and local
sanitary storage of provisions;
emergency preparedness requirements.
The LTC facility must establish and (B) Emergency lighting;
maintain an emergency preparedness (C) Fire detection, extinguishing, and
program that meets the requirements alarm systems; and
of this section. The emergency pre- (D) Sewage and waste disposal.
paredness program must include, but (2) A system to track the location of
not be limited to, the following ele- on-duty staff and sheltered residents in
ments: the LTC facility’s care during and after
(a) Emergency plan. The LTC facility an emergency. If on-duty staff and
must develop and maintain an emer- sheltered residents are relocated dur-
gency preparedness plan that must be ing the emergency, the LTC facility
reviewed, and updated at least annu- must document the specific name and
ally. The plan must do all of the fol- location of the receiving facility or
lowing: other location.
(1) Be based on and include a docu- (3) Safe evacuation from the LTC fa-
mented, facility-based and community- cility, which includes consideration of
based risk assessment, utilizing an all- care and treatment needs of evacuees;
hazards approach, including missing staff responsibilities; transportation;
residents. identification of evacuation loca-
(2) Include strategies for addressing tion(s); and primary and alternate
emergency events identified by the means of communication with external
risk assessment. sources of assistance.
99
§ 483.73 42 CFR Ch. IV (10–1–24 Edition)
(4) A means to shelter in place for (4) A method for sharing information
residents, staff, and volunteers who re- and medical documentation for resi-
main in the LTC facility. dents under the LTC facility’s care, as
(5) A system of medical documenta- necessary, with other health care pro-
tion that preserves resident informa- viders to maintain the continuity of
tion, protects confidentiality of resi- care.
dent information, and secures and (5) A means, in the event of an evacu-
maintains the availability of records. ation, to release resident information
(6) The use of volunteers in an emer- as permitted under 45 CFR
gency or other emergency staffing 164.510(b)(1)(ii).
strategies, including the process and (6) A means of providing information
role for integration of State or Feder- about the general condition and loca-
ally designated health care profes- tion of residents under the facility’s
sionals to address surge needs during care as permitted under 45 CFR
an emergency. 164.510(b)(4).
(7) The development of arrangements (7) A means of providing information
with other LTC facilities and other about the LTC facility’s occupancy,
providers to receive residents in the needs, and its ability to provide assist-
event of limitations or cessation of op- ance, to the authority having jurisdic-
erations to maintain the continuity of tion or the Incident Command Center,
services to LTC residents. or designee.
(8) The role of the LTC facility under (8) A method for sharing information
a waiver declared by the Secretary, in from the emergency plan that the fa-
accordance with section 1135 of the cility has determined is appropriate
Act, in the provision of care and treat- with residents and their families or
ment at an alternate care site identi- representatives.
fied by emergency management offi- (d) Training and testing. The LTC fa-
cials. cility must develop and maintain an
(c) Communication plan. The LTC fa- emergency preparedness training and
cility must develop and maintain an testing program that is based on the
emergency preparedness communica- emergency plan set forth in paragraph
tion plan that complies with Federal, (a) of this section, risk assessment at
State, and local laws and must be re- paragraph (a)(1) of this section, policies
viewed and updated at least annually. and procedures at paragraph (b) of this
The communication plan must include section, and the communication plan
all of the following: at paragraph (c) of this section. The
(1) Names and contact information training and testing program must be
for the following: reviewed and updated at least annu-
(i) Staff. ally.
(ii) Entities providing services under (1) Training program. The LTC facility
arrangement. must do all of the following:
(iii) Residents’ physicians. (i) Initial training in emergency pre-
(iv) Other LTC facilities. paredness policies and procedures to all
(v) Volunteers. new and existing staff, individuals pro-
(2) Contact information for the fol- viding services under arrangement, and
lowing: volunteers, consistent with their ex-
(i) Federal, State, tribal, regional, or pected roles.
local emergency preparedness staff. (ii) Provide emergency preparedness
(ii) The State Licensing and Certifi- training at least annually.
cation Agency. (iii) Maintain documentation of the
(iii) The Office of the State Long- training.
Term Care Ombudsman. (iv) Demonstrate staff knowledge of
(iv) Other sources of assistance. emergency procedures.
(3) Primary and alternate means for (2) Testing. The LTC facility must
communicating with the following: conduct exercises to test the emer-
(i) LTC facility’s staff. gency plan at least twice per year, in-
(ii) Federal, State, tribal, regional, cluding unannounced staff drills using
or local emergency management agen- the emergency procedures. The LTC fa-
cies. cility must do the following:
100
(i) Participate in an annual full-scale Facilities Code, NFPA 110, and Life
exercise that is community-based; or Safety Code.
(A) When a community-based exer- (3) Emergency generator fuel. LTC fa-
cise is not accessible, conduct an an- cilities that maintain an onsite fuel
nual individual, facility-based func- source to power emergency generators
tional exercise. must have a plan for how it will keep
(B) If the LTC facility experiences an emergency power systems operational
actual natural or man-made emergency during the emergency, unless it evacu-
that requires activation of the emer- ates.
gency plan, the LTC facility is exempt (f) Integrated healthcare systems. If a
from engaging its next required a full- LTC facility is part of a healthcare sys-
scale community-based or individual, tem consisting of multiple separately
facility-based functional exercise fol- certified healthcare facilities that
lowing the onset of the emergency elects to have a unified and integrated
event. emergency preparedness program, the
(ii) Conduct an additional annual ex- LTC facility may choose to participate
ercise that may include, but is not lim- in the healthcare system’s coordinated
ited to the following: emergency preparedness program. If
(A) A second full-scale exercise that elected, the unified and integrated
is community-based or an individual, emergency preparedness program must
facility-based functional exercise; or do all of the following:
(B) A mock disaster drill; or (1) Demonstrate that each separately
(C) A tabletop exercise or workshop certified facility within the system ac-
that is led by a facilitator includes a tively participated in the development
group discussion, using a narrated, of the unified and integrated emer-
clinically-relevant emergency scenario, gency preparedness program.
and a set of problem statements, di- (2) Be developed and maintained in a
rected messages, or prepared questions manner that takes into account each
designed to challenge an emergency separately certified facility’s unique
plan. circumstances, patient populations,
(iii) Analyze the LTC facility’s re- and services offered.
sponse to and maintain documentation (3) Demonstrate that each separately
of all drills, tabletop exercises, and certified facility is capable of actively
emergency events, and revise the LTC using the unified and integrated emer-
facility’s emergency plan, as needed. gency preparedness program and is in
(e) Emergency and standby power sys- compliance with the program.
tems. The LTC facility must implement (4) Include a unified and integrated
emergency and standby power systems emergency plan that meets the require-
based on the emergency plan set forth ments of paragraphs (a)(2), (3), and (4)
in paragraph (a) of this section. of this section. The unified and inte-
(1) Emergency generator location. The grated emergency plan must also be
generator must be located in accord- based on and include—
ance with the location requirements (i) A documented community-based
found in the Health Care Facilities risk assessment, utilizing an all-haz-
Code (NFPA 99 and Tentative Interim ards approach.
Amendments TIA 12–2, TIA 12–3, TIA (ii) A documented individual facility-
12–4, TIA 12–5, and TIA 12–6), Life Safe- based risk assessment for each sepa-
ty Code (NFPA 101 and Tentative In- rately certified facility within the
terim Amendments TIA 12–1, TIA 12–2, health system, utilizing an all-hazards
TIA 12–3, and TIA 12–4), and NFPA 110, approach.
when a new structure is built or when (5) Include integrated policies and
an existing structure or building is ren- procedures that meet the requirements
ovated. set forth in paragraph (b) of this sec-
(2) Emergency generator inspection and tion, a coordinated communication
testing. The LTC facility must imple- plan and training and testing programs
ment the emergency power system in- that meet the requirements of para-
spection, testing, and maintenance re- graphs (c) and (d) of this section, re-
quirements found in the Health Care spectively.
101
§ 483.75 42 CFR Ch. IV (10–1–24 Edition)
(g) The standards incorporated by § 483.75 Quality assurance and per-

reference in this section are approved formance improvement.
for incorporation by reference by the (a) Quality assurance and performance
Director of the Office of the Federal improvement (QAPI) program. Each LTC
Register in accordance with 5 U.S.C. facility, including a facility that is
552(a) and 1 CFR part 51. You may ob- part of a multiunit chain, must de-
tain the material from the sources list- velop, implement, and maintain an ef-
ed below. You may inspect a copy at fective, comprehensive, data-driven
the CMS Information Resource Center, QAPI program that focuses on indica-
7500 Security Boulevard, Baltimore, tors of the outcomes of care and qual-
MD or at the National Archives and ity of life. The facility must—
Records Administration (NARA). For (1) Maintain documentation and dem-
information on the availability of this onstrate evidence of its ongoing QAPI
material at NARA, call 202–741–6030, or program that meets the requirements
go to: http://www.archives.gov/fed- of this section. This may include but is
not limited to systems and reports
eral_register/code_of_federal_regulations/
demonstrating systematic identifica-
ibr_locations.html. If any changes in this
tion, reporting, investigation, analysis,
edition of the Code are incorporated by and prevention of adverse events; and
reference, CMS will publish a docu- documentation demonstrating the de-
ment in the FEDERAL REGISTER to an- velopment, implementation, and eval-
nounce the changes. uation of corrective actions or per-
(1) National Fire Protection Associa- formance improvement activities;
tion, 1 Batterymarch Park, Quincy, (2) Present its QAPI plan to the State
MA 02169, www.nfpa.org, 1.617.770.3000. Survey Agency no later than 1 year
(i) NFPA 99, Health Care Facilities after the promulgation of this regula-
Code 2012 edition, issued August 11, tion;
2011. (3) Present its QAPI plan to a State
(ii) Technical interim amendment Survey Agency or Federal surveyor at
(TIA) 12–2 to NFPA 99, issued August each annual recertification survey and
11, 2011. upon request during any other survey
(iii) TIA 12–3 to NFPA 99, issued Au- and to CMS upon request; and
gust 9, 2012. (4) Present documentation and evi-
dence of its ongoing QAPI program’s
(iv) TIA 12–4 to NFPA 99, issued
implementation and the facility’s com-
March 7, 2013. pliance with requirements to a State
(v) TIA 12–5 to NFPA 99, issued Au- Survey Agency, Federal surveyor or
gust 1, 2013. CMS upon request.
(vi) TIA 12–6 to NFPA 99, issued (b) Program design and scope. A facil-
March 3, 2014. ity must design its QAPI program to be
(vii) NFPA 101, Life Safety Code, 2012 ongoing, comprehensive, and to address
edition, issued August 11, 2011. the full range of care and services pro-
(viii) TIA 12–1 to NFPA 101, issued vided by the facility. It must:
August 11, 2011. (1) Address all systems of care and
(ix) TIA 12–2 to NFPA 101, issued Oc- management practices;
tober 30, 2012. (2) Include clinical care, quality of
(x) TIA 12–3 to NFPA 101, issued Oc- life, and resident choice;
(3) Utilize the best available evidence
tober 22, 2013.
to define and measure indicators of
quality and facility goals that reflect
tober 22, 2013. processes of care and facility oper-
(xii) NFPA 110, Standard for Emer- ations that have been shown to be pre-
gency and Standby Power Systems, dictive of desired outcomes for resi-
2010 edition, including TIAs to chapter dents of a SNF or NF.
7, issued August 6, 2009. (4) Reflect the complexities, unique
(2) [Reserved] care, and services that the facility pro-
vides.
[81 FR 64030, Sept. 16, 2016; 81 FR 80594, Nov.
16, 2016; 84 FR 51824, Sept. 30, 2019]
(c) Program feedback, data systems and
monitoring. A facility must establish
102
and implement written policies and (e) Program activities. (1) The facility
procedures for feedback, data collec- must set priorities for its performance
tions systems, and monitoring, includ- improvement activities that focus on
ing adverse event monitoring. The poli- high-risk, high-volume, or problem-
cies and procedures must include, at a prone areas; consider the incidence,
minimum, the following: prevalence, and severity of problems in
(1) Facility maintenance of effective those areas; and affect health out-
systems to obtain and use of feedback comes, resident safety, resident auton-
and input from direct care staff, other omy, resident choice, and quality of
staff, residents, and resident represent- care.
atives, including how such information (2) Performance improvement activi-
will be used to identify problems that ties must track medical errors and ad-
are high risk, high volume, or problem- verse resident events, analyze their
prone, and opportunities for improve- causes, and implement preventive ac-
ment. tions and mechanisms that include
(2) Facility maintenance of effective feedback and learning throughout the
systems to identify, collect, and use facility.
data and information from all depart- (3) As a part of their performance im-
ments, including but not limited to the provement activities, the facility must
facility assessment required at § 483.71 conduct distinct performance improve-
and including how such information ment projects. The number and fre-
will be used to develop and monitor quency of improvement projects con-
performance indicators.
ducted by the facility must reflect the
(3) Facility development, monitoring, scope and complexity of the facility’s
and evaluation of performance indica-
services and available resources, as re-
tors, including the methodology and
flected in the facility assessment re-
frequency for such development, moni-
quired at § 483.71. Improvement projects
toring, and evaluation.
must include at least annually a
(4) Facility adverse event moni-
project that focuses on high risk or
toring, including the methods by which
problem-prone areas identified through
the facility will systematically iden-
the data collection and analysis de-
tify, report, track, investigate, analyze
and use data and information relating scribed in paragraphs (c) and (d) of this
to adverse events in the facility, in- section.
cluding how the facility will use the (f) Governance and leadership. The
data to develop activities to prevent governing body and/or executive lead-
adverse events. ership (or organized group or individual
(d) Program systematic analysis and who assumes full legal authority and
systemic action. (1) The facility must responsibility for operation of the fa-
take actions aimed at performance im- cility) is responsible and accountable
provement and, after implementing for ensuring that—
those actions, measure its success, and (1) An ongoing QAPI program is de-
track performance to ensure that im- fined, implemented, and maintained
provements are realized and sustained. and addresses identified priorities.
(2) The facility will develop and im- (2) The QAPI program is sustained
plement policies addressing: during transitions in leadership and
(i) How they will use a systematic ap- staffing;
proach to determine underlying causes (3) The QAPI program is adequately
of problems impacting larger systems; resourced, including ensuring staff
(ii) How they will develop corrective time, equipment, and technical train-
actions that will be designed to effect ing as needed;
change at the systems level to prevent (4) The QAPI program identifies and
quality of care, quality of life, or safe- prioritizes problems and opportunities
ty problems ; and that reflect organizational process,
(iii) How the facility will monitor the functions, and services provided to
effectiveness of its performance im- resident based on performance indi-
provement activities to ensure that im- cator data, and resident and staff
provements are sustained. input, and other information.
103
§ 483.80 42 CFR Ch. IV (10–1–24 Edition)
(5) Corrective actions address gaps in § 483.80 Infection control.

systems, and are evaluated for effec- The facility must establish and main-
tiveness; and tain an infection prevention and con-
(6) Clear expectations are set around trol program designed to provide a
safety, quality, rights, choice, and re- safe, sanitary, and comfortable envi-
spect. ronment and to help prevent the devel-
(g) Quality assessment and assurance. opment and transmission of commu-
(1) A facility must maintain a quality nicable diseases and infections.
assessment and assurance committee (a) Infection prevention and control
consisting at a minimum of: program. The facility must establish an
(i) The director of nursing services; infection prevention and control pro-
(ii) The Medical Director or his or gram (IPCP) that must include, at a
her designee; minimum, the following elements:
(1) A system for preventing, identi-
(iii) At least three other members of
fying, reporting, investigating, and
the facility’s staff, at least one of who controlling infections and commu-
must be the administrator, owner, a nicable diseases for all residents, staff,
board member or other individual in a volunteers, visitors, and other individ-
leadership role; and uals providing services under a con-
(iv) The infection preventionist. tractual arrangement based upon the
(2) The quality assessment and assur- facility assessment conducted accord-
ance committee reports to the facili- ing to § 483.71 and following accepted
ty’s governing body, or designated per- national standards.
son(s) functioning as a governing body (2) Written standards, policies, and
regarding its activities, including im- procedures for the program, which
plementation of the QAPI program re- must include, but are not limited to:
quired under paragraphs (a) through (e) (i) A system of surveillance designed
of this section. The committee must: to identify possible communicable dis-
(i) Meet at least quarterly and as eases or infections before they can
needed to coordinate and evaluate ac- spread to other persons in the facility;
tivities under the QAPI program, such (ii) When and to whom possible inci-
as identifying issues with respect to dents of communicable disease or in-
which quality assessment and assur- fections should be reported;
(iii) Standard and transmission-based
ance activities, including performance
precautions to be followed to prevent
improvement projects required under
spread of infections;
the QAPI program, are necessary; and (iv) When and how isolation should
(ii) Develop and implement appro- be used for a resident; including but
priate plans of action to correct identi- not limited to:
fied quality deficiencies; and (A) The type and duration of the iso-
(iii) Regularly review and analyze lation, depending upon the infectious
data, including data collected under agent or organism involved, and
the QAPI program and data resulting (B) A requirement that the isolation
from drug regimen reviews, and act on should be the least restrictive possible
available data to make improvements. for the resident under the cir-
(h) Disclosure of information. A State cumstances.
or the Secretary may not require dis- (v) The circumstances under which
closure of the records of such com- the facility must prohibit employees
mittee except in so far as such disclo- with a communicable disease or in-
sure is related to the compliance of fected skin lesions from direct contact
such committee with the requirements with residents or their food, if direct
of this section. contact will transmit the disease; and
(i) Sanctions. Good faith attempts by (vi) The hand hygiene procedures to
be followed by staff involved in direct
the committee to identify and correct
resident contact.
quality deficiencies will not be used as
(3) An antibiotic stewardship pro-
a basis for sanctions.
gram that includes antibiotic use pro-
[81 FR 68867, Oct. 4, 2016, as amended at 82 FR tocols and a system to monitor anti-
32259, July 13, 2017; 89 FR 41000, May 10, 2024] biotic use.
104
(4) A system for recording incidents to medical contraindications or re-

identified under the facility’s IPCP and fusal.
the corrective actions taken by the fa- (2) Pneumococcal disease. The facility
cility. must develop policies and procedures
(b) Infection preventionist. The facility to ensure that—
must designate one or more indi- (i) Before offering the pneumococcal
vidual(s) as the infection immunization, each resident or the
preventionist(s) (IPs) who are respon- resident’s representative receives edu-
sible for the facility’s IPCP. The IP cation regarding the benefits and po-
must: tential side effects of the immuniza-
(1) Have primary professional train- tion;
ing in nursing, medical technology, (ii) Each resident is offered a pneu-
microbiology, epidemiology, or other mococcal immunization, unless the im-
related field; munization is medically contra-
(2) Be qualified by education, train- indicated or the resident has already
ing, experience or certification; been immunized;
(3) Work at least part-time at the fa- (iii) The resident or the resident’s
cility; and representative has the opportunity to
(4) Have completed specialized train- refuse immunization; and
ing in infection prevention and control. (iv) The resident’s medical record in-
(c) IP participation on quality assess- cludes documentation that indicates,
ment and assurance committee. The indi- at a minimum, the following:
vidual designated as the IP, or at least (A) That the resident or resident’s
one of the individuals if there is more
representative was provided education
than one IP, must be a member of the
regarding the benefits and potential
facility’s quality assessment and assur-
side effects of pneumococcal immuniza-
ance committee and report to the com-
tion; and
mittee on the IPCP on a regular basis.
(B) That the resident either received
(d) Influenza, pneumococcal, and
the pneumococcal immunization or did
COVID–19 immunizations—(1) Influenza.
The facility must develop policies and not receive the pneumococcal immuni-
procedures to ensure that— zation due to medical contraindication
or refusal.
(i) Before offering the influenza im-
munization, each resident or the resi- (3) COVID–19 immunizations. The LTC
dent’s representative receives edu- facility must develop and implement
cation regarding the benefits and po- policies and procedures to ensure all
tential side effects of the immuniza- the following:
tion; (i) When COVID–19 vaccine is avail-
(ii) Each resident is offered an influ- able to the facility, each resident and
enza immunization October 1 through staff member is offered the COVID–19
March 31 annually, unless the immuni- vaccine unless the immunization is
zation is medically contraindicated or medically contraindicated or the resi-
the resident has already been immu- dent or staff member has already been
nized during this time period; immunized;
(iii) The resident or the resident’s (ii) Before offering COVID–19 vaccine,
representative has the opportunity to all staff members are provided with
refuse immunization; and education regarding the benefits and
(iv) The resident’s medical record in- risks and potential side effects associ-
cludes documentation that indicates, ated with the vaccine;
at a minimum, the following: (iii) Before offering COVID–19 vac-
(A) That the resident or resident’s cine, each resident or the resident rep-
representative was provided education resentative receives education regard-
regarding the benefits and potential ing the benefits and risks and potential
side effects of influenza immunization; side effects associated with the COVID–
and 19 vaccine;
(B) That the resident either received (iv) In situations where COVID–19
the influenza immunization or did not vaccination requires multiple doses,
receive the influenza immunization due the resident, resident representative,
105
§ 483.80 42 CFR Ch. IV (10–1–24 Edition)
or staff member is provided with cur- including residents previously treated

rent information regarding those addi- for COVID–19.
tional doses, including any changes in (ii) Total deaths and COVID–19
the benefits or risks and potential side deaths among residents and staff.
effects associated with the COVID–19 (iii) Personal protective equipment
vaccine, before requesting consent for and hand hygiene supplies in the facil-
administration of any additional doses; ity.
(v) The resident or resident rep- (iv) Ventilator capacity and supplies
resentative, has the opportunity to ac- in the facility.
cept or refuse a COVID–19 vaccine, and
(v) Resident beds and census.
change their decision; and
(vi) Access to COVID–19 testing while
(vi) The resident’s medical record in-
cludes documentation that indicates, the resident is in the facility.
at a minimum, the following: (vii) Staffing shortages.
(A) That the resident or resident rep- (viii) The COVID–19 vaccine status of
resentative was provided education re- residents and staff, including total
garding the benefits and potential risks numbers of residents and staff, num-
associated with COVID–19 vaccine; and bers of residents and staff vaccinated,
(B) Each dose of COVID–19 vaccine numbers of each dose of COVID–19 vac-
administered to the resident; or cine received, and COVID–19 vaccina-
(C) If the resident did not receive the tion adverse events.
COVID–19 vaccine due to medical con- (ix) Therapeutics administered to
traindications or refusal; and residents for treatment of COVID–19.
(vii) The facility maintains docu- (2) Provide the information specified
mentation related to staff COVID–19 in paragraph (g)(1) of this section
vaccination that includes at a min- weekly, unless the Secretary specifies
imum, the following: a lesser frequency, to the Centers for
(A) That staff were provided edu- Disease Control and Prevention’s Na-
cation regarding the benefits and po- tional Healthcare Safety Network.
tential risks associated with COVID–19 This information will be posted pub-
vaccine; licly by CMS to support protecting the
(B) Staff were offered the COVID–19 health and safety of residents, per-
vaccine or information on obtaining sonnel, and the general public.
COVID–19 vaccine; and (3) Inform residents, their representa-
(C) The COVID–19 vaccine status of tives, and families of those residing in
staff and related information as indi- facilities by 5 p.m. the next calendar
cated by the Centers for Disease Con- day following the occurrence of either
trol and Prevention’s National a single confirmed infection of COVID–
Healthcare Safety Network (NHSN). 19, or three or more residents or staff
(e) Linens. Personnel must handle, with new-onset of respiratory symp-
store, process, and transport linens so toms occurring within 72 hours of each
as to prevent the spread of infection.
other. This information must do all of
(f) Annual review. The facility will
the following:
conduct an annual review of its IPCP
(i) Not include personally identifiable
and update their program, as nec-
essary. information.
(g) COVID–19 reporting. Until Decem- (ii) Include information on miti-
ber 31, 2024, with the exception of the gating actions implemented to prevent
requirements in paragraph (g)(1)(viii) or reduce the risk of transmission, in-
of this section, the facility must do all cluding if normal operations of the fa-
of the following: cility will be altered.
(1) Electronically report information (iii) Include any cumulative updates
about COVID–19 in a standardized for- for residents, their representatives, and
mat specified by the Secretary. To the families at least weekly or by 5 p.m.
extent as required by the Secretary, the next calendar day following the
this report must include the following: subsequent occurrence of either: Each
(i) Suspected and confirmed COVID– time a confirmed infection of COVID–19
19 infections among residents and staff, is identified, or whenever three or more
106
residents or staff with new onset of res- an alternate method of reporting sus-
piratory symptoms occur within 72 pected violations anonymously without
hours of each other. fear of retribution; and disciplinary
standards that set out the con-
[81 FR 68868, Oct. 4, 2016, as amended at 85 FR
27627, May 8, 2020; 85 FR 54873, Sept. 2, 2020; sequences for committing violations
86 FR 26335, May 13, 2021; 86 FR 61619, Nov. 5, for the operating organization’s entire
2021; 86 FR 62421, Nov. 9, 2021; 88 FR 36510, staff; individuals providing services
June 5, 2023; 89 FR 41000, May 10, 2024] under a contractual arrangement; and
volunteers, consistent with the volun-
§ 483.85 Compliance and ethics pro- teers’ expected roles.
gram. (2) Assignment of specific individuals
(a) Definitions. For purposes of this within the high-level personnel of the
section, the following definitions operating organization with the overall
apply: responsibility to oversee compliance
Compliance and ethics program means, with the operating organization’s com-
with respect to a facility, a program of pliance and ethics program’s standards,
the operating organization that— policies, and procedures, such as, but
(1) Has been reasonably designed, im- not limited to, the chief executive offi-
plemented, and enforced so that it is cer (CEO), members of the board of di-
likely to be effective in preventing and rectors, or directors of major divisions
detecting criminal, civil, and adminis- in the operating organization.
trative violations under the Act and in (3) Sufficient resources and authority
promoting quality of care; and to the specific individuals designated
(2) Includes, at a minimum, the rein paragraph (c)(2) of this section to
quired components specified in para- reasonably assure compliance with
graph (c) of this section. such standards, policies, and proce-
High-level personnel means indi- dures.
vidual(s) who have substantial control (4) Due care not to delegate substan-
over the operating organization or who tial discretionary authority to individ-
have a substantial role in the making uals who the operating organization
of policy within the operating organi- knew, or should have known through
zation. the exercise of due diligence, had a pro-
Operating organization means the in- pensity to engage in criminal, civil,
dividual(s) or entity that operates a fa- and administrative violations under
cility. the Social Security Act.
(b) General rule. Beginning November (5) The facility takes steps to effec-
28, 2019, the operating organization for tively communicate the standards,
each facility must have in operation a policies, and procedures in the oper-
compliance and ethics program (as de- ating organization’s compliance and
fined in paragraph (a) of this section) ethics program to the operating orga-
that meets the requirements of this nization’s entire staff; individuals pro-
section. viding services under a contractual ar-
(c) Required components for all facili- rangement; and volunteers, consistent
ties. The operating organization for with the volunteers’ expected roles. Re-
each facility must develop, implement, quirements include, but are not limited
and maintain an effective compliance to, mandatory participation in training
and ethics program that contains, at a as set forth at § 483.95(f) or orientation
minimum, the following components: programs, or disseminating informa-
(1) Established written compliance tion that explains in a practical man-
and ethics standards, policies, and pro- ner what is required under the pro-
cedures to follow that are reasonably gram.
capable of reducing the prospect of (6) The facility takes reasonable
criminal, civil, and administrative vio- steps to achieve compliance with the
lations under the Act and promote program’s standards, policies, and pro-
quality of care, which include, but are cedures. Such steps include, but are
not limited to, the designation of an not limited to, utilizing monitoring
appropriate compliance and ethics pro- and auditing systems reasonably de-
gram contact to which individuals may signed to detect criminal, civil, and ad-
report suspected violations, as well as ministrative violations under the Act
107
§ 483.90 42 CFR Ch. IV (10–1–24 Edition)
by any of the operating organization’s must report directly to the operating

staff, individuals providing services organization’s governing body and not
under a contractual arrangement, or be subordinate to the general counsel,
volunteers, having in place and publi- chief financial officer or chief oper-
cizing a reporting system whereby any ating officer.
of these individuals could report viola- (3) Designated compliance liaisons lo-
tions by others anonymously within cated at each of the operating organi-
the operating organization without zation’s facilities.
fear of retribution, and having a proc- (e) Annual review. The operating or-
ess for ensuring the integrity of any re- ganization for each facility must re-
ported data. view its compliance and ethics pro-
(7) Consistent enforcement of the op- gram annually and revise its program
erating organization’s standards, poli- as needed to reflect changes in all ap-
cies, and procedures through appro- plicable laws or regulations and within
priate disciplinary mechanisms, in- the operating organization and its fa-
cluding, as appropriate, discipline of cilities to improve its performance in
individuals responsible for the failure deterring, reducing, and detecting vio-
to detect and report a violation to the lations under the Act and in promoting
compliance and ethics program contact quality of care.
identified in the operating organiza-
tion’s compliance and ethics program. [81 FR 68869, Oct. 4, 2016, as amended at 82 FR
(8) After a violation is detected, the 32259, July 13, 2017]
operating organization must ensure
§ 483.90 Physical environment.
that all reasonable steps identified in
its program are taken to respond ap- The facility must be designed, con-
propriately to the violation and to pre- structed, equipped, and maintained to
vent further similar violations, includ- protect the health and safety of resi-
ing any necessary modification to the dents, personnel and the public.
operating organization’s program to (a) Life safety from fire. (1) Except as
prevent and detect criminal, civil, and otherwise provided in this section—
administrative violations under the (i) The LTC facility must meet the
Act. applicable provisions and must proceed
(d) Additional required components for in accordance with the Life Safety
operating organizations with five or more Code (NFPA 101 and Tentative Interim
facilities. In addition to all of the other Amendments TIA 12–1, TIA 12–2, TIA
requirements in paragraphs (a), (b), (c), 12–3, and TIA 12–4.)
and (e) of this section, operating orga- (ii) Notwithstanding paragraph
nizations that operate five or more fa- (a)(1)(i) of this section, corridor doors
cilities must also include, at a min- and doors to rooms containing flam-
imum, the following components in mable or combustible materials must
their compliance and ethics program: be provided with positive latching
(1) A mandatory annual training pro- hardware. Roller latches are prohibited
gram on the operating organization’s on such doors.
compliance and ethics program that (iii) If a facility is Medicare- or Med-
meets the requirements set forth in icaid-certified before July 5, 2016 and
§ 483.95(f). the facility has previously used the
(2) A designated compliance officer Fire Safety Evaluation System for
for whom the operating organization’s compliance, the facility may use the
compliance and ethics program is a scoring values in the following Manda-
major responsibility. This individual tory Values Chart:
108
(2) In consideration of a rec- (i) Install an approved, supervised

ommendation by the State survey automatic sprinkler system in accord-
agency or Accrediting Organization or ance with the 1999 edition of NFPA 13,
at the discretion of the Secretary, may Standard for the Installation of Sprinkler
waive, for periods deemed appropriate, Systems, as incorporated by reference,
specific provisions of the Life Safety throughout the building by August 13,
Code, which would result in unreason- 2013. The Director of the Office of the
able hardship upon a long-term care fa- Federal Register has approved the
cility, but only if the waiver will not NFPA 13 1999 edition of the Standard
adversely affect the health and safety for the Installation of Sprinkler Systems,
of the patients. issued July 22, 1999 for incorporation by
(3) The provisions of the Life safety reference in accordance with 5 U.S.C.
Code do not apply in a State where 552(a) and 1 CFR part 51. A copy of the
CMS finds, in accordance with applica- Code is available for inspection at the
ble provisions of sections CMS Information Resource Center, 7500
1819(d)(2)(B)(ii) and 1919(d)(2)(B)(ii) of Security Boulevard, Baltimore, MD or
the Act, that a fire and safety code im- at the National Archives and Records
posed by State law adequately protects Administration (NARA). For informa-
patients, residents and personnel in tion on the availability of this mate-
long term care facilities. rial at NARA, call 202–741–6030, or go
(4) A long-term care facility may in- to: http://www.archives.gov/fed-
stall alcohol-based hand rub dispensers eral_register/code_of_federal_regulations/
in its facility if the dispensers are in- ibr_locations.html. Copies may be ob-
stalled in a manner that adequately tained from the National Fire Protec-
protects against inappropriate access. tion Association, 1 Batterymarch Park,
(5) A long term care facility must: Quincy, MA 02269.
(i) Install, at least, battery-operated (ii) Test, inspect, and maintain an
single station smoke alarms in accord- approved, supervised automatic sprin-
ance with the manufacturer’s rec- kler system in accordance with the 1998
ommendations in resident sleeping edition of NFPA 25, Standard for the In-
rooms and common areas. spection, Testing, and Maintenance of
(ii) Have a program for inspection, Water-Based Fire Protection Systems, as
testing, maintenance, and battery re- incorporated by reference. The Direc-
placement that conforms to the manu- tor of the Office of the Federal Register
facturer’s recommendations and that has approved the NFPA 25, Standard for
verifies correct operation of the smoke the Inspection, Testing, and Maintenance
alarms. of Water-Based Fire Protection Systems,
(iii) Exception: 1998 edition, issued January 16, 1998 for
(A) The facility has system-based incorporation by reference in accord-
smoke detectors in patient rooms and ance with 5 U.S.C. 552(a) and 1 CFR
common areas that are installed, test- part 51. A copy of the Code is available
ed, and maintained in accordance with for inspection at the CMS Information
NFPA 72, National Fire Alarm Code, for Resource Center, 7500 Security Boule-
system-based smoke detectors; or vard, Baltimore, MD or at the National
(B) The facility is fully sprinklered Archives and Records Administration
in accordance with NFPA 13, Standard (NARA). For information on the avail-
for the Installation of Sprinkler Systems. ability of this material at NARA, call
(6) A long term care facility must: 202–741–6030, or go to: http://
109
§ 483.90 42 CFR Ch. IV (10–1–24 Edition)
www.archives.gov/federal_register/ (B) All other conditions of paragraph

code_of_federal_regulations/ (a)(8)(iii) of this section are met.
ibr_locations.html. Copies may be ob- (7) Buildings must have an outside
tained from the National Fire Protec- window or outside door in every sleep-
tion Association, 1 Batterymarch Park, ing room, and for any building con-
Quincy, MA 02269. structed after July 5, 2016 the sill
(iii) Subject to approval by CMS, a height must not exceed 36 inches above
long term care facility may be granted the floor. Windows in atrium walls are
an extension of the sprinkler installa- considered outside windows for the pur-
tion deadline for a time period not to poses of this requirement.
exceed 2 years from August 13, 2013, if (8) When a sprinkler system is shut
the facility meets all of the following down for more than 10 hours, the LTC
conditions: facility must:
(A) It is in the process of replacing (i) Evacuate the building or portion
its current building, or undergoing of the building affected by the system
major modifications to improve the outage until the system is back in
living conditions for residents in all service, or
unsprinklered living areas that re- (ii) Establish a fire watch until the
quires the movement of corridor, room, system is back in service.
partition, or structural walls or sup- (b) Standard: Building safety. Except
ports, in addition to the installation of as otherwise provided in this section,
a sprinkler system; or, has had its the LTC facility must meet the appli-
planned sprinkler installation so im- cable provisions and must proceed in
paired by a disaster or emergency, as accordance with the Health Care Fa-
indicated by a declaration under sec- cilities Code (NFPA 99 and Tentative
tion 319 of the Public Health Service Interim Amendments TIA 12–2, TIA 12–
Act, that CMS finds it would be im- 3, TIA 12–4, TIA 12–5 and TIA 12–6).
practical to meet the sprinkler instal- (1) Chapters 7, 8, 12, and 13 of the
lation due date. adopted Health Care Facilities Code do
(B) It demonstrates that it has made not apply to a LTC facility.
the necessary financial commitments (2) If application of the Health Care
to complete the building replacement Facilities Code required under para-
or modification; or pursuant to a de- graph (b) of this section would result in
clared disaster or emergency, CMS unreasonable hardship for the LTC fa-
finds it impractical to make reasonable cility, CMS may waive specific provi-
and necessary financial commitments. sions of the Health Care Facilities
(C) Before applying for the deadline Code, but only if the waiver does not
extension, it has submitted plans to adversely affect the health and safety
State and local authorities that are of residents.
necessary for approval of the replace- (c) Emergency power. (1) An emer-
ment building or major modification gency electrical power system must
that includes the required sprinkler in- supply power adequate at least for
stallation, and has received approval of lighting all entrances and exits; equip-
the plans from State and local authori- ment to maintain the fire detection,
ties. alarm, and extinguishing systems; and
(D) It agrees to complete interim life support systems in the event the
steps to improve fire safety, as deter- normal electrical supply is interrupted.
mined by CMS. (2) When life support systems are
(iv) An extension granted under para- used, the facility must provide emer-
graph (a)(8)(iii) of this section may be gency electrical power with an emer-
renewed once, for an additional period gency generator (as defined in NFPA
not to exceed 1 year, if the following 99, Health Care Facilities) that is lo-
conditions are met: cated on the premises.
(A) CMS finds that extenuating cir- (d) Space and equipment. The facility
cumstances beyond the control of the must—
facility will prevent full compliance (1) Provide sufficient space and
with the provisions in paragraph equipment in dining, health services,
(a)(8)(i) of this section by the end of the recreation, living, and program areas
first waiver period. to enable staff to provide residents
110
with needed services as required by with clothes racks and shelves acces-
these standards and as identified in sible to the resident.
each resident’s assessment and plan of (3) CMS, or in the case of a nursing
care; facility the survey agency, may permit
(2) Maintain all mechanical, elec- variations in requirements specified in
trical, and patient care equipment in paragraphs (d)(1) (i) and (ii) of this sec-
safe operating condition; and tion relating to rooms in individual
(3) Conduct regular inspection of all cases when the facility demonstrates in
bed frames, mattresses, and bed rails, if writing that the variations—
any, as part of a regular maintenance (i) Are in accordance with the special
program to identify areas of possible needs of the residents; and
entrapment. When bed rails and mat- (ii) Will not adversely affect resi-
tresses are used and purchased sepa- dents’ health and safety.
rately from the bed frame, the facility (f) Bathroom facilities. Each resident
must ensure that the bed rails, mat- room must be equipped with or located
tress, and bed frame are compatible. near toilet and bathing facilities. For
(e) Resident rooms. Resident rooms facilities that receive approval of con-
must be designed and equipped for ade- struction from State and local authori-
quate nursing care, comfort, and pri- ties or are newly certified after Novem-
vacy of residents. ber 28, 2016, each resident room must
(1) Bedrooms must— have its own bathroom equipped with
(i) Accommodate no more than four at least a commode and sink.
residents. For facilities that receive (g) Resident call system. The facility
approval of construction or reconstruc- must be adequately equipped to allow
tion plans by State and local authori- residents to call for staff assistance
ties or are newly certified after Novem- through a communication system
ber 28, 2016, bedrooms must accommo- which relays the call directly to a staff
date no more than two residents. member or to a centralized staff work
(ii) Measure at least 80 square feet area from—
per resident in multiple resident bed- (1) Each resident’s bedside; and
rooms, and at least 100 square feet in (2) Toilet and bathing facilities.
single resident rooms; (h) Dining and resident activities. The
(iii) Have direct access to an exit cor- facility must provide one or more
ridor; rooms designated for resident dining
(iv) Be designed or equipped to assure and activities. These rooms must—
full visual privacy for each resident; (1) Be well lighted;
(v) In facilities initially certified (2) Be well ventilated;
after March 31, 1992, except in private (3) Be adequately furnished; and
rooms, each bed must have ceiling sus- (4) Have sufficient space to accommo-
pended curtains, which extend around date all activities.
the bed to provide total visual privacy (i) Other environmental conditions. The
in combination with adjacent walls and facility must provide a safe, func-
curtains; tional, sanitary, and comfortable envi-
(vi) Have at least one window to the ronment for the residents, staff and the
outside; and public. The facility must—
(vii) Have a floor at or above grade (1) Establish procedures to ensure
level. that water is available to essential
(2) The facility must provide each areas when there is a loss of normal
resident with— water supply;
(i) A separate bed of proper size and (2) Have adequate outside ventilation
height for the safety and convenience by means of windows, or mechanical
of the resident; ventilation, or a combination of the
(ii) A clean, comfortable mattress; two;
(iii) Bedding appropriate to the (3) Equip corridors with firmly se-
weather and climate; and cured handrails on each side; and
(iv) Functional furniture appropriate (4) Maintain an effective pest control
to the resident’s needs, and individual program so that the facility is free of
closet space in the resident’s bedroom pests and rodents.
111
§ 483.95 42 CFR Ch. IV (10–1–24 Edition)
(5) Establish policies, in accordance (2) [Reserved]

with applicable Federal, State, and [56 FR 48876, Sept. 26, 1991, as amended at 57
local laws and regulations, regarding FR 43925, Sept. 23, 1992; 68 FR 1386, Jan. 10,
smoking, smoking areas, and smoking 2003; 69 FR 49268, Aug. 11, 2004; 70 FR 15238,
safety that also take into account non- Mar. 25, 2005; 71 FR 55340, Sept. 22, 2006; 73 FR
smoking residents. 47091, Aug. 13, 2008; 79 FR 27155, May 12, 2014;
81 FR 26899, May 4, 2016; 81 FR 42548, June 30,
(j) The standards incorporated by ref- 2016. Redesignated and amended at 81 FR
erence in this section are approved for 68861, 68870, Oct. 4, 2016; 82 FR 32259, July 13,
incorporation by reference by the Di- 2017; 86 FR 42524, Aug. 4, 2021; 87 FR 47618,
rector of the Office of the Federal Reg- Aug. 3, 2022]
ister in accordance with 5 U.S.C. 552(a)
§ 483.95 Training requirements.
and 1 CFR part 51. You may inspect a
copy at the CMS Information Resource A facility must develop, implement,
Center, 7500 Security Boulevard, Balti- and maintain an effective training pro-
more, MD or at the National Archives gram for all new and existing staff; in-
and Records Administration (NARA). dividuals providing services under a
For information on the availability of contractual arrangement; and volun-
teers, consistent with their expected
this material at NARA, call 202–741–
roles. A facility must determine the
6030, or go to: http://www.archives.gov/
amount and types of training necessary
federal_register/ based on a facility assessment as speci-
code_of_federal_regulations/ fied at § 483.71. Training topics must in-
ibr_locations.html. If any changes in this clude but are not limited to—
edition of the Code are incorporated by (a) Communication. A facility must in-
reference, CMS will publish a docu- clude effective communications as
ment in the FEDERAL REGISTER to an- mandatory training for direct care
nounce the changes. staff.
(1) National Fire Protection Associa- (b) Resident’s rights and facility respon-
tion, 1 Batterymarch Park, Quincy, sibilities. A facility must ensure that
MA 02169, www.nfpa.org, 1.617.770.3000. staff members are educated on the
(i) NFPA 99, Standards for Health rights of the resident and the respon-
Care Facilities Code of the National sibilities of a facility to properly care
Fire Protection Association 99, 2012 for its residents as set forth at § 483.10,
edition, issued August 11, 2011. respectively.
(c) Abuse, neglect, and exploitation. In
(ii) TIA 12–2 to NFPA 99, issued Au-
addition to the freedom from abuse, ne-
gust 11, 2011. glect, and exploitation requirements in
(iii) TIA 12–3 to NFPA 99, issued Au- § 483.12, facilities must also provide
gust 9, 2012. training to their staff that at a min-
(iv) TIA 12–4 to NFPA 99, issued imum educates staff on—
March 7, 2013. (1) Activities that constitute abuse,
(v) TIA 12–5 to NFPA 99, issued Au- neglect, exploitation, and misappro-
gust 1, 2013. priation of resident property as set
(vi) TIA 12–6 to NFPA 99, issued forth at § 483.12.
March 3, 2014. (2) Procedures for reporting incidents
(vii) NFPA 101, Life Safety Code, 2012 of abuse, neglect, exploitation, or the
edition, issued August 11, 2011; misappropriation of resident property.
(viii) TIA 12–1 to NFPA 101, issued (3) Dementia management and resi-
August 11, 2011. dent abuse prevention.
(d) Quality assurance and performance
(ix) TIA 12–2 to NFPA 101, issued Oc-
improvement. A facility must include as
tober 30, 2012. part of its QAPI program mandatory
(x) TIA 12–3 to NFPA 101, issued Oc- training that outlines and informs staff
tober 22, 2013. of the elements and goals of the facili-
(xi) TIA 12–4 to NFPA 101, issued Oc- ty’s QAPI program as set forth at
tober 22, 2013. § 483.75.
(e) Infection control. A facility must
include as part of its infection preven-
tion and control program mandatory
112
training that includes the written § 483.100 Basis.

standards, policies, and procedures for The requirements of §§ 483.100
the program as described at through 483.138 governing the State’s
§ 483.80(a)(2). responsibility for preadmission screen-
(f) Compliance and ethics. The oper- ing and annual resident review
ating organization for each facility (PASARR) of individuals with mental
must include as part of its compliance illness and intellectual disability are
and ethics program, as set forth at based on section 1919(e)(7) of the Act.
§ 483.85—
(1) An effective way to communicate § 483.102 Applicability and definitions.
that program’s standards, policies, and
(a) This subpart applies to the
procedures through a training program
screening or reviewing of all individ-
or in another practical manner which
uals with mental illness or intellectual
explains the requirements under the
disability who apply to or reside in
program.
Medicaid certified NFs regardless of
(2) Annual training if the operating
the source of payment for the NF serv-
organization operates five or more fa-
ices, and regardless of the individual’s
cilities.
or resident’s known diagnoses.
(g) Required in-service training for
(b) Definitions. As used in this sub-
nurse aides. In-service training must—
part—
(1) Be sufficient to ensure the con- (1) An individual is considered to
tinuing competence of nurse aides, but have a serious mental illness (MI) if
must be no less than 12 hours per year. the individual meets the following re-
(2) Include dementia management quirements on diagnosis, level of im-
training and resident abuse prevention pairment and duration of illness:
training. (i) Diagnosis. The individual has a
(3) Address areas of weakness as de- major mental disorder diagnosable
termined in nurse aides’ performance under the Diagnostic and Statistical
reviews and facility assessment at Manual of Mental Disorders, 3rd edi-
§ 483.70(e) and may address the special tion, revised in 1987.
needs of residents as determined by the Incorporation of the 1987 edition of
facility staff. the Diagnostic and Statistical Manual
(4) For nurse aides providing services of Mental Disorders, 3rd edition, was
to individuals with cognitive impair- approved by the Director of the Federal
ments, also address the care of the cog- Register in accordance with 5 U.S.C.
nitively impaired. 552(a) and 1 CFR part 51 that govern
(h) Required training of feeding assist- the use of incorporation by reference. 1
ants. A facility must not use any indi- This mental disorder is—
vidual working in the facility as a paid (A) A schizophrenic, mood, paranoid,
feeding assistant unless that individual panic or other severe anxiety disorder;
has successfully completed a State-ap- somatoform disorder; personality dis-
proved training program for feeding as- order; other psychotic disorder; or an-
sistants, as specified in § 483.160. other mental disorder that may lead to
(i) Behavioral health. A facility must a chronic disability; but
provide behavioral health training con-
sistent with the requirements at 1 The Diagnostic and Statistical Manual of
§ 483.40 and as determined by the facil- Mental Disorders is available for inspection
ity assessment at § 483.70(e). at the Centers for Medicare & Medicaid Serv-
[81 FR 68870, Oct. 4, 2016, as amended at 89 FR ices, room 132, East High Rise Building, 6325
41000, May 10, 2024] Security Boulevard, Baltimore, Maryland, or
at the National Archives and Records Ad-
ministration (NARA). For information on
Subpart C—Preadmission Screen- the availability of this material at NARA,
ing and Annual Review of call 202–741–6030, or go to: http://
Mentally Ill and Mentally Re- www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
tarded Individuals Copies may be obtained from the American
Psychiatric Association, Division of Publica-
SOURCE: 57 FR 56506, Nov. 30, 1992, unless tions and Marketing, 1400 K Street, NW.,
otherwise noted. Washington, DC 20005.
113
§ 483.104 42 CFR Ch. IV (10–1–24 Edition)
(B) Not a primary diagnosis of de- normal living situation, for which sup-
mentia, including Alzheimer’s disease portive services were required to main-
or a related disorder, or a non-primary tain functioning at home, or in a resi-
diagnosis of dementia unless the pri- dential treatment environment, or
mary diagnosis is a major mental dis- which resulted in intervention by hous-
order as defined in paragraph ing or law enforcement officials.
(b)(1)(i)(A) of this section. (2) An individual is considered to
(ii) Level of impairment. The disorder have dementia if he or she has a pri-
results in functional limitations in mary diagnosis of dementia, as de-
major life activities within the past 3 scribed in the Diagnostic and Statis-
to 6 months that would be appropriate tical Manual of Mental Disorders, 3rd
for the individual’s developmental edition, revised in 1987, or a non-pri-
stage. An individual typically has at mary diagnosis of dementia unless the
least one of the following characteris- primary diagnosis is a major mental
tics on a continuing or intermittent disorder as defined in paragraph
basis: (b)(1)(i)(A) of this section.
(A) Interpersonal functioning. The in- (3) An individual is considered to
dividual has serious difficulty inter- have intellectual disability (IID) if he
acting appropriately and commu- or she has—
nicating effectively with other persons, (i) A level of retardation (mild, mod-
has a possible history of altercations, erate, severe or profound) described in
evictions, firing, fear of strangers, the American Association on Intellec-
avoidance of interpersonal relation- tual Disability’s Manual on Classifica-
ships and social isolation; tion in Intellectual Disability (1983).
(B) Concentration, persistence, and Incorporation by reference of the 1983
pace. The individual has serious dif- edition of the American Association on
ficulty in sustaining focused attention Intellectual Disability’s Manual on
for a long enough period to permit the Classification in Intellectual Disability
completion of tasks commonly found was approved by the Director of the
in work settings or in work-like struc- Federal Register in accordance with 5
tured activities occurring in school or U.S.C. 552(a) and 1 CFR part 51 that
home settings, manifests difficulties in govern the use of incorporations by ref-
concentration, inability to complete erence;2 or
simple tasks within an established
(ii) A related condition as defined by
time period, makes frequent errors, or
§ 435.1010 of this chapter.
requires assistance in the completion
of these tasks; and [57 FR 56506, Nov. 30, 1992; 58 FR 25784, Apr.
(C) Adaptation to change. The indi- 28, 1993; 71 FR 39229, July 12, 2006]
vidual has serious difficulty in adapt-
ing to typical changes in cir- § 483.104 State plan requirement.
cumstances associated with work, As a condition of approval of the
school, family, or social interaction, State plan, the State must operate a
manifests agitation, exacerbated signs preadmission screening and annual
and symptoms associated with the ill- resident review program that meets
ness, or withdrawal from the situation,
or requires intervention by the mental 2 The American Association on Intellectual
health or judicial system. Disability’s Manual on Classification in In-
(iii) Recent treatment. The treatment tellectual Disability is available for inspec-
history indicates that the individual tion at the Centers for Medicare & Medicaid
has experienced at least one of the fol- Services, Room 132, East High Rise Building,
lowing: 6325 Security Boulevard, Baltimore, Mary-
(A) Psychiatric treatment more in- land, or at the National Archives and
tensive than outpatient care more than Records Administration (NARA). For infor-
mation on the availability of this material
once in the past 2 years (e.g., partial
at NARA, call 202–741–6030, or go to: http://
hospitalization or inpatient hos- www.archives.gov/federal_register/
pitalization); or code_of_federal_regulations/ibr_locations.html.
(B) Within the last 2 years, due to the Copies may be obtained from the American
mental disorder, experienced an epi- Association on Intellectual Disability, 1719
sode of significant disruption to the Kalorama Rd., NW., Washington, DC 20009.
114
the requirements of §§ 483.100 through view rather than preadmission screen-

438.138. ing.
(4) Interfacility transfers—(i) An inter-
§ 483.106 Basic rule. facility transfer occurs when an indi-
(a) Requirement. The State PASARR vidual is transferred from one NF to
program must require—(1) another NF, with or without an inter-
Preadmission screening of all individ- vening hospital stay. Interfacility
uals with mental illness or intellectual transfers are subject to annual resident
disability who apply as new admissions review rather than preadmission
to Medicaid NFs on or after January 1, screening.
1989; (ii) In cases of transfer of a resident
(2) Initial review, by April 1, 1990, of with MI or IID from a NF to a hospital
all current residents with intellectual or to another NF, the transferring NF
disability or mental illness who en- is responsible for ensuring that copies
tered Medicaid NFs prior to January 1, of the resident’s most recent PASARR
1989; and and resident assessment reports accom-
(3) At least annual review, as of April pany the transferring resident.
1, 1990, of all residents with mental ill- (c) Purpose. The preadmission screen-
ness or intellectual disability, regarding and annual resident review process
less of whether they were first screened must result in determinations based on
under the preadmission screening or a physical and mental evaluation of
annual resident review requirements. each individual with mental illness or
(b) Admissions, readmissions and inter- intellectual disability, that are de-
facility transfers—(1) New admission. An scribed in §§ 483.112 and 483.114.
individual is a new admission if he or (d) Responsibility for evaluations and
she is admitted to any NF for the first determinations. The PASARR deter-
time or does not qualify as a readmis- minations of whether an individual re-
sion. With the exception of certain hos- quires the level of services provided by
pital discharges described in paragraph a NF and whether specialized services
(b)(2) of this section, new admissions are needed—
are subject to preadmission screening. (1) For individuals with mental ill-
(2) Exempted hospital discharge. (i) An ness, must be made by the State men-
exempted hospital discharge means an tal health authority and be based on an
individual— independent physical and mental eval-
(A) Who is admitted to any NF di- uation performed by a person or entity
rectly from a hospital after receiving other than the State mental health au-
acute inpatient care at the hospital; thority; and
(B) Who requires NF services for the (2) For individuals with intellectual
condition for which he or she received disability, must be made by the State
care in the hospital; and intellectual disability or develop-
(C) Whose attending physician has mental disabilities authority.
certified before admission to the facil- (e) Delegation of responsibility—(1) The
ity that the individual is likely to re- State mental health and intellectual
quire less than 30 days nursing facility disability authorities may delegate by
services. subcontract or otherwise the evalua-
(ii) If an individual who enters a NF tion and determination functions for
as an exempted hospital discharge is which they are responsible to another
later found to require more than 30 entity only if—
days of NF care, the State mental (i) The State mental health and in-
health or intellectual disability au- tellectual disability authorities retain
thority must conduct an annual resi- ultimate control and responsibility for
dent review within 40 calendar days of the performance of their statutory ob-
admission. ligations;
(3) Readmissions. An individual is a (ii) The two determinations as to the
readmission if he or she was re- need for NF services and for specialized
admitted to a facility from a hospital services are made, based on a con-
to which he or she was transferred for sistent analysis of the data; and
the purpose of receiving care. Readmis- (iii) The entity to which the delega-
sions are subject to annual resident re- tion is made is not a NF or an entity
115
§ 483.108 42 CFR Ch. IV (10–1–24 Edition)
that has a direct or indirect affiliation defined in § 435.403 of this chapter, must
or relationship with a NF. pay for the PASARR and make the re-
(2) The State intellectual disability quired determinations, in accordance
authority has responsibility for both with § 431.52(b).
the evaluation and determination func- (b) Agreements. A State may include
tions for individuals with IID whereas arrangements for PASARR in its pro-
the State mental health authority has vider agreements with out-of-State fa-
responsibility only for the determina- cilities or reciprocal interstate agree-
tion function. ments.
(3) The evaluation of individuals with [57 FR 56506, Nov. 30, 1992; 58 FR 25784, Apr.
MI cannot be delegated by the State 28, 1993]
mental health authority because it
does not have responsibility for this § 483.112 Preadmission screening of
function. The evaluation function must applicants for admission to NFs.
be performed by a person or entity (a) Determination of need for NF serv-
other than the State mental health au- ices. For each NF applicant with MI or
thority. In designating an independent IID, the State mental health or intel-
person or entity to perform MI evalua- lectual disability authority (as appro-
tions, the State must not use a NF or priate) must determine, in accordance
an entity that has a direct or indirect with § 483.130, whether, because of the
affiliation or relationship with a NF. resident’s physical and mental condi-
[57 FR 56506, Nov. 30, 1992; 58 FR 25784, Apr. tion, the individual requires the level
28, 1993] of services provided by a NF.
(b) Determination of need for special-
§ 483.108 Relationship of PASARR to ized services. If the individual with men-
other Medicaid processes. tal illness or intellectual disability is
(a) PASARR determinations made by determined to require a NF level of
the State mental health or intellectual care, the State mental health or intel-
disability authorities cannot be coun- lectual disability authority (as appro-
termanded by the State Medicaid agen- priate) must also determine, in accord-
cy, either in the claims process or ance with § 483.130, whether the indi-
through other utilization control/re- vidual requires specialized services for
view processes or by the State survey the mental illness or intellectual dis-
and certification agency. Only appeals ability, as defined in § 483.120.
determinations made through the sys- (c) Timeliness—(1) Except as specified
tem specified in subpart E of this part in paragraph (c)(4) of this section, a
may overturn a PASARR determina- preadmission screening determination
tion made by the State mental health must be made in writing within an an-
or intellectual disability authorities. nual average of 7 to 9 working days of
(b) In making their determinations, referral of the individual with MI or
however, the State mental health and IID by whatever agent performs the
intellectual disability authorities must Level I identification, under § 483.128(a)
not use criteria relating to the need for of this part, to the State mental health
NF care or specialized services that are or intellectual disability authority for
inconsistent with this regulation and screening. (See § 483.128(a) for discus-
any supplementary criteria adopted by sion of Level I evaluation.)
the State Medicaid agency under its (2) The State may convey determina-
approved State plan. tions verbally to nursing facilities and
(c) To the maximum extent prac- the individual and confirm them in
ticable, in order to avoid duplicative writing.
testing and effort, the PASARR must (3) The State may compute separate
be coordinated with the routine resi- annual averages for the mentally ill
dent assessments required by § 483.20(b). and individuals with intellectual dis-
abilities/developmentally disabled pop-
§ 483.110 Out-of-State arrangements. ulations.
(a) Basic rule. The State in which the (4) The Secretary may grant an ex-
individual is a State resident (or would ception to the timeliness standard in
be a State resident at the time he or paragraph (c)(1) of this section when
she becomes eligible for Medicaid), as the State—
116
(i) Exceeds the annual average; and disability authority determines that a
(ii) Provides justification satisfac- resident or applicant for admission to a
tory to the Secretary that a longer NF requires a NF level of services, the
time period was necessary. NF may admit or retain the individual.
(b) Individuals needing NF services and
§ 483.114 Annual review of NF resi- specialized services. If the State mental
dents. health or intellectual disability au-
(a) Individuals with mental illness. For thority determines that a resident or
each resident of a NF who has mental applicant for admission requires both a
illness, the State mental health au- NF level of services and specialized
thority must determine in accordance services for the mental illness or intel-
with § 483.130 whether, because of the lectual disability—
resident’s physical and mental condi- (1) The NF may admit or retain the
tion, the resident requires— individual; and
(1) The level of services provided by— (2) The State must provide or arrange
(i) A NF; for the provision of the specialized
(ii) An inpatient psychiatric hospital services needed by the individual while
for individuals under age 21, as de- he or she resides in the NF.
scribed in section 1905(h) of the Act; or
(iii) An institution for mental dis- § 483.118 Residents and applicants de-
eases providing medical assistance to termined not to require NF level of
services.
individuals age 65 or older; and
(2) Specialized services for mental ill- (a) Applicants who do not require NF
ness, as defined in § 483.120. services. If the State mental health or
(b) Individuals with intellectual dis- intellectual disability authority deter-
ability. For each resident of a NF who mines that an applicant for admission
has intellectual disability, the State to a NF does not require NF services,
intellectual disability or develop- the applicant cannot be admitted. NF
mental disability authority must de- services are not a covered Medicaid
termine in accordance with § 483.130 service for that individual, and further
whether, because of his or her physical screening is not required.
or mental condition, the resident re- (b) Residents who require neither NF
quires— services nor specialized services for MI or
(1) The level of services provided by a IID. If the State mental health or in-
NF or an intermediate care facility for tellectual disability authority deter-
individuals with intellectual disabil- mines that a resident requires neither
ities; and the level of services provided by a NF
(2) Specialized services for intellec- nor specialized services for MI or IID,
tual disability as defined in § 483.120. regardless of the length of stay in the
(c) Frequency of review—(1) A review facility, the State must—
and determination must be conducted (1) Arrange for the safe and orderly
for each resident of a Medicaid NF who discharge of the resident from the fa-
has mental illness or intellectual dis- cility in accordance with § 483.15(b); and
ability not less often than annually. (2) Prepare and orient the resident
(2) ‘‘Annually’’ is defined as occur- for discharge.
ring within every fourth quarter after (c) Residents who do not require NF
the previous preadmission screen or an- services but require specialized services for
nual resident review. MI or IID—(1) Long term residents. Ex-
(d) April 1, 1990 deadline for initial re- cept as otherwise may be provided in
views. The first set of annual reviews an alternative disposition plan adopted
on residents who entered the NF prior under section 1919(e)(7)(E) of the Act,
to January 1, 1989, must be completed for any resident who has continuously
by April 1, 1990. resided in a NF for at least 30 months
before the date of the determination,
§ 483.116 Residents and applicants de- and who requires only specialized serv-
termined to require NF level of ices as defined in § 483.120, the State
services. must, in consultation with the resi-
(a) Individuals needing NF services. If dent’s family or legal representative
the State mental health or intellectual and caregivers—
117
§ 483.120 42 CFR Ch. IV (10–1–24 Edition)
(i) Offer the resident the choice of re- specified by the State which, combined
maining in the facility or of receiving with services provided by the NF, re-
services in an alternative appropriate sults in the continuous and aggressive
setting; implementation of an individualized
(ii) Inform the resident of the institu- plan of care that—
tional and noninstitutional alter- (i) Is developed and supervised by an
natives covered under the State Med- interdisciplinary team, which includes
icaid plan for the resident; a physician, qualified mental health
(iii) Clarify the effect on eligibility professionals and, as appropriate, other
for Medicaid services under the State professionals.
plan if the resident chooses to leave (ii) Prescribes specific therapies and
the facility, including its effect on re- activities for the treatment of persons
admission to the facility; and experiencing an acute episode of seri-
(iv) Regardless of the resident’s ous mental illness, which necessitates
choice, provide for, or arrange for the supervision by trained mental health
provision of specialized services for the personnel; and
mental illness or intellectual dis- (iii) Is directed toward diagnosing
ability. and reducing the resident’s behavioral
(2) Short term residents. Except as oth- symptoms that necessitated institu-
erwise may be provided in an alter- tionalization, improving his or her
native disposition plan adopted under level of independent functioning, and
section 1919(e)(7)(E) of the Act, for any achieving a functioning level that per-
resident who requires only specialized mits reduction in the intensity of men-
services, as defined in § 483.120, and who tal health services to below the level of
has not continuously resided in a NF specialized services at the earliest pos-
for at least 30 months before the date sible time.
of the determination, the State must, (2) For intellectual disability, spe-
in consultation with the resident’s cialized services means the services
family or legal representative and specified by the State which, combined
caregivers— with services provided by the NF or
(i) Arrange for the safe and orderly other service providers, results in
discharge of the resident from the fa- treatment which meets the require-
cility in accordance with § 483.15(b); ments of § 483.440(a)(1).
(ii) Prepare and orient the resident (b) Who must receive specialized serv-
for discharge; and ices. The State must provide or arrange
(iii) Provide for, or arrange for the for the provision of specialized serv-
provision of, specialized services for ices, in accordance with this subpart,
the mental illness or intellectual dis- to all NF residents with MI or IID
ability. whose needs are such that continuous
(3) For the purpose of establishing supervision, treatment and training by
length of stay in a NF, the 30 months of qualified mental health or intellectual
continuous residence in a NF or disability personnel is necessary, as
longer— identified by the screening provided in
(i) Is calculated back from the date § 483.130 or §§ 483.134 and 483.136.
of the first annual resident review de- (c) Services of lesser intensity than spe-
termination which finds that the indi- cialized services. The NF must provide
vidual is not in need of NF level of mental health or intellectual disability
services; services which are of a lesser intensity
(ii) May include temporary absences than specialized services to all resi-
for hospitalization or therapeutic dents who need such services.
leave; and
(iii) May consist of consecutive resi- § 483.122 FFP for NF services.
dences in more than one NF. (a) Basic rule. Except as otherwise
[57 FR 56506, Nov. 30, 1992, as amended at 81 may be provided in an alternative dis-
FR 68871, Oct. 4, 2016] position plan adopted under section
1919(e)(7)(E) of the Act, FFP is avail-
§ 483.120 Specialized services. able in State expenditures for NF serv-
(a) Definition—(1) For mental illness, ices provided to a Medicaid eligible in-
specialized services means the services dividual subject to the requirements of
118
this part only if the individual has tual disability authority for Level II
been determined— screening.
(1) To need NF care under § 483.116(a) (b) Adaptation to culture, language,
or ethnic origin. Evaluations performed
(2) Not to need NF services but to under PASARR and PASARR notices
need specialized services, meets the re- must be adapted to the cultural back-
quirements of § 483.118(c)(1), and elects ground, language, ethnic origin and
to stay in the NF. means of communication used by the
(b) FFP for late reviews. When a individual being evaluated.
preadmission screening has not been (c) Participation by individual and fam-
performed prior to admission or an an- ily. PASARR evaluations must in-
nual review is not performed timely, in volve—
accordance with § 483.114(c), but either (1) The individual being evaluated;
is performed at a later date, FFP is (2) The individual’s legal representa-
available only for services furnished tive, if one has been designated under
after the screening or review has been State law; and
performed, subject to the provisions of (3) The individual’s family if—
paragraph (a) of this section. (i) Available; and
(ii) The individual or the legal rep-
§ 483.124 FFP for specialized services. resentative agrees to family participa-
tion.
FFP is not available for specialized
(d) Interdisciplinary coordination.
services furnished to NF residents as
When parts of a PASARR evaluation
NF services.
are performed by more than one eval-
§ 483.126 Appropriate placement. uator, the State must ensure that
there is interdisciplinary coordination
Placement of an individual with MI among the evaluators.
or IID in a NF may be considered ap- (e) The State’s PASARR program
propriate only when the individual’s must use at least the evaluative cri-
needs are such that he or she meets the teria of § 483.130 (if one or both deter-
minimum standards for admission and minations can easily be made categori-
the individual’s needs for treatment do cally as described in § 483.130) or of
not exceed the level of services which §§ 483.132 and 483.134 or § 483.136 (or, in
can be delivered in the NF to which the the case of individuals with both MI
individual is admitted either through and IID, §§ 483.132, 483.134 and 483.136 if
NF services alone or, where necessary, a more extensive individualized evalua-
through NF services supplemented by tion is required).
specialized services provided by or ar- (f) Data. In the case of individualized
ranged for by the State. evaluations, information that is nec-
essary for determining whether it is
§ 483.128 PASARR evaluation criteria. appropriate for the individual with MI
(a) Level I: Identification of individuals or IID to be placed in an NF or in an-
with MI or IID. The State’s PASARR other appropriate setting should be
program must identify all individuals gathered throughout all applicable por-
who are suspected of having MI or IID tions of the PASARR evaluation
as defined in § 483.102. This identifica- (§§ 483.132 and 483.134 and/or § 483.136).
tion function is termed Level I. Level The two determinations relating to the
II is the function of evaluating and de- need for NF level of care and special-
termining whether NF services and ized services are interrelated and must
specialized services are needed. The be based upon a comprehensive anal-
State’s performance of the Level I ysis of all data concerning the indi-
identification function must provide at vidual.
least, in the case of first time identi- (g) Preexisting data. Evaluators may
fications, for the issuance of written use relevant evaluative data, obtained
notice to the individual or resident and prior to initiation of preadmission
his or her legal representative that the screening or annual resident review, if
individual or resident is suspected of the data are considered valid and accu-
having MI or IID and is being referred rate and reflect the current functional
to the State mental health or intellec- status of the individual. However, in
119
§ 483.130 42 CFR Ch. IV (10–1–24 Edition)
the case of individualized evaluations, (2) Explains the categorical deter-

to supplement and verify the currency mination(s) that has (have) been made
and accuracy of existing data, the and, if only one of the two required de-
State’s PASARR program may need to terminations can be made categori-
gather additional information nec- cally, describes the nature of any fur-
essary to assess proper placement and ther screening which is required;
treatment. (3) Identifies, to the extent possible,
(h) Findings. For both categorical and based on the available data, NF serv-
individualized determinations, findings ices, including any mental health or
of the evaluation must correspond to specialized psychiatric rehabilitative
the person’s current functional status services, that may be needed; and
as documented in medical and social (4) Includes the bases for the report’s
history records. conclusions.
(i) Evaluation report: Individualized de- (k) Interpretation of findings to indi-
terminations. For individualized vidual. For both categorical and indi-
PASARR determinations, findings vidualized determinations, findings of
must be issued in the form of a written the evaluation must be interpreted and
evaluative report which— explained to the individual and, where
(1) Identifies the name and profes- applicable, to a legal representative
sional title of person(s) who performed designated under State law.
the evaluation(s) and the date on which (l) Evaluation report. The evaluator
each portion of the evaluation was ad- must send a copy of the evaluation re-
ministered; port to the—
(2) Provides a summary of the med- (1) Individual or resident and his or
ical and social history, including the her legal representative;
positive traits or developmental (2) Appropriate State authority in
strengths and weaknesses or develop- sufficient time for the State authori-
mental needs of the evaluated indi- ties to meet the times identified in
vidual; § 483.112(c) for PASs and § 483.114(c) for
(3) If NF services are recommended, ARRs;
identifies the specific services which (3) Admitting or retaining NF;
are required to meet the evaluated in- (4) Individual’s attending physician;
dividual’s needs, including services re- and
quired in paragraph (i)(5) of this sec- (5) The discharging hospital if the in-
tion; dividual is seeking NF admission from
(4) If specialized services are not rec- a hospital.
ommended, identifies any specific in- (m) The evaluation may be termi-
tellectual disability or mental health nated if the evaluator finds at any time
services which are of a lesser intensity during the evaluation that the indi-
than specialized services that are re- vidual being evaluated—
quired to meet the evaluated individ-
(1) Does not have MI or IID; or
ual’s needs;
(2) Has—
(5) If specialized services are rec-
ommended, identifies the specific intel- (i) A primary diagnosis of dementia
lectual disability or mental health (including Alzheimer’s Disease or a re-
services required to meet the evaluated lated disorder); or
individual’s needs; and (ii) A non-primary diagnosis of de-
(6) Includes the bases for the report’s mentia without a primary diagnosis
conclusions. that is a serious mental illness, and
does not have a diagnosis of IID or a re-
(j) Evaluation report: Categorical deter-
lated condition.
minations. For categorical PASARR de-
terminations, findings must be issued [57 FR 56506, Nov. 30, 1992; 58 FR 25784, Apr.
in the form of an abbreviated written 28, 1993]
evaluative report which—
(1) Identifies the name and profes- § 483.130 PASARR determination cri-
sional title of the person applying the teria.
categorical determination and the data (a) Basis for determinations. Deter-
on which the application was made; minations made by the State mental
120
health or intellectual disability au- (2) Terminal illness, as defined for

thority as to whether NF level of serv- hospice purposes in § 418.3 of this chap-
ices and specialized services are needed ter;
must be based on an evaluation of data (3) Severe physical illnesses such as
concerning the individual, as specified coma, ventilator dependence, func-
in paragraph (b) of this section. tioning at a brain stem level, or diag-
(b) Types of determinations. Deter- noses such as chronic obstructive pul-
minations may be— monary disease, Parkinson’s disease,
(1) Advance group determinations, in Huntington’s disease, amyotrophic lat-
accordance with this section, by cat- eral sclerosis, and congestive heart
egory that take into account that cer- failure which result in a level of im-
tain diagnoses, levels of severity of ill- pairment so severe that the individual
ness, or need for a particular service could not be expected to benefit from
clearly indicate that admission to or specialized services;
residence in a NF is normally needed, (4) Provisional admissions pending
or that the provision of specialized further assessment in cases of delirium
services is not normally needed; or where an accurate diagnosis cannot be
(2) Individualized determinations made until the delirium clears;
based on more extensive individualized (5) Provisional admissions pending
evaluations as required in § 483.132, further assessment in emergency situa-
§ 483.134, or § 483.136 (or, in the case of tions requiring protective services,
an individual having both IID and MI, with placement in a nursing facility
§§ 483.134 and 483.136). not to exceed 7 days; and
(c) Group determinations by category. (6) Very brief and finite stays of up to
Advance group determinations by cat- a fixed number of days to provide res-
egory developed by the State mental pite to in-home caregivers to whom the
health or intellectual disability au- individual with MI or IID is expected to
thorities may be made applicable to in- return following the brief NF stay.
dividuals by the NF or other evaluator (e) Time limits. The State may specify
following Level I review only if exist- time limits for categorical determina-
ing data on the individual appear to be tions that NF services are needed and
current and accurate and are sufficient in the case of paragraphs (d)(4), (5) and
to allow the evaluator readily to deter- (6) of this section, must specify a time
mine that the individual fits into the limit which is appropriate for provi-
category established by the State au- sional admissions pending further as-
thorities (see § 483.132(c)). Sources of sessment and for emergency situations
existing data on the individual that and respite care. If an individual is
could form the basis for applying a cat- later determined to need a longer stay
egorical determination by the State than the State’s limit allows, the indi-
authorities would be hospital records, vidual must be subjected to an annual
physician’s evaluations, election of resident review before continuation of
hospice status, records of community the stay may be permitted and pay-
mental health centers or community ment made for days of NF care beyond
intellectual disability or develop- the State’s time limit.
mental disability providers. (f) The State mental health and in-
(d) Examples of categories. Examples of tellectual disability authorities may
categories for which the State mental make categorical determinations that
health or intellectual disability au- specialized services are not needed in
thority may make an advance group the provisional, emergency and respite
determination that NF services are admission situations identified in
needed are— § 483.130(d)(4)–(6). In all other cases, ex-
(1) Convalescent care from an acute cept for § 483.130(h), a determination
physical illness which— that specialized services are not needed
(i) Required hospitalization; and must be based on a more extensive in-
(ii) Does not meet all the criteria for dividualized evaluation under § 483.134
an exempt hospital discharge, which is or § 483.136.
not subject to preadmission screening, (g) Categorical determinations: No posi-
as specified in § 483.106(b)(2). tive specialized treatment determinations.
121
§ 483.130 42 CFR Ch. IV (10–1–24 Edition)
The State mental health and intellec- (4) The rights of the individual to ap-
tual disability authorities must not peal the determination under subpart E
make categorical determinations that of this part.
specialized services are needed. Such a (m) Placement options. Except as oth-
determination must be based on a more erwise may be provided in an alter-
extensive individualized evaluation native disposition plan adopted under
under § 483.134 or § 483.136 to determine section 1919(e)(7)(E) of the Act, the
the exact nature of the specialized placement options and the required
services that are needed. State actions are as follows:
(h) Categorical determinations: Demen- (1) Can be admitted to a NF. Any appli-
tia and IID. The State intellectual dis- cant for admission to a NF who has MI
ability authority may make categor- or IID and who requires the level of
ical determinations that individuals services provided by a NF, regardless of
with dementia, which exists in com- whether specialized services are also
bination with intellectual disability or needed, may be admitted to a NF, if
a related condition, do not need spe- the placement is appropriate, as deter-
cialized services. mined in § 483.126. If specialized serv-
(i) If a State mental health or intel- ices are also needed, the State is re-
lectual disability authority determines sponsible for providing or arranging for
NF needs by category, it may not the provision of the specialized serv-
waive the specialized services deter- ices.
mination. The appropriate State au- (2) Cannot be admitted to a NF. Any
thority must also determine whether applicant for admission to a NF who
specialized services are needed either has MI or IID and who does not require
by category (if permitted) or by indi- the level of services provided by a NF,
vidualized evaluations, as specified in regardless of whether specialized serv-
§ 483.134 or § 483.136. ices are also needed, is inappropriate
(j) Recording determinations. All deter- for NF placement and must not be ad-
minations made by the State mental mitted.
health and intellectual disability au- (3) Can be considered appropriate for
thority, regardless of how they are ar- continued placement in a NF. Any NF
rived at, must be recorded in the indi- resident with MI or IID who requires
vidual’s record. the level of services provided by a NF,
(k) Notice of determination. The State regardless of the length of his or her
mental health or intellectual disability stay or the need for specialized serv-
authority must notify in writing the ices, can continue to reside in the NF,
following entities of a determination if the placement is appropriate, as de-
made under this subpart: termined in § 483.126.
(4) May choose to remain in the NF
(1) The evaluated individual and his
even though the placement would other-
or her legal representative;
wise be inappropriate. Any NF resident
(2) The admitting or retaining NF;
with MI or IID who does not require
(3) The individual or resident’s at- the level of services provided by a NF
tending physician; and but does require specialized services
(4) The discharging hospital, unless and who has continuously resided in a
the individual is exempt from NF for at least 30 consecutive months
preadmission screening as provided for before the date of determination may
at § 483.106(b)(2). choose to continue to reside in the fa-
(l) Contents of notice. Each notice of cility or to receive covered services in
the determination made by the State an alternative appropriate institu-
mental health or intellectual disability tional or noninstitutional setting.
authority must include— Wherever the resident chooses to re-
(1) Whether a NF level of services is side, the State must meet his or her
needed; specialized services needs. The deter-
(2) Whether specialized services are mination notice must provide informa-
needed; tion concerning how, when, and by
(3) The placement options that are whom the various placement options
available to the individual consistent available to the resident will be fully
with these determinations; and explained to the resident.
122
(5) Cannot be considered appropriate for are performed in accordance with this
continued placement in a NF and must be subpart and subpart E.
discharged (short-term residents). Any NF [57 FR 56506, Nov. 30, 1992; 58 FR 25784, Apr.
resident with MI or IID who does not 28, 1993, as amended at 81 FR 68871, Oct. 4,
require the level of services provided 2016]
by a NF but does require specialized
services and who has resided in a NF § 483.132 Evaluating the need for NF
services and NF level of care
for less than 30 consecutive months (PASARR/NF).
must be discharged in accordance with
§ 483.15(b) to an appropriate setting (a) Basic rule. For each applicant for
where the State must provide special- admission to a NF and each NF resi-
ized services. The determination notice dent who has MI or IID, the evaluator
must assess whether—
must provide information on how,
(1) The individual’s total needs are
when, and by whom the resident will be
such that his or her needs can be met
advised of discharge arrangements and in an appropriate community setting;
of his/her appeal rights under both (2) The individual’s total needs are
PASARR and discharge provisions. such that they can be met only on an
(6) Cannot be considered appropriate for inpatient basis, which may include the
continued placement in a NF and must be option of placement in a home and
discharged (short or long-term residents). community-based services waiver pro-
Any NF resident with MI or IID who gram, but for which the inpatient care
does not require the level of services would be required;
provided by a NF and does not require (3) If inpatient care is appropriate
specialized services regardless of his or and desired, the NF is an appropriate
her length of stay, must be discharged institutional setting for meeting those
in accordance with § 483.15(b). The de- needs in accordance with § 483.126; or
termination notice must provide infor- (4) If the inpatient care is appro-
mation on how, when, and by whom the priate and desired but the NF is not the
resident will be advised of discharge ar- appropriate setting for meeting the in-
rangements and of his or her appeal dividual’s needs in accordance with
rights under both PASARR and dis- § 483.126, another setting such as an
charge provisions. ICF/IID (including small, community-
based facilities), an IMD providing
(n) Specialized services needed in a NF.
services to individuals aged 65 or older,
If a determination is made to admit or
or a psychiatric hospital is an appro-
allow to remain in a NF any individual priate institutional setting for meeting
who requires specialized services, the those needs.
determination must be supported by (b) Determining appropriate placement.
assurances that the specialized services In determining appropriate placement,
that are needed can and will be pro- the evaluator must prioritize the phys-
vided or arranged for by the State ical and mental needs of the individual
while the individual resides in the NF. being evaluated, taking into account
(o) Record retention. The State the severity of each condition.
PASARR system must maintain (c) Data. At a minimum, the data re-
records of evaluations and determina- lied on to make a determination must
tions, regardless of whether they are include:
performed categorically or individ- (1) Evaluation of physical status (for
ually, in order to support its deter- example, diagnoses, date of onset, med-
minations and actions and to protect ical history, and prognosis);
the appeal rights of individuals sub- (2) Evaluation of mental status (for
jected to PASARR; and example, diagnoses, date of onset, med-
(p) Tracking system. The State ical history, likelihood that the indi-
PASARR system must establish and vidual may be a danger to himself/her-
self or others); and
maintain a tracking system for all in-
(3) Functional assessment (activities
dividuals with MI or IID in NFs to en-
of daily living).
sure that appeals and future reviews (d) Based on the data compiled in
§ 483.132 and, as appropriate, in §§ 483.134
123
§ 483.134 42 CFR Ch. IV (10–1–24 Edition)
and 483.136, the State mental health or level of support can be provided to the
intellectual disability authority must individual in an alternative commu-
determine whether an NF level of serv- nity setting or whether the level of
ices is needed. support needed is such that NF place-
ment is required.
§ 483.134 Evaluating whether an indi- (6) The functional assessment must
vidual with mental illness requires address the following areas: Self-moni-
specialized services (PASARR/MI). toring of health status, self-admin-
(a) Purpose. The purpose of this sec- istering and scheduling of medical
tion is to identify the minimum data treatment, including medication com-
needs and process requirements for the pliance, or both, self-monitoring of nu-
State mental health authority, which tritional status, handling money,
is responsible for determining whether dressing appropriately, and grooming.
or not the applicant or resident with (c) Personnel requirements. (1) If the
MI, as defined in § 483.102(b)(1) of this history and physical examination are
part, needs a specialized services pro- not performed by a physician, then a
gram for mental illness as defined in physician must review and concur with
§ 483.120. the conclusions.
(b) Data. Minimum data collected (2) The State may designate the men-
must include—(1) A comprehensive his- tal health professionals who are quali-
tory and physical examination of the fied—
person. The following areas must be in- (i) To perform the evaluations re-
cluded (if not previously addressed): quired under paragraph (b) (2)–(6) of
(i) Complete medical history; this section including the—
(ii) Review of all body systems; (A) Comprehensive drug history;
(iii) Specific evaluation of the per- (B) Psychosocial evaluation;
son’s neurological system in the areas (C) Comprehensive psychiatric eval-
of motor functioning, sensory func- uation;
tioning, gait, deep tendon reflexes, cra- (D) Functional assessment; and
nial nerves, and abnormal reflexes; and (ii) To make the determination re-
(iv) In case of abnormal findings quired in paragraph (d) of this section.
which are the basis for an NF place- (d) Data interpretation. Based on the
ment, additional evaluations con- data compiled, a qualified mental
ducted by appropriate specialists. health professional, as designated by
the State, must validate the diagnosis
(2) A comprehensive drug history in-
of mental illness and determine wheth-
cluding current or immediate past use
er a program of psychiatric specialized
of medications that could mask symp-
services is needed.
toms or mimic mental illness.
(3) A psychosocial evaluation of the § 483.136 Evaluating whether an indi-
person, including current living ar- vidual with intellectual disability
rangements and medical and support requires specialized services
systems. (PASARR/IID).
(4) A comprehensive psychiatric eval- (a) Purpose. The purpose of this sec-
uation including a complete psy- tion is to identify the minimum data
chiatric history, evaluation of intellec- needs and process requirements for the
tual functioning, memory functioning, State intellectual disability authority
and orientation, description of current to determine whether or not the appli-
attitudes and overt behaviors, affect, cant or resident with intellectual dis-
suicidal or homicidal ideation, para- ability, as defined in § 483.102(b)(3) of
noia, and degree of reality testing this part, needs a continuous special-
(presence and content of delusions) and ized services program, which is analo-
hallucinations. gous to active treatment, as defined in
(5) A functional assessment of the in- § 435.1010 of this chapter and § 483.440.
dividual’s ability to engage in activi- (b) Data. Minimum data collected
ties of daily living and the level of sup- must include the individual’s com-
port that would be needed to assist the prehensive history and physical exam-
individual to perform these activities ination results to identify the fol-
while living in the community. The as- lowing information or, in the absence
sessment must determine whether this of data, must include information that
124
permits a reviewer specifically to as- care of clothing, and orientation skills

sess: (for individuals with visual impair-
(1) The individual’s medical prob- ments);
lems; (13) Vocational development, includ-
(2) The level of impact these prob- ing present vocational skills;
lems have on the individual’s inde- (14) Affective development such as in-
pendent functioning; terests, and skills involved with ex-
(3) All current medications used by pressing emotions, making judgments,
the individual and the current response and making independent decisions; and
of the individual to any prescribed (15) The presence of identifiable
medications in the following drug maladaptive or inappropriate behaviors
groups: of the individual based on systematic
(i) Hypnotics, observation (including, but not limited
(ii) Antipsychotics (neuroleptics), to, the frequency and intensity of iden-
(iii) Mood stabilizers and tified maladaptive or inappropriate be-
antidepressants, haviors).
(iv) Antianxiety-sedative agents, and (c) Data interpretation—(1) The State
(v) Anti-Parkinson agents. must ensure that a licensed psycholo-
(4) Self-monitoring of health status; gist identifies the intellectual func-
(5) Self-administering and scheduling tioning measurement of individuals
of medical treatments; with IID or a related condition.
(6) Self-monitoring of nutritional (2) Based on the data compiled in
status; paragraph (b) of this section, the State
(7) Self-help development such as intellectual disability authority, using
toileting, dressing, grooming, and eat- appropriate personnel, as designated by
ing; the State, must validate that the indi-
(8) Sensorimotor development, such vidual has IID or is a person with a re-
as ambulation, positioning, transfer lated condition and must determine
skills, gross motor dexterity, visual whether specialized services for intel-
motor perception, fine motor dexterity, lectual disability are needed. In mak-
eye-hand coordination, and extent to ing this determination, the State intel-
which prosthetic, orthotic, corrective lectual disability authority must make
or mechanical supportive devices can a qualitative judgment on the extent
improve the individual’s functional ca- to which the person’s status reflects,
pacity; singly and collectively, the character-
(9) Speech and language (communica- istics commonly associated with the
tion) development, such as expressive need for specialized services, includ-
language (verbal and nonverbal), recep- ing—
tive language (verbal and nonverbal), (i) Inability to—
extent to which non-oral communica- (A) Take care of the most personal
tion systems can improve the individ- care needs;
ual’s function capacity, auditory func- (B) Understand simple commands;
tioning, and extent to which amplifi- (C) Communicate basic needs and
cation devices (for example, hearing wants;
aid) or a program of amplification can (D) Be employed at a productive wage
improve the individual’s functional ca- level without systematic long term su-
pacity; pervision or support;
(10) Social development, such as (E) Learn new skills without aggres-
interpersonal skills, recreation-leisure sive and consistent training;
skills, and relationships with others; (F) Apply skills learned in a training
(11) Academic/educational develop- situation to other environments or set-
ment, including functional learning tings without aggressive and con-
skills; sistent training;
(12) Independent living development (G) Demonstrate behavior appro-
such as meal preparation, budgeting priate to the time, situation or place
and personal finances, survival skills, without direct supervision; and
mobility skills (orientation to the (H) Make decisions requiring in-
neighborhood, town, city), laundry, formed consent without extreme dif-
housekeeping, shopping, bedmaking, ficulty;
125
§ 483.138 42 CFR Ch. IV (10–1–24 Edition)
(ii) Demonstration of severe the State if he or she successfully com-

maladaptive behavior(s) that place the pleted a training and competency eval-
person or others in jeopardy to health uation program before July 1, 1989 if—
and safety; and (1) The aide would have satisfied this
(iii) Presence of other skill deficits or requirement if—
specialized training needs that neces- (i) At least 60 hours were substituted
sitate the availability of trained IID for 75 hours in sections 1819(f)(2) and
personnel, 24 hours per day, to teach 1919(f)(2) of the Act, and
the person functional skills. (ii) The individual has made up at
[57 FR 56506, Nov. 30, 1992; 58 FR 25784, Apr.
least the difference in the number of
28, 1993, as amended at 71 FR 39229, July 12, hours in the program he or she com-
2006] pleted and 75 hours in supervised prac-
tical nurse aide training or in regular
§ 483.138 Maintenance of services and in-service nurse aide education;
availability of FFP. or
(a) Maintenance of services. If a NF (2) The individual was found to be
mails a 30 day notice of its intent to competent (whether or not by the
transfer or discharge a resident, under State) after the completion of nurse
§ 483.15(b) of this chapter, the agency aide training of at least 100 hours dura-
may not terminate or reduce services tion.
until— (c) Waiver of requirements. A State
(1) The expiration of the notice pe- may—
riod; or (1) Waive the requirement for an indi-
(2) A subpart E appeal, if one has vidual to complete a competency eval-
been filed, has been resolved. uation program approved by the State
(b) Availability of FFP. FFP is avail- for any individual who can dem-
able for expenditures for services pro- onstrate to the satisfaction of the
vided to Medicaid beneficiaries dur- State that he or she has served as a
ing— nurse aide at one or more facilities of
(1) The 30 day notice period specified the same employer in the state for at
in § 483.15(b) of this chapter; or least 24 consecutive months before De-
(2) During the period an appeal is in cember 19, 1989; or
progress. (2) Deem an individual to have com-
[57 FR 56506, Nov. 30, 1992, as amended at 81 pleted a nurse aide training and com-
FR 68871, Oct. 4, 2016] petency evaluation program approved
by the State if the individual com-
Subpart D—Requirements That pleted, before July 1, 1989, such a pro-
gram that the State determines would
Must Be Met by States and have met the requirements for ap-
State Agencies: Nurse Aide proval at the time it was offered.
Training and Competency
[56 FR 48919, Sept. 26, 1991; 56 FR 59331, Nov.
Evaluation, and Paid Feeding 25, 1991, as amended at 60 FR 50443, Sept. 29,
Assistants 1995; 75 FR 21179, Apr. 23, 2010]
SOURCE: 56 FR 48919, Sept. 26, 1991, unless § 483.151 State review and approval of
otherwise noted. nurse aide training and competency
evaluation programs.
§ 483.150 Statutory basis; Deemed (a) State review and administration. (1)
meeting or waiver of requirements. The State—
(a) Statutory basis. This subpart is (i) Must specify any nurse aide train-
based on sections 1819(b)(5), 1819(f)(2), ing and competency evaluation pro-
1919(b)(5), and 1919(f)(2) of the Act, grams that the State approves as meet-
which establish standards for training ing the requirements of § 483.152 and/or
nurse-aides and for evaluating their competency evaluations programs that
competency. the State approves as meeting the re-
(b) Deemed meeting of requirements. A quirements of § 483.154; and
nurse aide is deemed to satisfy the re- (ii) May choose to offer a nurse aide
quirement of completing a training and training and competency evaluation
competency evaluation approved by program that meets the requirements
126
of § 483.152 and/or a competency evalua- Act of not less than $5,000 as adjusted
tion program that meets the require- annually under 45 CFR part 102; or
ments of § 483.154. (v) Has been subject to a remedy de-
(2) If the State does not choose to scribed in sections 1819(h)(2)(B) (i) or
offer a nurse aide training and com- (iii), 1819(h)(4), 1919(h)(1)(B)(i), or
petency evaluation program or com- 1919(h)(2)(A) (i), (iii) or (iv) of the Act.
petency evaluation program, the State (3) A State may not, until two years
must review and approve or disapprove since the assessment of the penalty (or
nurse aide training and competency penalties) has elapsed, approve a nurse
evaluation programs and nurse aide aide training and competency evalua-
competency evaluation programs upon tion program or competency evalua-
request. tion program offered by or in a facility
(3) The State survey agency must in that, within the two-year period begin-
the course of all surveys, determine ning October 1, 1988—
whether the nurse aide training and (i) Had its participation terminated
competency evaluation requirements under title XVIII of the Act or under
of §§ 483.35(c) and (d) and 483.95(g) are the State plan under title XIX of the
met. Act;
(b) Requirements for approval of pro- (ii) Was subject to a denial of pay-
grams. (1) Before the State approves a ment under title XVIII or title XIX;
nurse aide training and competency (iii) Was assessed a civil money pen-
evaluation program or competency alty of not less than $5,000 as adjusted
evaluation program, the State must— annually under 45 CFR part 102 for defi-
(i) Determine whether the nurse aide ciencies in nursing facility standards;
training and competency evaluation (iv) Operated under temporary man-
program meets the course require- agement appointed to oversee the oper-
ments of § 483.152: ation of the facility and to ensure the
(ii) Determine whether the nurse aide health and safety of its residents; or
competency evaluation program meets (v) Pursuant to State action, was
the requirements of § 483.154; and closed or had its residents transferred.
(iii) In all reviews other than the ini- (c) Waiver of disapproval of nurse aide
tial review, visit the entity providing training programs. (1) A facility may re-
the program. quest that CMS waive the disapproval
(2) The State may not approve a of its nurse aide training program
nurse aide training and competency when the facility has been assessed a
evaluation program or competency civil money penalty of not less than
evaluation program offered by or in a $5,000 as adjusted annually under 45
facility which, in the previous two CFR part 102 if the civil money penalty
years— was not related to the quality of care
(i) In the case of a skilled nursing fa- furnished to residents in the facility.
cility, has operated under a waiver (2) For purposes of this provision,
under section 1819(b)(4)(C)(ii)(II) of the ‘‘quality of care furnished to residents’’
Act; means the direct hands-on care and
(ii) In the case of a nursing facility, treatment that a health care profes-
has operated under a waiver under sec- sional or direct care staff furnished to
tion 1919(b)(4)(C)(ii) of the Act that was a resident.
granted on the basis of a demonstra- (3) Any waiver of disapproval of a
tion that the facility is unable to pro- nurse aide training program does not
vide nursing care required under sec- waive any requirement upon the facil-
tion 1919(b)(4)(C)(i) of the Act for a pe- ity to pay any civil money penalty.
riod in excess of 48 hours per week; (d) Time frame for acting on a request
(iii) Has been subject to an extended for approval. The State must, within 90
(or partial extended) survey under sec- days of the date of a request under
tions 1819(g)(2)(B)(i) or 1919(g)(2)(B)(i) paragraph (a)(3) of this section or re-
of the Act; ceipt of additional information from
(iv) Has been assessed a civil money the requester—
penalty described in section (1) Advise the requester whether or
1819(h)(2)(B)(ii) of 1919(h)(2)(A)(ii) of the not the program has been approved; or
127
§ 483.152 42 CFR Ch. IV (10–1–24 Edition)
(2) Request additional information (2) Include at least the subjects speci-
form the requesting entity. fied in paragraph (b) of this section;
(e) Duration of approval. The State (3) Include at least 16 hours of super-
may not grant approval of a nurse aide vised practical training. Supervised
training and competency evaluation practical training means training in a
program for a period longer than 2 laboratory or other setting in which
years. A program must notify the the trainee demonstrates knowledge
State and the State must review that while performing tasks on an indi-
program when there are substantive vidual under the direct supervision of a
changes made to that program within registered nurse or a licensed practical
the 2-year period. nurse;
(f) Withdrawal of approval. (1) The (4) Ensure that—
State must withdraw approval of a (i) Students do not perform any serv-
nurse aide training and competency ices for which they have not trained
evaluation program or nurse aide com- and been found proficient by the in-
petency evaluation program offered by structor; and
or in a facility described in paragraph
(ii) Students who are providing serv-
(b)(2) of this section.
ices to residents are under the general
(2) The State may withdraw approval supervision of a licensed nurse or a reg-
of a nurse aide training and com- istered nurse;
petency evaluation program or nurse
(5) Meet the following requirements
aide competency evaluation program if
for instructors who train nurse aides;
the State determines that any of the
applicable requirements of § 483.152 or (i) The training of nurse aides must
§ 483.154 are not met by the program. be performed by or under the general
(3) The State must withdraw ap- supervision of a registered nurse who
proval of a nurse aide training and possesses a minimum of 2 years of
competency evaluation program or a nursing experience, at least 1 year of
nurse aide competency evaluation pro- which must be in the provision of long
gram if the entity providing the pro- term care facility services;
gram refuses to permit unannounced (ii) Instructors must have completed
visits by the State. a course in teaching adults or have ex-
(4) If a State withdraws approval of a perience in teaching adults or super-
nurse aide training and competency vising nurse aides;
evaluation program or competency (iii) In a facility-based program, the
evaluation program— training of nurse aides may be per-
(i) The State must notify the pro- formed under the general supervision
gram in writing, indicating the rea- of the director of nursing for the facil-
son(s) for withdrawal of approval of the ity who is prohibited from performing
program. the actual training; and
(ii) Students who have started a (iv) Other personnel from the health
training and competency evaluation professions may supplement the in-
program from which approval has been structor, including, but not limited to,
withdrawn must be allowed to com- registered nurses, licensed practical/vo-
plete the course. cational nurses, pharmacists, dieti-
tians, social workers, sanitarians, fire
FR 21179, Apr. 23, 2010; 81 FR 61563, Sept. 6, safety experts, nursing home adminis-
2016; 81 FR 68871, Oct. 4, 2016] trators, gerontologists, psychologists,
physical and occupational therapists,
§ 483.152 Requirements for approval of activities specialists, speech/language/
a nurse aide training and com- hearing therapists, and resident rights
petency evaluation program. experts. Supplemental personnel must
(a) For a nurse aide training and have at least 1 year of experience in
competency evaluation program to be their fields;
approved by the State, it must, at a (6) Contain competency evaluation
minimum— procedures specified in § 483.154.
(1) Consist of no less than 75 clock (b) The curriculum of the nurse aide
hours of training; training program must include—
128
(1) At least a total of 16 hours of (iii) Understanding the behavior of

training in the following areas prior to cognitively impaired residents;
any direct contact with a resident: (iv) Appropriate responses to the be-
(i) Communication and interpersonal havior of cognitively impaired resi-
skills; dents; and
(ii) Infection control; (v) Methods of reducing the effects of
(iii) Safety/emergency procedures, in- cognitive impairments.
cluding the Heimlich maneuver; (6) Basic restorative services:
(iv) Promoting residents’ independ- (i) Training the resident in self care
ence; and according to the resident’s abilities;
(v) Respecting residents’ rights. (ii) Use of assistive devices in trans-
(2) Basic nursing skills; ferring, ambulation, eating, and dress-
(i) Taking and recording vital signs; ing;
(ii) Measuring and recording height (iii) Maintenance of range of motion;
and weight; (iv) Proper turning and positioning in
(iii) Caring for the residents’ environ- bed and chair;
ment; (v) Bowel and bladder training; and
(iv) Recognizing abnormal changes in (vi) Care and use of prosthetic and
body functioning and the importance of orthotic devices.
reporting such changes to a supervisor; (7) Residents’ Rights.
and (i) Providing privacy and mainte-
(v) Caring for residents when death is nance of confidentiality;
imminent. (ii) Promoting the residents’ right to
(3) Personal care skills, including, make personal choices to accommodate
but not limited to— their needs;
(iii) Giving assistance in resolving
(i) Bathing;
grievances and disputes;
(ii) Grooming, including mouth care;
(iv) Providing needed assistance in
(iii) Dressing;
getting to and participating in resident
(iv) Toileting; and family groups and other activities;
(v) Assisting with eating and hydra- (v) Maintaining care and security of
tion; residents’ personal possessions;
(vi) Proper feeding techniques; (vi) Promoting the resident’s right to
(vii) Skin care; and be free from abuse, mistreatment, and
(viii) Transfers, positioning, and neglect and the need to report any in-
turning. stances of such treatment to appro-
(4) Mental health and social service priate facility staff;
needs: (vii) Avoiding the need for restraints
(i) Modifying aide’s behavior in rein accordance with current professional
sponse to residents’ behavior; standards.
(ii) Awareness of developmental (c) Prohibition of charges. (1) No
tasks associated with the aging proc- nurse aide who is employed by, or who
ess; has received an offer of employment
(iii) How to respond to resident be- from, a facility on the date on which
havior; the aide begins a nurse aide training
(iv) Allowing the resident to make and competency evaluation program
personal choices, providing and rein- may be charged for any portion of the
forcing other behavior consistent with program (including any fees for text-
the resident’s dignity; and books or other required course mate-
(v) Using the resident’s family as a rials).
source of emotional support. (2) If an individual who is not em-
(5) Care of cognitively impaired resi- ployed, or does not have an offer to be
dents: employed, as a nurse aide becomes em-
(i) Techniques for addressing the ployed by, or receives an offer of em-
unique needs and behaviors of indi- ployment from, a facility not later
vidual with dementia (Alzheimer’s and than 12 months after completing a
others); nurse aide training and competency
(ii) Communicating with cognitively evaluation program, the State must
impaired residents; provide for the reimbursement of costs
129
§ 483.154 42 CFR Ch. IV (10–1–24 Edition)
incurred in completing the program on ployment from, a facility not later

a pro rata basis during the period in than 12 months after completing a
which the individual is employed as a nurse aide competency evaluation pro-
nurse aide. gram, the State must provide for the
reimbursement of costs incurred in
§ 483.154 Nurse aide competency eval- completing the program on a pro rata
uation. basis during the period in which the in-
(a) Notification to Individual. The dividual is employed as a nurse aide.
State must advise in advance any indi- (4) The skills demonstration part of
vidual who takes the competency eval- the evaluation must be—
uation that a record of the successful (i) Performed in a facility or labora-
completion of the evaluation will be in- tory setting comparable to the setting
cluded in the State’s nurse aid reg- in which the individual will function as
istry. a nurse aide; and
(b) Content of the competency evalua- (ii) Administered and evaluated by a
tion program—(1) Written or oral exami- registered nurse with at least one
nations. The competency evaluation year’s experience in providing care for
must— the elderly or the chronically ill of any
(i) Allow an aide to choose between a age.
written and an oral examination; (d) Facility proctoring of the com-
(ii) Address each course requirement petency evaluation. (1) The competency
specified in § 483.152(b); evaluation may, at the nurse aide’s op-
(iii) Be developed from a pool of test tion, be conducted at the facility in
questions, only a portion of which is which the nurse aide is or will be em-
used in any one examination; ployed unless the facility is described
(iv) Use a system that prevents dis- in § 483.151(b)(2).
closure of both the pool of questions (2) The State may permit the com-
and the individual competency evalua- petency evaluation to be proctored by
tions; and facility personnel if the State finds
(v) If oral, must be read from a pre- that the procedure adopted by the fa-
pared text in a neutral manner. cility assures that the competency
(2) Demonstration of skills. The skills evaluation program—
demonstration must consist of a dem- (i) Is secure from tampering;
onstration of randomly selected items (ii) Is standardized and scored by a
drawn from a pool consisting of the testing, educational, or other organiza-
tasks generally performed by nurse tion approved by the State; and
aides. This pool of skills must include (iii) Requires no scoring by facility
all of the personal care skills listed in personnel.
§ 483.152(b)(3). (3) The State must retract the right
(c) Administration of the competency to proctor nurse aide competency eval-
evaluation. (1) The competency exam- uations from facilities in which the
ination must be administered and eval- State finds any evidence of impro-
uated only by— priety, including evidence of tampering
(i) The State directly; or by facility staff.
(ii) A State approved entity which is (e) Successful completion of the com-
neither a skilled nursing facility that petency evaluation program. (1) The
participates in Medicare nor a nursing State must establish a standard for
facility that participates in Medicaid. satisfactory completion of the com-
(2) No nurse aide who is employed by, petency evaluation. To complete the
or who has received an offer of employ- competency evaluation successfully an
ment from, a facility on the date on individual must pass both the written
which the aide begins a nurse aide com- or oral examination and the skills dem-
petency evaluation program may be onstration.
charged for any portion of the pro- (2) A record of successful completion
gram. of the competency evaluation must be
(3) If an individual who is not em- included in the nurse aide registry pro-
ployed, or does not have an offer to be vided in § 483.156 within 30 days of the
employed, as a nurse aide becomes em- date if the individual is found to be
ployed by, or receives an offer of em- competent.
130
(f) Unsuccessful completion of the com- these requirements waived by the

petency evaluation program. (1) If the in- State do not qualify to remain on the
dividual does not complete the evalua- registry because they have performed
tion satisfactorily, the individual must no nursing or nursing-related services
be advised— for a period of 24 consecutive months.
(i) Of the areas which he or she; did (4) The State may not impose any
not pass; and charges related to registration on indi-
(ii) That he or she has at least three viduals listed in the registry.
opportunities to take the evaluation. (5) The State must provide informa-
(2) The State may impose a max- tion on the registry promptly.
imum upon the number of times an in- (c) Registry Content. (1) The registry
dividual upon the number of times an must contain at least the following in-
individual may attempt to complete formation on each individual who has
the competency evaluation success- successfully completed a nurse aide
fully, but the maximum may be no less training and competency evaluation
than three. program which meets the requirements
of § 483.152 or a competency evaluation
§ 483.156 Registry of nurse aides. which meets the requirements of
(a) Establishment of registry. The State § 483.154 and has been found by the
must establish and maintain a registry State to be competent to function as a
of nurse aides that meets the require- nurse aide or who may function as a
ment of this section. The registry— nurse aide because of meeting criteria
(1) Must include as a minimum the in § 483.150:
information contained in paragraph (c) (i) The individual’s full name.
of this section: (ii) Information necessary to identify
(2) Must be sufficiently accessible to each individual;
meet the needs of the public and health (iii) The date the individual became
care providers promptly; eligible for placement in the registry
(3) May include home health aides through successfully completing a
who have successfully completed a nurse aide training and competency
home health aide competency evalua- evaluation program or competency
tion program approved by the State if evaluation program or by meeting the
home health aides are differentiated requirements of § 483.150; and
from nurse aides; and (iv) The following information on any
(4) Must provide that any response to finding by the State survey agency of
an inquiry that includes a finding of abuse, neglect, or misappropriation of
abuse, neglect, or misappropriation of property by the individual:
property also include any statement (A) Documentation of the State’s in-
disputing the finding made by the vestigation, including the nature of the
nurse aide, as provided under para- allegation and the evidence that led
graph (c)(1)(ix) of this section. the State to conclude that the allega-
(b) Registry operation. (1) The State tion was valid;
may contract the daily operation and (B) The date of the hearing, if the in-
maintenance of the registry to a non- dividual chose to have one, and its out-
State entity. However, the State must come; and
maintain accountability for overall op- (C) A statement by the individual
eration of the registry and compliance disputing the allegation, if he or she
with these regulations. chooses to make one; and
(2) Only the State survey and certifi- (D) This information must be in-
cation agency may place on the reg- cluded in the registry within 10 work-
istry findings of abuse, neglect, or mis- ing days of the finding and must re-
appropriation of property. main in the registry permanently, un-
(3) The State must determine which less the finding was made in error, the
individuals who (i) have successfully individual was found not guilty in a
completed a nurse aide training and court of law, or the State is notified of
competency evaluation program or the individual’s death.
nurse aide competency evaluation pro- (2) The registry must remove entries
gram; (ii) have been deemed as meeting for individuals who have performed no
these requirements; or (iii) have had nursing or nursing-related services for
131
§ 483.158 42 CFR Ch. IV (10–1–24 Edition)
a period of 24 consecutive months, un- (2) Assistance with feeding and hy-
less the individual’s registry entry in- dration.
cludes documented findings of abuse, (3) Communication and interpersonal
neglect, or misappropriation of prop- skills.
erty. (4) Appropriate responses to resident
(d) Disclosure of information. The behavior.
State must— (5) Safety and emergency procedures,
(1) Disclose all of the information in including the Heimlich maneuver.
§ 483.156(c)(1) (iii) and (iv) to all re- (6) Infection control.
questers and may disclose additional (7) Resident rights.
information it deems necessary; and
(8) Recognizing changes in residents
(2) Promptly provide individuals with
that are inconsistent with their normal
all information contained in the reg-
behavior and the importance of report-
istry on them when adverse findings
ing those changes to the supervisory
are placed on the registry and upon re-
nurse.
quest. Individuals on the registry must
have sufficient opportunity to correct (b) Maintenance of records. A facility
any misstatements or inaccuracies must maintain a record of all individ-
contained in the registry. uals, used by the facility as feeding as-
sistants, who have successfully com-
[56 FR 48919, Sept. 26, 1991; 56 FR 59331, Nov. pleted the training course for paid
25, 1991] feeding assistants.
§ 483.158 FFP for nurse aide training [68 FR 55539, Sept. 26, 2003]
and competency evaluation.
(a) State expenditures for nurse aide Subpart E—Appeals of Dis-
training and competency evaluation charges, Transfers, and
programs and competency evaluation Preadmission Screening and
programs are administrative costs.
They are matched as indicated in
Annual Resident Review
§ 433.15(b)(8) of this chapter. (PASARR) Determinations
(b) FFP is available for State expend-
itures associated with nurse aide train- SOURCE: 57 FR 56514, Nov. 30, 1992, unless
ing and competency evaluation pro- otherwise noted.
grams and competency evaluation pro-
grams only for— § 483.200 Statutory basis.
(1) Nurse aides employed by a facil- This subpart is based on sections
ity; 1819(e)(3) and (f)(3) and 1919(e)(3) and
(2) Nurse aides who have an offer of (f)(3) of the Act, which require States
employment from a facility; to make available, to individuals who
(3) Nurse aides who become employed are discharged or transferred from
by a facility not later than 12 months SNFs or NFs, an appeals process that
after completing a nurse aide training complies with guidelines issued by the
and competency evaluation program or Secretary.
competency evaluation program; or
(4) Nurse aides who receive an offer of [60 FR 50443, Sept. 29, 1995]
employment from a facility not later
than 12 months after completing a
nurse aide training and competency For purposes of this subpart and sub-
evaluation program or competency parts B and C—
evaluation program. Discharge means movement from an
entity that participates in Medicare as
§ 483.160 Requirements for training of a skilled nursing facility, a Medicare
paid feeding assistants. certified distinct part, an entity that
(a) Minimum training course con- participates in Medicaid as a nursing
tents. A State-approved training facility, or a Medicaid certified dis-
course for paid feeding assistants must tinct part to a noninstitutional setting
include, at a minimum, 8 hours of when the discharging facility ceases to
training in the following: be legally responsible for the care of
(1) Feeding techniques. the resident.
132
Individual means an individual or any Subpart F—Requirements That

legal representative of the individual. Must be Met by States and
Resident means a resident of a SNF or State Agencies, Resident As-
NF or any legal representative of the
resident.
sessment
Transfer means movement from an § 483.315 Specification of resident as-
entity that participates in Medicare as sessment instrument.
a skilled nursing facility, a Medicare (a) Statutory basis. Sections 1819(e)(5)
certified distinct part, an entity that and 1919(e)(5) of the Act require that a
participates in Medicaid as a nursing State specify the resident assessment
facility or a Medicaid certified distinct instrument (RAI) to be used by long
part to another institutional setting term care facilities in the State when
when the legal responsibility for the conducting initial and periodic assess-
care of the resident changes from the ments of each resident’s functional ca-
transferring facility to the receiving pacity, in accordance with § 483.20.
facility. (b) State options in specifying an RAI.
The RAI that the State specifies must
§ 483.204 Provision of a hearing and
appeal system. be one of the following:
(1) The instrument designated by
(a) Each State must provide a system CMS.
for: (2) An alternate instrument specified
(1) A resident of a SNF or a NF to ap- by the State and approved by CMS,
peal a notice from the SNF or NF of in- using the criteria specified in the State
tent to discharge or transfer the resi- Operations Manual issued by CMS
dent; and (CMS Pub. 7) which is available for pur-
(2) An individual who has been ad- chase through the National Technical
versely affected by any PASARR deter- Information Service, 5285 Port Royal
mination made by the State in the con- Rd., Springfield, VA 22151.
text of either a preadmission screening (c) State requirements in specifying an
or an annual resident review under sub- RAI. (1) Within 30 days after CMS noti-
part C of part 483 to appeal that deter- fies the State of the CMS-designated
mination. RAI or changes to it, the State must do
(b) The State must provide an ap- one of the following:
peals system that meets the require- (i) Specify the CMS-designated RAI.
ments of this subpart, § 483.15(h), and (ii) Notify CMS of its intent to speci-
part 431 subpart E of this chapter. fy an alternate instrument.
(2) Within 60 days after receiving
[57 FR 56506, Nov. 30, 1992; 58 FR 25784, Apr.
CMS approval of an alternate RAI, the
28, 1993, as amended at 81 FR 68871, Oct. 4,
2016] State must specify the RAI for use by
all long term care facilities partici-
§ 483.206 Transfers, discharges and re- pating in the Medicare and Medicaid
locations subject to appeal. programs.
(3) After specifying an instrument,
(a) ‘‘Facility’’ means a certified enti-
the State must provide periodic edu-
ty, either a Medicare SNF or a Med-
cational programs for facility staff to
icaid NF (See § 483.5).
assist with implementation of the RAI.
(b) A resident has appeal rights when
(4) A State must audit implementa-
he or she is transferred from—
tion of the RAI through the survey
(1) A certified bed into a noncertified
process.
bed; and
(5) A State must obtain approval
(2) A bed in a certified entity to a bed from CMS before making any modifica-
in an entity which is certified as a dif- tions to its RAI.
ferent provider. (6) A State must adopt revisions to
(c) A resident has no appeal rights the RAI that are specified by CMS.
when he or she is moved from one bed (d) CMS-designated RAI. The CMS-
in the certified entity to another bed in designated RAI is published in the
the same certified entity. State Operations Manual issued by
[57 FR 56514, Nov. 30, 1992, as amended at 81 CMS (CMS Pub. 7), as updated periodi-
FR 68871, Oct. 4, 2016] cally, and consists of the following:
133
§ 483.350 42 CFR Ch. IV (10–1–24 Edition)
(1) The minimum data set (MDS) and poses directly related to the adminis-
common definitions. tration of the State Medicaid plan.
(2) Care area assessment (CAA) guide- (5) Transmission of data and reports
lines and care area triggers (CATs) to other entities only when authorized
that are necessary to accurately assess as a routine use by CMS.
residents, established by CMS. (j) Resident-identifiable data. (1) The
(3) The quarterly review, based on a State may not release information that
subset of the MDS specified by CMS. is resident-identifiable to the public.
(4) The requirements for use of the (2) The State may not release RAI
RAI that appear at § 483.20. data that is resident-identifiable ex-
(e) Minimum data set (MDS). The MDS cept in accordance with a written
includes assessment in the areas speci- agreement under which the beneficiary
fied in § 483.20(b)(i) through (xviii) of agrees to be bound by the restrictions
this chapter, and as defined in the RAI described in paragraph (i) of this sec-
manual published in the State Oper- tion.
ations Manual issued by CMS (CMS [62 FR 67212, Dec. 23, 1997, as amended at 74
Pub. 100–07). FR 40363, Aug. 11, 2009]
(f) [Reserved]
(g) Criteria for CMS approval of alter-
nate instrument. To receive CMS ap-
Subpart G—Condition of Partici-
proval, a State’s alternate instrument pation for the Use of Restraint
must use the standardized format, or- or Seclusion in Psychiatric
ganization, item labels and definitions, Residential Treatment Facili-
and instructions specified by CMS in ties Providing Inpatient Psy-
the latest issuance of the State Oper- chiatric Services for Individ-
ations Manual issued by CMS (CMS uals Under Age 21
Pub. 7).
(h) State MDS system and database re- SOURCE: 66 FR 7161, Jan. 22, 2001, unless
quirements. As part of facility agency otherwise noted.
responsibilities, the State Survey
Agency must: § 483.350 Basis and scope.
(1) Support and maintain the CMS (a) Statutory basis. Sections 1905(a)(16)
State system and database. and (h) of the Act provide that inpa-
(2) Specify to a facility the method of tient psychiatric services for individ-
transmission of data, and instruct the uals under age 21 include only inpa-
facility on this method. tient services that are provided in an
(3) Upon receipt of facility data from institution (or distinct part thereof)
CMS, ensure that a facility resolves er- that is a psychiatric hospital as defined
rors. in section 1861(f) of the Act or in an-
(4) Analyze data and generate re- other inpatient setting that the Sec-
ports, as specified by CMS. retary has specified in regulations. Ad-
(i) State identification of agency that ditionally, the Children’s Health Act of
receives RAI data. The State must iden- 2000 (Pub. L. 106–310) imposes proce-
tify the component agency that re- dural reporting and training require-
ceives RAI data, and ensure that this ments regarding the use of restraints
agency restricts access to the data ex- and involuntary seclusion in facilities,
cept for the following: specifically including facilities that
(1) Reports that contain no resident- provide inpatient psychiatric services
identifiable data. for children under the age of 21 as de-
(2) Transmission of reports to CMS. fined by sections 1905(a)(16) and (h) of
(3) Transmission of data and reports the Act.
to the State agency that conducts sur- (b) Scope. This subpart imposes re-
veys to ensure compliance with Medi- quirements regarding the use of re-
care and Medicaid participation restraint or seclusion in psychiatric resi-
quirements, for purposes related to this dential treatment facilities, that are
function. not hospitals, providing inpatient psy-
(4) Transmission of data and reports chiatric services to individuals under
to the State Medicaid agency for pur- age 21.
134
§ 483.352 Definitions. or an area from which the resident is

For purposes of this subpart, the fol- physically prevented from leaving.
lowing definitions apply: Serious injury means any significant
Drug used as a restraint means any impairment of the physical condition
drug that— of the resident as determined by quali-
(1) Is administered to manage a resi- fied medical personnel. This includes,
dent’s behavior in a way that reduces but is not limited to, burns, lacera-
the safety risk to the resident or oth- tions, bone fractures, substantial he-
ers; matoma, and injuries to internal or-
(2) Has the temporary effect of re- gans, whether self-inflicted or inflicted
stricting the resident’s freedom of by someone else.
movement; and Staff means those individuals with re-
(3) Is not a standard treatment for sponsibility for managing a resident’s
the resident’s medical or psychiatric health or participating in an emer-
condition. gency safety intervention and who are
Emergency safety intervention means employed by the facility on a full-time,
the use of restraint or seclusion as an part-time, or contract basis.
immediate response to an emergency Time out means the restriction of a
safety situation. resident for a period of time to a des-
Emergency safety situation means un- ignated area from which the resident is
anticipated resident behavior that not physically prevented from leaving,
places the resident or others at serious for the purpose of providing the resi-
threat of violence or injury if no inter- dent an opportunity to regain self-con-
vention occurs and that calls for an trol.
emergency safety intervention as de-
[66 FR 7161, Jan. 22, 2001, as amended at 66
fined in this section. FR 28116, May 22, 2001]
Mechanical restraint means any device
attached or adjacent to the resident’s § 483.354 General requirements for
body that he or she cannot easily re- psychiatric residential treatment
move that restricts freedom of move- facilities.
ment or normal access to his or her A psychiatric residential treatment
body. facility must meet the requirements in
Minor means a minor as defined
§ 441.151 through § 441.182 of this chap-
under State law and, for the purpose of
ter.
this subpart, includes a resident who
has been declared legally incompetent § 483.356 Protection of residents.
by the applicable State court.
Personal restraint means the applica- (a) Restraint and seclusion policy for
tion of physical force without the use the protection of residents. (1) Each resi-
of any device, for the purposes of re- dent has the right to be free from re-
straining the free movement of a resi- straint or seclusion, of any form, used
dent’s body. The term personal reas a means of coercion, discipline, con-
straint does not include briefly holding venience, or retaliation.
without undue force a resident in order (2) An order for restraint or seclusion
to calm or comfort him or her, or hold- must not be written as a standing order
ing a resident’s hand to safely escort a or on an as-needed basis.
resident from one area to another. (3) Restraint or seclusion must not
Psychiatric Residential Treatment Fa- result in harm or injury to the resident
cility means a facility other than a hos- and must be used only—
pital, that provides psychiatric serv- (i) To ensure the safety of the resi-
ices, as described in subpart D of part dent or others during an emergency
441 of this chapter, to individuals under safety situation; and
age 21, in an inpatient setting. (ii) Until the emergency safety situa-
Restraint means a ‘‘personal re- tion has ceased and the resident’s safe-
straint,’’ ‘‘mechanical restraint,’’ or ty and the safety of others can be en-
‘‘drug used as a restraint’’ as defined in sured, even if the restraint or seclusion
this section. order has not expired.
Seclusion means the involuntary con- (4) Restraint and seclusion must not
finement of a resident alone in a room be used simultaneously.
135
§ 483.358 42 CFR Ch. IV (10–1–24 Edition)
(b) Emergency safety intervention. An provided under the direction of a physi-

emergency safety intervention must be cian.
performed in a manner that is safe, (b) If the resident’s treatment team
proportionate, and appropriate to the physician is available, only he or she
severity of the behavior, and the resi- can order restraint or seclusion.
dent’s chronological and develop- (c) A physician or other licensed
mental age; size; gender; physical, practitioner permitted by the state and
medical, and psychiatric condition; and the facility to order restraint or seclu-
personal history (including any history sion must order the least restrictive
of physical or sexual abuse). emergency safety intervention that is
(c) Notification of facility policy. At ad- most likely to be effective in resolving
mission, the facility must— the emergency safety situation based
(1) Inform both the incoming resident on consultation with staff.
and, in the case of a minor, the resi- (d) If the order for restraint or seclu-
dent’s parent(s) or legal guardian(s) of sion is verbal, the verbal order must be
the facility’s policy regarding the use received by a registered nurse or other
of restraint or seclusion during an licensed staff such as a licensed prac-
emergency safety situation that may tical nurse, while the emergency safety
occur while the resident is in the pro- intervention is being initiated by staff
gram; or immediately after the emergency
(2) Communicate its restraint and se- safety situation ends. The physician or
clusion policy in a language that the other licensed practitioner permitted
resident, or his or her parent(s) or legal by the state and the facility to order
guardian(s) understands (including restraint or seclusion must verify the
American Sign Language, if appro- verbal order in a signed written form in
priate) and when necessary, the facility the resident’s record. The physician or
must provide interpreters or trans- other licensed practitioner permitted
lators; by the state and the facility to order
(3) Obtain an acknowledgment, in restraint or seclusion must be avail-
writing, from the resident, or in the able to staff for consultation, at least
case of a minor, from the parent(s) or by telephone, throughout the period of
legal guardian(s) that he or she has the emergency safety intervention.
been informed of the facility’s policy (e) Each order for restraint or seclu-
on the use of restraint or seclusion dur- sion must:
ing an emergency safety situation. (1) Be limited to no longer than the
Staff must file this acknowledgment in duration of the emergency safety situa-
the resident’s record; and tion; and
(4) Provide a copy of the facility pol- (2) Under no circumstances exceed 4
icy to the resident and in the case of a hours for residents ages 18 to 21; 2
minor, to the resident’s parent(s) or hours for residents ages 9 to 17; or 1
legal guardian(s). hour for residents under age 9.
(d) Contact information. The facility’s (f) Within 1 hour of the initiation of
policy must provide contact informa- the emergency safety intervention a
tion, including the phone number and physician, or other licensed practi-
mailing address, for the appropriate tioner trained in the use of emergency
State Protection and Advocacy organi- safety interventions and permitted by
zation. the state and the facility to assess the
physical and psychological well being
§ 483.358 Orders for the use of re- of residents, must conduct a face-to-
straint or seclusion. face assessment of the physical and
(a) Orders for restraint or seclusion psychological well being of the resi-
must be by a physician, or other li- dent, including but not limited to—
censed practitioner permitted by the (1) The resident’s physical and psy-
State and the facility to order re- chological status;
straint or seclusion and trained in the (2) The resident’s behavior;
use of emergency safety interventions. (3) The appropriateness of the inter-
Federal regulations at 42 CFR 441.151 vention measures; and
require that inpatient psychiatric serv- (4) Any complications resulting from
ices for beneficiaries under age 21 be the intervention.
136
(g) Each order for restraint or seclu- dent’s treatment team physician. The
sion must include— person ordering the use of restraint or
(1) The name of the ordering physi- seclusion must—
cian or other licensed practitioner per- (a) Consult with the resident’s treat-
mitted by the state and the facility to ment team physician as soon as pos-
order restraint or seclusion; sible and inform the team physician of
(2) The date and time the order was the emergency safety situation that re-
obtained; and quired the resident to be restrained or
(3) The emergency safety interven- placed in seclusion; and
tion ordered, including the length of (b) Document in the resident’s record
time for which the physician or other the date and time the team physician
licensed practitioner permitted by the was consulted.
state and the facility to order restraint
or seclusion authorized its use. [66 FR 7161, Jan. 22, 2001, as amended at 66
FR 28117, May 22, 2001]
(h) Staff must document the inter-
vention in the resident’s record. That § 483.362 Monitoring of the resident in
documentation must be completed by and immediately after restraint.
the end of the shift in which the inter-
vention occurs. If the intervention does (a) Clinical staff trained in the use of
not end during the shift in which it emergency safety interventions must
began, documentation must be com- be physically present, continually as-
pleted during the shift in which it ends. sessing and monitoring the physical
Documentation must include all of the and psychological well-being of the
following: resident and the safe use of restraint
(1) Each order for restraint or seclu- throughout the duration of the emer-
sion as required in paragraph (g) of this gency safety intervention.
section. (b) If the emergency safety situation
(2) The time the emergency safety continues beyond the time limit of the
intervention actually began and ended. order for the use of restraint, a reg-
(3) The time and results of the 1-hour istered nurse or other licensed staff,
assessment required in paragraph (f) of such as a licensed practical nurse,
this section. must immediately contact the ordering
(4) The emergency safety situation physician or other licensed practi-
that required the resident to be re- tioner permitted by the state and the
strained or put in seclusion. facility to order restraint or seclusion
(5) The name of staff involved in the to receive further instructions.
emergency safety intervention. (c) A physician, or other licensed
(i) The facility must maintain a practitioner permitted by the state and
record of each emergency safety situa- the facility to evaluate the resident’s
tion, the interventions used, and their well-being and trained in the use of
outcomes. emergency safety interventions, must
(j) The physician or other licensed evaluate the resident’s well-being im-
practitioner permitted by the state and mediately after the restraint is re-
the facility to order restraint or seclu- moved.
sion must sign the restraint or seclu- [66 FR 7161, Jan. 22, 2001, as amended at 66
sion order in the resident’s record as FR 28117, May 22, 2001]
soon as possible.
§ 483.364 Monitoring of the resident in
FR 28116, May 22, 2001]
and immediately after seclusion.
(a) Clinical staff, trained in the use of
§ 483.360 Consultation with treatment emergency safety interventions, must
team physician. be physically present in or imme-
If a physician or other licensed prac- diately outside the seclusion room,
titioner permitted by the state and the continually assessing, monitoring, and
facility to order restraint or seclusion evaluating the physical and psycho-
orders the use of restraint or seclusion, logical well-being of the resident in se-
that person must contact the resident’s clusion. Video monitoring does not
treatment team physician, unless the meet this requirement.
ordering physician is in fact the resi- (b) A room used for seclusion must—
137
§ 483.366 42 CFR Ch. IV (10–1–24 Edition)
(1) Allow staff full view of the resi- § 483.370 Postintervention debriefings.
dent in all areas of the room; and
(a) Within 24 hours after the use of
(2) Be free of potentially hazardous
restraint or seclusion, staff involved in
conditions such as unprotected light
an emergency safety intervention and
fixtures and electrical outlets.
the resident must have a face-to-face
(c) If the emergency safety situation discussion. This discussion must in-
continues beyond the time limit of the clude all staff involved in the interven-
order for the use of seclusion, a reg- tion except when the presence of a par-
istered nurse or other licensed staff, ticular staff person may jeopardize the
such as a licensed practical nurse, well-being of the resident. Other staff
must immediately contact the ordering and the resident’s parent(s) or legal
physician or other licensed practi- guardian(s) may participate in the
tioner permitted by the state and the disussion when it is deemed appro-
facility to order restraint or seclusion priate by the facility. The facility
to receive further instructions. must conduct such discussion in a lan-
(d) A physician, or other licensed guage that is understood by the resi-
practitioner permitted by the state and dent’s parent(s) or legal guardian(s).
the facility to evaluate the resident’s The discussion must provide both the
well-being and trained in the use of resident and staff the opportunity to
emergency safety interventions, must discuss the circumstances resulting in
evaluate the resident’s well-being im- the use of restraint or seclusion and
mediately after the resident is removed strategies to be used by the staff, the
from seclusion.
resident, or others that could prevent
[66 FR 7161, Jan. 22, 2001, as amended at 66 the future use of restraint or seclusion.
FR 28117, May 22, 2001] (b) Within 24 hours after the use of
restraint or seclusion, all staff involved
§ 483.366 Notification of parent(s) or in the emergency safety intervention,
legal guardian(s).
and appropriate supervisory and ad-
If the resident is a minor as defined ministrative staff, must conduct a de-
in this subpart: briefing session that includes, at a
(a) The facility must notify the par- minimum, a review and discussion of—
ent(s) or legal guardian(s) of the resi- (1) The emergency safety situation
dent who has been restrained or placed that required the intervention, includ-
in seclusion as soon as possible after ing a discussion of the precipitating
the initiation of each emergency safety factors that led up to the intervention;
intervention. (2) Alternative techniques that might
(b) The facility must document in the have prevented the use of the restraint
resident’s record that the parent(s) or or seclusion;
legal guardian(s) has been notified of (3) The procedures, if any, that staff
the emergency safety intervention, in- are to implement to prevent any recur-
cluding the date and time of notifica- rence of the use of restraint or seclu-
tion and the name of the staff person sion; and
providing the notification. (4) The outcome of the intervention,
including any injuries that may have
§ 483.368 Application of time out.
resulted from the use of restraint or se-
(a) A resident in time out must never clusion.
be physically prevented from leaving (c) Staff must document in the resi-
the time out area. dent’s record that both debriefing ses-
(b) Time out may take place away sions took place and must include in
from the area of activity or from other that documentation the names of staff
residents, such as in the resident’s who were present for the debriefing,
room (exclusionary), or in the area of names of staff that were excused from
activity or other residents the debriefing, and any changes to the
(inclusionary). resident’s treatment plan that result
(c) Staff must monitor the resident from the debriefings.
while he or she is in time out.
138
§ 483.372 Medical treatment for inju- at the time it executes a provider

ries resulting from an emergency agreement with the Medicaid agency.
safety intervention. (b) Reporting of serious occurrences.
(a) Staff must immediately obtain The facility must report each serious
medical treatment from qualified med- occurrence to both the State Medicaid
ical personnel for a resident injured as agency and, unless prohibited by State
a result of an emergency safety inter- law, the State-designated Protection
vention. and Advocacy system. Serious occur-
(b) The psychiatric residential treat- rences that must be reported include a
ment facility must have affiliations or resident’s death, a serious injury to a
written transfer agreements in effect resident as defined in § 483.352 of this
with one or more hospitals approved
part, and a resident’s suicide attempt.
for participation under the Medicaid
(1) Staff must report any serious oc-
program that reasonably ensure that—
(1) A resident will be transferred currence involving a resident to both
from the facility to a hospital and ad- the State Medicaid agency and the
mitted in a timely manner when a State-designated Protection and Advo-
transfer is medically necessary for cacy system by no later than close of
medical care or acute psychiatric care; business the next business day after a
(2) Medical and other information serious occurrence. The report must in-
needed for care of the resident in light clude the name of the resident involved
of such a transfer, will be exchanged in the serious occurrence, a description
between the institutions in accordance of the occurrence, and the name, street
with State medical privacy law, includ- address, and telephone number of the
ing any information needed to deter- facility.
mine whether the appropriate care can (2) In the case of a minor, the facility
be provided in a less restrictive setting; must notify the resident’s parent(s) or
and legal guardian(s) as soon as possible,
(3) Services are available to each and in no case later than 24 hours after
resident 24 hours a day, 7 days a week. the serious occurrence.
(c) Staff must document in the resi-
(3) Staff must document in the resi-
dent’s record, all injuries that occur as
dent’s record that the serious occur-
a result of an emergency safety inter-
vention, including injuries to staff re- rence was reported to both the State
sulting from that intervention. Medicaid agency and the State-des-
(d) Staff involved in an emergency ignated Protection and Advocacy sys-
safety intervention that results in an tem, including the name of the person
injury to a resident or staff must meet to whom the incident was reported. A
with supervisory staff and evaluate the copy of the report must be maintained
circumstances that caused the injury in the resident’s record, as well as in
and develop a plan to prevent future in- the incident and accident report logs
juries. kept by the facility.
(c) Reporting of deaths. In addition to
§ 483.374 Facility reporting. the reporting requirements contained
(a) Attestation of facility compliance. in paragraph (b) of this section, facili-
Each psychiatric residential treatment ties must report the death of any resi-
facility that provides inpatient psy- dent to the Centers for Medicare &
chiatric services to individuals under Medicaid Services (CMS) regional of-
age 21 must attest, in writing, that the fice.
facility is in compliance with CMS’s (1) Staff must report the death of any
standards governing the use of re- resident to the CMS regional office by
straint and seclusion. This attestation no later than close of business the next
must be signed by the facility director. business day after the resident’s death.
(1) A facility with a current provider
(2) Staff must document in the resi-
agreement with the Medicaid agency
dent’s record that the death was re-
must provide its attestation to the
ported to the CMS regional office.
State Medicaid agency by July 21, 2001.
(2) A facility enrolling as a Medicaid [66 FR 7161, Jan. 22, 2001, as amended at 66
provider must meet this requirement FR 28117, May 22, 2001]
139
§ 483.376 42 CFR Ch. IV (10–1–24 Edition)
§ 483.376 Education and training. Subpart I—Conditions of Participa-

(a) The facility must require staff to tion for Intermediate Care Fa-
have ongoing education, training, and cilities for Individuals with In-
demonstrated knowledge of— tellectual Disabilities
(1) Techniques to identify staff and
resident behaviors, events, and envi- SOURCE: 53 FR 20496, June 3, 1988, unless
ronmental factors that may trigger otherwise noted. Redesignated at 56 FR 48918,
emergency safety situations; Sept. 26, 1991.
(2) The use of nonphysical interven- § 483.400 Basis and purpose.
tion skills, such as de-escalation, medi-
This subpart implements section 1905
ation conflict resolution, active listen-
(c) and (d) of the Act which gives the
ing, and verbal and observational
Secretary authority to prescribe regu-
methods, to prevent emergency safety lations for intermediate care facility
situations; and services in facilities for individuals
(3) The safe use of restraint and the with intellectual disabilities or persons
safe use of seclusion, including the with related conditions.
ability to recognize and respond to
signs of physical distress in residents § 483.405 Relationship to other HHS
who are restrained or in seclusion. regulations.
(b) Certification in the use of In addition to compliance with the
cardiopulmonary resuscitation, includ- regulations set forth in this subpart,
ing periodic recertification, is required. facilities are obliged to meet the appli-
(c) Individuals who are qualified by cable provisions of other HHS regula-
education, training, and experience tions, including but not limited to
must provide staff training. those pertaining to nondiscrimination
on the basis of race, color, or national
(d) Staff training must include train-
origin (45 CFR part 80), nondiscrimina-
ing exercises in which staff members tion on the basis of handicap (45 CFR
successfully demonstrate in practice part 84), nondiscrimination on the
the techniques they have learned for basis of age (45 CFR part 91), protection
managing emergency safety situations. of human subjects of research (45 CFR
(e) Staff must be trained and dem- part 46), and fraud and abuse (42 CFR
onstrate competency before partici- part 455). Although those regulations
pating in an emergency safety inter- are not in themselves considered condi-
vention. tions of participation under this part,
(f) Staff must demonstrate their their violation may result in the termi-
competencies as specified in paragraph nation or suspension of, or the refusal
(a) of this section on a semiannual to grant or continue, Federal financial
basis and their competencies as speci- assistance.
fied in paragraph (b) of this section on § 483.410 Condition of participation:
an annual basis. Governing body and management.
(g) The facility must document in the
(a) Standard: Governing body. The fa-
staff personnel records that the train- cility must identify an individual or
ing and demonstration of competency individuals to constitute the governing
were successfully completed. Docu- body of the facility. The governing
mentation must include the date train- body must—
ing was completed and the name of per- (1) Exercise general policy, budget,
sons certifying the completion of train- and operating direction over the facil-
ing. ity;
(h) All training programs and mate- (2) Set the qualifications (in addition
rials used by the facility must be avail- to those already set by State law, if
able for review by CMS, the State Med- any) for the administrator of the facil-
icaid agency, and the State survey ity; and
agency. (3) Appoint the administrator of the
facility.
(b) Standard: Compliance with Federal,
Subpart H [Reserved] State, and local laws. The facility must
140
be in compliance with all applicable (e) Standard: Licensure. The facility

provisions of Federal, State and local must be licensed under applicable
laws, regulations and codes pertaining State and local law.
to health, safety, and sanitation. [53 FR 20496, June 3, 1988. Redesignated at 56
(c) Standard: Client records. (1) The fa- FR 48918, Sept. 26, 1991, and amended at 57
cility must develop and maintain a rec- FR 43925, Sept. 23, 1992]
ordkeeping system that includes a sep-
arate record for each client and that § 483.420 Condition of participation:
Client protections.
documents the client’s health care, ac-
tive treatment, social information, and (a) Standard: Protection of clients’
protection of the client’s rights. rights. The facility must ensure the
(2) The facility must keep confiden- rights of all clients. Therefore, the fa-
cility must—
tial all information contained in the
(1) Inform each client, parent (if the
clients’ records, regardless of the form
client is a minor), or legal guardian, of
or storage method of the records. the client’s rights and the rules of the
(3) The facility must develop and im- facility;
plement policies and procedures gov- (2) Inform each client, parent (if the
erning the release of any client infor- client is a minor), or legal guardian, of
mation, including consents necessary the client’s medical condition, develop-
from the client, or parents (if the cli- mental and behavioral status, attend-
ent is a minor) or legal guardian. ant risks of treatment, and of the right
(4) Any individual who makes an to refuse treatment;
entry in a client’s record must make it (3) Allow and encourage individual
legibly, date it, and sign it. clients to exercise their rights as cli-
(5) The facility must provide a legend ents of the facility, and as citizens of
to explain any symbol or abbreviation the United States, including the right
used in a client’s record. to file complaints, and the right to due
(6) The facility must provide each process;
(4) Allow individual clients to man-
identified residential living unit with
age their financial affairs and teach
appropriate aspects of each client’s
them to do so to the extent of their ca-
record.
pabilities;
(d) Standard: Services provided under (5) Ensure that clients are not sub-
agreements with outside sources. (1) If a jected to physical, verbal, sexual or
service required under this subpart is psychological abuse or punishment;
not provided directly, the facility must (6) Ensure that clients are free from
have a written agreement with an out- unnecessary drugs and physical re-
side program, resource, or service to straints and are provided active treat-
furnish the necessary service, including ment to reduce dependency on drugs
emergency and other health care. and physical restraints;
(2) The agreement must— (7) Provide each client with the op-
(i) Contain the responsibilities, func- portunity for personal privacy and en-
tions, objectives, and other terms sure privacy during treatment and care
agreed to by both parties; and of personal needs;
(ii) Provide that the facility is re- (8) Ensure that clients are not com-
sponsible for assuring that the outside pelled to perform services for the facil-
services meet the standards for quality ity and ensure that clients who do
work for the facility are compensated
of services contained in this subpart.
for their efforts at prevailing wages
(3) The facility must assure that out-
and commensurate with their abilities;
side services meet the needs of each (9) Ensure clients the opportunity to
client. communicate, associate and meet pri-
(4) If living quarters are not provided vately with individuals of their choice,
in a facility owned by the ICF/IID, the and to send and receive unopened mail;
ICF/IID remains directly responsible (10) Ensure that clients have access
for the standards relating to physical to telephones with privacy for incom-
environment that are specified in ing and outgoing local and long dis-
§ 483.470 (a) through (g), (j) and (k). tance calls except as contraindicated
141
§ 483.430 42 CFR Ch. IV (10–1–24 Edition)
by factors identified within their indi- (6) Notify promptly the client’s par-
vidual program plans; ents or guardian of any significant in-
(11) Ensure clients the opportunity to cidents, or changes in the client’s con-
participate in social, religious, and dition including, but not limited to, se-
community group activities; rious illness, accident, death, abuse, or
(12) Ensure that clients have the unauthorized absence.
right to retain and use appropriate per- (d) Standard: Staff treatment of clients.
sonal possessions and clothing, and en- (1) The facility must develop and im-
sure that each client is dressed in his plement written policies and proce-
or her own clothing each day; and dures that prohibit mistreatment, ne-
(13) Permit a husband and wife who glect or abuse of the client.
both reside in the facility to share a (i) Staff of the facility must not use
room. physical, verbal, sexual or psycho-
(b) Standard: Client finances. (1) The logical abuse or punishment.
facility must establish and maintain a (ii) Staff must not punish a client by
system that— withholding food or hydration that
(i) Assures a full and complete ac- contributes to a nutritionally adequate
counting of clients’ personal funds en- diet.
trusted to the facility on behalf of cli- (iii) The facility must prohibit the
ents; and employment of individuals with a con-
viction or prior employment history of
(ii) Precludes any commingling of
child or client abuse, neglect or mis-
client funds with facility funds or with
treatment.
the funds of any person other than an-
(2) The facility must ensure that all
other client.
allegations of mistreatment, neglect or
(2) The client’s financial record must
abuse, as well as injuries of unknown
be available on request to the client,
source, are reported immediately to
parents (if the client is a minor) or
the administrator or to other officials
legal guardian.
in accordance with State law through
(c) Standard: Communication with cli- established procedures.
ents, parents, and guardians. The facil- (3) The facility must have evidence
ity must— that all alleged violations are thor-
(1) Promote participation of parents oughly investigated and must prevent
(if the client is a minor) and legal further potential abuse while the inves-
guardians in the process of providing tigation is in progress.
active treatment to a client unless (4) The results of all investigations
their participation is unobtainable or must be reported to the administrator
inappropriate; or designated representative or to
(2) Answer communications from cli- other officials in accordance with
ents’ families and friends promptly and State law within five working days of
appropriately; the incident and, if the alleged viola-
(3) Promote visits by individuals with tion is verified, appropriate corrective
a relationship to the client (such as action must be taken.
family, close friends, legal guardians
and advocates) at any reasonable hour, § 483.430 Condition of participation:
without prior notice, consistent with Facility staffing.
the right of that client’s and other cli- (a) Standard: Qualified intellectual dis-
ents’ privacy, unless the interdiscipli- ability professional. Each client’s active
nary team determines that the visit treatment program must be integrated,
would not be appropriate; coordinated and monitored by a quali-
(4) Promote visits by parents or fied intellectual disability professional
guardians to any area of the facility who—
that provides direct client care serv- (1) Has at least one year of experi-
ices to the client, consistent with the ence working directly with persons
right of that client’s and other clients’ with intellectual disability or other de-
privacy; velopmental disabilities; and
(5) Promote frequent and informal (2) Is one of the following:
leaves from the facility for visits, trips, (i) A doctor of medicine or osteop-
or vacations; and athy.
142
(ii) A registered nurse. apy Association or another comparable

(iii) An individual who holds at least body.
a bachelor’s degree in a professional (iv) To be designated as a physical
category specified in paragraph (b)(5) therapy assistant, an individual must
of this section. be eligible for registration by the
(b) Standard: Professional program American Physical Therapy Associa-
services. (1) Each client must receive tion or be a graduate of a two year col-
the professional program services need- lege-level program approved by the
ed to implement the active treatment American Physical Therapy Associa-
program defined by each client’s indi- tion or another comparable body.
vidual program plan. Professional pro- (v) To be designated as a psycholo-
gram staff must work directly with cli- gist, an individual must have at least a
ents and with paraprofessional, non- master’s degree in psychology from an
professional and other professional pro- accredited school.
gram staff who work with clients. (vi) To be designated as a social
(2) The facility must have available worker, an individual must—
enough qualified professional staff to (A) Hold a graduate degree from a
carry out and monitor the various pro- school of social work accredited or ap-
fessional interventions in accordance proved by the Council on Social Work
with the stated goals and objectives of Education or another comparable body;
or
every individual program plan.
(B) Hold a Bachelor of Social Work
(3) Professional program staff must
degree from a college or university ac-
participate as members of the inter-
credited or approved by the Council on
disciplinary team in relevant aspects
Social Work Education or another
of the active treatment process.
comparable body.
(4) Professional program staff must (vii) To be designated as a speech-
participate in on-going staff develop- language pathologist or audiologist, an
ment and training in both formal and individual must—
informal settings with other profes- (A) Be eligible for a Certificate of
sional, paraprofessional, and nonprofes- Clinical Competence in Speech-Lan-
sional staff members. guage Pathology or Audiology granted
(5) Professional program staff must by the American Speech-Language-
be licensed, certified, or registered, as Hearing Association or another com-
applicable, to provide professional parable body; or
services by the State in which he or (B) Meet the educational require-
she practices. Those professional pro- ments for certification and be in the
gram staff who do not fall under the ju- process of accumulating the supervised
risdiction of State licensure, certifi- experience required for certification.
cation, or registration requirements, (viii) To be designated as a profes-
specified in § 483.410(b), must meet the sional recreation staff member, an in-
following qualifications: dividual must have a bachelor’s degree
(i) To be designated as an occupa- in recreation or in a specialty area
tional therapist, an individual must be such as art, dance, music or physical
eligible for certification as an occupa- education.
tional therapist by the American Occu- (ix) To be designated as a profes-
pational Therapy Association or an- sional dietitian, an individual must be
other comparable body. eligible for registration by the Amer-
(ii) To be designated as an occupa- ican Dietetics Association.
tional therapy assistant, an individual (x) To be designated as a human serv-
must be eligible for certification as a ices professional an individual must
certified occupational therapy assist- have at least a bachelor’s degree in a
ant by the American Occupational human services field (including, but
Therapy Association or another com- not limited to: sociology, special edu-
parable body. cation, rehabilitation counseling, and
(iii) To be designated as a physical psychology).
therapist, an individual must be eligi- (xi) If the client’s individual program
ble for certification as a physical ther- plan is being successfully implemented
apist by the American Physical Ther- by facility staff, professional program
143
§ 483.440 42 CFR Ch. IV (10–1–24 Edition)
staff meeting the qualifications of (3) Direct care staff must be provided
paragraph (b)(5) (i) through (x) of this by the facility in the following min-
section are not required— imum ratios of direct care staff to cli-
(A) Except for qualified intellectual ents:
disability professionals; (i) For each defined residential living
(B) Except for the requirements of unit serving children under the age of
paragraph (b)(2) of this section con- 12, severely and profoundly retarded
cerning the facility’s provision of clients, clients with severe physical
enough qualified professional program disabilities, or clients who are aggres-
staff; and sive, assaultive, or security risks, or
(C) Unless otherwise specified by who manifest severely hyperactive or
State licensure and certification re- psychotic-like behavior, the staff to
quirements. client ratio is 1 to 3.2.
(c) Standard: Facility staffing. (1) The (ii) For each defined residential liv-
facility must not depend upon clients ing unit serving moderately retarded
or volunteers to perform direct care clients, the staff to client ratio is 1 to
services for the facility. 4.
(2) There must be responsible direct (iii) For each defined residential liv-
care staff on duty and awake on a 24- ing unit serving clients who function
hour basis, when clients are present, to within the range of mild retardation,
take prompt, appropriate action in the staff to client ratio is 1 to 6.4.
case of injury, illness, fire or other (4) When there are no clients present
emergency, in each defined residential in the living unit, a responsible staff
living unit housing— member must be available by tele-
(i) Clients for whom a physician has phone.
ordered a medical care plan; (e) Standard: Staff training program.
(ii) Clients who are aggressive, (1) The facility must provide each em-
assaultive or security risks; ployee with initial and continuing
(iii) More than 16 clients; or training that enables the employee to
(iv) Fewer than 16 clients within a perform his or her duties effectively,
multi-unit building. efficiently, and competently.
(3) There must be a responsible direct (2) For employees who work with cli-
care staff person on duty on a 24 hour ents, training must focus on skills and
basis (when clients are present) to re- competencies directed toward clients’
spond to injuries and symptoms of ill- developmental, behavioral, and health
ness, and to handle emergencies, in needs.
each defined residential living unit
(3) Staff must be able to demonstrate
housing—
the skills and techniques necessary to
(i) Clients for whom a physician has
administer interventions to manage
not ordered a medical care plan;
the inappropriate behavior of clients.
(ii) Clients who are not aggressive,
assaultive or security risks; and (4) Staff must be able to demonstrate
(iii) Sixteen or fewer clients, the skills and techniques necessary to
(4) The facility must provide suffi- implement the individual program
cient support staff so that direct care plans for each client for whom they are
staff are not required to perform sup- responsible.
port services to the extent that these [53 FR 20496, June 3, 1988, as amended at 86
duties interfere with the exercise of FR 26335, May 13, 2021; 86 FR 61620, Nov. 5,
their primary direct client care duties. 2021; 88 FR 36510, June 5, 2023]
(d) Standard: Direct care (residential
living unit) staff. (1) The facility must § 483.440 Condition of participation:
provide sufficient direct care staff to Active treatment services.
manage and supervise clients in ac- (a) Standard: Active treatment. (1)
cordance with their individual program Each client must receive a continuous
plans. active treatment program, which in-
(2) Direct care staff are defined as the cludes aggressive, consistent imple-
present on-duty staff calculated over mentation of a program of specialized
all shifts in a 24-hour period for each and generic training, treatment, health
defined residential living unit. services and related services described
144
in this subpart, that is directed to- professions, disciplines or service areas

ward— that are relevant to—
(i) The acquisition of the behaviors (i) Identifying the client’s needs, as
necessary for the client to function described by the comprehensive func-
with as much self determination and tional assessments required in para-
independence as possible; and graph (c)(3) of this section; and
(ii) The prevention or deceleration of (ii) Designing programs that meet
regression or loss of current optimal the client’s needs.
functional status. (2) Appropriate facility staff must
(2) Active treatment does not include participate in interdisciplinary team
services to maintain generally inde- meetings. Participation by other agen-
pendent clients who are able to func- cies serving the client is encouraged.
tion with little supervision or in the Participation by the client, his or her
absence of a continuous active treat- parent (if the client is a minor), or the
ment program. client’s legal guardian is required un-
(b) Standard: Admissions, transfers, less that participation is unobtainable
and discharge. (1) Clients who are ad- or inappropriate.
mitted by the facility must be in need (3) Within 30 days after admission,
of and receiving active treatment serv- the interdisciplinary team must per-
ices. form accurate assessments or reassess-
(2) Admission decisions must be ments as needed to supplement the pre-
based on a preliminary evaluation of liminary evaluation conducted prior to
the client that is conducted or updated admission. The comprehensive func-
by the facility or by outside sources. tional assessment must take into con-
(3) A preliminary evaluation must sideration the client’s age (for exam-
contain background information as ple, child, young adult, elderly person)
well as currently valid assessments of and the implications for active treat-
functional developmental, behavioral, ment at each stage, as applicable, and
social, health and nutritional status to must—
determine if the facility can provide (i) Identify the presenting problems
for the client’s needs and if the client and disabilities and where possible,
is likely to benefit from placement in their causes;
the facility. (ii) Identify the client’s specific de-
(4) If a client is to be either trans- velopmental strengths;
ferred or discharged, the facility (iii) Identify the client’s specific de-
must— velopmental and behavioral manage-
(i) Have documentation in the cli- ment needs;
ent’s record that the client was trans- (iv) Identify the client’s need for
ferred or discharged for good cause; and services without regard to the actual
(ii) Provide a reasonable time to pre- availability of the services needed; and
pare the client and his or her parents (v) Include physical development and
or guardian for the transfer or dis- health, nutritional status,
charge (except in emergencies). sensorimotor development, affective
(5) At the time of the discharge, the development, speech and language de-
facility must— velopment and auditory functioning,
(i) Develop a final summary of the cognitive development, social develop-
client’s developmental, behavioral, so- ment, adaptive behaviors or inde-
cial, health and nutritional status and, pendent living skills necessary for the
with the consent of the client, parents client to be able to function in the
(if the client is a minor) or legal guard- community, and as applicable, voca-
ian, provide a copy to authorized per- tional skills.
sons and agencies; and (4) Within 30 days after admission,
(ii) Provide a post-discharge plan of the interdisciplinary team must pre-
care that will assist the client to ad- pare for each client an individual pro-
just to the new living environment. gram plan that states the specific ob-
(c) Standard: Individual program plan. jectives necessary to meet the client’s
(1) Each client must have an individual needs, as identified by the comprehen-
program plan developed by an inter- sive assessment required by paragraph
disciplinary team that represents the (c)(3) of this section, and the planned
145
§ 483.440 42 CFR Ch. IV (10–1–24 Edition)
sequence for dealing with those objec- be applied, and a schedule for the use of
tives. These objectives must— each support.
(i) Be stated separately, in terms of a (v) Provide that clients who have
single behavioral outcome; multiple disabling conditions spend a
(ii) Be assigned projected completion major portion of each waking day out
dates; of bed and outside the bedroom area,
(iii) Be expressed in behavioral terms moving about by various methods and
that provide measurable indices of per- devices whenever possible.
formance; (vi) Include opportunities for client
(iv) Be organized to reflect a develop- choice and self-management.
mental progression appropriate to the (7) A copy of each client’s individual
individual; and program plan must be made available
(v) Be assigned priorities. to all relevant staff, including staff of
(5) Each written training program de- other agencies who work with the cli-
signed to implement the objectives in ent, and to the client, parents (if the
the individual program plan must client is a minor) or legal guardian.
specify: (d) Standard: Program implementation.
(i) The methods to be used; (1) As soon as the interdisciplinary
(ii) The schedule for use of the meth- team has formulated a client’s indi-
od; vidual program plan, each client must
(iii) The person responsible for the receive a continuous active treatment
program; program consisting of needed interven-
(iv) The type of data and frequency of tions and services in sufficient number
data collection necessary to be able to and frequency to support the achieve-
assess progress toward the desired ob- ment of the objectives identified in the
jectives; individual program plan.
(v) The inappropriate client behav- (2) The facility must develop an ac-
ior(s), if applicable; and tive treatment schedule that outlines
(vi) Provision for the appropriate ex- the current active treatment program
pression of behavior and the replace- and that is readily available for review
ment of inappropriate behavior, if ap- by relevant staff.
plicable, with behavior that is adaptive (3) Except for those facets of the indi-
or appropriate. vidual program plan that must be im-
(6) The individual program plan must plemented only by licensed personnel,
also: each client’s individual program plan
(i) Describe relevant interventions to must be implemented by all staff who
support the individual toward inde- work with the client, including profes-
pendence. sional, paraprofessional and nonprofes-
(ii) Identify the location where pro- sional staff.
gram strategy information (which (e) Standard: Program documentation.
must be accessible to any person re- (1) Data relative to accomplishment of
sponsible for implementation) can be the criteria specified in client indi-
found. vidual program plan objectives must be
(iii) Include, for those clients who documented in measureable terms.
lack them, training in personal skills (2) The facility must document sig-
essential for privacy and independence nificant events that are related to the
(including, but not limited to, toilet client’s individual program plan and
training, personal hygiene, dental hy- assessments and that contribute to an
giene, self-feeding, bathing, dressing, overall understanding of the client’s
grooming, and communication of basic ongoing level and quality of func-
needs), until it has been demonstrated tioning.
that the client is developmentally in- (f) Standard: Program monitoring and
capable of acquiring them. change. (1) The individual program plan
(iv) Identify mechanical supports, if must be reviewed at least by the quali-
needed, to achieve proper body posi- fied intellectual disability professional
tion, balance, or alignment. The plan and revised as necessary, including, but
must specify the reason for each sup- not limited to situations in which the
port, the situations in which each is to client—
146
(i) Has successfully completed an ob- § 483.450 Condition of participation:

jective or objectives identified in the Client behavior and facility prac-
individual program plan; tices.
(ii) Is regressing or losing skills al- (a) Standard: Facility practices—Con-
ready gained; duct toward clients. (1) The facility
(iii) Is failing to progress toward must develop and implement written
identified objectives after reasonable policies and procedures for the man-
efforts have been made; or agement of conduct between staff and
(iv) Is being considered for training clients. These policies and procedures
towards new objectives. must—
(i) Promote the growth, development
(2) At least annually, the comprehen-
and independence of the client;
sive functional assessment of each cli-
(ii) Address the extent to which cli-
ent must be reviewed by the inter- ent choice will be accommodated in
disciplinary team for relevancy and up- daily decision-making, emphasizing
dated as needed, and the individual self-determination and self-manage-
program plan must be revised, as ap- ment, to the extent possible;
propriate, repeating the process set (iii) Specify client conduct to be al-
forth in paragraph (c) of this section. lowed or not allowed; and
(3) The facility must designate and (iv) Be available to all staff, clients,
use a specially constituted committee parents of minor children, and legal
or committees consisting of members guardians.
of facility staff, parents, legal guard- (2) To the extent possible, clients
ians, clients (as appropriate), qualified must participate in the formulation of
persons who have either experience or these policies and procedures.
training in contemporary practices to (3) Clients must not discipline other
change inappropriate client behavior, clients, except as part of an organized
and persons with no ownership or con- system of self-government, as set forth
trolling interest in the facility to— in facility policy.
(i) Review, approve, and monitor in- (b) Standard: Management of inappro-
priate client behavior. (1) The facility
dividual programs designed to manage
must develop and implement written
inappropriate behavior and other pro-
policies and procedures that govern the
grams that, in the opinion of the com- management of inappropriate client
mittee, involve risks to client protec- behavior. These policies and procedures
tion and rights; must be consistent with the provisions
(ii) Insure that these programs are of paragraph (a) of this section. These
conducted only with the written in- procedures must—
formed consent of the client, parent (if (i) Specify all facility approved inter-
the client is a minor), or legal guard- ventions to manage inappropriate cli-
ian; and ent behavior;
(iii) Review, monitor and make sug- (ii) Designate these interventions on
gestions to the facility about its prac- a hierarchy to be implemented, ranging
tices and programs as they relate to from most positive or least intrusive,
drug usage, physical restraints, time- to least positive or most intrusive;
out rooms, application of painful or (iii) Insure, prior to the use of more
noxious stimuli, control of inappro- restrictive techniques, that the client’s
priate behavior, protection of client record documents that programs incor-
rights and funds, and any other area porating the use of less intrusive or
that the committee believes need to be more positive techniques have been
addressed. tried systematically and demonstrated
to be ineffective; and
(4) The provisions of paragraph (f)(3)
(iv) Address the following:
of this section may be modified only if, (A) The use of time-out rooms.
in the judgment of the State survey (B) The use of physical restraints.
agency, Court decrees, State law or (C) The use of drugs to manage inap-
regulations provide for equivalent cli- propriate behavior.
ent protection and consultation. (D) The application of painful or nox-
ious stimuli.
147
§ 483.450 42 CFR Ch. IV (10–1–24 Edition)
(E) The staff members who may au- lead to less restrictive means of man-
thorize the use of specified interven- aging and eliminating the behavior for
tions. which the restraint is applied;
(F) A mechanism for monitoring and (ii) As an emergency measure, but
controlling the use of such interven- only if absolutely necessary to protect
tions. the client or others from injury; or
(2) Interventions to manage inappro- (iii) As a health-related protection
priate client behavior must be em- prescribed by a physician, but only if
ployed with sufficient safeguards and absolutely necessary during the con-
supervision to ensure that the safety, duct of a specific medical or surgical
welfare and civil and human rights of procedure, or only if absolutely nec-
clients are adequately protected. essary for client protection during the
(3) Techniques to manage inappro- time that a medical condition exists.
priate client behavior must never be (2) Authorizations to use or extend
used for disciplinary purposes, for the restraints as an emergency must be:
convenience of staff or as a substitute (i) In effect no longer than 12 con-
for an active treatment program. secutive hours; and
(4) The use of systematic interven- (ii) Obtained as soon as the client is
tions to manage inappropriate client restrained or stable.
behavior must be incorporated into the
(3) The facility must not issue orders
client’s individual program plan, in ac-
for restraint on a standing or as needed
cordance with § 483.440(c) (4) and (5) of
basis.
this subpart.
(4) A client placed in restraint must
(5) Standing or as needed programs to
be checked at least every 30 minutes by
control inappropriate behavior are not
staff trained in the use of restraints,
permitted.
released from the restraint as quickly
(c) Standard: Time-out rooms. (1) A cli-
as possible, and a record of these
ent may be placed in a room from
checks and usage must be kept.
which egress is prevented only if the
following conditions are met: (5) Restraints must be designed and
(i) The placement is a part of an ap- used so as not to cause physical injury
proved systematic time-out program as to the client and so as to cause the
required by paragraph (b) of this sec- least possible discomfort.
tion. (Thus, emergency placement of a (6) Opportunity for motion and exer-
client into a time-out room is not al- cise must be provided for a period of
lowed.) not less than 10 minutes during each
(ii) The client is under the direct con- two hour period in which restraint is
stant visual supervision of designated employed, and a record of such activity
staff. must be kept.
(iii) The door to the room is held (7) Barred enclosures must not be
shut by staff or by a mechanism requir- more than three feet in height and
ing constant physical pressure from a must not have tops.
staff member to keep the mechanism (e) Standard: Drug usage. (1) The facil-
engaged. ity must not use drugs in doses that
(2) Placement of a client in a time- interfere with the individual client’s
out room must not exceed one hour. daily living activities.
(3) Clients placed in time-out rooms (2) Drugs used for control of inappro-
must be protected from hazardous con- priate behavior must be approved by
ditions including, but not limited to, the interdisciplinary team and be used
presence of sharp corners and objects, only as an integral part of the client’s
uncovered light fixtures, unprotected individual program plan that is di-
electrical outlets. rected specifically towards the reduc-
(4) A record of time-out activities tion of and eventual elimination of the
must be kept. behaviors for which the drugs are em-
(d) Standard: Physical restraints. (1) ployed.
The facility may employ physical re- (3) Drugs used for control of inappro-
straint only— priate behavior must not be used until
(i) As an integral part of an indi- it can be justified that the harmful ef-
vidual program plan that is intended to fects of the behavior clearly outweigh
148
the potentially harmful effects of the (i) When COVID–19 vaccine is avail-
drugs. able to the facility, each client and
(4) Drugs used for control of inappro- staff member is offered the COVID–19
priate behavior must be— vaccine unless the immunization is
(i) Monitored closely, in conjunction medically contraindicated or the client
with the physician and the drug regi- or staff member has already been im-
men review requirement at § 483.460(j), munized.
for desired responses and adverse con- (ii) Before offering COVID–19 vaccine,
sequences by facility staff; and all staff members are provided with
(ii) Gradually withdrawn at least an- education regarding the benefits and
nually in a carefully monitored pro- risks and potential side effects associ-
gram conducted in conjunction with ated with the vaccine.
the interdisciplinary team, unless clin- (iii) Before offering COVID–19 vac-
ical evidence justifies that this is con- cine, each client or the client’s rep-
traindicated. resentative receives education regard-
ing the benefits and risks and potential
§ 483.460 Condition of participation: side effects associated with the COVID–
Health care services.
19 vaccine.
(a) Standard: Physician services. (1) (iv) In situations where COVID–19
The facility must ensure the avail- vaccination requires multiple doses,
ability of physician services 24 hours a the client, client’s representative, or
day. staff member is provided with current
(2) The physician must develop, in co- information regarding each additional
ordination with licensed nursing per- dose, including any changes in the ben-
sonnel, a medical care plan of treat- efits or risks and potential side effects
ment for a client if the physician deter- associated with the COVID–19 vaccine,
mines that an individual client re- before requesting consent for adminis-
quires 24-hour licensed nursing care. tration of each additional doses.
This plan must be integrated in the in- (v) The client, or client’s representa-
dividual program plan. tive, has the opportunity to accept or
(3) The facility must provide or ob- refuse a COVID–19 vaccine, and change
tain preventive and general medical their decision;
care as well as annual physical exami-
(vi) The client’s medical record in-
nations of each client that at a min-
cludes documentation that indicates,
imum include the following:
at a minimum, the following:
(i) Evaluation of vision and hearing.
(ii) Immunizations, using as a guide (A) That the client or client’s rep-
resentative was provided education re-
the recommendations of the Public
garding the benefits and risks and po-
Health Service Advisory Committee on
tential side effects of COVID–19 vac-
Immunization Practices or of the Com-
cine; and
mittee on the Control of Infectious Dis-
eases of the American Academy of Pe- (B) Each dose of COVID–19 vaccine
diatrics. administered to the client; or
(iii) Routine screening laboratory ex- (C) If the client did not receive the
aminations as determined necessary by COVID–19 vaccine due to medical con-
the physician, and special studies when traindications or refusal.
needed. (5) To the extent permitted by State
(iv) Tuberculosis control, appropriate law, the facility may utilize physician
to the facility’s population, and in ac- assistants and nurse practitioners to
cordance with the recommendations of provide physician services as described
the American College of Chest Physi- in this section.
cians or the section of diseases of the (b) Standard: Physician participation in
chest of the American Academy of Pe- the individual program plan. A physician
diatrics, or both. must participate in—
(4) The intermediate care facility for (1) The establishment of each newly
individuals with intellectual disabil- admitted client’s initial individual pro-
ities (ICF/IID) must develop and imple- gram plan as required by § 456.380 of
ment policies and procedures to ensure this chapter that specified plan of care
all of the following: requirements for ICFs; and
149
§ 483.460 42 CFR Ch. IV (10–1–24 Edition)
(2) If appropriate, physicians must including those clients with medical

participate in the review and update of care plans.
an individual program plan as part of (3) The facility must utilize reg-
the interdisciplinary team process ei- istered nurses as appropriate and re-
ther in person or through written required by State law to perform the
port to the interdisciplinary team. health services specified in this sec-
(c) Standard: Nursing services. The fa- tion.
cility must provide clients with nurs- (4) If the facility utilizes only li-
ing services in accordance with their censed practical or vocational nurses
needs. These services must include— to provide health services, it must have
(1) Participation as appropriate in a formal arrangement with a registered
the development, review, and update of nurse to be available for verbal or on-
an individual program plan as part of site consultation to the licensed prac-
the interdisciplinary team process; tical or vocational nurse.
(2) The development, with a physi- (5) Non-licensed nursing personnel
cian, of a medical care plan of treat- who work with clients under a medical
ment for a client when the physician care plan must do so under the super-
has determined that an individual cli- vision of licensed persons.
ent requires such a plan; (e) Standard: Dental services. (1) The
(3) For those clients certified as not facility must provide or make arrange-
needing a medical care plan, a review ments for comprehensive diagnostic
of their health status which must— and treatment services for each client
(i) Be by a direct physical examina- from qualified personnel, including li-
tion; censed dentists and dental hygienists
(ii) Be by a licensed nurse; either through organized dental serv-
(iii) Be on a quarterly or more fre- ices in-house or through arrangement.
quent basis depending on client need; (2) If appropriate, dental profes-
(iv) Be recorded in the client’s sionals must participate, in the devel-
record; and opment, review and update of an indi-
(v) Result in any necessary action vidual program plan as part of the
(including referral to a physician to ad- interdisciplinary process either in per-
dress client health problems). son or through written report to the
(4) Other nursing care as prescribed interdisciplinary team.
by the physician or as identified by cli- (3) The facility must provide edu-
ent needs; and cation and training in the maintenance
(5) Implementing, with other mem- of oral health.
bers of the interdisciplinary team, ap- (f) Standard: Comprehensive dental di-
propriate protective and preventive agnostic services. Comprehensive dental
health measures that include, but are diagnostic services include—
not limited to— (1) A complete extraoral and
(i) Training clients and staff as need- intraoral examination, using all diag-
ed in appropriate health and hygiene nostic aids necessary to properly evalu-
methods; ate the client’s oral condition, not
(ii) Control of communicable diseases later than one month after admission
and infections, including the instruc- to the facility (unless the examination
tion of other personnel in methods of was completed within twelve months
infection control; and before admission);
(iii) Training direct care staff in de- (2) Periodic examination and diag-
tecting signs and symptoms of illness nosis performed at least annually, in-
or dysfunction, first aid for accidents cluding radiographs when indicated
or illness, and basic skills required to and detection of manifestations of sys-
meet the health needs of the clients. temic disease; and
(d) Standard: Nursing staff. (1) Nurses (3) A review of the results of exam-
providing services in the facility must ination and entry of the results in the
have a current license to practice in client’s dental record.
the State. (g) Standard: Comprehensive dental
(2) The facility must employ or ar- treatment. The facility must ensure
range for licensed nursing services suf- comprehensive dental treatment serv-
ficient to care for clients health needs ices that include—
150
(1) The availability for emergency (3) Unlicensed personnel are allowed
dental treatment on a 24-hour-a-day to administer drugs only if State law
basis by a licensed dentist; and permits;
(2) Dental care needed for relief of (4) Clients are taught how to admin-
pain and infections, restoration of ister their own medications if the
teeth, and maintenance of dental interdisciplinary team determines that
health. self administration of medications is
(h) Standard: Documentation of dental an appropriate objective, and if the
services. (1) If the facility maintains an physician does not specify otherwise;
in-house dental service, the facility (5) The client’s physician is informed
must keep a permanent dental record of the interdisciplinary team’s decision
for each client, with a dental summary that self-administration of medications
maintained in the client’s living unit. is an objective for the client;
(2) If the facility does not maintain (6) No client self-administers medica-
an in-house dental service, the facility tions until he or she demonstrates the
must obtain a dental summary of the competency to do so;
results of dental visits and maintain (7) Drugs used by clients while not
the summary in the client’s living under the direct care of the facility are
unit. packaged and labeled in accordance
(i) Standard: Pharmacy services. The with State law; and
facility must provide or make arrange- (8) Drug administration errors and
ments for the provision of routine and adverse drug reactions are recorded
emergency drugs and biologicals to its and reported immediately to a physi-
clients. Drugs and biologicals may be cian.
obtained from community or contract
(l) Standard: Drug storage and record-
pharmacists or the facility may main-
keeping. (1) The facility must store
tain a licensed pharmacy.
drugs under proper conditions of sani-
(j) Standard: Drug regimen review. (1)
tation, temperature, light, humidity,
A pharmacist with input from the
and security.
interdisciplinary team must review the
drug regimen of each client at least (2) The facility must keep all drugs
quarterly. and biologicals locked except when
(2) The pharmacist must report any being prepared for administration.
irregularities in clients’ drug regimens Only authorized persons may have ac-
to the prescribing physician and inter- cess to the keys to the drug storage
disciplinary team. area. Clients who have been trained to
(3) The pharmacist must prepare a self administer drugs in accordance
record of each client’s drug regimen re- with § 483.460(k)(4) may have access to
views and the facility must maintain keys to their individual drug supply.
that record. (3) The facility must maintain
(4) An individual medication admin- records of the receipt and disposition of
istration record must be maintained all controlled drugs.
for each client. (4) The facility must, on a sample
(5) As appropriate the pharmacist basis, periodically reconcile the receipt
must participate in the development, and disposition of all controlled drugs
implementation, and review of each in schedules II through IV (drugs sub-
client’s individual program plan either ject to the Comprehensive Drug Abuse
in person or through written report to Prevention and Control Act of 1970, 21
the interdisciplinary team. U.S.C. 801 et seq., as implemented by 21
(k) Standard: Drug administration. The CFR part 308).
facility must have an organized system (5) If the facility maintains a li-
for drug administration that identifies censed pharmacy, the facility must
each drug up to the point of adminis- comply with the regulations for con-
tration. The system must assure that— trolled drugs.
(1) All drugs are administered in (m) Standard: Drug labeling. (1) Label-
compliance with the physician’s orders; ing of drugs and biologicals must—
(2) All drugs, including those that are (i) Be based on currently accepted
self-administered, are administered professional principles and practices;
without error; and
151
§ 483.470 42 CFR Ch. IV (10–1–24 Edition)
(ii) Include the appropriate accessory and at least 80 square feet in single cli-
and cautionary instructions, as well as ent bedrooms; and
the expiration date, if applicable. (v) In all facilities initially certified,
(2) The facility must remove from or in buildings constructed or with
use— major renovations or conversions on or
(i) Outdated drugs; and after October 3, 1988, have walls that
(ii) Drug containers with worn, illegi- extend from floor to ceiling.
ble, or missing labels. (2) If a bedroom is below grade level,
(3) Drugs and biologicals packaged in it must have a window that—
containers designated for a particular (i) Is usable as a second means of es-
client must be immediately removed cape by the client(s) occupying the
from the client’s current medication room; and
supply if discontinued by the physi- (ii) Is no more than 44 inches (meas-
cian. ured to the window sill) above the floor
(n) Standard: Laboratory services. (1) If unless the facility is surveyed under
a facility chooses to provide laboratory the Health Care Occupancy Chapter of
services, the laboratory must meet the the Life Safety Code, in which case the
requirements specified in part 493 of window must be no more than 36 inches
this chapter. (measured to the window sill) above
(2) If the laboratory chooses to refer the floor.
specimens for testing to another lab- (3) The survey agency may grant a
oratory, the referral laboratory must variance from the limit of four clients
be certified in the appropriate special- per room only if a physician who is a
ties and subspecialities of service in ac- member of the interdisciplinary team
cordance with the requirements of part and who is a qualified intellectual dis-
493 of this chapter. ability professional—
(i) Certifies that each client to be
FR 7136, Feb. 28, 1992; 86 FR 26336, May 13, placed in a bedroom housing more than
2021; 86 FR 61621, Nov. 5, 2021] four persons is so severely medically
impaired as to require direct and con-
§ 483.470 Condition of participation: tinuous monitoring during sleeping
Physical environment. hours; and
(a) Standard: Client living environment. (ii) Documents the reasons why hous-
(1) The facility must not house clients ing in a room of only four or fewer per-
of grossly different ages, develop- sons would not be medically feasible.
mental levels, and social needs in close (4) The facility must provide each cli-
physical or social proximity unless the ent with—
housing is planned to promote the (i) A separate bed of proper size and
growth and development of all those height for the convenience of the cli-
housed together. ent;
(2) The facility must not segregate (ii) A clean, comfortable, mattress;
clients solely on the basis of their (iii) Bedding appropriate to the
physical disabilities. It must integrate weather and climate; and
clients who have ambulation deficits or (iv) Functional furniture appropriate
who are deaf, blind, or have seizure dis- to the client’s needs, and individual
orders, etc., with others of comparable closet space in the client’s bedroom
social and intellectual development. with clothes racks and shelves acces-
(b) Standard: Client bedrooms. (1) Bed- sible to the client.
rooms must— (c) Standard: Storage space in bedroom.
(i) Be rooms that have at least one The facility must provide—
outside wall; (1) Space and equipment for daily
(ii) Be equipped with or located near out-of-bed activity for all clients who
toilet and bathing facilities; are not yet mobile, except those who
(iii) Accommodate no more than four have a short-term illness or those few
clients unless granted a variance under clients for whom out-of-bed activity is
paragraph (b)(3) of this section; a threat to health and safety; and
(iv) Measure at least 60 square feet (2) Suitable storage space, accessible
per client in multiple client bedrooms to clients, for personal possessions,
152
such as TVs, radios, prosthetic equip- informed choices about the use of den-
ment and clothing. tures, eyeglasses, hearing and other
(d) Standard: Client bathrooms. The fa- communications aids, braces, and other
cility must— devices identified by the interdiscipli-
(1) Provide toilet and bathing facili- nary team as needed by the client.
ties appropriate in number, size, and (3) Provide adequate clean linen and
design to meet the needs of the clients; dirty linen storage areas.
(2) Provide for individual privacy in (h) [Reserved]
toilets, bathtubs, and showers; and (i) Standard: Evacuation drills. (1) The
(3) In areas of the facility where cli- facility must hold evacuation drills at
ents who have not been trained to reg- least quarterly for each shift of per-
ulate water temperature are exposed to sonnel and under varied conditions to—
hot water, ensure that the temperature (i) Ensure that all personnel on all
of the water does not exceed 110 shifts are trained to perform assigned
°Fahrenheit. tasks;
(e) Standard: Heating and ventilation. (ii) Ensure that all personnel on all
(1) Each client bedroom in the facility shifts are familiar with the use of the
must have— facility’s fire protection features; and
(i) At least one window to the out- (iii) Evaluate the effectiveness of
side; and emergency and disaster plans and pro-
(ii) Direct outside ventilation by cedures.
means of windows, air conditioning, or (2) The facility must—
mechanical ventilation. (i) Actually evacuate clients during
(2) The facility must— at least one drill each year on each
(i) Maintain the temperature and hu- shift;
midity within a normal comfort range (ii) Make special provisions for the
by heating, air conditioning or other evacuation of clients with physical dis-
means; and abilities;
(ii) Ensure that the heating appa- (iii) File a report and evaluation on
ratus does not constitute a burn or each evacuation drill;
smoke hazard to clients. (iv) Investigate all problems with
(f) Standard: Floors. The facility must evacuation drills, including accidents,
have— and take corrective action; and
(1) Floors that have a resilient, non- (v) During fire drills, clients may be
abrasive, and slip-resistant surface; evacuated to a safe area in facilities
(2) Nonabrasive carpeting, if the area certified under the Health Care Occu-
used by clients is carpeted and serves pancies Chapter of the Life Safety
clients who lie on the floor or ambulate Code.
with parts of their bodies, other than (3) Facilities must meet the require-
feet, touching the floor; and ments of paragraphs (i)(1) and (2) of
(3) Exposed floor surfaces and floor this section for any live-in and relief
coverings that promote mobility in staff they utilize.
areas used by clients, and promote (j) Standard: Fire protection—(1) Gen-
maintenance of sanitary conditions. eral. Except as otherwise provided in
(g) Standard: Space and equipment. this section—
The facility must— (i) The facility must meet the appli-
(1) Provide sufficient space and cable provisions of either the Health
equipment in dining, living, health Care Occupancies Chapters or the Resi-
services, recreation, and program areas dential Board and Care Occupancies
(including adequately equipped and Chapter and must proceed in accord-
sound treated areas for hearing and ance with the Life Safety Code (NFPA
other evaluations if they are conducted 101 and Tentative Interim Amendments
in the facility) to enable staff to pro- TIA 12–1, TIA 12–2, TIA 12–3, and TIA
vide clients with needed services as re- 12–4.)
quired by this subpart and as identified (ii) Notwithstanding paragraph
in each client’s individual program (j)(1)(i) of this section, corridor doors
plan. and doors to rooms containing flam-
(2) Furnish, maintain in good repair, mable or combustible materials must
and teach clients to use and to make be provided with positive latching
153
§ 483.470 42 CFR Ch. IV (10–1–24 Edition)
hardware. Roller latches are prohibited Chapter 33.2.3.5.7.2, heat detection sys-
on such doors. tems in attics of the Life Safety Code.
(iii) Chapters 32.3.2.11.2 and 33.3.2.11.2 (v) Except as otherwise provided in
of the adopted 2012 Life Safety Code do this section, ICF–IIDs must meet the
not apply to a facility. applicable provisions and must proceed
(iv) Beginning July 5, 2019, an ICF– in accordance with the Health Care Fa-
IID must be in compliance with Chap- cilities Code (NFPA 99 and Tentative
ter 33.2.3.5.7.1, Sprinklers in attics, or Interim Amendments TIA 12–2, TIA 12–
Chapter 33.2.3.5.7.2, Heat detection sys- 3, TIA 12–4, TIA 12–5 and TIA 12–6).
tems in attics of the Life Safety Code. (A) Chapter 7,8,12 and 13 of the adopt-
(2) The State survey agency may ed Health Care Facilities Code does not
apply a single chapter of the LSC to apply to an ICF–IID.
the entire facility or may apply dif- (B) If application of the Health Care
ferent chapters to different buildings Facilities Code required under para-
or parts of buildings as permitted by graph (j)(5)(iv) of this section would re-
the LSC. sult in unreasonable hardship for the
(3) A facility that meets the LSC def- ICF–IID, CMS may waive specific pro-
inition of a residential board and care visions of the Health Care Facilities
occupancy must have its evacuation Code, but only if the waiver does not
capability evaluated in accordance adversely affect the health and safety
with the Evacuation Difficulty Index of of clients.
the Fire Safety Evaluation System for (k) Standard: Paint. The facility
Board and Care facilities (FSES/BC). must—
(4) If CMS finds that the State has a (1) Use lead-free paint inside the fa-
fire and safety code imposed by State cility; and
law that adequately protects a facili- (2) Remove or cover interior paint or
ty’s clients, CMS may allow the State plaster containing lead so that it is not
survey agency to apply the State’s fire accessible to clients.
and safety code instead of the LSC. (l) Standard: Infection control. (1) The
(5) Facilities that meet the Life Safety facility must provide a sanitary envi-
Code definition of a health care occu- ronment to avoid sources and trans-
pancy. (i) In consideration of a rec- mission of infections. There must be an
ommendation by the State survey active program for the prevention, con-
agency or Accrediting Organization or trol, and investigation of infection and
at the discretion of the Secretary, may communicable diseases.
waive, for periods deemed appropriate, (2) The facility must implement suc-
specific provisions of the Life Safety cessful corrective action in affected
Code, which would result in unreason- problem areas.
able hardship upon a residential board (3) The facility must maintain a
and care facility, but only if the waiver record of incidents and corrective ac-
will not adversely affect the health and tions related to infections.
safety of the patients. (4) The facility must prohibit em-
(ii) A facility may install alcohol- ployees with symptoms or signs of a
based hand rub dispensers if the dis- communicable disease from direct con-
pensers are installed in a manner that tact with clients and their food.
adequately protects against inappro- (m) The standards incorporated by
priate access. reference in this section are approved
(iii) When a sprinkler system is shut for incorporation by reference by the
down for more than 10 hours, the ICF– Director of the Office of the Federal
IID must: Register in accordance with 5 U.S.C.
(A) Evacuate the building or portion 552(a) and 1 CFR part 51. You may in-
of the building affected by the system spect a copy at the CMS Information
outage until the system is back in Resource Center, 7500 Security Boule-
service, or vard, Baltimore, MD or at the National
(B) Establish a fire watch until the Archives and Records Administration
system is back in service. (NARA). For information on the avail-
(iv) Beginning July 5, 2019, an ICF– ability of this material at NARA, call
IID must be in compliance with Chap- 202–741–6030, or go to: http://
ter 33.2.3.5.7.1, sprinklers in attics, or www.archives.gov/federal_register/
154
code_of_federal_regulations/ years The plan must do all of the fol-

ibr_locations.html. If any changes in this lowing:
edition of the Code are incorporated by (1) Be based on and include a docu-
reference, CMS will publish a documented, facility-based and community-
ment in the FEDERAL REGISTER to an- based risk assessment, utilizing an all-
nounce the changes. hazards approach, including missing
(1) National Fire Protection Associa- clients.
tion, 1 Batterymarch Park, Quincy, (2) Include strategies for addressing
MA 02169, www.nfpa.org, 1.617.770.3000. emergency events identified by the
(i) NFPA 99, Standards for Health risk assessment.
Care Facilities Code of the National (3) Address the special needs of its
Fire Protection Association 99, 2012 client population, including, but not
edition, issued August 11, 2011. limited to, persons at-risk; the type of
(ii) TIA 12–2 to NFPA 99, issued Au- services the ICF/IID has the ability to
gust 11, 2011. provide in an emergency; and con-
(iii) TIA 12–3 to NFPA 99, issued Au- tinuity of operations, including delega-
gust 9, 2012. tions of authority and succession
(iv) TIA 12–4 to NFPA 99, issued plans.
March 7, 2013. (4) Include a process for cooperation
(v) TIA 12–5 to NFPA 99, issued Au- and collaboration with local, tribal, re-
gust 1, 2013. gional, State, and Federal emergency
preparedness officials’ efforts to main-
(vi) TIA 12–6 to NFPA 99, issued
tain an integrated response during a
March 3, 2014.
disaster or emergency situation.
(vii) NFPA 101, Life Safety Code, 2012
(b) Policies and procedures. The ICF/
edition, issued August 11, 2011;
IID must develop and implement emer-
(viii) TIA 12–1 to NFPA 101, issued gency preparedness policies and proce-
August 11, 2011. dures, based on the emergency plan set
(ix) TIA 12–2 to NFPA 101, issued Oc- forth in paragraph (a) of this section,
tober 30, 2012. risk assessment at paragraph (a)(1) of
(x) TIA 12–3 to NFPA 101, issued Oc- this section, and the communication
tober 22, 2013. plan at paragraph (c) of this section.
(xi) TIA 12–4 to NFPA 101, issued Oc- The policies and procedures must be re-
tober 22, 2013. viewed and updated at least every 2
(2) [Reserved] years. At a minimum, the policies and
[53 FR 20496, June 3, 1988. Redesignated at 56 procedures must address the following:
FR 48918, Sept. 26, 1991, as amended at 68 FR (1) The provision of subsistence needs
1387, Jan. 10, 2003; 69 FR 49271, Aug. 11, 2004; for staff and clients, whether they
70 FR 15239, Mar. 25, 2005; 71 FR 55340, Sept. evacuate or shelter in place, include,
22, 2006; 81 FR 26900, May 4, 2016; 81 FR 64032, but are not limited to the following:
Sept. 16, 2016] (i) Food, water, medical, and pharma-
ceutical supplies.
§ 483.475 Condition of participation: (ii) Alternate sources of energy to
Emergency preparedness. maintain the following:
The Intermediate Care Facility for (A) Temperatures to protect client
Individuals with Intellectual Disabil- health and safety and for the safe and
ities (ICF/IID) must comply with all sanitary storage of provisions.
applicable Federal, State, and local (B) Emergency lighting.
emergency preparedness requirements. (C) Fire detection, extinguishing, and
The ICF/IID must establish and main- alarm systems.
tain an emergency preparedness pro- (D) Sewage and waste disposal.
gram that meets the requirements of (2) A system to track the location of
this section. The emergency prepared- on-duty staff and sheltered clients in
ness program must include, but not be the ICF/IID’s care during and after an
limited to, the following elements: emergency. If on-duty staff and shel-
(a) Emergency plan. The ICF/IID must tered clients are relocated during the
develop and maintain an emergency emergency, the ICF/IID must document
preparedness plan that must be re- the specific name and location of the
viewed, and updated at least every 2 receiving facility or other location.
155
§ 483.475 42 CFR Ch. IV (10–1–24 Edition)
(3) Safe evacuation from the ICF/IID, (iii) The State Licensing and Certifi-
which includes consideration of care cation Agency.
and treatment needs of evacuees; staff (iv) The State Protection and Advo-
responsibilities; transportation; identi- cacy Agency.
fication of evacuation location(s); and (3) Primary and alternate means for
primary and alternate means of com- communicating with the ICF/IID’s
munication with external sources of as- staff, Federal, State, tribal, regional,
sistance. and local emergency management
(4) A means to shelter in place for cli- agencies.
ents, staff, and volunteers who remain (4) A method for sharing information
in the facility. and medical documentation for clients
(5) A system of medical documenta- under the ICF/IID’s care, as necessary,
tion that preserves client information, with other health care providers to
protects confidentiality of client infor- maintain the continuity of care.
mation, and secures and maintains the (5) A means, in the event of an evacu-
availability of records. ation, to release client information as
(6) The use of volunteers in an emer- permitted under 45 CFR 164.510(b)(1)(ii).
gency or other emergency staffing (6) A means of providing information
strategies, including the process and about the general condition and loca-
role for integration of State or Feder- tion of clients under the facility’s care
ally designated health care profes- as permitted under 45 CFR 164.510(b)(4).
sionals to address surge needs during (7) A means of providing information
an emergency. about the ICF/IID’s occupancy, needs,
(7) The development of arrangements and its ability to provide assistance, to
with other ICF/IIDs or other providers the authority having jurisdiction, the
to receive clients in the event of limi- Incident Command Center, or designee.
tations or cessation of operations to (8) A method for sharing information
maintain the continuity of services to from the emergency plan that the fa-
ICF/IID clients. cility has determined is appropriate
(8) The role of the ICF/IID under a with clients and their families or rep-
waiver declared by the Secretary, in resentatives.
accordance with section 1135 of the (d) Training and testing. The ICF/IID
Act, in the provision of care and treat- must develop and maintain an emer-
ment at an alternate care site identi- gency preparedness training and test-
fied by emergency management offi- ing program that is based on the emer-
cials. gency plan set forth in paragraph (a) of
(c) Communication plan. The ICF/IID this section, risk assessment at para-
must develop and maintain an emer- graph (a)(1) of this section, policies and
gency preparedness communication procedures at paragraph (b) of this sec-
plan that complies with Federal, State, tion, and the communication plan at
and local laws and must be reviewed paragraph (c) of this section. The train-
and updated at least every 2 years. The ing and testing program must be re-
communication plan must include the viewed and updated at least every 2
following: years. The ICF/IID must meet the re-
(1) Names and contact information quirements for evacuation drills and
for the following: training at § 483.470(i).
(i) Staff. (1) Training program. The ICF/IID
(ii) Entities providing services under must do all the following:
arrangement. (i) Initial training in emergency pre-
(iii) Clients’ physicians. paredness policies and procedures to all
(iv) Other ICF/IIDs. new and existing staff, individuals pro-
(v) Volunteers. viding services under arrangement, and
(2) Contact information for the fol- volunteers, consistent with their ex-
lowing: pected roles.
(i) Federal, State, tribal, regional, (ii) Provide emergency preparedness
and local emergency preparedness training at least every 2 years.
staff. (iii) Maintain documentation of the
(ii) Other sources of assistance. training.
156
(iv) Demonstrate staff knowledge of tively participated in the development

emergency procedures. of the unified and integrated emer-
(v) If the emergency preparedness gency preparedness program.
policies and procedures are signifi- (2) Be developed and maintained in a
cantly updated, the ICF/IID must con- manner that takes into account each
duct training on the updated policies separately certified facility’s unique
and procedures. circumstances, patient populations,
(2) Testing. The ICF/IID must conduct and services offered.
exercises to test the emergency plan at (3) Demonstrate that each separately
least twice per year. The ICF/IID must certified facility is capable of actively
do the following: using the unified and integrated emer-
(i) Participate in an annual full-scale gency preparedness program and is in
exercise that is community-based; or compliance with the program.
(A) When a community-based exer- (4) Include a unified and integrated
cise is not accessible, conduct an an- emergency plan that meets the require-
nual individual, facility-based func- ments of paragraphs (a)(2), (3), and (4)
tional exercise; or. of this section. The unified and inte-
(B) If the ICF/IID experiences an ac- grated emergency plan must also be
tual natural or man-made emergency based on and include all of the fol-
that requires activation of the emer- lowing:
gency plan, the ICF/IID is exempt from (i) A documented community-based
engaging in its next required full-scale risk assessment, utilizing an all-haz-
community-based or individual, facil- ards approach.
ity-based functional exercise following (ii) A documented individual facility-
the onset of the emergency event. based risk assessment for each sepa-
(ii) Conduct an additional annual ex- rately certified facility within the
ercise that may include, but is not lim- health system, utilizing an all-hazards
ited to the following: approach.
(A) A second full-scale exercise that (5) Include integrated policies and
is community-based or an individual, procedures that meet the requirements
facility-based functional exercise; or set forth in paragraph (b) of this sec-
(B) A mock disaster drill; or tion, a coordinated communication
(C) A tabletop exercise or workshop plan and training and testing programs
that is led by a facilitator and includes that meet the requirements of para-
a group discussion, using a narrated, graphs (c) and (d) of this section, re-
clinically-relevant emergency scenario, spectively.
and a set of problem statements, di-
rected messages, or prepared questions [81 FR 64032, Sept. 16, 2016, as amended at 84
designed to challenge an emergency FR 51824, Sept. 30, 2019]
plan.
(iii) Analyze the ICF/IID’s response Dietetic services.
to and maintain documentation of all
drills, tabletop exercises, and emer- (a) Standard: Food and nutrition serv-
gency events, and revise the ICF/IID’s ices. (1) Each client must receive a
emergency plan, as needed. nourishing, well-balanced diet includ-
(e) Integrated healthcare systems. If an ing modified and specially-prescribed
ICF/IID is part of a healthcare system diets.
consisting of multiple separately cer- (2) A qualified dietitian must be em-
tified healthcare facilities that elects ployed either full-time, part-time, or
to have a unified and integrated emer- on a consultant basis at the facility’s
gency preparedness program, the ICF/ discretion.
IID may choose to participate in the (3) If a qualified dietitian is not em-
healthcare system’s coordinated emer- ployed full-time, the facility must des-
gency preparedness program. If elected, ignate a person to serve as the director
the unified and integrated emergency of food services.
preparedness program must do all of (4) The client’s interdisciplinary
the following: team, including a qualified dietitian
(1) Demonstrate that each separately and physician, must prescribe all modi-
certified facility within the system ac- fied and special diets including those
157
used as a part of a program to manage (3) Equip areas with tables, chairs,
inappropriate client behavior. eating utensils, and dishes designed to
(5) Foods proposed for use as a pri- meet the developmental needs of each
mary reinforcement of adaptive behav- client;
ior are evaluated in light of the client’s (4) Supervise and staff dining rooms
nutritional status and needs. adequately to direct self-help dining
(6) Unless otherwise specified by med- procedure, to assure that each client
ical needs, the diet must be prepared at receives enough food and to assure that
least in accordance with the latest edi- each client eats in a manner consistent
tion of the recommended dietary allow- with his or her developmental level:
ances of the Food and Nutrition Board and
of the National Research Council, Na- (5) Ensure that each client eats in an
tional Academy of Sciences, adjusted upright position, unless otherwise spec-
for age, sex, disability and activity. ified by the interdisciplinary team or a
(b) Standard: Meal services. (1) Each physician.
client must receive at least three
meals daily, at regular times com- PART 484—HOME HEALTH
parable to normal mealtimes in the SERVICES
community with—
(i) Not more than 14 hours between a Subpart A—General Provisions
substantial evening meal and breakfast
of the following day, except on week- Sec.
ends and holidays when a nourishing 484.1 Basis and scope.
snack is provided at bedtime, 16 hours 484.2 Definitions.
may elapse between a substantial
Subpart B—Patient Care
evening meal and breakfast; and
(ii) Not less than 10 hours between 484.40 Condition of participation: Release of
breakfast and the evening meal of the patient identifiable OASIS information.
same day, except as provided under 484.45 Condition of participation: Reporting
paragraph (b)(1)(i) of this section. OASIS information.
(2) Food must be served— 484.50 Condition of participation: Patient
rights.
(i) In appropriate quantity;
484.55 Condition of participation: Com-
(ii) At appropriate temperature; prehensive assessment of patients.
(iii) In a form consistent with the de- 484.58 Condition of participation: Discharge
velopmental level of the client; and planning.
(iv) With appropriate utensils. 484.60 Condition of participation: Care plan-
(3) Food served to clients individ- ning, coordination of services, and qual-
ually and uneaten must be discarded. ity of care.
(c) Standard: Menus. (1) Menus must— 484.65 Condition of participation: Quality
(i) Be prepared in advance; assessment and performance improve-
ment (QAPI).
(ii) Provide a variety of foods at each 484.70 Condition of participation: Infection
meal; prevention and control.
(iii) Be different for the same days of 484.75 Condition of participation: Skilled
each week and adjusted for seasonal professional services.
changes; and 484.80 Condition of participation: Home
(iv) Include the average portion sizes health aide services.
for menu items.
(2) Menus for food actually served Subpart C—Organizational Environment
must be kept on file for 30 days. 484.100 Condition of participation: Compli-
(d) Standard: Dining areas and service. ance with Federal, State, and local laws
The facility must— and regulations related to health and
(1) Serve meals for all clients, includ- safety of patients.
ing persons with ambulation deficits, 484.102 Condition of participation: Emer-
in dining areas, unless otherwise speci- gency preparedness.
484.105 Condition of participation: Organiza-
fied by the interdisciplinary team or a
tion and administration of services.
physician; 484.110 Condition of participation: Clinical
(2) Provide table service for all cli- records.
ents who can and will eat at a table, in- 484.115 Condition of participation: Per-
cluding clients in wheelchairs; sonnel qualifications.
158
Subpart D [Reserved] model data under the expanded Home

Health Value-Based Purchasing (HHVBP)
Subpart E—Prospective Payment System Model.
for Home Health Agencies 484.358 HHVBP Measure removal factors.
484.360 Calculation of the Total Perform-
484.200 Basis and scope. ance Score.
484.202 Definitions. 484.365 Payments for home health services
484.205 Basis of payment. under the Expanded Home Health Value-
484.215 Initial establishment of the calcula- Based Purchasing (HHVBP) Model.
tion of the national, standardized pro- 484.370 Process for determining and apply-
spective payment rates. ing the value-based payment adjustment
484.220 Calculation of the case-mix and under the Expanded Home Health Value-
wage area adjusted prospective payment Based Purchasing (HHVBP) Model.
rates. 484.375 Appeals process for the Expanded
484.225 Annual update of the unadjusted na- Home Health Value-Based Purchasing
tional, standardized prospective payment (HHVBP) Model.
rates.
AUTHORITY: 42 U.S.C. 1302 and 1395hh.
484.230 Low-utilization payment adjust-
ments. SOURCE: 54 FR 33367, Aug. 14, 1989, unless
484.235 Partial payment adjustments. otherwise noted.
484.240 Outlier payments.
484.245 Requirements under the Home Subpart A—General Provisions
Health Quality Reporting Program (HH
QRP).
484.250 OASIS data. SOURCE: 82 FR 4578, Jan. 13, 2017, unless
484.260 Limitation on review. otherwise noted.
484.265 Additional payment.
§ 484.1 Basis and scope.
Subpart F—Home Health Value-Based (a) Basis. This part is based on:
Purchasing (HHVBP) Models (1) Sections 1861(o) and 1891 of the
HHVBP MODEL COMPONENTS FOR COMPETING Act, which establish the conditions
HOME HEALTH AGENCIES WITHIN STATE that an HHA must meet in order to
BOUNDARIES FOR THE ORIGINAL HHVBP participate in the Medicare program
MODEL and which, along with the additional
484.300 Basis and scope of subpart. requirements set forth in this part, are
484.305 Definitions. considered necessary to ensure the
484.310 Applicability of the Home Health health and safety of patients; and
Value-Based Purchasing (HHVBP) Model. (2) Section 1861(z) of the Act, which
484.315 Data reporting for measures and specifies the institutional planning
evaluation and the public reporting of standards that HHAs must meet.
model data under the Home Health
Value-Based Purchasing (HHVBP) Model.
(b) Scope. The provisions of this part
484.320 Calculation of the Total Perform- serve as the basis for survey activities
ance Score. for the purpose of determining whether
484.325 Payments for home health services an agency meets the requirements for
under Home Health Value-Based Pur- participation in the Medicare program.
chasing (HHVBP) Model.
484.330 Process for determining and apply- § 484.2 Definitions.
ing the value-based payment adjustment
under the Home Health Value-Based Pur-
As used in subparts A, B, and C, of
chasing (HHVBP) Model. this part—
484.335 Appeals process for the Home Health Allowed practitioner means a physi-
Value-Based Purchasing (HHVBP) Model. cian assistant, nurse practitioner, or
clinical nurse specialist as defined at
HHVBP MODEL COMPONENTS FOR COMPETING this part.
HOME HEALTH AGENCIES (HHAS) FOR
Branch office means an approved loca-
HHVBP MODEL EXPANSION—EFFECTIVE
JANUARY 1, 2022 tion or site from which a home health
agency provides services within a por-
484.340 Basis and scope of this subpart. tion of the total geographic area served
by the parent agency. The parent home
484.350 Applicability of the Expanded Home
Health Value-Based Purchasing (HHVBP) health agency must provide super-
Model. vision and administrative control of
484.355 Data reporting for measures and any branch office. It is unnecessary for
evaluation and the public reporting of the branch office to independently
159
§ 484.2 42 CFR Ch. IV (10–1–24 Edition)
meet the conditions of participation as Public agency means an agency oper-

a home health agency. ated by a state or local government.
Clinical note means a notation of a Quality indicator means a specific,
contact with a patient that is written, valid, and reliable measure of access,
timed, and dated, and which describes care outcomes, or satisfaction, or a
signs and symptoms, treatment, drugs measure of a process of care.
administered and the patient’s reaction Representative means the patient’s
or response, and any changes in phys- legal representative, such as a guard-
ical or emotional condition during a ian, who makes health-care decisions
given period of time.
on the patient’s behalf, or a patient-se-
Clinical nurse specialist means an indi-
lected representative who participates
vidual as defined at § 410.76(a) and (b) of
this chapter, and who is working in in making decisions related to the pa-
collaboration with the physician as de- tient’s care or well-being, including but
fined at § 410.76(c)(3) of this chapter. not limited to, a family member or an
In advance means that HHA staff advocate for the patient. The patient
must complete the task prior to per- determines the role of the representa-
forming any hands-on care or any pa- tive, to the extent possible.
tient education. Simulation means a training and as-
Nurse practitioner means an individual sessment technique that mimics the re-
as defined at § 410.75(a) and (b) of this ality of the homecare environment, in-
chapter, and who is working in collabo- cluding environmental distractions and
ration with the physician as defined at constraints that evoke or replicate
§ 410.75(c)(3) of this chapter. substantial aspects of the real world in
Parent home health agency means the a fully interactive fashion, in order to
agency that provides direct support teach and assess proficiency in per-
and administrative control of a branch. forming skills, and to promote decision
Physician is a doctor of medicine, os- making and critical thinking.
teopathy, or podiatric medicine, and Subdivision means a component of a
who is not precluded from performing multi-function health agency, such as
this function under paragraph (d) of
the home care department of a hospital
this section. (A doctor of podiatric
or the nursing division of a health de-
medicine may perform only plan of
treatment functions that are con- partment, which independently meets
sistent with the functions he or she is the conditions of participation for
authorized to perform under State HHAs. A subdivision that has branch
law.) offices is considered a parent agency.
Physician assistant means an indi- Summary report means the compila-
vidual as defined at § 410.74(a) and (c) of tion of the pertinent factors of a pa-
this chapter. tient’s clinical notes that is submitted
Primary home health agency means the to the patient’s physician, physician
HHA which accepts the initial referral assistant, nurse practitioner, or clin-
of a patient, and which provides serv- ical nurse specialist.
ices directly to the patient or via an- Supervised practical training means
other health care provider under ar- training in a practicum laboratory or
rangements (as applicable). other setting in which the trainee dem-
Proprietary agency means a private, onstrates knowledge while providing
for-profit agency. covered services to an individual under
Pseudo-patient means a person the direct supervision of either a reg-
trained to participate in a role-play istered nurse or a licensed practical
situation, or a computer-based man- nurse who is under the supervision of a
nequin device. A pseudo-patient must registered nurse.
be capable of responding to and inter-
Verbal order means a physician, phy-
acting with the home health aide train-
ee, and must demonstrate the general sician assistant, nurse practitioner, or
characteristics of the primary patient clinical nurse specialist order that is
population served by the HHA in key spoken to appropriate personnel and
areas such as age, frailty, functional later put in writing for the purposes of
status, and cognitive status.
160
documenting as well as establishing or (d) Standard: Data Format. The HHA

revising the patient’s plan of care. must encode and transmit data using
the software available from CMS or
FR 51825, Sept. 30, 2019; 85 FR 27627, May 8,
software that conforms to CMS stand-
2020] ard electronic record layout, edit speci-
fications, and data dictionary, and that
includes the required OASIS data set.
Subpart B—Patient Care
FR 70356, Nov. 4, 2020]
SOURCE: 82 FR 4578, Jan. 13, 2017, unless
otherwise noted. § 484.50 Condition of participation: Pa-
tient rights.
§ 484.40 Condition of participation: Re-
lease of patient identifiable OASIS The patient and representative (if
information. any), have the right to be informed of
the patient’s rights in a language and
The HHA and agent acting on behalf
manner the individual understands.
of the HHA in accordance with a writ-
The HHA must protect and promote
ten contract must ensure the confiden-
the exercise of these rights.
tiality of all patient identifiable infor-
(a) Standard: Notice of rights. The
mation contained in the clinical
HHA must—
record, including OASIS data, and may
(1) Provide the patient and the pa-
not release patient identifiable OASIS
tient’s legal representative (if any), the
information to the public.
following information during the ini-
§ 484.45 Condition of participation: Re- tial evaluation visit, in advance of fur-
porting OASIS information. nishing care to the patient:
(i) Written notice of the patient’s
HHAs must electronically report all rights and responsibilities under this
OASIS data collected in accordance rule, and the HHA’s transfer and dis-
with § 484.55. charge policies as set forth in para-
(a) Standard: Encoding and transmit- graph (d) of this section. Written no-
ting OASIS data. An HHA must encode tice must be understandable to persons
and electronically transmit each com- who have limited English proficiency
pleted OASIS assessment to the CMS and accessible to individuals with dis-
system, regarding each beneficiary abilities;
with respect to which information is (ii) Contact information for the HHA
required to be transmitted (as deter- administrator, including the adminis-
mined by the Secretary), within 30 trator’s name, business address, and
days of completing the assessment of business phone number in order to re-
the beneficiary. ceive complaints.
(b) Standard: Accuracy of encoded (iii) An OASIS privacy notice to all
OASIS data. The encoded OASIS data patients for whom the OASIS data is
must accurately reflect the patient’s collected.
status at the time of assessment. (2) Obtain the patient’s or legal rep-
(c) Standard: Transmittal of OASIS resentative’s signature confirming that
data. An HHA must— he or she has received a copy of the no-
(1) For all completed assessments, tice of rights and responsibilities.
transmit OASIS data in a format that (3) [Reserved]
meets the requirements of paragraph (4) Provide written notice of the pa-
(d) of this section. tient’s rights and responsibilities under
(2) Transmit data using electronic this rule and the HHA’s transfer and
communications software that com- discharge policies as set forth in para-
plies with the Federal Information graph (d) of this section to a patient-
Processing Standard (FIPS 140–2, selected representative within 4 busi-
issued May 25, 2001) from the HHA or ness days of the initial evaluation
the HHA contractor to the CMS collec- visit.
tion site. (b) Standard: Exercise of rights. (1) If a
(3) Transmit data that includes the patient has been adjudged to lack legal
CMS-assigned branch identification capacity to make health care decisions
number, as applicable. as established by state law by a court
161
§ 484.50 42 CFR Ch. IV (10–1–24 Edition)
of proper jurisdiction, the rights of the Medicare, Medicaid, or any other feder-
patient may be exercised by the person ally-funded or federal aid program
appointed by the state court to act on known to the HHA,
the patient’s behalf. (ii) The charges for services that may
(2) If a state court has not adjudged a not be covered by Medicare, Medicaid,
patient to lack legal capacity to make or any other federally-funded or federal
health care decisions as defined by aid program known to the HHA,
state law, the patient’s representative (iii) The charges the individual may
may exercise the patient’s rights. have to pay before care is initiated;
(3) If a patient has been adjudged to and
lack legal capacity to make health (iv) Any changes in the information
care decisions under state law by a provided in accordance with paragraph
court of proper jurisdiction, the pa- (c)(7) of this section when they occur.
tient may exercise his or her rights to The HHA must advise the patient and
the extent allowed by court order. representative (if any), of these
(c) Standard: Rights of the patient. The changes as soon as possible, in advance
patient has the right to— of the next home health visit. The HHA
(1) Have his or her property and per- must comply with the patient notice
son treated with respect; requirements at 42 CFR 411.408(d)(2)
(2) Be free from verbal, mental, sex- and 42 CFR 411.408(f).
ual, and physical abuse, including inju- (8) Receive proper written notice, in
ries of unknown source, neglect and advance of a specific service being fur-
misappropriation of property; nished, if the HHA believes that the
(3) Make complaints to the HHA re- service may be non-covered care; or in
garding treatment or care that is (or advance of the HHA reducing or termi-
fails to be) furnished, and the lack of nating on-going care. The HHA must
respect for property and/or person by also comply with the requirements of
anyone who is furnishing services on 42 CFR 405.1200 through 405.1204.
behalf of the HHA; (9) Be advised of the state toll free
(4) Participate in, be informed about, home health telephone hot line, its
and consent or refuse care in advance contact information, its hours of oper-
of and during treatment, where appro- ation, and that its purpose is to receive
priate, with respect to— complaints or questions about local
(i) Completion of all assessments; HHAs.
(ii) The care to be furnished, based on (10) Be advised of the names, address-
the comprehensive assessment; es, and telephone numbers of the fol-
(iii) Establishing and revising the lowing Federally-funded and state-
plan of care; funded entities that serve the area
(iv) The disciplines that will furnish where the patient resides:
the care; (i) Agency on Aging,
(v) The frequency of visits; (ii) Center for Independent Living,
(vi) Expected outcomes of care, in- (iii) Protection and Advocacy Agen-
cluding patient-identified goals, and cy,
anticipated risks and benefits; (iv) Aging and Disability Resource
(vii) Any factors that could impact Center; and
treatment effectiveness; and (v) Quality Improvement Organiza-
(viii) Any changes in the care to be tion.
furnished. (11) Be free from any discrimination
(5) Receive all services outlined in or reprisal for exercising his or her
the plan of care. rights or for voicing grievances to the
(6) Have a confidential clinical HHA or an outside entity.
record. Access to or release of patient (12) Be informed of the right to ac-
information and clinical records is per- cess auxiliary aids and language serv-
mitted in accordance with 45 CFR parts ices as described in paragraph (f) of
160 and 164. this section, and how to access these
(7) Be advised, orally and in writing, services.
of— (d) Standard: Transfer and discharge.
(i) The extent to which payment for The patient and representative (if any),
HHA services may be expected from have a right to be informed of the
162
HHA’s policies for transfer and dis- (iii) Provide the patient and rep-
charge. The HHA may only transfer or resentative (if any), with contact infor-
discharge the patient from the HHA if: mation for other agencies or providers
(1) The transfer or discharge is nec- who may be able to provide care; and
essary for the patient’s welfare because (iv) Document the problem(s) and ef-
the HHA and the physician or allowed forts made to resolve the problem(s),
practitioner who is responsible for the and enter this documentation into its
home health plan of care agree that the clinical records;
HHA can no longer meet the patient’s (6) The patient dies; or
needs, based on the patient’s acuity. (7) The HHA ceases to operate.
The HHA must arrange a safe and ap- (e) Standard: Investigation of com-
propriate transfer to other care enti- plaints. (1) The HHA must—
ties when the needs of the patient ex- (i) Investigate complaints made by a
ceed the HHA’s capabilities; patient, the patient’s representative (if
(2) The patient or payer will no any), and the patient’s caregivers and
longer pay for the services provided by family, including, but not limited to,
the HHA; the following topics:
(3) The transfer or discharge is appro- (A) Treatment or care that is (or fails
priate because the physician or allowed to be) furnished, is furnished inconsist-
practitioner who is responsible for the ently, or is furnished inappropriately;
home health plan of care and the HHA and
agree that the measurable outcomes (B) Mistreatment, neglect, or verbal,
and goals set forth in the plan of care mental, sexual, and physical abuse, in-
in accordance with § 484.60(a)(2)(xiv) cluding injuries of unknown source,
have been achieved, and the HHA and and/or misappropriation of patient
the physician or allowed practitioner property by anyone furnishing services
who is responsible for the home health on behalf of the HHA.
plan of care agree that the patient no (ii) Document both the existence of
longer needs the HHA’s services; the complaint and the resolution of the
(4) The patient refuses services, or complaint; and
elects to be transferred or discharged; (iii) Take action to prevent further
(5) The HHA determines, under a pol- potential violations, including retalia-
icy set by the HHA for the purpose of tion, while the complaint is being in-
addressing discharge for cause that vestigated.
meets the requirements of paragraphs (2) Any HHA staff (whether employed
(d)(5)(i) through (d)(5)(iii) of this sec- directly or under arrangements) in the
tion, that the patient’s (or other per- normal course of providing services to
sons in the patient’s home) behavior is patients, who identifies, notices, or
disruptive, abusive, or uncooperative recognizes incidences or circumstances
to the extent that delivery of care to of mistreatment, neglect, verbal, men-
the patient or the ability of the HHA tal, sexual, and/or physical abuse, in-
to operate effectively is seriously im- cluding injuries of unknown source, or
paired. The HHA must do the following misappropriation of patient property,
before it discharges a patient for cause: must report these findings imme-
(i) Advise the patient, the representa- diately to the HHA and other appro-
tive (if any), the physician(s) or al- priate authorities in accordance with
lowed practitioner(s) issuing orders for state law.
the home health plan of care, and the (f) Standard: Accessibility. Information
patient’s primary care practitioner or must be provided to patients in plain
other health care professional who will language and in a manner that is ac-
be responsible for providing care and cessible and timely to—
services to the patient after discharge (1) Persons with disabilities, includ-
from the HHA (if any) that a discharge ing accessible Web sites and the provi-
for cause is being considered; sion of auxiliary aids and services at no
(ii) Make efforts to resolve the prob- cost to the individual in accordance
lem(s) presented by the patient’s be- with the Americans with Disabilities
havior, the behavior of other persons in Act and Section 504 of the Rehabilita-
the patient’s home, or situation; tion Act.
163
§ 484.55 42 CFR Ch. IV (10–1–24 Edition)
(2) Persons with limited English pro- must complete the comprehensive as-
ficiency through the provision of lan- sessment and for Medicare patients, de-
guage services at no cost to the indi- termine eligibility for the Medicare
vidual, including oral interpretation home health benefit, including home-
and written translations. bound status.
[82 FR 4578, Jan. 13, 2017, as amended at 84 (3) When physical therapy, speech-
FR 51825, Sept. 30, 2019; 85 FR 27628, May 8, language pathology, or occupational
2020; 86 FR 62421, Nov. 9, 2021] therapy is the only service ordered by
the physician or allowed practitioner, a
§ 484.55 Condition of participation: physical therapist, speech-language pa-
Comprehensive assessment of pathologist, or occupational therapist
tients.
may complete the comprehensive as-
Each patient must receive, and an sessment, and for Medicare patients,
HHA must provide, a patient-specific, determine eligibility for the Medicare
comprehensive assessment. For Medi- home health benefit, including home-
care beneficiaries, the HHA must verify bound status. For Medicare patients,
the patient’s eligibility for the Medi- the occupational therapist may com-
care home health benefit including plete the comprehensive assessment
homebound status, both at the time of when occupational therapy is ordered
the initial assessment visit and at the with another qualifying rehabilitation
time of the comprehensive assessment. therapy service (speech-language pa-
(a) Standard: Initial assessment visit. thology or physical therapy) that es-
(1) A registered nurse must conduct an tablishes program eligibility.
initial assessment visit to determine (c) Standard: Content of the com-
the immediate care and support needs prehensive assessment. The comprehen-
of the patient; and, for Medicare pa- sive assessment must accurately re-
tients, to determine eligibility for the flect the patient’s status, and must in-
Medicare home health benefit, includ- clude, at a minimum, the following in-
ing homebound status. The initial as- formation:
sessment visit must be held either (1) The patient’s current health, psy-
within 48 hours of referral, or within 48 chosocial, functional, and cognitive
hours of the patient’s return home, or status;
on the physician or allowed practi- (2) The patient’s strengths, goals, and
tioner-ordered start of care date. care preferences, including information
(2) When rehabilitation therapy serv- that may be used to demonstrate the
ice (speech language pathology, phys- patient’s progress toward achievement
ical therapy, or occupational therapy) of the goals identified by the patient
is the only service ordered by the phy- and the measurable outcomes identi-
sician or allowed practitioner who is fied by the HHA;
responsible for the home health plan of
(3) The patient’s continuing need for
care, the initial assessment visit may
home care;
be made by the appropriate rehabilita-
tion skilled professional. For Medicare (4) The patient’s medical, nursing, re-
patients, an occupational therapist habilitative, social, and discharge plan-
may complete the initial assessment ning needs;
when occupational therapy is ordered (5) A review of all medications the
with another qualifying rehabilitation patient is currently using in order to
therapy service (speech-language pa- identify any potential adverse effects
thology or physical therapy) that es- and drug reactions, including ineffec-
tablishes program eligibility. tive drug therapy, significant side ef-
(b) Standard: Completion of the com- fects, significant drug interactions, du-
prehensive assessment. (1) The com- plicate drug therapy, and noncompli-
prehensive assessment must be com- ance with drug therapy.
pleted in a timely manner, consistent (6) The patient’s primary care-
with the patient’s immediate needs, giver(s), if any, and other available
but no later than 5 calendar days after supports, including their:
the start of care. (i) Willingness and ability to provide
(2) Except as provided in paragraph care, and
(b)(3) of this section, a registered nurse (ii) Availability and schedules;
164
(7) The patient’s representative (if but is not limited to HHA, SNF, IRF,
any); or LTCH data on quality measures and
(8) Incorporation of the current data on resource use measures. The
version of the Outcome and Assessment HHA must ensure that the post-acute
Information Set (OASIS) items, using care data on quality measures and data
the language and groupings of the on resource use measures is relevant
OASIS items, as specified by the Sec- and applicable to the patient’s goals of
retary. The OASIS data items deter- care and treatment preferences.
mined by the Secretary must include: (b) Standard: Discharge or transfer
clinical record items, demographics summary content. (1) The HHA must
and patient history, living arrange- send all necessary medical information
ments, supportive assistance, sensory pertaining to the patient’s current
status, integumentary status, res- course of illness and treatment, post-
piratory status, elimination status, discharge goals of care, and treatment
neuro/emotional/behavioral status, ac- preferences, to the receiving facility or
tivities of daily living, medications, health care practitioner to ensure the
equipment management, emergent safe and effective transition of care.
care, and data items collected at inpa- (2) The HHA must comply with re-
tient facility admission or discharge quests for additional clinical informa-
only. tion as may be necessary for treatment
(d) Standard: Update of the comprehen- of the patient made by the receiving fa-
sive assessment. The comprehensive as- cility or health care practitioner.
sessment must be updated and revised
(including the administration of the [84 FR 51883, Sept. 30, 2019]
OASIS) as frequently as the patient’s
condition warrants due to a major de- § 484.60 Condition of participation:
cline or improvement in the patient’s Care planning, coordination of serv-
ices, and quality of care.
health status, but not less frequently
than— Patients are accepted for treatment
(1) The last 5 days of every 60 days on the reasonable expectation that an
beginning with the start-of-care date, HHA can meet the patient’s medical,
unless there is a— nursing, rehabilitative, and social
(i) Beneficiary elected transfer; needs in his or her place of residence.
(ii) Significant change in condition; Each patient must receive an individ-
or ualized written plan of care, including
(iii) Discharge and return to the any revisions or additions. The individ-
same HHA during the 60-day episode. ualized plan of care must specify the
(2) Within 48 hours of the patient’s care and services necessary to meet the
return to the home from a hospital ad- patient-specific needs as identified in
mission of 24 hours or more for any the comprehensive assessment, includ-
reason other than diagnostic tests, or ing identification of the responsible
on physician or allowed practitioner- discipline(s), and the measurable out-
ordered resumption date; comes that the HHA anticipates will
(3) At discharge. occur as a result of implementing and
[82 FR 4578, Jan. 13, 2017, as amended at 85 coordinating the plan of care. The indi-
FR 27628, May 8, 2020; 86 FR 62421, Nov. 9, vidualized plan of care must also speci-
2021] fy the patient and caregiver education
and training. Services must be fur-
§ 484.58 Condition of participation: nished in accordance with accepted
Discharge planning. standards of practice.
(a) Standard: Discharge planning. An (a) Standard: Plan of care. (1) Each pa-
HHA must develop and implement an tient must receive the home health
effective discharge planning process. services that are written in an individ-
For patients who are transferred to an- ualized plan of care that identifies pa-
other HHA or who are discharged to a tient-specific measurable outcomes and
SNF, IRF or LTCH, the HHA must as- goals, and which is established, periodi-
sist patients and their caregivers in se- cally reviewed, and signed by a doctor
lecting a post-acute care provider by of medicine, osteopathy, or podiatry or
using and sharing data that includes, allowed practitioner acting within the
165
§ 484.60 42 CFR Ch. IV (10–1–24 Edition)
scope of his or her state license, certifi- (3) Verbal orders must be accepted
cation, or registration. If a physician only by personnel authorized to do so
or allowed practitioner refers a patient by applicable state laws and regula-
under a plan of care that cannot be tions and by the HHA’s internal poli-
completed until after an evaluation cies.
visit, the physician or allowed practi- (4) When services are provided on the
tioner is consulted to approve addi- basis of a physician or allowed practi-
tions or modifications to the original tioner’s verbal orders, a nurse acting in
plan. accordance with state licensure re-
(2) The individualized plan of care quirements, or other qualified practi-
must include the following: tioner responsible for furnishing or su-
(i) All pertinent diagnoses; pervising the ordered services, in ac-
(ii) The patient’s mental, psycho- cordance with state law and the HHA’s
social, and cognitive status; policies, must document the orders in
(iii) The types of services, supplies, the patient’s clinical record, and sign,
and equipment required; date, and time the orders. Verbal or-
(iv) The frequency and duration of ders must be authenticated and dated
visits to be made; by the physician or allowed practi-
(v) Prognosis; tioner in accordance with applicable
(vi) Rehabilitation potential; state laws and regulations, as well as
(vii) Functional limitations; the HHA’s internal policies.
(viii) Activities permitted; (c) Standard: Review and revision of
(ix) Nutritional requirements; the plan of care. (1) The individualized
(x) All medications and treatments; plan of care must be reviewed and re-
(xi) Safety measures to protect vised by the physician or allowed prac-
against injury; titioner who is responsible for the
(xii) A description of the patient’s home health plan of care and the HHA
risk for emergency department visits as frequently as the patient’s condition
and hospital re-admission, and all nec- or needs require, but no less frequently
essary interventions to address the un- than once every 60 days, beginning
derlying risk factors. with the start of care date. The HHA
(xiii) Patient and caregiver education must promptly alert the relevant phy-
and training to facilitate timely dis- sician(s) or allowed practitioner(s) to
charge; any changes in the patient’s condition
(xiv) Patient-specific interventions or needs that suggest that outcomes
and education; measurable outcomes are not being achieved and/or that the
and goals identified by the HHA and plan of care should be altered.
the patient; (2) A revised plan of care must reflect
(xv) Information related to any ad- current information from the patient’s
vanced directives; and updated comprehensive assessment,
(xvi) Any additional items the HHA and contain information concerning
or physician or allowed practitioner the patient’s progress toward the meas-
may choose to include. urable outcomes and goals identified
(3) All patient care orders, including by the HHA and patient in the plan of
verbal orders, must be recorded in the care.
plan of care. (3) Revisions to the plan of care must
(b) Standard: Conformance with physi- be communicated as follows:
cian or allowed practitioner orders. (1) (i) Any revision to the plan of care
Drugs, services, and treatments are ad- due to a change in patient health sta-
ministered only as ordered by a physi- tus must be communicated to the pa-
cian or allowed practitioner. tient, representative (if any), care-
(2) Influenza and pneumococcal vac- giver, and all physicians or allowed
cines may be administered per agency practitioners issuing orders for the
policy developed in consultation with a HHA plan of care.
physician, physician assistant, nurse (ii) Any revisions related to plans for
practitioner, or clinical nurse spe- the patient’s discharge must be com-
cialist, and after an assessment of the municated to the patient, representa-
patient to determine for contraindica- tive, caregiver, all physicians or al-
tions. lowed practitioners issuing orders for
166
the HHA plan of care, and the patient’s (5) Name and contact information of
primary care practitioner or other the HHA clinical manager.
health care professional who will be re-
sponsible for providing care and serv- FR 27628, May 8, 2020]
ices to the patient after discharge from
the HHA (if any). § 484.65 Condition of participation:
(d) Standard: Coordination of care. The Quality assessment and perform-
HHA must: ance improvement (QAPI).
(1) Assure communication with all The HHA must develop, implement,
physicians or allowed practitioners in- evaluate, and maintain an effective,
volved in the plan of care. ongoing, HHA-wide, data-driven QAPI
(2) Integrate orders from all physi- program. The HHA’s governing body
cians or allowed practitioners involved must ensure that the program reflects
in the plan of care to assure the coordi- the complexity of its organization and
nation of all services and interventions services; involves all HHA services (in-
provided to the patient. cluding those services provided under
(3) Integrate services, whether serv- contract or arrangement); focuses on
ices are provided directly or under ar- indicators related to improved out-
rangement, to assure the identification comes, including the use of emergent
of patient needs and factors that could care services, hospital admissions and
affect patient safety and treatment ef- re-admissions; and takes actions that
fectiveness and the coordination of address the HHA’s performance across
care provided by all disciplines. the spectrum of care, including the pre-
(4) Coordinate care delivery to meet vention and reduction of medical er-
the patient’s needs, and involve the pa- rors. The HHA must maintain docu-
tient, representative (if any), and care- mentary evidence of its QAPI program
giver(s), as appropriate, in the coordi- and be able to demonstrate its oper-
nation of care activities. ation to CMS.
(5) Ensure that each patient, and his (a) Standard: Program scope. (1) The
or her caregiver(s) where applicable, program must at least be capable of
receive ongoing education and training showing measurable improvement in
provided by the HHA, as appropriate, indicators for which there is evidence
regarding the care and services identi- that improvement in those indicators
fied in the plan of care. The HHA must will improve health outcomes, patient
provide training, as necessary, to en- safety, and quality of care.
sure a timely discharge. (2) The HHA must measure, analyze,
(e) Standard: Written information to and track quality indicators, including
the patient. The HHA must provide the adverse patient events, and other as-
patient and caregiver with a copy of pects of performance that enable the
written instructions outlining: HHA to assess processes of care, HHA
(1) Visit schedule, including fre- services, and operations.
quency of visits by HHA personnel and (b) Standard: Program data. (1) The
personnel acting on behalf of the HHA. program must utilize quality indicator
(2) Patient medication schedule/in- data, including measures derived from
structions, including: medication OASIS, where applicable, and other rel-
name, dosage and frequency and which evant data, in the design of its pro-
medications will be administered by gram.
HHA personnel and personnel acting on (2) The HHA must use the data col-
behalf of the HHA. lected to—
(3) Any treatments to be adminis- (i) Monitor the effectiveness and
tered by HHA personnel and personnel safety of services and quality of care;
acting on behalf of the HHA, including and
therapy services. (ii) Identify opportunities for im-
(4) Any other pertinent instruction provement.
related to the patient’s care and treat- (3) The frequency and detail of the
ments that the HHA will provide, spe- data collection must be approved by
cific to the patient’s care needs. the HHA’s governing body.
167
§ 484.70 42 CFR Ch. IV (10–1–24 Edition)
(c) Standard: Program activities. (1) § 484.70 Condition of participation: In-

The HHA’s performance improvement fection prevention and control.
activities must— The HHA must maintain and docu-
(i) Focus on high risk, high volume, ment an infection control program
or problem-prone areas; which has as its goal the prevention
(ii) Consider incidence, prevalence, and control of infections and commu-
and severity of problems in those nicable diseases.
areas; and (a) Standard: Prevention. The HHA
(iii) Lead to an immediate correction must follow accepted standards of prac-
of any identified problem that directly tice, including the use of standard pre-
or potentially threaten the health and cautions, to prevent the transmission
safety of patients. of infections and communicable dis-
eases.
(2) Performance improvement activi-
(b) Standard: Control. The HHA must
ties must track adverse patient events, maintain a coordinated agency-wide
analyze their causes, and implement program for the surveillance, identi-
preventive actions. fication, prevention, control, and in-
(3) The HHA must take actions aimed vestigation of infectious and commu-
at performance improvement, and, nicable diseases that is an integral part
after implementing those actions, the of the HHA’s quality assessment and
HHA must measure its success and performance improvement (QAPI) pro-
track performance to ensure that im- gram. The infection control program
provements are sustained. must include:
(d) Standard: Performance improvement (1) A method for identifying infec-
projects. Beginning July 13, 2018 HHAs tious and communicable disease prob-
must conduct performance improve- lems; and
ment projects. (2) A plan for the appropriate actions
that are expected to result in improve-
(1) The number and scope of distinct
ment and disease prevention.
improvement projects conducted annu- (c) Standard: Education. The HHA
ally must reflect the scope, com- must provide infection control edu-
plexity, and past performance of the cation to staff, patients, and care-
HHA’s services and operations. giver(s).
(2) The HHA must document the
quality improvement projects under- FR 61621, Nov. 5, 2021; 88 FR 36510, June 5,
taken, the reasons for conducting these 2023]
projects, and the measurable progress
achieved on these projects. § 484.75 Condition of participation:
(e) Standard: Executive responsibilities. Skilled professional services.
The HHA’s governing body is respon- Skilled professional services include
sible for ensuring the following: skilled nursing services, physical ther-
(1) That an ongoing program for qual- apy, speech-language pathology serv-
ity improvement and patient safety is ices, and occupational therapy, as spec-
defined, implemented, and maintained; ified in § 409.44 of this chapter, and phy-
(2) That the HHA-wide quality assess- sician or allowed practitioner and med-
ment and performance improvement ef- ical social work services as specified in
forts address priorities for improved § 409.45 of this chapter. Skilled profes-
sionals who provide services to HHA
quality of care and patient safety, and
patients directly or under arrangement
that all improvement actions are eval-
must participate in the coordination of
uated for effectiveness; care.
(3) That clear expectations for pa- (a) Standard: Provision of services by
tient safety are established, imple- skilled professionals. Skilled profes-
mented, and maintained; and sional services are authorized, deliv-
(4) That any findings of fraud or ered, and supervised only by health
waste are appropriately addressed. care professionals who meet the appro-
priate qualifications specified under
FR 31732, July 10, 2017] § 484.115 and who practice according to
the HHA’s policies and procedures.
168
(b) Standard: Responsibilities of skilled (ii) A competency evaluation pro-

professionals. Skilled professionals gram that meets the requirements of
must assume responsibility for, but not paragraph (c) of this section; or
be restricted to, the following: (iii) A nurse aide training and com-
(1) Ongoing interdisciplinary assess- petency evaluation program approved
ment of the patient; by the state as meeting the require-
(2) Development and evaluation of ments of § 483.151 through § 483.154 of
the plan of care in partnership with the this chapter, and is currently listed in
patient, representative (if any), and good standing on the state nurse aide
caregiver(s); registry; or
(3) Providing services that are or- (iv) The requirements of a state li-
dered by the physician or allowed prac- censure program that meets the provi-
titioner as indicated in the plan of sions of paragraphs (b) and (c) of this
care; section.
(4) Patient, caregiver, and family (2) A home health aide or nurse aide
counseling; is not considered to have completed a
(5) Patient and caregiver education; program, as specified in paragraph
(6) Preparing clinical notes; (a)(1) of this section, if, since the indi-
(7) Communication with all physi- vidual’s most recent completion of the
cians involved in the plan of care and program(s), there has been a contin-
other health care practitioners (as ap- uous period of 24 consecutive months
propriate) related to the current plan during which none of the services fur-
of care; nished by the individual as described in
(8) Participation in the HHA’s QAPI § 409.40 of this chapter were for com-
program; and pensation. If there has been a 24-month
(9) Participation in HHA-sponsored lapse in furnishing services for com-
in-service training. pensation, the individual must com-
(c) Supervision of skilled professional plete another program, as specified in
assistants. (1) Nursing services are pro- paragraph (a)(1) of this section, before
vided under the supervision of a reg- providing services.
istered nurse that meets the require- (b) Standard: Content and duration of
ments of § 484.115(k). home health aide classroom and super-
vised practical training. (1) Home health
(2) Rehabilitative therapy services
aide training must include classroom
are provided under the supervision of
and supervised practical training in a
an occupational therapist or physical
practicum laboratory or other setting
therapist that meets the requirements
in which the trainee demonstrates
of § 484.115(f) or (h), respectively.
knowledge while providing services to
(3) Medical social services are pro-
an individual under the direct super-
vided under the supervision of a social
vision of a registered nurse, or a li-
worker that meets the requirements of
censed practical nurse who is under the
§ 484.115(m).
supervision of a registered nurse. Class-
[82 FR 4578, Jan. 13, 2017, as amended at 85 room and supervised practical training
FR 27628, May 8, 2020] must total at least 75 hours.
(2) A minimum of 16 hours of class-
§ 484.80 Condition of participation: room training must precede a min-
Home health aide services. imum of 16 hours of supervised prac-
All home health aide services must tical training as part of the 75 hours.
be provided by individuals who meet (3) A home health aide training pro-
the personnel requirements specified in gram must address each of the fol-
paragraph (a) of this section. lowing subject areas:
(a) Standard: Home health aide quali- (i) Communication skills, including
fications. (1) A qualified home health the ability to read, write, and verbally
aide is a person who has successfully report clinical information to patients,
completed: representatives, and caregivers, as well
(i) A training and competency eval- as to other HHA staff.
uation program as specified in para- (ii) Observation, reporting, and docu-
graphs (b) and (c) respectively of this mentation of patient status and the
section; or care or service furnished.
169
§ 484.80 42 CFR Ch. IV (10–1–24 Edition)
(iii) Reading and recording tempera- (b)(3)(i), (iii), (ix), (x), and (xi) of this
ture, pulse, and respiration. section must be evaluated by observing
(iv) Basic infection prevention and an aide’s performance of the task with
control procedures. a patient or pseudo-patient. The re-
(v) Basic elements of body func- maining subject areas may be evalu-
tioning and changes in body function ated through written examination, oral
that must be reported to an aide’s su- examination, or after observation of a
pervisor. home health aide with a patient, or
(vi) Maintenance of a clean, safe, and with a pseudo-patient as part of a sim-
healthy environment. ulation.
(vii) Recognizing emergencies and (2) A home health aide competency
the knowledge of instituting emer- evaluation program may be offered by
gency procedures and their application. any organization, except as specified in
(viii) The physical, emotional, and paragraph (f) of this section.
developmental needs of and ways to (3) The competency evaluation must
work with the populations served by be performed by a registered nurse in
the HHA, including the need for respect consultation with other skilled profes-
for the patient, his or her privacy, and sionals, as appropriate.
his or her property. (4) A home health aide is not consid-
(ix) Appropriate and safe techniques ered competent in any task for which
in performing personal hygiene and
he or she is evaluated as unsatisfac-
grooming tasks that include—
tory. An aide must not perform that
(A) Bed bath;
task without direct supervision by a
(B) Sponge, tub, and shower bath;
registered nurse until after he or she
(C) Hair shampooing in sink, tub, and
has received training in the task for
bed;
which he or she was evaluated as ‘‘un-
(D) Nail and skin care;
satisfactory,’’ and has successfully
(E) Oral hygiene;
completed a subsequent evaluation. A
(F) Toileting and elimination;
home health aide is not considered to
(x) Safe transfer techniques and am-
have successfully passed a competency
bulation;
evaluation if the aide has an ‘‘unsatis-
(xi) Normal range of motion and posi-
factory’’ rating in more than one of the
tioning;
required areas.
(xii) Adequate nutrition and fluid in-
take; (5) The HHA must maintain docu-
(xiii) Recognizing and reporting mentation which demonstrates that
changes in skin condition; and the requirements of this standard have
(xiv) Any other task that the HHA been met.
may choose to have an aide perform as (d) Standard: In-service training. A
permitted under state law. home health aide must receive at least
(xv) The HHA is responsible for train- 12 hours of in-service training during
ing home health aides, as needed, for each 12-month period. In-service train-
skills not covered in the basic checking may occur while an aide is fur-
list, as described in paragraph (b)(3)(ix) nishing care to a patient.
of this section. (1) In-service training may be offered
(4) The HHA must maintain docu- by any organization and must be super-
mentation that demonstrates that the vised by a registered nurse.
requirements of this standard have (2) The HHA must maintain docu-
been met. mentation that demonstrates the re-
(c) Standard: Competency evaluation. quirements of this standard have been
An individual may furnish home health met.
services on behalf of an HHA only after (e) Standard: Qualifications for instruc-
that individual has successfully com- tors conducting classroom and supervised
pleted a competency evaluation pro- practical training. Classroom and super-
gram as described in this section. vised practical training must be per-
(1) The competency evaluation must formed by a registered nurse who pos-
address each of the subjects listed in sesses a minimum of 2 years nursing
paragraph (b)(3) of this section. Subject experience, at least 1 year of which
areas specified under paragraphs must be in home health care, or by
170
other individuals under the general su- registered nurse or other appropriate
pervision of the registered nurse. skilled professional, with written pa-
(f) Standard: Eligible training and com- tient care instructions for a home
petency evaluation organizations. A health aide prepared by that registered
home health aide training program and nurse or other appropriate skilled pro-
competency evaluation program may fessional (that is, physical therapist,
be offered by any organization except speech-language pathologist, or occu-
by an HHA that, within the previous 2 pational therapist).
years: (2) A home health aide provides serv-
(1) Was out of compliance with the ices that are:
requirements of paragraphs (b), (c), (d), (i) Ordered by the physician or al-
or (e) of this section; or lowed practitioner;
(2) Permitted an individual who does (ii) Included in the plan of care;
not meet the definition of a ‘‘qualified (iii) Permitted to be performed under
home health aide’’ as specified in para- state law; and
graph (a) of this section to furnish (iv) Consistent with the home health
home health aide services (with the ex- aide training.
ception of licensed health professionals (3) The duties of a home health aide
and volunteers); or include:
(3) Was subjected to an extended (or (i) The provision of hands-on personal
partially extended) survey as a result care;
of having been found to have furnished (ii) The performance of simple proce-
substandard care (or for other reasons dures as an extension of therapy or
as determined by CMS or the state); or nursing services;
(4) Was assessed a civil monetary (iii) Assistance in ambulation or ex-
penalty of $5,000 or more as an inter- ercises; and
mediate sanction; or (iv) Assistance in administering
(5) Was found to have compliance de- medications ordinarily self-adminis-
ficiencies that endangered the health tered.
and safety of the HHA’s patients, and (4) Home health aides must be mem-
had temporary management appointed bers of the interdisciplinary team,
to oversee the management of the must report changes in the patient’s
HHA; or condition to a registered nurse or other
(6) Had all or part of its Medicare appropriate skilled professional, and
payments suspended; or must complete appropriate records in
(7) Was found under any federal or compliance with the HHA’s policies
state law to have: and procedures.
(i) Had its participation in the Medi- (h) Standard: Supervision of home
care program terminated; or health aides. (1)(i) If home health aide
(ii) Been assessed a penalty of $5,000 services are provided to a patient who
or more for deficiencies in federal or is receiving skilled nursing, physical or
state standards for HHAs; or occupational therapy, or speech lan-
(iii) Been subjected to a suspension of guage pathology services—
Medicare payments to which it other- (A) A registered nurse or other appro-
wise would have been entitled; or priate skilled professional who is fa-
(iv) Operated under temporary man- miliar with the patient, the patient’s
agement that was appointed to oversee plan of care, and the written patient
the operation of the HHA and to ensure care instructions described in para-
the health and safety of the HHA’s pa- graph (g) of this section, must com-
tients; or plete a supervisory assessment of the
(v) Been closed, or had its patients aide services being provided no less fre-
transferred by the state; or quently than every 14 days; and
(vi) Been excluded from participating (B) The home health aide does not
in federal health care programs or need to be present during the super-
debarred from participating in any gov- visory assessment described in para-
ernment program. graph (h)(1)(i)(A) of this section.
(g) Standard: Home health aide assign- (ii) The supervisory assessment must
ments and duties. (1) Home health aides be completed onsite (that is, an in per-
are assigned to a specific patient by a son visit), or on the rare occasion by
171
§ 484.80 42 CFR Ch. IV (10–1–24 Edition)
using two-way audio-video tele- nurse or other appropriate skilled pro-

communications technology that al- fessional;
lows for real-time interaction between (ii) Maintaining an open communica-
the registered nurse (or other appro- tion process with the patient, rep-
priate skilled professional) and the pa- resentative (if any), caregivers, and
tient, not to exceed 1 virtual super- family;
visory assessment per patient in a 60-
(iii) Demonstrating competency with
day episode.
assigned tasks;
(iii) If an area of concern in aide
services is noted by the supervising (iv) Complying with infection preven-
registered nurse or other appropriate tion and control policies and proce-
skilled professional, then the super- dures;
vising individual must make an on-site (v) Reporting changes in the pa-
visit to the location where the patient tient’s condition; and
is receiving care in order to observe (vi) Honoring patient rights.
and assess the aide while he or she is (5) If the home health agency chooses
performing care. to provide home health aide services
(iv) A registered nurse or other ap- under arrangements, as defined in sec-
propriate skilled professional must tion 1861(w)(1) of the Act, the HHA’s re-
make an annual on-site visit to the lo- sponsibilities also include, but are not
cation where a patient is receiving care limited to:
in order to observe and assess each aide
(i) Ensuring the overall quality of
while he or she is performing care.
(2)(i) If home health aide services are care provided by an aide;
provided to a patient who is not receiv- (ii) Supervising aide services as de-
ing skilled nursing care, physical or oc- scribed in paragraphs (h)(1) and (2) of
cupational therapy, or speech language this section; and
pathology services— (iii) Ensuring that home health aides
(A) The registered nurse must make who provide services under arrange-
an onsite, in person visit every 60 days ment have met the training or com-
to assess the quality of care and serv- petency evaluation requirements, or
ices provided by the home health aide both, of this part.
and to ensure that services meet the (i) Standard: Individuals furnishing
patient’s needs; and Medicaid personal care aide-only services
(B) The home health aide does not under a Medicaid personal care benefit.
need to be present during this visit. An individual may furnish personal
(ii) Semi-annually the registered care services, as defined in § 440.167 of
nurse must make an on-site visit to the this chapter, on behalf of an HHA. Be-
location where each patient is receiv-
fore the individual may furnish per-
ing care in order to observe and assess
sonal care services, the individual must
each home health aide while he or she
meet all qualification standards estab-
is performing non-skilled care.
(3) If a deficiency in aide services is lished by the state. The individual only
verified by the registered nurse or needs to demonstrate competency in
other appropriate skilled professional the services the individual is required
during an on-site visit, then the agency to furnish.
must conduct, and the home health [82 FR 4578, Jan. 13, 2017, as amended at 84
aide must complete, retraining and a FR 51825, Sept. 30, 2019; 85 FR 27628, May 8,
competency evaluation for the defi- 2020; 86 FR 62421, Nov. 9, 2021]
cient and all related skills.
(4) Home health aide supervision
must ensure that aides furnish care in
Subpart C—Organizational
a safe and effective manner, including, Environment
but not limited to, the following ele-
ments: SOURCE: 82 FR 4578, Jan. 13, 2017, unless
(i) Following the patient’s plan of otherwise noted.
care for completion of tasks assigned
to a home health aide by the registered
172
§ 484.100 Condition of participation: for a patient’s equipment when assist-

Compliance with Federal, State, ing with self-administered tests.
and local laws and regulations re- (2) If the HHA refers specimens for
lated to the health and safety of pa- laboratory testing, the referral labora-
tients. tory must be certified in the appro-
The HHA and its staff must operate priate specialties and subspecialties of
and furnish services in compliance with services in accordance with the appli-
all applicable federal, state, and local cable requirements of part 493 of this
laws and regulations related to the chapter.
health and safety of patients. If state
or local law provides licensing of § 484.102 Condition of participation:
HHAs, the HHA must be licensed. Emergency preparedness.
(a) Standard: Disclosure of ownership The Home Health Agency (HHA)
and management information. The HHA must comply with all applicable Fed-
must comply with the requirements of eral, State, and local emergency pre-
part 420 subpart C, of this chapter. The paredness requirements. The HHA
HHA also must disclose the following must establish and maintain an emer-
information to the state survey agency gency preparedness program that
at the time of the HHA’s initial request meets the requirements of this section.
for certification, for each survey, and The emergency preparedness program
at the time of any change in ownership must include, but not be limited to, the
or management: following elements:
(1) The names and addresses of all (a) Emergency plan. The HHA must
persons with an ownership or control- develop and maintain an emergency
ling interest in the HHA as defined in preparedness plan that must be re-
§ 420.201, § 420.202, and § 420.206 of this viewed, and updated at least every 2
chapter. years. The plan must do all of the fol-
(2) The name and address of each per- lowing:
son who is an officer, a director, an (1) Be based on and include a docu-
agent, or a managing employee of the mented, facility-based and community-
HHA as defined in § 420.201, § 420.202, and based risk assessment, utilizing an all-
§ 420.206 of this chapter. hazards approach.
(3) The name and business address of (2) Include strategies for addressing
the corporation, association, or other emergency events identified by the
company that is responsible for the risk assessment.
management of the HHA, and the (3) Address patient population, in-
names and addresses of the chief execu- cluding, but not limited to, the type of
tive officer and the chairperson of the services the HHA has the ability to
board of directors of that corporation, provide in an emergency; and con-
association, or other company respon- tinuity of operations, including delega-
sible for the management of the HHA. tions of authority and succession
(b) Standard: Licensing. The HHA, its plans.
branches, and all persons furnishing (4) Include a process for cooperation
services to patients must be licensed, and collaboration with local, tribal, re-
certified, or registered, as applicable, gional, State, and Federal emergency
in accordance with the state licensing preparedness officials’ efforts to main-
authority as meeting those require- tain an integrated response during a
ments. disaster or emergency situation.
(c) Standard: Laboratory services. (1) If (b) Policies and procedures. The HHA
the HHA engages in laboratory testing must develop and implement emer-
outside of the context of assisting an gency preparedness policies and proce-
individual in self-administering a test dures, based on the emergency plan set
with an appliance that has been cleared forth in paragraph (a) of this section,
for that purpose by the Food and Drug risk assessment at paragraph (a)(1) of
Administration, the testing must be in this section, and the communication
compliance with all applicable require- plan at paragraph (c) of this section.
ments of part 493 of this chapter. The The policies and procedures must be re-
HHA may not substitute its equipment viewed and updated at least every 2
173
§ 484.102 42 CFR Ch. IV (10–1–24 Edition)
years. At a minimum, the policies and Federal, State, tribal, regional, and
procedures must address the following: local emergency management agencies.
(1) The plans for the HHA’s patients (4) A method for sharing information
during a natural or man-made disaster. and medical documentation for pa-
Individual plans for each patient must tients under the HHA’s care, as nec-
be included as part of the comprehen- essary, with other health care pro-
sive patient assessment, which must be viders to maintain the continuity of
conducted according to the provisions care.
at § 484.55. (5) A means of providing information
(2) The procedures to inform State
about the general condition and loca-
and local emergency preparedness offi-
tion of patients under the facility’s
cials about HHA patients in need of
evacuation from their residences at care as permitted under 45 CFR
any time due to an emergency situa- 164.510(b)(4).
tion based on the patient’s medical and (6) A means of providing information
psychiatric condition and home envi- about the HHA’s needs, and its ability
ronment. to provide assistance, to the authority
(3) The procedures to follow up with having jurisdiction, the Incident Com-
on-duty staff and patients to determine mand Center, or designee.
services that are needed, in the event (d) Training and testing. The HHA
that there is an interruption in serv- must develop and maintain an emer-
ices during or due to an emergency. gency preparedness training and test-
The HHA must inform State and local ing program that is based on the emer-
officials of any on-duty staff or pa- gency plan set forth in paragraph (a) of
tients that they are unable to contact. this section, risk assessment at para-
(4) A system of medical documenta- graph (a)(1) of this section, policies and
tion that preserves patient informa- procedures at paragraph (b) of this sec-
tion, protects confidentiality of patient tion, and the communication plan at
information, and secures and main- paragraph (c) of this section. The train-
tains the availability of records. ing and testing program must be re-
(5) The use of volunteers in an emer-
viewed and updated at least every 2
gency or other emergency staffing
years.
strategies, including the process and
role for integration of State or Feder- (1) Training program. The HHA must
ally designated health care profes- do all of the following:
sionals to address surge needs during (i) Initial training in emergency pre-
an emergency. paredness policies and procedures to all
(c) Communication plan. The HHA new and existing staff, individuals pro-
must develop and maintain an emer- viding services under arrangement, and
gency preparedness communication volunteers, consistent with their ex-
plan that complies with Federal, State, pected roles.
and local laws and must be reviewed (ii) Provide emergency preparedness
and updated at least every 2 years. The training at least every 2 years.
communication plan must include all (iii) Maintain documentation of the
of the following: training.
(1) Names and contact information (iv) Demonstrate staff knowledge of
for the following: emergency procedures.
(i) Staff. (v) If the emergency preparedness
(ii) Entities providing services under
policies and procedures are signifi-
arrangement.
cantly updated, the HHA must conduct
(iii) Patients’ physicians.
(iv) Volunteers. training on the updated policies and
(2) Contact information for the fol- procedures.
lowing: (2) Testing. The HHA must conduct
(i) Federal, State, tribal, regional, or exercises to test the emergency plan at
local emergency preparedness staff. least annually. The HHA must do the
(ii) Other sources of assistance. following:
(3) Primary and alternate means for (i) Participate in a full-scale exercise
communicating with the HHA’s staff, that is community-based; or
174
(A) When a community-based exer- using the unified and integrated emer-
cise is not accessible, conduct an an- gency preparedness program and is in
nual individual, facility-based func- compliance with the program.
tional exercise every 2 years; or. (4) Include a unified and integrated
(B) If the HHA experiences an actual emergency plan that meets the require-
natural or man-made emergency that ments of paragraphs (a)(2), (3), and (4)
requires activation of the emergency of this section. The unified and inte-
plan, the HHA is exempt from engaging grated emergency plan must also be
in its next required full-scale commu- based on and include all of the fol-
nity-based or individual, facility-based lowing:
functional exercise following the onset (i) A documented community-based
of the emergency event. risk assessment, utilizing an all-haz-
(ii) Conduct an additional exercise ards approach.
every 2 years, opposite the year the (ii) A documented individual facility-
full-scale or functional exercise under based risk assessment for each sepa-
paragraph (d)(2)(i) of this section is rately certified facility within the
conducted, that may include, but is not health system, utilizing an all-hazards
limited to the following: approach.
(A) A second full-scale exercise that (5) Include integrated policies and
is community-based or an individual, procedures that meet the requirements
facility-based functional exercise; or set forth in paragraph (b) of this sec-
(B) A mock disaster drill; or tion, a coordinated communication
(C) A tabletop exercise or workshop plan and training and testing programs
that is led by a facilitator and includes that meet the requirements of para-
a group discussion, using a narrated, graphs (c) and (d) of this section, re-
clinically-relevant emergency scenario, spectively.
and a set of problem statements, di- [82 FR 4578, Jan. 13, 2017, as amended at 84
rected messages, or prepared questions FR 51825, Sept. 30, 2019]
designed to challenge an emergency
plan. § 484.105 Condition of participation:
(iii) Analyze the HHA’s response to Organization and administration of
and maintain documentation of all services.
drills, tabletop exercises, and emer- The HHA must organize, manage, and
gency events, and revise the HHA’s administer its resources to attain and
emergency plan, as needed. maintain the highest practicable func-
(e) Integrated healthcare systems. If a tional capacity, including providing
HHA is part of a healthcare system optimal care to achieve the goals and
consisting of multiple separately cer- outcomes identified in the patient’s
tified healthcare facilities that elects plan of care, for each patient’s medical,
to have a unified and integrated emer- nursing, and rehabilitative needs. The
gency preparedness program, the HHA HHA must assure that administrative
may choose to participate in the and supervisory functions are not dele-
healthcare system’s coordinated emer- gated to another agency or organiza-
gency preparedness program. If elected, tion, and all services not furnished di-
the unified and integrated emergency rectly are monitored and controlled.
preparedness program must do all of The HHA must set forth, in writing, its
the following: organizational structure, including
(1) Demonstrate that each separately lines of authority, and services fur-
certified facility within the system ac- nished.
tively participated in the development (a) Standard: Governing body. A gov-
of the unified and integrated emer- erning body (or designated persons so
gency preparedness program. functioning) must assume full legal au-
(2) Be developed and maintained in a thority and responsibility for the agen-
manner that takes into account each cy’s overall management and oper-
separately certified facility’s unique ation, the provision of all home health
circumstances, patient populations, services, fiscal operations, review of
and services offered. the agency’s budget and its operational
(3) Demonstrate that each separately plans, and its quality assessment and
certified facility is capable of actively performance improvement program.
175
§ 484.105 42 CFR Ch. IV (10–1–24 Edition)
(b) Standard: Administrator. (1) The (2) An HHA must have a written
administrator must: agreement with another agency, with
(i) Be appointed by and report to the an organization, or with an individual
governing body; when that entity or individual fur-
(ii) Be responsible for all day-to-day nishes services under arrangement to
operations of the HHA; the HHA’s patients. The HHA must
(iii) Ensure that a clinical manager maintain overall responsibility for the
as described in paragraph (c) of this services provided under arrangement,
section is available during all oper- as well as the manner in which they
ating hours; are furnished. The agency, organiza-
(iv) Ensure that the HHA employs tion, or individual providing services
qualified personnel, including assuring under arrangement may not have been:
the development of personnel qualifica- (i) Denied Medicare or Medicaid en-
tions and policies. rollment;
(2) When the administrator is not (ii) Been excluded or terminated from
available, a qualified, pre-designated any federal health care program or
person, who is authorized in writing by Medicaid;
the administrator and the governing (iii) Had its Medicare or Medicaid
body, assumes the same responsibil- billing privileges revoked; or
ities and obligations as the adminis- (iv) Been debarred from participating
trator. The pre-designated person may in any government program.
be the clinical manager as described in (3) The primary HHA is responsible
paragraph (c) of this section. for patient care, and must conduct and
(3) The administrator or a pre-des- provide, either directly or under ar-
ignated person is available during all rangements, all services rendered to
operating hours. patients.
(c) Clinical manager. One or more (f) Standard: Services furnished. (1)
qualified individuals must provide Skilled nursing services and at least
oversight of all patient care services one other therapeutic service (physical
and personnel. Oversight must include therapy, speech-language pathology, or
the following— occupational therapy; medical social
(1) Making patient and personnel as- services; or home health aide services)
signments, are made available on a visiting basis,
(2) Coordinating patient care, in a place of residence used as a pa-
(3) Coordinating referrals, tient’s home. An HHA must provide at
(4) Assuring that patient needs are least one of the services described in
continually assessed, and this subsection directly, but may pro-
(5) Assuring the development, imple- vide the second service and additional
mentation, and updates of the individ- services under arrangement with an-
ualized plan of care. other agency or organization.
(d) Standard: Parent-branch relation- (2) All HHA services must be provided
ship. (1) The parent HHA is responsible in accordance with current clinical
for reporting all branch locations of practice guidelines and accepted pro-
the HHA to the state survey agency at fessional standards of practice.
the time of the HHA’s request for ini- (g) Standard: Outpatient physical ther-
tial certification, at each survey, and apy or speech-language pathology serv-
at the time the parent proposes to add ices. An HHA that furnishes outpatient
or delete a branch. physical therapy or speech-language
(2) The parent HHA provides direct pathology services must meet all of the
support and administrative control of applicable conditions of this part and
its branches. the additional health and safety re-
(e) Standard: Services under arrange- quirements set forth in § 485.711,
ment. (1) The HHA must ensure that all § 485.713, § 485.715, § 485.719, § 485.723, and
services furnished under arrangement § 485.727 of this chapter to implement
provided by other entities or individ- section 1861(p) of the Act.
uals meet the requirements of this part (h) Standard: Institutional planning.
and the requirements of section 1861(w) The HHA, under the direction of the
of the Act (42 U.S.C. 1395x (w)). governing body, prepares an overall
176
plan and a budget that includes an an- (A) Whether the proposed capital ex-
nual operating budget and capital expenditure is required to conform, or is
penditure plan. likely to be required to conform, to
(1) Annual operating budget. There is current standards, criteria, or plans de-
an annual operating budget that in- veloped in accordance with the Public
cludes all anticipated income and ex- Health Service Act or the Mental Re-
penses related to items that would, tardation Facilities and Community
under generally accepted accounting Mental Health Centers Construction
principles, be considered income and Act of 1963.
expense items. However, it is not re- (B) Whether a capital expenditure
quired that there be prepared, in con- proposal has been submitted to the des-
nection with any budget, an item by ignated planning agency for approval
item identification of the components in accordance with section 1122 of the
of each type of anticipated income or Act (42 U.S.C. 1320a–1) and imple-
expense. menting regulations.
(2) Capital expenditure plan. (i) There (C) Whether the designated planning
is a capital expenditure plan for at agency has approved or disapproved the
least a 3-year period, including the op- proposed capital expenditure if it was
erating budget year. The plan includes presented to that agency.
and identifies in detail the anticipated (3) Preparation of plan and budget. The
sources of financing for, and the objec- overall plan and budget is prepared
tives of, each anticipated expenditure under the direction of the governing
of more than $600,000 for items that body of the HHA by a committee con-
would under generally accepted ac- sisting of representatives of the gov-
counting principles, be considered cap- erning body, the administrative staff,
ital items. In determining if a single and the medical staff (if any) of the
capital expenditure exceeds $600,000, HHA.
the cost of studies, surveys, designs, (4) Annual review of plan and budget.
plans, working drawings, specifica- The overall plan and budget is reviewed
tions, and other activities essential to and updated at least annually by the
the acquisition, improvement, mod- committee referred to in paragraph
ernization, expansion, or replacement (i)(3) of this section under the direction
of land, plant, building, and equipment of the governing body of the HHA.
are included. Expenditures directly or
indirectly related to capital expendi- § 484.110 Condition of participation:
tures, such as grading, paving, broker Clinical records.
commissions, taxes assessed during the The HHA must maintain a clinical
construction period, and costs involved record containing past and current in-
in demolishing or razing structures on formation for every patient accepted
land are also included. Transactions by the HHA and receiving home health
that are separated in time, but are services. Information contained in the
components of an overall plan or pa- clinical record must be accurate, ad-
tient care objective, are viewed in their here to current clinical record docu-
entirety without regard to their tim- mentation standards of practice, and
ing. Other costs related to capital ex- be available to the physician(s) or al-
penditures include title fees, permit lowed practitioner(s) issuing orders for
and license fees, broker commissions, the home health plan of care, and ap-
architect, legal, accounting, and appropriate HHA staff. This information
praisal fees; interest, finance, or car- may be maintained electronically.
rying charges on bonds, notes and (a) Standard: Contents of clinical
other costs incurred for borrowing record. The record must include:
funds. (1) The patient’s current comprehen-
(ii) If the anticipated source of fi- sive assessment, including all of the as-
nancing is, in any part, the anticipated sessments from the most recent home
payment from title V (Maternal and health admission, clinical notes, plans
Child Health Services Block Grant) or of care, and physician or allowed prac-
title XVIII (Medicare) or title XIX titioner orders;
(Medicaid) of the Social Security Act, (2) All interventions, including medi-
the plan specifies the following: cation administration, treatments, and
177
§ 484.115 42 CFR Ch. IV (10–1–24 Edition)
services, and responses to those inter- ized use. The HHA must be in compli-
ventions; ance with the rules regarding protected
(3) Goals in the patient’s plans of health information set out at 45 CFR
care and the patient’s progress toward parts 160 and 164.
achieving them; (e) Standard: Retrieval of clinical
(4) Contact information for the pa- records. A patient’s clinical record
tient, the patient’s representative (if (whether hard copy or electronic form)
any), and the patient’s primary care- must be made available to a patient,
giver(s); free of charge, upon request at the next
(5) Contact information for the pri- home visit, or within 4 business days
mary care practitioner or other health (whichever comes first).
care professional who will be respon- [82 FR 4578, Jan. 13, 2017, as amended at 85
sible for providing care and services to FR 70356, Nov. 4, 2020]
the patient after discharge from the
HHA; and § 484.115 Condition of participation:
(6)(i) A completed discharge sum- Personnel qualifications.
mary that is sent to the primary care HHA staff are required to meet the
practitioner or other health care pro- following standards:
fessional who will be responsible for (a) Standard: Administrator, home
providing care and services to the pa- health agency. (1) For individuals that
tient after discharge from the HHA (if began employment with the HHA prior
any) within 5 business days of the pa- to January 13, 2018, a person who:
tient’s discharge; or (i) Is a licensed physician;
(ii) A completed transfer summary (ii) Is a registered nurse; or
that is sent within 2 business days of a (iii) Has training and experience in
planned transfer, if the patient’s care health service administration and at
will be immediately continued in a least 1 year of supervisory administra-
health care facility; or tive experience in home health care or
(iii) A completed transfer summary a related health care program.
that is sent within 2 business days of (2) For individuals that begin em-
becoming aware of an unplanned trans- ployment with an HHA on or after Jan-
fer, if the patient is still receiving care uary 13, 2018, a person who:
in a health care facility at the time (i) Is a licensed physician, a reg-
when the HHA becomes aware of the istered nurse, or holds an under-
transfer. graduate degree; and
(b) Standard: Authentication. All en- (ii) Has experience in health service
tries must be legible, clear, complete, administration, with at least 1 year of
and appropriately authenticated, supervisory or administrative experi-
dated, and timed. Authentication must ence in home health care or a related
include a signature and a title (occupa- health care program.
tion), or a secured computer entry by a (b) Standard: Audiologist. A person
unique identifier, of a primary author who:
who has reviewed and approved the (1) Meets the education and experi-
entry. ence requirements for a Certificate of
(c) Standard: Retention of records. (1) Clinical Competence in audiology
Clinical records must be retained for 5 granted by the American Speech-Lan-
years after the discharge of the pa- guage-Hearing Association; or
tient, unless state law stipulates a (2) Meets the educational require-
longer period of time. ments for certification and is in the
(2) The HHA’s policies must provide process of accumulating the supervised
for retention of clinical records even if experience required for certification.
it discontinues operation. When an (c) Standard: Clinical manager. A per-
HHA discontinues operation, it must son who is a licensed physician, phys-
inform the state agency where clinical ical therapist, speech-language pathol-
records will be maintained. ogist, occupational therapist, audiol-
(d) Standard: Protection of records. The ogist, social worker, or a registered
clinical record, its contents, and the nurse.
information contained therein must be (d) Standard: Home health aide. A per-
safeguarded against loss or unauthor- son who meets the qualifications for
178
home health aides specified in section Association and the American Occupa-
1891(a)(3) of the Act and implemented tional Therapy Association; or
at § 484.80. (ii) Is eligible for the National Reg-
(e) Standard: Licensed practical (voca- istration Examination of the American
tional) nurse. A person who has com- Occupational Therapy Association or
pleted a practical (vocational) nursing the National Board for Certification in
program, is licensed in the state where Occupational Therapy.
practicing, and who furnishes services (4) On or before December 31, 1977—
under the supervision of a qualified (i) Had 2 years of appropriate experi-
registered nurse. ence as an occupational therapist; and
(f) Standard: Occupational therapist. A (ii) Had achieved a satisfactory grade
person who— on an occupational therapist pro-
(1)(i) Is licensed or otherwise regu- ficiency examination conducted, ap-
lated, if applicable, as an occupational proved, or sponsored by the U.S. Public
therapist by the state in which prac- Health Service.
ticing, unless licensure does not apply; (5) If educated outside the United
(ii) Graduated after successful com- States, must meet both of the fol-
pletion of an occupational therapist lowing:
education program accredited by the (i) Graduated after successful com-
Accreditation Council for Occupational pletion of an occupational therapist
Therapy Education (ACOTE) of the education program accredited as sub-
American Occupational Therapy Asso- stantially equivalent to occupational
ciation, Inc. (AOTA), or successor orga- therapist entry level education in the
nizations of ACOTE; and United States by one of the following:
(iii) Is eligible to take, or has suc- (A) The Accreditation Council for Oc-
cessfully completed the entry-level cer- cupational Therapy Education
tification examination for occupa- (ACOTE).
tional therapists developed and admin- (B) Successor organizations of
istered by the National Board for Cer- ACOTE.
tification in Occupational Therapy, (C) The World Federation of Occupa-
Inc. (NBCOT). tional Therapists.
(2) On or before December 31, 2009— (D) A credentialing body approved by
(i) Is licensed or otherwise regulated, the American Occupational Therapy
if applicable, as an occupational thera- Association.
pist by the state in which practicing; (E) Successfully completed the entry
or level certification examination for oc-
(ii) When licensure or other regula- cupational therapists developed and
tion does not apply— administered by the National Board for
(A) Graduated after successful com- Certification in Occupational Therapy,
pletion of an occupational therapist Inc. (NBCOT).
education program accredited by the (ii) On or before December 31, 2009, is
accreditation Council for Occupational licensed or otherwise regulated, if ap-
Therapy Education (ACOTE) of the plicable, as an occupational therapist
American Occupational Therapy Asso- by the state in which practicing.
ciation, Inc. (AOTA) or successor orga- (g) Standard: Occupational therapy as-
nizations of ACOTE; and sistant. A person who—
(B) Is eligible to take, or has success- (1) Meets all of the following:
fully completed the entry-level certifi- (i) Is licensed or otherwise regulated,
cation examination for occupational if applicable, as an occupational ther-
therapists developed and administered apy assistant by the state in which
by the National Board for Certification practicing, unless licensure does apply.
in Occupational Therapy, Inc., (ii) Graduated after successful com-
(NBCOT). pletion of an occupational therapy as-
(3) On or before January 1, 2008— sistant education program accredited
(i) Graduated after successful com- by the Accreditation Council for Occu-
pletion of an occupational therapy pro- pational Therapy Education, (ACOTE)
gram accredited jointly by the Com- of the American Occupational Therapy
mittee on Allied Health Education and Association, Inc. (AOTA) or its suc-
Accreditation of the American Medical cessor organizations.
179
§ 484.115 42 CFR Ch. IV (10–1–24 Edition)
(iii) Is eligible to take or successfully (C) The World Federation of Occupa-

completed the entry-level certification tional Therapists.
examination for occupational therapy (D) By a credentialing body approved
assistants developed and administered by the American Occupational Therapy
by the National Board for Certification Association; and
in Occupational Therapy, Inc. (E) Successfully completed the entry
(NBCOT). level certification examination for oc-
(2) On or before December 31, 2009— cupational therapy assistants devel-
(i) Is licensed or otherwise regulated oped and administered by the National
as an occupational therapy assistant, if Board for Certification in Occupational
applicable, by the state in which prac- Therapy, Inc. (NBCOT).
ticing; or any qualifications defined by (ii) [Reserved]
the state in which practicing, unless li- (h) Standard: Physical therapist. A per-
censure does not apply; or son who is licensed, if applicable, by
(ii) Must meet both of the following: the state in which practicing, unless li-
(A) Completed certification require- censure does not apply and meets one
ments to practice as an occupational of the following requirements:
therapy assistant established by a (1)(i) Graduated after successful com-
credentialing organization approved by pletion of a physical therapist edu-
the American Occupational Therapy cation program approved by one of the
Association. following:
(B) After January 1, 2010, meets the (A) The Commission on Accreditation
requirements in paragraph (f)(1) of this in Physical Therapy Education
section. (CAPTE).
(3) After December 31, 1977 and on or (B) Successor organizations of
before December 31, 2007— CAPTE.
(i) Completed certification require- (C) An education program outside the
ments to practice as an occupational United States determined to be sub-
therapy assistant established by a stantially equivalent to physical thera-
credentialing organization approved by pist entry level education in the United
the American Occupational Therapy States by a credentials evaluation or-
Association; or ganization approved by the American
(ii) Completed the requirements to Physical Therapy Association or an or-
practice as an occupational therapy as- ganization identified in 8 CFR 212.15(e)
sistant applicable in the state in which as it relates to physical therapists.
practicing. (ii) Passed an examination for phys-
(4) On or before December 31, 1977— ical therapists approved by the state in
(i) Had 2 years of appropriate experi- which physical therapy services are
ence as an occupational therapy assist- provided.
ant; and (2) On or before December 31, 2009—
(ii) Had achieved a satisfactory grade (i) Graduated after successful com-
on an occupational therapy assistant pletion of a physical therapy cur-
proficiency examination conducted, ap- riculum approved by the Commission
proved, or sponsored by the U.S. Public on Accreditation in Physical Therapy
Health Service. Education (CAPTE); or
(5) If educated outside the United (ii) Meets both of the following:
States, on or after January 1, 2008— (A) Graduated after successful com-
(i) Graduated after successful completion of an education program deter-
pletion of an occupational therapy as- mined to be substantially equivalent to
sistant education program that is ac- physical therapist entry level edu-
credited as substantially equivalent to cation in the United States by a cre-
occupational therapist assistant entry dentials evaluation organization ap-
level education in the United States proved by the American Physical Ther-
by— apy Association or identified in 8 CFR
(A) The Accreditation Council for Oc- 212.15(e) as it relates to physical thera-
cupational Therapy Education pists.
(ACOTE). (B) Passed an examination for phys-
(B) Its successor organizations. ical therapists approved by the state in
180
which physical therapy services are pist assistant, if applicable, by the

provided. state in which practicing, unless licen-
(3) Before January 1, 2008 graduated sure does not apply and meets one of
from a physical therapy curriculum ap- the following requirements:
proved by one of the following: (1)(i) Graduated from a physical ther-
(i) The American Physical Therapy apist assistant curriculum approved by
Association. the Commission on Accreditation in
(ii) The Committee on Allied Health Physical Therapy Education of the
Education and Accreditation of the American Physical Therapy Associa-
American Medical Association. tion; or if educated outside the United
(iii) The Council on Medical Edu- States or trained in the United States
cation of the American Medical Asso- military, graduated from an education
ciation and the American Physical program determined to be substan-
Therapy Association. tially equivalent to physical therapist
(4) On or before December 31, 1977 was assistant entry level education in the
licensed or qualified as a physical ther- United States by a credentials evalua-
apist and meets both of the following: tion organization approved by the
(i) Has 2 years of appropriate experi- American Physical Therapy Associa-
ence as a physical therapist. tion or identified at 8 CFR 212.15(e);
(ii) Has achieved a satisfactory grade and
on a proficiency examination con- (ii) Passed a national examination
ducted, approved, or sponsored by the for physical therapist assistants.
U.S. Public Health Service. (2) On or before December 31, 2009,
(5) Before January 1, 1966— meets one of the following:
(i) Was admitted to membership by (i) Is licensed, or otherwise regulated
the American Physical Therapy Asso- in the state in which practicing.
ciation; (ii) In states where licensure or other
(ii) Was admitted to registration by regulations do not apply, graduated be-
the American Registry of Physical fore December 31, 2009, from a 2-year
Therapists; or college-level program approved by the
(iii) Graduated from a physical ther- American Physical Therapy Associa-
apy curriculum in a 4-year college or tion and after January 1, 2010, meets
university approved by a state depart- the requirements of paragraph (h)(1) of
ment of education. this section.
(6) Before January 1, 1966 was li- (3) Before January 1, 2008, where li-
censed or registered, and before Janu- censure or other regulation does not
ary 1, 1970, had 15 years of fulltime ex- apply, graduated from a 2-year college
perience in the treatment of illness or level program approved by the Amer-
injury through the practice of physical ican Physical Therapy Association.
therapy in which services were ren- (4) On or before December 31, 1977,
dered under the order and direction of was licensed or qualified as a physical
attending and referring doctors of med- therapist assistant and has achieved a
icine or osteopathy. satisfactory grade on a proficiency ex-
(7) If trained outside the United amination conducted, approved, or
States before January 1, 2008, meets sponsored by the U.S. Public Health
the following requirements: Service.
(i) Was graduated since 1928 from a (j) Standard: Physician. A person who
physical therapy curriculum approved meets the qualifications and conditions
in the country in which the curriculum specified in section 1861(r) of the Act
was located and in which there is a and implemented at § 410.20(b) of this
member organization of the World Con- chapter.
federation for Physical Therapy. (k) Standard: Registered nurse. A grad-
(ii) Meets the requirements for mem- uate of an approved school of profes-
bership in a member organization of sional nursing who is licensed in the
the World Confederation for Physical state where practicing.
Therapy. (l) Standard: Social Work Assistant. A
(i) Standard: Physical therapist assist- person who provides services under the
ant. A person who is licensed, reg- supervision of a qualified social worker
istered or certified as a physical thera- and:
181
§ 484.200 42 CFR Ch. IV (10–1–24 Edition)
(1) Has a baccalaureate degree in so- § 484.200 Basis and scope.

cial work, psychology, sociology, or
(a) Basis. This subpart implements
other field related to social work, and
has had at least 1 year of social work section 1895 of the Act, which provides
experience in a health care setting; or for the implementation of a prospec-
(2) Has 2 years of appropriate experi- tive payment system (PPS) for HHAs
ence as a social work assistant, and has for portions of cost reporting periods
achieved a satisfactory grade on a pro- occurring on or after October 1, 2000.
ficiency examination conducted, ap- (b) Scope. This subpart sets forth the
proved, or sponsored by the U.S. Public framework for the HHA PPS, including
Health Service, except that the deter- the methodology used for the develop-
minations of proficiency do not apply ment of the payment rates, associated
with respect to persons initially li- adjustments, and related rules.
censed by a state or seeking initial
qualification as a social work assistant § 484.202 Definitions.
after December 31, 1977. As used in this subpart—
(m) Standard: Social worker. A person Case-mix index means a scale that
who has a master’s or doctoral degree measures the relative difference in re-
from a school of social work accredited
source intensity among different
by the Council on Social Work Edu-
groups in the clinical model.
cation, and has 1 year of social work
experience in a health care setting. Discipline means one of the six home
(n) Standard: Speech-language patholo- health disciplines covered under the
gist. A person who has a master’s or Medicare home health benefit (skilled
doctoral degree in speech-language pa- nursing services, home health aide
thology, and who meets either of the services, physical therapy services, oc-
following requirements: cupational therapy services, speech-
(1) Is licensed as a speech-language language pathology services, and med-
pathologist by the state in which the ical social services).
individual furnishes such services; or Furnishing Negative Pressure Wound
(2) In the case of an individual who Therapy (NPWT) using a disposable de-
furnishes services in a state which does vice means the device is paid separately
not license speech-language patholo- (specified by the assigned CPT® code)
gists: and does not include payment for the
(i) Has successfully completed 350 professional services. The nursing and
clock hours of supervised clinical therapy services are to be included as
practicum (or is in the process of accu- part of the payment under the home
mulating supervised clinical experi- health prospective payment system.
ence);
HHCAHPS stands for Home Health
(ii) Performed not less than 9 months
Care Consumer Assessment of
of supervised full-time speech-language
Healthcare Providers and Systems.
pathology services after obtaining a
master’s or doctoral degree in speech- HH QRP stands for Home Health
language pathology or a related field; Quality Reporting Program.
and Home health market basket index
(iii) Successfully completed a na- means an index that reflects changes
tional examination in speech-language over time in the prices of an appro-
pathology approved by the Secretary. priate mix of goods and services in-
cluded in home health services.
FR 31732, July 10, 2017] Rural area means an area defined in
§ 412.64(b)(1)(ii)(C) of this chapter.
Subpart D [Reserved] Urban area means an area defined in
§ 412.64(b)(1)(ii)(A) and (B) of this chap-
ter.
Subpart E—Prospective Payment
System for Home Health Agencies [70 FR 68142, Nov. 9, 2005, as amended at 81
FR 76796, Nov. 3, 2016; 83 FR 56628, Nov. 13,
2018; 84 FR 60644, Nov. 8, 2019; 88 FR 77878,
SOURCE: 65 FR 41212, July 3, 2000, unless
Nov. 13, 2023]
otherwise noted.
182
§ 484.205 Basis of payment. the national, standardized prospective

payment.
(a) Method of payment. An HHA re-
(g) Split percentage payments. Nor-
ceives a national, standardized pro-
mally, there are two payments (initial
spective payment amount for home
and final) paid for an HH PPS unit of
health services previously paid on a
payment. The initial payment is made
reasonable cost basis (except the
in response to a request for anticipated
osteoporosis drug defined in section
payment (RAP) as described in para-
1861(kk) of the Act) as of August 5, 1997.
graph (h) of this section, and the resid-
The national, standardized prospective
ual final payment is made in response
payment is determined in accordance
to the submission of a final claim.
with § 484.215.
Split percentage payments are made in
(b) Unit of payment—(1) Episodes before
accordance with requirements at
December 31, 2019. For episodes begin-
§ 409.43(c) of this chapter.
ning on or before December 31, 2019, an
(1) Split percentage payments for epi-
HHA receives a unit of payment equal
sodes beginning on or before December 31,
to a national, standardized prospective
2019—(i) Initial and residual final pay-
60-day episode payment amount.
ments for initial episodes on or before De-
(2) Periods on or after January 1, 2020. cember 31, 2019. (A) The initial payment
For periods beginning on or after Janu- for initial episodes is paid to an HHA
ary 1, 2020, a HHA receives a unit of at 60 percent of the case-mix and wage-
payment equal to a national, standard- adjusted 60-day episode rate.
ized prospective 30-day payment (B) The residual final payment for
amount. initial episodes is paid at 40 percent of
(c) OASIS data. A HHA must submit the case-mix and wage-adjusted 60-day
to CMS the OASIS data described at episode rate.
§ 484.55(b) and (d) in order for CMS to (ii) Initial and residual final payments
administer the payment rate meth- for subsequent episodes before December
odologies described in §§ 484.215, 484.220, 31, 2019. (A) The initial payment for
484. 230, 484.235, and 484.240. subsequent episodes is paid to an HHA
(d) Payment adjustments. The na- at 50 percent of the case-mix and wage-
tional, standardized prospective pay- adjusted 60-day episode rate.
ment amount represents payment in (B) The residual final payment for
full for all costs associated with fur- subsequent episodes is paid at 50 per-
nishing home health services and is cent of the case-mix and wage-adjusted
subject to the following adjustments 60-day episode rate.
and additional payments: (2) Split percentage payments for peri-
(1) A low-utilization payment adjust- ods beginning on or after January 1, 2020
ment (LUPA) of a predetermined per- through December 31, 2020—(i) HHAs cer-
visit rate as specified in § 484.230. tified for participation on or before De-
(2) A partial payment adjustment as cember 31, 2018. (A) The initial payment
specified in § 484.235. for all 30-day periods is paid to an HHA
(3) An outlier payment as specified in at 20 percent of the case-mix and wage-
§ 484.240. adjusted 30-day payment rate.
(e) Medical review. All payments (B) The residual final payment for all
under this system may be subject to a 30-day periods is paid at 80 percent of
medical review adjustment reflecting the case-mix and wage-adjusted 30-day
the following: payment rate.
(1) Beneficiary eligibility. (ii) HHAs certified for participation in
(2) Medical necessity determinations. Medicare on or after January 1, 2019.
(3) Case-mix group assignment. Split percentage payments are not
(f) Durable medical equipment (DME) made to HHAs that are certified for
and disposable devices. DME provided as participation in Medicare effective on
a home health service as defined in sec- or after January 1, 2019. Newly enrolled
tion 1861(m) of the Act is paid the fee HHAs must submit a request for antici-
schedule amount. Separate payment is pated payment, which is set at 0 per-
made for ‘‘furnishing NPWT using a cent, at the beginning of every 30-day
disposable device,’’ as that term is de- period. An HHA that is certified for
fined in § 484.202, and is not included in participation in Medicare effective on
183
§ 484.205 42 CFR Ch. IV (10–1–24 Edition)
or after January 1, 2019 receives a sin- (2) A RAP is based on the physician
gle payment for a 30-day period of care or allowed practitioner signature re-
after the final claim is submitted. quirements in § 409.43(c) of this chapter
(3) Split percentage payments for peri- and is not a Medicare claim for pur-
ods beginning on or after January 1, 2021 poses of the Act (although it is a
through December 31, 2021. All HHAs ‘‘claim’’ for purposes of Federal, civil,
must submit a request for anticipated criminal, and administrative law en-
payment within 5 calendar days after forcement authorities, including but
the start of care date for initial 30-day not limited to the following:
periods and within 5 calendar days (i) Civil Monetary Penalties Law (as
after the ‘‘from date’’ for each subse- defined in 42 U.S.C. 1320a–7a(i)(2)).
quent 30-day period of care, which is (ii) The Civil False Claims Act (as de-
set at 0 percent at the beginning of fined in 31 U.S.C. 3729(c)).
every 30-day period. HHAs receive a
(iii) The Criminal False Claims Act
single payment for a 30-day period of
(18 U.S.C. 287)).
care after the final claim is submitted.
(4) Payments for periods beginning on (iv) The RAP is canceled and recov-
or after January 1, 2022. All HHAs must ered unless the claim is submitted
submit a Notice of Admission (NOA) at within the greater of 60 days from the
the beginning of the initial 30-day pe- end date of the appropriate unit of pay-
riod of care as described in paragraph ment, as defined in paragraph (b) of
(j) of this section. HHAs receive a sin- this section, or 60 days from the
gle payment for a 30-day period of care issuance of the RAP.
after the final claim is submitted. (3) CMS has the authority to reduce,
(h) Requests for anticipated payment disprove, or cancel a RAP in situations
(RAP) for 30-day periods of care starting when protecting Medicare program in-
on January 1, 2020 through December 31, tegrity warrants this action.
2020. (1) HHAs that are certified for (i) Submission of RAPs for CY 2021—(1)
participation in Medicare effective by General. All HHAs must submit a RAP,
December 31, 2018 submit requests for which is to be paid at 0 percent, within
anticipated payment (RAPs) to request 5 calendar days after the start of care
the initial split percentage payment as and within 5 calendar days after the
specified in paragraph (g) of this sec- ‘‘from date’’ for each subsequent 30-day
tion. HHAs that are certified for par- period of care.
ticipation in Medicare effective on or (2) Criteria for RAP submission for CY
after January 1, 2019 are still required 2021. The HHA shall submit RAPs only
to submit RAPs although no split per- when all of the following conditions are
centage payments are made in response met:
to these RAP submissions. The HHA (i) Once physician or allowed practi-
can submit a RAP when all of the fol- tioner’s written or verbal orders that
lowing conditions are met: contain the services required for the
(i) After the OASIS assessment re- initial visit have been received and
quired at § 484.55(b)(1) and (d) is com-
documented as required at §§ 484.60(b)
plete, locked or export ready, or there
and 409.43(d) of this chapter.
is an agency-wide internal policy es-
tablishing the OASIS data is finalized (ii) The initial visit within the 60-day
for transmission to the national assess- certification period must have been
ment system. made and the individual admitted to
(ii) Once a physician or allowed prac- home health care.
titioner’s verbal orders for home care (3) Consequences of failure to submit a
have been received and documented as timely RAP. When a home health agen-
required at §§ 484.60(b) and 409.43(d) of cy does not file the required RAP for
this chapter. its Medicare patients within 5 calendar
(iii) A plan of care has been estab- days after the start of each 30-day pe-
lished and sent to the physician or al- riod of care—
lowed practitioner as required at (i) Medicare does not pay for those
§ 409.43(c) of this chapter. days of home health services based on
(iv) The first service visit under that the ‘‘from date’’ on the claim to the
plan has been delivered. date of filing of the RAP;
184
(ii) The wage and case-mix adjusted (2) Criteria for NOA submission. In
30-day period payment amount is re- order to submit the NOA, the following
duced by 1/30th for each day from the criteria must be met:
home health based on the ‘‘from date’’ (i) Once a physician or allowed prac-
on the claim until the date of filing of titioner’s written or verbal orders that
the RAP; contains the services required for the
(iii) No LUPA payments are made initial visit have been received and
that fall within the late period; documented as required at §§ 484.60(b)
(iv) The payment reduction cannot and 409.43(d) of this chapter.
exceed the total payment of the claim; (ii) The initial visit must have been
and made and the individual admitted to
(v)(A) The non-covered days are a home health care.
provider liability; and (3) Consequences of failure to submit a
(B) The provider must not bill the timely Notice of Admission. When a home
beneficiary for the non-covered days. health agency does not file the re-
(4) Exception to the consequences for quired NOA for its Medicare patients
filing the RAP late. (i) CMS may waive within 5 calendar days after the start
the consequences of failure to submit a of care—
timely-filed RAP specified in para- (i) Medicare does not pay for those
graph (i)(3) of this section. days of home health services from the
(ii) CMS determines if a cir- start date to the date of filing of the
cumstance encountered by a home notice of admission;
health agency is exceptional and quali- (ii) The wage and case-mix adjusted
fies for waiver of the consequence spec- 30-day period payment amount is re-
ified in paragraph (i)(3) of this section. duced by 1/30th for each day from the
(iii) A home health agency must fully home health start of care date until
document and furnish any requested the date of filing of the NOA;
documentation to CMS for a deter- (iii) No LUPA payments are made
mination of exception. An exceptional that fall within the late NOA period;
circumstance may be due to, but is not (iv) The payment reduction cannot
limited to the following: exceed the total payment of the claim;
(A) Fires, floods, earthquakes, or and
similar unusual events that inflict ex- (v)(A) The non-covered days are a
tensive damage to the home health provider liability; and
agency’s ability to operate. (B) The provider must not bill the
(B) A CMS or Medicare contractor beneficiary for the non-covered days.
systems issue that is beyond the con- (4) Exception to the consequences for
trol of the home health agency. filing the NOA late. (i) CMS may waive
(C) A newly Medicare-certified home the consequences of failure to submit a
health agency that is notified of that timely-filed NOA specified in para-
certification after the Medicare certifi- graph (j)(3) of this section.
cation date, or which is awaiting its (ii) CMS determines if a cir-
user ID from its Medicare contractor. cumstance encountered by a home
(D) Other situations determined by health agency is exceptional and quali-
CMS to be beyond the control of the fies for waiver of the consequence spec-
home health agency. ified in paragraph (j)(3) of this section.
(j) Submission of Notice of Admission (iii) A home health agency must fully
(NOA)—(1) For periods of care that begin document and furnish any requested
on and after January 1, 2022. For all 30- documentation to CMS for a deter-
day periods of care after January 1, mination of exception. An exceptional
2022, all HHAs must submit a Notice of circumstance may be due to, but is not
Admission (NOA) to their Medicare limited to the following:
contractor within 5 calendar days after (A) Fires, floods, earthquakes, or
the start of care date. The NOA is a similar unusual events that inflict ex-
one-time submission to establish the tensive damage to the home health
home health period of care and covers agency’s ability to operate.
contiguous 30-day periods of care until (B) A CMS or Medicare contractor
the individual is discharged from Medi- systems issue that is beyond the con-
care home health services. trol of the home health agency.
185
§ 484.215 42 CFR Ch. IV (10–1–24 Edition)
(C) A newly Medicare-certified home amounts for Part B therapies that

health agency that is notified of that could have been unbundled to Part B
certification after the Medicare certifi- prior to October 1, 2000. The resulting
cation date, or which is awaiting its amount is the unadjusted national 60-
user ID from its Medicare contractor. day episode rate.
(D) Other situations determined by (e) Standardization of the data for vari-
CMS to be beyond the control of the ation in area wage levels and case-mix.
home health agency. CMS standardizes—
[83 FR 56628, Nov. 13, 2018, as amended at 84 (1) The cost data described in para-
FR 60644, Nov. 8, 2019; 85 FR 27628, May 8, graph (a) of this section to remove the
2020] effects of geographic variation in wage
levels and variation in case-mix;
§ 484.215 Initial establishment of the
calculation of the national, stand- (2) The cost data for geographic vari-
ardized prospective payment rates. ation in wage levels using the hospital
wage index; and
(a) Determining an HHA’s costs. In cal-
(3) The cost data for HHA variation
culating the initial unadjusted na-
in case-mix using the case-mix indices
tional 60-day episode payment applica-
and other data that indicate HHA case-
ble for a service furnished by an HHA
mix.
using data on the most recent available
audited cost reports, CMS determines (f) For periods beginning on or after
each HHA’s costs by summing its al- January 1, 2020, a national, standard-
lowable costs for the period. CMS de- ized prospective 30-day payment rate
termines the national mean cost per applies. The national, standardized pro-
visit. spective 30-day payment rate is an
(b) Determining HHA utilization. In amount determined by the Secretary,
calculating the initial unadjusted na- as subsequently adjusted in accordance
tional 60-day episode payment, CMS de- with § 484.225.
termines the national mean utilization [65 FR 41212, July 3, 2000, as amended at 83
for each of the six disciplines using FR 56629, Nov. 13, 2018]
home health claims data.
(c) Use of the market basket index. CMS § 484.220 Calculation of the case-mix
uses the HHA market basket index to and wage area adjusted prospective
adjust the HHA cost data to reflect payment rates.
cost increases occurring between Octo- CMS adjusts the national, standard-
ber 1, 1996 through September 30, 2001. ized prospective payment rates as ref-
(d) Calculation of the unadjusted na- erenced in § 484.215 to account for the
tional average prospective payment following:
amount for the 60-day episode. For epi- (a) HHA case-mix using a case-mix
sodes beginning on or before December index to explain the relative resource
31, 2019, CMS calculates the unadjusted utilization of different patients. To ad-
national 60-day episode payment in the dress changes to the case-mix that are
following manner: a result of changes in the coding or
(1) By computing the mean national classification of different units of serv-
cost per visit. ice that do not reflect real changes in
(2) By computing the national mean
case-mix, the national, standardized
utilization for each discipline.
prospective payment rate will be ad-
(3) By multiplying the mean national
justed downward as follows:
cost per visit by the national mean uti-
lization summed in the aggregate for (1) For CY 2008, the adjustment is 2.75
the six disciplines. percent.
(4) By adding to the amount derived (2) For CY 2009 and CY 2010, the ad-
in paragraph (d)(3) of this section, justment is 2.75 percent in each year.
amounts for nonroutine medical sup- (3) For CY 2011, the adjustment is 3.79
plies, an OASIS adjustment for esti- percent.
mated ongoing reporting costs, an (4) For CY 2012, the adjustment is 3.79
OASIS adjustment for the one time im- percent.
plementation costs associated with as- (5) For CY 2013, the adjustment is 1.32
sessment scheduling form changes and percent.
186
(6) For CY 2016, CY 2017, and CY 2018, § 484.230 Low-utilization payment ad-
the adjustment is 0.97 percent in each justments.
year. (a) For episodes beginning on or be-
(b) Geographic differences in wage fore December 31, 2019, an episode with
levels using an appropriate wage index four or fewer visits is paid the national
based on the site of service of the bene- per-visit amount by discipline deter-
ficiary. mined in accordance with § 484.215(a)
(c) Beginning on January 1, 2023, and updated annually by the applicable
CMS applies a cap on decreases to the market basket for each visit type, in
home health wage index such that the accordance with § 484.225.
wage index applied to a geographic (1) The national per-visit amount is
area is not less than 95 percent of the adjusted by the appropriate wage index
wage index applied to that geographic based on the site of service of the bene-
area in the prior calendar year. The 5- ficiary.
percent cap on negative wage index (2) An amount is added to the low-
changes is implemented in a budget utilization payment adjustments for
neutral manner through the use of low-utilization episodes that occur as
wage index budget neutrality factors. the beneficiary’s only episode or initial
episode in a sequence of adjacent epi-
[72 FR 49879, Aug. 29, 2007, as amended at 80 sodes.
FR 68717, Nov. 5, 2015; 83 FR 56629, Nov. 13, (3) For purposes of the home health
2018; 87 FR 66886, Nov. 4, 2022] PPS, a sequence of adjacent episodes
for a beneficiary is a series of claims
§ 484.225 Annual update of the with no more than 60 days without
unadjusted national, standardized
prospective payment rates. home care between the end of one epi-
sode, which is the 60th day (except for
(a) CMS annually updates the episodes that have been PEP-adjusted),
unadjusted national, standardized pro- and the beginning of the next episode.
spective payment rate on a calendar (b) For periods beginning on or after
year basis (in accordance with section January 1, 2020, an HHA receives a na-
1895(b)(1)(B) of the Act). tional 30-day payment of a predeter-
(b) For 2007 and subsequent calendar mined rate for home health services,
years, in accordance with section unless CMS determines at the end of
1895(b)(3)(B)(v) of the Act, in the case of the 30-day period that the HHA fur-
a home health agency that does not nished minimal services to a patient
submit home health quality data, as during the 30-day period.
specified by the Secretary, the (1) For each payment group used to
unadjusted national, standardized pro- case-mix adjust the 30-day payment
spective rate is equal to the rate for rate, the 10th percentile value of total
the previous calendar year increased by visits during a 30-day period of care is
the applicable home health market used to create payment group specific
basket index amount minus 2 percent- thresholds with a minimum threshold
age points. Any reduction of the per- of at least 2 visits for each case-mix
centage change will apply only to the group.
calendar year involved and will not be (2) A 30-day period with a total num-
taken into account in computing the ber of visits less than the threshold is
prospective payment amount for a sub- paid the national per-visit amount by
discipline determined in accordance
sequent calendar year.
with § 484.215(a) and updated annually
(c) For CY 2020, the national, stand-
by the applicable market basket for
ardized prospective 30-day payment each visit type, in accordance with
amount is an amount determined by § 484.225.
the Secretary. CMS annually updates (3) The national per-visit amount is
this amount on a calendar year basis in adjusted by the appropriate wage index
accordance with paragraphs (a) and (b) based on the site of service for the ben-
of this section. eficiary.
[80 FR 68717, Nov. 5, 2015, as amended at 83 (c) An amount is added to low-utili-
FR 56629, Nov. 13, 2018; 84 FR 60645, Nov. 8, zation payment adjustments for low-
2019] utilization periods that occur as the
187
§ 484.235 42 CFR Ch. IV (10–1–24 Edition)
beneficiary’s only 30-day period or ini- length of time the patient remained
tial 30-day period in a sequence of adja- under its care based on the first
cent periods of care. For purposes of billable visit date through and includ-
the home health PPS, a sequence of ad- ing the last billable visit date. The
jacent periods of care for a beneficiary PEP is calculated by determining the
is a series of claims with no more than actual days served as a proportion of 60
60 days without home care between the multiplied by the initial 60-day pay-
end of one period, which is the 30th day ment amount.
(except for episodes that have been par- (b) Partial payment adjustments for pe-
tial payment adjusted), and the begin- riods beginning on or after January 1,
ning of the next episode. 2020. (1) An HHA receives a national,
[83 FR 56629, Nov. 13, 2018] standardized 30-day payment of a pre-
determined rate for home health serv-
§ 484.235 Partial payment adjustments. ices unless CMS determines an inter-
(a) Partial episode payments (PEPs) for vening event, defined as a beneficiary
episodes beginning on or before December elected transfer or discharge with goals
31, 2019. (1) An HHA receives a national, met or no expectation of return to
standardized 60-day payment of a pre- home health and the beneficiary re-
determined rate for home health serv- turned to home health during the 30-
ices unless CMS determines an inter- day period, warrants a new 30-day pe-
vening event, defined as a beneficiary riod for purposes of payment. A start of
elected transfer or discharge with goals care OASIS assessment and certifi-
met or no expectation of return to cation of the new plan of care are re-
home health and the beneficiary required.
turned to home health during the 60- (2) The partial payment adjustment
day episode, warrants a new 60-day epi- does not apply in situations of trans-
sode for purposes of payment. A start fers among HHAs of common owner-
of care OASIS assessment and physi- ship.
cian or allowed practitioner certifi- (i) Those situations are considered
cation of the new plan of care are re- services provided under arrangement
quired. on behalf of the originating HHA by
(2) The PEP adjustment does not the receiving HHA with the common
apply in situations of transfers among ownership interest for the balance of
HHAs of common ownership. the 30-day period.
(i) Those situations are considered
services provided under arrangement (ii) The common ownership exception
on behalf of the originating HHA by to the transfer partial payment adjust-
the receiving HHA with the common ment does not apply if the beneficiary
ownership interest for the balance of moves to a different MSA or Non-MSA
the 60-day episode. during the 30-day period before the
(ii) The common ownership exception transfer to the receiving HHA.
to the transfer PEP adjustment does (iii) The transferring HHA in situa-
not apply if the beneficiary moves to a tions of common ownership not only
different MSA or Non-MSA during the serves as a billing agent, but must also
60-day episode before the transfer to exercise professional responsibility
the receiving HHA. over the arranged-for services in order
(iii) The transferring HHA in situa- for services provided under arrange-
tions of common ownership not only ments to be paid.
serves as a billing agent, but must also (3) If the intervening event warrants
exercise professional responsibility a new 30-day payment and a new physi-
over the arranged-for services in order cian or allowed practitioner certifi-
for services provided under arrange- cation and a new plan of care, the ini-
ments to be paid. tial HHA receives a partial payment
(3) If the intervening event warrants adjustment reflecting the length of
a new 60-day payment and a new physi- time the patient remained under its
cian or allowed practitioner certifi- care based on the first billable visit
cation and a new plan of care, the ini- date through and including the last
tial HHA receives a partial episode billable visit date. The partial payment
payment adjustment reflecting the is calculated by determining the actual
188
days served as a proportion of 30 multi- (B) On measures specified under sec-

plied by the initial 30-day payment tions 1899B(c)(1) and 1899B(d)(1) of the
amount. Act.
[83 FR 56629, Nov. 13, 2018, as amended at 85 (ii) Standardized patient assessment
FR 27628, May 8, 2020] data required under section 1899B(b)(1)
of the Act.
§ 484.240 Outlier payments. (iii) For purposes of HHCAHPS sur-
(a) For episodes beginning on or be- vey data submission, the following ad-
fore December 31, 2019, an HHA receives ditional requirements apply:
an outlier payment for an episode (A) Patient count. An HHA that has
whose estimated costs exceeds a less than 60 eligible unique HHCAHPS
threshold amount for each case-mix patients must annually submit to CMS
group. The outlier threshold for each their total HHCAHPS patient count to
case-mix group is the episode payment CMS to be exempt from the HHCAHPS
amount for that group, or the PEP ad- reporting requirements for a calendar
justment amount for the episode, plus year.
a fixed dollar loss amount that is the (B) Survey requirements. An HHA must
same for all case-mix groups. contract with an approved, inde-
(b) For periods beginning on or after pendent HHCAHPS survey vendor to
January 1, 2020, an HHA receives an administer the HHCAHPS on its behalf.
outlier payment for a 30-day period (C) CMS approval. CMS approves an
whose estimated cost exceeds a thresh- HHCAHPS survey vendor if the appli-
old amount for each case-mix group. cant has been in business for a min-
The outlier threshold for each case-mix imum of 3 years and has conducted sur-
group is the 30-day payment amount veys of individuals and samples for at
for that group, or the partial payment least 2 years.
adjustment amount for the 30-day pe-
(1) For HHCAHPS, a ‘‘survey of indi-
riod, plus a fixed dollar loss amount
viduals’’ is defined as the collection of
that is the same for all case-mix
groups. data from at least 600 individuals se-
(c) The outlier payment is a propor- lected by statistical sampling methods
tion of the amount of imputed cost be- and the data collected are used for sta-
yond the threshold. tistical purposes.
(d) CMS imputes the cost for each (2) All applicants that meet the re-
claim by multiplying the national per- quirements in this paragraph
15 minute unit amount of each dis- (b)(1)(iii)(C) are approved by CMS.
cipline by the number of 15 minute (D) Disapproval by CMS. No organiza-
units in the discipline and computing tion, firm, or business that owns, oper-
the total imputed cost for all dis- ates, or provides staffing for an HHA is
ciplines. permitted to administer its own
HHCAHPS Survey or administer the
[83 FR 56630, Nov. 13, 2018]
survey on behalf of any other HHA in
§ 484.245 Requirements under the the capacity as an HHCAHPS survey
Home Health Quality Reporting vendor. Such organizations are not be
Program (HH QRP). approved by CMS as HHCAHPS survey
(a) Participation. Beginning January vendors.
1, 2007, an HHA must report Home (E) Compliance with oversight activi-
Health Quality Reporting Program (HH ties. Approved HHCAHPS survey ven-
QRP) data in accordance with the re- dors must fully comply with all
quirements of this section. HHCAHPS oversight activities, includ-
(b) Data submission. (1) Except as pro- ing allowing CMS and its HHCAHPS
vided in paragraph (d) of this section, program team to perform site visits at
and for a program year, an HHA must the vendors’ company locations.
submit all of the following to CMS: (2)(i) Data submission requirements.
(i) Data— The data submitted under paragraph
(A) Required under section (b) of this section must be submitted in
1895(b)(3)(B)(v)(II) of the Act, including the form and manner, and at a time,
HHCAHPS survey data; and specified by CMS.
189
§ 484.245 42 CFR Ch. IV (10–1–24 Edition)
(ii) Data completion thresholds. (A) A HHAPU reconsiderations at

home health agency must meet or ex- HHAPUReconsiderations@cms.hhs.gov
ceed the data submission threshold for that contains all of the following infor-
each submission year (July 1 through mation:
June 30) set at 90 percent of all re- (i) HHA CMS Certification Number
quired OASIS or successor instrument (CCN).
records submitted through the CMS (ii) HHA Business Name.
designated data submission systems. (iii) HHA Business Address.
(B) A home health agency must meet (iv) CEO or CEO-designated personnel
or exceed the data submission compli- contact information including name,
ance threshold described in paragraph title, telephone number, email address,
(b)(2)(ii)(A) of this section to avoid re- and mailing address (the address must
ceiving a 2-percentage point reduction be a physical address, not a post office
to its annual payment update for a box).
given fiscal year described under (v) HHA’s reason for requesting the
§ 484.225(b). exception or extension.
(3) Measure removal factors. CMS may
(vi) Evidence of the impact of ex-
remove a quality measure from the HH
traordinary circumstances, including,
QRP based on one or more of the fol-
but not limited to, photographs, news-
lowing factors:
paper, and other media articles.
(i) Measure performance among
(vii) Date when the HHA believes it
HHAs is so high and unvarying that
will be able to again submit data under
meaningful distinctions in improve-
paragraph (b) of this section and a jus-
ments in performance can no longer be
tification for the proposed date.
made.
(ii) Performance or improvement on (3) Except as provided in paragraph
a measure does not result in better pa- (c)(4) of this section, CMS does not con-
tient outcomes. sider an exception or extension request
(iii) A measure does not align with unless the HHA requesting such excep-
current clinical guidelines or practice. tion or extension has complied fully
(iv) The availability of a more broad- with the requirements in this para-
ly applicable (across settings, popu- graph (c).
lations, or conditions) measure for the (4) CMS may grant exceptions or ex-
particular topic. tensions to HHAs without a request if
(v) The availability of a measure that it determines that one or more of the
is more proximal in time to desired pa- following has occurred:
tient outcomes for the particular topic. (i) An extraordinary circumstance,
(vi) The availability of a measure such as an act of nature, affects an en-
that is more strongly associated with tire region or locale.
desired patient outcomes for the par- (ii) A systemic problem with one of
ticular topic. CMS’s data collection systems directly
(vii) Collection or public reporting of affects the ability of an HHA to submit
a measure leads to negative unintended data under paragraph (b) of this sec-
consequences other than patient harm. tion.
(viii) The costs associated with a (d) Reconsiderations. (1)(i) HHAs that
measure outweigh the benefit of its do not meet the quality reporting re-
continued use in the program. quirements under this section for a
(c) Exceptions and extension require- program year will receive a letter of
ments. (1) An HHA may request and noncompliance via the United States
CMS may grant exceptions or exten- Postal Service and the CMS-designated
sions to the reporting requirements data submission system.
under paragraph (b) of this section for (ii) An HHA may request reconsider-
one or more quarters, when there are ation no later than 30 calendar days
certain extraordinary circumstances after the date identified on the letter
beyond the control of the HHA. of non-compliance.
(2) An HHA may request an exception (2) Reconsideration requests may be
or extension within 90 days of the date submitted to CMS by sending an email
that the extraordinary circumstances to CMS HHAPU reconsiderations at
occurred by sending an email to CMS HHAPureConsiderations@cms.hhs.gov
190
containing all of the following infor- application of the unit of payments,

mation: the computation of initial standard
(i) HHA CCN. prospective payment amounts, the es-
(ii) HHA Business Name. tablishment of the adjustment for
(iii) HHA Business Address. outliers, and the establishment of case-
(iv) CEO or CEO-designated personnel mix and area wage adjustment factors.
contact information including name,
title, telephone number, email address, § 484.265 Additional payment.
and mailing address (the address must An additional payment is made to a
be a physical address, not a post office home health agency in accordance with
box). § 476.78 of this chapter for the costs of
(v) CMS identified reason(s) for non- sending requested patient records to
compliance as stated in the non-com- the QIO in electronic format, by fac-
pliance letter. simile, or by photocopying and mail-
(vi) Reason(s) for requesting recon- ing.
sideration, including all supporting
[85 FR 59026, Sept. 18, 2020]
documentation.
(3) CMS does not consider a reconsid-
eration request unless the HHA has Subpart F—Home Health Value-
complied fully with the submission re- Based Purchasing (HHVBP) Models
quirements in paragraphs (d)(1) and (2)
of this section. SOURCE: 80 FR 68718, Nov. 5, 2015, unless
(4) CMS makes a decision on the re- otherwise noted.
quest for reconsideration and provide
notice of the decision to the HHA via HHVBP MODEL COMPONENTS FOR COM-
letter sent via the United States Postal PETING HOME HEALTH AGENCIES WITH-
Service. IN STATE BOUNDARIES FOR THE ORIGI-
(e) Appeals. An HHA that is dissatis- NAL HHVBP MODEL
fied with CMS’ decision on a request
§ 484.300 Basis and scope of subpart.
for reconsideration submitted under
paragraph (d) of this section may file This subpart is established under sec-
an appeal with the Provider Reim- tions 1102, 1115A, and 1871 of the Act (42
bursement Review Board (PRRB) under U.S.C. 1315a), which authorizes the Sec-
42 CFR part 405, subpart R. retary to issue regulations to operate
the Medicare program and test innova-
[84 FR 60645, Nov. 8, 2019, as amended at 87 tive payment and service delivery mod-
FR 66886, Nov. 4, 2022; 88 FR 77878, Nov. 13,
els to improve coordination, quality,
2023]
and efficiency of health care services
§ 484.250 OASIS data. furnished under Title XVIII.
An HHA must submit to CMS the § 484.305 Definitions.
OASIS data described at § 484.55(b) and
As used in this subpart—
(d) as is necessary for CMS to admin-
Applicable measure means a measure
ister the payment rate methodologies
for which a competing HHA has pro-
described in §§ 484.215, 484.220, 484.230,
vided a minimum of—
484.235, and 484.240.
(1) Twenty home health episodes of
[84 FR 60646, Nov. 8, 2019] care per year for the OASIS-based
measures;
§ 484.260 Limitation on review. (2) Twenty home health episodes of
An HHA is not entitled to judicial or care per year for the claims-based
administrative review under sections measures; or
1869 or 1878 of the Act, or otherwise, (3) Forty completed surveys for the
with regard to the establishment of the HHCAHPS measures.
payment unit, including the national Applicable percent means a maximum
60-day prospective episode payment upward or downward adjustment for a
rate, adjustments and outlier pay- given performance year, not to exceed
ments. An HHA is not entitled to the the following:
review regarding the establishment of (1) For CY 2018, 3-percent.
the transition period, definition and (2) For CY 2019, 5-percent.
191
§ 484.310 42 CFR Ch. IV (10–1–24 Edition)
(3) For CY 2020, 6-percent. Total Performance Score means the nu-
(4) For CY 2021, 7-percent. meric score ranging from 0 to 100
Benchmark refers to the mean of the awarded to each competing HHA based
top decile of Medicare-certified HHA on its performance under the HHVBP
performance on the specified quality Model.
measure during the baseline period, Value-based purchasing means meas-
calculated for each state. uring, reporting, and rewarding excel-
Competing home health agency or agen- lence in health care delivery that takes
cies means an agency or agencies: into consideration quality, efficiency,
(1) That has or have a current Medi- and alignment of incentives. Effective
care certification; and, health care services and high per-
(2) Is or are being paid by CMS for forming health care providers may be
home health care delivered within any rewarded with improved reputations
of the states specified in § 484.310. through public reporting, enhanced
Home health prospective payment sys- payments through differential reim-
tem (HH PPS) refers to the basis of pay- bursements, and increased market
ment for home health agencies as set share through purchaser, payer, and/or
forth in §§ 484.200 through 484.245. consumer selection.
Larger-volume cohort means the group [80 FR 68718, Nov. 5, 2015, as amended at 81
of competing home health agencies FR 76796, Nov. 3, 2016; 82 FR 51752, Nov. 7,
within the boundaries of selected 2017; 86 FR 62422, Nov. 9, 2021]
states that are participating in
§ 484.310 Applicability of the Home
HHCAHPs in accordance with § 484.250. Health Value-Based Purchasing
Linear exchange function is the means (HHVBP) Model.
to translate a competing HHA’s Total
Performance Score into a value-based (a) General rule. The HHVBP Model
payment adjustment percentage. applies to all Medicare-certified home
health agencies (HHAs) in selected
New measures means those measures
states.
to be reported by competing HHAs
(b) Selected states. Nine states have
under the HHVBP Model that are not
been selected in accordance with CMS’s
otherwise reported by Medicare-cer-
selection methodology. All Medicare-
tified HHAs to CMS and were identified
certified HHAs that provide services in
to fill gaps to cover National Quality
Massachusetts, Maryland, North Caro-
Strategy Domains not completely cov-
lina, Florida, Washington, Arizona,
ered by existing measures in the home
Iowa, Nebraska, and Tennessee will be
health setting.
required to compete in this model.
Payment adjustment means the
amount by which a competing HHA’s § 484.315 Data reporting for measures
final claim payment amount under the and evaluation and the public re-
HH PPS is changed in accordance with porting of model data under the
the methodology described in § 484.325. Home Health Value-Based Pur-
Performance period means the time chasing (HHVBP) Model.
period during which data are collected (a) Competing home health agencies
for the purpose of calculating a com- will be evaluated using a set of quality
peting HHA’s performance on meas- measures.
ures. (b) Competing home health agencies
Selected state(s) means those nine in selected states will be required to re-
states that were randomly selected to port information on New Measures, as
compete/participate in the HHVBP determined appropriate by the Sec-
Model via a computer algorithm de- retary, to CMS in the form, manner,
signed for random selection and identi- and at a time specified by the Sec-
fied at § 484.310(b). retary, and subject to any exceptions
Smaller-volume cohort means the or extensions CMS may grant to home
group of competing home health agen- health agencies for the Public Health
cies within the boundaries of selected Emergency as defined in § 400.200 of this
states that are exempt from participa- chapter.
tion in HHCAHPs in accordance with (c) Competing home health agencies
§ 484.250. in selected states will be required to
192
collect and report such information as § 484.325 Payments for home health
the Secretary determines is necessary services under Home Health Value-
for purposes of monitoring and evalu- Based Purchasing (HHVBP) Model.
ating the HHVBP Model under section CMS will determine a payment ad-
1115A(b)(4) of the Act (42 U.S.C. 1315a). justment up to the maximum applica-
ble percentage, upward or downward,
[80 FR 68718, Nov. 5, 2015, as amended at 81
FR 76796, Nov. 3, 2016; 84 FR 60646, Nov. 8, under the HHVBP Model for each com-
2019; 85 FR 27628, May 8, 2020; 86 FR 62422, peting home health agency based on
Nov. 9, 2021] the agency’s Total Performance Score
using a linear exchange function. Pay-
§ 484.320 Calculation of the Total Per- ment adjustments made under the
formance Score. HHVBP Model will be calculated as a
percentage of otherwise-applicable pay-
A competing home health agency’s
ments for home health services pro-
Total Performance Score for a model
vided under section 1895 of the Act (42
year is calculated as follows: U.S.C. 1395fff).
(a) CMS will award points to the
competing home health agency for per- § 484.330 Process for determining and
formance on each of the applicable applying the value-based payment
measures excluding the New Measures. adjustment under the Home Health
(b) CMS will award points to the Value-Based Purchasing (HHVBP)
Model.
competing home health agency for re-
porting on each of the New Measures (a) General. Competing home health
worth up to ten percent of the Total agencies will be ranked within the
Performance Score. larger-volume and smaller-volume co-
(c)(1) For performance years 1 horts in selected states based on the
performance standards that apply to
through 3, CMS will sum all points
the HHVBP Model for the baseline
awarded for each applicable measure
year, and CMS will make value-based
excluding the New Measures, weighted
payment adjustments to the competing
equally at the individual measure level HHAs as specified in this section.
to calculate a value worth 90 percent of (b) Calculation of the value-based pay-
the Total Performance Score. ment adjustment amount. The value-
(2) For performance years 4 and 5, based payment adjustment amount is
CMS will sum all points awarded for calculated by multiplying the Home
each applicable measure within each Health Prospective Payment final
category of measures (OASIS-based, claim payment amount as calculated
claims-based and HHCAHPS) excluding in accordance with § 484.205 by the pay-
the New Measures, weighted at 35 per- ment adjustment percentage.
cent for the OASIS-based measure cat- (c) Calculation of the payment adjust-
egory, 35 percent for the claims-based ment percentage. The payment adjust-
measure category, and 30 percent for ment percentage is calculated as the
the HHCAHPS measure category when product of: The applicable percent as
all three measure categories are re- defined in § 484.320, the competing
ported, to calculate a value worth 90 HHA’s Total Performance Score di-
percent of the Total Performance vided by 100, and the linear exchange
Score. function slope.
(d) The sum of the points awarded to § 484.335 Appeals process for the Home
a competing HHA for each applicable Health Value-Based Purchasing
measure and the points awarded to a (HHVBP) Model.
competing HHA for reporting data on (a) Requests for recalculation—(1) Mat-
each New Measure is the competing ters for recalculation. Subject to the
HHA’s Total Performance Score for the limitations on review under section
calendar year. 1115A of the Act, a HHA may submit a
[80 FR 68718, Nov. 5, 2015, as amended at 81 request for recalculation under this
FR 76796, Nov. 3, 2016; 83 FR 56630, Nov. 13, section if it wishes to dispute the cal-
2018] culation of the following:
(i) Interim performance scores.
193
§ 484.335 42 CFR Ch. IV (10–1–24 Edition)
(ii) Annual total performance scores. calculation request submitted under

(iii) Application of the formula to paragraph (a) of this section, or the de-
calculate annual payment adjustment cision to deny the recalculation re-
percentages. quest submitted under paragraph (a) of
(2) Time for filing a request for recal- this section.
culation. A recalculation request must (2) Time for filing a request for recon-
be submitted in writing within 15 cal- sideration. The request for reconsider-
endar days after CMS posts the HHA- ation must be submitted via the
specific information on the HHVBP Se-
HHVBP Secure Portal within 15 cal-
cure Portal, in a time and manner
endar days from CMS’ notification to
specified by CMS.
(3) Content of request. (i) The pro- the HHA contact of the outcome of the
vider’s name, address associated with recalculation process.
the services delivered, and CMS Certifi- (3) Content of request. (i) The name of
cation Number (CCN). the HHA, address associated with the
(ii) The basis for requesting recal- services delivered, and CMS Certifi-
culation to include the specific quality cation Number (CCN).
measure data that the HHA believes is (ii) The basis for requesting reconsid-
inaccurate or the calculation the HHA eration to include the specific quality
believes is incorrect. measure data that the HHA believes is
(iii) Contact information for a person inaccurate or the calculation the HHA
at the HHA with whom CMS or its believes is incorrect.
agent can communicate about this re- (iii) Contact information for a person
quest, including name, email address, at the HHA with whom CMS or its
telephone number, and mailing address
agent can communicate about this re-
(must include physical address, not
quest, including name, email address,
just a post office box).
(iv) The HHA may include in the re- telephone number, and mailing address
quest for recalculation additional doc- (must include physical address, not
umentary evidence that CMS should just a post office box).
consider. Such documents may not in- (iv) The HHA may include in the re-
clude data that was to have been filed quest for reconsideration additional
by the applicable data submission documentary evidence that CMS
deadline, but may include evidence of should consider. Such documents may
timely submission. not include data that was to have been
(4) Scope of review for recalculation. In filed by the applicable data submission
conducting the recalculation, CMS will deadline, but may include evidence of
review the applicable measures and timely submission.
performance scores, the evidence and (4) Scope of review for reconsideration.
findings upon which the determination In conducting the reconsideration re-
was based, and any additional docu- view, CMS will review the applicable
mentary evidence submitted by the measures and performance scores, the
home health agency. CMS may also re- evidence and findings upon which the
view any other evidence it believes to determination was based, and any addi-
be relevant to the recalculation.
tional documentary evidence sub-
(5) Recalculation decision. CMS will
mitted by the HHA. CMS may also re-
issue a written notification of findings.
A recalculation decision is subject to view any other evidence it believes to
the request for reconsideration process be relevant to the reconsideration. The
in accordance with paragraph (b) of HHA must prove its case by a prepon-
this section. derance of the evidence with respect to
(b) Requests for reconsideration—(1) issues of fact.
Matters for reconsideration. A home (5) Reconsideration decision. CMS re-
health agency may request reconsider- consideration officials will issue a
ation of the recalculation of its annual written determination.
total performance score and payment
[81 FR 76796, Nov. 3, 2016]
adjustment percentage following a de-
cision on the home health agency’s re-
194
HHVBP MODEL COMPONENTS FOR COM- (1) Has or have a current Medicare
PETING HOME HEALTH AGENCIES certification; and
(HHAS) FOR HHVBP MODEL EXPAN- (2) Is or are being paid by CMS for
SION—EFFECTIVE JANUARY 1, 2022 home health care services.
HHA baseline year means the calendar
SOURCE: 86 FR 62422, Nov. 9, 2021, unless year used to determine the improve-
otherwise noted. ment threshold for each measure for
§ 484.340 Basis and scope of this sub- each individual competing HHA.
part. Home health prospective payment sys-
tem (HH PPS) refers to the basis of pay-
This subpart is established under sec-
ment for HHAs as set forth in §§ 484.200
tions 1102, 1115A, and 1871 of the Act (42
through 484.245.
U.S.C. 1315a), which authorizes the Sec-
retary to issue regulations to operate Improvement threshold means an indi-
the Medicare program and test innova- vidual competing HHA’s performance
tive payment and service delivery mod- level on a measure during the HHA
els to reduce program expenditures baseline year.
while preserving or enhancing the qual- Larger-volume cohort means the group
ity of care furnished to individuals of competing HHAs that are partici-
under Titles XVIII and XIX of the Act. pating in the HHCAHPS survey in ac-
cordance with § 484.245.
§ 484.345 Definitions. Linear exchange function is the means
As used in this subpart— to translate a competing HHA’s Total
Achievement threshold means the me- Performance Score into a value-based
dian (50th percentile) of home health payment adjustment percentage.
agency performance on a measure dur- Model baseline year means the cal-
ing a Model baseline year, calculated endar year used to determine the
separately for the larger- and smaller- benchmark and achievement threshold
volume cohorts. for each measure for all competing
Applicable measure means a measure HHAs.
(OASIS- and claims-based measures) or Nationwide means the 50 States and
a measure component (HHCAHPS sur- the U.S. territories, including the Dis-
vey measure) for which a competing trict of Columbia.
HHA has provided a minimum of one of Payment adjustment means the
the following: amount by which a competing HHA’s
(1) Twenty home health episodes of final claim payment amount under the
care per year for each of the OASIS- HH PPS is changed in accordance with
based measures. the methodology described in § 484.370.
(2) Twenty home health episodes of Payment year means the calendar
care per year for each of the claims- year in which the applicable percent, a
based measures.
maximum upward or downward adjust-
(3) Forty completed surveys for each ment, applies.
component included in the HHCAHPS
Performance year means the calendar
survey measure.
year during which data are collected
Applicable percent means a maximum
for the purpose of calculating a com-
upward or downward adjustment for a
given payment year based on the appli- peting HHA’s performance on meas-
cable performance year, not to exceed 5 ures.
percent. Pre-Implementation year means CY
Benchmark refers to the mean of the 2022.
top decile of Medicare-certified HHA Smaller-volume cohort means the
performance on the specified quality group of competing HHAs that are ex-
measure during the Model baseline empt from participation in the
year, calculated separately for the HHCAHPS survey in accordance with
larger- and smaller-volume cohorts. § 484.245.
Competing home health agency or agen- Total Performance Score (TPS) means
cies (HHA or HHAs) means an agency or the numeric score ranging from 0 to 100
agencies that meet the following: awarded to each competing HHA based
195
§ 484.350 42 CFR Ch. IV (10–1–24 Edition)
on its performance under the expanded veys of individuals and samples for at
HHVBP Model. least 2 years.
(C) Definition of survey of individuals.
FR 66887, Nov. 4, 2022] For the HHCAHPS survey, a ‘‘survey of
individuals’’ is defined as the collec-
§ 484.350 Applicability of the Ex- tion of data from at least 600 individ-
panded Home Health Value-Based uals selected by statistical sampling
Purchasing (HHVBP) Model. methods and the data collected are
(a) General rule. The expanded used for statistical purposes.
HHVBP Model applies to all Medicare- (D) Administration of the HHCAHPS
certified HHAs nationwide. survey. No organization, firm, or busi-
(b) New HHAs. A new HHA is certified ness that owns, operates, or provides
by Medicare on or after January 1, 2022. staffing for an HHA is permitted to ad-
For new HHAs, the following apply: minister its own HHCAHPS survey or
(1) The HHA baseline year is the first administer the survey on behalf of any
full calendar year of services beginning other HHA in the capacity as an
after the date of Medicare certifi- HHCAHPS survey vendor. Such organi-
cation. zations are not approved by CMS as
(2) The first performance year is the HHCAHPS survey vendors.
first full calendar year following the (E) Compliance by HHCAHPS survey
HHA baseline year. vendors. Approved HHCAHPS survey
(c) Existing HHAs. An existing HHA is vendors must fully comply with all
certified by Medicare before January 1, HHCAHPS survey oversight activities,
2022 and the HHA baseline year is CY including allowing CMS and its
2022. HHCAHPS survey team to perform site
visits at the vendors’ company loca-
[86 FR 62422, Nov. 9, 2021, as amended at 87 tions.
FR 66887, Nov. 4, 2022] (F) Patient count exemption. An HHA
that has less than 60 eligible unique
§ 484.355 Data reporting for measures
and evaluation and the public re- HHCAHPS survey patients must annu-
porting of model data under the ex- ally submit to CMS its total HHCAHPS
panded Home Health Value-Based survey patient count to be exempt
Purchasing (HHVBP) Model. from the HHCAHPS survey reporting
(a) Competing home health agencies requirements for a calendar year.
will be evaluated using a set of quality (2) [Reserved]
measures. (b) Competing home health agencies
(1) Data submission. Except as pro- are required to collect and report such
vided in paragraph (d) of this section, information as the Secretary deter-
for the pre-implementation year and mines is necessary for purposes of mon-
each performance year, an HHA must itoring and evaluating the expanded
submit all of the following to CMS in HHVBP Model under section 1115A(b)(4)
the form and manner, and at a time, of the Act (42 U.S.C. 1315a).
specified by CMS: (c) For each performance year of the
(i) Data on measures specified under expanded HHVBP Model, CMS publicly
the expanded HHVBP model. reports applicable measure bench-
(ii) HHCAHPS survey data. For pur- marks and achievement thresholds for
poses of HHCAHPS Survey data sub- each cohort as well as all of the fol-
mission, the following additional re- lowing for each competing HHA that
quirements apply: qualified for a payment adjustment for
(A) Survey requirements. An HHA must the applicable performance year on a
contract with an approved, inde- CMS website:
pendent HHCAHPS survey vendor to (1) The Total Performance Score.
administer the HHCAHPS survey on its (2) The percentile ranking of the
behalf. Total Performance Score.
(B) CMS approval. CMS approves an (3) The payment adjustment percent-
HHCAHPS survey vendor if the appli- age.
cant has been in business for a min- (4) Applicable measure results and
imum of 3 years and has conducted sur- improvement thresholds.
196
(d) CMS may grant an exception with (h) The costs associated with a meas-
respect to quality data reporting re- ure outweigh the benefit of its contin-
quirements in the event of extraor- ued use in the program.
dinary circumstances beyond the con- [88 FR 77878, Nov. 13, 2023]
trol of the HHA. CMS may grant an ex-
ception as follows: § 484.360 Calculation of the Total Per-
(1) A competing HHA that wishes to formance Score.
request an exception with respect to A competing HHA’s Total Perform-
quality data reporting requirements ance Score for a performance year is
must submit its request to CMS within calculated as follows:
90 days of the date that the extraor- (a) CMS awards points to the com-
dinary circumstances occurred. Spe- peting home health agency for per-
cific requirements for submission of a formance on each of the applicable
request for an exception are available measures.
on the CMS website. (1) CMS awards greater than or equal
(2) CMS may grant an exception to to 0 points and less than 10 points for
one or more HHAs that have not re- achievement to each competing home
quested an exception if CMS deter- health agency whose performance on a
mines either of the following: measure during the applicable perform-
(i) That a systemic problem with ance year meets or exceeds the applica-
CMS data collection systems directly ble cohort’s achievement threshold but
affected the ability of the HHA to sub- is less than the applicable cohort’s
mit data. benchmark for that measure.
(ii) That an extraordinary cir- (2) CMS awards greater than 0 but
cumstance has affected an entire re- less than 9 points for improvement to
each competing home health agency
gion or locale.
whose performance on a measure dur-
§ 484.358 HHVBP Measure removal facing the applicable performance year ex-
tors. ceeds the improvement threshold but is
less than the applicable cohort’s bench-
CMS may remove a quality measure mark for that measure.
from the expanded HHVBP Model based (3) CMS awards 10 points to a com-
on one or more of the following factors: peting home health agency whose per-
(a) Measure performance among formance on a measure during the ap-
HHAs is so high and unvarying that plicable performance year meets or ex-
meaningful distinctions in improve- ceeds the applicable cohort’s bench-
ments in performance can no longer be mark for that measure.
made (that is, topped out). (b) For all performance years, CMS
(b) Performance or improvement on a calculates the weighted sum of points
measure does not result in better pa- awarded for each applicable measure
tient outcomes. within each category of measures
(c) A measure does not align with (OASIS-based, claims-based, and
current clinical guidelines or practice. HHCAHPS Survey-based) weighted at
(d) A more broadly applicable meas- 35 percent for the OASIS-based meas-
ure (across settings, populations, or ure category, 35 percent for the claims-
conditions) for the particular topic is based measure category, and 30 percent
for the HHCAHPS survey measure cat-
available.
egory when all three measure cat-
(e) A measure that is more proximal
egories are reported, to calculate a
in time to desired patient outcomes for value worth 100 percent of the Total
the particular topic is available. Performance Score.
(f) A measure that is more strongly (1) Where a single measure category
associated with desired patient out- is not included in the calculation of the
comes for the particular topic is avail- Total Performance Score for an indi-
able. vidual HHA, due to insufficient volume
(g) Collection or public reporting of a for all of the measures in the category,
measure leads to negative unintended the remaining measure categories are
consequences other than patient harm. reweighted such that the proportional
197
§ 484.365 42 CFR Ch. IV (10–1–24 Edition)
contribution of each remaining meas- § 484.370 Process for determining and

ure category is consistent with the applying the value-based payment
weights assigned when all three meas- adjustment under the Expanded
ure categories are available. Where two Home Health Value-Based Pur-
chasing (HHVBP) Model.
measure categories are not included in
the calculation of the Total Perform- (a) General. Competing home health
ance Score for an individual HHA, due agencies are ranked within the larger-
to insufficient volume for all measures volume and smaller-volume cohorts na-
in those measure categories, the re- tionwide based on the performance
maining measure category is weighted standards in this part that apply to the
at 100 percent of the Total Performance expanded HHVBP Model, and CMS
Score. makes value-based payment adjust-
ments to the competing HHAs as speci-
(2) When one or more, but not all, of
fied in this section.
the measures in a measure category
(b) Calculation of the value-based pay-
are not included in the calculation of
ment adjustment amount. The value-
the Total Performance Score for an in- based payment adjustment amount is
dividual HHA, due to insufficient vol- calculated by multiplying the home
ume for at least one measure in the health prospective payment final claim
category, the remaining measures in payment amount as calculated in ac-
the category are reweighted such that cordance with § 484.205 by the payment
the proportional contribution of each adjustment percentage.
remaining measure is consistent with (c) Calculation of the payment adjust-
the weights assigned when all measures ment percentage. The payment adjust-
within the category are available. ment percentage is calculated as the
(c) The sum of the weight-adjusted product of all of the following:
points awarded to a competing HHA for (1) The applicable percent as defined
each applicable measure is the com- in § 484.345.
peting HHA’s Total Performance Score (2) The competing HHA’s Total Per-
for the calendar year. A competing formance Score divided by 100.
HHA must have a minimum of five ap- (3) The linear exchange function
plicable measures to receive a Total slope.
Performance Score. [86 FR 62422, Nov. 9, 2021, as amended at 87
FR 66887, Nov. 4, 2022]
§ 484.365 Payments for home health
services under the Expanded Home § 484.375 Appeals process for the Ex-
Health Value–Based Purchasing panded Home Health Value-Based
(HHVBP) Model. Purchasing (HHVBP) Model.
CMS determines a payment adjust- (a) Requests for recalculation—(1) Mat-
ment up to the applicable percent, up- ters for recalculation. Subject to the
ward or downward, under the expanded limitations on judicial and administra-
HHVBP Model for each competing HHA tive review under section 1115A of the
based on the agency’s Total Perform- Act, a HHA may submit a request for
ance Score using a linear exchange recalculation under this section if it
function that includes all other HHAs wishes to dispute the calculation of the
in its cohort that received a Total Per- following:
formance Score for the applicable per- (i) Interim performance scores.
formance year. Payment adjustments (ii) Annual total performance scores.
made under the expanded HHVBP (iii) Application of the formula to
Model are calculated as a percentage of calculate annual payment adjustment
otherwise-applicable payments for percentages.
home health services provided under (2) Time for filing a request for recal-
section 1895 of the Act (42 U.S.C. culation. A recalculation request must
1395fff). be submitted in writing within 15 cal-
endar days after CMS posts the HHA-
specific information on the CMS
website, in a time and manner specified
by CMS.
198
(3) Content of request. (i) The pro- (3) Content of request. (i) The name of
vider’s name, address associated with the HHA, address associated with the
the services delivered, and CMS Certifi- services delivered, and CMS Certifi-
cation Number (CCN). cation Number (CCN).
(ii) The basis for requesting recal- (ii) The basis for requesting reconsid-
culation to include the specific data eration to include the specific data
that the HHA believes is inaccurate or that the HHA believes is inaccurate or
the calculation the HHA believes is in- the calculation the HHA believes is in-
correct. correct.
(iii) Contact information for a person (iii) Contact information for a person
at the HHA with whom CMS or its at the HHA with whom CMS or its
agent can communicate about this reagent can communicate about this re-
quest, including name, email address, quest, including name, email address,
telephone number, and mailing address telephone number, and mailing address
(must include physical address, not (must include physical address, not
just a post office box). just a post office box).
(iv) The HHA may include in the re- (iv) The HHA may include in the re-
quest for recalculation additional doc- quest for reconsideration additional
umentary evidence that CMS should documentary evidence that CMS
consider. Such documents may not in- should consider. The documents may
not include data that was to have been
clude data that was to have been filed
filed by the applicable data submission
by the applicable data submission
deadline, but may include evidence of
deadline, but may include evidence of
timely submission.
timely submission.
(4) Scope of review for reconsideration.
(4) Scope of review for recalculation. In In conducting the reconsideration re-
conducting the recalculation, CMS review, CMS reviews the applicable
views the applicable measures and per- measures and performance scores, the
formance scores, the evidence and find- evidence and findings upon which the
ings upon which the determination was determination was based, and any addi-
based, and any additional documentary tional documentary evidence sub-
evidence submitted by the HHA. CMS mitted by the HHA. CMS may also re-
may also review any other evidence it view any other evidence it believes to
believes to be relevant to the recal- be relevant to the reconsideration. The
culation. HHA must prove its case by a prepon-
(5) Recalculation decision. CMS issues derance of the evidence with respect to
a written notification of findings. A re- issues of fact.
calculation decision is subject to the (5) Reconsideration decision. (i) CMS
request for reconsideration process in reconsideration officials issue a writ-
accordance with paragraph (b) of this ten decision that is final and binding
section. upon issuance unless the CMS Adminis-
(b) Requests for reconsideration—(1) trator—
Matters for reconsideration. A home (A) Renders a final determination re-
health agency may request reconsider- versing or modifying the reconsider-
ation of the recalculation of its annual ation decision; or
total performance score and payment (B) Does not review the reconsider-
adjustment percentage following a de- ation decision within 14 days of the re-
cision on the HHA’s recalculation request.
quest submitted under paragraph (a) of (ii) An HHA may request that the
this section, or the decision to deny CMS Administrator review the recon-
the recalculation request submitted sideration decision within 7 calendar
under paragraph (a) of this section. days of the decision.
(2) Time for filing a request for recon- (iii) If the CMS Administrator re-
sideration. The request for reconsider- ceives a request to review, the CMS Ad-
ation must be submitted via the CMS ministrator must do one of the fol-
website within 15 calendar days from lowing:
CMS’ notification to the HHA contact (A) Render a final determination
of the outcome of the recalculation based on his or her review of the recon-
process. sideration decision.
199
(B) Decline to review a reconsider- 485.516 Condition of participation: Emer-

ation decision made by CMS. gency services.
(C) Choose to take no action. 485.518 Condition of participation: Labora-
tory services.
(iv) If the CMS Administrator does 485.520 Condition of participation:
not review an HHA’s request within 14 Radiologic services.
days (as described in paragraph 485.522 Condition of participation: Pharma-
(b)(5)(iii)(B) or (C) of this section), the ceutical services.
reconsideration official’s written re- 485.524 Condition of participation: Addi-
consideration decision is final. tional outpatient medical and health
services.
[86 FR 62422, Nov. 9, 2021, as amended at 88 485.526 Condition of participation: Infection
FR 77879, Nov. 13, 2023] prevention and control and antibiotic
stewardship programs.
PART 485—CONDITIONS OF PAR- 485.528 Condition of participation: Staffing
and staff responsibilities.
TICIPATION: SPECIALIZED PRO- 485.530 Condition of participation: Nursing
VIDERS services.
485.532 Condition of participation: Dis-
Subpart A [Reserved] charge planning.
485.534 Condition of participation: Patient’s
Subpart B—Conditions of Participation: rights.
Comprehensive Outpatient Rehabilita- 485.536 Condition of participation: Quality
tion Facilities assessment and performance improve-
ment program.
Sec. 485.538 Condition of participation: Agree-
485.50 Basis and scope. ments.
485.51 Definition. 485.540 Condition of participation: Medical
485.54 Condition of participation: Compli- records.
ance with State and local laws. 485.542 Condition of participation: Emer-
485.56 Condition of participation: Governing gency preparedness.
body and administration. 485.544 Condition of participation: Physical
485.58 Condition of participation: Com- environment.
prehensive rehabilitation program. 485.546 Condition of participation: Skilled
485.60 Condition of participation: Clinical nursing facility distinct part unit.
records.
485.62 Condition of participation: Physical Subpart F—Conditions of Participation:
environment. Critical Access Hospitals (CAHs)
485.64 [Reserved]
485.66 Condition of participation: Utiliza- 485.601 Basis and scope.
tion review plan. 485.603 Rural health network.
485.68 Condition of participation: Emer- 485.604 Personnel qualifications.
gency preparedness. 485.606 Designation and certification of
485.70 Personnel qualifications. CAHs.
485.74 Appeal rights. 485.608 Condition of participation: Compli-
ance with Federal, State, and local laws
Subparts C–D [Reserved] and regulations.
485.610 Condition of participation: Status
Subpart E—Conditions of Participation: and location.
Rural Emergency Hospitals (REHs) 485.612 Condition of participation: Compli-
ance with hospital requirements at the
485.500 Basis and scope. time of application.
485.502 Definitions. 485.614 Condition of participation: Patient’s
485.504 Basic requirements. rights.
485.506 Designation and certification of 485.616 Condition of participation: Agree-
REHs. ments.
485.508 Condition of participation: Compli- 485.618 Condition of participation: Emer-
ance with Federal, state, and local laws gency services.
and regulations. 485.620 Condition of participation: Number
485.510 Condition of participation: Gov- of beds and length of stay.
erning body and organizational structure 485.623 Condition of participation: Physical
of the REH. plant and environment.
485.512 Condition of participation: Medical 485.625 Condition of participation: Emer-
staff. gency preparedness.
485.514 Condition of participation: Provision 485.627 Condition of participation: Organiza-
of services. tional structure.
200
485.631 Condition of participation: Staffing Subpart I [Reserved]
and staff responsibilities.
485.635 Condition of participation: Provision Subpart J—Conditions of Participation:
of services. Community Mental Health Centers
485.638 Condition of participation: Clinical (CMHCs)
records.
485.639 Condition of participation: Surgical 485.900 Basis and scope.
services. 485.902 Definitions.
485.640 Condition of participation: Infection 485.904 Condition of participation: Per-
prevention and control and antibiotic sonnel qualifications.
stewardship programs. 485.910 Condition of participation: Client
485.641 Condition of participation: Quality rights.
assessment and performance improve- 485.914 Condition of participation: Admis-
ment program. sion, initial evaluation, comprehensive
485.642 Condition of participation: Dis- assessment, and discharge or transfer of
charge planning. the client.
485.643 Condition of participation: Organ, 485.916 Condition of participation: Treat-
tissue, and eye procurement. ment team, person-centered active treat-
485.645 Special requirements for CAH pro- ment plan, and coordination of services.
viders of long-term care services 485.917 Condition of participation: Quality
(‘‘swing-beds’’). assessment and performance improve-
485.647 Condition of participation: psy- ment.
chiatric and rehabilitation distinct part 485.918 Condition of participation: Organiza-
units. tion, governance, administration of serv-
ices, partial hospitalization services, and
Subpart G [Reserved] intensive outpatient services.
485.920 Condition of participation: Emer-
Subpart H—Conditions of Participation for gency preparedness.
Clinics, Rehabilitation Agencies, and AUTHORITY: 42 U.S.C. 1302 and 1395(hh).
Public Health Agencies as Providers of
SOURCE: 48 FR 56293, Dec. 15, 1982, unless
Outpatient Physical Therapy and otherwise noted. Redesignated at 50 FR 33034,
Speech-Language Pathology Services Aug. 16, 1985.
485.703 Definitions. Subpart A [Reserved]
485.705 Personnel qualifications.
485.707 Condition of participation: Compli- Subpart B—Conditions of Partici-
ance with Federal, State, and local laws.
485.709 Condition of participation: Adminis-
pation: Comprehensive Out-
trative management. patient Rehabilitation Facili-
485.711 Condition of participation: Plan of ties
care and physician involvement.
485.713 Condition of participation: Physical § 485.50 Basis and scope.
therapy services. This subpart sets forth the condi-
485.715 Condition of participation: Speech
tions that facilities must meet to be
pathology services.
certified as comprehensive outpatient
485.717 Condition of participation: Rehabili-
tation program. rehabilitation facilities (CORFs) under
485.719 Condition of participation: Arrange- section 1861(cc)(2) of the Social Secu-
ments for physical therapy and speech rity Act and be accepted for participa-
pathology services to be performed by tion in Medicare in accordance with
other than salaried organization per- part 489 of this chapter.
sonnel.
485.721 Condition of participation: Clinical § 485.51 Definition.
records.
As used in this subpart, unless the
485.723 Condition of participation: Physical
environment.
context indicates otherwise, ‘‘com-
485.725 Condition of participation: Infection
prehensive outpatient rehabilitation facil-
control. ity’’, ‘‘CORF’’, or ‘‘facility’’ means a
485.727 Condition of participation: Emer- nonresidential facility that—
gency preparedness. (a) Is established and operated exclu-
485.729 Condition of participation: Program sively for the purpose of providing di-
evaluation. agnostic, therapeutic, and restorative
201
§ 485.54 42 CFR Ch. IV (10–1–24 Edition)
services to outpatients for the rehabili- (3) Designates, in writing, an indi-

tation of injured, disabled, or sick per- vidual who, in the absence of the ad-
sons, at a single fixed location, by or ministrator, acts on behalf of the ad-
under the supervision of a physician ministrator; and
except as provided in paragraph (c) of (4) Retains professional and adminis-
this section; trative responsibility for all personnel
(b) Meets all the requirements of this providing facility services.
subpart. (c) Standard: Group of professional per-
(c) Exception. May provide influenza, sonnel. The facility must have a group
pneumococcal and Hepatitis B vaccines of professional personnel associated
provided the applicable conditions of with the facility that—
coverage under § 410.58 and § 410.63 of (1) Develops and periodically reviews
this chapter are met. policies to govern the services provided
[48 FR 56293, Dec. 15, 1982, as amended at 72 by the facility; and
FR 66408, Nov. 27, 2007] (2) Consists of at least one physician
and one professional representing each
§ 485.54 Condition of participation: of the services provided by the facility.
Compliance with State and local (d) Standard: Institutional budget plan.
laws.
The facility must have an institutional
The facility and all personnel who budget plan that meets the following
provide services must be in compliance conditions:
with applicable State and local laws (1) It is prepared, under the direction
and regulations. of the governing body, by a committee
(a) Standard: Licensure of facility. If consisting of representatives of the
State or local law provides for licens- governing body and the administrative
ing, the facility must be currently li- staff.
censed or approved as meeting the (2) It provides for—
standards established for licensure.
(i) An annual operating budget pre-
(b) Standard: Licensure of personnel. pared according to generally accepted
Personnel that provide service must be
accounting principles;
licensed, certified, or registered in ac-
(ii) A 3-year capital expenditure plan
cordance with applicable State and
if expenditures in excess of $100,000 are
local laws.
anticipated, for that period, for the ac-
§ 485.56 Condition of participation: quisition of land; the improvement of
Governing body and administra- land, buildings, and equipment; and the
tion. replacement, modernization, and ex-
The facility must have a governing pansion of buildings and equipment;
body that assumes full legal responsi- and
bility for establishing and imple- (iii) Annual review and updating by
menting policies regarding the man- the governing body.
agement and operation of the facility. (e) Standard: Patient care policies. The
(a) Standard: Disclosure of ownership. facility must have written patient care
The facility must comply with the pro- policies that govern the services it fur-
visions of part 420, subpart C of this nishes. The patient care policies must
chapter that require health care pro- include the following:
viders and fiscal agents to disclose cer- (1) A description of the services the
tain information about ownership and facility furnishes through employees
control. and those furnished under arrange-
(b) Standard: Administrator. The gov- ments.
erning body must appoint an adminis- (2) Rules for and personnel respon-
trator who— sibilities in handling medical emer-
(1) Is responsible for the overall man- gencies.
agement of the facility under the au- (3) Rules for the storage, handling,
thority delegated by the governing and administration of drugs and
body; biologicals.
(2) Implements and enforces the fa- (4) Criteria for patient admission,
cility’s policies and procedures; continuing care, and discharge.
202
(5) Procedures for preparing and (v) May not include clauses that
maintaining clinical records on all pa- state or imply that the contractor has
tients. power and authority to act on behalf of
(6) A procedure for explaining to the the facility, or clauses that give the
patient and the patient’s family the ex- contractor rights, duties, discretions,
tent and purpose of the services to be or responsibilities that enable it to dic-
provided. tate the administration, management,
(7) A procedure to assist the referring or operations of the facility.
physician in locating another level of
care for—patients whose treatment has § 485.58 Condition of participation:
terminated and who are discharged. Comprehensive rehabilitation pro-
gram.
(8) A requirement that patients ac-
cepted by the facility must be under The facility must provide a coordi-
the care of a physician. nated rehabilitation program that in-
(9) A requirement that there be a cludes, at a minimum, physicians’ serv-
plan of treatment established by a phy- ices, physical therapy services, and so-
sician for each patient. cial or psychological services. These
(10) A procedure to ensure that the services must be furnished by per-
group of professional personnel reviews sonnel that meet the qualifications set
and takes appropriate action on rec- forth in §§ 485.70 and 484.115 of this
ommendations from the utilization re- chapter and must be consistent with
view committee regarding patient care the plan of treatment and the results
policies. of comprehensive patient assessments.
(f) Standard: Delegation of authority. (a) Standard: Physician services. (1) A
The responsibility for overall adminis- facility physician must be present in
tration, management, and operation the facility for a sufficient time to—
must be retained by the facility itself (i) Provide, in accordance with ac-
and not delegated to others. cepted principles of medical practice,
(1) The facility may enter into a con- medical direction, medical care serv-
tract for purposes of assistance in fi- ices, consultation, and medical super-
nancial management and may delegate vision of nonphysician staff;
to others the following and similar (ii) Establish the plan of treatment
services: in cases where a plan has not been es-
(i) Bookkeeping. tablished by the referring physician;
(ii) Assistance in the development of (iii) Assist in establishing and imple-
procedures for billing and accounting menting the facility’s patient care
systems. policies; and
(iii) Assistance in the development of (iv) Participate in plan of treatment
an operating budget. reviews, patient case review con-
(iv) Purchase of supplies in bulk ferences, comprehensive patient assess-
form. ment and reassessments, and utiliza-
(v) The preparation of financial tion review.
statements. (2) The facility must provide for
(2) When the services listed in para- emergency physician services during
graph (f)(1) of this section are dele- the facility operating hours.
gated, a contract must be in effect and: (b) Standard: Plan of treatment. For
(i) May not be for a term of more each patient, a physician must estab-
than 5 years; lish a plan of treatment before the fa-
(ii) Must be subject to termination cility initiates treatment. The plan of
within 60 days of written notice by ei- treatment must meet the following re-
ther party; quirements:
(iii) Must contain a clause requiring (1) It must delineate anticipated
renegotiation of any provision that goals and specify the type, amount, fre-
CMS finds to be in contravention to quency and duration of services to be
any new, revised or amended Federal provided.
regulation or law; (2) It must be promptly evaluated
(iv) Must state that only the facility after changes in the patient’s condition
may bill the Medicare program; and and revised when necessary.
203
§ 485.58 42 CFR Ch. IV (10–1–24 Edition)
(3) It must, if appropriate, be devel- (iv) Rehabilitation goals, if deter-

oped in consultation with the facility mined.
physician and the appropriate facility (2) Services may be provided by facil-
professional personnel. ity employees or by others under ar-
(4) It must be reviewed at least every rangements made by the facility.
60 days by a facility physician who, (3) The facility must have on its
when appropriate, consults with the premises the necessary equipment to
professional personnel providing serv- implement the plan of treatment and
ices. The results of this review must be sufficient space to allow adequate care.
communicated to the patient’s refer- (4) The services must be furnished by
ring physician for concurrence before personnel that meet the qualifications
treatment is continued or discon- of § 485.70 and the number of qualified
tinued.
personnel must be adequate for the vol-
(5) It must be revised if the com- ume and diversity of services offered.
prehensive reassessment of the pa- Personnel that do not meet the quali-
tient’s status or the results of the pa-
fications specified in § 485.70(a) through
tient case review conference indicate
(m) may be used by the facility in as-
the need for revision.
sisting qualified staff.
(c) Standard: Coordination of services.
(5) A qualified professional must ini-
The facility must designate, in writing,
a qualified professional to ensure that tiate and coordinate the appropriate
professional personnel coordinate their portions of the plan of treatment, mon-
related activities and exchange infor- itor the patient’s progress, and rec-
mation about each patient under their ommend changes, in the plan, if nec-
care. Mechanisms to assist in the co- essary.
ordination of services must include— (6) A qualified professional rep-
(1) Providing to all personnel associ- resenting each service made available
ated with the facility, a schedule indi- at the facility must be either on the
cating the frequency and type of serv- premises of the facility or must be
ices provided at the facility; available through direct telecommuni-
(2) A procedure for communicating to cation for consultation and assistance
all patient care personnel pertinent in- during the facility’s operating hours.
formation concerning significant At least one qualified professional
changes in the patient’s status; must be on the premises during the fa-
(3) Periodic clinical record entries, cility’s operating hours.
noting at least the patient’s status in (7) All services must be provided con-
relationship to goal attainment; and sistent with accepted professional
(4) Scheduling patient case review standards and practice.
conferences for purposes of deter- (e) Standard: Scope and site of serv-
mining appropriateness of treatment, ices—(1) Basic requirements. The facility
when indicated by the results of the must provide all the CORF services re-
initial comprehensive patient assess- quired in the plan of treatment and, ex-
ment, reassessment(s), the rec- cept as provided in paragraph (e)(2) of
ommendation of the facility physician this section, must provide the services
(or other physician who established the on its premises.
plan of treatment), or upon the rec- (2) Exceptions. Physical therapy, oc-
ommendation of one of the profes- cupational therapy, and speech-lan-
sionals providing services. guage pathology services may be fur-
(d) Standard: Provision of services. (1) nished away from the premises of the
All patients must be referred to the fa- CORF including the individual’s home
cility by a physician who provides the when payment is not otherwise made
following information to the facility under Title XVIII of the Act. In addi-
before treatment is initiated: tion, a single home environment eval-
(i) The patient’s significant medical uation is covered if there is a need to
history. evaluate the potential impact of the
(ii) Current medical findings. home environment on the rehabilita-
(iii) Diagnosis(es) and contraindication goals. The single home environ-
tions to any treatment modality. ment evaluation requires the presence
204
of the patient and the physical thera- (1) The initial assessment and subse-
pist, occupational therapist, or speech- quent reassessments of the patient’s
language pathologist, as appropriate. needs;
(f) Standard: Patient assessment. Each (2) Current plan of treatment;
qualified professional involved in the (3) Identification data and consent or
patient’s care, as specified in the plan authorization forms;
of treatment, must— (4) Pertinent medical history, past
(1) Carry out an initial patient as- and present;
sessment; and (5) A report of pertinent physical ex-
(2) In order to identify whether or aminations if any;
not the current plan of treatment is (6) Progress notes or other docu-
appropriate, perform a patient reas- mentation that reflect patient reaction
sessment after significant changes in to treatment, tests, or injury, or the
the patient’s status. need to change the established plan of
(g) Standard: Laboratory services. (1) If treatment; and
the facility provides its own laboratory (7) Upon discharge, a discharge sum-
services, the services must meet the mary including patient status relative
applicable requirements for labora- to goal achievement, prognosis, and fu-
tories specified in part 493 of this chap- ture treatment considerations.
ter. (b) Standard: Protection of clinical
(2) If the facility chooses to refer record information. The facility must
specimens for laboratory testing, the safeguard clinical record information
referral laboratory must be certified in against loss, destruction, or unauthor-
the appropriate specialties and sub- ized use. The facility must have proce-
specialties of services in accordance dures that govern the use and removal
with the requirements of part 493 of of records and the conditions for re-
this chapter. lease of information. The facility must
obtain the patient’s written consent
[48 FR 56293, Dec. 15, 1982, as amended at 56 before releasing information not re-
FR 8852, Mar. 1, 1991; 57 FR 7137, Feb. 28, 1992;
73 FR 69941, Nov. 19, 2008; 82 FR 4591, Jan. 13,
quired to be released by law.
2017; 86 FR 61622, Nov. 5, 2021; 88 FR 36510, (c) Standard: Retention and preserva-
June 5, 2023] tion. The facility must retain clinical
record information for 5 years after pa-
§ 485.60 Condition of participation: tient discharge and must make provi-
Clinical records. sion for the maintenance of such
The facility must maintain clinical records in the event that it is no longer
records on all patients in accordance able to treat patients.
with accepted professional standards
and practice. The clinical records must § 485.62 Condition of participation:
Physical environment.
be completely, promptly, and accu-
rately documented, readily accessible, The facility must provide a physical
and systematically organized to facili- environment that protects the health
tate retrieval and compilation of infor- and safety or patients, personnel, and
mation. the public.
(a) Standard: Content. Each clinical (a) Standard: Safety and comfort of pa-
record must contain sufficient infor- tients. The physical premises of the fa-
mation to identify the patient clearly cility and those areas of its sur-
and to justify the diagnosis and treat- rounding physical structure that are
ment. Entries in the clinical record used by the patients (including at least
must be made as frequently as is nec- all stairwells, corridors and passage-
essary to insure effective treatment ways) must meet the following require-
and must be signed by personnel pro- ments:
viding services. All entries made by as- (1) Applicable Federal, State, and
sistant level personnel must be local building, fire, and safety codes
countersigned by the corresponding must be met.
professional. Documentation on each (2) Fire extinguishers must be easily
patient must be consolidated into one accessible and fire regulations must be
clinical record that must contain— prominently posted.
205
§ 485.64 42 CFR Ch. IV (10–1–24 Edition)
(3) A fire alarm system with local (in- (2) The interior of the facility, the
house) capability must be functional, exterior of the physical structure hous-
and where power is generated by elec- ing the facility, and the exterior walk-
tricity, an alternate power source with ways and parking areas are clean and
automatic triggering must be present. orderly and maintained free of any de-
(4) Lights, supported by an emer- fects that are a hazard to patients, per-
gency power source, must be placed at sonnel, and the public.
exits. (d) Standard: Access for the physically
(5) A sufficient number of staff to impaired. The facility must ensure the
evacuate patients during a disaster following:
must be on the premises of the facility (1) Doorways, stairwells, corridors,
whenever patients are being treated. and passageways used by patients are—
(6) Lighting must be sufficient to (i) Of adequate width to allow for
carry out services safely; room tem- easy movement of all patients (includ-
perature must be maintained at coming those on stretchers or in wheel-
fortable levels; and ventilation through chairs); and
windows, mechanical means, or a com- (ii) In the case of stairwells, equipped
bination of both must be provided. with firmly attached handrails on at
(7) Safe and sufficient space must be least one side.
available for the scope of services of- (2) At least one toilet facility is ac-
fered. cessible and constructed to allow utili-
(b) Standard: Sanitary environment. zation by ambulatory and non-
The facility must maintain a sanitary ambulatory individuals.
environment and establish a program (3) At least one entrance is usable by
to identify, investigate, prevent, and individuals in wheelchairs.
control the cause of patient infections. (4) In multi-story buildings, elevators
(1) The facility must establish writ- are accessible to and usable by the
ten policies and procedures designed to physically impaired on the level that
control and prevent infection in the fa- they use to enter the building and all
cility and to investigate and identify levels normally used by the patients of
possible causes of infection. the facility.
(5) Parking spaces are large enough
(2) The facility must monitor the in-
and close enough to the facility to
fection control program to ensure that
allow safe access by the physically im-
the staff implement the policies and
paired.
procedures and that the policies and
procedures are consistent with current § 485.64 [Reserved]
practices in the field.
(3) The facility must make available § 485.66 Condition of participation:
at all times a quantity of laundered Utilization review plan.
linen adequate for proper care and The facility must have in effect a
comfort of patients. Linens must be written utilization review plan that is
handled, stored, and processed in a implemented annually, to assess the
manner that prevents the spread of in- necessity of services and promotes the
fection. most efficient use of services provided
(4) Provisions must be in effect to en- by the facility.
sure that the facility’s premises are (a) Standard: Utilization review com-
maintained free of rodent and insect mittee. The utilization review com-
infestation. mittee, consisting of the group of pro-
(c) Standard: Maintenance of equip- fessional personnel specified in
ment, physical location, and grounds. § 485.56(c), a committee of this group, or
The facility must establish a written a group of similar composition, com-
preventive maintenance program to en- prised by professional personnel not as-
sure that— sociated with the facility, must carry
(1) All equipment is properly main- out the utilization review plan.
tained and equipment needing periodic (b) Standard: Utilization review plan.
calibration is calibrated consistent The utilization review plan must con-
with the manufacturer’s recommenda- tain written procedures for evalu-
tions; and ating—
206
(1) Admissions, continued care, and (5) Be developed and maintained with
discharges using, at a minimum, the assistance from fire, safety, and other
criteria established in the patient care appropriate experts.
policies; (b) Policies and procedures. The CORF
(2) The applicability of the plan of must develop and implement emer-
treatment to established goals; and gency preparedness policies and proce-
(3) The adequacy of clinical records dures, based on the emergency plan set
with regard to— forth in paragraph (a) of this section,
(i) Assessing the quality of services risk assessment at paragraph (a)(1) of
provided; and this section, and the communication
plan at paragraph (c) of this section.
(ii) Determining whether the facili-
The policies and procedures must be re-
ty’s policies and clinical practices are
viewed and updated at least every 2
compatible and promote appropriate
years. At a minimum, the policies and
and efficient utilization of services. procedures must address the following:
[48 FR 56293, Dec. 15, 1982. Redesignated at 50 (1) Safe evacuation from the CORF,
FR 33034, Aug. 16, 1985, as amended at 84 FR which includes staff responsibilities,
51826, Sept. 30, 2019] and needs of the patients.
(2) A means to shelter in place for pa-
§ 485.68 Condition of participation: tients, staff, and volunteers who re-
Emergency preparedness. main in the facility.
The Comprehensive Outpatient Reha- (3) A system of medical documenta-
bilitation Facility (CORF) must com- tion that preserves patient informa-
ply with all applicable Federal, State, tion, protects confidentiality of patient
and local emergency preparedness re- information, and secures and main-
quirements. The CORF must establish tains the availability of records.
and maintain an emergency prepared- (4) The use of volunteers in an emer-
ness program that meets the require- gency and other emergency staffing
ments of this section. The emergency strategies, including the process and
preparedness program must include, role for integration of State or Feder-
but not be limited to, the following ele- ally designated health care profes-
ments: sionals to address surge needs during
(a) Emergency plan. The CORF must an emergency.
develop and maintain an emergency (c) Communication plan. The CORF
preparedness plan that must be re- must develop and maintain an emer-
viewed and updated at least every 2 gency preparedness communication
plan that complies with Federal, State,
years. The plan must do all of the fol-
lowing:
(1) Be based on and include a docu-
mented, facility-based and community- of the following:
based risk assessment, utilizing an all- (1) Names and contact information
hazards approach. for the following:
(2) Include strategies for addressing (i) Staff.
emergency events identified by the (ii) Entities providing services under
risk assessment. arrangement.
(3) Address patient population, in- (iii) Patients’ physicians.
cluding, but not limited to, the type of (iv) Other CORFs.
services the CORF has the ability to (v) Volunteers.
provide in an emergency; and con- (2) Contact information for the fol-
tinuity of operations, including delega- lowing:
tions of authority and succession (i) Federal, State, tribal, regional
plans. and local emergency preparedness
(4) Include a process for cooperation staff.
and collaboration with local, tribal, re- (ii) Other sources of assistance.
gional, State, and Federal emergency (3) Primary and alternate means for
preparedness officials’ efforts to main- communicating with the CORF’s staff,
tain an integrated response during a Federal, State, tribal, regional, and
disaster or emergency situation. local emergency management agencies.
207
§ 485.68 42 CFR Ch. IV (10–1–24 Edition)
(4) A method for sharing information vidual, facility-based functional exer-

and medical documentation for pa- cise every 2 years; or
tients under the CORF’s care, as nec- (B) If the CORF experiences an actual
essary, with other health care pro- natural or man-made emergency that
viders to maintain the continuity of requires activation of the emergency
care. plan, the CORF is exempt from engag-
(5) A means of providing information ing in its next required community-
about the CORF’s needs, and its ability based or individual, facility-based func-
to provide assistance, to the authority tional exercise following the onset of
having jurisdiction or the Incident the emergency event.
Command Center, or designee. (ii) Conduct an additional exercise
(d) Training and testing. The CORF
every 2 years, opposite the year the
full-scale or functional exercise under
gency preparedness training and test-
paragraph (d)(2)(i) of this section is
ing program that is based on the emer-
conducted, that may include, but is not
gency plan set forth in paragraph (a) of
limited to the following:
this section, risk assessment at para-
graph (a)(1) of this section, policies and (A) A second full-scale exercise that
procedures at paragraph (b) of this sec- is community-based or an individual,
tion, and the communication plan at facility-based functional exercise; or
paragraph (c) of this section. The train- (B) A mock disaster drill; or
ing and testing program must be re- (C) A tabletop exercise or workshop
viewed and updated at least every 2 that is led by a facilitator and includes
years. a group discussion, using a narrated,
(1) Training program. The CORF must clinically-relevant emergency scenario,
do all of the following: and a set of problem statements, di-
(i) Provide initial training in emer- rected messages, or prepared questions
gency preparedness policies and proce- designed to challenge an emergency
dures to all new and existing staff, in- plan.
dividuals providing services under ar- (iii) Analyze the CORF’s response to
rangement, and volunteers, consistent and maintain documentation of all
with their expected roles. drills, tabletop exercises, and emer-
(ii) Provide emergency preparedness gency events, and revise the CORF’s
training at least every 2 years. emergency plan, as needed.
(iii) Maintain documentation of the (e) Integrated healthcare systems. If a
training. CORF is part of a healthcare system
(iv) Demonstrate staff knowledge of consisting of multiple separately cer-
emergency procedures. All new per- tified healthcare facilities that elects
sonnel must be oriented and assigned to have a unified and integrated emer-
specific responsibilities regarding the gency preparedness program, the CORF
CORF’s emergency plan within 2 weeks may choose to participate in the
of their first workday. The training healthcare system’s coordinated emer-
program must include instruction in
gency preparedness program. If elected,
the location and use of alarm systems
the unified and integrated emergency
and signals and firefighting equipment.
preparedness program must do all of
(v) If the emergency preparedness
the following:
cantly updated, the CORF must con- (1) Demonstrate that each separately
duct training on the updated policies certified facility within the system ac-
and procedures. tively participated in the development
(2) Testing. The CORF must conduct of the unified and integrated emer-
exercises to test the emergency plan at gency preparedness program.
least annually. The CORF must do the (2) Be developed and maintained in a
following: manner that takes into account each
(i) Participate in a full-scale exercise separately certified facility’s unique
that is community-based every 2 years; circumstances, patient populations,
or and services offered.
(A) When a community-based exer- (3) Demonstrate that each separately
cise is not accessible, conduct an indi- certified facility is capable of actively
208
using the unified and integrated emer- (2) Have successfully completed a
gency preparedness program and is in training program in orthotics that is
compliance with the program. jointly recognized by the American
(4) Include a unified and integrated Council on Education and the Amer-
emergency plan that meets the require- ican Board for Certification in
ments of paragraphs (a)(2), (3), and (4) Orthotics and Prosthetics; and
of this section. The unified and inte- (3) Be eligible to take that Board’s
grated emergency plan must also be certification examination in orthotics.
based on and include the following: (e) A physical therapist and a phys-
(i) A documented community–based ical therapist assistant must meet the
risk assessment, utilizing an all-haz- qualifications in § 484.115 of this chap-
ards approach. ter.
(ii) A documented individual facility- (f) A prosthetist must—
based risk assessment for each sepa- (1) Be licensed by the State in which
rately certified facility within the practicing, if applicable;
health system, utilizing an all-hazards (2) Have successfully completed a
approach. training program in prosthetics that is
(5) Include integrated policies and jointly recognized by the American
procedures that meet the requirements Council on Education and the Amer-
set forth in paragraph (b) of this sec- ican Board for Certification in
tion, a coordinated communication Orthotics and Prosthetics; and
plan and training and testing programs (3) Be eligible to take that Board’s
that meet the requirements of para- certification examination in pros-
graphs (c) and (d) of this section, re- thetics.
spectively. (g) A psychologist must be certified or
[81 FR 64035, Sept. 16, 2016, as amended at 84 licensed by the State in which he or
FR 51826, Sept. 30, 2019] she is practicing, if that State requires
certification or licensing, and must
§ 485.70 Personnel qualifications. hold a masters degree in psychology
This section sets forth the qualifica- from and educational institution ap-
tions that must be met, as a condition proved by the State in which the insti-
of participation, under § 485.58, and as a tution is located.
condition of coverage of services under (h) A registered nurse must be a grad-
§ 410.100 of this chapter. uate of an approved school of nursing
(a) A facility physician must be a and be licensed as a registered nurse by
doctor of medicine or osteopathy who— the State in which practicing, if appli-
(1) Is licensed under State law to cable.
practice medicine or surgery; and (i) A rehabilitation counselor must—
(2) Has had, subsequent to com- (1) Be licensed by the State in which
pleting a 1-year hospital internship, at practicing, if applicable;
least 1 year of training in the medical (2) Hold at least a bachelor’s degree;
management of patients requiring re- and
habilitation services; or (3) Be eligible to take the certifi-
(3) Has had at least 1 year of full- cation examination administered by
time or part-time experience in a reha- the Commission on Rehabilitation
bilitation setting providing physicians’ Counselor Certification.
services similar to those required in (j) A respiratory therapist must com-
this subpart. plete one the following criteria:
(b) A licensed practical nurse must be (1) Criterion 1. All of the following
licensed as a practical or vocational must be completed:
nurse by the State in which practicing, (i) Be licensed by the State in which
if applicable. practicing, if applicable.
(c) An occupational therapist and an (ii) Have successfully completed a na-
occupational therapy assistant must tionally-accredited educational pro-
meet the qualifications in § 484.115 of gram for respiratory therapists.
this chapter. (iii)(A) Be eligible to take the reg-
(d) An orthotist must— istry examination administered by the
(1) Be licensed by the State in which National Board for Respiratory Care
practicing, if applicable; for respiratory therapists; or
209
§ 485.74 42 CFR Ch. IV (10–1–24 Edition)
(B) Have passed the registry exam- Subparts C–D [Reserved]

ination administered by the National
Board for Respiratory Care for res-
piratory therapists.
Subpart E—Conditions of Partici-
(2) Criterion 2: All of the following pation: Rural Emergency Hos-
must be completed: pitals (REHs)
(i) Be licensed by the State in which
practicing, if applicable. SOURCE: 87 FR 72293, Nov. 23, 2022, unless
(ii) Have equivalent training and ex- otherwise noted.
perience as determined by the National
Board for Respiratory Care. § 485.500 Basis and scope.
(k) A respiratory therapy technician
Section 1861(kkk) of the Act requires
must—
the Secretary to establish the condi-
(1) Be licensed by the State in which
tions REHs must meet in order to par-
practicing, if applicable;
(2) Have successfully completed a ticipate in the Medicare program and
training program accredited by the which are considered necessary to en-
Committees on Allied Health Edu- sure the health and safety of patients
cation and Accreditation (CAHEA) in receiving services at these entities.
collaboration with the Joint Review
Committee for Respiratory Therapy § 485.502 Definitions.
Education; and As used in this subpart, rural emer-
(3) Either— gency hospital or REH means an entity
(i) Be eligible to take the certifi- that operates for the purpose of pro-
cation examination for respiratory viding emergency department services,
therapy technicians administered by observation care, and other outpatient
the National Board for Respiratory medical and health services specified
Therapy, Inc,; or by the Secretary in which the annual
(ii) Have equivalent training and exper patient average length of stay does
perience as determined by the National not exceed 24 hours. The time calcula-
Board for Respiratory Therapy, Inc.
tion for determining the length of stay
(l) A social worker must—
of a patient receiving REH services be-
(1) Be licensed by the State in which
practicing, if applicable; gins with the registration, check-in or
(2) Hold at least a bachelor’s degree triage of the patient (whichever occurs
from a school accredited or approved first) and ends with the discharge of
by the Council on Social Work Edu- the patient from the REH. The dis-
cation; and charge occurs when the physician or
(3) Have 1 year of social work experi- other appropriate clinician has signed
ence in a health care setting. the discharge order, or at the time the
(m) A speech-language pathologist outpatient service is completed and
must meet the qualifications set forth documented in the medical record. The
in part 484 of this chapter. entity must not provide inpatient serv-
[48 FR 56293, Dec. 15, 1982. Redesignated and ices, except those furnished in a unit
amended at 50 FR 33034, Aug. 16, 1985; 51 FR that is a distinct part licensed as a
41352, Nov. 14, 1986; 60 FR 2327, Jan. 9, 1995; 72 skilled nursing facility to furnish post-
FR 66408, Nov. 27, 2007; 73 FR 69941, Nov. 19, hospital extended care services.
2008; 74 FR 62014, Nov. 25, 2009; 82 FR 4591,
Jan. 13, 2017; 86 FR 61622, Nov. 5, 2021; 88 FR § 485.504 Basic requirements.
36510, June 5, 2023]
Participation as an REH is limited to
§ 485.74 Appeal rights. facilities that—
The appeal provisions set forth in (a) Meet the definition in § 485.502.
part 498 of this chapter, for providers, (b) Have in effect a provider agree-
are applicable to any entity that is ment as defined at § 489.3 of this chap-
participating or seeks to participate in ter to provide services.
the Medicare program as a CORF. (c) Meet the conditions of participa-
[48 FR 56293, Dec. 15, 1982, as amended at 52 tion set out in this subpart.
FR 22454, June 12, 1987]
210
§ 485.506 Designation and certification (1) Determine, in accordance with

of REHs. state law, which categories of practi-
CMS certifies a facility as an REH if tioners are eligible candidates for ap-
the facility was, as of December 27, pointment to the medical staff.
2020— (2) Appoint members of the medical
(a) A critical access hospital; or staff after considering the rec-
(b) A hospital as defined in section ommendations of the existing members
1886(d)(1)(B) of the Act with not more of the medical staff.
than 50 beds located in a county (or (3) Ensure that the medical staff has
equivalent unit of local government) bylaws.
that is considered rural (as defined in (4) Approve medical staff bylaws and
section 1886(d)(2)(D) of the Act); or other medical staff rules and regula-
(c) A hospital as defined in section tions.
1886(d)(1)(B) of the Act with not more (5) Ensure that the medical staff is
than 50 beds that was treated as being accountable to the governing body for
located in a rural area that has had an the quality of care provided to pa-
active reclassification from urban to tients.
rural status as specified in § 412.103 of (6) Ensure the criteria for selection
this chapter as of December 27, 2020. are individual character, competence,
[87 FR 72293, Nov. 23, 2022, as amended at 88 training, experience, and judgment.
FR 82183, Nov. 22, 2023] (i) Members of the medical staff must
be legally and professionally qualified
Compliance with Federal, state, and for the positions to which they are ap-
local laws and regulations. pointed and for the performance of
privileges granted. The REH grants
(a) The REH must be in compliance privileges in accordance with rec-
with applicable Federal laws related to ommendations from qualified medical
the health and safety of patients. personnel.
(b) The REH must be located in a
(ii) Medical staff privileges must be
state that provides for the licensing of
periodically reappraised by the REH.
such hospitals under state or applica-
The scope of procedures performed in
ble local law; and is
the REH must be periodically reviewed
(1) Licensed in the state as an REH;
and amended as appropriate.
or
(2) Approved as meeting standards for (iii) If the REH assigns patient care
licensing established by the agency of responsibilities to practitioners other
the state or locality responsible for li- than physicians, it must have estab-
censing hospitals. lished policies and procedures, ap-
(c) The REH must assure that per- proved by the governing body, for over-
sonnel are licensed or meet other appli- seeing and evaluating their clinical ac-
cable standards that are required by tivities.
state or local laws to provide services (7) Ensure that under no cir-
within the applicable scope of practice. cumstances is the accordance of staff
membership or professional privileges
§ 485.510 Condition of participation: in the REH dependent solely upon cer-
Governing body and organizational tification, fellowship, or membership
structure of the REH in a specialty body or society.
There must be an effective governing (8) Ensure that, when telemedicine
body, or responsible individual or indi- services are furnished to the REH’s pa-
viduals, that is legally responsible for tients through an agreement with a
the conduct of the REH. If an REH does distant-site hospital, the agreement is
not have an organized governing body, written and that it specifies that it is
the person or persons legally respon- the responsibility of the governing
sible for the conduct of the REH must body of the distant-site hospital to
carry out the functions specified in meet the requirements in paragraphs
this subpart that pertain to the gov- (a)(1) through (7) of this section with
erning body. regard to the distant-site hospital’s
(a) Standard: Medical staff. The gov- physicians and practitioners providing
erning body must: telemedicine services. The governing
211
§ 485.512 42 CFR Ch. IV (10–1–24 Edition)
body of the REH whose patients are re- or not they are furnished under con-
ceiving the telemedicine services may, tracts. The governing body must en-
in accordance with § 485.512(a)(3), grant sure that a contractor of services (in-
privileges based on its medical staff cluding one for shared services and
recommendations that rely on informa- joint ventures) furnishes services that
tion provided by the distant-site hos- permit the REH to comply with all ap-
pital. plicable conditions of participation and
(9) Ensure that when telemedicine standards for the contracted services.
services are furnished to the REH’s pa- (1) The governing body must ensure
tients through an agreement with a that the services performed under a
distant-site telemedicine entity, the contract are provided in a safe and ef-
written agreement specifies that the fective manner.
distant-site telemedicine entity is a (2) The REH must maintain a list of
contractor of services to the REH and all contracted services, including the
as such, in accordance with paragraph scope and nature of the services pro-
(b) of this section, furnishes the con- vided.
tracted services in a manner that per-
mits the REH to comply with all appli- § 485.512 Condition of participation:
cable conditions of participation for Medical staff.
the contracted services, including, but The REH must have an organized
not limited to, the requirements in medical staff that operates under by-
paragraphs (a)(1) through (7) of this laws approved by the governing body,
section with regard to the distant-site and which is responsible for the quality
telemedicine entity’s physicians and of medical care provided to patients by
practitioners providing telemedicine the REH.
services. The governing body of the (a) Standard: Eligibility and process for
REH whose patients are receiving the appointment to medical staff. The med-
telemedicine services may, in accord- ical staff must be composed of doctors
ance with § 485.512(a)(4), grant privi- of medicine or osteopathy. In accord-
leges to physicians and practitioners ance with state law, including scope-of-
employed by the distant-site telemedi- practice laws, the medical staff may
cine entity based on such REH’s med- also include other categories of physi-
ical staff recommendations; such staff cians (as listed at § 482.12(c)(1) of this
recommendations may rely on infor- chapter and non-physician practi-
mation provided by the distant-site tioners who are determined to be eligi-
telemedicine entity. ble for appointment by the governing
(10) Consult directly with the indi- body.
vidual assigned the responsibility for (1) The medical staff must periodi-
the organization and conduct of the cally conduct appraisals of its mem-
REH’s medical staff, or their designee. bers.
At a minimum, this direct consultation (2) The medical staff must examine
must occur periodically throughout the the credentials of all eligible can-
fiscal or calendar year and include dis- didates for medical staff membership
cussion of matters related to the qual- and make recommendations to the gov-
ity of medical care provided to patients erning body on the appointment of
of the REH. For a multi-facility sys- these candidates in accordance with
tem, including a multi-hospital or state law, including scope-of-practice
multi-REH system, using a single gov- laws, and the medical staff bylaws,
erning body, the single multi-facility rules, and regulations. A candidate who
or multi-REH system governing body has been recommended by the medical
must consult directly with the indi- staff and who has been appointed by
vidual responsible for the organized the governing body is subject to all
medical staff (or their designee) of each medical staff bylaws, rules, and regula-
hospital or REH within its system in tions, in addition to the requirements
addition to the other requirements of contained in this section.
this paragraph (a). (3) When telemedicine services are
(b) Standard: Contracted services. The furnished to the REH’s patients
governing body must be responsible for through an agreement with a distant-
services furnished in the REH whether site hospital, the governing body of the
212
REH whose patients are receiving the made by the distant-site telemedicine
telemedicine services may choose, in entity when making recommendations
lieu of the requirements in paragraphs on privileges for the individual distant-
(a)(1) and (2) of this section, to have its site physicians and practitioners pro-
medical staff rely upon the viding such services, if the REH’s gov-
credentialing and privileging decisions erning body ensures, through its writ-
made by the distant-site hospital when ten agreement with the distant-site
making recommendations on privileges telemedicine entity, that the distant-
for the individual distant-site physi- site telemedicine entity furnishes serv-
cians and practitioners providing such ices that, in accordance with paragraph
services, if the REH’s governing body (d) of this section, permit the REH to
ensures, through its written agreement comply with all applicable conditions
with the distant-site hospital, that all of participation for the contracted
of the following provisions are met: services. The REH’s governing body
(i) The distant-site hospital providing must also ensure, through its written
the telemedicine services is a Medi- agreement with the distant-site tele-
care-participating hospital. medicine entity, that all of the fol-
(ii) The individual distant-site physi- lowing provisions are met:
cian or practitioner is privileged at the (i) The distant-site telemedicine enti-
distant-site hospital providing the tele- ty’s medical staff credentialing and
medicine services, which provides a privileging process and standards at
current list of the distant-site physi- least meet the standards at
cian’s or practitioner’s privileges at § 485.510(a)(1) through (7) and para-
the distant-site hospital. graphs (a)(1) and (2) of this section.
(iii) The individual distant-site phy- (ii) The individual distant-site physi-
sician or practitioner holds a license cian or practitioner is privileged at the
issued or recognized by the state in distant-site telemedicine entity pro-
which the REH whose patients are re- viding the telemedicine services, which
ceiving the telemedicine services is lo- provides the REH with a current list of
cated. the distant-site physician’s or practi-
(iv) With respect to a distant-site tioner’s privileges at the distant-site
physician or practitioner, who holds telemedicine entity.
current privileges at the REH whose (iii) The individual distant-site phy-
patients are receiving the telemedicine sician or practitioner holds a license
services, the REH has evidence of an issued or recognized by the state in
internal review of the distant-site phy- which the REH whose patients are re-
sician’s or practitioner’s performance ceiving such telemedicine services is
of these privileges and sends the dis- located.
tant-site hospital such performance in- (iv) With respect to a distant-site
formation for use in the periodic ap- physician or practitioner, who holds
praisal of the distant-site physician or current privileges at the REH whose
practitioner. At a minimum, this infor- patients are receiving the telemedicine
mation must include all adverse events services, the REH has evidence of an
that result from the telemedicine serv- internal review of the distant-site phy-
ices provided by the distant-site physi- sician’s or practitioner’s performance
cian or practitioner to the REH’s pa- of these privileges and sends the dis-
tients and all complaints the REH has tant-site telemedicine entity such per-
received about the distant-site physi- formance information for use in the
cian or practitioner. periodic appraisal of the distant-site
(4) When telemedicine services are physician or practitioner. At a min-
furnished to the REH’s patients imum, this information must include
through an agreement with a distant- all adverse events that result from the
site telemedicine entity, the governing telemedicine services provided by the
body of the REH whose patients are re- distant-site physician or practitioner
ceiving the telemedicine services may to the REH’s patients, and all com-
choose, in lieu of the requirements in plaints the REH has received about the
paragraphs (a)(1) and (2) of this section, distant-site physician or practitioner.
to have its medical staff rely upon the (b) Standard: Medical staff organiza-
credentialing and privileging decisions tion and accountability. The medical
213
§ 485.512 42 CFR Ch. IV (10–1–24 Edition)
staff must be well organized and ac- the unified and integrated medical
countable to the governing body for staff structure after a majority vote by
the quality of the medical care pro- the members to maintain a separate
vided to patients. and distinct medical staff for their
(1) The medical staff must be orga- REH;
nized in a manner approved by the gov- (iii) The unified and integrated med-
erning body. ical staff is established in a manner
(2) If the medical staff has an execu- that takes into account each member
tive committee, a majority of the REH’s unique circumstances and any
members of the committee must be significant differences in patient popu-
doctors of medicine or osteopathy.
lations and services offered in each
(3) The responsibility for organiza-
hospital, critical access hospital
tion and conduct of the medical staff
must be assigned only to one of the fol- (CAH), and REH; and
lowing: (iv) The unified and integrated med-
(i) An individual doctor of medicine ical staff establishes and implements
or osteopathy. policies and procedures to ensure that
(ii) A doctor of dental surgery or den- the needs and concerns expressed by
tal medicine, when permitted by state members of the medical staff, at each
law of the state in which the hospital of its separately certified hospitals,
is located. CAHs, and REHs, regardless of practice
(iii) A doctor of podiatric medicine, or location, are given due consider-
when permitted by state law of the ation, and that the unified and inte-
state in which the hospital is located. grated medical staff has mechanisms in
(4) If an REH is part of a system con- place to ensure that issues localized to
sisting of multiple separately certified particular hospitals, CAHs, and REHs
hospitals, critical access hospitals, and/ are duly considered and addressed.
or REHs, and the system elects to have (c) Standard: Medical staff bylaws. The
a unified and integrated medical staff medical staff must adopt and enforce
for its member hospitals, critical ac- bylaws to carry out its responsibilities.
cess hospitals, and/or REHs after deter- The bylaws must:
mining that such a decision is in ac-
(1) Be approved by the governing
cordance with all applicable state and
local laws, each separately certified body.
REH must demonstrate that: (2) Include a statement of the duties
(i) The medical staff members of each and privileges of each category of med-
separately certified REH in the system ical staff (for example, active, cour-
(that is, all medical staff members who tesy, etc.).
hold specific privileges to practice at (3) Describe the organization of the
that REH) have voted by majority, in medical staff.
accordance with medical staff bylaws, (4) Describe the qualifications to be
either to accept a unified and inte- met by a candidate in order for the
grated medical staff structure or to opt medical staff to recommend that the
out of such a structure and to maintain candidate be appointed by the gov-
a separate and distinct medical staff erning body.
for their respective REH; (5) Include criteria for determining
(ii) The unified and integrated med- the privileges to be granted to indi-
ical staff has bylaws, rules, and re- vidual practitioners and a procedure
quirements that describe its processes for applying the criteria to individuals
for self-governance, appointment, requesting privileges. For distant-site
credentialing, privileging, and over-
physicians and practitioners requesting
sight, as well as its peer review policies
privileges to furnish telemedicine serv-
and due process rights guarantees, and
which include a process for the mem- ices under an agreement with the REH,
bers of the medical staff of each sepa- the criteria for determining privileges
rately certified REH (that is, all med- and the procedure for applying the cri-
ical staff members who hold specific teria are also subject to the require-
privileges to practice at that REH) to ments in § 485.510(a)(8) and (9) and para-
be advised of their rights to opt out of graphs (a)(3) and (4) of this section.
214
§ 485.514 Condition of participation: dures and needs anticipated by the fa-

Provision of services. cility.
(a) The REH’s health care services (c) Standard: Compliance with CAH re-
must be furnished in accordance with quirements. The REH must meet the re-
appropriate written policies that are quirements specified in § 485.618, with
consistent with applicable state law. respect to:
(1) 24-hour availability of emergency
(b) The policies must be developed
services (§ 485.618(a)).
with the advice of members of the
(2) Equipment, supplies, and medica-
REH’s professional health care staff,
tion (§ 485.618(b)).
including one or more doctors of medi-
(3) Blood and blood products
cine or osteopathy and one or more
(§ 485.618(c)).
physician assistants, nurse practi-
(4) Personnel (§ 485.618(d)).
tioners, or clinical nurse specialists, if
(5) Coordination with emergency re-
they are on staff under the provisions
sponse systems (§ 485.618(e)).
of § 485.528(b)(1).
(c) The policies must include the fol- § 485.518 Condition of participation:
lowing: Laboratory services.
(1) A description of the services the The REH must provide basic labora-
REH furnishes, including those fur- tory services essential to the imme-
nished through agreement or arrange- diate diagnosis and treatment of the
ment. patient consistent with nationally rec-
(2) Policies and procedures for emer- ognized standards of care for emer-
gency medical services. gency services, patient population, and
(3) Guidelines for the medical man- services offered. The REH must ensure
agement of health problems that in- that—
clude the conditions requiring medical (a) Laboratory services are available,
consultation and/or patient referral, either directly or through a contrac-
the maintenance of health care tual agreement with a certified labora-
records, and procedures for the periodic tory that meets requirements of part
review and evaluation of the services 493 of this chapter.
furnished by the REH. (b) Emergency laboratory services
(4) Policies and procedures that ad- are available 24 hours a day.
dress the post-acute care needs of pa-
tients receiving services in the REH. § 485.520 Condition of participation:
(d) The policies must be reviewed at Radiologic services.
least biennially by the group of profes- The REH must maintain, or have
sional personnel required under para- available, diagnostic radiologic serv-
graph (b) of this section and updated as ices. If therapeutic services are also
necessary by the REH. provided, the therapeutic services, as
well as the diagnostic services, must be
§ 485.516 Condition of participation: furnished by the REH and provided by
Emergency services.
personnel qualified under state law.
The REH must provide the emer- The REH must ensure that REH pa-
gency care necessary to meet the needs tients or personnel are not exposed to
of its patients in accordance with ac- radiation hazards.
ceptable standards of practice. (a) Standard: Radiologic services. The
(a) Standard: Organization and direc- REH must maintain, or have available,
tion. The emergency services of the radiologic services according to needs
REH must be— of the patients.
(1) Organized under the direction of a (b) Standard: Safety for patients and
qualified member of the medical staff; personnel. The radiologic services, par-
and ticularly ionizing radiology proce-
(2) Integrated with other depart- dures, must be free from hazards for
ments of the REH. patients and personnel.
(b) Standard: Personnel. There must (1) Proper safety precautions must be
be adequate medical and nursing per- maintained against radiation hazards.
sonnel qualified in emergency care to This includes adequate shielding for
meet the written emergency proce- patients, personnel, and facilities, as
215
§ 485.522 42 CFR Ch. IV (10–1–24 Edition)
well as appropriate storage, use, and drug storage area must be adminis-
disposal of radioactive materials. tered in accordance with accepted pro-
(2) Periodic inspection of equipment fessional principles and in accordance
must be made and hazards identified with state and Federal laws.
must be promptly corrected. (1) A pharmacist or competent indi-
(3) Radiation workers must be vidual in accordance with state scope
checked periodically, by the use of ex- of practice laws must be responsible for
posure meters or badge tests, for developing, supervising, and coordi-
amount of radiation exposure. nating all the activities of the phar-
(4) Radiologic services must be pro- macy services. The pharmacist or com-
vided only on the order of practitioners petent individual in accordance with
with clinical privileges or, consistent state law and scope of practice must be
with state law, of other practitioners available for a sufficient time to pro-
authorized by the medical staff and the vide oversight of the REH’s pharmacy
governing body to order the services. services based on the scope and com-
(c) Standard: Personnel. (1) The REH plexity of the services offered at the
must have a full-time, part-time, or REH.
consulting qualified radiologist, or (2) The pharmaceutical service must
other personnel qualified under State have an adequate number of personnel
law, to interpret only those radiologic to ensure quality pharmaceutical serv-
tests that are determined by the med- ices for the provision of all services
ical staff to require specialized knowl- provided by the REH.
edge. For purposes of this section, a ra- (3) Current and accurate records
diologist is a doctor of medicine or os- must be kept of the receipt and disposi-
teopathy who is qualified by education tion of all scheduled drugs.
and experience in radiology.
(b) Standard: Delivery of services.
(2) Only personnel designated as
Drugs and biologicals must be con-
qualified by the medical staff may use
trolled and distributed in accordance
the radiologic equipment and admin-
with applicable standards of practice,
ister procedures.
consistent with Federal and state law,
(d) Standard: Records. Records of
to ensure patient safety.
radiologic services must be main-
(1) All compounding, packaging, and
tained.
dispensing of drugs must be done by a
(1) The radiologist or other practi-
licensed pharmacist or a licensed phy-
tioner who performs radiology services
sician, or under the supervision of a
must sign reports of their interpreta-
pharmacist or competent individual in
tions.
accordance with state law and scope of
(2) The REH must maintain the fol-
practice and performed consistent with
lowing for at least 5 years:
state and Federal laws.
(i) Copies of reports and printouts.
(ii) Films, scans, and other image (2) All drugs and biologicals must be
records, as appropriate. kept in a secure area, and locked when
appropriate.
§ 485.522 Condition of participation: (i) All drugs listed in Schedules II,
Pharmaceutical services. III, IV, and V of the Comprehensive
The REH must have pharmaceutical Drug Abuse Prevention and Control
services that meet the needs of its pa- Act of 1970 (21 U.S.C. 801 et seq.) must
tients. The REH must have a pharmacy be kept locked within a secure area.
or a drug storage area that is directed (ii) Only authorized personnel may
by a registered pharmacist or other have access to locked areas.
qualified individual in accordance with (3) Outdated, mislabeled, or other-
state scope of practice laws. The med- wise unusable drugs and biologicals
ical staff is responsible for developing must not be available for patient use.
policies and procedures that minimize (4) Drugs and biologicals must be re-
drug errors. This function may be dele- moved from the pharmacy or storage
gated to the REH’s registered phar- area only by personnel designated in
macist or other qualified individual. the policies of the medical staff and
(a) Standard: Pharmacy management pharmaceutical service, in accordance
and administration. The pharmacy or with Federal and state law.
216
(c) Standard: Administration of drugs. care, including follow-up care, as ap-

Drugs must be prepared and adminis- propriate;
tered according to established policies (3) Have effective communication
and acceptable standards of practice. systems in place between the REH and
(1) Adverse reactions must be re- the patient (or responsible individual)
ported to the physician responsible for and their family, ensuring that the
the patient and must be documented in REH is responsive to their needs and
the record. preferences;
(2) Blood transfusions, blood prod- (4) Have established relationships
ucts, and intravenous medications with hospitals that have the resources
must be administered in accordance and capacity available to deliver care
with state law and approved medical that is beyond the scope of care deliv-
staff policies and procedures. ered at the REH; and
(3) Orders given orally for drugs and (5) Have personnel providing these
biologicals must be followed by a writ- services who meet the requirements at
ten order, signed by the prescribing paragraph (b) of this section.
physician or other authorized pre- (b) Standard: Personnel for additional
scriber. outpatient and medical health services.
The REH must—
(4) There must be an REH procedure
(1) Assign one or more individuals to
for reporting transfusion reactions, ad-
be responsible for outpatient services.
verse drug reactions, and errors in ad-
(2) Have appropriate professional and
ministration of drugs.
nonprofessional personnel available at
§ 485.524 Condition of participation: each location where outpatient serv-
Additional outpatient medical and ices are offered, based on the scope and
health services. complexity of outpatient services.
(3) For any specialty services offered
If the REH provides outpatient med- at the REH, have a doctor of medicine
ical and health services in addition to or osteopathy, nurse practitioner, clin-
providing emergency services and ob- ical nurse specialist, or physician as-
servation care, the medical and health sistant providing services with experi-
services must be appropriately orga- ence and training in the specialty serv-
nized and meet the needs of the pa- ice area and in accordance with their
tients in accordance with acceptable scope of practice.
standards of practice. (c) Standard: Orders for outpatient
(a) Standard: Patient services. The medical and health services. Out-
REH may provide outpatient and med- patient medical and health services
ical health diagnostic and therapeutic must be ordered by a practitioner who
items and services that are commonly meets the following conditions:
furnished in a physician’s office or at (1) Is responsible for the care of the
another entry point into the health patient.
care delivery system that include, but (2) Is licensed in the state where they
are not limited to, radiology, labora- provide care to the patient.
tory, outpatient rehabilitation, sur- (3) Is acting within their scope of
gical, maternal health, and behavioral practice under state law.
health services. If the REH provides (4) Is authorized in accordance with
outpatient and medical health diag- state law and policies adopted by the
nostic and therapeutic items and serv- medical staff, and approved by the gov-
ices, those items and services must erning body, to order the applicable
align with the health needs of the com- outpatient services. This applies to the
munity served by the REH. If the REH following:
provides outpatient medical and health (i) All practitioners who are ap-
services in addition to providing emer- pointed to the REH’s medical staff and
gency services, the REH must— who have been granted privileges to
(1) Provide items and services based order the applicable outpatient serv-
on nationally recognized guidelines and ices.
standards of practice; (ii) All practitioners not appointed to
(2) Have a system in place for referral the medical staff, but who satisfy the
from the REH to different levels of requirements of paragraphs (c)(1)
217
§ 485.526 42 CFR Ch. IV (10–1–24 Edition)
through (4) of this section for author- (D) A doctor of podiatric medicine;
ization by the medical staff and the (E) A certified registered nurse anes-
REH for ordering the applicable out- thetist (CRNA), as defined in § 410.69(b)
patient services for their patients. of this chapter;
(d) Standard: Surgical services. If the (F) An anesthesiologist’s assistant,
REH provides outpatient surgical serv- as defined in § 410.69(b) of this chapter;
ices, surgical procedures must be per- or
formed in a safe manner by qualified (G) A supervised trainee in an ap-
practitioners who have been granted proved educational program, as de-
clinical privileges by the governing scribed in § 413.85 or §§ 413.76 through
body, or responsible individual, of the 413.83 of this chapter.
REH in accordance with the designa- (ii) In those cases in which a CRNA
tion requirements under paragraph (a) administers the anesthesia, the anes-
of this section. thetist must be under the supervision
(1) Designation of qualified practi- of the operating practitioner except as
tioners. The REH designates the practi- provided in paragraph (e) of this sec-
tioners who are allowed to perform sur- tion. An anesthesiologist’s assistant
gery for REH patients, in accordance who administers anesthesia must be
with its approved policies and proce- under the supervision of an anesthe-
dures, and with state scope of practice siologist.
laws. Surgery is performed only by— (4) Discharge. All patients are dis-
(i) A doctor of medicine or osteop- charged in the company of a respon-
athy, including an osteopathic practi- sible adult, except those exempted by
tioner recognized under section the practitioner who performed the
1101(a)(7) of the Act; surgical procedure.
(ii) A doctor of dental surgery or den- (5) Standard: State exemption. (i) An
tal medicine; or REH may be exempted from the re-
(iii) A doctor of podiatric medicine. quirement for physician supervision of
(2) Anesthetic risk and evaluation. (i) CRNAs as described in paragraph (d)(3)
A qualified practitioner, as specified in of this section, if the state in which the
paragraph (a) of this section, must ex- REH is located submits a letter to CMS
amine the patient immediately before signed by the Governor, following con-
surgery to evaluate the risk of the pro- sultation with the state’s Boards of
cedure to be performed. Medicine and Nursing, requesting ex-
(ii) A qualified practitioner, as speci- emption from physician supervision for
fied in paragraph (d)(3) of this section, CRNAs. The letter from the Governor
must examine each patient before sur- must attest that they have consulted
gery to evaluate the risk of anesthesia. with the state Boards of Medicine and
(iii) Before discharge from the REH, Nursing about issues related to access
each patient must be evaluated for to and the quality of anesthesia serv-
proper anesthesia recovery by a quali- ices in the state and has concluded
fied practitioner, as specified in para- that it is in the best interests of the
graph (d)(3) of this section. state’s citizens to opt-out of the cur-
(3) Administration of anesthesia. The rent physician supervision require-
REH designates the person who is al- ment, and that the opt-out is con-
lowed to administer anesthesia to REH sistent with state law.
patients in accordance with its ap- (ii) The request for exemption and
proved policies and procedures and recognition of state laws and the with-
with state scope-of-practice laws. drawal of the request may be sub-
(i) Anesthesia must be administered mitted at any time, and are effective
by only— upon submission.
(A) A qualified anesthesiologist;
(B) A doctor of medicine or osteop- § 485.526 Condition of participation:
athy other than an anesthesiologist; Infection prevention and control
including an osteopathic practitioner and antibiotic stewardship pro-
recognized under section 1101(a)(7) of grams.
the Act; The REH must have active facility-
(C) A doctor of dental surgery or den- wide programs for the surveillance,
tal medicine; prevention, and control of healthcare-
218
associated infections (HAIs) and other is appointed by the governing body, or

infectious diseases, and for the optimi- responsible individual, as the leader(s)
zation of antibiotic use through stew- of the antibiotic stewardship program
ardship. The programs must dem- and that the appointment is based on
onstrate adherence to nationally recog- the recommendations of medical staff
nized infection prevention and control leadership and pharmacy leadership;
guidelines, as well as to best practices (2) The facility-wide antibiotic stew-
for improving antibiotic use where ap- ardship program:
plicable, and for reducing the develop- (i) Demonstrates coordination among
ment and transmission of HAIs and an- all components of the REH responsible
tibiotic-resistant organisms. Infection for antibiotic use and resistance, in-
prevention and control problems and cluding, but not limited to, the infec-
antibiotic use issues identified in the tion prevention and control program,
programs must be addressed in collabo- the QAPI program, the medical staff,
ration with the facility-wide quality nursing services, and pharmacy serv-
assessment and performance improve- ices;
ment (QAPI) program. (ii) Documents the evidence-based
(a) Standard: Infection prevention and use of antibiotics in all departments
control program organization and policies. and services of the REH; and
The REH must demonstrate that: (iii) Documents any improvements,
(1) An individual (or individuals), including sustained improvements, in
who is qualified through education, proper antibiotic use;
training, experience, or certification in (3) The antibiotic stewardship pro-
infection prevention and control, is ap- gram adheres to nationally recognized
pointed by the governing body, or re- guidelines, as well as best practices, for
sponsible individual, as the infection improving antibiotic use; and
preventionist(s)/infection control pro- (4) The antibiotic stewardship pro-
fessional(s) responsible for the infec- gram reflects the scope and complexity
tion prevention and control program of the services furnished by an REH.
and that the appointment is based on (c) Standard: Leadership responsibil-
the recommendations of medical staff ities. (1) The governing body, or respon-
leadership and nursing leadership; sible individual, must ensure all of the
(2) The infection prevention and con- following:
trol program, as documented in its (i) Systems are in place and oper-
policies and procedures, employs meth- ational for the tracking of all infection
ods for preventing and controlling the surveillance, prevention and control,
transmission of infections within the and antibiotic use activities, in order
REH and between the REH and other to demonstrate the implementation,
health care settings; success, and sustainability of such ac-
(3) The infection prevention and con- tivities.
trol program include surveillance, pre- (ii) All HAIs and other infectious dis-
vention, and control of HAIs, including eases identified by the infection pre-
maintaining a clean and sanitary envi- vention and control program as well as
ronment to avoid sources and trans- antibiotic use issues identified by the
mission of infection, and that the pro- antibiotic stewardship program are ad-
gram also addresses any infection con- dressed in collaboration with the
trol issues identified by public health REH’s QAPI leadership.
authorities; and (2) The infection prevention and con-
(4) The infection prevention and control professional(s) are responsible for:
trol program reflects the scope and (i) The development and implementa-
complexity of the services furnished by tion of facility-wide infection surveil-
the REH. lance, prevention, and control policies
(b) Standard: Antibiotic stewardship and procedures that adhere to nation-
program organization and policies. The ally recognized guidelines.
REH must demonstrate that — (ii) All documentation, written or
(1) An individual (or individuals), electronic, of the infection prevention
who is qualified through education, and control program and its surveil-
training, or experience in infectious lance, prevention, and control activi-
diseases and/or antibiotic stewardship, ties.
219
§ 485.526 42 CFR Ch. IV (10–1–24 Edition)
(iii) Communication and collabora- sible and accountable for ensuring that
tion with the REH’s QAPI program on each of its separately certified REHs
infection prevention and control issues. meets all of the requirements of this
(iv) Competency-based training and section. Each separately certified REH
education of REH personnel and staff, subject to the system governing body
including medical staff, and, as appli- must demonstrate that:
cable, personnel providing contracted (1) The unified and integrated infec-
services in the REH, on the practical tion prevention and control and anti-
applications of infection prevention biotic stewardship programs are estab-
and control guidelines, policies and lished in a manner that takes into ac-
procedures. count each member REH’s unique cir-
(v) The prevention and control of cumstances and any significant dif-
HAIs, including auditing of adherence ferences in patient populations and
to infection prevention and control services offered in each REH;
policies and procedures by REH per- (2) The unified and integrated infec-
sonnel. tion prevention and control and anti-
(vi) Communication and collabora- biotic stewardship programs establish
tion with the antibiotic stewardship and implement policies and procedures
program. to ensure that the needs and concerns
(3) The leader(s) of the antibiotic of each of its separately certified
stewardship program is responsible for: REHs, regardless of practice or loca-
(i) The development and implementation, are given due consideration;
tion of a facility-wide antibiotic stew-
(3) The unified and integrated infec-
ardship program, based on nationally
recognized guidelines, to monitor and
biotic stewardship programs have
improve the use of antibiotics.
mechanisms in place to ensure that
(ii) All documentation, written or
issues localized to particular REHs are
electronic, of antibiotic stewardship
duly considered and addressed; and
program activities.
(iii) Communication and collabora- (4) A qualified individual (or individ-
tion with medical staff, nursing, and uals) with expertise in infection pre-
pharmacy leadership, as well as the vention and control and in antibiotic
REH’s infection prevention and control stewardship has been designated at the
and QAPI programs, on antibiotic use REH as responsible for communicating
issues. with the unified infection prevention
(iv) Competency-based training and and control and antibiotic stewardship
education of REH personnel and staff, programs, for implementing and main-
including medical staff, and, as appli- taining the policies and procedures
cable, personnel providing contracted governing infection prevention and
services in the REH, on the practical control and antibiotic stewardship as
applications of antibiotic stewardship directed by the unified infection pre-
guidelines, policies, and procedures. vention and control and antibiotic
(d) Standard:Unified and integrated in- stewardship programs, and for pro-
fection prevention and control and anti- viding education and training on the
biotic stewardship programs for multi-fa- practical applications of infection pre-
cility systems. If a REH is part of a sys- vention and control and antibiotic
tem consisting of multiple separately stewardship to REH staff.
certified hospitals, CAHs, and/or REHs (e) COVID–19 and seasonal influenza
using a system governing body that is reporting. Beginning at the conclusion
legally responsible for the conduct of of the COVID–19 Public Health Emer-
two or more hospitals, CAHs, and/or gency, as defined in § 400.200 of this
REHs, the system governing body can chapter, and continuing until April 30,
elect to have unified and integrated in- 2024, except when the Secretary speci-
fection prevention and control and an- fies an earlier end date for the require-
tibiotic stewardship programs for all of ments of this paragraph (e), the REH
its member facilities after determining must electronically report information
that such a decision is in accordance about COVID–19 and seasonal influenza
with all applicable state and local laws. in a standardized format specified by
The system governing body is respon- the Secretary.
220
(1) Related to COVID–19, to the ex- (i) Suspected and confirmed infec-
tent as required by the Secretary, this tions of the relevant infectious disease
report must include the following data pathogen among patients and staff.
elements: (ii) Total deaths attributed to the
(i) Suspected and confirmed COVID– relevant infectious disease pathogen
19 infections among patients and staff. among patients and staff.
(ii) Total COVID–19 deaths among pa- (iii) Personal protective equipment
tients and staff. and other relevant supplies in the REH.
(iii) Personal protective equipment (iv) Capacity and supplies in the REH
and testing supplies. relevant to the immediate and long
(iv) Ventilator use, capacity, and term treatment of the relevant infec-
supplies. tious disease pathogen, such as venti-
(v) Total patient census and capac- lator and dialysis/continuous renal re-
ity. placement therapy capacity and sup-
(vi) Staffing shortages. plies.
(vii) COVID–19 vaccine administra- (v) Total patient census, capacity,
tion data of patients and staff. and capability.
(viii) Relevant therapeutic inven- (vi) Staffing shortages.
tories or usage, or both. (vii) Vaccine administration data of
(2) Related to seasonal influenza, to patients and staff for conditions mon-
the extent as required by the Sec- itored under this section and where a
retary, this report must include the specific vaccine is applicable.
following data elements: (viii) Relevant therapeutic inven-
(i) Confirmed influenza infections tories or usage, or both.
among patients and staff. (ix) Isolation capacity, including air-
(ii) Total influenza deaths among pa- borne isolation capacity.
tients and staff. (x) Key co-morbidities or exposure
(iii) Confirmed co-morbid influenza risk factors, or both, of patients being
and COVID–19 infections among pa- treated for the pathogen or disease of
tients and staff. interest in this section that are cap-
(f) Standard: Reporting of data related tured with interoperable data stand-
to viral and bacterial pathogens and in- ards and elements.
fectious diseases of pandemic or epidemic (2) Unless the Secretary specifies an
potential. The REH must electronically alternative format by which the REH
report information on acute res- must report these data elements, the
piratory illness (including, but not lim- REH must report the applicable infec-
ited to, seasonal influenza virus, influ- tion (confirmed and suspected) and
enza-like illness, and severe acute res- vaccination data in a format that pro-
piratory infection), SARS-CoV–2/ vides person-level information, which
COVID–19, and other viral and bac- must include medical record identifier,
terial pathogens and infectious dis- race, ethnicity, age, sex, residential
eases of pandemic or epidemic poten- county and zip code, and relevant
tial only when the Secretary has de- comorbidities for affected patients. Fa-
clared a Public Health Emergency cilities must not report any directly or
(PHE), as defined in § 400.200 of this potentially individually-identifiable in-
chapter, directly related to such spe- formation for affected patients (for ex-
cific pathogens and infectious diseases. ample, name, social security number)
The requirements of this paragraph (f) that is not set out in this section or
will be applicable to local, state, re- otherwise specified by the Secretary.
gional, or national PHEs as declared by (3) The REH must provide the infor-
the Secretary. mation specified in this paragraph (f)
(1) The REH must electronically re- on a daily basis, unless the Secretary
port information about the infectious specifies a lesser frequency, to the Cen-
disease pathogen, relevant to the de- ters for Disease Control and Preven-
clared PHE, in a standardized format tion’s (CDC) National Healthcare Safe-
specified by the Secretary. To the ex- ty Network or other CDC-supported
tent as required by the Secretary, this surveillance systems as determined by
report must include, the following: the Secretary.
221
§ 485.526 42 CFR Ch. IV (10–1–24 Edition)
(g) Standard: COVID–19 vaccination of received, at a minimum, a single-dose

REH staff. Until November 4, 2024, un- COVID–19 vaccine, or the first dose of
less the Secretary specifies an earlier the primary vaccination series for a
end date for the requirements of this multi-dose COVID–19 vaccine prior to
paragraph (g), the REH must develop staff providing any care, treatment, or
and implement policies and procedures other services for the REH and/or its
to ensure that all staff are fully vac- patients;
cinated for COVID–19. For purposes of (ii) A process for ensuring that all
this section, staff are considered fully staff specified in paragraph (f)(1) of this
vaccinated if it has been 2 weeks or section are fully vaccinated for COVID–
more since they completed a primary 19, except for those staff who have been
vaccination series for COVID–19. The granted exemptions to the vaccination
completion of a primary vaccination requirements of this section, or those
series for COVID–19 is defined here as staff for whom COVID–19 vaccination
the administration of a single-dose must be temporarily delayed, as rec-
vaccine, or the administration of all ommended by the CDC, due to clinical
required doses of a multi-dose vaccine. precautions and considerations;
(1) Regardless of clinical responsi- (iii) A process for ensuring the imple-
bility or patient contact, the policies mentation of additional precautions,
and procedures must apply to the fol- intended to mitigate the transmission
lowing REH staff, who provide any and spread of COVID–19, for all staff
care, treatment, or other services for who are not fully vaccinated for
the REH and/or its patients: COVID–19;
(i) REH employees;
(iv) A process for tracking and se-
(ii) Licensed practitioners;
curely documenting the COVID–19 vac-
(iii) Students, trainees, and volun-
cination status of all staff specified in
teers; and
paragraph (f)(1) of this section;
(iv) Individuals who provide care,
treatment, or other services for the (v) A process for tracking and se-
REH and/or its patients, under contract curely documenting the COVID–19 vac-
or by other arrangement. cination status of any staff who have
(2) The policies and procedures of this obtained any booster doses as rec-
section do not apply to the following ommended by the CDC;
REH staff: (vi) A process by which staff may re-
(i) Staff who exclusively provide tele- quest an exemption from the staff
health or telemedicine services outside COVID–19 vaccination requirements
of the REH setting and who do not based on an applicable Federal law;
have any direct contact with patients (vii) A process for tracking and se-
and other staff specified in paragraph curely documenting information pro-
(f)(1) of this section; and vided by those staff who have re-
(ii) Staff who provide support serv- quested, and for whom the REH has
ices for the REH that are performed ex- granted, an exemption from the staff
clusively outside of the REH setting COVID–19 vaccination requirements
and who do not have any direct contact based on recognized clinical contra-
with patients and other staff specified indications or applicable Federal laws;
in paragraph (f)(1) of this section. (viii) A process for ensuring that all
(3) The policies and procedures must documentation, which confirms recog-
include, at a minimum, the following nized clinical contraindications to
components: COVID–19 vaccines and which supports
(i) A process for ensuring all staff staff requests for medical exemptions
specified in paragraph (f)(1) of this sec- from vaccination, has been signed and
tion (except for those staff who have dated by a licensed practitioner, who is
pending requests for, or who have been not the individual requesting the ex-
granted, exemptions to the vaccination emption, and who is acting within
requirements of this section, or those their respective scope of practice as de-
staff for whom COVID–19 vaccination fined by, and in accordance with, all
must be temporarily delayed, as rec- applicable state and local laws, and for
ommended by the CDC, due to clinical further ensuring that such documenta-
precautions and considerations) have tion contains:
222
(A) All information specifying which doctor of medicine or osteopathy must

of the authorized COVID–19 vaccines —
are clinically contraindicated for the (i) Provide medical direction for the
staff member to receive and the recog- REH’s health care activities and con-
nized clinical reasons for the contra- sultation for, and medical supervision
indications; and of, the health care staff.
(B) A statement by the authen- (ii) In conjunction with the physician
ticating practitioner recommending assistant and/or nurse practitioner
that the staff member be exempted member(s), participate in developing,
from the REH’s COVID–19 vaccination executing, and periodically reviewing
requirements for staff based on the rec- the REH’s written policies governing
ognized clinical contraindications; the services it furnishes.
(ix) A process for ensuring the track- (iii) In conjunction with the physi-
ing and secure documentation of the cian assistant and/or nurse practitioner
vaccination status of staff for whom members, periodically review the
COVID–19 vaccination must be tempo- REH’s patient records, provide medical
rarily delayed, as recommended by the orders, and provide medical care serv-
CDC, due to clinical precautions and ices to the patients of the REH.
considerations, including, but not lim-
(iv) Periodically review and sign a
ited to, individuals with acute illness
sample of outpatient records of pa-
secondary to COVID–19, and individuals
tients cared for by nurse practitioners,
who received monoclonal antibodies or
clinical nurse specialists, certified
convalescent plasma for COVID–19
nurse midwives, or physician assistants
treatment; and
only to the extent where state law re-
(x) Contingency plans for staff who
quires record reviews or co-signatures,
are not fully vaccinated for COVID–19.
or both, by a collaborating physician.
§ 485.528 Condition of participation: (2) A doctor of medicine or osteop-
Staffing and staff responsibilities. athy must be present for sufficient pe-
riods of time to provide medical direc-
(a) Standard: Emergency department
tion, consultation, and supervision for
staffing. The emergency department of
the services provided in the REH, and
the REH must be staffed 24 hours a
is available through direct radio or
day, 7 days a week by an individual or
individuals competent in the skills telephone communication or electronic
needed to address emergency medical communication for consultation, as-
care. This individual(s) must be able to sistance with medical emergencies, or
receive patients and activate the ap- patient referral.
propriate medical resources to meet (d) Standard: Physician assistant, nurse
the care needed by the patient. practitioner, and clinical nurse specialist
(b) Standard: Staffing. (1) The REH responsibilities. (1) The physician assist-
must have a professional health care ant, the nurse practitioner, or clinical
staff that includes one or more doctors nurse specialist members of the REH’s
of medicine or osteopathy, and may in- staff must —
clude one or more physician assistants, (i) Participate in the development,
nurse practitioners, or clinical nurse execution and periodic review of the
specialists. written policies governing the services
(2) Any ancillary personnel are super- the REH furnishes; and
vised by the professional staff. (ii) Participate with a doctor of med-
(3) The staff is sufficient to provide icine or osteopathy in a periodic review
the services essential to the operation of the patients’ health records.
of the REH. (2) The physician assistant, nurse
(4) A registered nurse, clinical nurse practitioner, or clinical nurse spe-
specialist, or licensed practical nurse is cialist performs the following func-
on duty whenever the REH has one or tions to the extent they are not being
more patients receiving emergency performed by a doctor of medicine or
care or observation care. osteopathy:
(c) Standard: Responsibilities of the (i) Provides services in accordance
doctor of medicine or osteopathy. (1) The with the REH’s policies.
223
§ 485.530 42 CFR Ch. IV (10–1–24 Edition)
(ii) Arranges for, or refers patients services must meet the needs of pa-
to, needed services that cannot be fur- tients.
nished at the REH, and assures that (a) Standard: Organization and staff-
adequate patient health records are ing. Patient care responsibilities must
maintained and transferred as required be delineated for all nursing service
when patients are referred. personnel. Nursing services must be
(3) Whenever a patient is placed in provided in accordance with recognized
observation care at the REH by a nurse standards of practice.
practitioner, physician assistant, or (b) Standard: Nursing leadership. The
clinical nurse specialist, a doctor of director of the nursing service must be
medicine or osteopathy on the staff of a licensed registered nurse. The indi-
the REH is notified of the patient’s sta- vidual is responsible for the operation
tus. of the service, including determining
(e) Standard: Periodic review of clinical the types and numbers of nursing per-
privileges and performance. The REH re- sonnel and staff necessary to provide
quires that — nursing care for all areas of the REH.
(1) The quality and appropriateness
of the diagnosis and treatment fur- § 485.532 Condition of participation:
nished by nurse practitioners, clinical Discharge planning.
nurse specialists, and physician assist-
An REH must have an effective dis-
ants at the REH must be evaluated by
charge planning process that focuses
a member of the REH staff who is a
on the patient’s goals and treatment
doctor of medicine or osteopathy or by
preferences and includes the patient
another doctor of medicine or osteop-
and their caregivers/support person(s)
athy under contract with the REH.
(2) The quality and appropriateness as active partners in the discharge
of the diagnosis and treatment fur- planning for post-discharge care. The
nished by doctors of medicine or oste- discharge planning process and the dis-
opathy at the REH must be evaluated charge plan must be consistent with
by one of the following — the patient’s goals for care and their
(i) One Quality Improvement Organi- treatment preferences, ensure an effec-
zation (QIO) or equivalent entity. tive transition of the patient from the
(ii) In the case of distant-site physi- REH to post-discharge care, and reduce
cians and practitioners providing tele- the factors leading to preventable hos-
medicine services to the REH’s patient pital admissions or readmissions.
under an agreement between the REH (a) Standard: Discharge planning proc-
and a distant-site hospital, the distant- ess. The REH’s discharge planning
site hospital; or process must identify, at an early stage
(iii) In the case of distant-site physi- of the provision of services, those pa-
cians and practitioners providing tele- tients who are likely to suffer adverse
medicine services to the REH’s pa- health consequences upon discharge in
tients under a written agreement be- the absence of adequate discharge plan-
tween the REH and a distant-site tele- ning and must provide a discharge
medicine entity, one Quality Improve- planning evaluation for those patients
ment Organization (QIO) or equivalent so identified as well as for other pa-
entity. tients upon the request of the patient,
(3) The REH staff consider the find- patient’s representative, or patient’s
ings of the evaluation and make the physician.
necessary changes as specified in para- (1) Any discharge planning evalua-
graphs (b) through (d) of this section. tion must be made on a timely basis to
ensure that appropriate arrangements
§ 485.530 Condition of participation: for post-REH care will be made before
Nursing services. discharge and to avoid unnecessary
The REH must have an organized delays in discharge.
nursing service that is available to pro- (2) A discharge planning evaluation
vide 24-hour nursing services for the must include an evaluation of a pa-
provision of patient care. The nursing tient’s likely need for appropriate serv-
services must be furnished and super- ices following those furnished by the
vised by a registered nurse. Nursing REH, including, but not limited to,
224
hospice care services, post-REH ex- where applicable, along with all nec-
tended care services, home health serv- essary medical information pertaining
ices, and non-health care services and to the patient’s current course of ill-
community-based care providers, and ness and treatment, post-discharge
must also include a determination of goals of care, and treatment pref-
the availability of the appropriate erences, at the time of discharge, to
services as well as of the patient’s ac- the appropriate post-acute care service
cess to those services. providers and suppliers, facilities,
(3) The discharge planning evaluation agencies, and other outpatient service
must be included in the patient’s med- providers and practitioners responsible
ical record for use in establishing an for the patient’s follow-up or ancillary
appropriate discharge plan and the re- care.
sults of the evaluation must be dis-
cussed with the patient (or the pa- § 485.534 Condition of participation:
tient’s representative). Patient’s rights.
(4) Upon the request of a patient’s An REH must protect and promote
physician, the REH must arrange for each patient’s rights.
the development and initial implemen- (a) Standard: Notice of rights. (1) An
tation of a discharge plan for the pa- REH must inform each patient, or
tient. when appropriate, the patient’s rep-
(5) Any discharge planning evalua- resentative (as allowed under state
tion or discharge plan required under law), of the patient’s rights, in advance
this paragraph (a) must be developed of furnishing or discontinuing patient
by, or under the supervision of, a reg- care whenever possible.
istered nurse, social worker, or other (2) The REH must establish a process
appropriately qualified personnel. for prompt resolution of patient griev-
(6) The REH’s discharge planning ances and must inform each patient
process must require regular re-evalua- whom to contact to file a grievance.
tion of the patient’s condition to iden- The REH’s governing body or respon-
tify changes that require modification sible individual must approve and be
of the discharge plan. The discharge responsible for the effective operation
plan must be updated, as needed, to re- of the grievance process and must re-
flect these changes. view and resolve grievances, unless it
(7) The REH must assess its dis- delegates the responsibility in writing
charge planning process on a regular to a grievance committee. The griev-
basis. The assessment must include on- ance process must include a mecha-
going periodic review of a representa- nism for timely referral of patient con-
tive sample of discharge plans. cerns regarding quality of care or pre-
(8) The REH must assist patients, mature discharge to the appropriate
their families, or the patient’s rep- Utilization and Quality Control Qual-
resentative in selecting a post-acute ity Improvement Organization. At a
care provider by using and sharing data minimum:
that includes, but is not limited to, (i) The REH must establish a clearly
home health agency (HHA), skilled explained procedure for the submission
nursing facility (SNF), inpatient reha- of a patient’s written or verbal griev-
bilitation facility (IRF), or long term ance to the REH.
care hospital (LTCH) data on quality (ii) The grievance process must speci-
measures and data on resource use fy time frames for review of the griev-
measures. The REH must ensure that ance and the provision of a response.
the post-acute care data on quality (iii) In its resolution of the griev-
measures and data on resource use ance, the REH must provide the pa-
measures is relevant and applicable to tient with written notice of its decision
the patient’s goals of care and treat- that contains the name of the REH
ment preferences. contact person, the steps taken on be-
(b) Standard: Discharge of the patient half of the patient to investigate the
and provision and transmission of the pa- grievance, the results of the grievance
tient’s necessary medical information. process, and the date of completion.
The REH must discharge the patient, (b) Standard: Exercise of rights. The
and also transfer or refer the patient patient has the right to—
225
§ 485.534 42 CFR Ch. IV (10–1–24 Edition)
(1) Participate in the development immediate physical safety of the pa-

and implementation of their plan of tient, a staff member, or others and
care. must be discontinued at the earliest
(2) Make informed decisions regard- possible time.
ing their care, including being in- (1)(i) A restraint is—
formed of their health status, and (A) Any manual method, physical or
being able to request or refuse treat- mechanical device, material, or equip-
ment. This right must not be construed ment that immobilizes or reduces the
as a mechanism to demand the provi- ability of a patient to move their arms,
sion of treatment or services deemed legs, body, or head freely; or
medically unnecessary or inappro- (B) A drug or medication when it is
priate. used as a restriction to manage the pa-
(3) Formulate advance directives and tient’s behavior or restrict the pa-
to have REH staff and practitioners tient’s freedom of movement and is not
who provide care in the REH comply a standard treatment or dosage for the
with these directives, in accordance patient’s condition.
with §§ 489.100, 489.102, and 489.104 of (C) A restraint does not include de-
this chapter. vices, such as orthopedically prescribed
(c) Standard: Privacy and safety. The devices, surgical dressings or bandages,
patient has the right to— protective helmets, or other methods
(1) Personal privacy. that involve the physical holding of a
(2) Receive care in a safe setting. patient for the purpose of conducting
(3) Be free from all forms of abuse or routine physical examinations or tests,
harassment. or to protect the patient from falling
(d) Standard: Confidentiality of patient out of bed, off of a stretcher, or out of
records. (1) The patient has the right to a chair, or to permit the patient to par-
the confidentiality of their medical ticipate in activities without the risk
records. of physical harm (this does not include
(2) The patient has the right to ac- a physical escort).
cess their medical records, including (ii) Seclusion is the involuntary con-
current medical records, upon an oral finement of a patient alone in a room
or written request. or area from which the patient is phys-
(i) The records must be provided in ically prevented from leaving. Seclu-
the form and format requested by the sion may only be used for the manage-
individual, if it is readily producible in ment of violent or self-destructive be-
such form and format. This includes in havior.
an electronic form or format when such (2) Restraint or seclusion may only
medical records are maintained elec- be used when less restrictive interven-
tronically or if not, in a readable hard tions have been determined to be inef-
copy form or such other form and for- fective to protect the patient, a staff
mat as agreed to by the facility and member or others from harm.
the individual. (3) The type or technique of restraint
(ii) The records must be provided or seclusion used must be the least re-
within a reasonable time frame. The strictive intervention that will be ef-
REH must not frustrate the legitimate fective to protect the patient, a staff
efforts of individuals to gain access to member, or others from harm.
their own medical records and must ac- (4) The REH must have written poli-
tively seek to meet these requests as cies and procedures regarding the use
quickly as its record keeping system of restraint and seclusion that are con-
permits. sistent with current standards of prac-
(e) Standard: Restraint or seclusion. All tice.
patients have the right to be free from (f) Standard: Restraint or seclusion:
physical or mental abuse, and corporal Staff training requirements. The patient
punishment. All patients have the has the right to safe implementation of
right to be free from restraint or seclu- restraint or seclusion by trained staff.
sion, of any form, imposed as a means (1) The REH must provide patient-
of coercion, discipline, convenience, or centered competency-based training
retaliation by staff. Restraint or seclu- and education of REH personnel and
sion may only be imposed to ensure the staff, including medical staff, and, as
226
applicable, personnel providing con- (ii) Recorded in the internal log or

tracted services in the REH, on the use other system for deaths described in
of restraint and seclusion. paragraph (g)(2) of this section.
(2) The training must include alter- (4) For deaths described in paragraph
natives to the use of restraint/seclu- (g)(2) of this section, entries into the
sion. internal log or other system must be
(g) Standard: Death reporting require- documented as follows:
ments. REHs must report deaths associ- (i) Each entry must be made not
ated with the use of seclusion or re- later than seven days after the date of
straint. death of the patient.
(1) With the exception of deaths de- (ii) Each entry must document the
scribed under paragraph (g)(2) of this patient’s name, date of birth, date of
section, the REH must report the fol- death, name of attending physician or
lowing information to CMS by tele- other licensed practitioner who is re-
phone, facsimile, or electronically, as
sponsible for the care of the patient,
determined by CMS, no later than the
medical record number, and primary
close of business on the next business
diagnosis(es).
day following knowledge of the pa-
tient’s death: (iii) The information must be made
(i) Each death that occurs while a pa- available in either written or elec-
tient is in restraint or seclusion. tronic form to CMS immediately upon
(ii) Each death that occurs within 24 request.
hours after the patient has been re- (h) Standard: Patient visitation rights.
moved from restraint or seclusion. An REH must have written policies and
(iii) Each death known to the REH procedures regarding the visitation
that occurs within 1 week after re- rights of patients, including those set-
straint or seclusion where it is reason- ting forth any clinically necessary or
able to assume that use of restraint or reasonable restriction or limitation
placement in seclusion contributed di- that the REH may need to place on
rectly or indirectly to a patient’s such rights and the reasons for the
death, regardless of the type(s) of re- clinical restriction or limitation. An
straint used on the patient during this REH must meet the following require-
time. ‘‘Reasonable to assume’’ in this ments:
context includes, but is not limited to, (1) Inform each patient (or support
deaths related to restrictions of move- person, where appropriate) of their vis-
ment for prolonged periods of time, or itation rights, including any clinical
death related to chest compression, re- restriction or limitation on such
striction of breathing, or asphyxiation. rights, when they are informed of their
(2) When no seclusion has been used other rights under this section.
and when the only restraints used on (2) Inform each patient (or support
the patient are those applied exclu- person, where appropriate) of the right,
sively to the patient’s wrist(s), and subject to their consent, to receive the
which are composed solely of soft, non-
visitors whom they designate, includ-
rigid, cloth-like materials, the REH
ing, but not limited to, a spouse, a do-
staff must record in an internal log or
other system, the following informa- mestic partner (including a same-sex
tion: domestic partner), another family
(i) Any death that occurs while a pa- member, or a friend, and their right to
tient is in such restraints. withdraw or deny such consent at any
(ii) Any death that occurs within 24 time.
hours after a patient has been removed (3) Not restrict, limit, or otherwise
from such restraints. deny visitation privileges on the basis
(3) The staff must document in the of race, color, national origin, religion,
patient’s medical record the date and sex, gender identity, sexual orienta-
time the death was: tion, or disability.
(i) Reported to CMS for deaths de- (4) Ensure that all visitors enjoy full
scribed in paragraph (g)(1) of this sec- and equal visitation privileges con-
tion; or sistent with patient preferences.
227
§ 485.536 42 CFR Ch. IV (10–1–24 Edition)
§ 485.536 Condition of participation: or serious injury or the risk thereof.

Quality assessment and perform- Medical error means an error that oc-
ance improvement program. curs in the delivery of health care serv-
The REH must develop, implement, ices.
and maintain an effective, ongoing, (3) The REH must take actions aimed
REH-wide, data-driven quality assess- at performance improvement and, after
ment and performance improvement implementing those actions, the REH
(QAPI) program. The REH’s governing must measure its success, and track
body must ensure that the program re- performance to ensure that improve-
flects the complexity of the REH’s or- ments are sustained.
ganization and services; involves all (d) Standard: Executive responsibilities.
REH departments and services (includ- The REH’s governing body (or orga-
ing those services furnished under con- nized group or individual who assumes
tract or arrangement); and focuses on full legal authority and responsibility
indicators related to improved health for operations of the REH), medical
outcomes and the prevention and re- staff, and administrative officials are
duction of medical errors. The REH responsible and accountable for ensur-
must maintain and demonstrate evi- ing the following:
dence of its QAPI program for review (1) That an ongoing program for qual-
by CMS. ity improvement and patient safety,
(a) Standard: Program scope. (1) The including the reduction of medical er-
program must include, but not be lim- rors, is defined, implemented, and
ited to, an ongoing program that shows maintained.
measurable improvement in indicators (2) That the REH-wide quality assess-
for which there is evidence that it will ment and performance improvement ef-
improve health outcomes and identify forts address priorities for improved
and reduce medical errors. quality of care and patient safety; and
(2) The REH must measure, analyze, that all improvement actions are eval-
and track quality indicators, including uated.
adverse patient events, staffing, and (3) That clear expectations for safety
other aspects of performance that as- are established.
sess processes of care including REH (4) That adequate resources are allo-
service and operations. cated for measuring, assessing, improv-
(b) Standard: Program data collection ing, and sustaining the REH’s perform-
and analysis. The program must incor- ance and reducing risk to patients.
porate quality indicator data including (e) Standard: Unified and integrated
patient care data, and other relevant QAPI program for an REH in a multi-fa-
data, in order to achieve the goals of cility system. If an REH is part of a sys-
the QAPI program. tem consisting of multiple separately
(c) Standard: Program activities. (1) certified hospitals, CAHs, and/or REHs
The REH must set priorities for its per- using a system governing body that is
formance improvement activities legally responsible for the conduct of
that— two or more hospitals, CAHs, and/or
(i) Focus on high-risk, high-volume, REHs, the system governing body can
or problem-prone areas; elect to have a unified and integrated
(ii) Consider the incidence, preva- QAPI program for all of its member fa-
lence, and severity of problems in those cilities after determining that such a
areas; and decision is in accordance with all appli-
(iii) Affect health outcomes, patient cable state and local laws. The system
safety, and quality of care. governing body is responsible and ac-
(2) Performance improvement activi- countable for ensuring that each of its
ties must track medical errors and ad- separately certified REHs meets all of
verse patient events, analyze their the requirements of this section. Each
causes, and implement preventive ac- separately certified REH subject to the
tions and mechanisms that include system governing body must dem-
feedback and learning throughout the onstrate that—
REH. An adverse patient event means (1) The unified and integrated QAPI
an untoward, undesirable, and usually program is established in a manner
unanticipated event that causes death that takes into account each member
228
REH’s unique circumstances and any (i) Identification and social data, evi-
significant differences in patient popu- dence of properly executed informed
lations and services offered in each consent forms, pertinent medical his-
REH; and tory, assessment of the health status
(2) The unified and integrated QAPI and health care needs of the patient,
program establishes and implements and a brief summary of the episode,
policies and procedures to ensure that disposition, and instructions to the pa-
the needs and concerns of each of its tient;
separately certified REHs, regardless of (ii) Reports of physical examinations,
practice or location, are given due con- diagnostic and laboratory test results,
sideration, and that the unified and in- including clinical laboratory services,
tegrated QAPI program has mecha- and consultative findings;
nisms in place to ensure that issues lo- (iii) All orders of doctors of medicine
calized to particular REHs are duly or osteopathy or other practitioners,
considered and addressed. reports of treatments and medications,
nursing notes and documentation of
Agreements. complications, and other pertinent in-
formation necessary to monitor the pa-
The REH must have in effect an tient’s progress, such as temperature
agreement with at least one certified graphics, progress notes describing the
hospital that is a level I or level II patient’s response to treatment; and
trauma center for the referral and (iv) Dated signatures of the doctor of
transfer of patients requiring emer- medicine or osteopathy or other health
gency medical care beyond the capa- care professional.
bilities of the REH that is—
(b) Standard: Protection of record infor-
(a) Licensed as a hospital in a state
mation. (1) The REH must maintain the
that provides for the licensing of hos-
confidentiality of record information
pitals under state or applicable local
and provides safeguards against loss,
law or approved by the agency of such
destruction, or unauthorized use.
state or locality responsible for licens-
(2) The REH must have written poli-
ing hospitals, as meeting standards es-
cies and procedures that govern the use
tablished for licensing established by
and removal of records from the REH
the agency of the state; and
and the conditions for the release of in-
(b) Licensed or designated by the
formation.
state or local government authority as
level I or level II trauma center or is (3) The patient’s written consent is
verified by the American College of required for release of information not
Surgeons as a level I or level II trauma required by law.
center. (c) Standard: Retention of records. The
records must be retained for at least 5
§ 485.540 Condition of participation: years from date of last entry, and
Medical records. longer if required by state statute, or if
(a) Standard: Records system. (1) The the records may be needed in any pend-
REH must maintain a medical records ing proceeding.
system in accordance with written (d) Standard: Electronic notifications. If
policies and procedures. the REH utilizes an electronic medical
(2) The records must be legible, com- records system or other electronic ad-
plete, accurately documented, readily ministrative system, which is
accessible, and systematically orga- conformant with the content exchange
nized. standard at 45 CFR 170.205(d)(2), then
(3) A designated member of the pro- the REH must demonstrate that—
fessional staff is responsible for main- (1) The system’s notification capac-
taining the records and for ensuring ity is fully operational and the REH
that they are completely and accu- uses it in accordance with all state and
rately documented, readily accessible, Federal statutes and regulations appli-
and systematically organized. cable to the REH’s exchange of patient
(4) For each patient receiving health health information.
care services, the REH must maintain (2) The system sends notifications
a record that includes, as applicable— that must include at least patient
229
§ 485.542 42 CFR Ch. IV (10–1–24 Edition)
name, treating practitioner name, and (1) Be based on and include a docu-
sending institution name. mented, facility-based and community-
(3) To the extent permissible under based risk assessment, utilizing an all-
applicable Federal and state law and hazards approach.
regulations, and not inconsistent with (2) Include strategies for addressing
the patient’s expressed privacy pref- emergency events identified by the
erences, the system sends notifications risk assessment.
directly, or through an intermediary (3) Address patient population, in-
that facilitates exchange of health including, but not limited to, the type of
formation, at the time of the patient’s services the REH has the ability to
registration in the REH’s emergency provide in an emergency; and con-
department. tinuity of operations, including delega-
(4) To the extent permissible under tions of authority and succession
applicable Federal and state law and plans.
regulations, and not inconsistent with (4) Include a process for cooperation
the patient’s expressed privacy pref- and collaboration with local, tribal, re-
erences, the system sends notifications gional, state, and Federal emergency
directly, or through an intermediary preparedness officials’ efforts to main-
that facilitates exchange of health in- tain an integrated response during a
formation, either immediately prior to, disaster or emergency situation.
or at the time the patient’s discharge (b) Policies and procedures. The REH
or transfer from the REH’s emergency must develop and implement emer-
department. gency preparedness policies and proce-
(5) The REH has made a reasonable dures, based on the emergency plan set
effort to ensure that the system sends forth in paragraph (a) of this section,
the notifications to all applicable post- risk assessment at paragraph (a)(1) of
acute care services providers and sup- this section, and the communication
pliers, as well as to any of the fol- plan at paragraph (c) of this section.
lowing practitioners and entities, The policies and procedures must be re-
which need to receive notification of viewed and updated at least every 2
the patient’s status for treatment, care years. At a minimum, the policies and
coordination, or quality improvement procedures must address the following:
purposes: (1) The provision of subsistence needs
(i) The patient’s established primary for staff and patients, whether they
care practitioner; evacuate or shelter in place, include,
(ii) The patient’s established primary but are not limited to—
care practice group or entity; or (i) Food, water, medical, and pharma-
(iii) Other practitioner, or other ceutical supplies;
practice group or entity, identified by (ii) Alternate sources of energy to
the patient as the practitioner, or prac- maintain:
tice group or entity, primarily respon- (A) Temperatures to protect patient
sible for their care. health and safety and for the safe and
sanitary storage of provisions;
§ 485.542 Condition of participation: (B) Emergency lighting;
Emergency preparedness. (C) Fire detection, extinguishing, and
The REH must comply with all appli- alarm systems; and
cable Federal, state, and local emer- (D) Sewage and waste disposal.
gency preparedness requirements. The (2) A system to track the location of
REH must establish and maintain an on-duty staff and sheltered patients in
emergency preparedness program that the REH’s care during an emergency. If
meets the requirements of this section. on-duty staff or sheltered patients are
The emergency preparedness program relocated during the emergency, the
must include, but not be limited to, the REH must document the specific name
following elements: and location of the receiving facility or
(a) Emergency plan. The REH must other location.
develop and maintain an emergency (3) Safe evacuation from the REH,
preparedness plan that must be re- which includes the following:
viewed, and updated at least every 2 (i) Consideration of care and treat-
years. The plan must do the following: ment needs of evacuees.
230
(ii) Staff responsibilities. essary, with other health care pro-

(iii) Transportation. viders to maintain the continuity of
(iv) Identification of evacuation loca- care.
tion(s). (5) A means, in the event of an evacu-
(v) Primary and alternate means of ation, to release patient information as
communication with external sources permitted under 45 CFR 164.510(b)(1)(ii).
of assistance. (6) A means of providing information
(4) A means to shelter in place for pa- about the general condition and loca-
tients, staff, and volunteers who re- tion of patients under the facility’s
main in the REH. care as permitted under 45 CFR
(5) A system of medical documenta- 164.510(b)(4).
tion that does the following: (7) A means of providing information
(i) Preserves patient information. about the REH’s needs, and its ability
(ii) Protects confidentiality of pa- to provide assistance, to the authority
tient information. having jurisdiction, the Incident Com-
(iii) Secures and maintains the avail- mand Center, or designee.
ability of records. (d) Training and testing. The REH
(6) The use of volunteers in an emer- must develop and maintain an emer-
gency and other staffing strategies, in- gency preparedness training and test-
cluding the process and role for inte- ing program that is based on the emer-
gration of state and federally des- gency plan set forth in paragraph (a) of
ignated health care professionals to ad- this section, risk assessment at para-
dress surge needs during an emergency. graph (a)(1) of this section, policies and
(7) The role of the REH under a waiv- procedures at paragraph (b) of this sec-
er declared by the Secretary, in accord- tion, and the communication plan at
ance with section 1135 of the Act, in paragraph (c) of this section. The train-
the provision of care and treatment at ing and testing program must be re-
an alternate care site identified by viewed and updated at least every 2
emergency management officials. years.
(c) Communication plan. The REH (1) Training program. The REH must
must develop and maintain an emer- do all of the following:
gency preparedness communication
(i) Provide initial training in emer-
plan that complies with Federal, state,
gency preparedness policies and proce-
dures to all new and existing staff, in-
dividuals providing on-site services
under arrangement, and volunteers,
of the following:
consistent with their expected roles.
(1) Names and contact information
(ii) Provide emergency preparedness
for the following:
training at least every 2 years.
(i) Staff.
(ii) Entities providing services under (iii) Maintain documentation of all
arrangement. emergency preparedness training.
(iii) Patients’ physicians. (iv) Demonstrate staff knowledge of
(iv) Volunteers. emergency procedures.
(2) Contact information for the fol- (v) If the emergency preparedness
lowing: policies and procedures are signifi-
(i) Federal, state, tribal, regional, cantly updated, the REH must conduct
and local emergency preparedness training on the updated policies and
staff. procedures.
(ii) Other sources of assistance. (2) Testing. The REH must conduct
(3) Primary and alternate means for exercises to test the emergency plan at
communicating with the following: least annually. The REH must do the
(i) REH’s staff. following:
(ii) Federal, state, tribal, regional, (i) Participate in a full-scale exercise
and local emergency management that is community-based every 2 years.
agencies. (A) When a community-based exer-
(4) A method for sharing information cise is not accessible, conduct a facil-
and medical documentation for pa- ity-based functional exercise every 2
tients under the REH’s care, as nec- years; or
231
§ 485.542 42 CFR Ch. IV (10–1–24 Edition)
(B) If the REH experiences an actual power systems operational during the
natural or man-made emergency that emergency, unless it evacuates.
requires activation of the emergency (f) Integrated healthcare systems. If an
plan, the REH is exempt from engaging REH is part of a healthcare system
in its next required community-based consisting of multiple separately cer-
or individual, facility-based functional tified healthcare facilities that elects
exercise following the onset of the to have a unified and integrated emer-
emergency event. gency preparedness program, the REH
(ii) Conduct an additional exercise at may choose to participate in the
least every 2 years, opposite the year healthcare system’s coordinated emer-
the full-scale or functional exercise gency preparedness program. If elected,
under paragraph (d)(2)(i) of this section the unified and integrated emergency
is conducted, that may include, but is preparedness program must—
not limited to the following: (1) Demonstrate that each separately
(A) A second full-scale exercise that certified facility within the system ac-
is community-based, or an individual, tively participated in the development
facility-based functional exercise; or of the unified and integrated emer-
(B) A mock disaster drill; or gency preparedness program.
(C) A tabletop exercise or workshop (2) Be developed and maintained in a
that is led by a facilitator and includes manner that takes into account each
a group discussion using a narrated, separately certified facility’s unique
clinically-relevant emergency scenario, circumstances, patient populations,
and a set of problem statements, di- and services offered.
rected messages, or prepared questions (3) Demonstrate that each separately
designed to challenge an emergency certified facility is capable of actively
plan. using the unified and integrated emer-
(iii) Analyze the REH’s response to gency preparedness program and is in
and maintain documentation of all compliance.
drills, tabletop exercises, and emer- (4) Include a unified and integrated
gency events and revise the REH’s emergency plan that meets the require-
emergency plan, as needed. ments of paragraphs (a)(2), (3), and (4)
(e) Emergency and standby power sys- of this section. The unified and inte-
tems. The REH must implement emer- grated emergency plan must also be
gency and standby power systems based on and include the following:
based on the emergency plan set forth (i) A documented community-based
in paragraph (a) of this section. risk assessment, utilizing an all-haz-
(1) Emergency generator location. The ards approach.
generator must be located in accord- (ii) A documented individual facility-
ance with the location requirements based risk assessment for each sepa-
found in the Health Care Facilities rately certified facility within the
Code (NFPA 99 and Tentative Interim health system, utilizing an all-hazards
Amendments TIA 12–2, TIA 12–3, TIA approach.
12–4, TIA 12–5, and TIA 12–6), Life Safe- (5) Include integrated policies and
ty Code (NFPA 101 and Tentative In- procedures that meet the requirements
terim Amendments TIA 12–1, TIA 12–2, set forth in paragraph (b) of this sec-
TIA 12–3, and TIA 12–4), and NFPA 110, tion, a coordinated communication
when a new structure is built or when plan and training and testing programs
an existing structure or building is ren- that meet the requirements of para-
ovated. graphs (c) and (d) of this section, re-
(2) Emergency generator inspection and spectively.
testing. The REH must implement (g) Incorporation by reference. The ma-
emergency power system inspection terial listed in this paragraph (g) is in-
and testing requirements found in the corporated by reference into this sec-
Health Care Facilities Code, NFPA 110, tion with the approval of the Director
and the Life Safety Code. of the Federal Register in accordance
(3) Emergency generator fuel. REHs with 5 U.S.C. 552(a) and 1 CFR part 51.
that maintain an onsite fuel source to To enforce any edition other than that
power emergency generators must have specified in this section, CMS must
a plan for how it will keep emergency publish a document in the FEDERAL
232
REGISTER and the material must be (a) Standard: Buildings. The condition
available to the public. All approved of the physical plant and the overall
material is available for inspection at REH environment must be developed
CMS and the National Archives and and maintained in such a manner that
Records Administration (NARA). Con- the safety and well-being of patients
tact CMS at: CMS Information Re- are ensured.
source Center, 7500 Security Boulevard, (1) There must be emergency power
Baltimore, MD, email: and lighting in at least the operating,
scott.cooper@cms.hhs.gov or call (410) recovery, and emergency rooms, and
786–9465. For information on the avail- stairwells. In all other areas not serv-
ability of this material at NARA, iced by the emergency supply source,
email: fr.inspection@nara.gov, or go to: battery lamps and flashlights must be
www.archives.gov/federal-register/cfr/ibr- available.
locations.html. The material may be ob- (2) There must be facilities for emer-
tained from the following source(s) in gency gas and water supply.
this paragraph (g): (3) The REH must have a safe and
(1) National Fire Protection Associa- sanitary environment, properly con-
tion, 1 Batterymarch Park, Quincy, structed, equipped, and maintained to
MA 02169, www.nfpa.org, 1.617.770.3000. protect the health and safety of pa-
(i) NFPA 99, Health Care Facilities tients.
Code, 2012 edition, issued August 11, (b) Standard: Facilities. The REH must
2011. maintain adequate facilities for its
(ii) Technical interim amendment
services.
(TIA) 12–2 to NFPA 99, issued August
(1) Diagnostic and therapeutic facili-
11, 2011.
ties must be located for the safety of
(iii) TIA 12–3 to NFPA 99, issued Au-
patients.
gust 9, 2012.
(iv) TIA 12–4 to NFPA 99, issued (2) Facilities, supplies, and equip-
March 7, 2013. ment must be maintained to ensure an
(v) TIA 12–5 to NFPA 99, issued Au- acceptable level of safety and quality.
gust 1, 2013. (3) The extent and complexity of fa-
(vi) TIA 12–6 to NFPA 99, issued cilities must be determined by the
March 3, 2014. services offered.
(vii) NFPA 101, Life Safety Code, 2012 (4) There must be proper ventilation,
edition, issued August 11, 2011. light, and temperature controls in pa-
(viii) TIA 12–1 to NFPA 101, issued tient care, pharmaceutical, food prepa-
August 11, 2011. ration, and other appropriate areas.
(ix) TIA 12–2 to NFPA 101, issued Oc- (c) Standard: Safety from fire. (1) Ex-
tober 30, 2012. cept as otherwise provided in this sec-
(x) TIA 12–3 to NFPA 101, issued Oc- tion, the REH must meet the provi-
tober 22, 2013. sions applicable to Ambulatory Health
(xi) TIA 12–4 to NFPA 101, issued Oc- Care Occupancies, regardless of the
tober 22, 2013. number of patients served, and must
(xii) NFPA 110, Standard for Emer- proceed in accordance with the Life
gency and Standby Power Systems, Safety Code (NFPA 101 and Tentative
2010 edition, including TIAs to chapter Interim Amendments TIA 12–1, TIA 12–
7, issued August 6, 2009. 2, TIA 12–3, and TIA 12–4).
(2) [Reserved] (2) In consideration of a rec-
[87 FR 72293, Nov. 23, 2022; 88 FR 299, Jan. 4, ommendation by the state survey agen-
2023] cy or accrediting organization or at the
discretion of the Secretary, CMS may
§ 485.544 Condition of participation: waive, for periods deemed appropriate,
Physical environment. specific provisions of the Life Safety
The REH must be constructed, ar- Code, which would result in unreason-
ranged, and maintained to ensure the able hardship upon an REH, but only if
safety of the patient, and to provide fa- the waiver will not adversely affect the
cilities for diagnosis and treatment and health and safety of the patients.
for special services appropriate to the (3) The provisions of the Life Safety
needs of the community. Code do not apply in a state if CMS
233
§ 485.546 42 CFR Ch. IV (10–1–24 Edition)
finds that a fire and safety code im- locations.html. The material may be ob-
posed by state law adequately protects tained from the following source(s) in
patients in an REH. this paragraph (e).
(4) An REH may place alcohol-based (1) National Fire Protection Associa-
hand rub dispensers in its facility if the tion, 1 Batterymarch Park, Quincy,
dispensers are installed in a manner MA 02169, www.nfpa.org, 1.617.770.3000.
that adequately protects against inap- (i) NFPA 99, Health Care Facilities
propriate access. Code, 2012 edition, issued August 11,
(5) When a sprinkler system is shut 2011.
down for more than 10 hours, the REH (ii) Technical interim amendment
must:
(TIA) 12–2 to NFPA 99, issued August
(i) Evacuate the building or portion
11, 2011.
of the building affected by the system
outage until the system is back in (iii) TIA 12–3 to NFPA 99, issued Au-
service, or gust 9, 2012.
(ii) Establish a fire watch until the (iv) TIA 12–4 to NFPA 99, issued
system is back in service. March 7, 2013.
(d) Standard: Building safety. Except (v) TIA 12–5 to NFPA 99, issued Au-
as otherwise provided in this section, gust 1, 2013.
the REH must meet the applicable pro- (vi) TIA 12–6 to NFPA 99, issued
visions and must proceed in accordance March 3, 2014.
with the 2012 edition of the Health Care (vii) NFPA 101, Life Safety Code, 2012
Facilities Code (NFPA 99, and Ten- edition, issued August 11, 2011;
tative Interim Amendments TIA 12–2, (viii) TIA 12–1 to NFPA 101, issued
TIA 12–3, TIA 12–4, TIA 12–5 and TIA 12– August 11, 2011.
6). (ix) TIA 12–2 to NFPA 101, issued Oc-
(1) Chapters 7, 8, 12, and 13 of the tober 30, 2012.
adopted Health Care Facilities Code do (x) TIA 12–3 to NFPA 101, issued Oc-
not apply to an REH. tober 22, 2013.
(2) If application of the Health Care
Facilities Code required under para-
tober 22, 2013.
graph (d) of this section would result in
unreasonable hardship for the REH, (2) [Reserved]
CMS may waive specific provisions of
the Health Care Facilities Code, but Skilled nursing facility distinct part
only if the waiver does not adversely unit.
affect the health and safety of patients.
(e) Incorporation by reference. The ma- If the REH provides skilled nursing
terial listed in this paragraph (e) is in- facility services in a distinct part unit,
corporated by reference into this sec- the services furnished by the distinct
tion with the approval the Director of part unit must be separately licensed
the Federal Register in accordance and certified and comply with the re-
with 5 U.S.C. 552(a) and 1 CFR part 51. quirements of participation for long-
To enforce any edition other than that term care facilities specified in part
specified in this section, CMS must 483, subpart B, of this chapter.
publish a document in the FEDERAL
REGISTER and the material must be Subpart F—Conditions of Partici-
available to the public. All approved pation: Critical Access Hos-
material is available for inspection at pitals (CAHs)
CMS and the National Archives and
Records Administration (NARA). Con-
tact CMS at: CMS Information Re- SOURCE: 58 FR 30671, May 26, 1993, unless
source Center, 7500 Security Boulevard, otherwise noted.
Baltimore, MD, email
scott.cooper@cms.hhs.gov or call (410)
786–9465. For information on the avail- (a) Statutory basis. This subpart is
ability of this material at NARA, email based on section 1820 of the Act which
fr.inspection@nara.gov or go to: sets forth the conditions for desig-
www.archives.gov/federal-register/cfr/ibr- nating certain hospitals as CAHs.
234
(b) Scope. This subpart sets forth the sional nurse who is currently licensed
conditions that a hospital must meet to practice in the State, who meets the
to be designated as a CAH. State’s requirements governing the
[58 FR 30671, May 26, 1993, as amended at 62
qualification of nurse practitioners,
FR 46037, Aug. 29, 1997] and who meets one of the following
conditions:
§ 485.603 Rural health network. (1) Is currently certified as a primary
A rural health network is an organi- care nurse practitioner by the Amer-
zation that meets the following speci- ican Nurses’ Association or by the Na-
fications: tional Board of Pediatric Nurse Practi-
(a) It includes— tioners and Associates.
(1) At least one hospital that the (2) Has successfully completed a 1
State has designated or plans to des- academic year program that—
ignate as a CAH; and (i) Prepares registered nurses to per-
(2) At least one hospital that fur- form an expanded role in the delivery
nishes acute care services. of primary care;
(b) The members of the organization (ii) Includes at least 4 months (in the
have entered into agreements regard- aggregate) of classroom instruction
ing— and a component of supervised clinical
(1) Patient referral and transfer; practice; and
(2) The development and use of com- (iii) Awards a degree, diploma, or cer-
munications systems, including, where tificate to persons who successfully
feasible, telemetry systems and sys- complete the program.
tems for electronic sharing of patient (3) Has successfully completed a for-
data; and mal educational program (for pre-
(3) The provision of emergency and paring registered nurses to perform an
nonemergency transportation among expanded role in the delivery of pri-
members. mary care) that does not meet the re-
(c) Each CAH has an agreement with quirements of paragraph (a)(2) of this
respect to credentialing and quality as- section, and has been performing an ex-
surance with at least— panded role in the delivery of primary
(1) One hospital that is a member of care for a total of 12 months during the
the network when applicable; 18-month period immediately preceding
(2) One QIO or equivalent entity; or June 25, 1993.
(3) One other appropriate and quali- (c) Physician assistant. A physician
fied entity identified in the State rural assistant must be a person who meets
health care plan. the applicable State requirements gov-
[58 FR 30671, May 26, 1993, as amended at 62 erning the qualifications for assistants
FR 46035, Aug. 29, 1997; 63 FR 26359, May 12, to primary care physicians, and who
1998] meets at least one of the following con-
ditions:
§ 485.604 Personnel qualifications. (1) Is currently certified by the Na-
Staff that furnish services in a CAH tional Commission on Certification of
must meet the applicable requirements Physician Assistants to assist primary
of this section. care physicians.
(a) Clinical nurse specialist. A clinical (2) Has satisfactorily completed a
nurse specialist must be a person who— program for preparing physician assist-
(1) Is a registered nurse and is li- ants that—
censed to practice nursing in the State (i) Was at least one academic year in
in which the clinical nurse specialist length;
services are performed in accordance (ii) Consisted of supervised clinical
with State nurse licensing laws and practice and at least 4 months (in the
regulations; and aggregate) of classroom instruction di-
(2) Holds a master’s or doctoral level rected toward preparing students to de-
degree in a defined clinical area of liver health care; and
nursing from an accredited educational (iii) Was accredited by the American
institution. Medical Association’s Committee on
(b) Nurse practitioner. A nurse practi- Allied Health Education and Accredita-
tioner must be a registered profes- tion.
235
§ 485.606 42 CFR Ch. IV (10–1–24 Edition)
(3) Has satisfactorily completed a (a) Standard: Compliance with Federal

formal educational program (for pre- laws and regulations. The CAH is in
paring physician assistants) that does compliance with applicable Federal
not meet the requirements of para- laws and regulations related to the
graph (c)(2) of this section and has been health and safety of patients.
assisting primary care physicians for a (b) Standard: Compliance with State
total of 12 months during the 18-month and local laws and regulations. All pa-
period immediately preceding June 25, tient care services are furnished in ac-
1993. cordance with applicable State and
local laws and regulations.
(c) Standard: Licensure of CAH. The
FR 46037, Aug. 29, 1997; 77 FR 29076, May 16,
2012] CAH is licensed in accordance with ap-
plicable Federal, State and local laws
§ 485.606 Designation and certification and regulations.
of CAHs. (d) Standard: Licensure, certification or
registration of personnel. Staff of the
(a) Criteria for State designation. (1) A
CAH are licensed, certified, or reg-
State that has established a Medicare
istered in accordance with applicable
rural hospital flexibility program de-
Federal, State, and local laws and reg-
scribed in section 1820(c) of the Act
ulations.
may designate one or more facilities as
CAHs if each facility meets the CAH [58 FR 30671, May 26, 1993, as amended at 62
conditions of participation in this sub- FR 46037, Aug. 29, 1997]
part F.
(2) The State must not deny any hos- Status and location.
pital that is otherwise eligible for des-
ignation as a CAH under this para- (a) Standard: Status. The facility is—
graph (a) solely because the hospital (1) A currently participating hospital
has entered into an agreement under that meets all conditions of participa-
which the hospital may provide tion set forth in this subpart;
posthospital SNF care as described in (2) A recently closed facility, pro-
§ 482.58 of this chapter. vided that the facility—
(b) Criteria for CMS certification. (i) Was a hospital that ceased oper-
CMS certifies a facility as a CAH if— ations on or after the date that is 10
years before November 29, 1999; and
(1) The facility is designated as a
(ii) Meets the criteria for designation
CAH by the State in which it is located
under this subpart as of the effective
and has been surveyed by the State
date of its designation; or
survey agency or by CMS and found to
(3) A health clinic or a health center
meet all conditions of participation in
(as defined by the State) that—
this part and all other applicable re-
(i) Is licensed by the State as a
quirements for participation in part 489
health clinic or a health center;
of this chapter. (ii) Was a hospital that was
(2) The facility is a medical assist- downsized to a health clinic or a health
ance facility operating in Montana or a center; and
rural primary care hospital designated (iii) As of the effective date of its
by CMS before August 5, 1997, and is designation, meets the criteria for des-
otherwise eligible to be designated as a ignation set forth in this subpart.
CAH by the State under the rules in (b) Standard: Location in a rural area
this subpart. or treatment as rural. The CAH meets
[62 FR 46036, Aug. 29, 1997, as amended at 63 the requirements of either paragraph
FR 26359, May 12, 1998; 79 FR 27155, May 12, (b)(1) or (b)(2) of this section or the re-
2014] quirements of paragraph (b)(3), (b)(4),
or (b)(5) of this section.
§ 485.608 Condition of participation: (1) The CAH meets the following re-
Compliance with Federal, State, quirements:
and local laws and regulations. (i) The CAH is located outside any
The CAH and its staff are in compli- area that is a Metropolitan Statistical
ance with applicable Federal, State Area, as defined by the Office of Man-
and local laws and regulations. agement and Budget, or that has been
236
recognized as urban under § 412.64(b), county that, prior to the most recent
excluding paragraph (b)(3) of this chap- OMB standards for delineating statis-
ter; tical areas adopted by CMS and the
(ii) The CAH has not been classified most recent Census Bureau data, was
as an urban hospital for purposes of the located in a rural area as defined by
standardized payment amount by CMS OMB, but under the most recent OMB
or the Medicare Geographic Classifica- standards for delineating statistical
tion Review Board under § 412.230(e) of areas adopted by CMS and the most re-
this chapter, and is not among a group cent Census Bureau data, is located in
of hospitals that have been redesig- an urban area.
nated to an adjacent urban area under (c) Standard: Location relative to other
§ 412.232 of this chapter. facilities or necessary provider certifi-
(2) The CAH is located within a Met-
cation. (1) The CAH is located more
ropolitan Statistical Area, as defined
than a 35-mile drive on primary roads
by the Office of Management and Budg-
(or, in the case of mountainous terrain
et, but is being treated as being located
or in areas with only secondary roads
in a rural area in accordance with
§ 412.103 of this chapter. available, a 15-mile drive) from a hos-
(3) Effective for October 1, 2004 pital or another CAH, or before Janu-
through September 30, 2006, the CAH ary 1, 2006, the CAH is certified by the
does not meet the location require- State as being a necessary provider of
ments in either paragraph (b)(1) or health care services to residents in the
(b)(2) of this section and is located in a area. A CAH that is designated as a
county that, in FY 2004, was not part of necessary provider on or before Decem-
a Metropolitan Statistical Area as de- ber 31, 2005, will maintain its necessary
fined by the Office of Management and provider designation after January 1,
Budget, but as of FY 2005 was included 2006.
as part of such a Metropolitan Statis- (2) Primary roads of travel for deter-
tical Area as a result of the most re- mining the driving distance of a CAH
cent census data and implementation and its proximity to other providers is
of the new Metropolitan Statistical defined as:
Area definitions announced by the Of- (i) A numbered Federal highway, in-
fice of Management and Budget on cluding interstates, intrastates, ex-
June 3, 2003. pressways, or any other numbered Fed-
(4) Effective for October 1, 2009 eral highway with 2 or more lanes each
through September 30, 2011, the CAH way; or
does not meet the location require- (ii) A numbered State highway with 2
ments in either paragraph (b)(1) or or more lanes each way.
(b)(2) of this section and is located in a
(d) Standard: Relocation of CAHs with
county that, in FY 2009, was not part of
a necessary provider designation. A CAH
a Metropolitan Statistical Area as de-
fined by the Office of Management and that has a necessary provider designa-
Budget, but, as of FY 2010, was included tion from the State that was in effect
as part of such a Metropolitan Statis- prior to January 1, 2006, and relocates
tical Area as a result of the most re- its facility after January 1, 2006, can
cent census data and implementation continue to meet the location require-
of the new Metropolitan Statistical ment of paragraph (c) of this section
Area definitions announced by the Of- based on the necessary provider des-
fice of Management and Budget on No- ignation only if the relocated facility
vember 20, 2008. meets the requirements as specified in
(5) Effective on or after October 1, paragraph (d)(1) of this section.
2014, for a period of 2 years beginning (1) If a necessary provider CAH relo-
with the effective date of the most re- cates its facility and begins providing
cent Office of Management and Budget services in a new location, the CAH can
(OMB) standards for delineating statis- continue to meet the location require-
tical areas adopted by CMS, the CAH ment of paragraph (c) of this section
no longer meets the location require- based on the necessary provider des-
ments in either paragraph (b)(1) or ignation only if the CAH in its new lo-
(b)(2) of this section and is located in a cation—
237
§ 485.612 42 CFR Ch. IV (10–1–24 Edition)
(i) Serves at least 75 percent of the tainous terrain or in areas with only
same service area that it served prior secondary roads available, a 15-mile
to its relocation; drive) from a hospital or another CAH.
(ii) Provides at least 75 percent of the (3) If either a CAH or a CAH that has
same services that it provided prior to been designated as a necessary provider
the relocation; and by the State does not meet the require-
(iii) Is staffed by 75 percent of the ments in paragraph (e)(1) of this sec-
same staff (including medical staff, tion, by co-locating with another hos-
contracted staff, and employees) that pital or CAH on or after January 1,
were on staff at the original location. 2008, or creates or acquires an off-cam-
(2) If a CAH that has been designated pus provider-based location or off-cam-
as a necessary provider by the State pus distinct part unit on or after Janu-
begins providing services at another lo- ary 1, 2008, that does not meet the re-
cation after January 1, 2006, and does quirements in paragraph (e)(2) of this
not meet the requirements in para- section, the CAH’s provider agreement
graph (d)(1) of this section, the action will be subject to termination in ac-
will be considered a cessation of busi- cordance with the provisions of
ness as described in § 489.52(b)(3). § 489.53(a)(3) of this subchapter, unless
(e) Standard: Off-campus and co-loca- the CAH terminates the off-campus ar-
tion requirements for CAHs. A CAH may rangement or the co-location arrange-
continue to meet the location requirement, or both.
ments of paragraph (c) of this section
only if the CAH meets the following: [62 FR 46036, Aug. 29, 1997, as amended at 65
(1) If a CAH with a necessary pro- FR 47052, Aug. 1, 2000; 66 FR 39938, Aug. 1,
vider designation is co-located (that is, 2001; 69 FR 49271, Aug. 11, 2004; 69 FR 60252,
Oct. 7, 2004; 70 FR 47490, Aug. 12, 2005; 71 FR
it shares a campus, as defined in 48143, Aug. 18, 2006; 72 FR 66934, Nov. 27, 2007;
§ 413.65(a)(2) of this chapter, with an- 73 FR 9862, Feb. 22, 2008; 74 FR 44001, Aug. 27,
other hospital or CAH), the necessary 2009; 75 FR 50418, Aug. 16, 2010; 79 FR 50359,
provider CAH can continue to meet the Aug. 22, 2014; 87 FR 72307, Nov. 23, 2022; 88 FR
location requirement of paragraph (c) 299, Jan. 4, 2023]
of this section only if the co-location
arrangement was in effect before Janu- § 485.612 Condition of participation:
ary 1, 2008, and the type and scope of Compliance with hospital require-
services offered by the facility co-lo- ments at the time of application.
cated with the necessary provider CAH Except for recently closed facilities
do not change. A change of ownership as described in § 485.610(a)(2), or health
of any of the facilities with a co-loca- clinics or health centers as described in
tion arrangement that was in effect be- § 485.610(a)(3), the facility is a hospital
fore January 1, 2008, will not be consid- that has a provider agreement to par-
ered to be a new co-location arrange- ticipate in the Medicare program as a
ment. hospital at the time the hospital ap-
(2) If a CAH or a necessary provider plies for designation as a CAH.
CAH operates an off-campus provider-
based location, excluding an RHC as [66 FR 32196, June 13, 2001]
defined in § 405.2401(b) of this chapter,
but including a department or remote Patient’s rights.
location, as defined in § 413.65(a)(2) of
this chapter, or an off-campus distinct A CAH must protect and promote
part psychiatric or rehabilitation unit, each patient’s rights.
as defined in § 485.647, that was created (a) Standard: Notice of rights. (1) A
or acquired by the CAH on or after hospital must inform each patient, or
January 1, 2008, the CAH can continue when appropriate, the patient’s rep-
to meet the location requirement of resentative (as allowed under state
paragraph (c) of this section only if the law), of the patient’s rights, in advance
off-campus provider-based location or of furnishing or discontinuing patient
off-campus distinct part unit is located care whenever possible.
more than a 35-mile drive on primary (2) The hospital must establish a
roads, as defined in paragraph (c)(2) of process for prompt resolution of pa-
this section (or, in the case of moun- tient grievances and must inform each
238
patient whom to contact to file a griev- (c) Standard: Privacy and safety. (1)
ance. The hospital’s governing body The patient has the right to personal
must approve and be responsible for privacy.
the effective operation of the grievance (2) The patient has the right to re-
process and must review and resolve ceive care in a safe setting.
grievances, unless it delegates the re- (3) The patient has the right to be
sponsibility in writing to a grievance free from all forms of abuse or harass-
committee. The grievance process ment.
must include a mechanism for timely (d) Standard: Confidentiality of patient
referral of patient concerns regarding records. (1) The patient has the right to
quality of care or premature discharge the confidentiality of their clinical
to the appropriate Utilization and records.
Quality Control Quality Improvement (2) The patient has the right to ac-
Organization. At a minimum: cess their medical records, including
current medical records, upon an oral
(i) The hospital must establish a
or written request, in the form and for-
clearly explained procedure for the mat requested by the individual, if it is
submission of a patient’s written or readily producible in such form and
verbal grievance to the hospital. format (including in an electronic form
(ii) The grievance process must speci- or format when such medical records
fy time frames for review of the griev- are maintained electronically); or, if
ance and the provision of a response. not, in a readable hard copy form or
(iii) In its resolution of the griev- such other form and format as agreed
ance, the hospital must provide the pa- to by the facility and the individual,
tient with written notice of its decision and within a reasonable time frame.
that contains the name of the hospital The hospital must not frustrate the le-
contact person, the steps taken on be- gitimate efforts of individuals to gain
half of the patient to investigate the access to their own medical records
grievance, the results of the grievance and must actively seek to meet these
process, and the date of completion. requests as quickly as its record keep-
(b) Standard: Exercise of rights. (1) The ing system permits.
patient has the right to participate in (e) Standard: Restraint or seclusion. All
the development and implementation patients have the right to be free from
of their plan of care. physical or mental abuse, and corporal
(2) The patient or their representa- punishment. All patients have the
tive (as allowed under state law) has right to be free from restraint or seclu-
the right to make informed decisions sion, of any form, imposed as a means
regarding their care. The patient’s of coercion, discipline, convenience, or
retaliation by staff. Restraint or seclu-
rights include being informed of their
sion may only be imposed to ensure the
health status, being involved in care
immediate physical safety of the pa-
planning and treatment, and being able
tient, a staff member, or others and
to request or refuse treatment. This
must be discontinued at the earliest
right must not be construed as a mech-
possible time.
anism to demand the provision of (1)(i) A restraint is—
treatment or services deemed medi- (A) Any manual method, physical or
cally unnecessary or inappropriate. mechanical device, material, or equip-
(3) The patient has the right to for- ment that immobilizes or reduces the
mulate advance directives and to have ability of a patient to move their arms,
hospital staff and practitioners who legs, body, or head freely; or
provide care in the hospital comply (B) A drug or medication when it is
with these directives, in accordance used as a restriction to manage the pa-
with §§ 489.100, 489.102, and 489.104 of tient’s behavior or restrict the pa-
this chapter. tient’s freedom of movement and is not
(4) The patient has the right to have a standard treatment or dosage for the
a family member or representative of patient’s condition.
their choice and their own physician (C) A restraint does not include de-
notified promptly of their admission to vices, such as orthopedically prescribed
the hospital. devices, surgical dressings or bandages,
239
§ 485.614 42 CFR Ch. IV (10–1–24 Edition)
protective helmets, or other methods (i) Each death that occurs while a pa-
that involve the physical holding of a tient is in restraint or seclusion.
patient for the purpose of conducting (ii) Each death that occurs within 24
routine physical examinations or tests, hours after the patient has been re-
or to protect the patient from falling moved from restraint or seclusion.
out of bed, or to permit the patient to (iii) Each death known to the hos-
participate in activities without the pital that occurs within 1 week after
risk of physical harm (this does not in- restraint or seclusion where it is rea-
clude a physical escort). sonable to assume that use of restraint
(ii) Seclusion is the involuntary con-
or placement in seclusion contributed
finement of a patient alone in a room
directly or indirectly to a patient’s
or area from which the patient is phys-
ically prevented from leaving. Seclu- death, regardless of the type(s) of re-
sion may only be used for the manage- straint used on the patient during this
ment of violent or self-destructive be- time. ‘‘Reasonable to assume’’ in this
havior. context includes, but is not limited to,
(2) Restraint or seclusion may only deaths related to restrictions of move-
be used when less restrictive interven- ment for prolonged periods of time, or
tions have been determined to be inef- death related to chest compression, re-
fective to protect the patient a staff striction of breathing, or asphyxiation.
member or others from harm. (2) When no seclusion has been used
(3) The type or technique of restraint and when the only restraints used on
or seclusion used must be the least re- the patient are those applied exclu-
strictive intervention that will be ef- sively to the patient’s wrist(s), and
fective to protect the patient, a staff which are composed solely of soft, non-
member, or others from harm. rigid, cloth-like materials, the hospital
(4) The CAH must have written poli- staff must record in an internal log or
cies and procedures regarding the use other system, the following informa-
of restraint and seclusion that are con- tion:
sistent with current standards of prac- (i) Any death that occurs while a pa-
tice.
tient is in such restraints.
(f) Standard: Restraint or seclusion:
Staff training requirements. The patient (ii) Any death that occurs within 24
has the right to safe implementation of hours after a patient has been removed
restraint or seclusion by trained staff. from such restraints.
(1) The CAH must provide patient- (3) The staff must document in the
centered, trauma informed com- patient’s medical record the date and
petency-based training and education time the death was:
of CAH personnel and staff, including (i) Reported to CMS for deaths de-
medical staff, and, as applicable, per- scribed in paragraph (g)(1) of this sec-
sonnel providing contracted services in tion; or
the CAH, on the use of restraint and se- (ii) Recorded in the internal log or
clusion. other system for deaths described in
(2) The training must include alter- paragraph (g)(2) of this section.
natives to the use of restraint/seclu- (4) For deaths described in paragraph
sion. (g)(2) of this section, entries into the
(g) Standard: Death reporting require- internal log or other system must be
ments. Hospitals must report deaths as- documented as follows:
sociated with the use of seclusion or re-
(i) Each entry must be made not
straint.
later than seven days after the date of
(1) With the exception of deaths de-
scribed under paragraph (g)(2) of this death of the patient.
section, the hospital must report the (ii) Each entry must document the
following information to CMS by tele- patient’s name, date of birth, date of
phone, facsimile, or electronically, as death, name of attending physician or
determined by CMS, no later than the other licensed practitioner who is re-
close of business on the next business sponsible for the care of the patient,
day following knowledge of the pa- medical record number, and primary
tient’s death: diagnosis(es).
240
(iii) The information must be made (3) The provision of emergency and
available in either written or elec- nonemergency transportation between
tronic form to CMS immediately upon the facility and the hospital.
request. (b) Standard: Agreements for
(h) Standard: Patient visitation rights. credentialing and quality assurance.
A CAH must have written policies and Each CAH that is a member of a rural
procedures regarding the visitation health network shall have an agree-
rights of patients, including those set- ment with respect to credentialing and
ting forth any clinically necessary or quality assurance with at least—
reasonable restriction or limitation (1) One hospital that is a member of
that the CAH may need to place on the network;
such rights and the reasons for the (2) One QIO or equivalent entity; or
clinical restriction or limitation. A (3) One other appropriate and quali-
CAH must meet the following require- fied entity identified in the State rural
ments: health care plan.
(1) Inform each patient (or support (c) Standard: Agreements for
person, where appropriate) of his or her credentialing and privileging of telemedi-
visitation rights, including any clinical cine physicians and practitioners. (1) The
restriction or limitation on such governing body of the CAH must en-
rights, in advance of furnishing patient sure that, when telemedicine services
care whenever possible. are furnished to the CAH’s patients
(2) Inform each patient (or support through an agreement with a distant-
person, where appropriate) of the right, site hospital, the agreement is written
subject to his or her consent, to receive and specifies that it is the responsi-
the visitors whom he or she designates, bility of the governing body of the dis-
including, but not limited to, a spouse, tant-site hospital to meet the following
a domestic partner (including a same- requirements with regard to its physi-
sex domestic partner), another family cians or practitioners providing tele-
member, or a friend, and his or her medicine services:
right to withdraw or deny such consent (i) Determine, in accordance with
at any time. State law, which categories of practi-
(3) Not restrict, limit, or otherwise tioners are eligible candidates for ap-
deny visitation privileges on the basis pointment to the medical staff.
of race, color, national origin, religion, (ii) Appoint members of the medical
sex, gender identity, sexual orienta- staff after considering the rec-
tion, or disability. ommendations of the existing members
(4) Ensure that all visitors enjoy full of the medical staff.
and equal visitation privileges con- (iii) Assure that the medical staff has
sistent with patient preferences. bylaws.
(iv) Approve medical staff bylaws and
[87 FR 72307, 72309, Nov. 23, 2022] other medical staff rules and regula-
tions.
§ 485.616 Condition of participation: (v) Ensure that the medical staff is
Agreements.
accountable to the governing body for
(a) Standard: Agreements with network the quality of care provided to pa-
hospitals. In the case of a CAH that is a tients.
member of a rural health network as (vi) Ensure the criteria for selection
defined in § 485.603 of this chapter, the are individual character, competence,
CAH has in effect an agreement with at training, experience, and judgment.
least one hospital that is a member of (vii) Ensure that under no cir-
the network for— cumstances is the accordance of staff
(1) Patient referral and transfer; membership or professional privileges
(2) The development and use of com- in the hospital dependent solely upon
munications systems of the network, certification, fellowship or membership
including the network’s system for the in a specialty body or society.
electronic sharing of patient data, and (2) When telemedicine services are
telemetry and medical records, if the furnished to the CAH’s patients
network has in operation such a sys- through an agreement with a distant-
tem; and site hospital, the CAH’s governing body
241
§ 485.616 42 CFR Ch. IV (10–1–24 Edition)
or responsible individual may choose to and practitioners providing telemedi-

rely upon the credentialing and privi- cine services.
leging decisions made by the governing (4) When telemedicine services are
body of the distant-site hospital re- furnished to the CAH’s patients
garding individual distant-site physi- through an agreement with a distant-
cians or practitioners. The CAH’s gov- site telemedicine entity, the CAH’s
erning body or responsible individual governing body or responsible indi-
must ensure, through its written agree- vidual may choose to rely upon the
ment with the distant-site hospital, credentialing and privileging decisions
that the following provisions are met: made by the governing body of the dis-
(i) The distant-site hospital providing tant-site telemedicine entity regarding
telemedicine services is a Medicare- individual distant-site physicians or
participating hospital. practitioners. The CAH’s governing
(ii) The individual distant-site physi- body or responsible individual must en-
cian or practitioner is privileged at the sure, through its written agreement
distant-site hospital providing the tele- with the distant-site telemedicine enti-
medicine services, which provides a ty, that the following provisions are
current list of the distant-site physi- met:
cian’s or practitioner’s privileges at (i) The distant-site telemedicine enti-
the distant-site hospital; ty’s medical staff credentialing and
(iii) The individual distant-site phy- privileging process and standards at
sician or practitioner holds a license least meet the standards at paragraphs
issued or recognized by the State in (c)(1)(i) through (c)(1)(vii) of this sec-
which the CAH is located; and tion.
(iv) With respect to a distant-site (ii) The individual distant-site physi-
physician or practitioner, who holds cian or practitioner is privileged at the
current privileges at the CAH whose distant-site telemedicine entity pro-
patients are receiving the telemedicine viding the telemedicine services, which
services, the CAH has evidence of an provides a current list to the CAH of
internal review of the distant-site phy- the distant-site physician’s or practi-
sician’s or practitioner’s performance tioner’s privileges at the distant-site
of these privileges and sends the dis- telemedicine entity.
tant-site hospital such information for (iii) The individual distant-site phy-
use in the periodic appraisal of the in- sician or practitioner holds a license
dividual distant-site physician or prac- issued or recognized by the State in
titioner. At a minimum, this informa- which the CAH whose patients are re-
tion must include all adverse events ceiving the telemedicine services is lo-
that result from the telemedicine serv- cated.
ices provided by the distant-site physi- (iv) With respect to a distant-site
cian or practitioner to the CAH’s pa- physician or practitioner, who holds
tients and all complaints the CAH has current privileges at the CAH whose
received about the distant-site physi- patients are receiving the telemedicine
cian or practitioner. services, the CAH has evidence of an
(3) The governing body of the CAH internal review of the distant-site phy-
must ensure that when telemedicine sician’s or practitioner’s performance
services are furnished to the CAH’s pa- of these privileges and sends the dis-
tients through an agreement with a tant-site telemedicine entity such in-
distant-site telemedicine entity, the formation for use in the periodic ap-
agreement is written and specifies that praisal of the distant-site physician or
the distant-site telemedicine entity is practitioner. At a minimum, this infor-
a contractor of services to the CAH and mation must include all adverse events
as such, in accordance with that result from the telemedicine serv-
§ 485.635(c)(4)(ii), furnishes the con- ices provided by the distant-site physi-
tracted services in a manner that en- cian or practitioner to the CAH’s pa-
ables the CAH to comply with all appli- tients and all complaints the CAH has
cable conditions of participation for received about the distant-site physi-
the contracted services, including, but cian or practitioner.
not limited to, the requirements in this [62 FR 46036, Aug. 29, 1997, as amended at 76
section with regard to its physicians FR 25564, May 5, 2011]
242
§ 485.618 Condition of participation: radio contact, and available on site

Emergency services. within the following timeframes:
The CAH provides emergency care (i) Within 30 minutes, on a 24-hour a
necessary to meet the needs of its inpa- day basis, if the CAH is located in an
tients and outpatients. area other than an area described in
(a) Standard: Availability. Emergency paragraph (d)(1)(ii) of this section; or
services are available on a 24-hours a (ii) Within 60 minutes, on a 24-hour a
day basis. day basis, if all of the following re-
(b) Standard: Equipment, supplies, and quirements are met:
medication. Equipment, supplies, and (A) The CAH is located in an area
medication used in treating emergency designated as a frontier area (that is,
cases are kept at the CAH and are read- an area with fewer than six residents
ily available for treating emergency per square mile based on the latest
cases. The items available must in- population data published by the Bu-
clude the following: reau of the Census) or in an area that
(1) Drugs and biologicals commonly meets the criteria for a remote loca-
used in life-saving procedures, includ- tion adopted by the State in its rural
ing analgesics, local anesthetics, anti- health care plan, and approved by CMS,
biotics, anticonvulsants, antidotes and under section 1820(b) of the Act.
emetics, serums and toxoids, (B) The State has determined, under
antiarrythmics, cardiac glycosides, criteria in its rural health care plan,
antihypertensives, diuretics, and elec- that allowing an emergency response
trolytes and replacement solutions. time longer than 30 minutes is the only
(2) Equipment and supplies commonly feasible method of providing emer-
used in life-saving procedures, includ- gency care to residents of the area
ing airways, endotracheal tubes, ambu served by the CAH.
bag/valve/mask, oxygen, tourniquets, (C) The State maintains documenta-
immobilization devices, nasogastric tion showing that the response time of
tubes, splints, IV therapy supplies, suc- up to 60 minutes at a particular CAH it
tion machine, defibrillator, cardiac designates is justified because other
monitor, chest tubes, and indwelling available alternatives would increase
urinary catheters. the time needed to stabilize a patient
(c) Standard: Blood and blood products. in an emergency.
The facility provides, either directly or (2) A registered nurse with training
under arrangements, the following: and experience in emergency care can
(1) Services for the procurement, be utilized to conduct specific medical
safekeeping, and transfusion of blood, screening examinations only if—
including the availability of blood (i) The registered nurse is on site and
products needed for emergencies on a immediately available at the CAH
24-hours a day basis. when a patient requests medical care;
(2) Blood storage facilities that meet and
the requirements of 42 CFR part 493, (ii) The nature of the patient’s re-
subpart K, and are under the control quest for medical care is within the
and supervision of a pathologist or scope of practice of a registered nurse
other qualified doctor of medicine or and consistent with applicable State
osteopathy. If blood banking services laws and the CAH’s bylaws or rules and
are provided under an arrangement, regulations.
the arrangement is approved by the fa- (3) A registered nurse satisfies the
cility’s medical staff and by the per- personnel requirement specified in
sons directly responsible for the oper- paragraph (d)(1) of this section for a
ation of the facility. temporary period if—
(d) Standard: Personnel. (1) Except as (i) The CAH has no greater than 10
specified in paragraph (d)(3) of this sec- beds;
tion, there must be a doctor of medi- (ii) The CAH is located in an area
cine or osteopathy, a physician assist- designated as a frontier area or remote
ant, a nurse practitioner, or a clinical location as described in paragraph
nurse specialist, with training or expe- (d)(1)(ii)(A) of this section;
rience in emergency care, on call and (iii) The State in which the CAH is
immediately available by telephone or located submits a letter to CMS signed
243
§ 485.620 42 CFR Ch. IV (10–1–24 Edition)
by the Governor, following consulta- beds. Inpatient beds may be used for ei-
tion on the issue of using RNs on a ther inpatient or swing-bed services.
temporary basis as part of their State (b) Standard: Length of stay. The CAH
rural healthcare plan with the State provides acute inpatient care for a pe-
Boards of Medicine and Nursing, and in riod that does not exceed, on an annual
accordance with State law, requesting average basis, 96 hours per patient.
that a registered nurse with training
[62 FR 46036, Aug. 29, 1997, as amended at 65
and experience in emergency care be
FR 47052, Aug. 1, 2000; 69 FR 49271, Aug. 11,
included in the list of personnel speci- 2004; 69 FR 60252, Oct. 7, 2004; 78 FR 50970,
fied in paragraph (d)(1) of this section. Aug. 19, 2013]
The letter from the Governor must at-
test that he or she has consulted with § 485.623 Condition of participation:
State Boards of Medicine and Nursing Physical plant and environment.
about issues related to access to and (a) Standard: Construction. The CAH is
the quality of emergency services in constructed, arranged, and maintained
the States. The letter from the Gov- to ensure access to and safety of pa-
ernor must also describe the cir- tients, and provides adequate space for
cumstances and duration of the tem- the provision of services.
porary request to include the reg- (b) Standard: Maintenance. The CAH
istered nurses on the list of personnel has housekeeping and preventive main-
specified in paragraph (d)(1) of this sec- tenance programs to ensure that—
tion;
(1) All essential mechanical, elec-
(iv) Once a Governor submits a let-
trical, and patient-care equipment is
ter, as specified in paragraph (d)(3)(iii)
maintained in safe operating condition;
of this section, a CAH must submit
documentation to the State survey (2) There is proper routine storage
agency demonstrating that it has been and prompt disposal of trash;
unable, due to the shortage of such per- (3) Drugs and biologicals are appro-
sonnel in the area, to provide adequate priately stored;
coverage as specified in this paragraph (4) The premises are clean and or-
(d). derly; and
(4) The request, as specified in para- (5) There is proper ventilation, light-
graph (d)(3)(iii) of this section, and the ing, and temperature control in all
withdrawal of the request, may be sub- pharmaceutical, patient care, and food
mitted to us at any time, and are effec- preparation areas.
tive upon submission. (c) Standard: Life safety from fire. (1)
(e) Standard: Coordination with emer- Except as otherwise provided in this
gency response systems. The CAH must, section—
in coordination with emergency re- (i) The CAH must meet the applicable
sponse systems in the area, establish provisions and must proceed in accord-
procedures under which a doctor of ance with the Life Safety Code (NFPA
medicine or osteopathy is immediately 101 and Tentative Interim Amendments
available by telephone or radio contact TIA 12–1, TIA 12–2, TIA 12–3, and TIA
on a 24-hours a day basis to receive 12–4.)
emergency calls, provide information (ii) Notwithstanding paragraph
on treatment of emergency patients, (d)(1)(i) of this section, corridor doors
and refer patients to the CAH or other and doors to rooms containing flam-
appropriate locations for treatment. mable or combustible materials must
be provided with positive latching
FR 46037, Aug. 29, 1997; 64 FR 41544, July 30, hardware. Roller latches are prohibited
1999; 67 FR 80041, Dec. 31, 2002; 69 FR 49271, on such doors.
Aug. 11, 2004; 71 FR 68230, Nov. 24, 2006] (2) In consideration of a rec-
ommendation by the State survey
§ 485.620 Condition of participation: agency or Accrediting Organization or
Number of beds and length of stay. at the discretion of the Secretary, may
(a) Standard: Number of beds. Except waive, for periods deemed appropriate,
as permitted for CAHs having distinct specific provisions of the Life Safety
part units under § 485.647, the CAH Code, which would result in unreason-
maintains no more than 25 inpatient able hardship upon a CAH, but only if
244
the waiver will not adversely affect the only if the waiver does not adversely
health and safety of the patients. affect the health and safety of patients.
(3) After consideration of State sur- (e) The standards incorporated by
vey agency findings, CMS may waive reference in this section are approved
specific provisions of the Life Safety for incorporation by reference by the
Code that, if rigidly applied, would re- Director of the Office of the Federal
sult in unreasonable hardship on the Register in accordance with 5 U.S.C.
CAH, but only if the waiver does not 552(a) and 1 CFR part 51. You may in-
adversely affect the health and safety spect a copy at the CMS Information
of patients. Resource Center, 7500 Security Boule-
(4) The CAH maintains written evi-
vard, Baltimore, MD or at the National
dence of regular inspection and ap-
Archives and Records Administration
proval by State or local fire control
agencies. (NARA). For information on the avail-
(5) A CAH may install alcohol-based ability of this material at NARA, call
hand rub dispensers in its facility if the 202–741–6030, or go to: http://
dispensers are installed in a manner www.archives.gov/federal_register/
that adequately protects against inap- code_of_federal_regulations/
propriate access. ibr_locations.html. If any changes in this
(6) When a sprinkler system is shut edition of the Code are incorporated by
down for more than 10 hours, the CAH reference, CMS will publish a docu-
must: ment in the FEDERAL REGISTER to an-
(i) Evacuate the building or portion nounce the changes.
of the building affected by the system (1) National Fire Protection Associa-
outage until the system is back in tion, 1 Batterymarch Park, Quincy,
service, or MA 02169, www.nfpa.org, 1.617.770.3000.
(ii) Establish a fire watch until the (i) NFPA 99, Standards for Health
system is back in service. Care Facilities Code of the National
(7) Buildings must have an outside Fire Protection Association 99, 2012
window or outside door in every sleep- edition, issued August 11, 2011.
ing room, and for any building con-
(ii) TIA 12–2 to NFPA 99, issued Au-
structed after July 5, 2016 the sill
gust 11, 2011.
height must not exceed 36 inches above
the floor. Windows in atrium walls are (iii) TIA 12–3 to NFPA 99, issued Au-
considered outside windows for the pur- gust 9, 2012.
poses of this requirement. (iv) TIA 12–4 to NFPA 99, issued
(i) The sill height requirement does March 7, 2013.
not apply to newborn nurseries and (v) TIA 12–5 to NFPA 99, issued Au-
rooms intended for occupancy for less gust 1, 2013.
than 24 hours. (vi) TIA 12–6 to NFPA 99, issued
(ii) Special nursing care areas of new March 3, 2014.
occupancies shall not exceed 60 inches. (vii) NFPA 101, Life Safety Code, 2012
(d) Standard: Building safety. Except edition, issued August 11, 2011;
as otherwise provided in this section, (viii) TIA 12–1 to NFPA 101, issued
the CAH must meet the applicable pro- August 11, 2011.
visions and must proceed in accordance (ix) TIA 12–2 to NFPA 101, issued Oc-
with the Health Care Facilities Code tober 30, 2012.
(NFPA 99 and Tentative Interim
(x) TIA 12–3 to NFPA 101, issued Oc-
Amendments TIA 12–2, TIA 12–3, TIA
12–4, TIA 12–5 and TIA 12–6). tober 22, 2013.
(1) Chapters 7, 8, 12, and 13 of the (xi) TIA 12–4 to NFPA 101, issued Oc-
adopted Health Care Facilities Code do tober 22, 2013.
not apply to a CAH. (2) [Reserved]
(2) If application of the Health Care [58 FR 30671, May 26, 1993, as amended at 62
Facilities Code required under para- FR 46036, 46037, Aug. 29, 1997; 68 FR 1387, Jan.
graph (e) of this section would result in 10, 2003; 69 FR 49271, Aug. 11, 2004; 70 FR 15239,
unreasonable hardship for the CAH, Mar. 25, 2005; 71 FR 55341, Sept. 22, 2006; 77 FR
CMS may waive specific provisions of 29076, May 16, 2012; 81 FR 26901, May 4, 2016;
the Health Care Facilities Code, but 81 FR 64036, Sept. 16, 2016]
245
§ 485.625 42 CFR Ch. IV (10–1–24 Edition)
§ 485.625 Condition of participation: (B) Emergency lighting;

Emergency preparedness. (C) Fire detection, extinguishing, and
The CAH must comply with all appli- alarm systems; and
cable Federal, State, and local emer- (D) Sewage and waste disposal.
gency preparedness requirements. The (2) A system to track the location of
CAH must develop and maintain a com- on-duty staff and sheltered patients in
prehensive emergency preparedness the CAH’s care during an emergency. If
program, utilizing an all-hazards ap- on-duty staff and sheltered patients are
proach. The emergency preparedness relocated during the emergency, the
plan must include, but not be limited CAH must document the specific name
to, the following elements: and location of the receiving facility or
(a) Emergency plan. The CAH must de- other location.
velop and maintain an emergency pre- (3) Safe evacuation from the CAH,
paredness plan that must be reviewed which includes consideration of care
and updated at least every 2 years. The and treatment needs of evacuees; staff
plan must do all of the following: responsibilities; transportation; identi-
(1) Be based on and include a docu- fication of evacuation location(s); and
mented, facility-based and community- primary and alternate means of com-
based risk assessment, utilizing an all- munication with external sources of as-
hazards approach. sistance.
(2) Include strategies for addressing (4) A means to shelter in place for pa-
emergency events identified by the tients, staff, and volunteers who re-
risk assessment. main in the facility.
(3) Address patient population, in- (5) A system of medical documenta-
cluding, but not limited to, persons at- tion that preserves patient informa-
risk; the type of services the CAH has tion, protects confidentiality of patient
the ability to provide in an emergency; information, and secures and main-
and continuity of operations, including tains the availability of records.
delegations of authority and succession
(6) The use of volunteers in an emer-
plans.
gency or other emergency staffing
(4) Include a process for cooperation
strategies, including the process and
and collaboration with local, tribal, re-
role for integration of State or Feder-
gional, State, and Federal emergency
ally designated health care profes-
sionals to address surge needs during
tain an integrated response during a
an emergency.
disaster or emergency situation.
(b) Policies and procedures. The CAH (7) The development of arrangements
must develop and implement emer- with other CAHs or other providers to
gency preparedness policies and proce- receive patients in the event of limita-
dures, based on the emergency plan set tions or cessation of operations to
forth in paragraph (a) of this section, maintain the continuity of services to
risk assessment at paragraph (a)(1) of CAH patients.
this section, and the communication (8) The role of the CAH under a waiv-
plan at paragraph (c) of this section. er declared by the Secretary, in accord-
The policies and procedures must be re- ance with section 1135 of the Act, in
viewed and updated at least every 2 the provision of care and treatment at
years. At a minimum, the policies and an alternate care site identified by
procedures must address the following: emergency management officials.
(1) The provision of subsistence needs (c) Communication plan. The CAH
for staff and patients, whether they must develop and maintain an emer-
evacuate or shelter in place, include, gency preparedness communication
but are not limited to— plan that complies with Federal, State,
(i) Food, water, medical, and pharma- and local laws and must be reviewed
ceutical supplies; and updated at least every 2 years. The
(ii) Alternate sources of energy to communication plan must include all
maintain: of the following:
(A) Temperatures to protect patient (1) Names and contact information
health and safety and for the safe and for the following:
sanitary storage of provisions; (i) Staff.
246
(ii) Entities providing services under ing staff, individuals providing services
arrangement. under arrangement, and volunteers,
(iii) Patients’ physicians. consistent with their expected roles.
(iv) Other CAHs and hospitals. (ii) Provide emergency preparedness
(v) Volunteers. training at least every 2 years.
(2) Contact information for the fol- (iii) Maintain documentation of the
lowing: training.
(i) Federal, State, tribal, regional, (iv) Demonstrate staff knowledge of
and local emergency preparedness emergency procedures.
staff.
(v) If the emergency preparedness
(ii) Other sources of assistance.
(3) Primary and alternate means for
cantly updated, the CAH must conduct
communicating with the following:
training on the updated policies and
(i) CAH’s staff.
procedures.
(ii) Federal, State, tribal, regional,
and local emergency management (2) Testing. The CAH must conduct
agencies. exercises to test the emergency plan at
(4) A method for sharing information least twice per year. The CAH must do
and medical documentation for pa- the following:
tients under the CAH’s care, as nec- (i) Participate in an annual full-scale
essary, with other health care pro- exercise that is community-based; or
viders to maintain the continuity of (A) When a community-based exer-
care. cise is not accessible, conduct an an-
(5) A means, in the event of an evacu- nual individual, facility-based func-
ation, to release patient information as tional exercise; or.
permitted under 45 CFR 164.510(b)(1)(ii). (B) If the CAH experiences an actual
(6) A means of providing information natural or man-made emergency that
about the general condition and loca- requires activation of the emergency
tion of patients under the facility’s plan, the CAH is exempt from engaging
care as permitted under 45 CFR in its next required full-scale commu-
164.510(b)(4). nity-based or individual, facility-based
(7) A means of providing information functional exercise following the onset
about the CAH’s occupancy, needs, and of the emergency event.
its ability to provide assistance, to the (ii) Conduct an annual additional ex-
authority having jurisdiction or the In- ercise, that may include, but is not
cident Command Center, or designee. limited to the following:
(d) Training and testing. The CAH (A) A second full-scale exercise that
is community-based or an individual,
gency preparedness training and test-
facility-based functional exercise; or
ing program that is based on the emer-
gency plan set forth in paragraph (a) of (B) A mock disaster drill; or
this section, risk assessment at para- (C) A tabletop exercise or workshop
graph (a)(1) of this section, policies and that is led by a facilitator and includes
procedures at paragraph (b) of this sec- a group discussion, using a narrated,
tion, and the communication plan at clinically-relevant emergency scenario,
paragraph (c) of this section. The train- and a set of problem statements, di-
ing and testing program must be re- rected messages, or prepared questions
viewed and updated at least every 2 designed to challenge an emergency
years. plan.
(1) Training program. The CAH must (iii) Analyze the CAH’s response to
do all of the following: and maintain documentation of all
(i) Initial training in emergency pre- drills, tabletop exercises, and emer-
paredness policies and procedures, in- gency events, and revise the CAH’s
cluding prompt reporting and extin- emergency plan, as needed.
guishing of fires, protection, and where (e) Emergency and standby power sys-
necessary, evacuation of patients, per- tems. The CAH must implement emer-
sonnel, and guests, fire prevention, and gency and standby power systems
cooperation with firefighting and dis- based on the emergency plan set forth
aster authorities, to all new and exist- in paragraph (a) of this section.
247
§ 485.625 42 CFR Ch. IV (10–1–24 Edition)
(1) Emergency generator location. The (i) A documented community–based

generator must be located in accord- risk assessment, utilizing an all-haz-
ance with the location requirements ards approach.
found in the Health Care Facilities (ii) A documented individual facility-
Code (NFPA 99 and Tentative Interim based risk assessment for each sepa-
Amendments TIA 12–2, TIA 12–3, TIA rately certified facility within the
12–4, TIA 12–5, and TIA 12–6), Life Safe- health system, utilizing an all-hazards
ty Code (NFPA 101 and Tentative In- approach.
terim Amendments TIA 12–1, TIA 12–2, (5) Include integrated policies and
TIA 12–3, and TIA 12–4), and NFPA 110, procedures that meet the requirements
when a new structure is built or when set forth in paragraph (b) of this sec-
an existing structure or building is ren- tion, a coordinated communication
ovated. plan and training and testing programs
(2) Emergency generator inspection and that meet the requirements of para-
testing. The CAH must implement graphs (c) and (d) of this section, re-
emergency power system inspection spectively.
and testing requirements found in the (g) The standards incorporated by
Health Care Facilities Code, NFPA 110, reference in this section are approved
and the Life Safety Code. for incorporation by reference by the
(3) Emergency generator fuel. CAHs Director of the Office of the Federal
that maintain an onsite fuel source to Register in accordance with 5 U.S.C.
power emergency generators must have 552(a) and 1 CFR part 51. You may ob-
a plan for how it will keep emergency tain the material from the sources list-
power systems operational during the ed below. You may inspect a copy at
emergency, unless it evacuates. the CMS Information Resource Center,
(f) Integrated healthcare systems. If a 7500 Security Boulevard, Baltimore,
CAH is part of a healthcare system MD or at the National Archives and
consisting of multiple separately cer- Records Administration (NARA). For
tified healthcare facilities that elects information on the availability of this
to have a unified and integrated emer- material at NARA, call 202–741–6030, or
gency preparedness program, the CAH go to: http://www.archives.gov/fed-
may choose to participate in the eral_register/code_of_federal_regulations/
healthcare system’s coordinated emer- ibr_locations.html. If any changes in this
gency preparedness program. If elected, edition of the Code are incorporated by
the unified and integrated emergency reference, CMS will publish a docu-
preparedness program must do all of ment in the FEDERAL REGISTER to an-
the following: nounce the changes.
(1) Demonstrate that each separately (1) National Fire Protection Associa-
certified facility within the system action, 1 Batterymarch Park, Quincy,
tively participated in the development MA 02169, www.nfpa.org, 1.617.770.3000.
of the unified and integrated emer- (i) NFPA 99, Health Care Facilities
gency preparedness program. Code, 2012 edition, issued August 11,
(2) Be developed and maintained in a 2011.
manner that takes into account each (ii) Technical interim amendment
separately certified facility’s unique (TIA) 12–2 to NFPA 99, issued August
circumstances, patient populations, 11, 2011.
and services offered. (iii) TIA 12–3 to NFPA 99, issued Au-
(3) Demonstrate that each separately gust 9, 2012.
certified facility is capable of actively (iv) TIA 12–4 to NFPA 99, issued
using the unified and integrated emer- March 7, 2013.
gency preparedness program and is in (v) TIA 12–5 to NFPA 99, issued Au-
compliance with the program. gust 1, 2013.
(4) Include a unified and integrated (vi) TIA 12–6 to NFPA 99, issued
emergency plan that meets the require- March 3, 2014.
ments of paragraphs (a)(2), (3), and (4) (vii) NFPA 101, Life Safety Code, 2012
of this section. The unified and inte- edition, issued August 11, 2011.
grated emergency plan must also be (viii) TIA 12–1 to NFPA 101, issued
based on and include— August 11, 2011.
248
(ix) TIA 12–2 to NFPA 101, issued Oc- on duty whenever the CAH has one or
tober 30, 2012. more inpatients.
(x) TIA 12–3 to NFPA 101, issued Oc- (b) Standard: Responsibilities of the
tober 22, 2013. doctor of medicine or osteopathy. (1) The
(xi) TIA 12–4 to NFPA 101, issued Oc- doctor of medicine or osteopathy—
tober 22, 2013. (i) Provides medical direction for the
(xii) NFPA 110, Standard for Emer- CAH’s health care activities and con-
gency and Standby Power Systems, sultation for, and medical supervision
2010 edition, including TIAs to chapter of, the health care staff;
7, issued August 6, 2009. (ii) In conjunction with the physician
(2) [Reserved] assistant and/or nurse practitioner
member(s), participates in developing,
[81 FR 64036, Sept. 16, 2016; 81 FR 80594, Nov. executing, and periodically reviewing
16, 2016, as amended at 84 FR 51826, Sept. 30,
2019]
the CAH’s written policies governing
the services it furnishes.
§ 485.627 Condition of participation: (iii) In conjunction with the physi-
Organizational structure. cian assistant and/or nurse practitioner
members, periodically reviews the
(a) Standard: Governing body or re-
CAH’s patient records, provides med-
sponsible individual. The CAH has a gov-
ical orders, and provides medical care
erning body or an individual that as-
services to the patients of the CAH;
sumes full legal responsibility for de-
and
termining, implementing and moni-
(iv) Periodically reviews and signs
toring policies governing the CAH’s
the records of all inpatients cared for
total operation and for ensuring that
by nurse practitioners, clinical nurse
those policies are administered so as to
specialists, certified nurse midwives, or
provide quality health care in a safe
physician assistants.
environment.
(v) Periodically reviews and signs a
(b) Standard: Disclosure. The CAH dis-
sample of outpatient records of pa-
closes the names and addresses of—
tients cared for by nurse practitioners,
(1) The person principally responsible
clinical nurse specialists, certified
for the operation of the CAH; and
nurse midwives, or physician assistants
(2) The person responsible for med- only to the extent required under State
ical direction. law where State law requires record re-
[58 FR 30671, May 26, 1993, as amended at 62 views or co-signatures, or both, by a
FR 46037, Aug. 29, 1997; 84 FR 51827, Sept. 30, collaborating physician.
2019] (2) A doctor of medicine or osteop-
athy is present for sufficient periods of
§ 485.631 Condition of participation: time to provide medical direction, con-
Staffing and staff responsibilities.
sultation, and supervision for the serv-
(a) Standard: Staffing—(1) The CAH ices provided in the CAH, and is avail-
has a professional health care staff able through direct radio or telephone
that includes one or more doctors of communication or electronic commu-
medicine or osteopathy, and may in- nication for consultation, assistance
clude one or more physician assistants, with medical emergencies, or patient
nurse practitioners, or clinical nurse referral.
specialists. (c) Standard: Physician assistant, nurse
(2) Any ancillary personnel are super- practitioner, and clinical nurse specialist
vised by the professional staff. responsibilities. (1) The physician assist-
(3) The staff is sufficient to provide ant, the nurse practitioner, or clinical
the services essential to the operation nurse specialist members of the CAH’s
of the CAH. staff—
(4) A doctor of medicine or osteop- (i) Participate in the development,
athy, nurse practitioner, clinical nurse execution and periodic review of the
specialist, or physician assistant is written policies governing the services
available to furnish patient care serv- the CAH furnishes; and
ices at all times the CAH operates. (ii) Participate with a doctor of med-
(5) A registered nurse, clinical nurse icine or osteopathy in a periodic review
specialist, or licensed practical nurse is of the patients’ health records.
249
§ 485.631 42 CFR Ch. IV (10–1–24 Edition)
(2) The physician assistant, nurse necessary changes as specified in para-

practitioner, or clinical nurse spe- graphs (b) through (d) of this section.
cialist performs the following func- (e) Standard: Unified and integrated
tions to the extent they are not being medical staff for a CAH in a multi-facility
performed by a doctor of medicine or system. If a CAH is part of a system
osteopathy: consisting of multiple separately cer-
(i) Provides services in accordance tified hospitals, CAHs, and/or REHs,
with the CAH’s policies. and the system elects to have a unified
(ii) Arranges for, or refers patients and integrated medical staff for its
to, needed services that cannot be fur- member hospitals, CAHs, and/or REHs
nished at the CAH, and assures that after determining that such a decision
adequate patient health records are is in accordance with all applicable
maintained and transferred as required
state and local laws, each separately
when patients are referred.
certified CAH must demonstrate that:
(3) Whenever a patient is admitted to
the CAH by a nurse practitioner, physi- (1) The medical staff members of
cian assistant, or clinical nurse spe- each separately certified CAH in the
cialist, a doctor of medicine or osteop- system (that is, all medical staff mem-
athy on the staff of the CAH is notified bers who hold specific privileges to
of the admission. practice at that CAH) have voted by
(d) Standard: Periodic review of clinical majority, in accordance with medical
privileges and performance. The CAH re- staff bylaws, either to accept a unified
quires that— and integrated medical staff structure
(1) The quality and appropriateness or to opt out of such a structure and to
of the diagnosis and treatment fur- maintain a separate and distinct med-
nished by nurse practitioners, clinical ical staff for their respective CAH;
nurse specialist, and physician assist- (2) The unified and integrated med-
ants at the CAH are evaluated by a ical staff has bylaws, rules, and re-
member of the CAH staff who is a doc- quirements that describe its processes
tor of medicine or osteopathy or by an- for self-governance, appointment,
other doctor of medicine or osteopathy credentialing, privileging, and over-
under contract with the CAH. sight, as well as its peer review policies
(2) The quality and appropriateness and due process rights guarantees, and
of the diagnosis and treatment fur- which include a process for the mem-
nished by doctors of medicine or oste- bers of the medical staff of each sepa-
opathy at the CAH are evaluated by— rately certified CAH (that is, all med-
(i) One hospital that is a member of ical staff members who hold specific
the network, when applicable; privileges to practice at that CAH) to
(ii) One Quality Improvement Orga- be advised of their rights to opt out of
nization (QIO) or equivalent entity; the unified and integrated medical
(iii) One other appropriate and quali-
staff structure after a majority vote by
fied entity identified in the State rural
the members to maintain a separate
health care plan;
and distinct medical staff for their
(iv) In the case of distant-site physi-
cians and practitioners providing tele- CAH;
medicine services to the CAH’s patient (3) The unified and integrated med-
under an agreement between the CAH ical staff is established in a manner
and a distant-site hospital, the distant- that takes into account each member
site hospital; or CAH’s unique circumstances and any
(v) In the case of distant-site physi- significant differences in patient popu-
cians and practitioners providing tele- lations and services offered in each
medicine services to the CAH’s pa- hospital, CAH, and REH; and
tients under a written agreement be- (4) The unified and integrated med-
tween the CAH and a distant-site tele- ical staff establishes and implements
medicine entity, one of the entities policies and procedures to ensure that
listed in paragraphs (d)(2)(i) through the needs and concerns expressed by
(iii) of this section. members of the medical staff, at each
(3) The CAH staff consider the find- of its separately certified hospitals,
ings of the evaluation and make the CAHs, and REHs, regardless of practice
250
or location, are given due consider- practices. All patient diets, including
ation, and that the unified and inte- therapeutic diets, must be ordered by
grated medical staff has mechanisms in the practitioner responsible for the
place to ensure that issues localized to care of the patients or by a qualified
particular hospitals, CAHs, and REHs dietitian or qualified nutrition profes-
are duly considered and addressed. sional as authorized by the medical
staff in accordance with State law gov-
FR 46037, Aug. 29, 1997; 70 FR 68728, Nov. 10, erning dietitians and nutrition profes-
2005; 79 FR 27155, May 12, 2014; 84 FR 51827, sionals and that the requirement of
Sept. 30, 2019; 87 FR 72308, Nov. 23, 2022] § 483.25(i) of this chapter is met with re-
spect to inpatients receiving post CAH
§ 485.635 Condition of participation: SNF care.
Provision of services. (vii) [Reserved]
(a) Standard: Patient care policies. (1) (viii) Policies and procedures that ad-
The CAH’s health care services are fur- dress the post-acute care needs of pa-
nished in accordance with appropriate tients receiving CAH services.
written policies that are consistent (4) These policies are reviewed at
with applicable State law. least biennially by the group of profes-
(2) The policies are developed with sional personnel required under para-
the advice of members of the CAH’s graph (a)(2) of this section and updated
professional healthcare staff, including as necessary by the CAH.
one or more doctors of medicine or os- (b) Standard: Patient services—(1) Gen-
teopathy and one or more physician as- eral: (i) The CAH provides those diag-
sistants, nurse practitioners, or clin- nostic and therapeutic services and
ical nurse specialists, if they are on supplies that are commonly furnished
staff under the provisions of in a physician’s office or at another
§ 485.631(a)(1). entry point into the health care deliv-
(3) The policies include the following: ery system, such as a low intensity
(i) A description of the services the hospital outpatient department or
CAH furnishes, including those fur- emergency department. These CAH
nished through agreement or arrange- services include medical history, phys-
ment. ical examination, specimen collection,
(ii) Policies and procedures for emer- assessment of health status, and treat-
gency medical services. ment for a variety of medical condi-
(iii) Guidelines for the medical man- tions.
agement of health problems that in- (ii) The CAH furnishes acute care in-
clude the conditions requiring medical patient services.
consultation and/or patient referral, (2) Laboratory services. The CAH pro-
the maintenance of health care vides basic laboratory services essen-
records, and procedures for the periodic tial to the immediate diagnosis and
review and evaluation of the services treatment of the patient that meet the
furnished by the CAH. standards imposed under section 353 of
(iv) Rules for the storage, handling, the Public Health Service Act (42
dispensation, and administration of U.S.C. 263a). (See the laboratory re-
drugs and biologicals. These rules must quirements specified in part 493 of this
provide that there is a drug storage chapter.) The services provided include
area that is administered in accordance the following:
with accepted professional principles, (i) Chemical examination of urine by
that current and accurate records are stick or tablet method or both (includ-
kept of the receipt and disposition of ing urine ketones).
all scheduled drugs, and that outdated, (ii) Hemoglobin or hematocrit.
mislabeled, or otherwise unusable (iii) Blood glucose.
drugs are not available for patient use. (iv) Examination of stool specimens
(v) Procedures for reporting adverse for occult blood.
drug reactions and errors in the admin- (v) Pregnancy tests.
istration of drugs. (vi) Primary culturing for trans-
(vi) Procedures that ensure that the mittal to a certified laboratory.
nutritional needs of inpatients are met (3) Radiology services. Radiology serv-
in accordance with recognized dietary ices furnished by the CAH are provided
251
§ 485.638 42 CFR Ch. IV (10–1–24 Edition)
by personnel qualified under State law, (d) Standard: Nursing services. Nursing
and do not expose CAH patients or per- services must meet the needs of pa-
sonnel to radiation hazards. tients.
(4) Emergency procedures. In accord- (1) A registered nurse must provide
ance with requirements of § 485.618, the (or assign to other personnel) the nurs-
CAH provides medical services as a ing care of each patient, including pa-
first response to common life-threat- tients at a SNF level of care in a
ening injuries and acute illness. swing-bed CAH. The care must be pro-
(c) Standard: Services provided through vided in accordance with the patient’s
needs and the specialized qualifications
agreements or arrangements. (1) The CAH
and competence of the staff available.
has agreements or arrangements (as
(2) A registered nurse or, where per-
appropriate) with one or more pro- mitted by State law, a physician as-
viders or suppliers participating under sistant, must supervise and evaluate
Medicare to furnish other services to the nursing care for each patient, in-
its patients, including— cluding patients at a SNF level of care
(i) Services of doctors of medicine or in a swing-bed CAH.
osteopathy; (3) All drugs, biologicals, and intra-
(ii) Additional or specialized diag- venous medications must be adminis-
nostic and clinical laboratory services tered by or under the supervision of a
that are not available at the CAH; and registered nurse, a doctor of medicine
(iii) Food and other services to meet or osteopathy, or, where permitted by
inpatients’ nutritional needs to the ex- State law, a physician assistant, in ac-
tent these services are not provided di- cordance with written and signed or-
rectly by the CAH. ders, accepted standards of practice,
(2) If the agreements or arrange- and Federal and State laws.
ments are not in writing, the CAH is (4) A nursing care plan must be devel-
able to present evidence that patients oped and kept current for each inpa-
referred by the CAH are being accepted tient.
and treated. (e) Standard: Rehabilitation Therapy
Services. Physical therapy, occupa-
(3) The CAH maintains a list of all
tional therapy, and speech-language
services furnished under arrangements
pathology services furnished at the
or agreements. The list describes the
CAH, if provided, are provided by staff
nature and scope of the services pro-
qualified under State law, and con-
vided. sistent with the requirements for ther-
(4) The person principally responsible apy services in § 409.17 of this subpart.
for the operation of the CAH under
§ 485.627(b)(2) of this chapter is also re- [58 FR 30671, May 26, 1993; 58 FR 49935, Sept.
24, 1993, as amended at 59 FR 45403, Sept. 1,
sponsible for the following:
1994; 62 FR 46037, Aug. 29, 1997; 72 FR 66408,
(i) Services furnished in the CAH Nov. 27, 2007; 73 FR 69941, Nov. 19, 2008; 75 FR
whether or not they are furnished 70844, Nov. 19, 2010; 76 FR 25564, May 5, 2011;
under arrangements or agreements. 77 FR 29076, May 16, 2012; 78 FR 50970, Aug. 19,
(ii) Ensuring that a contractor of 2013; 79 FR 27156, May 12, 2014; 81 FR 68871,
services (including one for shared serv- Oct. 4, 2016; 82 FR 32260, July 13, 2017; 84 FR
51827, 51883, Sept. 30, 2019; 87 FR 72309, Nov.
ices and joint ventures) furnishes serv-
23, 2022]
ices that enable the CAH to comply
with all applicable conditions of par- § 485.638 Conditions of participation:
ticipation and standards for the con- Clinical records.
tracted services. (a) Standard: Records system—(1) The
(5) In the case of distant-site physi- CAH maintains a clinical records sys-
cians and practitioners providing tele- tem in accordance with written poli-
medicine services to the CAH’s pa- cies and procedures.
tients under a written agreement be- (2) The records are legible, complete,
tween the CAH and a distant-site tele- accurately documented, readily acces-
medicine entity, the distant-site tele- sible, and systematically organized.
medicine entity is not required to be a (3) A designated member of the pro-
Medicare-participating provider or sup- fessional staff is responsible for main-
plier. taining the records and for ensuring
252
that they are completely and accu- cable to the CAH’s exchange of patient
rately documented, readily accessible, health information.
and systematically organized. (2) The system sends notifications
(4) For each patient receiving health that must include at least patient
care services, the CAH maintains a name, treating practitioner name, and
record that includes, as applicable— sending institution name.
(i) Identification and social data, evi- (3) To the extent permissible under
dence of properly executed informed applicable federal and state law and
consent forms, pertinent medical his- regulations, and not inconsistent with
tory, assessment of the health status
the patient’s expressed privacy pref-
and health care needs of the patient,
erences, the system sends notifications
and a brief summary of the episode,
disposition, and instructions to the pa- directly, or through an intermediary
tient; that facilitates exchange of health in-
(ii) Reports of physical examinations, formation, at the time of:
diagnostic and laboratory test results, (i) The patient’s registration in the
including clinical laboratory services, CAH’s emergency department (if appli-
and consultative findings; cable).
(iii) All orders of doctors of medicine (ii) The patient’s admission to the
or osteopathy or other practitioners, CAH’s inpatient services (if applicable).
reports of treatments and medications, (4) To the extent permissible under
nursing notes and documentation of applicable federal and state law and
complications, and other pertinent in- regulations, and not inconsistent with
formation necessary to monitor the pa- the patient’s expressed privacy pref-
tient’s progress, such as temperature erences, the system sends notifications
graphics, progress notes describing the directly, or through an intermediary
patient’s response to treatment; and that facilitates exchange of health in-
(iv) Dated signatures of the doctor of formation, either immediately prior to,
medicine or osteopathy or other health or at the time of:
care professional.
(i) The patient’s discharge or transfer
(b) Standard: Protection of record infor-
mation. (1) The CAH maintains the con- from the CAH’s emergency department
fidentiality of record information and (if applicable).
provides safeguards against loss, de- (ii) The patient’s discharge or trans-
struction, or unauthorized use. fer from the CAH’s inpatient services
(2) Written policies and procedures (if applicable).
govern the use and removal of records (5) The CAH has made a reasonable
from the CAH and the conditions for effort to ensure that the system sends
the release of information. the notifications to all applicable post-
(3) The patient’s written consent is acute care services providers and sup-
required for release of information not pliers, as well as to any of the fol-
required by law. lowing practitioners and entities,
(c) Standard: Retention of records. The which need to receive notification of
records are retained for at least 6 years the patient’s status for treatment, care
from date of last entry, and longer if coordination, or quality improvement
required by State statute, or if the purposes:
records may be needed in any pending (i) The patient’s established primary
proceeding. care practitioner;
(d) Standard: Electronic notifications. If (ii) The patient’s established primary
the CAH utilizes an electronic medical care practice group or entity; or
records system or other electronic ad-
(iii) Other practitioner, or other
ministrative system, which is
practice group or entity, identified by
conformant with the content exchange
standard at 45 CFR 170.205(d)(2), then the patient as the practitioner, or prac-
the CAH must demonstrate that— tice group or entity, primarily respon-
(1) The system’s notification capac- sible for his or her care.
ity is fully operational and the CAH [58 FR 30671, May 26, 1993, as amended at 62
uses it in accordance with all State and FR 46037, Aug. 29, 1997; 85 FR 25638, May 1,
Federal statutes and regulations appli- 2020]
253
§ 485.639 42 CFR Ch. IV (10–1–24 Edition)
§ 485.639 Condition of participation: (v) A certified registered nurse anes-

Surgical services. thetist (CRNA), as defined in § 410.69(b)
If a CAH provides surgical services, of this chapter;
surgical procedures must be performed (vi) An anesthesiologist’s assistant,
in a safe manner by qualified practi- as defined in § 410.69(b) of this chapter;
tioners who have been granted clinical or
privileges by the governing body, or re- (vii) A supervised trainee in an ap-
sponsible individual, of the CAH in ac- proved educational program, as de-
cordance with the designation require- scribed in § 413.85 or §§ 413.76 through
ments under paragraph (a) of this sec- 413.83 of this chapter.
tion. (2) In those cases in which a CRNA
(a) Designation of qualified practi- administers the anesthesia, the anes-
tioners. The CAH designates the practi- thetist must be under the supervision
tioners who are allowed to perform sur- of the operating practitioner except as
gery for CAH patients, in accordance provided in paragraph (e) of this sec-
with its approved policies and proce- tion. An anesthesiologist’s assistant
dures, and with State scope of practice who administers anesthesia must be
laws. Surgery is performed only by— under the supervision of an anesthe-
(1) A doctor of medicine or osteop- siologist.
athy, including an osteopathic practi- (d) Discharge. All patients are dis-
tioner recognized under section charged in the company of a respon-
1101(a)(7) of the Act; sible adult, except those exempted by
(2) A doctor of dental surgery or den- the practitioner who performed the
tal medicine; or surgical procedure.
(3) A doctor of podiatric medicine. (e) Standard: State exemption. (1) A
(b) Anesthetic risk and evaluation. (1) CAH may be exempted from the re-
A qualified practitioner, as specified in quirement for physician supervision of
paragraph (a) of this section, must ex- CRNAs as described in paragraph (c)(2)
amine the patient immediately before of this section, if the State in which
surgery to evaluate the risk of the pro- the CAH is located submits a letter to
cedure to be performed. CMS signed by the Governor, following
(2) A qualified practitioner, as speci- consultation with the State’s Boards of
fied in paragraph (c) of this section, Medicine and Nursing, requesting ex-
must examine each patient before sur-
emption from physician supervision for
gery to evaluate the risk of anesthesia.
CRNAs. The letter from the Governor
(3) Before discharge from the CAH, must attest that he or she has con-
each patient must be evaluated for
sulted with the State Boards of Medi-
proper anesthesia recovery by a quali-
cine and Nursing about issues related
fied practitioner, as specified in para-
to access to and the quality of anes-
graph (c) of this section.
thesia services in the State and has
(c) Administration of anesthesia. The
concluded that it is in the best inter-
CAH designates the person who is al-
ests of the State’s citizens to opt-out of
lowed to administer anesthesia to CAH
patients in accordance with its ap- the current physician supervision re-
proved policies and procedures and quirement, and that the opt-out is con-
with State scope-of-practice laws. sistent with State law.
(1) Anesthesia must be administered (2) The request for exemption and
by only— recognition of State laws and the with-
(i) A qualified anesthesiologist; drawal of the request may be sub-
(ii) A doctor of medicine or osteop- mitted at any time, and are effective
athy other than an anesthesiologist; upon submission.
including an osteopathic practitioner [60 FR 45851, Sept. 1, 1995, as amended at 62
recognized under section 1101(a)(7) of FR 46037, Aug. 29, 1997; 66 FR 39938, Aug. 1,
the Act; 2001; 66 FR 56769, Nov. 13, 2001; 77 FR 29076,
(iii) A doctor of dental surgery or May 16, 2012; 85 FR 72910, Nov. 16, 2020]
dental medicine;
(iv) A doctor of podiatric medicine;
254
§ 485.640 Condition of participation: (b) Standard: Antibiotic stewardship

Infection prevention and control program organization and policies. The
and antibiotic stewardship pro- CAH must demonstrate that:
grams. (1) An individual (or individuals),
The CAH must have active facility- who is qualified through education,
wide programs, for the surveillance, training, or experience in infectious
prevention, and control of HAIs and diseases and/or antibiotic stewardship,
other infectious diseases and for the is appointed by the governing body, or
optimization of antibiotic use through responsible individual, as the leader(s)
stewardship. The programs must dem- of the antibiotic stewardship program
onstrate adherence to nationally recog- and that the appointment is based on
nized infection prevention and control the recommendations of medical staff
guidelines, as well as to best practices leadership and pharmacy leadership;
for improving antibiotic use where ap- (2) The facility-wide antibiotic stew-
plicable, and for reducing the develop- ardship program:
ment and transmission of HAIs and an- (i) Demonstrates coordination among
tibiotic-resistant organisms. Infection all components of the CAH responsible
prevention and control problems and for antibiotic use and resistance, in-
antibiotic use issues identified in the cluding, but not limited to, the infec-
programs must be addressed in coordi- tion prevention and control program,
nation with the facility-wide quality the QAPI program, the medical staff,
assessment and performance improve- nursing services, and pharmacy serv-
ment (QAPI) program. ices;
(ii) Documents the evidence-based
(a) Standard: Infection prevention and
use of antibiotics in all departments
control program organization and policies.
and services of the CAH; and
The CAH must demonstrate that:
(iii) Documents any improvements,
(1) An individual (or individuals), including sustained improvements, in
who is qualified through education, proper antibiotic use;
training, experience, or certification in (3) The antibiotic stewardship pro-
infection prevention and control, is ap- gram adheres to nationally recognized
pointed by the governing body, or re- guidelines, as well as best practices, for
sponsible individual, as the infection improving antibiotic use; and
preventionist(s)/infection control pro- (4) The antibiotic stewardship pro-
fessional(s) responsible for the infec- gram reflects the scope and complexity
tion prevention and control program of the CAH services provided.
and that the appointment is based on (c) Standard: Leadership responsibil-
the recommendations of medical staff ities. (1) The governing body, or respon-
leadership and nursing leadership; sible individual, must ensure all of the
(2) The infection prevention and con- following:
trol program, as documented in its (i) Systems are in place and oper-
policies and procedures, employs meth- ational for the tracking of all infection
ods for preventing and controlling the surveillance, prevention and control,
transmission of infections within the and antibiotic use activities, in order
CAH and between the CAH and other to demonstrate the implementation,
healthcare settings; success, and sustainability of such ac-
(3) The infection prevention and con- tivities.
trol includes surveillance, prevention, (ii) All HAIs and other infectious dis-
and control of HAIs, including main- eases identified by the infection pre-
taining a clean and sanitary environ- vention and control program as well as
ment to avoid sources and trans- antibiotic use issues identified by the
mission of infection, and that the pro- antibiotic stewardship program are ad-
gram also addresses any infection con- dressed in collaboration with the
trol issues identified by public health CAH’s QAPI leadership.
authorities; and (2) The infection prevention and con-
(4) The infection prevention and control professional(s) is responsible for:
trol program reflects the scope and (i) The development and implementa-
complexity of the CAH services pro- tion of facility-wide infection surveil-
vided. lance, prevention, and control policies
255
§ 485.640 42 CFR Ch. IV (10–1–24 Edition)
and procedures that adhere to nation- (i) The CAH’s current inventory sup-
ally recognized guidelines. plies of any COVID–19-related thera-
(ii) All documentation, written or peutics that have been distributed and
electronic, of the infection prevention delivered to the CAH under the author-
and control program and its surveil- ity and direction of the Secretary; and
lance, prevention, and control activi- (ii) The CAH’s current usage rate for
ties. any COVID–19-related therapeutics
(iii) Communication and collabora- that have been distributed and deliv-
tion with the CAH’s QAPI program on ered to the CAH under the authority
infection prevention and control issues. and direction of the Secretary.
(iv) Competency-based training and (2) Beginning at the conclusion of the
education of CAH personnel and staff, COVID–19 Public Health Emergency, as
including medical staff, and, as appli- defined in § 400.200 of this chapter, and
cable, personnel providing contracted continuing until April 30, 2024, except
services in the CAH, on the practical when the Secretary specifies an earlier
applications of infection prevention end date for the requirements of this
and control guidelines, policies and paragraph (d)(2), the CAH must elec-
procedures. tronically report information about
(v) The prevention and control of COVID–19 in a standardized format
HAIs, including auditing of adherence specified by the Secretary. To the ex-
to infection prevention and control tent as required by the Secretary, this
policies and procedures by CAH per- report must include the following data
sonnel. elements:
(i) Confirmed COVID–19 infections
(vi) Communication and collabora-
among patients.
tion with the antibiotic stewardship
(ii) Total deaths among patients.
program.
(iii) Personal protective equipment
(3) The leader(s) of the antibiotic and testing supplies.
stewardship program is responsible for: (iv) Ventilator use, capacity, and
(i) The development and implementa- supplies.
tion of a facility-wide antibiotic stew- (v) Total bed and intensive care unit
ardship program, based on nationally bed census and capacity.
recognized guidelines, to monitor and (vi) Staffing shortages.
improve the use of antibiotics. (vii) COVID–19 vaccine administra-
(ii) All documentation, written or tion data of patients and staff.
electronic, of antibiotic stewardship (viii) Relevant therapeutic inven-
program activities. tories or usage, or both.
(iii) Communication and collabora- (e) Standard: Reporting of acute res-
tion with medical staff, nursing, and piratory illness, including seasonal influ-
pharmacy leadership, as well as the enza virus, influenza-like illness, and se-
CAH’s infection prevention and control vere acute respiratory infection. (1) Dur-
and QAPI programs, on antibiotic use ing the Public Health Emergency, as
issues. defined in § 400.200 of this chapter, the
(iv) Competency-based training and CAH must report information, in ac-
education of CAH personnel and staff, cordance with a frequency as specified
including medical staff, and, as appli- by the Secretary, on Acute Respiratory
cable, personnel providing contracted Illness (including, but not limited to,
services in the CAHs, on the practical Seasonal Influenza Virus, Influenza-
applications of antibiotic stewardship like Illness, and Severe Acute Res-
guidelines, policies, and procedures. piratory Infection) in a standardized
(d) COVID–19 reporting. (1) During the format specified by the Secretary.
Public Health Emergency, as defined in (2) Beginning at the conclusion of the
§ 400.200 of this chapter, the CAH must COVID–19 Public Health Emergency, as
report information in accordance with defined in § 400.200 of this chapter, and
a frequency as specified by the Sec- continuing until April 30, 2024, except
retary on COVID–19 in a standardized when the Secretary specifies an earlier
format specified by the Secretary. This end date for the requirements of this
report must include, but not be limited paragraph (e)(2), the CAH must elec-
to, the following data elements: tronically report information about
256
Centers for Medicare & Medicaid Services, HHS § 485.640, Nt.
seasonal influenza in a standardized (4) A qualified individual (or individ-

format specified by the Secretary. To uals) with expertise in infection pre-
the extent as required by the Sec- vention and control and in antibiotic
retary, this report must include the stewardship has been designated at the
following data elements: CAH as responsible for communicating
(i) Confirmed influenza infections with the unified infection prevention
among patients. and control and antibiotic stewardship
(ii) Total deaths among patients. programs, for implementing and main-
(iii) Confirmed co-morbid influenza taining the policies and procedures
and COVID–19 infections among pa- governing infection prevention and
tients. control and antibiotic stewardship as
(f) [Reserved] directed by the unified infection pre-
vention and control and antibiotic
(g) Standard: Unified and integrated in-
stewardship programs, and for pro-
fection prevention and control and anti-
viding education and training on the
biotic stewardship programs for a CAH in
practical applications of infection pre-
a multi-facility system. If a CAH is part vention and control and antibiotic
of a system consisting of multiple sep- stewardship to CAH staff.
arately certified hospitals, CAHs, and/
or REHs using a system governing [84 FR 51827, Sept. 30, 2019, as amended at 85
body that is legally responsible for the FR 54873, Sept. 2, 2020; 85 FR 86304, Dec. 29,
conduct of two or more hospitals, 2020; 86 FR 61623, Nov. 5, 2021; 87 FR 49410,
Aug. 10, 2022; 87 FR 72309, Nov. 23, 2022; 88 FR
CAHs, and/or REHs, the system gov- 36510, June 5, 2023]
erning body can elect to have unified
and integrated infection prevention EDITORIAL NOTE: At 85 FR 86304, Dec. 29,
2020, this section was amended, effective Dec.
and control and antibiotic stewardship
4, 2020; however, due to a publication error,
programs for all of its member facili- the amendments were codified at 86 FR 33902,
ties after determining that such a deci- June 28, 2021.
sion is in accordance with all applica-
EFFECTIVE DATE NOTE: At 89 FR 69913, Aug.
ble state and local laws. The system 28, 2024, § 485.640 was amended by revising
governing body is responsible and ac- paragraph (d) and removing paragraph (e), ef-
countable for ensuring that each of its fective Nov. 1, 2024. For the convenience of
separately certified CAHs meets all of the user, the revised text is set forth as fol-
the requirements of this section. Each lows:
separately certified CAH subject to the
§ 485.640 Condition of participation: Infec-
system governing body must dem- tion prevention and control and anti-
onstrate that: biotic stewardship programs.
(1) The unified and integrated infec-
tion prevention and control and anti- * * * * *
biotic stewardship programs are estab-
(d) Respiratory illness reporting—(1) Ongoing
lished in a manner that takes into ac- reporting. The CAH must electronically re-
count each member CAH’s unique cir- port information on acute respiratory ill-
cumstances and any significant dif- nesses, including influenza, SARS–CoV–2/
ferences in patient populations and COVID–19, and RSV.
services offered in each CAH; (i) The report must be in a standardized
(2) The unified and integrated infec- format and frequency specified by the Sec-
tion prevention and control and anti- retary.
(ii) To the extent as required by the Sec-
biotic stewardship programs establish retary, the report must include the following
and implement policies and procedures data elements:
to ensure that the needs and concerns (A) Confirmed infections for a limited set
of each of its separately certified of respiratory illnesses, including but not
CAHs, regardless of practice or loca- limited to influenza, SARS–CoV–2/COVID–19,
tion, are given due consideration; and RSV, among newly admitted and hos-
(3) The unified and integrated infec- pitalized patients.
(B) Total bed census and capacity, includ-
ing for critical hospital units and age groups.
biotic stewardship programs have (C) Limited patient demographic informa-
mechanisms in place to ensure that tion, including but not limited to age.
issues localized to particular CAHs are (2) Public health emergency (PHE) reporting.
duly considered and addressed; and In the event that the Secretary has declared
257
§ 485.641 42 CFR Ch. IV (10–1–24 Edition)
a national, State, or local PHE for an acute (c) Standard: Governance and leader-
infectious illness, the CAH must also elec- ship. The CAH’s governing body or re-
tronically report the following data ele- sponsible individual is ultimately re-
ments in a standardized format and fre-
sponsible for the CAH’s QAPI program
quency specified by the Secretary:
(i) Supply inventory shortages.
and is responsible and accountable for
(ii) Staffing shortages. ensuring that the QAPI program meets
(iii) Relevant medical countermeasures the requirements of paragraph (b) of
and therapeutic inventories, usage, or both. this section.
(iv) Facility structure and operating sta- (d) Standard: Program activities. For
tus, including CAH/ED diversion status. each of the areas listed in paragraph
(b) of this section, the CAH must:
* * * * * (1) Focus on measures related to im-
proved health outcomes that are shown
§ 485.641 Condition of participation: to be predictive of desired patient out-
Quality assessment and perform- comes.
ance improvement program. (2) Use the measures to analyze and
The CAH must develop, implement, track its performance.
and maintain an effective, ongoing, (3) Set priorities for performance im-
CAH-wide, data-driven quality assess- provement, considering either high-
ment and performance improvement volume, high-risk services, or problem-
(QAPI) program. The CAH must main- prone areas.
tain and demonstrate evidence of the (e) Standard: Program data collection
effectiveness of its QAPI program. and analysis. The program must incor-
(a) Definitions. For the purposes of porate quality indicator data including
this section— patient care data, and other relevant
data, in order to achieve the goals of
Adverse event means an untoward, un-
the QAPI program.
desirable, and usually unanticipated
(f) Standard: Unified and integrated
event that causes death or serious in-
QAPI program for a CAH in a multi-facil-
jury or the risk thereof.
ity system. If a CAH is part of a system
Error means the failure of a planned consisting of multiple separately cer-
action to be completed as intended or tified hospitals, CAHs, and/or REHs
the use of a wrong plan to achieve an using a system governing body that is
aim. Errors can include problems in legally responsible for the conduct of
practice, products, procedures, and sys- two or more hospitals, CAHs, and/or
tems; and REHs, the system governing body can
Medical error means an error that oc- elect to have a unified and integrated
curs in the delivery of healthcare serv- QAPI program for all of its member fa-
ices. cilities after determining that such a
(b) Standard: QAPI Program Design decision is in accordance with all appli-
and scope. The CAH’s QAPI program cable state and local laws. The system
must: governing body is responsible and ac-
(1) Be appropriate for the complexity countable for ensuring that each of its
of the CAH’s organization and services separately certified CAHs meets all of
provided. the requirements of this section. Each
(2) Be ongoing and comprehensive. separately certified CAH subject to the
(3) Involve all departments of the system governing body must dem-
CAH and services (including those serv- onstrate that:
ices furnished under contract or ar- (1) The unified and integrated QAPI
rangement). program is established in a manner
(4) Use objective measures to evalu- that takes into account each member
ate its organizational processes, func- CAH’s unique circumstances and any
tions and services. significant differences in patient popu-
(5) Address outcome indicators relations and services offered in each
lated to improved health outcomes and CAH; and
the prevention and reduction of med- (2) The unified and integrated QAPI
ical errors, adverse events, CAH-ac- program establishes and implements
quired conditions, and transitions of policies and procedures to ensure that
care, including readmissions. the needs and concerns of each of its
258
separately certified CAHs, regardless of (3) The discharge planning evaluation

practice or location, are given due con- must be included in the patient’s med-
sideration, and that the unified and in- ical record for use in establishing an
tegrated QAPI program has mecha- appropriate discharge plan and the re-
nisms in place to ensure that issues lo- sults of the evaluation must be dis-
calized to particular CAHs are duly cussed with the patient (or the pa-
considered and addressed. tient’s representative).
(4) Upon the request of a patient’s
physician, the CAH must arrange for
FR 72309, Nov. 23, 2022]
the development and initial implemen-
§ 485.642 Condition of participation: tation of a discharge plan for the pa-
Discharge planning. tient.
(5) Any discharge planning evalua-
A Critical Access Hospital (CAH) tion or discharge plan required under
must have an effective discharge plan- this paragraph must be developed by,
ning process that focuses on the pa- or under the supervision of, a reg-
tient’s goals and treatment preferences istered nurse, social worker, or other
and includes the patient and his or her appropriately qualified personnel.
caregivers/support person(s) as active (6) The CAH’s discharge planning
partners in the discharge planning for process must require regular re-evalua-
post-discharge care. The discharge tion of the patient’s condition to iden-
planning process and the discharge tify changes that require modification
plan must be consistent with the pa- of the discharge plan. The discharge
tient’s goals for care and his or her plan must be updated, as needed, to re-
treatment preferences, ensure an effec- flect these changes.
tive transition of the patient from the (7) The CAH must assess its discharge
CAH to post-discharge care, and reduce planning process on a regular basis.
the factors leading to preventable CAH The assessment must include ongoing,
and hospital readmissions. periodic review of a representative
(a) Standard: Discharge planning proc- sample of discharge plans, including
ess. The CAH’s discharge planning proc- those patients who were readmitted
ess must identify, at an early stage of within 30 days of a previous admission,
hospitalization, those patients who are to ensure that the plans are responsive
likely to suffer adverse health con- to patient post-discharge needs.
sequences upon discharge in the ab- (8) The CAH must assist patients,
sence of adequate discharge planning their families, or the patient’s rep-
and must provide a discharge planning resentative in selecting a post-acute
evaluation for those patients so identi- care provider by using and sharing data
fied as well as for other patients upon that includes, but is not limited to,
the request of the patient, patient’s HHA, SNF, IRF, or LTCH data on qual-
representative, or patient’s physician. ity measures and data on resource use
(1) Any discharge planning evalua- measures. The CAH must ensure that
tion must be made on a timely basis to the post-acute care data on quality
ensure that appropriate arrangements measures and data on resource use
for post-CAH care will be made before measures is relevant and applicable to
discharge and to avoid unnecessary the patient’s goals of care and treat-
delays in discharge. ment preferences.
(2) A discharge planning evaluation (b) Standard: Discharge of the patient
must include an evaluation of a pa- and provision and transmission of the pa-
tient’s likely need for appropriate post- tient’s necessary medical information.
CAH services, including, but not lim- The CAH must discharge the patient,
ited to, hospice care services, post-CAH and also transfer or refer the patient
extended care services, home health where applicable, along with all nec-
services, and non-health care services essary medical information pertaining
and community based care providers, to the patient’s current course of ill-
and must also include a determination ness and treatment, post-discharge
of the availability of the appropriate goals of care, and treatment pref-
services as well as of the patient’s ac- erences, at the time of discharge, to
cess to those services. the appropriate post-acute care service
259
§ 485.643 42 CFR Ch. IV (10–1–24 Edition)
providers and suppliers, facilities, sue bank and eye bank in educating
agencies, and other outpatient service staff on donation issues, reviewing
providers and practitioners responsible death records to improve identification
for the patient’s follow-up or ancillary of potential donors, and maintaining
care. potential donors while necessary test-
[84 FR 51883, Sept. 30, 2019] ing and placement of potential donated
organs, tissues, and eyes take place.
§ 485.643 Condition of participation: (f) For purposes of these standards,
Organ, tissue, and eye procurement. the term ‘‘organ’’ means a human kid-
The CAH must have and implement ney, liver, heart, lung, pancreas, or in-
written protocols that: testines (or multivisceral organs).
(a) Incorporate an agreement with an [65 FR 47110, Aug. 1, 2000, as amended at 66
OPO designated under part 486 of this FR 39938, Aug. 1, 2001]
chapter, under which it must notify, in
a timely manner, the OPO or a third § 485.645 Special requirements for
party designated by the OPO of individ- CAH providers of long-term care
uals whose death is imminent or who services (‘‘swing-beds’’)
have died in the CAH. The OPO deter- A CAH must meet the following re-
mines medical suitability for organ do- quirements in order to be granted an
nation and, in the absence of alter- approval from CMS to provide post-
native arrangements by the CAH, the CAH SNF care, as specified in § 409.30 of
OPO determines medical suitability for this chapter, and to be paid for SNF-
tissue and eye donation, using the defi- level services, in accordance with para-
nition of potential tissue and eye donor graph (c) of this section.
and the notification protocol developed (a) Eligibility. A CAH must meet the
in consultation with the tissue and eye following eligibility requirements:
banks identified by the CAH for this (1) The facility has been certified as a
purpose; CAH by CMS under § 485.606(b) of this
(b) Incorporate an agreement with at subpart; and
least one tissue bank and at least one (2) The facility provides not more
eye bank to cooperate in the retrieval, than 25 inpatient beds. Any bed of a
processing, preservation, storage and unit of the facility that is licensed as a
distribution of tissues and eyes, as may distinct-part SNF at the time the facil-
be appropriate to assure that all usable ity applies to the State for designation
tissues and eyes are obtained from po- as a CAH is not counted under para-
tential donors, insofar as such an graph (a) of this section.
agreement does not interfere with (b) Facilities participating as rural pri-
organ procurement; mary care hospitals (RPCHs) on Sep-
(c) Ensure, in collaboration with the tember 30, 1997. These facilities must
designated OPO, that the family of meet the following requirements:
each potential donor is informed of its (1) Notwithstanding paragraph (a) of
option to either donate or not donate this section, a CAH that participated
organs, tissues, or eyes. The individual in Medicare as a RPCH on September
designated by the CAH to initiate the 30, 1997, and on that date had in effect
request to the family must be a des- an approval from CMS to use its inpa-
ignated requestor. A designated re- tient facilities to provide post-hospital
questor is an individual who has com- SNF care may continue in that status
pleted a course offered or approved by under the same terms, conditions and
the OPO and designed in conjunction limitations that were applicable at the
with the tissue and eye bank commu- time those approvals were granted.
nity in the methodology for approach- (2) A CAH that was granted swing-bed
ing potential donor families and re- approval under paragraph (b)(1) of this
questing organ or tissue donation; section may request that its applica-
(d) Encourage discretion and sensi- tion to be a CAH and swing-bed pro-
tivity with respect to the cir- vider be reevaluated under paragraph
cumstances, views, and beliefs of the (a) of this section. If this request is ap-
families of potential donors; proved, the approval is effective not
(e) Ensure that the CAH works coop- earlier than October 1, 1997. As of the
eratively with the designated OPO, tis- date of approval, the CAH no longer
260
has any status under paragraph (b)(1) § 485.647 Condition of participation:

of this section and may not request re- psychiatric and rehabilitation dis-
instatement under paragraph (b)(1) of tinct part units.
this section. (a) Conditions. (1) If a CAH provides
(c) Payment. Payment for inpatient inpatient psychiatric services in a dis-
RPCH services to a CAH that has quali- tinct part unit, the services furnished
fied as a CAH under the provisions in by the distinct part unit must comply
paragraph (a) of this section is made in with the hospital requirements speci-
accordance with § 413.70 of this chapter. fied in subparts A, B, C, and D of part
Payment for post-hospital SNF-level of 482 of this subchapter, the common re-
care services is made in accordance quirements of § 412.25(a)(2) through (f)
with the payment provisions in § 413.114 of part 412 of this chapter for hospital
of this chapter. units excluded from the prospective
(d) SNF services. The CAH is substan- payment systems, and the additional
tially in compliance with the following requirements of § 412.27 of part 412 of
SNF requirements contained in subpart this chapter for excluded psychiatric
B of part 483 of this chapter: units.
(1) Resident rights (§ 483.10(b)(7), (2) If a CAH provides inpatient reha-
(c)(1), (c)(2)(iii), (c)(6), (d), (e)(2) and (4), bilitation services in a distinct part
(f)(4)(ii) and (iii), (g)(8) and (17), (g)(18) unit, the services furnished by the dis-
introductory text, and (h) of this chap- tinct part unit must comply with the
ter). hospital requirements specified in sub-
(2) Admission, transfer, and discharge parts A, B, C, and D of part 482 of this
rights (§ 483.5 definition of transfer & subchapter, the common requirements
discharge, § 483.15(c)(1), (c)(2), (c)(3), of § 412.25(a)(2) through (f) of part 412 of
(c)(4), (c)(5), (c)(7), (c)(8), and (c)(9) of this chapter for hospital units excluded
this chapter). from the prospective payments sys-
(3) Freedom from abuse, neglect and tems, and the additional requirements
exploitation (§ 483.12(a)(1), (a)(2), of §§ 412.29 and § 412.30 of part 412 of this
(a)(3)(i), (a)(3)(ii), (a)(4), (b)(1), (b)(2), chapter related specifically to rehabili-
(c)(1), (c)(2), (c)(3), and (c)(4) of this tation units.
chapter). (b) Eligibility requirements. (1) To be
(4) Social services (§ 483.40(d) of this eligible to receive Medicare payments
chapter). for psychiatric or rehabilitation serv-
(5) Comprehensive assessment, com- ices as a distinct part unit, the facility
prehensive care plan, and discharge provides no more than 10 beds in the
planning (§ 483.20(b), and § 483.21(b) and distinct part unit.
(c)(2) of this chapter), except that the (2) The beds in the distinct part are
CAH is not required to use the resident excluded from the 25 inpatient-bed
assessment instrument (RAI) specified count limit specified in § 485.620(a).
by the State that is required under (3) The average annual 96-hour length
§ 483.20(b), or to comply with the re- of stay requirement specified under
quirements for frequency, scope, and § 485.620(b) does not apply to the 10 beds
number of assessments prescribed in in the distinct part units specified in
§ 413.343(b) of this chapter). paragraph (b)(1) of this section, and ad-
(6) Specialized rehabilitative services missions and days of inpatient care in
(§ 483.65 of this chapter). the distinct part units are not taken
(7) Dental services (§ 483.55(a)(2), (3), into account in determining the CAH’s
(4), and (5) and (b) of this chapter). compliance with the limits on the
(8) Nutrition (§ 483.25(g)(1) and (g)(2) number of beds and length of stay in
of this chapter). § 485.620.
[63 FR 26359, May 12, 1998, as amended at 64 [69 FR 49272, Aug. 11, 2004]
FR 41544, July 30, 1999; 67 FR 50120, Aug. 1,
2002; 69 FR 49272, Aug. 11, 2004; 81 FR 68871,
Oct. 4, 2016; 82 FR 32260, July 13, 2017; 84 FR
Subpart G [Reserved]
51828, Sept. 30, 2019]
261
§ 485.701 42 CFR Ch. IV (10–1–24 Edition)
Subpart H—Conditions of Partici- Rehabilitation agency. An agency

pation for Clinics, Rehabilita- that—
(1) Provides an integrated inter-
tion Agencies, and Public disciplinary rehabilitation program de-
Health Agencies as Providers signed to upgrade the physical func-
of Outpatient Physical Ther- tioning of handicapped disabled indi-
apy and Speech-Language viduals by bringing specialized reha-
Pathology Services bilitation staff together to perform as
a team; and
§ 485.701 Basis and scope. (2) Provides at least physical therapy
This subpart implements section or speech-language pathology services.
1861(p)(4) of the Act, which— Supervision. Authoritative procedural
(a) Defines outpatient physical ther- guidance that is for the accomplish-
apy and speech pathology services; ment of a function or activity and
(b) Imposes requirements with re- that—
spect to adequate program, facilities, (1) Includes initial direction and peri-
policies, staffing, and clinical records; odic observation of the actual perform-
and ance of the function or activity; and
(c) Authorizes the Secretary to estab- (2) Is furnished by a qualified per-
lish by regulation other health and son—
safety requirements. (i) Whose sphere of competence en-
compasses the particular function or
[60 FR 2327, Jan. 9, 1995] activity; and
(ii) Who (unless otherwise provided in
this subpart) is on the premises if the
Clinic. A facility that is established person performing the function or ac-
primarily to furnish outpatient physi- tivity does not meet the assistant-level
cian services and that meets the fol- practitioner qualifications specified in
lowing tests of physician involvement: § 485.705.
(1) The medical services are furnished
[41 FR 20865, May 21, 1976. Redesignated at 42
by a group of three or more physicians
FR 52826, Sept. 30, 1977, and amended at 53
practicing medicine together. FR 12015, Apr. 12, 1988; 54 FR 38679, Sept. 20,
(2) A physician is present during all 1989. Redesignated and amended at 60 FR
hours of operation of the clinic to fur- 2326, 2327, Jan. 9, 1995; 60 FR 50447, Sept. 29,
nish medical services, as distinguished 1995; 73 FR 69941, Nov. 19, 2008]
from purely administrative services.
Extension location. A location or site § 485.705 Personnel qualifications.
from which a rehabilitation agency (a) General qualification requirements.
provides services within a portion of Except as specified in paragraphs (b)
the total geographic area served by the and (c) of this section, all personnel
primary site. The extension location is who are involved in the furnishing of
part of the rehabilitation agency. The outpatient physical therapy, occupa-
extension location should be located tional therapy, and speech-language
sufficiently close to share administra- pathology services directly by or under
tion, supervision, and services in a arrangements with an organization
manner that renders it unnecessary for must be legally authorized (licensed or,
the extension location to independ- if applicable, certified or registered) to
ently meet the conditions of participa- practice by the State in which they
tion as a rehabilitation agency. perform the functions or actions, and
Organization. A clinic, rehabilitation must act only within the scope of their
agency, or public health agency. State license or State certification or
Public health agency. An official agen- registration.
cy established by a State or local gov- (b) Exception for Federally defined
ernment, the primary function of qualifications. The following Federally
which is to maintain the health of the defined qualifications must be met:
population served by performing envi- (1) For a physician, the qualifications
ronmental health services, preventive and conditions as defined in section
medical services, and in certain cases, 1861(r) of the Act and the requirements
therapeutic services. in part 484 of this chapter.
262
(2) For a speech-language pathologist, fying body that has established stand-
the qualifications specified in section ards for nurse practitioners; or
1861(11)(1) of the Act and the require- (iii) Be a registered professional
ments in part 484 of this chapter. nurse who is authorized by the State in
(c) Exceptions when no State Licensing which the services are furnished to
laws or State certification or registration practice as a nurse practitioner in ac-
requirements exist. If no State licensing cordance with State law and have been
laws or State certification or registra- granted a Medicare billing number as a
tion requirements exist for the profes- nurse practitioner by December 31,
sion, the following requirements must 2000; or
be met—
(iv) Be a nurse practitioner who on or
(1) An administrator is a person who
after January 1, 2001, applies for a
has a bachelor’s degree and:
Medicare billing number for the first
(i) Has experience or specialized
time and meets the standards for nurse
training in the administration of
practitioners in paragraphs (c)(8)(i) and
health institutions or agencies; or
(c)(8)(ii) of this section; or
(ii) Is qualified and has experience in
one of the professional health dis- (v) Be a nurse practitioner who on or
ciplines. after January 1, 2003, applies for a
(2) An occupational therapist must Medicare billing number for the first
meet the requirements in part 484 of time and possesses a master’s degree in
this chapter. nursing and meets the standards for
(3) An occupational therapy assistant nurse practitioners in paragraphs
must meet the requirements in part 484 (b)(1)(i) and (b)(1)(ii) of this section.
of this chapter. (9) A clinical nurse specialist is a per-
(4) A physical therapist must meet the son who must:
requirements in part 484 of this chap- (i) Be a registered nurse who is cur-
ter. rently licensed to practice in the State
(5) A physical therapist assistant must where he or she practices and be au-
meet the requirements in part 484 of thorized to perform the services of a
this chapter. clinical nurse specialist in accordance
(6) A social worker must meet the re- with State law;
quirements in part 484 of this chapter. (ii) Have a master’s degree in a de-
(7) A vocational specialist is a person fined clinical area of nursing from an
who has a baccalaureate degree and— accredited educational institution;
(i) Two years experience in voca- and,
tional counseling in a rehabilitation (iii) Be certified as a clinical nurse
setting such as a sheltered workshop, specialist by the American Nurses
State employment service agency, etc.; Credentialing Center.
or (10) A physician assistant is a person
(ii) At least 18 semester hours in vo- who:
cational rehabilitation, educational or (i) Has graduated from a physician
vocational guidance, psychology, social assistant educational program that is
work, special education or personnel
accredited by the Commission on Ac-
administration, and 1 year of experi-
creditation of Allied Health Education
ence in vocational counseling in a re-
habilitation setting; or Programs; or
(iii) A master’s degree in vocational (ii) Has passed the national certifi-
counseling. cation examination that is adminis-
(8) A nurse practitioner is a person tered by the National Commission on
who must: Certification of Physician Assistants;
(i) Be a registered professional nurse and
who is authorized by the State in (iii) Is licensed by the State to prac-
which the services are furnished to tice as a physician assistant.
practice as a nurse practitioner in ac- [63 FR 58912, Nov. 2, 1998; 64 FR 25457, May 12,
cordance with State law; and 1999; 64 FR 59442, Nov. 2, 1999]
(ii) Be certified as a nurse practi-
tioner by a recognized national certi-
263
§ 485.707 42 CFR Ch. IV (10–1–24 Edition)
§ 485.707 Condition of participation: that are kept current. Personnel

Compliance with Federal, State, records include the qualifications of all
and local laws. professional and assistant level per-
The organization and its staff are in sonnel, as well as evidence of State li-
compliance with all applicable Federal, censure if applicable.
State, and local laws and regulations. (d) Standard: Patient care policies. Pa-
(a) Standard: Licensure of organization. tient care practices and procedures are
In any State in which State or applica- supported by written policies estab-
ble local law provides for the licensing lished by a group of professional per-
of organizations, a clinic, rehabilita- sonnel including one or more physi-
tion agency, or public health agency is cians associated with the clinic or re-
licensed in accordance with applicable habilitation agency, one or more quali-
laws. fied physical therapists (if physical
(b) Standard: Licensure or registration therapy services are provided), and one
of personnel. Staff of the organization or more qualified speech pathologists
are licensed or registered in accordance (if speech pathology services are pro-
with applicable laws. vided). The policies govern the out-
[41 FR 20865, May 21, 1976. Redesignated at 42 patient physical therapy and/or speech
FR 52826, Sept. 30, 1977. Further redesignated pathology services and related services
and amended at 60 FR 2326, 2327, Jan. 9, 1995] that are provided. These policies are
§ 485.709 Condition of participation: evaluated at least annually by the
Administrative management. group of professional personnel, and re-
vised as necessary based upon this
The clinic or rehabilitation agency
evaluation.
has an effective governing body that is
legally responsible for the conduct of [41 FR 20865, May 21, 1976. Redesignated at 42
the clinic or rehabilitation agency. The FR 52826, Sept. 30, 1977, and amended at 53
governing body designates an adminis- FR 12015, Apr. 12, 1988. Redesignated and
trator, and establishes administrative amended at 60 FR 2326, 2327, Jan. 9, 1995; 60
policies. FR 50447, Sept. 29, 1995]
(a) Standard: Governing body. There is
a governing body (or designated per- Plan of care and physician involve-
son(s) so functioning) which assumes ment.
full legal responsibility for the overall
conduct of the clinic or rehabilitation For each patient in need of out-
agency and for compliance with appli- patient physical therapy or speech pa-
cable laws and regulations. The name thology services, there is a written
of the owner(s) of the clinic or rehabili- plan of care established and periodi-
tation agency is fully disclosed to the cally reviewed by a physician, or by a
State agency. In the case of corpora- physical therapist or speech patholo-
tions, the names of the corporate offi- gist respectively.
cers are made known. (a) Standard: Medical history and prior
(b) Standard: Administrator. The gov- treatment. The following are obtained
erning body— by the organization before or at the
(1) Appoints a qualified full-time ad- time of initiation of treatment:
ministrator; (1) The patient’s significant past his-
(2) Delegates to the administrator tory.
the internal operation of the clinic or (2) Current medical findings, if any.
rehabilitation agency in accordance (3) Diagnosis(es), if established.
with written policies;
(4) Physician’s orders, if any.
(3) Defines clearly the administra-
tor’s responsibilities for procurement (5) Rehabilitation goals, if deter-
and direction of personnel; and mined.
(4) Designates a competent individual (6) Contraindications, if any.
to act during temporary absence of the (7) The extent to which the patient is
administrator. aware of the diagnosis(es) and prog-
(c) Standard: Personnel policies. Per- nosis.
sonnel practices are supported by ap- (8) If appropriate, the summary of
propriate written personnel policies treatment furnished and results
264
achieved during previous periods of re- (iii) Administer tests and measure-
habilitation services or institutional- ments of strength, balance, endurance,
ization. range of motion, and activities of daily
(b) Standard: Plan of care. (1) For each living.
patient there is a written plan of care (2) A qualified physical therapist is
established by the physician or by the present or readily available to offer su-
physical therapist or speech-language pervision when a physical therapist as-
pathologist who furnishes the services. sistant furnishes services.
(2) The plan of care for physical ther- (i) If a qualified physical therapist is
apy or speech pathology services indi- not on the premises during all hours of
cates anticipated goals and specifies operation, patients are scheduled so as
for those services the— to ensure that the therapist is present
(i) Type; when special skills are needed, for ex-
(ii) Amount; ample, for evaluation and reevaluation.
(iii) Frequency; and (ii) When a physical therapist assist-
(iv) Duration. ant furnishes services off the organiza-
(3) The plan of care and results of tion’s premises, those services are su-
treatment are reviewed by the physi- pervised by a qualified physical thera-
cian or by the individual who estab-
pist who makes an onsite supervisory
lished the plan at least as often as the
visit at least once every 30 days.
patient’s condition requires, and the
indicated action is taken. (b) Standard: Facilities and equipment.
(4) Changes in the plan of care are The organization has the equipment
noted in the clinical record. If the pa- and facilities required to provide the
tient has an attending physician, the range of services necessary in the
therapist or speech-language patholo- treatment of the types of disabilities it
gist who furnishes the services prompt- accepts for service.
ly notifies him or her of any change in (c) Standard: Personnel qualified to
the patient’s condition or in the plan of provide physical therapy services. Phys-
care. ical therapy services are provided by,
(c) Standard: Emergency care. The re- or under the supervision of, a qualified
habilitation agency must establish pro- physical therapist. The number of
cedures to be followed by personnel in qualified physical therapists and quali-
an emergency, which cover immediate fied physical therapist assistants is
care of the patient, persons to be noti- adequate for the volume and diversity
fied, and reports to be prepared. of physical therapy services offered. A
[54 FR 38679, Sept. 20, 1989. Redesignated and qualified physical therapist is on the
amended at 60 FR 2326, 2327, Jan. 9, 1995; 63 premises or readily available during
FR 58913, Nov. 2, 1998; 73 FR 69941, Nov. 19, the operating hours of the organiza-
2008] tion.
(d) Standard: Supportive personnel. If
Physical therapy services. personnel are available to assist quali-
fied physical therapists by performing
If the organization offers physical services incident to physical therapy
therapy services, it provides an ade- that do not require professional knowl-
quate program of physical therapy and edge and skill, these personnel are in-
has an adequate number of qualified structed in appropriate patient care
personnel and the equipment necessary
services by qualified physical thera-
to carry out its program and to fulfill
pists who retain responsibility for the
its objectives.
treatment prescribed by the attending
(a) Standard: Adequate program. (1)
physician.
The organization is considered to have
an adequate outpatient physical ther- [41 FR 20865, May 21, 1976. Redesignated at 42
apy program if it can: FR 52826, Sept. 30, 1977. Further redesignated
(i) Provide services using therapeutic and amended at 60 FR 2326, 2327, Jan. 9, 1995;
exercise and the modalities of heat, 60 FR 50447, Sept. 29, 1995]
cold, water, and electricity;
(ii) Conduct patient evaluations; and
265
§ 485.715 42 CFR Ch. IV (10–1–24 Edition)
§ 485.715 Condition of participation: the contract must specify the term of

Speech pathology services. the contract, the manner of termi-
If speech pathology services are of- nation or renewal and provide that the
fered, the organization provides an ade- agency retains responsibility for the
quate program of speech pathology and control and supervision of the services.
has an adequate number of qualified [73 FR 69942, Nov. 19, 2008]
personnel and the equipment necessary
to carry out its program and to fulfill § 485.719 Condition of participation:
its objectives. Arrangements for physical therapy
(a) Standard: Adequate program. The and speech pathology services to be
organization is considered to have an performed by other than salaried
adequate outpatient speech pathology organization personnel.
program if it can provide the diag- (a) Conditions. If an organization pro-
nostic and treatment services to effec- vides outpatient physical therapy or
tively treat speech disorders. speech pathology services under an ar-
(b) Standard: Facilities and equipment. rangement with others, the services
The organization has the equipment are to be furnished in accordance with
and facilities required to provide the the terms of a written contract, which
range of services necessary in the provides that the organization retains
treatment of the types of speech dis- of professional and administrative re-
orders it accepts for service. sponsibility for, and control and super-
(c) Standard: Personnel qualified to vision of, the services.
provide speech pathology services. Speech (b) Standard: Contract provisions. The
pathology services are given or super- contract—
vised by a qualified speech pathologist (1) Specifies the term of the contract
and the number of qualified speech pa- and the manner of termination or re-
thologists is adequate for the volume newal;
and diversity of speech pathology serv-
(2) Requires that personnel who fur-
ices offered. At least one qualified
nish the services meet the require-
speech pathologist is present at all
ments that are set forth in this subpart
times when speech pathology services
for salaried personnel; and
are furnished.
(3) Provides that the contracting out-
[41 FR 20865, May 21, 1976. Redesignated at 42 side resource may not bill the patient
FR 52826, Sept. 30, 1977. Further redesignated or Medicare for the services. This limi-
and amended at 60 FR 2326, Jan. 9, 1995] tation is based on section 1861(w)(1) of
§ 485.717 Condition of participation: the Act, which provides that—
Rehabilitation program. (i) Only the provider may bill the
beneficiary for covered services fur-
This condition and standards apply
nished under arrangements; and
only to a rehabilitation agency’s own
patients, not to patients of hospitals, (ii) Receipt of Medicare payment by
skilled nursing facilities (SNFs), or the provider, on behalf of an entitled
Medicaid nursing facilities (NFs) to individual, discharges the liability of
which the agency furnishes services. the individual or any other person to
The hospital, SNF, or NF is responsible pay for those services.
for ensuring that qualified staff furnish [56 FR 46562, Sept. 13, 1991. Redesignated and
services for which they arrange or con- amended at 60 FR 2326, 2328, Jan. 9, 1995; 60
tract for their patients. The rehabilita- FR 50447, Sept. 29, 1995]
tion agency provides physical therapy
and speech-language pathology serv- § 485.721 Condition of participation:
ices to all of its patients who need Clinical records.
them. The organization maintains clinical
(a) Standard: Qualification of staff. records on all patients in accordance
The agency’s therapy services are fur- with accepted professional standards,
nished by qualified individuals as di- and practices. The clinical records are
rect services and/or services provided completely and accurately docu-
under contract. mented, readily accessible, and system-
(b) Standard: Arrangements for services. atically organized to facilitate retriev-
If services are provided under contract, ing and compiling information.
266
(a) Standard: Protection of clinical trieval of records for research or ad-

record information. The organization ministrative action.
recognizes the confidentiality of clin- (f) Standard: Location and facilities.
ical record information and provides The organization maintains adequate
safeguards against loss, destruction, or facilities and equipment, conveniently
unauthorized use. Written procedures located, to provide efficient processing
govern the use and removal of records of clinical records (reviewing, indexing,
and the conditions for release of infor- filing, and prompt retrieval).
mation. The patient’s written consent
is required for release of information [41 FR 20865, May 21, 1976. Redesignated at 42
not authorized by law. FR 52826, Sept. 30, 1977. Further redesignated
and amended at 60 FR 2326, Jan. 9, 1995]
(b) Standard: Content. The clinical
record contains sufficient information § 485.723 Condition of participation:
to identify the patient clearly, to jus- Physical environment.
tify the diagnosis(es) and treatment,
and to document the results accu- The building housing the organiza-
rately. All clinical records contain the tion is constructed, equipped, and
following general categories of data: maintained to protect the health and
(1) Documented evidence of the as- safety of patients, personnel, and the
sessment of the needs of the patient, of public and provides a functional, sani-
an appropriate plan of care, and of the tary, and comfortable environment.
care and services furnished. (a) Standard: Safety of patients. The
(2) Identification data and consent organization satisfies the following re-
forms. quirements:
(3) Medical history. (1) It complies with all applicable
(4) Report of physical examinations, State and local building, fire, and safe-
if any. ty codes.
(5) Observations and progress notes. (2) Permanently attached automatic
(6) Reports of treatments and clinical fire-extinguishing systems of adequate
findings. capacity are installed in all areas of
(7) Discharge summary including the premises considered to have special
final diagnosis(es) and prognosis. fire hazards. Fire extinguishers are
(c) Standard: Completion of records and conveniently located on each floor of
centralization of reports. Current clin- the premises. Fire regulations are
ical records and those of discharged pa- prominently posted.
tients are completed promptly. All (3) Doorways, passageways and stair-
clinical information pertaining to a pa- wells negotiated by patients are:
tient is centralized in the patient’s (i) Of adequate width to allow for
clinical record. Each physician signs easy movement of all patients (includ-
the entries that he or she makes in the ing those on stretchers or in wheel-
clinical record. chairs), (ii) free from obstruction at all
(d) Standard: Retention and preserva- times, and (iii) in the case of stair-
tion. Clinical records are retained for wells, equipped with firmly attached
at least: handrails on at least one side.
(1) The period determined by the re- (4) Lights are placed at exits and in
spective State statute, or the statute corridors used by patients and are sup-
of limitations in the State; or ported by an emergency power source.
(2) In the absence of a State statute— (5) A fire alarm system with local
(i) Five years after the date of dis- alarm capability and, where applicable,
charge; or an emergency power source, is func-
(ii) In the case of a minor, 3 years tional.
after the patient becomes of age under (6) At least two persons are on duty
State law or 5 years after the date of on the premises of the organization
discharge, whichever is longer. whenever a patient is being treated.
(e) Standard: Indexes. Clinical records (7) No occupancies or activities unde-
are indexed at least according to name sirable or injurious to the health and
of patient to facilitate acquisition of safety of patients are located in the
statistical medical information and re- building.
267
§ 485.725 42 CFR Ch. IV (10–1–24 Edition)
(b) Standard: Maintenance of equip- (b) All personnel follow written pro-
ment, building, and grounds. The organi- cedures for effective aseptic tech-
zation establishes a written preventive- niques. The procedures are reviewed
maintenance program to ensure that— annually and revised if necessary to
(1) The equipment is operative, and is improve them.
properly calibrated; and (c) Standard: Housekeeping. (1) The or-
(2) The interior and exterior of the ganization employs sufficient house-
building are clean and orderly and keeping personnel and provides all nec-
maintained free of any defects that are essary equipment to maintain a safe,
a potential hazard to patients, per- clean, and orderly interior. A full-time
sonnel, and the public. employee is designated as the one re-
(c) Standard: Other environmental con- sponsible for the housekeeping services
siderations. The organization provides a and for supervision and training of
functional, sanitary, and comfortable housekeeping personnel.
environment for patients, personnel, (2) An organization that has a con-
and the public. tract with an outside resource for
(1) Provision is made for adequate housekeeping services may be found to
and comfortable lighting levels in all be in compliance with this standard
areas; limitation of sounds at comfort
provided the organization or outside
levels; a comfortable room tempera-
resource or both meet the require-
ture; and adequate ventilation through
ments of the standard.
windows, mechanical means, or a com-
bination of both. (d) Standard: Linen. The organization
(2) Toilet rooms, toilet stalls, and has available at all times a quantity of
lavatories are accessible and con- linen essential for proper care and
structed so as to allow use by non- comfort of patients. Linens are han-
ambulatory and semiambulatory indi- dled, stored, processed, and transported
viduals. in such a manner as to prevent the
(3) Whatever the size of the building, spread of infection.
there is an adequate amount of space (e) Standard: Pest control. The organi-
for the services provided and disabil- zation’s premises are maintained free
ities treated, including reception area, from insects and rodents through oper-
staff space, examining room, treatment ation of a pest-control program.
areas, and storage. [41 FR 20865, May 21, 1976. Redesignated at 42
[41 FR 20865, May 21, 1976. Redesignated at 42 FR 52826, Sept. 30, 1977. Further redesignated
FR 52826, Sept. 30, 1977. Further redesignated and amended at 60 FR 2326, 2328, Jan. 9, 1995;
and amended at 60 FR 2326, Jan. 9, 1995] 60 FR 50447, Sept. 29, 1995; 86 FR 61623, Nov.
5, 2021; 88 FR 36510, June 5, 2023]
Infection control. § 485.727 Condition of participation:
Emergency preparedness.
The organization that provides out-
patient physical therapy services es- The Clinics, Rehabilitation Agencies,
tablishes an infection-control com- and Public Health Agencies as Pro-
mittee of representative professional viders of Outpatient Physical Therapy
staff with responsibility for overall in- and Speech-Language Pathology Serv-
fection control. All necessary house- ices (‘‘Organizations’’) must comply
keeping and maintenance services are with all applicable Federal, State, and
provided to maintain a sanitary and local emergency preparedness require-
comfortable environment and to help ments. The Organizations must estab-
prevent the development and trans- lish and maintain an emergency pre-
mission of infection. paredness program that meets the re-
(a) Standard: Infection-control com- quirements of this section. The emer-
mittee. The infection-control com- gency preparedness program must in-
mittee establishes policies and proce- clude, but not be limited to, the fol-
dures for investigating, controlling, lowing elements:
and preventing infections in the orga- (a) Emergency plan. The Organiza-
nization and monitors staff perform- tions must develop and maintain an
ance to ensure that the policies and emergency preparedness plan that
procedures are executed. must be reviewed and updated at least
268
every 2 years. The plan must do all of (c) Communication plan. The Organi-
the following: zations must develop and maintain an
(1) Be based on and include a docu- emergency preparedness communica-
mented, facility-based and community- tion plan that complies with Federal,
based risk assessment, utilizing an all- State, and local laws and must be re-
hazards approach. viewed and updated at least every 2
(2) Include strategies for addressing years. The communication plan must
emergency events identified by the include all of the following:
risk assessment. (1) Names and contact information
(3) Address patient population, infor the following:
cluding, but not limited to, the type of (i) Staff.
services the Organizations have the (ii) Entities providing services under
ability to provide in an emergency; and arrangement.
continuity of operations, including del- (iii) Patients’ physicians.
egations of authority and succession (iv) Other Organizations.
plans. (v) Volunteers.
(4) Address the location and use of (2) Contact information for the fol-
alarm systems and signals; and meth- lowing:
ods of containing fire.
(i) Federal, state, tribal, regional and
(5) Include a process for cooperation
local emergency preparedness staff.
and collaboration with local, tribal, re-
preparedness officials’ efforts to main- (3) Primary and alternate means for
tain an integrated response during a communicating with the following:
disaster or emergency situation. (i) Organizations’ staff.
(6) Be developed and maintained with (ii) Federal, state, tribal, regional,
assistance from fire, safety, and other and local emergency management
appropriate experts. agencies.
(b) Policies and procedures. The Orga- (4) A method for sharing information
nizations must develop and implement and medical documentation for pa-
emergency preparedness policies and tients under the Organizations’ care, as
procedures, based on the emergency necessary, with other health care pro-
plan set forth in paragraph (a) of this viders to maintain the continuity of
section, risk assessment at paragraph care.
(a)(1) of this section, and the commu- (5) A means of providing information
nication plan at paragraph (c) of this about the Organizations’ needs, and
section. The policies and procedures their ability to provide assistance, to
must be reviewed and updated at least the authority having jurisdiction or
every 2 years. At a minimum, the poli- the Incident Command Center, or des-
cies and procedures must address the ignee.
following: (d) Training and testing. The Organi-
(1) Safe evacuation from the Organi- zations must develop and maintain an
zations, which includes staff respon- emergency preparedness training and
sibilities, and needs of the patients. testing program that is based on the
(2) A means to shelter in place for pa- emergency plan set forth in paragraph
tients, staff, and volunteers who re- (a) of this section, risk assessment at
main in the facility. paragraph (a)(1) of this section, policies
(3) A system of medical documenta- and procedures at paragraph (b) of this
tion that preserves patient informa- section, and the communication plan
tion, protects confidentiality of patient at paragraph (c) of this section. The
information, and secures and main- training and testing program must be
tains the availability of records. reviewed and updated at least every 2
(4) The use of volunteers in an emer- years.
gency or other emergency staffing (1) Training program. The Organiza-
strategies, including the process and tions must do all of the following:
role for integration of State and Feder- (i) Initial training in emergency pre-
ally designated health care profes- paredness policies and procedures to all
sionals to address surge needs during new and existing staff, individuals pro-
an emergency. viding services under arrangement, and
269
§ 485.729 42 CFR Ch. IV (10–1–24 Edition)
volunteers, consistent with their ex- rately certified healthcare facilities

pected roles. that elects to have a unified and inte-
(ii) Provide emergency preparedness grated emergency preparedness pro-
training at least every 2 years. gram, the Organizations may choose to
(iii) Maintain documentation of the participate in the healthcare system’s
training. coordinated emergency preparedness
(iv) Demonstrate staff knowledge of program. If elected, the unified and in-
emergency procedures. tegrated emergency preparedness pro-
(v) If the emergency preparedness gram must do all of the following:
policies and procedures are signifi- (1) Demonstrate that each separately
cantly updated, the Organizations certified facility within the system ac-
must conduct training on the updated tively participated in the development
policies and procedures. of the unified and integrated emer-
(2) Testing. The Organizations must gency preparedness program.
conduct exercises to test the emer- (2) Be developed and maintained in a
gency plan at least annually. The Orga-
manner that takes into account each
nizations must do the following:
separately certified facility’s unique
(i) Participate in a full-scale exercise
circumstances, patient populations,
that is community-based every 2 years;
and services offered.
or
(A) When a community-based exer- (3) Demonstrate that each separately
cise is not accessible, an individual, fa- certified facility is capable of actively
cility-based functional exercise every 2 using the unified and integrated emer-
years; or. gency preparedness program and is in
(B) If the Organizations experience compliance.
an actual natural or man-made emer- (4) Include a unified and integrated
gency that requires activation of the emergency plan that meets the require-
emergency plan, the organization is ex- ments of paragraphs (a)(2), (3), and (4)
empt from engaging in its next re- of this section. The unified and inte-
quired full-scale community-based or grated emergency plan must also be
individual, facility-based functional ex- based on and include all of the fol-
ercise following the onset of the emer- lowing:
gency event. (i) A documented community-based
(ii) Conduct an additional exercise risk assessment, utilizing an all-haz-
every 2 years, opposite the year the ards approach.
full-scale or functional exercise under (ii) A documented individual facility-
paragraph (d)(2)(i) of this section is based risk assessment for each sepa-
conducted, that may include, but is not rately certified facility within the
limited to the following: health system, utilizing an all-hazards
(A) A second full-scale exercise that approach.
is community-based or an individual, (5) Include integrated policies and
facility-based functional exercise; or procedures that meet the requirements
(B) A mock disaster drill; or set forth in paragraph (b) of this sec-
(C) A tabletop exercise or workshop tion, a coordinated communication
that is led by a facilitator and includes plan and training and testing programs
a group discussion, using a narrated, that meet the requirements of para-
clinically-relevant emergency scenario, graphs (c) and (d) of this section, re-
and a set of problem statements, di- spectively.
rected messages, or prepared questions
designed to challenge an emergency [81 FR 64037, Sept. 16, 2016, as amended by 84
plan. FR 51829, Sept. 30, 2019]
(iii) Analyze the Organization’s re-
sponse to and maintain documentation § 485.729 Condition of participation:
Program evaluation.
of all drills, tabletop exercises, and
emergency events, and revise their The organization has procedures that
emergency plan, as needed. provide for a systematic evaluation of
(e) Integrated healthcare systems. If the its total program to ensure appropriate
Organizations are part of a healthcare utilization of services and to determine
system consisting of multiple sepa- whether the organization’s policies are
270
followed in providing services to pa- (3) Section 1866(e)(2) of the Act speci-
tients through employees or under ar- fies that a provider of services for pur-
rangements with others. poses of provider agreement require-
(a) Standard: Clinical-record review. A ments includes a CMHC as defined in
sample of active and closed clinical section 1861(ff)(3)(B) of the Act, but
records is reviewed quarterly by the only with respect to providing partial
appropriate health professionals to en- hospitalization services and intensive
sure that established policies are fol- outpatient services.
lowed in providing services. (b) Scope. The provisions of this sub-
(b) Standard: Annual statistical evalua- part serve as the basis of survey activi-
tion. An evaluation is conducted annu- ties for the purpose of determining
ally of statistical data such as number whether a CMHC meets the specified
of different patients treated, number of requirements that are considered nec-
patient visits, condition on admission essary to ensure the health and safety
and discharge, number of new patients, of clients; and for the purpose of deter-
number of patients by diagnosis(es), mining whether a CMHC qualifies for a
sources of referral, number and cost of provider agreement under Medicare.
units of service by treatment given,
[78 FR 64630, Oct. 29, 2013, as amended at 88
and total staff days or work hours by
FR 82183, Nov. 22, 2023]
discipline.
[41 FR 20865, May 21, 1976. Redesignated at 42 § 485.902 Definitions.
FR 52826, Sept. 30, 1977. Further redesignated As used in this subpart, unless the
and amended at 60 FR 2326, 2329, Jan. 9, 1995]
context indicates otherwise—
Active treatment plan means an indi-
Subpart I [Reserved] vidualized client plan that focuses on
the provision of care and treatment
Subpart J—Conditions of Partici- services that address the client’s phys-
pation: Community Mental ical, psychological, psychosocial, emo-
Health Centers (CMHCs) tional, and therapeutic needs and goals
as identified in the comprehensive as-
SOURCE: 78 FR 64630, Oct. 29, 2013, unless sessment.
otherwise noted. Community mental health center
(CMHC) means an entity as defined in
§ 485.900 Basis and scope. § 410.2 of this chapter.
(a) Basis. This subpart is based on the Comprehensive assessment means a
following sections of the Social Secu- thorough evaluation of the client’s
rity Act: physical, psychological, psychosocial,
(1) Section 1832(a)(2)(J) of the Act emotional, and therapeutic needs re-
specifies that payments may be made lated to the diagnosis under which care
under Medicare Part B for partial hos- is being furnished by the CMHC.
pitalization services and intensive out- Employee of a CMHC means an indi-
patient services furnished by a commu- vidual—
nity mental health center (CMHC) as (1) Who works for the CMHC and for
described in section 1861(ff)(3)(B) of the whom the CMHC is required to issue a
Act. W–2 form on his or her behalf; or
(2) Section 1861(ff) of the Act de- (2) For whom an agency or organiza-
scribes the items and services that are tion issues a W–2 form, and who is as-
covered under Medicare Part B as signed to such CMHC if the CMHC is a
‘‘partial hospitalization services’’ and subdivision of an agency or organiza-
‘‘intensive outpatient services’’ and the tion.
conditions under which the items and Initial evaluation means an immediate
services must be provided. In addition, care and support assessment of the cli-
section 1861(ff) of the Act specifies that ent’s physical, psychosocial (including
the entities authorized to provide par- a screen for harm to self or others), and
tial hospitalization services and inten- therapeutic needs related to the psy-
sive outpatient services under Medi- chiatric illness and related conditions
care Part B include CMHCs and defines for which care is being furnished by the
that term. CMHC.
271
§ 485.904 42 CFR Ch. IV (10–1–24 Edition)
Representative means an individual (b) Standard: Personnel qualifications

who has the authority under State law for certain disciplines. The following
to authorize or terminate medical care qualifications must be met:
on behalf of a client who is mentally or (1) Administrator of a CMHC. A CMHC
physically incapacitated. This includes employee who meets the education and
a legal guardian. experience requirements established by
Restraint means— the CMHC’s governing body for that
(1) Any manual method, physical or position and who is responsible for the
mechanical device, material, or equip- day-to-day operation of the CMHC.
ment that immobilizes or reduces the (2) Clinical psychologist. An individual
ability of a client to move his or her who meets the qualifications at
§ 410.71(d) of this chapter.
arms, legs, body, or head freely, not in-
(3) Clinical Social worker. An indi-
cluding devices, such as orthopedically
vidual who meets the qualifications at
prescribed devices, surgical dressings
or bandages, protective helmets, or (4) Social worker. An individual who—
other methods that involve the phys- (i) Has a baccalaureate degree in so-
ical holding of a client for the purpose cial work from an institution accred-
of conducting routine physical exami- ited by the Council on Social Work
nations or tests, or to protect the cli- Education, or a baccalaureate degree in
ent from falling out of bed, or to per- psychology or sociology, and is super-
mit the client to participate in activi- vised by a clinical social worker, as de-
ties without the risk of physical harm scribed in paragraph (b)(3) of this sec-
(this does not include a client being tion; and
physically escorted); or (ii) Has 1 year of social work experi-
(2) A drug or medication when it is ence in a psychiatric healthcare set-
used as a restriction to manage the cli- ting.
ent’s behavior or restrict the client’s (5) Mental health counselor. An indi-
freedom of movement, and which is not vidual who meets the applicable edu-
a standard treatment or dosage for the cation, training, and other require-
client’s condition. ments of § 410.54 of this chapter.
Seclusion means the involuntary con- (6) Occupational therapist. A person
finement of a client alone in a room or who meets the requirements for the
an area from which the client is phys- definition of ‘‘occupational therapist’’
ically prevented from leaving. at § 484.4 of this chapter.
Volunteer means an individual who is (7) Physician. An individual who
an unpaid worker of the CMHC; or if meets the qualifications and conditions
as defined in section 1861(r) of the Act,
the CMHC is a subdivision of an agency
and provides the services at § 410.20 of
or organization, is an unpaid worker of
this chapter, and has experience pro-
the agency or organization and is as-
viding mental health services to cli-
signed to the CMHC. All volunteers
ents.
must meet the standard training re-
(8) Physician assistant. An individual
quirements under § 485.918(d). who meets the qualifications and con-
§ 485.904 Condition of participation: ditions as defined in section
Personnel qualifications. 1861(s)(2)(K)(i) of the Act and provides
the services, in accordance with State
(a) Standard: General qualification re- law, at § 410.74 of this chapter.
quirements. All professionals who fur- (9) Advanced practice nurse. An indi-
nish services directly, under an individual who meets the following quali-
vidual contract, or under arrangements fications:
with a CMHC, must be legally author- (i) Is a nurse practitioner who meets
ized (licensed, certified or registered) the qualifications at § 410.75 of this
in accordance with applicable Federal, chapter; or
State and local laws, and must act only (ii) Is a clinical nurse specialist who
within the scope of their State li- meets the qualifications at § 410.76 of
censes, certifications, or registrations. this chapter.
All personnel qualifications must be (10) Psychiatric registered nurse. A reg-
kept current at all times. istered nurse, who is a graduate of an
272
approved school of professional nurs- (iii) Voice grievances and understand

ing, is licensed as a registered nurse by the CMHC grievance process; including
the State in which he or she is prac- but not limited to grievances regarding
ticing, and has at least 1 year of edu- mistreatment and treatment or care
cation and/or training in psychiatric that is (or fails to be) furnished.
nursing. (iv) Not be subjected to discrimina-
(11) Psychiatrist. An individual who tion or reprisal for exercising his or her
specializes in assessing and treating rights.
persons having psychiatric disorders; is (2) If a client has been adjudged in-
board certified, or is eligible to be competent under State law by a court
board certified by the American Board of proper jurisdiction, the rights of the
of Psychiatry and Neurology, or has client are exercised by the person ap-
documented equivalent education, pointed in accordance with State law
training or experience, and is fully li- to act on the client’s behalf.
censed to practice medicine in the (3) If a State court has not adjudged
State in which he or she practices. a client incompetent, any legal rep-
(12) Marriage and family therapist. An resentative designated by the client in
individual who meets the applicable accordance with State law may exer-
education, training, and other require- cise the client’s rights to the extent al-
ments of § 410.53 of this chapter. lowed under State law.
[78 FR 64630, Oct. 29, 2013, as amended at 86 (c) Standard: Rights of the client. The
FR 61624, Nov. 5, 2021; 88 FR 36510, June 5, client has a right to—
2023; 88 FR 82183, Nov. 22, 2023] (1) Be involved in developing his or
her active treatment plan.
§ 485.910 Condition of participation: (2) Refuse care or treatment.
Client rights. (3) Have a confidential clinical
The client has the right to be in- record. Access to or release of client in-
formed of his or her rights. The CMHC formation and the clinical record cli-
must protect and promote the exercise ent information is permitted only in
of these client rights. accordance with 45 CFR parts 160 and
(a) Standard: Notice of rights and re- 164.
sponsibilities. (1) During the initial eval- (4) Be free from mistreatment, ne-
uation, the CMHC must provide the cli- glect, or verbal, mental, sexual, and
ent, the client’s representative (if ap- physical abuse, including injuries of
propriate) or surrogate with verbal and unknown source, and misappropriation
written notice of the client’s rights and of client property.
responsibilities. The verbal notice (5) Receive information about spe-
must be in a language and manner that cific limitations on services that he or
the client or client’s representative or she will be furnished.
surrogate understands. Written notice (6) Not be compelled to perform serv-
must be understandable to persons who ices for the CMHC, and to be com-
have limited English proficiency. pensated by the CMHC for any work
(2) During the initial evaluation, the performed for the CMHC at prevailing
CMHC must inform and distribute writ- wages and commensurate with the cli-
ten information to the client con- ent’s abilities.
cerning its policies on filing a griev- (d) Standard: Addressing violations of
ance. client rights. The CMHC must adhere to
(3) The CMHC must obtain the cli- the following requirements:
ent’s and/or the client representative’s (1) Ensure that all alleged violations
signature confirming that he or she has involving mistreatment, neglect, or
received a copy of the notice of rights verbal, mental, sexual, and physical
and responsibilities. abuse, including injuries of unknown
(b) Standard: Exercise of rights and resource, and misappropriation of client
spect for property and person. (1) The cli- property by anyone, including those
ent has the right to— furnishing services on behalf of the
(i) Exercise his or her rights as a cli- CMHC, are reported immediately to
ent of the CMHC. the CMHC’s administrator by CMHC
(ii) Have his or her property and per- employees, volunteers and contracted
son treated with respect. staff.
273
§ 485.910 42 CFR Ch. IV (10–1–24 Edition)
(2) Immediately investigate all al- (i) Restraint or seclusion may only
leged violations involving anyone fur- be used when less restrictive interven-
nishing services on behalf of the CMHC tions have been determined to be inef-
and immediately take action to pre- fective to protect the client or other
vent further potential violations while individuals from harm.
the alleged violation is being verified. (ii) The type or technique of restraint
Investigations and documentation of or seclusion used must be the least re-
all alleged violations must be con- strictive intervention that will be ef-
ducted in accordance with procedures fective to protect the client or other
established by the CMHC. individuals from harm.
(3) Take appropriate corrective ac- (iii) The use of restraint or seclusion
tion in accordance with State law if must be implemented in accordance
the alleged violation is investigated by with safe and appropriate restraint and
the CMHC’s administration or verified seclusion techniques as determined by
by an outside entity having jurisdic- State law.
tion, such as the State survey and cer- (iv) The condition of the client who is
tification agency or the local law en- restrained or secluded must be continu-
forcement agency; and ously monitored by a physician or by
(4) Ensure that, within 5 working trained staff who have completed the
days of becoming aware of the viola- training criteria specified in paragraph
tion, all violations are reported to the (f) of this section.
State survey and certification agency, (v) When restraint or seclusion is
and verified violations are reported to used, there must be documentation in
State and local entities having juris- the client’s clinical record of the fol-
diction. lowing:
(A) A description of the client’s be-
(e) Standard: Restraint and seclusion.
havior and the intervention used.
(1) All clients have the right to be free
(B) Alternatives or other less restric-
from physical or mental abuse, and
tive interventions attempted (as appli-
corporal punishment. All clients have
cable).
the right to be free from restraint or
(C) The client’s condition or symp-
seclusion, of any form, imposed as a tom(s) that warranted the use of the
means of coercion, discipline, conven- restraint or seclusion.
ience, or retaliation by staff. Restraint (D) The client’s response to the inter-
or seclusion, defined in § 485.902, may vention(s) used, including the rationale
only be imposed to ensure the imme- for continued use of the intervention.
diate physical safety of the client, (E) The name of the hospital to
staff, or other individuals. which the client was transferred.
(2) The use of restraint or seclusion (f) Standard: Restraint or seclusion:
must be in accordance with the written Staff training requirements. The client
order of a physician or other licensed has the right to safe implementation of
independent practitioner who is au- restraint or seclusion by trained staff.
thorized to order restraint or seclusion Application of restraint or seclusion in
in accordance with State law and must a CMHC must only be imposed when a
not exceed one 1-hour duration per client becomes an immediate physical
order. threat to himself or herself, staff or
(3) The CMHC must obtain a cor- other individuals and only in facilities
responding order for the client’s imme- where restraint and seclusion are per-
diate transfer to a hospital when remitted.
straint or seclusion is ordered. (1) Training intervals. In facilities
(4) Orders for the use of restraint or where restraint and seclusion are per-
seclusion must never be written as a mitted, all appropriate client care staff
standing order or on an as-needed working in the CMHC must be trained
basis. and able to demonstrate competency in
(5) When a client becomes an imme- the application of restraints, imple-
diate threat to the physical safety of mentation of seclusion, monitoring, as-
himself or herself, staff or other indi- sessment, and providing care for a cli-
viduals, the CMHC must adhere to the ent in restraint or seclusion and use of
following requirements: alternative methods to restraint and
274
seclusion. In facilities where restraint onstration of competency were success-

and seclusion are not permitted, appro- fully completed.
priate client care staff working in (g) Standard: Death reporting require-
CMHC must be trained in the use of al- ments. The CMHC must report deaths
ternative methods to restraint and se- associated with the use of seclusion or
clusion. Training will occur as follows: restraint.
(i) Before performing any of the ac- (1) The CMHC must report to CMS
tions specified in this paragraph (f). each death that occurs while a client is
(ii) As part of orientation. in restraint or seclusion awaiting
(iii) Subsequently on a periodic basis, transfer to a hospital.
consistent with the CMHC’s policy. (2) Each death referenced in para-
graph (g)(1) of this section must be re-
(2) Training content. The CMHC must
ported to the CMS Regional Office by
require all appropriate staff caring for
telephone no later than the close of
clients to have appropriate education,
business the next business day fol-
training, and demonstrated knowledge
lowing knowledge of the client’s death.
based on the specific needs of the client (3) Staff must document in the cli-
population in at least the following: ent’s clinical record the date and time
(i) Techniques to identify staff and the death was reported to CMS.
client behaviors, events, and environ-
mental factors that may trigger cir- § 485.914 Condition of participation:
cumstances that could require the use Admission, initial evaluation, com-
of restraint or seclusion. prehensive assessment, and dis-
(ii) The use of nonphysical interven- charge or transfer of the client.
tion skills. The CMHC must ensure that all cli-
(iii) In facilities where restraint and ents admitted into its program are ap-
seclusion are permitted, choosing the propriate for the services the CMHC
least restrictive intervention based on furnishes in its facility.
an individualized assessment of the cli- (a) Standard: Admission. (1) The CMHC
ent’s medical and behavioral status or must determine that each client is ap-
condition. propriate for the services it provides as
(iv) The safe application and use of specified in § 410.2 of this chapter.
all types of restraint or seclusion that (2) For clients assessed and admitted
are permitted in the CMHC, including to receive partial hospitalization serv-
training in how to recognize and re- ices and intensive outpatient services,
spond to signs of physical and psycho- the CMHC must also meet separate re-
logical distress. quirements as specified in § 485.918(f)
and (g), as applicable.
(v) In facilities where restraint and
(b) Standard: Initial evaluation. (1) A
seclusion are permitted, clinical identi-
licensed mental health professional
fication of specific behavioral changes
employed by the CMHC and acting
that indicate that restraint or seclu-
within his or her state scope of prac-
sion is no longer necessary.
tice requirements must complete the
(vi) In facilities where restraint and initial evaluation within 24 hours of
seclusion are permitted, monitoring the client’s admission to the CMHC.
the physical and psychological well- (2) The initial evaluation, at a min-
being of the client who is restrained or imum, must include the following:
secluded, including, but not limited to, (i) The admitting diagnosis as well as
respiratory and circulatory status, other diagnoses.
skin integrity, vital signs, and any spe- (ii) The source of referral.
cial requirements specified by the (iii) The reason for admission as stat-
CMHC’s policy. ed by the client or other individuals
(3) Trainer requirements. Individuals who are significantly involved.
providing staff training must be quali- (iv) Identification of the client’s im-
fied as evidenced by education, train- mediate clinical care needs related to
ing, and experience in techniques used the psychiatric diagnosis.
to address clients’ behaviors. (v) A list of current prescriptions and
(4) Training documentation. The CMHC over-the-counter medications, as well
must document in the staff personnel as other substances that the client
records that the training and dem- may be taking.
275
§ 485.914 42 CFR Ch. IV (10–1–24 Edition)
(vi) For partial hospitalization serv- (vi) An assessment of intellectual

ices only, include an explanation as to functioning, memory functioning, and
why the client would be at risk for hos- orientation.
pitalization if the partial hospitaliza- (vii) Complications and risk factors
tion services were not provided. that may affect the care planning.
(3) Based on the findings of the ini- (viii) Functional status, including
tial evaluation, the CMHC must deter- the client’s ability to understand and
mine the appropriate members of each participate in his or her own care, and
client’s interdisciplinary treatment the client’s strengths and goals.
team. (ix) Factors affecting client safety or
(c) Standard: Comprehensive assess- the safety of others, including behav-
ment. (1) The comprehensive assess- ioral and physical factors, as well as
ment must be completed by licensed suicide risk factors.
mental health professionals who are (x) A drug profile that includes a re-
members of the interdisciplinary treat- view of all of the client’s prescription
ment team, performing within their and over-the-counter medications;
State’s scope of practice. herbal remedies; and other alternative
(2) The comprehensive assessment treatments or substances that could af-
must be completed in a timely manner, fect drug therapy.
consistent with the client’s immediate (xi) The need for referrals and further
needs, but no later than 4 working days evaluation by appropriate health care
after admission to the CMHC. professionals, including the client’s
(3) The comprehensive assessment primary health care provider (if any),
must identify the physical, psycho- when warranted.
logical, psychosocial, emotional, thera- (xii) Factors to be considered in dis-
peutic, and other needs related to the charge planning.
client’s psychiatric illness. The (xiii) Identification of the client’s
CMHC’s interdisciplinary treatment current social and health care support
team must ensure that the active systems.
treatment plan is consistent with the (xiv) For pediatric clients, the CMHC
findings of the comprehensive assess- must assess the social service needs of
ment. the client, and make referrals to social
services and child welfare agencies as
(4) The comprehensive assessment, at
appropriate.
a minimum, must include the fol-
lowing: (d) Standard: Update of the comprehen-
sive assessment. (1) The CMHC must up-
(i) The reasons for the admission.
date each client’s comprehensive as-
(ii) A psychiatric evaluation, com- sessment via the CMHC interdiscipli-
pleted by a psychiatrist, non-physician nary treatment team, in consultation
practitioner or psychologist practicing with the client’s primary health care
within the scope of State licensure provider (if any), when changes in the
that includes the medical history and client’s status, responses to treatment,
severity of symptoms. Information or goal achievement have occurred and
may be gathered from the client’s pri- in accordance with current standards
mary health care provider (if any), con- of practice.
tingent upon the client’s consent. (2) For clients that receive partial
(iii) Information concerning previous hospitalization program (PHP) or in-
and current mental status, including tensive outpatient (IOP) services, the
but not limited to, previous thera- assessment must be updated no less
peutic interventions and hospitaliza- frequently than every 30 days.
tions. (3) The update must include informa-
(iv) Information regarding the onset tion on the client’s progress toward de-
of symptoms of the illness and cir- sired outcomes, a reassessment of the
cumstances leading to the admission. client’s response to care and therapies,
(v) A description of attitudes and be- and the client’s goals.
haviors, including cultural and envi- (e) Standard: Discharge or transfer of
ronmental factors that may affect the the client. (1) If the client is transferred
client’s treatment plan. to another entity, the CMHC must,
276
within 2 working days, forward to the (2) Based on the findings of the com-
entity, a copy of— prehensive assessment, the CMHC must
(i) The CMHC discharge summary. determine the appropriate licensed
(ii) The client’s clinical record, if re- mental health professional, who is a
quested. member of the client’s interdiscipli-
(2) If a client refuses the services of a nary treatment team, to coordinate
CMHC, or is discharged from a CMHC care and treatment decisions with each
due to noncompliance with the treat- client, to ensure that each client’s
ment plan, the CMHC must forward to needs are assessed, and to ensure that
the primary health care provider (if the active treatment plan is imple-
any) a copy of— mented as indicated.
(i) The CMHC discharge summary. (3) The interdisciplinary treatment
(ii) The client’s clinical record, if re- team may include:
quested. (i) A doctor of medicine, osteopathy
(3) The CMHC discharge summary or psychiatry (who is an employee of or
must include— under contract with the CMHC).
(i) A summary of the services pro- (ii) A psychiatric registered nurse.
vided, including the client’s symptoms, (iii) A clinical social worker.
treatment and recovery goals and pref- (iv) A clinical psychologist.
erences, treatments, and therapies. (v) An occupational therapist.
(ii) The client’s current active treat- (vi) Other licensed mental health
ment plan at time of discharge. professionals, as necessary.
(iii) The client’s most recent physi- (vii) Other CMHC staff or volunteers,
cian orders. as necessary.
(iv) Any other documentation that (4) If the CMHC has more than one
will assist in post-discharge continuity interdisciplinary team, it must des-
of care. ignate the treatment team responsible
(4) The CMHC must adhere to all Fed- for establishing policies and procedures
eral and State-related requirements governing the coordination of services
pertaining to the medical privacy and and the day-to-day provision of CMHC
the release of client information. care and services.
(b) Standard: Person-centered active
[78 FR 64630, Oct. 29, 2013, as amended at 84
FR 51829, Sept. 30, 2019; 88 FR 82183, Nov. 22, treatment plan. All CMHC care and serv-
2023] ices furnished to clients must be con-
sistent with an individualized, written,
§ 485.916 Condition of participation: active treatment plan that is estab-
Treatment team, person-centered lished by the CMHC interdisciplinary
active treatment plan, and coordi- treatment team, the client, and the cli-
nation of services. ent’s primary caregiver(s), in accord-
The CMHC must designate an inter- ance with the client’s recovery goals
disciplinary treatment team that is re- and preferences, within 7 working days
sponsible, with the client, for direct- of admission to the CMHC. The CMHC
ing, coordinating, and managing the must ensure that each client and the
care and services furnished for each cli- client’s primary caregiver(s), as appli-
ent. The interdisciplinary treatment cable, receive education and training
team is composed of individuals who provided by the CMHC that are con-
work together to meet the physical, sistent with the client’s and caregiver’s
medical, psychosocial, emotional, and responsibilities as identified in the ac-
therapeutic needs of CMHC clients. tive treatment plan.
(a) Standard: Delivery of services. (1) (c) Standard: Content of the person-
An interdisciplinary treatment team, centered active treatment plan. The
led by a physician, nurse practitioner CMHC must develop a person-centered
(NP), physician assistant (PA), clinical individualized active treatment plan
nurse specialist (CNS), clinical psy- for each client. The active treatment
chologist, clinical social worker, mar- plan must take into consideration cli-
riage and family therapist (MFT), or ent recovery goals and the issues iden-
mental health counselor (MHC), must tified in the comprehensive assess-
provide the care and services offered by ment. The active treatment plan must
the CMHC. include all services necessary to assist
277
§ 485.917 42 CFR Ch. IV (10–1–24 Edition)
the client in meeting his or her recov- (2) Ensure that care and services are
ery goals, including the following: provided in accordance with the active
(1) Client diagnoses. treatment plan.
(2) Treatment goals. (3) Ensure that the care and services
(3) Interventions. provided are based on all assessments
(4) A detailed statement of the type, of the client.
duration, and frequency of services, in- (4) Provide for and ensure the ongo-
cluding social work, psychiatric nursing sharing of information among all
ing, counseling, and therapy services, disciplines providing care and services,
necessary to meet the client’s specific whether the care and services are pro-
needs. vided by employees or those under con-
(5) Drugs, treatments, and individual tract with the CMHC.
and/or group therapies. (5) Provide for ongoing sharing of in-
(6) Family psychotherapy with the formation with other health care and
non-medical providers, including the
primary focus on treatment of the cli-
primary health care provider, fur-
ent’s conditions.
nishing services to a client for condi-
(7) The interdisciplinary treatment tions unrelated to the psychiatric con-
team’s documentation of the client’s or dition for which the client has been ad-
representative’s and primary care- mitted, and non-medical supports ad-
giver’s (if any) understanding, involve- dressing environmental factors such as
ment, and agreement with the plan of housing and employment.
care, in accordance with the CMHC’s
policies. [78 FR 64630, Oct. 29, 2013, as amended at 88
(d) Standard: Review of the person-cen- FR 82183, Nov. 22, 2023]
tered active treatment plan. The CMHC
interdisciplinary treatment team must Quality assessment and perform-
review, revise, and document the indi- ance improvement.
vidualized active treatment plan as fre-
quently as the client’s condition re- The CMHC must develop, implement,
quires, but no less frequently than and maintain an effective, ongoing,
CMHC-wide data-driven quality assess-
every 30-calendar day. A revised active
ment and performance improvement
treatment plan must include informa-
program (QAPI). The CMHC’s gov-
tion from the client’s initial evalua-
erning body must ensure that the pro-
tion and comprehensive assessments,
gram reflects the complexity of its or-
the client’s progress toward outcomes
ganization and services, involves all
and goals specified in the active treat- CMHC services (including those serv-
ment plan, and changes in the client’s ices furnished under contract or ar-
goals. The CMHC must also meet par- rangement), focuses on indicators re-
tial hospitalization program require- lated to improved behavioral health or
ments specified under § 424.24(e) of this other healthcare outcomes, and takes
chapter or intensive outpatient service actions to demonstrate improvement
requirements as specified under in CMHC performance. The CMHC must
§ 424.24(d) of this chapter, as applicable, maintain documentary evidence of its
if such services are included in the ac- quality assessment and performance
tive treatment plan. improvement program and be able to
(e) Standard: Coordination of services. demonstrate its operation to CMS.
The CMHC must develop and maintain (a) Standard: Program scope. (1) The
a system of communication that CMHC program must be able to dem-
assures the integration of services in onstrate measurable improvement in
accordance with its policies and proce- indicators related to improving behav-
dures and, at a minimum, would do the ioral health outcomes and CMHC serv-
following: ices.
(1) Ensure that the interdisciplinary (2) The CMHC must measure, ana-
treatment team maintains responsi- lyze, and track quality indicators; ad-
bility for directing, coordinating, and verse client events, including the use of
supervising the care and services pro- restraint and seclusion; and other as-
vided. pects of performance that enable the
278
CMHC to assess processes of care, (e) Standard: Executive responsibilities.

CMHC services, and operations. The CMHC’s governing body is respon-
(b) Standard: Program data. (1) The sible for ensuring the following:
program must use quality indicator (1) That an ongoing QAPI program
data, including client care, and other for quality improvement and client
relevant data, in the design of its pro- safety is defined, implemented, main-
gram. tained, and evaluated annually.
(2) The CMHC must use the data col- (2) That the CMHC-wide quality as-
lected to do the following: sessment and performance improve-
(i) Monitor the effectiveness and ment efforts address priorities for im-
safety of services and quality of care. proved quality of care and client safe-
(ii) Identify opportunities and prior- ty, and that all improvement actions
ities for improvement. are evaluated for effectiveness.
(3) That one or more individual(s)
(3) The frequency and detail of the
who are responsible for operating the
data collection must be approved by
QAPI program are designated.
the CMHC’s governing body.
(c) Standard: Program activities. (1) § 485.918 Condition of participation:
The CMHC’s performance improvement Organization, governance, adminis-
activities must: tration of services, partial hos-
(i) Focus on high risk, high volume, pitalization services, and intensive
or problem-prone areas. outpatient services.
(ii) Consider incidence, prevalence, The CMHC must organize, manage,
and severity of problems. and administer its resources to provide
(iii) Give priority to improvements CMHC services, including specialized
that affect behavioral outcomes, client services for children, elderly individ-
safety, and person-centered quality of uals, individuals with serious mental
care. illness, and residents of its mental
(2) Performance improvement activi- health service area who have been dis-
ties must track adverse client events, charged from an inpatient mental
analyze their causes, and implement health facility.
preventive actions and mechanisms (a) Standard: Governing body and ad-
that include feedback and learning ministrator. (1) A CMHC must have a
throughout the CMHC. designated governing body made up of
two or more designated persons, one of
(3) The CMHC must take actions
which may be the administrator, that
aimed at performance improvement
assumes full legal authority and re-
and, after implementing those actions, sponsibility for the management of the
the CMHC must measure its success CMHC, the services it furnishes, its fis-
and track performance to ensure that cal operations, and continuous quality
improvements are sustained. improvement. One member of the gov-
(d) Standard: Performance improvement erning body must possess knowledge
projects. CMHCs must develop, imple- and experience as a mental health cli-
ment and evaluate performance im- nician.
provement projects. (2) The CMHC’s governing body must
(1) The number and scope of distinct appoint an administrator who reports
performance improvement projects to the governing body and is respon-
conducted annually, based on the needs sible for the day-to-day operation of
of the CMHC’s population and internal the CMHC. The administrator must be
organizational needs, must reflect the a CMHC employee and meet the edu-
scope, complexity, and past perform- cation and experience requirements es-
ance of the CMHC’s services and oper- tablished by the CMHC’s governing
ations. body.
(2) The CMHC must document what (b) Standard: Provision of services. (1)
performance improvement projects are A CMHC must be primarily engaged in
being conducted, the reasons for con- providing the following care and serv-
ducting these projects, and the measur- ices to all clients served by the CMHC
able progress achieved on these regardless of payer type, and must do
projects. so in a manner that is consistent with
279
§ 485.918 42 CFR Ch. IV (10–1–24 Edition)
the following accepted standards of (viii) Provides psychiatric nursing

practice: services.
(i) Provides outpatient services, in- (ix) Provides clinical social work
cluding specialized outpatient services services.
for children, elderly individuals, indi- (x) Provides family counseling serv-
viduals with serious mental illness, and ices, with the primary purpose of treat-
residents of its mental health service ing the individual’s condition.
area who have been discharged from in- (xi) Provides occupational therapy
patient mental health facilities.
services.
(ii) Provides 24-hour-a-day emer-
gency care services. (xii) Provides services of other staff
(iii) Provides day treatment, partial trained to work with psychiatric cli-
hospitalization services, or intensive ents.
outpatient services, other than in an (xiii) Provides drugs and biologicals
individual’s home or in an inpatient or furnished for therapeutic purposes that
residential setting, or psychosocial re- cannot be self-administered.
habilitation services. (xiv) Provides client training and
(iv) Provides screening for clients education as related to the individual’s
being considered for admission to State care and active treatment.
mental health facilities to determine (xv) Provides individualized thera-
the appropriateness of such services, peutic activity services that are not
unless otherwise directed by State law. primarily recreational or diversionary.
(v) Provides at least 40 percent of its (xvi) Provides diagnostic services.
items and services to individuals who (2) The CMHC and individuals fur-
are not eligible for benefits under title nishing services on its behalf must
XVIII of the Act, as measured by the
meet applicable State licensing and
total number of CMHC clients treated
certification requirements.
by the CMHC for whom services are not
paid for by Medicare, divided by the (c) Standard: Professional management
total number of clients treated by the responsibility. A CMHC that has a writ-
CMHC for each 12-month period of en- ten agreement with another agency, in-
rollment. dividual, or organization to furnish any
(A) A CMHC is required to submit to services under arrangement must re-
CMS a certification statement pro- tain administrative and financial man-
vided by an independent entity that agement and oversight of staff and
certifies that the CMHC’s client popu- services for all arranged services. As
lation meets the 40 percent require- part of retaining financial manage-
ment specified at this paragraph ment responsibility, the CMHC must
(b)(1)(v). retain all payment responsibility for
(B) The certification statement de- services furnished under arrangement
scribed in paragraph (b)(1)(v)(A) of this on its behalf. Arranged services must
section is required upon initial applica- be supported by a written agreement
tion to enroll in Medicare, and as a which requires that all services be as
part of revalidation, including any off follows:
cycle revalidation, thereafter carried (1) Authorized by the CMHC.
out pursuant to § 424.530 of this chapter. (2) Furnished in a safe and effective
Medicare enrollment will be denied or
manner.
revoked in instances where the CMHC
fails to provide the certification state- (3) Delivered in accordance with es-
ment as required. Medicare enrollment tablished professional standards, the
will also be denied or revoked if the 40 policies of the CMHC, and the client’s
percent requirement as specified in active treatment plan.
this paragraph (b)(1)(v) is not met. (d) Standard: Staff training. (1) A
(vi) Provides individual and group CMHC must provide education about
psychotherapy utilizing a psychiatrist, CMHC care and services, and person-
psychologist, or other licensed mental centered care to all employees, volun-
health counselor, to the extent author- teers, and staff under contract who
ized under State law. have contact with clients and their
(vii) Provides physician services. families.
280
(2) A CMHC must provide an initial (2) Provide the services and meet the
orientation for each individual fur- requirements specified in § 410.44 of this
nishing services that addresses the spe- chapter.
cific duties of his or her job. (3) Meet the requirements for cov-
(3) A CMHC must assess the skills erage as described in § 410.111 of this
and competence of all individuals fur- chapter.
nishing care and, as necessary, provide (4) Meet the content of certification
in-service training and education pro- and plan of treatment requirements as
grams where indicated. The CMHC described in § 424.24(d) of this chapter.
must have written policies and proce- (h) Standard: Compliance with Federal,
dures describing its method(s) of as- State, and local laws and regulations re-
lated to the health and safety of clients.
sessing competency and must maintain
The CMHC and its staff must operate
a written description of the in-service
and furnish services in compliance with
training provided during the previous
all applicable Federal, State, and local
12 months.
laws and regulations related to the
(e) Standard: Physical environment—(1) health and safety of clients. If State or
Environmental conditions. The CMHC local law provides for licensing of
must provide a safe, functional, sani- CMHCs, the CMHC must be licensed.
tary, and comfortable environment for The CMHC staff must follow the
clients and staff that is conducive to CMHC’s policies and procedures.
the provision of services that are iden-
tified in paragraph (b) of this section. [78 FR 64630, Oct. 29, 2013, as amended at 88
FR 82183, Nov. 22, 2023]
(2) Building. The CMHC services must
be provided in a location that meets § 485.920 Condition of participation:
Federal, State, and local health and Emergency preparedness.
safety standards and State health care The Community Mental Health Cen-
occupancy regulations. ter (CMHC) must comply with all ap-
(3) Infection control. There must be plicable Federal, State, and local emer-
policies, procedures, and monitoring gency preparedness requirements. The
for the prevention, control, and inves- CMHC must establish and maintain an
tigation of infection and communicable emergency preparedness program that
diseases with the goal of avoiding meets the requirements of this section.
sources and transmission of infection. The emergency preparedness program
(4) Therapy sessions. The CMHC must must include, but not be limited to, the
ensure that individual or group ther- following elements:
apy sessions are conducted in a manner (a) Emergency plan. The CMHC must
that maintains client privacy and en- develop and maintain an emergency
sures client dignity. preparedness plan that must be re-
(f) Standard: Partial hospitalization viewed, and updated at least every 2
services. A CMHC providing partial hos- years. The plan must do all of the fol-
pitalization services must— lowing:
(1) Provide services as defined in (1) Be based on and include a docu-
§ 410.2 of this chapter. mented, facility-based and community-
(2) Provide the services and meet the based risk assessment, utilizing an all-
requirements specified in § 410.43 of this hazards approach.
(2) Include strategies for addressing
chapter.
emergency events identified by the
(3) Meet the requirements for cov- risk assessment.
erage as described in § 410.110 of this (3) Address client population, includ-
chapter. ing, but not limited to, the type of
(4) Meet the content of certification services the CMHC has the ability to
and plan of treatment requirements as provide in an emergency; and con-
described in § 424.24(e) of this chapter. tinuity of operations, including delega-
(g) Standard: Intensive outpatient serv- tions of authority and succession
ices. A CMHC providing intensive out- plans.
patient services must— (4) Include a process for cooperation
(1) Provide services as defined in and collaboration with local, tribal, re-
§ 410.2 of this chapter. gional, State, and Federal emergency
281
§ 485.920 42 CFR Ch. IV (10–1–24 Edition)
preparedness officials’ efforts to main- identified by emergency management

tain an integrated response during a officials.
disaster or emergency situation. (c) Communication plan. The CMHC
(b) Policies and procedures. The CMHC must develop and maintain an emer-
must develop and implement emergency preparedness communication
gency preparedness policies and proce- plan that complies with Federal, State,
dures, based on the emergency plan set and local laws and must be reviewed
forth in paragraph (a) of this section, and updated at least every 2 years. The
risk assessment at paragraph (a)(1) of communication plan must include all
this section, and the communication of the following:
plan at paragraph (c) of this section. (1) Names and contact information
The policies and procedures must be re- for the following:
viewed and updated at least every 2 (i) Staff.
years. At a minimum, the policies and (ii) Entities providing services under
procedures must address the following: arrangement.
(1) A system to track the location of (iii) Clients’ physicians.
on-duty staff and sheltered clients in (iv) Other CMHCs.
the CMHC’s care during and after an (v) Volunteers.
emergency. If on-duty staff and shel- (2) Contact information for the fol-
tered clients are relocated during the lowing:
emergency, the CMHC must document (i) Federal, State, tribal, regional,
the specific name and location of the and local emergency preparedness
receiving facility or other location. staff.
(2) Safe evacuation from the CMHC,
which includes consideration of care
communicating with the following:
and treatment needs of evacuees; staff
(i) CMHC’s staff.
responsibilities; transportation; identi-
(ii) Federal, State, tribal, regional,
fication of evacuation location(s); and
and local emergency management
primary and alternate means of com-
agencies.
munication with external sources of as-
(4) A method for sharing information
sistance.
and medical documentation for clients
(3) A means to shelter in place for cli- under the CMHC’s care, as necessary,
ents, staff, and volunteers who remain with other health care providers to
in the facility. maintain the continuity of care.
(4) A system of medical documenta- (5) A means, in the event of an evacu-
tion that preserves client information, ation, to release client information as
protects confidentiality of client infor- permitted under 45 CFR 164.510(b)(1)(ii).
mation, and secures and maintains the (6) A means of providing information
availability of records. about the general condition and loca-
(5) The use of volunteers in an emer- tion of clients under the facility’s care
gency or other emergency staffing as permitted under 45 CFR 164.510(b)(4).
strategies, including the process and (7) A means of providing information
role for integration of state or Feder- about the CMHC’s needs, and its ability
ally designated health care profes- to provide assistance, to the authority
sionals to address surge needs during having jurisdiction or the Incident
an emergency. Command Center, or designee.
(6) The development of arrangements (d) Training and testing. The CMHC
with other CMHCs or other providers must develop and maintain an emer-
to receive clients in the event of limi- gency preparedness training and test-
tations or cessation of operations to ing program that is based on the emer-
maintain the continuity of services to gency plan set forth in paragraph (a) of
CMHC clients. this section, risk assessment at para-
(7) The role of the CMHC under a graph (a)(1) of this section, policies and
waiver declared by the Secretary of procedures at paragraph (b) of this sec-
Health and Human Services, in accord- tion, and the communication plan at
ance with section 1135 of the Social Se- paragraph (c) of this section. The train-
curity Act, in the provision of care and ing and testing program must be re-
treatment at an alternate care site viewed and updated at least every 2
282
years. If the emergency preparedness (e) Integrated healthcare systems. If a

policies and procedures are signifi- CMHC is part of a healthcare system
cantly updated, the CMHC must con- consisting of multiple separately cer-
duct training on the updated policies tified healthcare facilities that elects
and procedures. to have a unified and integrated emer-
(1) Training. The CMHC must provide gency preparedness program, the
initial training in emergency prepared- CMHC may choose to participate in the
ness policies and procedures to all new healthcare system’s coordinated emer-
and existing staff, individuals pro- gency preparedness program. If elected,
viding services under arrangement, and
the unified and integrated emergency
volunteers, consistent with their ex-
pected roles, and maintain documenta-
tion of the training. The CMHC must the following:
demonstrate staff knowledge of emer- (1) Demonstrate that each separately
gency procedures. Thereafter, the certified facility within the system ac-
CMHC must provide emergency pre- tively participated in the development
paredness training at least every 2 of the unified and integrated emer-
years. gency preparedness program.
(2) Testing. The CMHC must conduct (2) Be developed and maintained in a
exercises to test the emergency plan at manner that takes into account each
least annually. The CMHC must: separately certified facility’s unique
(i) Participate in a full-scale exercise circumstances, patient populations,
that is community-based every 2 years; and services offered.
or (3) Demonstrate that each separately
(A) When a community-based exer- certified facility is capable of actively
cise is not accessible, conduct an indi-
using the unified and integrated emer-
vidual, facility-based every 2 years; or.
gency preparedness program and is in
(B) If the CMHC experiences an ac-
tual natural or man-made emergency compliance.
that requires activation of the emer- (4) Include a unified and integrated
gency plan, the CMHC is exempt from emergency plan that meets the require-
engaging in its next required commu- ments of paragraphs (a)(2), (3), and (4)
nity-based or individual, facility-based of this section. The unified and inte-
functional exercise following the onset grated emergency plan must also be
of the emergency event. based on and include all of the fol-
(ii) Conduct an additional exercise lowing:
every 2 years, opposite the year the (i) A documented community-based
full-scale or functional exercise under risk assessment, utilizing an all-haz-
paragraph (d)(2)(i) of this section is ards approach.
conducted, that may include, but is not (ii) A documented individual facility-
limited to following: based risk assessment for each sepa-
(A) A second full-scale exercise that rately certified facility within the
is community-based or an individual, health system, utilizing an all-hazards
approach.
(B) A mock disaster drill; or
(5) Include integrated policies and
(C) A tabletop exercise or workshop
that is led by a facilitator and includes procedures that meet the requirements
a group discussion, using a narrated, set forth in paragraph (b) of this sec-
clinically-relevant emergency scenario, tion, a coordinated communication
and a set of problem statements, di- plan and training and testing programs
rected messages, or prepared questions that meet the requirements of para-
designed to challenge an emergency graphs (c) and (d) of this section, re-
plan. spectively.
(iii) Analyze the CMHC’s response to [81 FR 64039, Sept. 16, 2016, as amended at 84
and maintain documentation of all FR 51829, Sept. 30, 2019]
drills, tabletop exercises, and emer-
gency events, and revise the CMHC’s
emergency plan, as needed.
283
PART 486—CONDITIONS FOR COV- ORGAN PROCUREMENT ORGANIZATION PROCESS

PERFORMANCE MEASURES
ERAGE OF SPECIALIZED SERVICES
486.320 Condition: Participation in Organ
FURNISHED BY SUPPLIERS Procurement and Transplantation Net-
work.
Subpart A—General Provisions 486.322 Condition: Relationships with hos-
pitals, critical access hospitals, and tis-
Sec. sue banks.
486.1 Basis and scope. 486.324 Condition: Administration and gov-
erning body.
Subpart B [Reserved] 486.326 Condition: Human resources.
486.328 Condition: Reporting of data.
Subpart C—Conditions for Coverage: 486.330 Condition: Information manage-
Portable X-Ray Services ment.
486.342 Condition: Requesting consent.
486.100 Condition for coverage: Compliance 486.344 Condition: Evaluation and manage-
with Federal, State, and local laws and ment of potential donors and organ
regulations. placement and recovery.
486.102 Condition for coverage: Supervision 486.346 Condition: Organ preparation and
by a qualified physician. transport.
486.348 Condition: Quality assessment and
486.104 Condition for coverage: Qualifica-
performance improvement (QAPI).
tions, orientation, and health of tech- 486.360 Condition for Coverage: Emergency
nical personnel. preparedness.
486.106 Condition for coverage: Referral for
service and preservation of records. Subpart H—[Reserved]
486.108 Condition for coverage: Safety
standards. Subpart I—Requirements for Home Infusion
486.110 Condition for coverage: Inspection of Therapy Suppliers
equipment.
GENERAL PROVISIONS
Subparts D–F [Reserved] 486.500 Basis and scope.
Subpart G—Requirements for Certification
and Designation and Conditions for STANDARDS FOR HOME INFUSION THERAPY
Coverage: Organ Procurement Orga- 486.520 Plan of care.
nizations 486.525 Required services.
AUTHORITY: 42 U.S.C. 273, 1302, 1320b–8, and
1395hh.
REQUIREMENTS FOR CERTIFICATION AND Subpart A—General Provisions

DESIGNATION
486.303 Requirements for certification.
486.304 Requirements for designation. (a) Statutory basis. This part is based
486.306 OPO service area size designation on the following sections of the Act:
and documentation requirements. 1102 and 1138(b), 1871 of the Social Security
486.308 Designation of one OPO for each Act, section 371(b) of the Public Health Serv-
service area. ice Act—for coverage of organ procurement
486.309 Re-certification from August 1, 2006 services.
through July 31, 2010. 1861(p)—for coverage of outpatient physical
486.310 Changes in control or ownership or therapy services furnished by physical thera-
service area. pists in independent practice.
1861(s) (3), (15), and (17)—for coverage of
RE-CERTIFICATION AND DE-CERTIFICATION portable X-ray services.
486.312 De-certification. (b) Scope. (1) This part sets forth the
486.314 Appeals. conditions for coverage of certain spe-
486.316 Re-certification and competition cialized services that are furnished by
processes. suppliers and that are not specified in
other portions of this chapter.
ORGAN PROCUREMENT ORGANIZATION OUTCOME
(2) The conditions for coverage of
REQUIREMENTS
other specialized services furnished by
486.318 Condition: Outcome measures. suppliers are set forth in the following
284
regulations which, unless otherwise in- (c) Standard—licensure or registration

dicated, are part of this chapter: of equipment. All portable X-ray equip-
(i) Ambulatory surgical center (ASC) ment used in providing portable X-ray
services—Part 416. services is licensed or registered in ac-
(ii) Ambulance services—Part 410, cordance with all applicable State and
subpart B. local laws.
(iii) ESRD services—Part 405, subpart (d) Standard—conformity with other
U. Federal, State, and local laws and regula-
(iv) Laboratory services—Part 493. tions. The supplier of portable X-ray
(v) Mammography services—Part 410, services agrees to render such services
subpart B (§ 410.34) and 21 CFR part 900, in conformity with Federal, State, and
subpart B, of the Food and Drug Ad- local laws relating to safety standards.
ministration regulations.
[34 FR 388, Jan. 10, 1969. Redesignated at 42
(vi) Rural health clinic and Federally
FR 52826, Sept. 30, 1977. Further redesignated
qualified health center services—Part and amended at 60 FR 2326, Jan. 9, 1995; 60 FR
491, subpart A. 45086, Aug. 30, 1995]
FR 31046, May 31, 2006] § 486.102 Condition for coverage: Su-
pervision by a qualified physician.
Subpart B [Reserved] Portable X-ray services are provided
under the supervision of a qualified
Subpart C—Conditions for Cov- physician.
erage: Portable X-Ray Serv- (a) Standard—physician supervision.
ices The performance of the roentgenologic
procedures is subject to the supervision
of a physician who meets the require-
AUTHORITY: Secs. 1102, 1861(s) (3), (11) and ments of paragraph (b) of this section
(12), 1864, and 1871 of the Social Security Act
(42 U.S.C. 1302, 1395x(s) (3), (11), and (12),
and one of the following requirements
1395aa and 1395hh). is met:
(1) The supervising physician owns
SOURCE: 34 FR 388, Jan. 10, 1969, unless oth-
the equipment and it is operated only
erwise noted. Redesignated at 42 FR 52826,
Sept. 30, 1977, and further redesignated and by his employees, or
amended at 60 FR 2326, Jan. 9, 1995. (2) The supervising physician cer-
tifies annually that he periodically
§ 486.100 Condition for coverage: Com- checks the procedural manuals and ob-
pliance with Federal, State, and serves the operators’ performance, that
local laws and regulations. he has verified that equipment and per-
The supplier of portable X-ray serv- sonnel meet applicable Federal, State,
ices is in conformity with all applica- and local licensure and registration re-
ble Federal, State, and local laws and quirements and that safe operating
regulations. procedures are used.
(a) Standard—licensure or registration (b) Standard—qualifications of the phy-
of supplier. In any State in which State sician supervisor. Portable X-ray serv-
or applicable local law provides for the ices are provided under the supervision
licensure or registration of suppliers of of a licensed doctor of medicine or li-
X-ray services, the supplier is (1) licensed doctor of osteopathy who is
censed or registered pursuant to such qualified by advanced training and ex-
law, or (2) approved by the agency of perience in the use of X-rays for diag-
the State or locality responsible for li- nostic purposes, i.e., he (1) is certified
censure or registration as meeting the in radiology by the American Board of
standards established for such licen- Radiology or by the American Osteo-
sure or registration. pathic Board of Radiology or possesses
(b) Standard—licensure or registration qualifications which are equivalent to
of personnel. All personnel engaged in those required for such certification, or
operating portable X-ray equipment (2) is certified or meets the require-
are currently licensed or registered in ments for certification in a medical
accordance with all applicable State specialty in which he has become
and local laws. qualified by experience and training in
285
§ 486.104 42 CFR Ch. IV (10–1–24 Edition)
the use of X-rays for diagnostic pur- (5) Considerations in determining the
poses, or (3) specializes in radiology area which will receive the primary
and is recognized by the medical com- beam;
munity as a specialist in radiology. (6) Determination of the time inter-
val at which to check personnel radi-
FR 52826, Sept. 30, 1977. Further redesignated ation monitors;
and amended at 60 FR 2326, Jan. 9, 1995; 60 FR (7) Use of the personnel radiation
45086, Aug. 30, 1995] monitor in providing an additional
check on safety of equipment;
§ 486.104 Condition for coverage: (8) Proper use and maintenance of
Qualifications, orientation and equipment;
health of technical personnel. (9) Proper maintenance of records;
Portable X-ray services are provided (10) Technical problems which may
by qualified technologists. arise and methods of solution;
(a) Standard: Qualifications of tech- (11) Protection against electrical haz-
nologists. All operators of the portable ards;
X-ray equipment meet the require- (12) Hazards of excessive exposure to
ments of paragraph (a)(1) or (2) of this radiation.
section. (c) Standard: Employee records.
(1) Successful completion of a pro- Records are maintained and include
gram of formal training in X-ray tech- evidence that—
nology at which the operator received (1) Each employee is qualified for his
appropriate training and demonstrated or her position by means of training
competence in the use of equipment and experience; and
and administration of portable x-ray (2) Employees receive adequate
procedures; or health supervision.
(2) Successful completion of 24 full
months of training and experience [34 FR 388, Jan. 10, 1969. Redesignated at 42
under the direct supervision of a physi- FR 52826, Sept. 30, 1977, and amended at 53
FR 12015, Apr. 12, 1988; 60 FR 45086, Aug. 30,
cian who is certified in radiology or 1995; 73 FR 69942, Nov. 19, 2008; 84 FR 51830,
who possesses qualifications which are Sept. 30, 2019]
equivalent to those required for such
certification. § 486.106 Condition for coverage: Re-
(b) Standard—personnel orientation. ferral for service and preservation
The supplier of portable X-ray services of records.
has an orientation program for per- All portable X-ray services performed
sonnel, based on a procedural manual for Medicare beneficiaries are ordered
which is: Available to all members of by a physician or a nonphysician prac-
the staff, incorporates relevant por- titioner as provided in § 410.32(a) of this
tions of professionally recognized docu- chapter or by a nonphysician practi-
ments, and includes instruction in all tioner as provided in § 410.32(a)(2) and
of the following: records are properly preserved.
(1) Precautions to be followed to pro- (a) Standard—referral by a physician or
tect the patient from unnecessary ex- nonphysician practitioners. Portable X-
posure to radiation; ray examinations are performed only
(2) Precautions to be followed to pro- on the order of a physician licensed to
tect an individual supporting the pa- practice in the State or by a nonphysi-
tient during X-ray procedures from un- cian practitioner acting within the
necessary exposure to radiation; scope of State law. Such nonphysician
(3) Precautions to be followed to pro- practitioners may be treated the same
tect other individuals in the sur- as physicians treating beneficiaries for
rounding environment from exposure the purpose of this paragraph. The sup-
to radiation; plier’s records show that:
(4) Precautions to be followed to pro- (1) The portable X-ray test was or-
tect the operator of portable X-ray dered by a licensed physician or a non-
equipment from unnecessary exposure physician practitioner acting within
to radiation; the State scope of law; and
286
(2) Such physician or non-physician Operating kVp Total filtration (inherent plus
added)
practitioner’s order meets the require-
ments at § 410.32 of this chapter, and in- Below 50 kVp .................. 0.5 millimeters aluminum.
cludes a statement concerning the con- 50–70 kVp ....................... 1.5 millimeters aluminum.
Above 70 kVp ................. 2.5 millimeters aluminum.
dition of the patient which indicates
why portable X-ray services are nec-
(2) If the filter in the machine is not
essary.
accessible for examination or the total
(b) Standard—records of examinations filtration is unknown, it can be as-
performed. The supplier makes for each sumed that the requirements are met if
patient a record of the date of the port- the half-value layer is not less than
able X-ray examination, the name of that shown in the following table:
the patient, a description of the proce-
dures ordered and performed, the refer- Operating kVp Half-value layer
ring physician or nonphysician practi- 50 kVp ............................. 0.6 millimeters aluminum.
tioner, the operator(s) of the portable 70 kVp ............................. 1.6 millimeters aluminum.
X-ray equipment who performed the 90 kVp ............................. 2.6 millimeters aluminum.
100 kVp ........................... 2.8 millimeters aluminum.
examination, the physician to whom 110 kVp ........................... 3.0 millimeters aluminum.
the radiograph was sent, and the date 120 kVp ........................... 3.3 millimeters aluminum.
it was sent.
(c) Standard—preservation of records. (c) Standard—termination of exposure.
Such reports are maintained for a pe- A device is provided to terminate the
riod of at least 2 years, or for the pe- exposure after a preset time or expo-
riod of time required by State law for sure.
such records (as distinguished from re- (d) Standard—control panel. The con-
quirements as to the radiograph itself), trol panel provides a device (usually a
whichever is longer. milliammeter or a means for an audi-
ble signal to give positive indication of
[34 FR 388, Jan. 10, 1969. Redesignated at 42 the production of X-rays whenever the
FR 52826, Sept. 30, 1977. Further redesignated X-ray tube is energized. The control
and amended at 60 FR 2326, Jan. 9, 1995; 60 FR panel includes appropriate indicators
45086, Aug. 30, 1995; 77 FR 69372, Nov. 16, 2012; (labelled control settings and/or me-
84 FR 51830, Sept. 30, 2019]
ters) which show the physical factors
§ 486.108 Condition for coverage: Safe- (such as kVp, mA, exposure time or
ty standards. whether timing is automatic) used for
the exposure.
X-ray examinations are conducted (e) Standard—exposure control switch.
through the use of equipment which is The exposure control switch is of the
free of unnecessary hazards for pa- dead-man type and is so arranged that
tients, personnel, and other persons in the operator can stand at least 6 feet
the immediate environment, and from the patient and well away from
through operating procedures which the useful beam.
provide minimum radiation exposure (f) Standard—protection against elec-
to patients, personnel, and other per- trical hazards. Only shockproof equip-
sons in the immediate environment. ment is used. All electrical equipment
(a) Standard—tube housing and devices is grounded.
to restrict the useful beam. The tube (g) Standard—mechanical supporting or
housing is of diagnostic type. Dia- restraining devices. Mechanical sup-
phragms, cones, or adjustable collima- porting or restraining devices are pro-
tors capable of restricting the useful vided so that such devices can be used
beam to the area of clinical interest when a patient must be held in position
are used and provide the same degree of for radiography.
protection as is required of the hous- (h) Standard—protective gloves and
ing. aprons. Protective gloves and aprons
(b) Standard—total filtration. (1) The are provided so that when the patient
aluminum equivalent of the total fil- must be held by an individual, that in-
tration in the primary beam is not less dividual is protected with these shield-
than that shown in the following table ing devices.
except when contraindicated for a par- (i) Standard—restriction of the useful
ticular diagnostic procedure. beam. Diaphragms, cones, or adjustable
287
§ 486.110 42 CFR Ch. IV (10–1–24 Edition)
collimators are used to restrict the Subpart G—Requirements for Cer-

useful beam to the area of clinical in- tification and Designation and
terest. Conditions for Coverage:
(j) Standard—personnel monitoring. A
device which can be worn to monitor
Organ Procurement Organiza-
radiation exposure (e.g., a film badge) tions
is provided to each individual who op-
erates portable X-ray equipment. The SOURCE: 71 FR 31046, May 31, 2006, unless
device is evaluated for radiation expo- otherwise noted.
sure to the operator at least monthly
and appropriate records are maintained
by the supplier of portable X-ray serv- (a) Statutory basis. (1) Section 1138(b)
ices of radiation exposure measured by of the Act sets forth the requirements
such a device for each individual. that an organ procurement organiza-
(k) Standard—personnel and public tion (OPO) must meet to have its organ
protection. No individual occupation- procurement services to hospitals cov-
ally exposed to radiation is permitted ered under Medicare and Medicaid.
to hold patients during exposures ex- These include certification as a
cept during emergencies, nor is any ‘‘qualified’’ OPO and designation as the
other individual regularly used for this OPO for a particular service area.
service. Care is taken to assure that (2) Section 371(b) of the Public Health
pregnant women do not assist in port- Service Act sets forth the requirements
able X-ray examinations. for certification and the functions that
a qualified OPO is expected to perform.
(3) Section 1102 of the Act authorizes
FR 52826, Sept. 30, 1977. Further redesignated
and amended at 60 FR 2326, Jan. 9, 1995; 60 FR the Secretary of Health and Human
45086, Aug. 30, 1995] Services to make and publish rules and
regulations necessary to the efficient
§ 486.110 Condition for coverage: In- administration of the functions that
spection of equipment. are assigned to the Secretary under the
Inspections of all X-ray equipment Act.
and shielding are made by qualified in- (4) Section 1871 of the Act authorizes
dividuals at intervals not greater than the Secretary to prescribe regulations
every 24 months. as may be necessary to carry out the
(a) Standard—qualified inspectors. In- administration of the Medicare pro-
spections are made at least every 24 gram under title XVIII.
months by a radiation health specialist (b) Scope. This subpart sets forth—
who is on the staff of or approved by an (1) The conditions and requirements
appropriate State or local government that an OPO must meet;
agency. (2) The procedures for certification
(b) Standard—records of inspection and and designation of OPOs; and
scope of inspection. The supplier main- (3) The terms of the agreement with
tains records of current inspections CMS and the basis for and the effect of
which include the extent to which de-certification.
equipment and shielding are in compli- (4) The requirements for an OPO to
ance with the safety standards outlined be re-certified.
in § 486.108.
FR 52826, Sept. 30, 1977. Further redesignated As used in this subpart, the following
and amended at 60 FR 2326, Jan. 9, 1995; 60 FR definitions apply:
45086, Aug. 30, 1995; 60 FR 50447, Sept. 29, 1995] Adverse event means an untoward, un-
desirable, and usually unanticipated
Subparts D–F [Reserved] event that causes death or serious in-
jury or the risk thereof. As applied to
OPOs, adverse events include but are
not limited to transmission of disease
288
from a donor to a beneficiary, avoid- Medicare and Medicaid payment under

able loss of a medically suitable poten- section 1138(b)(1)(F) of the Act.
tial donor for whom consent for dona- Donation rate is the number of donors
tion has been obtained, or delivery to a as a percentage of the donor potential.
transplant center of the wrong organ Donation service area (DSA) means a
or an organ whose blood type does not geographical area of sufficient size to
match the blood type of the intended ensure maximum effectiveness in the
beneficiary. procurement and equitable distribution
Agreement cycle refers to the time pe- of organs and that either includes an
riod of at least 4 years when an agree- entire metropolitan statistical area or
ment is in effect between CMS and an does not include any part of such an
OPO. area and that meets the standards of
Assessment period is a 12-month period this subpart.
in which an OPO’s outcome measures Donor means a deceased individual
will be evaluated for performance. The from whom at least one vascularized
final assessment period is the 12-month organ (heart, liver, lung, kidney, pan-
assessment period used to calculate creas, or intestine) is transplanted. An
outcome measures for re-certification. individual also would be considered a
Certification means a CMS determina- donor if only the pancreas is procured
tion that an OPO meets the require- and is used for research or islet cell
ments for certification at § 486.303. transplantation.
Death record review means an assess- Donor after cardiac death (DCD)
ment of the medical chart of a de- means an individual who donates after
ceased patient to evaluate potential for his or her heart has irreversibly
organ donation. stopped beating. A donor after cardiac
Death that is consistent with organ do- death may be termed a non-
nation means all deaths from the state heartbeating or asystolic donor.
death certificates with the primary Donor document means any docu-
cause of death listed as the ICD–10–CM mented indication of an individual’s
codes I20–I25 (ischemic heart disease); choice regarding his or her wishes con-
I60–I69 (cerebrovascular disease); V–1– cerning organ and/or tissue donation
Y89 (external causes of death): Blunt that was made by that individual or
trauma, gunshot wounds, drug over- another authorized individual in ac-
dose, suicide, drowning, and asphyxia- cordance with any applicable State
tion. law.’’
Decertification means a CMS deter- Donor potential is the number of inpa-
mination that an OPO no longer meets tient deaths within the DSA among pa-
the requirements for certification at tients 75 and younger with a primary
§ 486.303. cause of death that is consistent with
Designated requestor or effective re- organ donation. For OPOs servicing a
questor is an individual (generally em- hospital with a waiver under
ployed by a hospital), who is trained to § 486.308(e), the donor potential of the
handle or participate in the donation county for that hospital will be ad-
consent process. The designated re- justed using the proportion of Medicare
questor may request consent for dona- beneficiary inpatient deaths in the hos-
tion from the family of a potential pital compared with the total Medicare
donor or from the individual(s) respon- beneficiary inpatient deaths in the
sible for making the donation decision county.
in circumstances permitted under Entire metropolitan statistical area
State law, provide information about means a metropolitan statistical area
donation to the family or decision- (MSA), a consolidated metropolitan
maker(s), or provide support to or col- statistical area (CMSA), or a primary
laborate with the OPO in the donation metropolitan statistical area (PMSA)
consent process. listed in the State and Metropolitan
Designation means CMS assignment Area Data Book published by the U.S.
of a geographic service area to an OPO. Bureau of the Census. CMS does not
Once an OPO is certified and assigned a recognize a CMSA as a metropolitan
geographic service area, organ procure- area for the purposes of establishing a
ment costs of the OPO are eligible for geographical area for an OPO.
289
§ 486.302 42 CFR Ch. IV (10–1–24 Edition)
Kidney transplantation rate is the Organ transplantation rate is the num-

number of kidneys transplanted from ber of organs transplanted from donors
kidney donors in the DSA as a percent- in the DSA as a percentage of the
age of the donor potential. donor potential. Organs transplanted
Lowest rate among the top 25 percent into patients on the OPTN waiting list
will be calculated by taking the num- as part of research are included in the
ber of total DSAs in the time period organ transplantation rate. The organ
identified for establishing the thresh- transplantation rate will be risk-ad-
old rate. The total number of DSAs justed for the average age of the donor
will be multiplied by 0.25 and rounded potential using the following method-
to the closest integer (0.5 will round to ology:
the higher integer). The donation rates (1) The age groups used for the ad-
and organ transplantation rates in justed transplantation rates are: <1, 1–
each DSA will be separately ranked 5, 6–11, 12–17, 18–24, 25–29, 30–34, 35–39,
and the threshold rate will be the rate 40–44, 45–49, 50–54, 55–59, 60–64, 65–69, 70–
that corresponds to that integer when 75.
counting down the ranking. (2) Calculate a national age-specific
Open area means an OPO service area transplantation rate for each age
for which CMS has notified the public group.
that it is accepting applications for An expected transplantation rate for
designation. each OPO is calculated as
Organ means a human kidney, liver, è(g=1)Gdg*Rg/ègdg, where dg is the
heart, lung, pancreas, or intestine (or number of potential donors in the OPO
multivisceral organs when trans- in age group g, Rg is the age-specific
planted at the same time as an intes- national transplantation rate in age
tine). The pancreas counts as an organ group g, and ègdg is the OPO’s total
even if it is used for research or islet number of individuals in the donor po-
cell transplantation. tential. This can be interpreted as the
overall expected transplantation rate
Number of for an OPO if each of its age-specific
Organ type organs transplantation rates were equal to the
transplanted national age-specific.
(1) Right or Left Kidney ....................... 1
(3) Calculate the age-adjusted organ
(2) Right and Left Kidney .................... 2 transplantation rate as (O/E)*P, where
(3) Double/En-Bloc Kidney .................. 2 O is the OPO’s observed unadjusted
(4) Heart .............................................. 1 transplantation rate, E is the expected
(5) Intestine ......................................... 1 transplantation rate calculated in Step
(6) Intestine Segment 1 or Segment 2 1 2, and P is the unadjusted national
(7) Intestine Segment 1 and Segment transplantation rate.
2 ....................................................... 2 Re-certification cycle means the 4-year
(8) Liver ............................................... 1 cycle during which an OPO is certified.
(9) Liver Segment 1 or Segment 2 ..... 1 Transplant hospital means a hospital
(10) Liver Segments 1 and Segment 2 2 that provides organ transplants and
(11) Right or Left Lung ........................ 1 other medical and surgical specialty
(12) Right and Left Lung ..................... 2 services required for the care of trans-
(13) Double/En-bloc Lung ................... 2
plant patients. There may be one or
(14) Pancreas (transplanted whole, re-
search, islet transplant) ................... 1 more types of organ transplant centers
(15) Pancreas Segment 1 or Segment operating within the same transplant
2 ....................................................... 1 hospital.
(16) Pancreas Segment 1 and Seg- Urgent need occurs when an OPO’s
ment 2 .............................................. 2 noncompliance with one or more condi-
tions for coverage has caused, or is
Organ procurement organization (OPO) likely to cause, serious injury, harm,
means an organization that performs impairment, or death to a potential or
or coordinates the procurement, pres- actual donor or an organ beneficiary.
ervation, and transport of organs and [71 FR 31046, May 31, 2006, as amended at 77
maintains a system for locating pro- FR 29031, May 16, 2012; 81 FR 79880, Nov. 14,
spective beneficiaries for available or- 2016; 84 FR 61492, Nov. 12, 2019; 85 FR 77947,
gans. Dec. 2, 2020]
290
REQUIREMENTS FOR CERTIFICATION AND 273(b) and § 486.303 to be eligible for des-
DESIGNATION ignation.
(c) An OPO must enter into an agree-
§ 486.303 Requirements for certifi- ment with CMS in order for the organ
cation. procurement costs attributable to the
In order to be certified as a qualified OPO to be reimbursed under Medicare
organ procurement organization, an and Medicaid.
organ procurement organization must:
(a) Have received a grant under 42 § 486.306 OPO service area size des-
U.S.C. 273(a) or have been certified or ignation and documentation re-
quirements.
re-certified by the Secretary within the
previous 4 years as being a qualified (a) General documentation requirement.
OPO. An OPO must make available to CMS
(b) Be a non-profit entity that is ex- documentation verifying that the OPO
empt from Federal income taxation meets the requirements of paragraphs
under section 501 of the Internal Rev- (b) and (c) of this section at the time of
enue Code of 1986. application and throughout the period
(c) Have accounting and other fiscal of its designation.
procedures necessary to assure the fis- (b) Service area designation. The de-
cal stability of the organization, in- fined service area either includes an
cluding procedures to obtain payment entire metropolitan statistical area or
for kidneys and non-renal organs pro- a New England county metropolitan
vided to transplant hospitals. statistical area as specified by the Di-
(d) Have an agreement with CMS, as rector of the Office of Management and
the Secretary’s designated representa- Budget or does not include any part of
tive, to be reimbursed under title XVIII such an area.
for the procurement of kidneys. (c) Service area location and character-
(e) Have been re-certified as an OPO istics. An OPO must define and docu-
under the Medicare program from Jan- ment a proposed service area’s location
uary 1, 2002 through December 31, 2005. through the following information:
(f) Have procedures to obtain pay- (1) The names of counties (or parishes
ment for non-renal organs provided to in Louisiana) served or, if the service
transplant centers. area includes an entire State, the name
(g) Agree to enter into an agreement of the State.
with any hospital or critical access (2) Geographic boundaries of the serv-
hospital in the OPO’s service area, in- ice area.
cluding a transplant hospital that re- (3) The number and the names of all
quests an agreement. hospitals and critical access hospitals
(h) Meet the conditions for coverage in the service area that have both a
for organ procurement organizations, ventilator and an operating room.
which include both outcome and proc- [71 FR 31046, May 31, 2006, as amended at 79
ess performance measures. FR 27156, May 12, 2014]
(i) Meet the provisions of titles XI,
XVIII, and XIX of the Act, section § 486.308 Designation of one OPO for
371(b) of the Public Health Services each service area.
Act, and any other applicable Federal (a) CMS designates only one OPO per
regulations. service area. A service area is open for
competition when the OPO for the
§ 486.304 Requirements for designa- service area is de-certified and all ad-
tion. ministrative appeals under § 486.314 are
(a) Designation is a condition for exhausted.
payment. Payment may be made under (b) Designation periods—
the Medicare and Medicaid programs (1) General. An OPO is normally des-
for organ procurement costs attrib- ignated for a 4-year agreement cycle.
utable to payments made to an OPO by The period may be shorter, for exam-
a hospital only if the OPO has been ple, if an OPO has voluntarily termi-
designated by CMS as an OPO. nated its agreement with CMS and
(b) An OPO must be certified as a CMS selects a successor OPO for the
qualified OPO by CMS under 42 U.S.C. balance of the 4-year agreement cycle.
291
§ 486.309 42 CFR Ch. IV (10–1–24 Edition)
In rare situations, a designation period OPO within 30 days of notification of

may be longer, for example, a designa- the final determination.
tion may be extended if additional [71 FR 31046, May 31, 2006, as amended at 79
time is needed to select a successor FR 27156, May 12, 2014]
OPO to replace an OPO that has been
de-certified. § 486.309 Re-certification from August
(2) Re-Certification. Re-certification 1, 2006 through July 31, 2010.
must occur not more frequently than An OPO will be considered to be re-
once every 4 years. certified for the period of August 1, 2006
(c) Unless CMS has granted a hos- through July 31, 2010 if an OPO met the
pital a waiver under paragraphs standards to be a qualified OPO within
(d) through (f) of this section, the a 4-year period ending December 31,
hospital must enter into an agreement 2001 and has an agreement with the
only with the OPO designated to serve Secretary that is scheduled to termi-
the area in which the hospital is lo- nate on July 31, 2006. Agreements based
cated. on the August 1, 2006 through July 31,
(d) If CMS changes the OPO des- 2010 re-certification cycle will end on
ignated for an area, hospitals located January 31, 2011.
in that area must enter into agree-
ments with the newly designated OPO § 486.310 Changes in control or owner-
or submit a request for a waiver in ac- ship or service area.
cordance with paragraph (e) of this sec- (a) OPO requirements. (1) A designated
tion within 30 days of notice of the OPO considering a change in control
change in designation. (see § 413.17(b)(3)) or ownership or in its
(e) A hospital may request and CMS service area must notify CMS before
may grant a waiver permitting the hos- putting it into effect. This notification
pital to have an agreement with a des- is required to ensure that the OPO, if
ignated OPO other than the OPO des- changed, will continue to satisfy Medi-
ignated for the service area in which care and Medicaid requirements. The
the hospital is located. To qualify for a merger of one OPO into another or the
waiver, the hospital must submit data consolidation of one OPO with another
to CMS establishing that— is considered a change in control or
(1) The waiver is expected to increase ownership.
organ donations; and (2) A designated OPO considering a
(2) The waiver will ensure equitable change in its service area must obtain
treatment of patients listed for trans- prior CMS approval. In the case of a
plants within the service area served service area change that results from a
by the hospital’s designated OPO and change of control or ownership due to
within the service area served by the merger or consolidation, the OPOs
OPO with which the hospital seeks to must resubmit the information re-
enter into an agreement. quired in an application for designa-
(f) In making a determination on tion. The OPO must provide informa-
waiver requests, CMS considers— tion specific to the board structure of
(1) Cost effectiveness; the new organization, as well as oper-
(2) Improvements in quality; ating budgets, financial information,
(3) Changes in a hospital’s designated and other written documentation CMS
OPO due to changes in the definitions determines to be necessary for designa-
of metropolitan statistical areas, if ap- tion.
plicable; and (b) CMS requirements. (1) If CMS finds
(4) The length and continuity of a that the OPO has changed to such an
hospital’s relationship with an OPO extent that it no longer satisfies the
other than the hospital’s designated requirements for OPO designation,
OPO. CMS may de-certify the OPO and de-
(g) A hospital may continue to oper- clare the OPO’s service area to be an
ate under its existing agreement with open area. An OPO may appeal such a
an out-of-area OPO while CMS is proc- de-certification as set forth in § 486.314.
essing the waiver request. If a waiver The OPO’s service area is not opened
request is denied, a hospital must enter for competition until the conclusion of
into an agreement with the designated the administrative appeals process.
292
(2) If CMS finds that the changed most recent re-certification cycle, or
OPO continues to satisfy the require- the other requirements for certifi-
ments for OPO designation, the period cation at § 486.303. CMS will de-certify
of designation of the changed OPO is the OPO as of the ending date of the
the remaining portion of the 4-year agreement.
term of the OPO that was reorganized. (d) Notice to OPO. Except in cases of
If more than one designated OPO is in- urgent need, CMS gives written notice
volved in the reorganization, the re- of de-certification to an OPO at least 90
maining designation term is the long- days before the effective date of the de-
est of the remaining periods unless certification. In cases of urgent need,
CMS determines that a shorter period CMS gives written notice of de-certifi-
is in the best interest of the Medicare cation to an OPO at least 3 calendar
and Medicaid programs. The changed days prior to the effective date of the
OPO must continue to meet the re- de-certification. The notice of de-cer-
quirements for certification at § 486.303 tification states the reasons for de-cer-
throughout the remaining period. tification and the effective date.
(e) Public notice. Once CMS approves
RE-CERTIFICATION AND DE- the date for a voluntary termination,
CERTIFICATION the OPO must provide prompt public
notice in the service area of the date of
§ 486.312 De-certification. de-certification and such other infor-
(a) Voluntary termination of agreement. mation as CMS may require. In the
If an OPO wishes to terminate its case of involuntary termination or
agreement, the OPO must send CMS nonrenewal of an agreement, CMS also
written notice of its intention to ter- provides notice to the public in the
minate its agreement and the proposed service area of the date of de-certifi-
effective date. CMS may approve the cation. No payment under titles XVIII
proposed date, set a different date no or XIX of the Act will be made with re-
later than 6 months after the proposed spect to organ procurement costs at-
effective date, or set a date less than 6 tributable to the OPO on or after the
months after the proposed effective effective date of de-certification.
date if it determines that a different [71 FR 31046, May 31, 2006, as amended at 82
date would not disrupt services to the FR 38515, Aug. 14, 2017]
service area. If CMS determines that a
designated OPO has ceased to furnish § 486.314 Appeals.
organ procurement services to its serv- If an OPO’s de-certification is due to
ice area, the cessation of services is involuntary termination or non-re-
deemed to constitute a voluntary ter- newal of its agreement with CMS, the
mination by the OPO, effective on a OPO may appeal the de-certification on
date determined by CMS. CMS will de- substantive and procedural grounds.
certify the OPO as of the effective date (a) Notice of initial determination. CMS
of the voluntary termination. mails notice to the OPO of an initial
(b) Involuntary termination of agree- de-certification determination. The no-
ment. During the term of the agree- tice contains the reasons for the deter-
ment, CMS may terminate an agree- mination, the effect of the determina-
ment with an OPO if the OPO no longer tion, and the OPO’s right to seek re-
meets the requirements for certifi- consideration.
cation at § 486.303. CMS may also termi- (b) Reconsideration. (1) Filing request.
nate an agreement immediately in If the OPO is dissatisfied with the de-
cases of urgent need, such as the dis- certification determination, it has 15
covery of unsound medical practices. business days from receipt of the no-
CMS will de-certify the OPO as of the tice of de-certification to seek recon-
effective date of the involuntary termi- sideration from CMS. The request for
nation. reconsideration must state the issues
(c) Non-renewal of agreement. CMS or findings of fact with which the OPO
will not voluntarily renew its agree- disagrees and the reasons for disagree-
ment with an OPO if the OPO fails to ment.
meet the requirements for certification (2) An OPO must seek reconsider-
at § 486.318, based on findings from the ation before it is entitled to seek a
293
§ 486.314 42 CFR Ch. IV (10–1–24 Edition)
hearing before a hearing officer. If an no more than 60 calendar days fol-

OPO does not request reconsideration lowing the receipt of the request for a
or its request is not made timely, the hearing.
OPO has no right to further adminis- (g) Conduct of hearing. (1) The hearing
trative review. is open to both parties, CMS and the
(3) Reconsideration determination. CMS OPO.
makes a written reconsidered deter- (2) The hearing officer inquires fully
mination within 10 business days of re- into all the matters at issue and re-
ceipt of the request for reconsider- ceives in evidence the testimony of
ation, affirming, reversing, or modi- witnesses and any documents that are
fying the initial determination and the relevant and material.
findings on which it was based. CMS (3) The hearing officer provides the
augments the administrative record to parties with an opportunity to enter an
include any additional materials sub- objection to the inclusion of any docu-
mitted by the OPO, and a copy of the ment. The hearing officer will consider
reconsideration decision and sends the the objection and will rule on the docu-
supplemented administrative record to ment’s admissibility.
the CMS hearing officer. (4) The hearing officer decides the
(c) Request for hearing. An OPO disorder in which the evidence and the ar-
satisfied with the CMS reconsideration guments of the parties are presented
decision, must file a request for a hear- and the conduct of the hearing.
ing before a CMS hearing officer within (5) The hearing officer rules on the
40 business days of receipt of the notice admissibility of evidence and may
of the reconsideration determination. admit evidence that would be inadmis-
If an OPO does not request a hearing or sible under rules applicable to court
its request is not received timely, the procedures.
OPO has no right to further adminis- (6) The hearing officer rules on mo-
trative review. tions and other procedural items.
(d) Administrative record. The hearing (7) The hearing officer regulates the
officer sends the administrative record course of the hearing and conduct of
to both parties within 10 business days counsel.
of receipt of the request for a hearing. (8) The hearing officer may examine
(1) The administrative record con- witnesses.
sists of, but is not limited to, the fol-
(9) The hearing officer takes any ac-
lowing:
tion authorized by the rules in this
(i) Factual findings from the sur-
subpart.
vey(s) on the OPO conditions for cov-
(h) Parties’ rights. CMS and the OPO
erage.
may:
(ii) Data from the outcome measures.
(iii) Rankings of OPOs based on the (1) Appear by counsel or other au-
outcome data. thorized representative, in all hearing
(iv) Correspondence between CMS proceedings.
and the affected OPO. (2) Participate in any pre-hearing
(2) The administrative record will not conference held by the hearing officer.
include any privileged information. (3) Agree to stipulations as to facts
(e) Pre-Hearing conference. At any which will be made a part of the
time before the hearing, the CMS hear- record.
ing officer may call a pre-hearing con- (4) Make opening statements at the
ference if he or she believes that a con- hearing.
ference would more clearly define the (5) Present relevant evidence on the
issues. At the pre-hearing conference, issues at the hearing.
the hearing officer may establish the (6) Present witnesses, who then must
briefing schedule, sets the hearing be available for cross-examination, and
date, and addresses other administra- cross-examine witnesses presented by
tive matters. The hearing officer will the other party.
issue an order reflecting the results of (7) Present oral arguments at the
the pre-hearing conference. hearing.
(f) Date of hearing. The hearing offi- (i) Hearing officer’s decision. The
cer sets a date for the hearing that is hearing officer renders a decision on
294
the appeal of the notice of de-certifi- the final assessment period of the
cation within 20 business days of the agreement cycle.
hearing. (2) Tier 2. An OPO’s DSA is open for
(1) Reversal of de-certification. If the competition and the OPO is eligible to
hearing officer reverses CMS’ deter- compete to retain its DSA and for any
mination to de-certify an OPO in a case open DSA if it meets all of the fol-
involving the involuntary termination lowing:
of the OPO’s agreement, CMS will not (i) It has been shown by survey to be
terminate the OPO’s agreement and in compliance with the requirements
will not de-certify the OPO. for certification at § 486.303, including
(2) De-certification is upheld. If the de- the conditions for coverage at §§ 486.320
certification determination is upheld through 486.360; and
by the hearing officer, the OPO is de- (ii) It meets the outcome require-
certified and it has no further adminis- ments as described in § 486.318(e)(5) at
trative appeal rights. the final assessment period of the
(j) Extension of agreement. If there is agreement cycle.
insufficient time prior to expiration of (3) Tier 3. An OPO will receive a no-
an agreement with CMS to allow for tice of de-certification determination
competition of the service area and, if under § 486.314 and cannot compete for
any open DSA if it meets either of the
necessary, transition of the service
following:
area to a successor OPO, CMS may
(i) Has been shown by survey to not
choose to extend the OPO’s agreement
be in compliance with the require-
with CMS.
ments for certification at § 486.303, in-
(k) Effects of de-certification. Medicare cluding the conditions for coverage at
and Medicaid payments may not be §§ 486.320 through 486.360; or
made for organ procurement services (ii) Has outcome requirements as de-
the OPO furnishes on or after the effec- scribed in § 486.318(e)(6) at the final as-
tive date of de-certification. CMS will sessment period of the agreement
then open the de-certified OPO’s serv- cycle.
ice area for competition as set forth in (b) De-certification and competition. If
§ 486.316(c). an OPO fails to meet the outcome
§ 486.316 Re-certification and competi- measures set forth in § 486.318(e)(6) at
tion processes. the final assessment period prior to the
end of the agreement cycle, or it meets
(a) Re-certification of OPOs. Based the requirements described in para-
upon performance on the outcome graph (a)(3) of this section:
measures set forth in § 486.318 and the (1) CMS will send the OPO a notice of
re-certification survey, each OPO will its initial de-certification determina-
be designated into either Tier 1, Tier 2, tion and the OPO has the right to ap-
or Tier 3. The tier in which the OPO is peal as established in § 486.314;
designated will determine whether the (2) If the OPO does not appeal or the
OPO is re-certified (Tier 1), must com- OPO appeals and the reconsideration
pete to retain its DSA (Tier 2), or will official and CMS hearing officer uphold
receive an initial de-certification de- the de-certification, the OPO’s service
termination (Tier 3). area is opened for competition from
(1) Tier 1. An OPO is re-certified for other OPOs that qualify to compete for
at least an additional 4 years, the open service areas as set forth in para-
OPO’s DSA is not opened for competi- graph (c) of this section. The de-cer-
tion, and the OPO can compete for any tified OPO is not permitted to compete
open DSA if it meets all of the fol- for its open area or any other open
lowing: area.
(i) It has been shown by survey to be (3) The OPO competing for the open
in compliance with the requirements service area must submit information
for certification at § 486.303, including and data that describe the barriers in
the conditions for coverage at §§ 486.320 its service area, how they affected
through 486.360; and organ donation, what steps the OPO
(ii) It meets the outcome require- took to overcome them, and the re-
ments as described in § 486.318(e)(4) for sults.
295
§ 486.318 42 CFR Ch. IV (10–1–24 Edition)
(c) Criteria to compete. To compete for outcome measure requirements de-

an open DSA, an OPO must meet the scribed in § 486.318(a)(1) and (3) for OPOs
performance requirements of the out- not operating exclusively in the non-
come measures for Tier 1 or Tier 2 at contiguous States, Commonwealths,
§ 486.318(e)(4) and (5), and the require- Territories, or possessions; or
ments for certification at § 486.303, in- § 486.318(b)(1) and (3) for OPOs operating
cluding the conditions for coverage at exclusively in noncontiguous States,
§§ 486.320 through 486.360 at the most re- Commonwealths, Territories, and pos-
cent routine survey. The OPO must sessions. An OPO is not required to
compete for the entire DSA. meet the second outcome measure de-
(d) Criteria for selection. CMS will des- scribed in § 486.318(a)(2) or (b)(2) for the
ignate an OPO for an open service area 2022 recertification cycle. If an OPO
based on the following criteria: does not meet one of the outcome
(1) Performance on the outcome measures as described in paragraphs
measures at § 486.318; § 486.318(a)(1), (a)(3), (b)(1), or (b)(3), or
(2) Relative success in meeting the has been shown by survey to not be in
process performance measures and compliance with the requirements for
other conditions at §§ 486.320 through certification at § 486.303, including the
486.348; conditions for coverage at §§ 486.320
(3) Contiguity to the open service through 486.360, the OPO is de-certified.
area. If the OPO does not appeal or the OPO
(4) Success in identifying and over- appeals and the reconsideration official
coming barriers to donation within its and CMS hearing officer uphold the de-
own service area and the relevance of certification, the OPO’s service area is
those barriers to barriers in the open opened for competition from other
area. An OPO competing for an open OPOs. The de-certified OPO is not per-
service area must submit information mitted to compete for its open area or
and data that describe the barriers in any other open area. An OPO com-
its service area, how they affected peting for an open service area must
organ donation, what steps the OPO submit information and data that de-
took to overcome them, and the re- scribe the barriers in its service area,
sults. how they affected organ donation,
(e) No OPO applies. If no OPO applies what steps the OPO took to overcome
to compete for a de-certified OPO’s them, and the results.
open area, CMS may select a single [71 FR 31046, May 31, 2006, as amended at 78
OPO to take over the entire open area FR 75199, Dec. 10, 2013; 84 FR 61492, Nov. 12,
or may adjust the service area bound- 2019; 85 FR 77947, Dec. 2, 2020]
aries of two or more contiguous OPOs
to incorporate the open area. CMS will ORGAN PROCUREMENT ORGANIZATION
make its decision based on the criteria OUTCOME REQUIREMENTS
in paragraph (d) of this section.
(f) Extension of the agreement cycle for § 486.318 Condition: Outcome meas-
extraordinary circumstances. OPOs can ures.
seek a 1-year extension of the agree- (a) With the exception of OPOs oper-
ment cycle if there are extraordinary ating exclusively in noncontiguous
circumstances beyond the control of States, Commonwealths, Territories,
the OPOs that has affected the data of or possessions, an OPO must meet two
the final assessment period so that it out of the three following outcome
does not accurately capture their per- measures:
formance. OPOs must request this ex- (1) The OPO’s donation rate of eligi-
tension within 90 days of the end of the ble donors as a percentage of eligible
occurrence of the extraordinary cir- deaths is no more than 1.5 standard de-
cumstance but no later than the last viations below the mean national dona-
day of the final assessment period. tion rate of eligible donors as a per-
(g) Exception. For the 2022 recertifi- centage of eligible deaths, averaged
cation cycle only, an OPO is recertified over the 4 years of the re-certification
for an additional 4 years and its service cycle. Both the numerator and denomi-
area is not opened for competition nator of an individual OPO’s donation
when the OPO meets one out of the two rate ratio are adjusted by adding a 1
296
for each donation after cardiac death ments of the most current OPTN ag-
donor and each donor over the age of gregate donor yield measure.
70; (i) The initial criteria used to iden-
(2) The observed donation rate is not tify OPOs with lower than expected
significantly lower than the expected organ yield, for all organs as well as for
donation rate for 18 or more months of each organ type, will include all of the
the 36 months of data used for re-cer- following:
tification, as calculated by the SRTR; (A) More than 10 fewer observed or-
(3) The OPO data reports, averaged gans per 100 donors than expected yield
over the 4 years of the recertification (Observed per 100 donors—Expected per
cycle, must meet the rules and require- 100 donors <¥10);
ments of the most current OPTN ag- (B) A ratio of observed to expected
gregate donor yield measure. yield less than 0.90; and
(i) The initial criteria used to iden- (C) A two-sided p-value is less than
tify OPOs with lower than expected 0.05.
organ yield, for all organs as well as for (ii) The number of organs used for re-
each organ type, will include all of the search per donor, including pancreata
following: used for islet cell research.
(A) More than 10 fewer observed or- (4) The outcome measures described
gans per 100 donors than expected yield in § 486.318(b)(1) through (3) are effec-
(Observed per 100 donors—Expected per tive until July 31, 2022.
100 donors <¥10); (c) Data for the outcome measures.
(1) An OPO’s performance on the out-
(B) A ratio of observed to expected
come measures is based on 36 months
yield less than 0.90; and
of data, beginning with January 1 of
(C) A two-sided p-value is less than
the first full year of the re-certifi-
0.05.
cation cycle and ending 36 months
(ii) The number of organs used for re- later on December 31, 7 months prior to
search per donor, including pancreata the end of the re-certification cycle.
used for islet cell research. (2) If an OPO takes over another
(4) The outcome measures described OPO’s service area on a date later than
in § 486.318(a)(1) through (3) are effec- January 1 of the first full year of the
tive until July 31, 2022. re-certification cycle so that 36 months
(b) For OPOs operating exclusively in of data are not available to evaluate
noncontiguous States, Common- the OPO’s performance in its new serv-
wealths, Territories, and possessions, ice area, we will not hold the OPO ac-
an OPO must meet two out of the three countable for its performance in the
following outcome measures: new area until the end of the following
(1) The OPO’s donation rate of eligi- re-certification cycle when 36 months
ble donors as a percentage of eligible of data are available.
deaths is no more than 1.5 standard de- (3) An OPO’s performance on the out-
viations below the mean national dona- come measures described in
tion rate of eligible donors as a per- § 486.318(a)(1) through (3) and
centage of eligible deaths, averaged § 486.318(b)(1) through (3) is based on the
over the 4 years of the re-certification data described in § 486.318(c)(1) and (2)
cycle. Both the numerator and denomi- until July 31, 2022.
nator of an individual OPO’s donation (d) An OPO is evaluated by meas-
rate ratio are adjusted by adding a 1 uring the donation rate and the organ
for each donation after cardiac death transplantation rate in their DSA.
donor and each donor over the age of (1) For all OPOs, except as set forth
70; in paragraph (d)(2) of this section, for
(2) The observed donation rate is not all OPOs:
significantly lower than the expected (i) The donation rate is calculated as
donation rate for 18 or more months of the number of donors in the DSA as a
the 36 months of data used for re-cer- percentage of the donor potential.
tification, as calculated by the SRTR; (ii) The organ transplantation rate is
(3) The OPO data reports, averaged calculated as the number of organs
over the 4 years of the recertification transplanted from donors in the DSA
cycle, must meet the rules and require- as a percentage of the donor potential.
297
§ 486.318 42 CFR Ch. IV (10–1–24 Edition)
The organ transplantation rate is ad- accordance with the following param-
justed for the average age of the donor eters and requirements:
potential. (1) For each assessment period,
(iii) The numerator for the donation threshold rates will be established
rate is the number of donors in the based on donation rates during the 12-
DSA. The numerator for the organ month period immediately prior to the
transplantation rate is the number of period being evaluated:
organs transplanted from donors in the (i) The lowest rate among the top 25
DSA. The numbers of donors and or- percent in DSAs, and
gans transplanted are based on the (ii) The median rate among the
data submitted to the OPTN as re- DSAs.
quired in § 486.328 and § 121.11 of this (2) For each assessment period,
title. For calculating each measure, threshold rates will be established
the data used is from the same time pe- based on the organ transplantation or
riod as the data for the donor poten- kidney transplantation rates during
tial. the 12-month period prior to the period
(iv) The denominator for the outcome being evaluated:
measures is the donor potential and is (i) The lowest rate among the top 25
based on inpatient deaths within the percent, and
DSA from patients 75 or younger with (ii) The median rate among the
a primary cause of death that is con- DSAs.
sistent with organ donation. The data (3) The 95 percent confidence interval
is obtained from the most recent 12- for each DSA’s donation and organ
months data from state death certifi- transplantation rates will be cal-
cates. culated using a one-sided test.
(2) For the OPO representing the Ha- (4) Tier 1—OPOs that have an upper
waii DSA: limit of the one-sided 95 percent con-
(i) The donation rate is calculated as fidence interval for their donation and
the number of donors in the DSA as a organ transplantation rates that are at
percentage of the donor potential. or above the top 25 percent threshold
(ii) The kidney transplantation rate rate established for their DSA will be
is calculated as the number of kidneys identified at each assessment period.
transplanted from kidney donors in the (5) Tier 2—OPOs that have an upper
DSA as a percentage of the donor po- limit of the one-sided 95 percent con-
tential. fidence interval for their donation and
(iii) The numerator for the donation organ transplantation rates that are at
rate is the number of donors in the or above the median threshold rate es-
DSA. The numerator for the kidney tablished for their DSA but is not in
transplantation rate is the number of Tier 1 as described in paragraph (e)(4)
kidneys transplanted from kidney do- of this section will be identified at
nors in the DSA. The numbers of do- each assessment period.
nors and kidneys transplanted are (6) Tier 3—OPOs that have an upper
based on the data submitted to the limit of the one-sided 95 percent con-
OPTN as required in § 486.328 and fidence interval for their donation or
§ 121.11 of this title. For calculating organ transplantation rates that are
each measure, the data used is from below the median threshold rate estab-
the same time period as the data for lished for their DSA will be identified
the donor potential. at each assessment period. OPOs that
(iv) The denominator for the outcome have an upper limit of the one-sided 95
measures is the donor potential and is percent confidence interval for their
based on inpatient deaths within the donation and organ transplantation
DSA from patients 75 or younger with rates that are below the median
a primary cause of death that is con- threshold rate for their DSA are also
sistent with organ donation. The data included in Tier 3.
is obtained from the most recent 12- (7) For the OPO exclusively serving
months data from state death certifi- the DSA that includes the non-contig-
cates. uous state of Hawaii and surrounding
(e) An OPO must demonstrate a suc- territories, the kidney transplantation
cess rate on the outcome measures in rate will be used instead of the organ
298
transplantation rate. The comparative § 486.322 Condition: Relationships

performance and designation to a Tier with hospitals, critical access hos-
will be the same as in paragraphs (e)(4), pitals, and tissue banks.
(5), and (6) of this section except kid- (a) Standard: Hospital agreements.
ney transplantation rates will be used. An OPO must have a written agree-
(f)(1) An OPO’s performance on the ment with 95 percent of the Medicare
outcome measures is based on an eval- and Medicaid participating hospitals
uation at least every 12 months, with and critical access hospitals in its serv-
the most recent 12 months of data ice area that have both a ventilator
available from the OPTN and state and an operating room and have not
death certificates, beginning January 1 been granted a waiver by CMS to work
of the first year of the agreement cycle with another OPO. The agreement
and ending December 31, prior to the must describe the responsibilities of
end of the agreement cycle. both the OPO and hospital or critical
(2) An assessment period is the most access hospital in regard to donation
recent 12 months prior to the evalua- after cardiac death (if the OPO has a
tion of the outcome measures in which protocol for donation after cardiac
death) and the requirements for hos-
data is available.
pitals at § 482.45 or § 485.643. The agree-
(3) If an OPO takes over another ment must specify the meaning of the
OPO’s DSA on a date later than Janu- terms ‘‘timely referral’’ and ‘‘immi-
ary 1 of the first year of the agreement nent death.’’
cycle so that 12 months of data are not (b) Standard: Designated requestor
available to evaluate the OPO’s per- training for hospital staff. The OPO
formance in its new DSA, we will hold must offer to provide designated re-
the OPO accountable for its perform- questor training on at least an annual
ance on the outcome measures in the basis for hospital and critical access
new area once 12 months of data are hospital staff.
available. (c) Standard: Cooperation with tissue
banks.
FR 75199, Dec. 10, 2013; 81 FR 79881, Nov. 14, (1) The OPO must have arrangements
2016; 85 FR 77948, Dec. 2, 2020] to cooperate with tissue banks that
have agreements with hospitals and
ORGAN PROCUREMENT ORGANIZATION critical access hospitals with which the
PROCESS PERFORMANCE MEASURES OPO has agreements. The OPO must
cooperate in the following activities,
§ 486.320 Condition: Participation in as may be appropriate, to ensure that
Organ Procurement and Transplan- all usable tissues are obtained from po-
tation Network. tential donors:
After being designated, an OPO must (i) Screening and referral of potential
become a member of, participate in, tissue donors.
(ii) Obtaining informed consent from
and abide by the rules and require-
families of potential tissue donors.
ments of the OPTN established and op-
(iii) Retrieval, processing, preserva-
erated in accordance with section 372 of
tion, storage, and distribution of tis-
the Public Health Service Act (42 sues.
U.S.C. 274). The term ‘‘rules and re- (iv) Providing designated requestor
quirements of the OPTN’’ means those training.
rules and requirements approved by the (2) An OPO is not required to have an
Secretary. No OPO is considered out of arrangement with a tissue bank that is
compliance with section 1138(b)(1)(D) of unwilling to have an arrangement with
the Act or this section until the Sec- the OPO.
retary approves a determination that
the OPO failed to comply with the § 486.324 Condition: Administration
rules and requirements of the OPTN. and governing body.
The Secretary may impose sanctions (a) While an OPO may have more
under section 1138 only after such non- than one board, the OPO must have an
compliance has been determined in this advisory board that has both the au-
manner. thority described in paragraph (b) of
299
§ 486.324 42 CFR Ch. IV (10–1–24 Edition)
this section and the following member- (7) Transportation of organs to trans-
ship: plant hospitals.
(1) Members who represent hospital (8) Coordination of activities with
administrators, either intensive care or transplant hospitals in the OPO’s serv-
emergency room personnel, tissue ice area.
banks, and voluntary health associa- (9) Participation in the OPTN.
tions in the OPO’s service area. (10) Arrangements to cooperate with
(2) Individuals who represent the pub- tissue banks for the retrieval, proc-
lic residing in the OPO’s service area. essing, preservation, storage, and dis-
(3) A physician with knowledge, expe- tribution of tissues as may be appro-
rience, or skill in the field of human priate to assure that all useable tissues
histocompatibility, or an individual are obtained from potential donors.
with a doctorate degree in a biological (11) Annual evaluation of the effec-
science and with knowledge, experi- tiveness of the OPO in acquiring or-
ence, or skills in the field of human gans.
histocompatibility. (12) Assistance to hospitals in estab-
(4) A neurosurgeon or other physician lishing and implementing protocols for
with knowledge or skills in the neuro- making routine inquiries about organ
sciences. donations by potential donors.
(5) A transplant surgeon representing (c) The advisory board described in
each transplant hospital in the service paragraph (a) of this section has no au-
area with which the OPO has arrange- thority over any other activity of the
ments to coordinate its activities. The OPO and may not serve as the OPO’s
transplant surgeon must have prac- governing body or board of directors.
ticing privileges and perform trans- Members of the advisory board de-
plants in the transplant hospital rep- scribed in paragraph (a) of this section
resented. are prohibited from serving on any
(6) An organ donor family member. other OPO board.
(b) The OPO board described in para- (d) The OPO must have bylaws for
graph (a) of this section has the au- each of its board(s) that address poten-
thority to recommend policies for the tial conflicts of interest, length of
following: terms, and criteria for selecting and re-
(1) Procurement of organs. moving members.
(2) Effective agreements to identify (e) A governing body must have full
potential organ donors with a substan- legal authority and responsibility for
tial majority of hospitals in its service the management and provision of all
area that have facilities for organ do- OPO services and must develop and
nation. oversee implementation of policies and
(3) Systematic efforts, including pro- procedures considered necessary for the
fessional education, to acquire all use- effective administration of the OPO,
able organs from potential donors. including fiscal operations, the OPO’s
(4) Arrangements for the acquisition quality assessment and performance
and preservation of donated organs and improvement (QAPI) program, and
provision of quality standards for the services furnished under contract or ar-
acquisition of organs that are con- rangement, including agreements for
sistent with the standards adopted by these services. The governing body
the OPTN, including arranging for must appoint an individual to be re-
testing with respect to preventing the sponsible for the day-to-day operation
acquisition of organs that are infected of the OPO.
with the etiologic agent for acquired (f) The OPO must have procedures to
immunodeficiency syndrome (AIDS). address potential conflicts of interest
(5) Appropriate tissue typing of or- for the governing body described in
gans. paragraph (d) of this section.
(6) A system for allocation of organs (g) The OPO’s policies must state
among transplant patients that is con- whether the OPO recovers organs from
sistent with the rules and requirements donors after cardiac death.
of the OPTN, as defined in § 486.320 of [71 FR 31046, May 31, 2006, as amended at 77
this part. FR 29031, May 16, 2012]
300
§ 486.326 Condition: Human resources. to the extent possible, preserves them

for transplantation.
All OPOs must have a sufficient num-
(c) Standard: Education, training, and
ber of qualified staff, including a direc-
performance evaluation. The OPO must
tor, a medical director, organ procure-
provide its staff with the education,
ment coordinators, and hospital devel-
training, and supervision necessary to
opment staff to obtain all usable or-
furnish required services. Training
gans from potential donors, and to en-
must include but is not limited to per-
sure that required services are provided
formance expectations for staff, appli-
to families of potential donors, hos-
cable organizational policies and proce-
pitals, tissue banks, and individuals
dures, and QAPI activities. OPOs must
and facilities that use organs for re-
evaluate the performance of their
search.
staffs and provide training, as needed,
(a) Standard: Qualifications. (1) The to improve individual and overall staff
OPO must ensure that all individuals performance and effectiveness.
who provide services and/or supervise (d) Standard: Medical director. The
services, including services furnished OPO’s medical director is a physician
under contract or arrangement, are licensed in at least one of the States or
qualified to provide or supervise the territories within the OPO’s service
services. area or as required by State or terri-
(2) The OPO must develop and imple- tory law or by the jurisdiction in which
ment a written policy that addresses the OPO is located. The medical direc-
potential conflicts of interest for the tor is responsible for implementation
OPO’s director, medical director, sen- of the OPO’s protocols for donor eval-
ior management, and procurement co- uation and management and organ re-
ordinators. covery and placement. The medical di-
(3) The OPO must have credentialing rector is responsible for oversight of
records for physicians and other practi- the clinical management of potential
tioners who routinely recover organs in donors, including providing assistance
hospitals under contract or arrange- in managing a donor case when the sur-
ment with the OPO and ensure that all geon on call is unavailable.
physicians and other practitioners who
recover organs in hospitals with which § 486.328 Condition: Reporting of data.
the OPO has agreements are qualified (a) An OPO must provide individ-
and trained. ually-identifiable, hospital-specific
(b) Standard: Staffing. (1) The OPO organ donation and transplantation
must provide sufficient coverage, ei- data and other information to the
ther by its own staff or under contract Organ Procurement and Transplan-
or arrangement, to assure both that tation Network, the Scientific Registry
hospital referral calls are screened for of Transplant Recipients, and HHS, as
donor potential and that potential do- requested by the Secretary. The data
nors are evaluated for medical suit- may include, but are not limited to:
ability for organ and/or tissue donation (1) Number of hospital deaths;
in a timely manner. (2) Results of death record reviews;
(2) The OPO must have a sufficient (3) Number and timeliness of referral
number of qualified staff to provide in- calls from hospitals;
formation and support to potential (4) [Reserved]
organ donor families; request consent (5) Data related to non-recovery of
for donation; ensure optimal mainte- organs;
nance of the donor, efficient placement (6) Data about consents for donation;
of organs, and adequate oversight of (7) Number of donors;
organ recovery; and conduct QAPI ac- (8) Number of organs recovered, by
tivities, such as death record reviews type of organ; and
and hospital development. (9) Number of organs transplanted,
(3) The OPO must provide a sufficient by type of organ.
number of recovery personnel, either (b) An OPO must provide hospital-
from its own staff or under contract or specific organ donation data annually
arrangement, to ensure that all usable to the transplant hospitals with which
organs are recovered in a manner that, it has agreements.
301
§ 486.330 42 CFR Ch. IV (10–1–24 Edition)
(c) Data to be used for OPO re-certifi- (a) Donor information. The OPO must
cation purposes must be reported to maintain a record for every donor. The
the OPTN and must include data for all record must include, at a minimum, in-
deaths in all hospitals and critical ac- formation identifying the donor (for
cess hospitals in the OPO’s donation example, name, address, date of birth,
service area, unless a hospital or crit- social security number or other unique
ical access hospital has been granted a identifier, such as Medicare health in-
waiver to work with a different OPO. surance claim number), organs and
(d) Data reported by the OPO to the (when applicable) tissues recovered,
OPTN must be reported within 30 days date of the organ recovery, donor man-
after the end of the month in which a agement data, all test results, current
death occurred. If an OPO determines hospital history, past medical and so-
through death record review or other cial history, the pronouncement of
means that the data it reported to the death, and consent and next-of-kin in-
OPTN was incorrect, it must report the formation.
corrected data to the OPTN within 30 (b) Disposition of organs. The OPO
days of the end of the month in which must maintain records showing the dis-
the error is identified. position of each organ recovered for
(e) For the purpose of determining the purpose of transplantation, includ-
the information to be collected under ing information identifying transplant
paragraph (a) of this section, the fol- beneficiaries.
lowing definitions apply: (c) Data retention. Donor and trans-
(1) Kidneys procured. Each kidney re- plant beneficiary records must be
covered will be counted individually. maintained in a human readable and
En bloc kidneys recovered will count as reproducible paper or electronic format
two kidneys procured. for 7 years.
(2) Kidneys transplanted. Each kidney (d) Format of records. The OPO must
transplanted will be counted individ- maintain data in a format that can
ually. En bloc kidney transplants will readily be transferred to a successor
be counted as two kidneys trans- OPO and in the event of a transfer
planted. must provide to CMS copies of all
(3) Extra-renal organs procured. Each records, data, and software necessary
organ recovered is counted individ- to ensure uninterrupted service by a
ually. successor OPO. Records and data sub-
(4) Extra-renal organs transplanted. ject to this requirement include donor
Each organ or part thereof trans- and transplant beneficiary records and
planted will be counted individually. procedural manuals and other mate-
For example, a single liver is counted rials used in conducting OPO oper-
as one organ procured and each portion ations.
that is transplanted will count as one
transplant. Further, a heart and double § 486.342 Condition: Requesting con-
lung transplant will be counted as sent.
three organs transplanted. A kidney/ An OPO must encourage discretion
pancreas transplant will count as one and sensitivity with respect to the cir-
kidney transplanted and one extra- cumstances, views, and beliefs of po-
renal organ transplanted. tential donor families.
[71 FR 31046, May 31, 2006, as amended at 85 (a) An OPO must have a written pro-
FR 77949, Dec. 2, 2020] tocol to ensure that, in the absence of
a donor document, the individual(s) re-
§ 486.330 Condition: Information man- sponsible for making the donation de-
agement. cision are informed of their options to
An OPO must establish and use an donate organs or tissues (when the
electronic information management OPO is making a request for tissues) or
system to maintain the required med- to decline to donate. The OPO must
ical, social and identifying information provide to the individual(s) responsible
for every donor and transplant bene- for making the donation decision, at a
ficiary and develop and follow proce- minimum, the following:
dures to ensure the confidentiality and (1) A list of the organs and/or tissues
security of the information. that may be recovered.
302
(2) The most likely uses for the do- (1) Verify that death has been pro-
nated organs or tissues. nounced according to applicable local,
(3) A description of the screening and State, and Federal laws.
recovery processes. (2) Determine whether there are con-
(4) Information about the organiza- ditions that may influence donor ac-
tions that will recover, process, and ceptance.
distribute the tissue. (3) If possible, obtain the potential
(5) Information regarding access to donor’s medical and social history.
and release of the donor’s medical (4) Review the potential donor’s med-
records. ical chart and perform a physical ex-
(6) An explanation of the impact the amination of the donor.
donation process will have on burial ar- (5) Obtain the potential donor’s vital
rangements and the appearance of the signs and perform all pertinent tests.
donor’s body. (c) Testing. The OPO must do the fol-
(7) Contact information for indi- lowing:
vidual(s) with questions or concerns. (1) Arrange for screening and testing
(8) A copy of the signed consent form of the potential donor for infectious
if a donation is made. disease according to current standards
of practice, including testing for the
(b) If an OPO does not request con-
human immunodeficiency virus.
sent to donation because a potential
(2) Ensure that screening and testing
donor consented to donation before his
of the potential donor (including point-
or her death in a manner that satisfied
of-care testing and blood typing) are
applicable State law requirements in
conducted by a laboratory that is cer-
the potential donor’s State of resi-
tified in the appropriate specialty or
dence, the OPO must provide informa-
subspecialty of service in accordance
tion about the donation to the family with part 493 of this chapter.
of the potential donor, as requested.
(3) Ensure that the potential donor’s
§ 486.344 Condition: Evaluation and blood is typed using two separate blood
management of potential donors samples.
and organ placement and recovery. (4) Document potential donor’s
record with all test results, including
The OPO must have written proto-
blood type, before organ recovery.
cols for donor evaluation and manage-
(d) Standard: Collaboration with trans-
ment and organ placement and recov-
plant programs. (1) The OPO must estab-
ery that meet current standards of
lish protocols in collaboration with
practice and are designed to maximize transplant programs that define the
organ quality and optimize the number roles and responsibilities of the OPO
of donors and the number of organs re- and the transplant program for all ac-
covered and transplanted per donor. tivities associated with the evaluation
(a) Potential donor protocol manage- and management of potential donors,
ment. (1) The medical director is re- organ recovery, and organ placement,
sponsible for ensuring that potential including donation after cardiac death,
donor evaluation and management pro- if the OPO has implemented a protocol
tocols are implemented correctly and for donation after cardiac death.
appropriately to ensure that potential (2) The protocol must ensure that:
donors are thoroughly assessed for (i) The OPO is responsible for two
medical suitability for organ donation separate determinations of the donor’s
and clinically managed to optimize blood type;
organ viability and function. (ii) If the identity of the intended re-
(2) The OPO must implement a sys- cipient is known, the OPO has a proce-
tem that ensures that a qualified phy- dure to ensure that prior to organ re-
sician or other qualified individual is covery, an individual from the OPO’s
available to assist in the medical man- staff compares the blood type of the
agement of a potential donor when the donor with the blood type of the in-
surgeon on call is unavailable. tended recipient, and the accuracy of
(b) Potential donor evaluation. The the comparison is verified by a dif-
OPO must do the following: ferent individual;
303
§ 486.346 42 CFR Ch. IV (10–1–24 Edition)
(iii) Documentation of the donor’s propriate specialty or subspecialty of

blood type accompanies the organ to service in accordance with part 493 of
the hospital where the transplant will this chapter.
take place. (b)(1) The OPO must send complete
(3) The established protocols must be documentation of donor information to
reviewed regularly with the transplant the transplant center with the organ,
programs to incorporate practices that including donor evaluation, the com-
have been shown to maximize organ do- plete record of the donor’s manage-
nation and transplantation.
ment, documentation of consent, docu-
(e) Documentation of beneficiary infor-
mentation of the pronouncement of
mation. If the intended beneficiary has
been identified prior to recovery of an death, and documentation for deter-
organ for transplantation, the OPO mining organ quality. This information
must have written documentation from is available to the transplant center
the OPTN showing, at a minimum, the electronically.
intended organ beneficiary’s ranking in (2) The OPO must physically send a
relation to other suitable candidates paper copy of the following documenta-
and the recipient’s OPTN identification tion with each organ:
number and blood type. (i) Blood type;
(f) Donation after cardiac death. If an (ii) Blood subtype, if used for alloca-
OPO recovers organs from donors after tion; and
cardiac death, the OPO must have pro- (iii) Infectious disease testing results
tocols that address the following: available at the time of organ pack-
(1) Criteria for evaluating patients aging.
for donation after cardiac death; (3) The source documentation must
(2) Withdrawal of support, including
be placed in a watertight container in
the relationship between the time of
either of the following:
consent to donation and the with-
drawal of support; (i) A location specifically designed
(3) Use of medications and interven- for documentation; or
tions not related to withdrawal of sup- (ii) Between the inner and external
port; transport materials.
(4) Involvement of family members (4) Two individuals, one of whom
prior to organ recovery; must be an OPO employee, must verify
(5) Criteria for declaration of death that the documentation that accom-
and the time period that must elapse panies an organ to a transplant center
prior to organ recovery. is correct.
(g) Organ allocation. The OPO must (c) The OPO must develop and follow
have a system to allocate donated or- a written protocol for packaging, label-
gans among transplant patients that is ing, handling, and shipping organs in a
consistent with the rules and require- manner that ensures their arrival with-
ments of the OPTN, as defined in out compromise to the quality of the
§ 486.320 of this part.
organ. The protocol must include pro-
(h) Organ placement. The OPO must
cedures to check the accuracy and in-
develop and implement a protocol to
maximize placement of organs for tegrity of labels, packaging, and con-
transplantation. tents prior to transport, including
verification by two individuals, one of
[71 FR 31046, May 31, 2006, as amended at 79 whom must be an OPO employee, that
FR 27156, May 12, 2014]
information listed on the labels is cor-
§ 486.346 Condition: Organ prepara- rect.
tion and transport. (d) All packaging in which an organ
(a) The OPO must arrange for testing is transported must be marked with
of organs for infectious disease and tis- the identification number, specific con-
sue typing of organs according to cur- tents, and donor’s blood type.
rent standards of practice. The OPO [71 FR 31046, May 31, 2006, as amended at 81
must ensure that testing and tissue FR 79881, Nov. 14, 2016]
typing of organs are conducted by a
laboratory that is certified in the ap-
304
§ 486.348 Condition: Quality assess- (2) An OPO must incorporate data on

ment and performance improve- the outcome measures into their QAPI
ment (QAPI). program.
The OPO must develop, implement, (3) If the outcome measure at each
assessment period during the re-certifi-
and maintain a comprehensive, data-
cation cycle is statistically signifi-
driven QAPI program designed to mon-
cantly lower than the top 25 percent of
itor and evaluate performance of all donation rates or organ or kidney
donation services, including services transplantation (Tier 2 and Tier 3
provided under contract or arrange- OPOs) rates as described in
ment. § 486.318(e)(5) and (6), the OPO must
(a) Standard: Components of a QAPI identify opportunities for improvement
program. The OPO’s QAPI program and implement changes that lead to
must include objective measures to improvement in these measures.
evaluate and demonstrate improved
performance with regard to OPO activi- FR 77949, Dec. 2, 2020]
ties, such as hospital development, des-
ignated requestor training, donor man- § 486.360 Condition for Coverage:
agement, timeliness of on-site response Emergency preparedness.
to hospital referrals, consent practices, The Organ Procurement Organization
organ recovery and placement, and (OPO) must comply with all applicable
organ packaging and transport. The Federal, State, and local emergency
OPO must take actions that result in preparedness requirements. The OPO
performance improvements and track must establish and maintain an emer-
performance to ensure that improve- gency preparedness program that
ments are sustained. meets the requirements of this section.
(b) Standard: Death record reviews. As The emergency preparedness program
part of its ongoing QAPI efforts, an must include, but not be limited to, the
OPO must conduct at least monthly following elements:
death record reviews in every Medicare (a) Emergency plan. The OPO must de-
and Medicaid participating hospital in velop and maintain an emergency pre-
its service area that has a Level I or paredness plan that must be reviewed
Level II trauma center or 150 or more and updated at least every 2 years. The
beds, a ventilator, and an intensive plan must do all of the following:
care unit (unless the hospital has a (1) Be based on and include a docu-
waiver to work with another OPO), mented, facility-based and community-
with the exception of psychiatric and based risk assessment, utilizing an all-
rehabilitation hospitals. When missed hazards approach.
opportunities for donation are identi- (2) Include strategies for addressing
fied, the OPO must implement actions emergency events identified by the
to improve performance. risk assessment.
(3) Address the type of hospitals with
(c) Standard: Adverse events. (1) An
which the OPO has agreements; the
OPO must establish written policies to
type of services the OPO has the capac-
address, at a minimum, the process for
ity to provide in an emergency; and
identification, reporting, analysis, and
continuity of operations, including del-
prevention of adverse events that occur
egations of authority and succession
during the organ donation process. plans.
(2) The OPO must conduct a thorough (4) Include a process for cooperation
analysis of any adverse event and must and collaboration with local, tribal, re-
use the analysis to affect changes in gional, State, and Federal emergency
the OPO’s policies and practices to pre- preparedness officials’ efforts to main-
vent repeat incidents. tain an integrated response during a
(d) Standard: Review of outcome meas- disaster or emergency situation.
ures. (1) An OPO must include a process (b) Policies and procedures. The OPO
to review its performance on the out- must develop and implement emer-
come measure requirements at § 486.318. gency preparedness policies and proce-
The process must be a continuous ac- dures, based on the emergency plan set
tivity to improve performance. forth in paragraph (a) of this section,
305
§ 486.360 42 CFR Ch. IV (10–1–24 Edition)
risk assessment at paragraph (a)(1) of paragraph (c) of this section. The train-
this section, and, the communication ing and testing program must be re-
plan at paragraph (c) of this section. viewed and updated at least every 2
The policies and procedures must be re- years.
viewed and updated at least every 2 (1) Training. The OPO must do all of
years. At a minimum, the policies and the following:
procedures must address the following: (i) Initial training in emergency pre-
(1) A system to track the location of paredness policies and procedures to all
on-duty staff during and after an emer- new and existing staff, individuals pro-
gency. If on-duty staff is relocated dur- viding services under arrangement, and
ing the emergency, the OPO must doc- volunteers, consistent with their ex-
ument the specific name and location pected roles.
of the receiving facility or other loca-
(ii) Provide emergency preparedness
tion.
training at every 2 years.
(2) A system of medical documenta-
tion that preserves potential and ac- (iii) Maintain documentation of the
tual donor information, protects con- training.
fidentiality of potential and actual (iv) Demonstrate staff knowledge of
donor information, and secures and emergency procedures.
maintains the availability of records. (v) If the emergency preparedness
(c) Communication plan. The OPO policies and procedures are signifi-
must develop and maintain an emer- cantly updated, the OPO must conduct
gency preparedness communication training on the updated policies and
plan that complies with Federal, State, procedures.
and local laws and must be reviewed (2) Testing. The OPO must conduct
and updated at least every 2 years. The exercises to test the emergency plan.
communication plan must include all The OPO must do the following:
of the following: (i) Conduct a paper-based, tabletop
(1) Names and contact information exercise or workshop at least annually.
for the following: A tabletop exercise is led by a
(i) Staff. facilitator and includes a group discus-
(ii) Entities providing services under sion, using a narrated, clinically-rel-
arrangement. evant emergency scenario, and a set of
(iii) Volunteers. problem statements, directed mes-
(iv) Other OPOs. sages, or prepared questions designed
(v) Transplant and donor hospitals in to challenge an emergency plan. If the
the OPO’s Donation Service Area OPO experiences an actual natural or
(DSA). man-made emergency that requires ac-
(2) Contact information for the fol- tivation of the emergency plan, the
lowing: OPO is exempt from engaging in its
(i) Federal, State, tribal, regional, next required testing exercise fol-
and local emergency preparedness lowing the onset of the emergency
staff.
event.
(ii) Analyze the OPO’s response to
communicating with the following: and maintain documentation of all ta-
(i) OPO’s staff. bletop exercises, and emergency
(ii) Federal, State, tribal, regional, events, and revise the OPO’s emer-
and local emergency management gency plan, as needed.
agencies. (e) Continuity of OPO operations dur-
(d) Training and testing. The OPO ing an emergency. Each OPO must have
must develop and maintain an emer- a plan to continue operations during an
gency preparedness training and test- emergency.
ing program that is based on the emer- (1) The OPO must develop and main-
gency plan set forth in paragraph (a) of tain in the protocols with transplant
this section, risk assessment at para- programs required under § 486.344(d),
graph (a)(1) of this section, policies and mutually agreed upon protocols that
procedures at paragraph (b) of this sec- address the duties and responsibilities
tion, and the communication plan at of the transplant program, the hospital
306
in which the transplant program is op- (ii) A documented individual facility-

erated, and the OPO during an emer- based risk assessment for each sepa-
gency. rately certified facility within the
(2) The OPO must have the capability health system, utilizing an all-hazards
to continue its operation from an alter- approach.
nate location during an emergency. (5) Include integrated policies and
The OPO could either have: procedures that meet the requirements
(i) An agreement with one or more set forth in paragraph (b) of this sec-
other OPOs to provide essential organ tion, a coordinated communication
procurement services to all or a por- plan and training and testing programs
tion of its DSA in the event the OPO that meet the requirements of para-
cannot provide those services during an graphs (c) and (d) of this section, re-
emergency; spectively.
(ii) If the OPO has more than one lo-
cation, an alternate location from FR 51830, Sept. 30, 2019]
which the OPO could conduct its oper-
ation; or
(iii) A plan to relocate to another lo- Subpart H—[Reserved]
cation as part of its emergency plan as
required by paragraph (a) of this sec- Subpart I—Requirements for Home
tion. Infusion Therapy Suppliers
(f) Integrated healthcare systems. If an
OPO is part of a healthcare system SOURCE: 83 FR 56630, Nov. 13, 2018, unless
consisting of multiple separately cer- otherwise noted.
tified healthcare facilities that elects
to have a unified and integrated emer- GENERAL PROVISIONS
gency preparedness program, the OPO
may choose to participate in the § 486.500 Basis and scope.
healthcare system’s coordinated emer- Section 1861(s)(2)(iii) of the Act re-
gency preparedness program. If elected, quires the Secretary to establish the
the unified and integrated emergency conditions that home infusion therapy
suppliers must meet in order to partici-
the following:
pate in the Medicare program and
(1) Demonstrate that each separately which are considered necessary to en-
certified facility within the system ac- sure the health and safety of patients.
tively participated in the development
of the unified and integrated emer- § 486.505 Definitions.
gency preparedness program.
(2) Be developed and maintained in a As used in §§ 486.520 and 486.525:
manner that takes into account each Applicable provider means a physician,
separately certified facility’s unique a nurse practitioner, and a physician
circumstances, patient populations, assistant.
and services offered. Home means a place of residence used
(3) Demonstrate that each separately as the home of an individual, including
certified facility is capable of actively an institution that is used as a home.
using the unified and integrated emer- An institution that is used as a home
gency preparedness program and is in may not be a hospital, CAH, or SNF as
compliance. defined in section 1861(e)(1),
(4) Include a unified and integrated 1861(mm)(1), or 1819(a)(1) of the Act, re-
emergency plan that meets the require- spectively.
ments of paragraphs (a)(2), (3), and (4) Home infusion drug means a parental
of this section. The unified and inte- drug or biological administered intra-
grated emergency plan must also be venously, or subcutaneously for an ad-
based on and include all of the fol- ministration period of 15 minutes or
lowing: more, in the home of an individual
(i) A documented community-based through a pump that is an item of du-
risk assessment, utilizing an all-haz- rable medical equipment. The term
ards approach. does not include insulin pump systems
307
§ 486.520 42 CFR Ch. IV (10–1–24 Edition)
or a self-administered drug or biologi- (1) Professional services, including

cal on a self-administered drug exclu- nursing services.
sion list. (2) Patient training and education
Infusion drug administration calendar not otherwise paid for as durable med-
day means the day on which home infu- ical equipment as described in
sion therapy services are furnished by § 424.57(c)(12) of this chapter.
skilled professionals in the individual’s (3) Remote monitoring and moni-
home on the day of infusion drug ad- toring services for the provision of
ministration. The skilled services pro- home infusion therapy services and
vided on such day must be so inher- home infusion drugs.
ently complex that they can only be (b) All home infusion therapy sup-
safely and effectively performed by, or pliers must provide home infusion ther-
under the supervision of, professional apy services in accordance with nation-
or technical personnel. ally recognized standards of practice,
Qualified home infusion therapy sup- and in accordance with all applicable
plier means a supplier of home infusion state and federal laws and regulations.
therapy that meets the all of the fol-
lowing criteria which are set forth at [83 FR 56630, Nov. 13, 2018, as amended at 86
FR 61625, Nov. 5, 2021; 88 FR 36510, June 5,
section 1861(iii)(3)(D)(i) of the Act: 2023]
(1) Furnishes infusion therapy to in-
dividuals with acute or chronic condi-
tions requiring administration of home PART 488—SURVEY, CERTIFI-
infusion drugs. CATION, AND ENFORCEMENT
(2) Ensures the safe and effective pro- PROCEDURES
vision and administration of home in-
fusion therapy on a 7-day-a-week, 24- Subpart A—General Provisions
hour-a-day basis.
Sec.
(3) Is accredited by an organization 488.1 Definitions.
designated by the Secretary in accord- 488.2 Statutory basis.
ance with section 1834(u)(5) of the Act. 488.3 Conditions of participation, conditions
(4) Meets such other requirements as for coverage, conditions for certification
the Secretary determines appropriate. and long term care requirements.
488.4 General rules for a CMS-approved ac-
[83 FR 56630, Nov. 13, 2018, as amended at 84 creditation program for providers and
FR 60646, Nov. 8, 2019] suppliers.
488.5 Application and re-application proce-
STANDARDS FOR HOME INFUSION dures for national accrediting organiza-
THERAPY tions.
488.6 Providers or suppliers that participate
§ 486.520 Plan of care. in the Medicaid program under a CMS-
The qualified home infusion therapy approved accreditation program.
supplier ensures the following: 488.7 Release and use of accreditation sur-
veys.
(a) All patients must be under the
488.8 Ongoing review of accrediting organi-
care of an applicable provider. zations.
(b) All patients must have a plan of 488.9 Validation surveys.
care established by a physician that 488.10 State survey agency review: Statu-
prescribes the type, amount, and dura- tory provisions.
tion of the home infusion therapy serv- 488.11 State survey agency functions.
ices that are to be furnished. 488.12 Effect of survey agency certification.
(c) The plan of care for each patient 488.13 Loss of accreditation.
must be periodically reviewed by the 488.14 Effect of QIO review.
physician. 488.18 Documentation of findings.
488.20 Periodic review of compliance and ap-
§ 486.525 Required services. proval.
488.24 Certification of noncompliance.
(a) The qualified home infusion ther- 488.26 Determining compliance.
apy supplier must provide the fol- 488.28 Providers or suppliers, other than
lowing services on a 7-day-a-week, 24- SNFs, NFs, HHAs, and Hospice programs
hour-a-day basis in accordance with with deficiencies.
the plan of care: 488.30 Revisit user fee for revisit surveys.
308
Subpart B—Special Requirements 488.335 Action on complaints of resident ne-

glect and abuse, and misappropriation of
488.52 [Reserved] resident property.
488.54 Temporary waivers applicable to hos-
pitals. Subpart F—Enforcement of Compliance
488.56 Temporary waivers applicable to For Long-Term Care Facilities with Defi-
skilled nursing facilities. ciencies
488.60 Special procedures for approving end
stage renal disease facilities. 488.400 Statutory basis.
488.61 Special procedures for approval and 488.401 Definitions.
re-approval of organ transplant pro- 488.402 General provisions.
grams. 488.404 Factors to be considered in selecting
488.64 Remote facility variances for utiliza- remedies.
tion review requirements. 488.406 Available remedies.
488.68 State Agency responsibilities for 488.408 Selection of remedies.
OASIS collection and data base require- 488.410 Action when there is immediate
ments. jeopardy.
488.70 Special requirements for rural emer- 488.412 Action when there is no immediate
gency hospitals (REHs). jeopardy.
488.414 Action when there is repeated sub-
Subpart C—Survey Forms and Procedures standard quality of care.
488.415 Temporary management.
488.100 Long term care survey forms, Part 488.417 Denial of payment for all new admis-
A. sions.
488.105 Long term care survey forms, Part 488.418 Secretarial authority to deny all
B. payments.
488.110 Procedural guidelines. 488.422 State monitoring.
488.115 Care guidelines. 488.424 Directed plan of correction.
488.425 Directed inservice training.
Subpart D—Reconsideration of Adverse 488.426 Transfer of residents, or closure of
Determinations—Deeming Authority for the facility and transfer of residents.
Accreditation Organizations and CLIA 488.430 Civil money penalties: Basis for im-
Exemption of Laboratories Under State posing penalty.
Programs 488.431 Civil money penalties imposed by
CMS and independent informal dispute
488.201 Reconsideration. resolution: for SNFS, dually-partici-
488.203 Withdrawal of request for reconsid- pating SNF/NFs, and NF-only facilities.
eration. 488.432 Civil money penalties imposed by
488.205 Right to informal hearing. the State: NF-only.
488.207 Informal hearing procedures. 488.433 Civil money penalties: Uses and ap-
488.209 Hearing officer’s findings. proval of civil money penalties imposed
488.211 Final reconsideration determina- by CMS.
tion. 488.434 Civil money penalties: Notice of pen-
alty.
Subpart E—Survey and Certification of 488.436 Civil money penalties: Waiver of
Long-Term Care Facilities hearing, reduction of penalty amount.
488.438 Civil money penalties: Amount of
488.300 Statutory basis. penalty.
488.301 Definitions. 488.440 Civil money penalties: Effective date
488.303 State plan requirement. and duration of penalty.
488.305 Standard surveys. 488.442 Civil money penalties: Due date for
488.307 Unannounced surveys. payment of penalty.
488.308 Survey frequency. 488.444 Civil money penalties: Settlement of
488.310 Extended survey. penalties.
488.312 Consistency of survey results. 488.446 Administrator sanctions: long-term
488.314 Survey teams. care facility closures.
488.318 Inadequate survey performance. 488.447 Civil Money Penalties imposed for
488.320 Sanctions for inadequate survey per- failure to comply with 42 CFR 483.80(g)(1)
formance. and (2).
488.325 Disclosure of results of surveys and 488.450 Continuation of payments to a facil-
activities. ity with deficiencies.
488.330 Certification of compliance or non- 488.452 State and Federal disagreements in-
compliance. volving findings not in agreement in non-
488.331 Informal dispute resolution. State operated NFs and dually partici-
488.332 Investigation of complaints of viola- pating facilities when there is no imme-
tions and monitoring of compliance. diate jeopardy.
488.334 Educational programs. 488.454 Duration of remedies.
309
488.456 Termination of provider agreement. APPROVAL AND OVERSIGHT OF HOME INFUSION
THERAPY SUPPLIER ACCREDITING ORGANIZA-
Subpart G [Reserved] TIONS
488.1010 Application and reapplication pro-

Subpart H—Termination of Medicare Cov- cedures for national home infusion ther-
erage and Alternative Sanctions for apy accrediting organizations.
End-Stage Renal Disease (ESRD) Facili- 488.1015 Resubmitting a request for re-
ties approval.
488.1020 Public notice and comment.
488.604 Termination of Medicare coverage. 488.1025 Release and use of home infusion
488.606 Alternative sanctions. therapy accreditation surveys.
488.608 Notice of alternative sanction and 488.1030 Ongoing review of home infusion
appeal rights: Termination of coverage. therapy accrediting organizations.
488.610 Notice of appeal rights: Alternative 488.1035 Ongoing responsibilities of a CMS-
sanctions. approved home infusion therapy accredi-
tation organization.
Subpart I—Survey and Certification of 488.1040 Onsite observations of home infu-
Home Health Agencies sion therapy accrediting organization op-
erations.
488.700 Basis and scope. 488.1045 Voluntary and involuntary termi-
488.705 Definitions. nation.
488.710 Standard surveys. 488.1050 Reconsideration.
488.715 Partial extended surveys.
488.720 Extended surveys. Subpart M—Survey and Certification of
488.725 Unannounced surveys. Hospice Programs
488.730 Survey frequency and content. 488.1100 Basis and scope.
488.735 Surveyor qualifications. 488.1105 Definitions.
488.740 Certification of compliance or non- 488.1110 Hospice program: surveys and hot-
compliance. line.
488.745 Informal Dispute Resolution (IDR). 488.1115 Surveyor qualifications and prohi-
bition of conflicts of interest.
Subpart J—Alternative Sanctions for Home 488.1120 Survey teams.
Health Agencies With Deficiencies 488.1125 Consistency of survey results.
488.1130 Informal dispute resolution (IDR).
488.800 Statutory basis. 488.1135 Hospice Special Focus Program
488.805 Definitions. (SFP).
488.810 General provisions.
488.815 Factors to be considered in selecting Subpart N—Enforcement Remedies for
sanctions. Hospice Programs With Deficiencies
488.820 Available sanctions.
488.1200 Statutory basis.
488.825 Action when deficiencies pose imme-
diate jeopardy.
488.1210 General provisions.
488.830 Action when deficiencies are at the
488.1215 Factors to be considered in select-
condition-level but do not pose imme- ing remedies.
diate jeopardy. 488.1220 Available remedies.
488.835 Temporary management. 488.1225 Action when deficiencies pose im-
488.840 Suspension of payment for all new mediate jeopardy.
patient admissions. 488.1230 Action when deficiencies are at the
488.845 Civil money penalties. condition-level but do not pose imme-
488.850 Directed plan of correction. diate jeopardy.
488.855 Directed in-service training. 488.1235 Temporary management.
488.860 Continuation of payments to an 488.1240 Suspension of payment for all new
HHA with deficiencies. patient admissions.
488.865 Termination of provider agreement. 488.1245 Civil money penalties.
488.1250 Directed plan of correction.
Subpart K [Reserved] 488.1255 Directed in-service training.
488.1260 Continuation of payments to a hos-
Subpart L—Accreditation of Home Infusion pice program with deficiencies.
488.1265 Termination of provider agreement.
Therapy Suppliers
AUTHORITY: 42 U.S.C 1302 and 1395hh.
GENERAL PROVISIONS
SOURCE: 53 FR 22859, June 17, 1988, unless
488.1000 Basis and scope. otherwise noted.
310
Subpart A—General Provisions National accrediting organization

means an organization that accredits
§ 488.1 Definitions. provider entities, as that term is de-
As used in this part— fined in section 1865(a)(4) of the Act,
under a specific program and whose ac-
Act means the Social Security Act.
credited provider entities under each
Certification means a determination
program are widely located geographi-
made by the state survey agency that
cally across the United States.
providers and suppliers are in compli-
ance with the applicable conditions of Provider of services or provider refers
participation, conditions for coverage, to a hospital, critical access hospital,
conditions for certification, or require- rural emergency hospital, skilled nurs-
ments. ing facility, nursing facility, home
health agency, hospice, comprehensive
Conditions for certification means the
outpatient rehabilitation facility, or a
health and safety standards RHCs must
meet to participate in the Medicare clinic, rehabilitation agency or public
program. health agency that furnishes out-
patient physical therapy or speech pa-
Conditions for coverage means the re-
thology services.
quirements suppliers must meet to par-
ticipate in the Medicare program. Rate of disparity means the percent-
Conditions of participation means the age of all sample validation surveys for
requirements providers other than which a State survey agency finds non-
skilled nursing facilities must meet to compliance with one or more Medicare
participate in the Medicare program conditions and no comparable condi-
and includes conditions of certification tion level deficiency was cited by the
for rural health clinics. accreditation organization, where it is
Deemed status means that CMS has reasonable to conclude that the defi-
certified a provider or supplier for ciencies were present at the time of the
Medicare participation, based on all of accreditation organization’s most re-
the following criteria having been met: cent surveys of providers or suppliers
The provider or supplier has volun- of the same type.
tarily applied for, and received, accred- Example: Assume that during a validation
itation from a CMS-approved national review period State survey agencies perform
accrediting organization under the ap- validation surveys at 200 facilities of the
plicable Medicare accreditation pro- same type (for example, ambulatory surgical
gram; the accrediting organization has centers, home health agencies) accredited by
recommended the provider or supplier the same accreditation organization. The
State survey agencies find 60 of the facilities
to CMS for Medicare participation;
out of compliance with one or more Medicare
CMS has accepted the accrediting orga- conditions, and it is reasonable to conclude
nization’s recommendation; and CMS that these deficiencies were present at the
finds that all other participation re- time of the most recent survey by an accred-
quirements have been met. itation organization. The accreditation orga-
Full review means a survey of a pro- nization, however, has found deficiencies
vider or supplier for compliance with comparable to the condition level defi-
all of the Medicare conditions or re- ciencies at only 22 of the 60 facilities. These
validation results would yield ((60–22)/200) a
quirements applicable to that provider rate of disparity of 19 percent.
or supplier type.
Immediate jeopardy means a situation Reasonable assurance means that an
in which the provider’s or supplier’s accrediting organization has dem-
non-compliance with one or more onstrated to CMS’s satisfaction that
Medicare requirements, conditions of its accreditation program require-
participation, conditions for coverage ments meet or exceed the Medicare
or certification has caused, or is likely program requirements.
to cause, serious injury, harm, impair- State includes the District of Colum-
ment, or death to a resident or patient. bia, the Commonwealth of Puerto Rico,
Medicare condition means any condi- the Virgin Islands, Guam, and Amer-
tion of participation or for coverage, ican Samoa.
including any long term care require- State survey agency refers to the state
ments. health agency or other appropriate
311
§ 488.2 42 CFR Ch. IV (10–1–24 Edition)
state or local agency CMS uses to per- Supplier means any of the following:
form survey and review functions pro- Independent laboratory; portable X-ray
vided for in sections 1864, 1819(g), and services; physical therapist in inde-
1919(g) of the Act. pendent practice; ESRD facility; rural
Substantial allegation of non-compli- health clinic; Federally qualified
ance means a complaint from any of a health center; chiropractor; or ambula-
variety of sources (such as patient, rel- tory surgical center.
ative, or third party), including com-
plaints submitted in person, by tele- FR 5373, Feb. 2, 1989; 56 FR 48879, Sept. 26,
phone, through written correspond- 1991; 57 FR 24982, June 12, 1992; 58 FR 30676,
ence, or in newspaper or magazine arti- May 26, 1993; 58 FR 61838, Nov. 23, 1993; 62 FR
cles, that would, if found to be present, 46037, Aug. 29, 1997; 71 FR 68230, Nov. 24, 2006;
adversely affect the health and safety 80 FR 29834, May 22, 2015; 88 FR 59335, Aug. 28,
of patients or residents and raises 2023]
doubts as to a provider’s or supplier’s
compliance with any Medicare condi- § 488.2 Statutory basis.
tion of participation, condition for cov- This part is based on the indicated
erage, condition for certification, or re- provisions of the following sections of
quirements. the Act:
TABLE 1 TO § 488.2
Section Subject
1128 ................................ Exclusion of entities from participation in Medicare.

1128A ............................. Civil money penalties.
1138(b) ........................... Requirements for organ procurement organizations and organ procurement agencies.
1814 ................................ Conditions for, and limitations on, payment for Part A services.
1819 ................................ Requirements for skilled nursing facilities (SNFs).
1820 ................................ Requirements for critical access hospitals (CAHs).
1822 ................................ Hospice Program survey and enforcement procedures.
1832(a)(2)(C) .................. Requirements for Organizations that provide outpatient physical therapy and speech language pa-
thology services.
1832(a)(2)(F) .................. Requirements for ambulatory surgical centers (ASCs).
1832(a)(2)(J) ................... Requirements for partial hospitalization services and intensive outpatient services provided by
CMHCs.
1861(e) ........................... Requirements for hospitals.
1861(f) ............................ Requirements for psychiatric hospitals.
1861(m) .......................... Requirements for Home Health Services.
1861(o) ........................... Requirements for Home Health Agencies.
1861(p)(4) ....................... Requirements for rehabilitation agencies.
1861(z) ........................... Institutional planning standards that hospitals and SNFs must meet.
1861(aa) ......................... Requirements for rural health clinics (RHCs) and federally qualified health centers (FQHCs).
1861(cc)(2) ..................... Requirements for comprehensive outpatient rehabilitation facilities (CORFs).
1861(dd) ......................... Requirements for hospices.
1861(ee) ......................... Discharge planning guidelines for hospitals.
1861(ff)(3)(A) .................. Requirements for CMHCs.
1861(ss)(2) ..................... Accreditation of religious nonmedical health care institutions.
1861(kkk) ........................ Requirements for rural emergency hospitals (REHs).
1863 ................................ Consultation with state agencies, accrediting bodies, and other organizations to develop conditions of
participation, conditions for coverage, conditions for certification, and requirements for providers or
suppliers.
1864 ................................ Use of State survey agencies.
1865 ................................ Effect of accreditation.
1875(b) ........................... Requirements for performance review of CMS-approved accreditation programs.
1880 ................................ Requirements for hospitals and SNFs of the Indian Health Service.
1881 ................................ Requirements for end stage renal disease (ESRD) facilities.
1883 ................................ Requirements for hospitals that furnish extended care services.
1891 ................................ Conditions of participation for home health agencies; home health quality.
1902 ................................ Requirements for participation in the Medicaid program.
1913 ................................ Medicaid requirements for hospitals that provide nursing facility (NF) care.
1919 ................................ Medicaid requirements for NFs.
312
[88 FR 59335, Aug. 28, 2023, as amended at 88 gram and CMS has found that the pro-
FR 82183, Nov. 22, 2023] gram provides reasonable assurance for
providers or suppliers accredited under
§ 488.3 Conditions of participation,
conditions for coverage, conditions the program:
for certification and long term care (1) When a provider or supplier dem-
requirements. onstrates full compliance with all of
(a) Basic rules. To be approved for the accreditation program require-
participation in, or coverage under, the ments of the accrediting organization’s
Medicare program, a prospective pro- CMS-approved accreditation program,
vider or supplier must meet the fol- the accrediting organization may rec-
lowing: ommend that CMS grant deemed status
(1) Meet the applicable statutory to the provider or supplier.
definitions in section 1138(b), 1819, 1820, (2) CMS may deem the provider or
1832(a)(2)(C), 1832(a)(2)(F), 1832(a)(2)(J), supplier, excluding kidney transplant
1834(e), 1861, 1881, 1883, 1891, 1913 or 1919 centers within a hospital and ESRD fa-
of the Act. cilities, to be in compliance with the
(2) Be in compliance with the appli- applicable Medicare conditions or re-
cable conditions, certification require- quirements. The deemed status pro-
ments, or long term care requirements vider or supplier is subject to valida-
prescribed in part 405 subparts U or X, tion surveys as provided at § 488.9.
part 410 subpart E, part 416, part 418 (b) [Reserved]
subpart C, parts 482 through 486, part
491 subpart A, or part 494 of this chap- [80 FR 29835, May 22, 2015]
ter.
(b) Special conditions. The Secretary § 488.5 Application and re-application
shall consult with state agencies and procedures for national accrediting
national AOs, as applicable, to develop organizations.
CoP, CfC, conditions for certification (a) Information submitted with applica-
and long term care requirements. tion. A national accrediting organiza-
(1) The Secretary may, at a state’s tion applying to CMS for approval or
request, approve health and safety re- re-approval of an accreditation pro-
quirements for providers or suppliers in gram under § 488.4 must furnish CMS
the state that exceed Medicare pro- with all of the following information
gram requirements. and materials to demonstrate that the
(2) If a state or political subdivision program provides reasonable assurance
imposes requirements on institutions that the entities accredited under the
(that exceed the Medicare program re-
program meet or exceed the applicable
quirements) as a condition for the pur-
Medicare conditions or requirements.
chase of health services under a state
This information must include the fol-
Medicaid plan approved under title XIX
of the Act, (or if Guam, Puerto Rico, or lowing:
the Virgin Islands does so under a state (1) Documentation that demonstrates
plan for Old Age Assistance under title the organization meets the definition
I of the Act, or for Aid to the Aged, of a ‘‘national accrediting organiza-
Blind, and Disabled under the original tion’’ under § 488.1 as it relates to the
title XVI of the Act), the Secretary im- accreditation program.
poses similar requirements as a condi- (2) The type of provider or supplier
tion for payment under Medicare in accreditation program for which the
that state or political subdivision. organization is requesting approval or
re-approval.
[80 FR 29835, May 22, 2015]
(3) A detailed crosswalk (in table for-
§ 488.4 General rules for a CMS-ap- mat) that identifies, for each of the ap-
proved accreditation program for plicable Medicare conditions or re-
providers and suppliers. quirements, the exact language of the
(a) The following requirements apply organization’s comparable accredita-
when a national accrediting organization requirements and standards.
tion has applied for CMS approval of a (4) A detailed description of the orga-
provider or supplier accreditation pro- nization’s survey process to confirm
313
§ 488.5 42 CFR Ch. IV (10–1–24 Edition)
that a provider or supplier meets or ex- this section, a copy of all survey re-
ceeds the Medicare program require- ports and related information for appli-
ments. This description must include cants seeking initial participation in
all of the following information: Medicare, and, upon request from CMS,
(i) Frequency of surveys performed a copy of the most recent accreditation
and an agreement by the organization survey for a specified provider or sup-
to re-survey every accredited provider plier, together with any other informa-
or supplier, through unannounced sur- tion related to the survey as CMS may
veys, no later than 36 months after the require (including corrective action
prior accreditation effective date, in- plans).
cluding an explanation of how the ac- (ix) A statement acknowledging that
crediting organization will maintain the accrediting organization will pro-
the schedule it proposes. If there is a vide timely notification to CMS when
statutorily-mandated survey interval an accreditation survey or complaint
of less than 36 months, the organiza- investigation identifies an immediate
tion must indicate how it will adhere jeopardy as that term is defined at
to the statutory schedule. § 489.3 of this chapter. Using the format
(ii) Documentation demonstrating specified by CMS, the accrediting orga-
the comparability of the organization’s nization must notify CMS within two
survey process and surveyor guidance business days from the date the accred-
to those required for state survey agen- iting organization identifies the imme-
cies conducting federal Medicare sur- diate jeopardy.
veys for the same provider or supplier (x) For accrediting organizations ap-
type, in accordance with the applicable plying for approval or re-approval of
requirements or conditions of partici- CMS–approved hospice programs, a
pation or conditions for coverage or statement acknowledging that the ac-
certification. crediting organization (AO) will in-
(iii) Copies of the organization’s sur-
clude a statement of deficiencies (that
vey forms, guidelines, and instructions
is, the Form CMS–2567 or a successor
to surveyors.
form) to document findings of the hos-
(iv) Documentation demonstrating
pice Medicare conditions of participa-
that the organization’s survey reports
tion in accordance with section
identify, for each finding of non-com-
1822(a)(2)(A)(ii) of the Act and will sub-
pliance with accreditation standards,
mit such in a manner specified by CMS.
the comparable Medicare CoP, CfC,
conditions for certification, or require- (5) The criteria for determining the
ments. size and composition of the organiza-
(v) Description of the organization’s tion’s survey teams for the type of pro-
accreditation survey review process. vider or supplier to be accredited, in-
(vi) Description of the organization’s cluding variations in team size and
procedures and timelines for notifying composition for individual provider or
surveyed facilities of non-compliance supplier surveys.
with the accreditation program’s (6) The overall adequacy of the num-
standards. ber of the organization’s surveyors, in-
(vii) Description of the organization’s cluding how the organization will in-
procedures and timelines for moni- crease the size of the survey staff to
toring the provider’s or supplier’s cor- match growth in the number of accred-
rection of identified non-compliance ited facilities while maintaining re-ac-
with the accreditation program’s creditation intervals for existing ac-
standards. credited facilities.
(viii) A statement acknowledging (7) A description of the education and
that, as a condition for CMS approval experience requirements surveyors
of a national accrediting organization’s must meet.
accreditation program, the organiza- (8) A description of the content and
tion agrees to provide CMS with infor- frequency of the organization’s in-serv-
mation extracted from each accredita- ice training it provides to survey per-
tion survey for a specified provider or sonnel.
supplier as part of its data submissions (9) A description of the organization’s
required under paragraph (a)(11)(ii) of evaluation systems used to monitor
314
the performance of individual sur- cision to revoke, withdraw, or revise

veyors and survey teams. the accreditation status of a specific
(10) The organization’s policies and deemed status provider or supplier,
procedures to avoid conflicts of inter- within three business days from the
est, including the appearance of con- date the organization takes an action.
flicts of interest, involving individuals (14) A list of all facilities currently
who conduct surveys or participate in accredited by the organization under
accreditation decisions. the program for which CMS approval is
(11) A description of the organiza- sought, including the type and cat-
tion’s data management and analysis egory of accreditation currently held
system for its surveys and accredita- by each provider or supplier, and the
tion decisions, including all of the fol- expiration date of each provider’s or
lowing: supplier’s current accreditation.
(i) A detailed description of how the (15) A schedule of all surveys ex-
organization uses its data to assure the pected to be conducted by the organiza-
compliance of its accreditation pro- tion for the accreditation program
gram with the Medicare program re- under review during the 6-month period
quirements. following submission of the applica-
(ii) A statement acknowledging that tion.
the organization agrees to submit (16) The three most recent audited fi-
timely, accurate, and complete data to nancial statements of the organization
support CMS’s evaluation of the ac- that demonstrate that the organiza-
crediting organization’s performance. tion’s staffing, funding, and other re-
Data to be submitted includes, but is sources are adequate to perform the re-
not limited to, accredited provider or quired surveys and related activities.
supplier identifying information, sur- (17) A statement that it will:
vey schedules, survey findings, and no- (i) Provide written notification to
tices of accreditation decisions. The or- CMS and to all providers or suppliers
ganization must submit necessary data accredited under a CMS-approved ac-
according to the instructions and time- creditation program at least 90 cal-
frames CMS specifies. endar days in advance of the effective
(12) The organization’s procedures for date of a decision by the organization
responding to, and investigating, com- to voluntarily terminate its CMS-ap-
plaints against accredited facilities, in- proved accreditation program, includ-
cluding policies and procedures regarding the implications for their deemed
ing referrals when applicable to appro- status in accordance with § 488.8(g)(2);
priate licensing bodies and ombudsman (ii) Adhere to the requirements for
programs. written notice to its accredited pro-
(13) The organization’s accreditation viders or suppliers at § 488.8(e) in the
status decision-making process, includ- case of an involuntary termination;
ing its policies and procedures for and
granting, withholding, or removing ac- (iii) Include a written statement that
creditation status for facilities that if a fully accredited and deemed facil-
fail to meet the accrediting organiza- ity in good standing provides written
tion’s standards or requirements, as- notification that they wish to volun-
signment of less than full accreditation tarily withdraw from the accrediting
status or other actions taken by the or- organization’s CMS-approved accredi-
ganization in response to non-compli- tation program, the accrediting organi-
ance with its standards and require- zation must continue the facility’s cur-
ments. The organization must furnish rent accreditation in full force and ef-
the following: fect until the effective date of with-
(i) A description of all types and cat- drawal identified by the facility or the
egories of accreditation decisions asso- expiration date of the term of accredi-
ciated with the program for which ap- tation, whichever comes first.
proval is sought, including the dura- (18) A statement that it will provide
tion of each. written notification to CMS of any pro-
(ii) A statement acknowledging that posed changes in the organization’s
the organization agrees to notify CMS CMS-approved accreditation program
(in a manner CMS specifies) of any de- and that it agrees not to implement
315
§ 488.5 42 CFR Ch. IV (10–1–24 Edition)
the proposed changes without prior (2) Voluntary termination of a CMS-ap-

written notice of continued program proved accreditation program. An accred-
approval from CMS except as provided iting organization may voluntarily ter-
for at § 488.8(b)(2). minate its CMS-approved accreditation
(19) A statement that, in response to program at any time. The accrediting
a written notice from CMS to the orga- organization must notify CMS of its
nization of a change in the applicable decision to voluntarily terminate its
conditions or requirements or in the approved accreditation program at
survey process, the organization will least 90 calendar days in advance of the
provide CMS with proposed cor- effective date of the termination. In
responding changes in the organiza- accordance with the requirement at
tion’s requirements for its CMS-ap- § 488.4(a)(17)(i), the accrediting organi-
proved accreditation program to ensure zation must also provide written notice
continued comparability with the CMS at least 90 days in advance of the effec-
conditions or requirements or survey tive date of the termination to each of
process. The organization must comply its deemed status providers or sup-
with the following requirements: pliers.
(i) The proposed changes must be (d) Re-submitting a request. (1) Except
submitted within 30 calendar days of as provided in paragraph (d)(2) of this
the date of the written CMS notice to section, an organization whose request
the organization or by a date specified for CMS’s approval or re-approval of an
in the notice, whichever is later. CMS accreditation program has been denied
will give due consideration to an orga- may resubmit its application if the or-
nization’s request for an extension of ganization satisfies all of the following
the deadline. requirements:
(ii) The proposed changes will not be (i) Revises its accreditation program
implemented without prior written no- to address the issues related to the de-
tice of continued program approval nial of its previous request.
from CMS, except as provided for at (ii) Demonstrates that it can provide
§ 488.8(b)(1)(iv). reasonable assurance.
(20) A statement acknowledging that, (iii) Resubmits the application in its
as a condition for CMS’s approval of an entirety.
accreditation program, the organiza- (2) If an accrediting organization has
tion will agree to permit its surveyors requested, in accordance with subpart
to serve as witnesses in a legal pro- D of this part, a reconsideration of
ceeding if CMS takes an adverse action CMS’s determination that its request
against a provider or supplier on the for approval of an accreditation pro-
basis of the organization’s accredita- gram is denied, it may not submit a
tion survey findings, and will cooperate new application for approval of an ac-
with CMS to make surveyors and other creditation program for the type of
staff available when needed. provider or supplier at issue in the re-
(b) Additional information needed. If consideration until the reconsideration
CMS determines that additional infor- is administratively final.
mation is necessary to make a deter- (e) Public notice and comment. CMS
mination for approval or denial of the publishes a notice in the FEDERAL REG-
organization’s initial application or re- ISTER when the following conditions
application for CMS’s approval of an are met:
accreditation program, CMS will notify (1) Proposed notice. When CMS re-
the organization and afford it an oppor- ceives a complete application from a
tunity to provide the additional infor- national accrediting organization seek-
mation. ing CMS’s approval of an accreditation
(c)(1) Withdrawing an application. An program, it publishes a proposed no-
accrediting organization may withdraw tice. The proposed notice identifies the
its initial application for CMS’s-ap- organization and the type of providers
proval of its accreditation program at or suppliers to be covered by the ac-
any time before CMS publishes the creditation program and provides 30
final notice described in paragraph calendar days for the public to submit
(e)(2) of this section. comments to CMS.
316
(2) Final notice. When CMS decides to ganizations for Advanced Diagnostic
approve or disapprove a national ac- Imaging (ADI) suppliers; Home Infu-
crediting organization’s application, it sion Therapy (HIT) suppliers; Diabetic
publishes a final notice within 210 cal- Self-Management Training (DSMT) en-
endar days from the date CMS deter- tities, and clinical laboratories.
mines the AO’s applications was com- (ii) This notice must be provided to
plete, unless the application was for a CMS in writing.
skilled nursing facility accreditation (iii) This notice must be provided to
program. There is no timeframe for CMS no less than 90 calendar days
publication of a final notice for a na- prior to the anticipated effective date
tional accrediting organization’s appli- of the change of ownership transaction.
cation for approval of a skilled nursing (iv) CMS will complete their review
facility accreditation program. The of the AO’s request for approval for the
final notice specifies the basis for the transfer of the existing CMS approval
CMS decision. for the accreditation programs to be
(i) Approval or re-approval. If CMS ap- transferred in the change of ownership
proves or re-approves the accrediting within 90 days from receipt of said AO’s
organization’s accreditation program, request.
the final notices describes how the ac-
(2) Information submitted with the re-
creditation program provides reason-
quest for approval for change of owner-
able assurance. The final notice speci-
ship transaction. The person(s) or orga-
fies the effective date and term of the
nization(s) acquiring an existing CMS-
approval (which may not be later than
approved accrediting organization or
the publication date of the notice and
accreditation programs (that is, pur-
which will not exceed 6 years.
chaser, buyer or transferee) through a
(ii) Disapproval. If CMS does not ap-
change of ownership transaction must
prove the accrediting organization’s
do the following:
accreditation program, the final notice
(i) Seek approval from CMS for the
describes, except in the case of a
purchase or transfer of the existing
skilled nursing facility accreditation
CMS approval for the accreditation
program, how the organization fails to
program(s) to be transferred in the
provide reasonable assurance. In the
change of ownership event; and
case of an application for a skilled
nursing facility accreditation program, (ii) Meet the requirements of para-
disapproval may be based on the pro- graphs (f)(2)(iii) through (f)(4) of this
gram’s failure to provide reasonable as- section to demonstrate that the enti-
surance, or on CMS’s decision to exer- ties that will be accredited with the
cise its discretion in accordance with transferred accrediting program(s) con-
section 1865(a)(1)(B) of the Act. The tinue to meet or exceed the applicable
final notice specifies the effective date Medicare conditions or requirements.
of the decision. (iii) The following information must
(f) Change of ownership. What Con- be submitted to CMS in the pur-
stitutes Change of Ownership. A descrip- chaser’s/buyer’s/transferee’s request for
tion of what could constitute a change approval of a transfer of the existing
of ownership with respect to a national CMS approval for the accreditation
accrediting organization are those ac- program(s) to be transferred in the
tivities described in § 489.18(a)(1) change or ownership transaction:
through (3) of this chapter. (A) The legal name and address of the
(1) Notice to CMS. Any CMS-approved new owner;
accrediting organization that is con- (B) The three most recent audited fi-
templating or negotiating a change of nancial statements of the organization
ownership must notify CMS of the that demonstrate the organization’s
change of ownership. staffing, funding and other resources
(i) This notice requirement applies to are adequate to perform the required
any national accrediting organization surveys and related activities;
with CMS-approved accreditation pro- (C) A transition plan that summa-
gram(s) that is the subject of a poten- rizes the details of how the accredita-
tial or actual change of ownership tion functions will be transitioned to
transaction, including accrediting or- the new owner, including:
317
§ 488.5 42 CFR Ch. IV (10–1–24 Edition)
(1) Changes to management and gov- (i) All parties to the change of owner-
ernance structures including current ship transaction must notify the pro-
and proposed organizational charts; viders and suppliers affected by such
(2) A list of the CMS-approved ac- change within 15 calendar days after
creditation programs that will be being notified of CMS’s approval of the
transferred to the purchaser/buyer/ transfer of the existing CMS-approval
transferee, for the accreditation programs to be
(3) Employee changes, if applicable, transferred in the change of ownership
(4) Anticipated timelines for action; transaction.
(5) Plans for notification to employ- (ii) If applicable, the purchaser/buyer/
ees; and transferee must acknowledge in writ-
(6) Any other relevant information ing to CMS that the accrediting orga-
that CMS finds necessary. nization or accreditation program(s)
(D) The prospective new AO’s policies being acquired through a purchase or
and procedures to avoid conflicts of in- transfer of ownership was under a per-
terest, including the appearance of conformance review or under probationary
flicts of interest, involving individuals status at the time the change of owner-
who conduct surveys or participate in ship notice was submitted.
accreditation decisions, as required by (5) Federal Register notice. CMS will
paragraph (a)(10) of this section. publish a notice of approval in the FED-
(3) Written acknowledgements. The ERAL REGISTER of the transfer of the
purchaser/buyer/transferee must pro- existing CMS approval for the accredi-
vide a written acknowledgement to tation program(s) to be transferred to
CMS, which states the following: the new owner, only after CMS receives
(i) If the application for the transfer written confirmation from the new
of the existing CMS-approval for the owner that the change of ownership
accreditation program(s) to be trans- has taken place.
ferred in the change of ownership (6) Notification to parties in the event
transaction is approved by CMS, said that CMS does not approve the transfer of
purchaser/buyer/transferee must as- the existing CMS approval. In the event
sume complete responsibility for the that CMS does not approve the transfer
operations (that is, managerial, finan- of the existing CMS approval for the
cial, and legal) of the CMS-approved accreditation program(s) to be trans-
accreditation programs transferred, ferred in the change of ownership
immediately upon the finalization of transaction, CMS will notify all parties
the change of ownership transaction; to the change of ownership transaction
(ii) The purchaser/buyer/transferee of such in writing.
agrees to operate the transferred CMS- (7) Withdrawal of CMS approval for
approved accreditation program(s) transferred accreditation programs due to
under all of the CMS imposed terms failure to notify CMS of intent to transfer
and conditions, to include program reaccreditation programs. In the event
views and probationary status terms, that CMS was not made aware of or did
currently approved by CMS; and not approve the transfer of the existing
(iii) The purchaser/buyer/transferee CMS-approval for the accreditation
must not operate the accreditation program(s) to be transferred under a
program(s) it acquired in the change in change of ownership:
ownership transaction as CMS ap- (i) The existing AO would be per-
proved accreditation programs, until mitted to continue operating their ex-
the effective date set forth within the isting CMS-approved accreditation pro-
notice of approval from CMS. grams, if the change of ownership
(iv) The purchaser/buyer/transferee transaction was not completed, unless
agrees to operate the transferred CMS- our review of the transaction revealed
approved accreditation program(s) issues with the AO that were the sub-
under all of the terms and conditions ject of the un-finalized change of own-
found at §§ 488.5 through 488.9. ership transaction that was previously
(4) Notification. The following written unknown to CMS.
notifications are required after the (ii) If a change of ownership trans-
change of ownership transaction has action was completed without notice to
been approved by CMS: CMS or the approval of CMS, CMS
318
would be able to withdraw the existing ing approval from a transferred non-
approval of the AO’s accreditation pro- certified accreditation program for Ad-
grams in accordance with vanced Diagnostic Imaging (ADI) sup-
§ 488.8(c)(3)(ii) and (iii). pliers; Home Infusion Therapy (HIT)
(8) Withdrawal of CMS approval for ac- suppliers; or Diabetic Self-Management
creditation programs which are trans- Training (DSMT) entities, because a
ferred notwithstanding CMS’ disapproval change of ownership transaction was
of the transfer. In the event that the completed without notice to or the ap-
parties complete the change of owner- proval of CMS, such affected non-cer-
ship transaction, notwithstanding CMS tified supplier’s deemed status would
disapproval and the purchaser/buyer/ continue in effect for 1 year after the
transferee attempts to operate the
removal of the existing CMS accredita-
transferred accreditation program(s)
tion approval, if such non-certified sup-
under the CMS-approval granted to the
previous owner, CMS will withdraw the plier take the steps specified para-
existing approval of the transferred ac- graphs (f)(10)(i) and (ii) of this sec-
creditation program(s) in accordance tion—
with the procedures set out at (i) The non-certified supplier must
§§ 488.8(c)(3)(ii) and (iii). submit an application to another CMS-
(9) Requirements for continuation of a approved accreditation program within
deemed status accreditation of Medicare- 60 calendar days from the date of publi-
certified providers and suppliers after cation of the removal notice in the
CMS withdraws the existing approval of FEDERAL REGISTER; and
the transferred accreditation program(s). (ii) The non-certified supplier must
If CMS withdraws the existing approval provide written notice to CMS stating
of the transferred accreditation pro- that it has submitted an application
gram(s) because the change of owner- for accreditation under another CMS-
ship transaction was completed with- approved accreditation program within
out notice to CMS or the approval of the 60-calendar days from the date of
CMS, an affected Medicare-Certified publication of the removal notice in
provider or supplier’s deemed status the FEDERAL REGISTER.
will continue in effect for 180 calendar
(iii) Failure to comply with the
days if the Medicare-Certified provider
above-stated timeframe requirements
or supplier takes the following steps
will result in de-recognition of such
set forth is § 488.8(g).
(i) The Medicare-certified provider or provider or supplier’s accreditation.
supplier must submit an application to [80 FR 29835, May 22, 2015, as amended at 82
another CMS-approved accreditation FR 38516, Aug. 14, 2017; 82 FR 46143, Oct. 4,
program within 60 calendar days from 2017; 83 FR 56631, Nov. 13, 2018; 86 FR 62425,
the date of publication of the removal Nov. 9, 2021; 87 FR 25427, Apr. 29, 2022; 87 FR
notice in the FEDERAL REGISTER; and 36410, June 17, 2022]
(ii) The Medicare-certified provider
or supplier must provide written notice § 488.6 Providers or suppliers that par-
to the SA that it has submitted an ap- ticipate in the Medicaid program
plication for accreditation under an- under a CMS-approved accredita-
tion program.
other CMS-approved accreditation pro-
gram within this same 60-calendar day A provider or supplier that has been
timeframe in accordance with § 488.8(g). granted ‘‘deemed status’’ by CMS by
(iii) Failure to comply with the time- virtue of its accreditation from a CMS-
frame requirements specified in approved accreditation program is eli-
§ 488.8(g) will place the provider or sup- gible to participate in the Medicaid
plier under the SA’s authority for con- program if they are not required under
tinued participation in Medicare and Medicaid regulations to comply with
on-going monitoring. any requirements other than Medicare
(10) Requirements for continuation of participation requirements.
accreditation for non-certified suppliers
when CMS withdraws the existing ap- [80 FR 29837, May 22, 2015]
proval of the transferred accreditation
program(s). If CMS withdraws its exist-
319
§ 488.7 42 CFR Ch. IV (10–1–24 Edition)
§ 488.7 Release and use of accredita- (2) Analysis of the results of the vali-
tion surveys. dation surveys under § 488.9(a)(1), in-
A Medicare participating provider or cluding the rate of disparity between
supplier deemed to meet program re- certifications of the accrediting orga-
quirements in accordance with § 488.4 nization and certifications of the SA.
must authorize its accrediting organi- (3) Review of the organization’s con-
zation to release to CMS a copy of its tinued fulfillment of the requirements
most current accreditation survey and in § 488.5(a).
any information related to the survey (b) Comparability review. CMS assesses
that CMS may require (including, but the equivalency of an accrediting orga-
not limited to, corrective action nization’s CMS-approved program re-
plans). quirements to the comparable Medi-
(a) CMS may determine that a pro- care requirements if the following con-
vider or supplier does not meet the ap- ditions exist:
plicable Medicare conditions or re- (1) CMS imposes new Medicare cer-
quirements on the basis of its own in- tification requirements or changes its
vestigation of the accreditation survey survey process.
or any other information related to the (i) CMS provides written notice of
survey. the changes to the affected accrediting
organization.
(b) With the exception of home
(ii) CMS specifies in its written no-
health agency and hospice program
tice a timeframe, not less than 30 cal-
surveys, general disclosure of an ac-
endar days from the date of the notice,
crediting organization’s survey infor-
for the accrediting organization to sub-
mation is prohibited under section
mit its proposed equivalent changes,
1865(b) of the Act. CMS may publicly
including its implementation time-
disclose an accreditation survey and
frame, for CMS review. CMS may ex-
information related to the survey,
tend the deadline after due consider-
upon written request, to the extent
ation of a written request for extension
that the accreditation survey and sur-
by the accrediting organization, sub-
vey information are related to an en-
mitted prior to the original deadline.
forcement action taken by CMS.
(iii) After completing the com-
(c) CMS posts inspection reports from
parability review CMS provides written
a State or local survey agency or ac-
notification to the organization wheth-
crediting organization conducted on or
er or not the accreditation program,
after October 1, 2022, for hospice pro-
including the proposed revisions and
grams, including copies of a hospice
implementation timeframe, continues
program’s survey deficiencies, and en-
to meet or exceed all applicable Medi-
forcement actions (for example, invol-
care requirements.
untary terminations) taken as a result
(iv) If, no later than 60 calendar days
of such surveys, on its public website
after receipt of the organization’s pro-
in a manner that is prominent, easily
posed changes, CMS does not provide
accessible, readily understandable, and
the written notice to the organization
searchable for the general public and
required in paragraph (b)(1)(iii) of this
allows for timely updates.
section, then the revised program will
[80 FR 29837, May 22, 2015, as amended at 86 be deemed to meet or exceed all appli-
FR 62425, Nov. 9, 2021] cable Medicare requirements and to
have continued CMS approval.
§ 488.8 Ongoing review of accrediting (v) If an organization fails to submit
organizations. its proposed changes within the re-
(a) Performance review. In accordance quired timeframe, or fails to imple-
with section 1875(b) of the Act, CMS ment the proposed changes that have
evaluates the performance of each been determined by CMS or deemed to
CMS-approved accreditation program be comparable, CMS may open an ac-
on an ongoing basis. This review in- creditation program review in accord-
cludes, but is not limited to the fol- ance with paragraph (c) of this section.
lowing: (2) An accrediting organization pro-
(1) Review of the organization’s sur- poses to adopt new requirements or to
vey activity. change its survey process.
320
(i) An accrediting organization must tified deficiencies including a timeline

provide written notice to CMS of any for implementation not to exceed 180
proposed changes in its accreditation calendar days after receipt of the no-
requirements or survey process and tice that CMS is initiating an accredi-
must not implement any changes be- tation program review.
fore receiving CMS’s approval, except (2) CMS reviews the accrediting orga-
as provided below. nization’s plan of correction for accept-
(ii) If, no later than 60 calendar days ability.
after receipt of the organization’s pro- (3) If CMS determines as a result of
posed changes, CMS does not provide the accreditation program review or a
written notice to the organization that review of an application for renewal of
the accreditation program, including an existing CMS-approved accredita-
the proposed revisions, continues or tion program that the accrediting or-
does not continue to meet or exceed all ganization has failed to meet any of
applicable Medicare requirements, then the requirements of this subpart, CMS
the revised program will be deemed to may place the accrediting organiza-
meet or exceed all applicable Medicare tion’s CMS-approved accreditation pro-
requirements and to have continued gram on probation for a period up to
CMS approval. 180 calendar days to implement correc-
(iii) If an organization implements tive actions, not to exceed the accred-
changes that have neither been deter- iting organization’s current term of ap-
mined by CMS nor deemed to be com- proval. In the case of a renewal appli-
parable to the applicable Medicare re- cation where CMS has placed the ac-
quirements, CMS may open an accredi- creditation program on probation, CMS
tation program review in accordance indicates that any approval of the ap-
with paragraph (c) of this section. plication is conditional while the pro-
(c) CMS-approved accreditation program is placed on probation.
gram review. If a comparability or per-
(i) Within 60 calendar days after the
formance review reveals evidence of
end of any probationary period, CMS
substantial non-compliance of an ac-
issues a written determination to the
crediting organization’s CMS-approved
accreditation program with the re- accrediting organization as to whether
quirements of this subpart, CMS may or not a CMS-approved accreditation
initiate an accreditation program re- program continues to meet the require-
view. ments of this subpart, including the
(1) If an accreditation program re- reasons for the determination.
view is initiated, CMS provides written (ii) If CMS has determined that the
notice to the organization indicating accrediting organization does not meet
that its CMS-approved accreditation the requirements, CMS withdraws ap-
program approval may be in jeopardy proval of the CMS-approved accredita-
and that an accreditation program re- tion program. The notice of determina-
view is being initiated. The notice pro- tion provided to the accrediting organi-
vides all of the following information: zation includes notice of the removal
(i) A statement of the instances, of approval, reason for the removal, in-
rates or patterns of non-compliance cluding the effective date determined
identified, as well as other related in- in accordance with paragraph (c)(3)(iii)
formation, if applicable. of this section.
(ii) A description of the process to be (iii) CMS publishes in the FEDERAL
followed during the review, including a REGISTER a notice of its decision to
description of the opportunities for the withdraw approval of a CMS-approved
accrediting organization to offer fac- accreditation program, including the
tual information related to CMS’s find- reasons for the withdrawal, effective 60
ings. calendar days from the date of publica-
(iii) A description of the possible action of the notice.
tions that may be imposed by CMS (d) Immediate jeopardy. If at any time
based on the findings of the accredita- CMS determines that the continued ap-
tion program review. proval of a CMS-approved accredita-
(iv) The actions the accrediting orga- tion program of any accrediting orga-
nization must take to address the iden- nization poses an immediate jeopardy
321
§ 488.9 42 CFR Ch. IV (10–1–24 Edition)
to the patients of the entities accred- quired at § 488.5(a)(17), an affected pro-

ited under that program, or the contin- vider’s or supplier’s deemed status con-
ued approval otherwise constitutes a tinues in effect for 180 calendar days
significant hazard to the public health, after the termination effective date if
CMS may immediately withdraw the the provider or supplier submits an ap-
approval of a CMS-approved accredita- plication to another CMS-approved ac-
tion program of that accrediting orga- creditation program within 60 calendar
nization and publish a notice of the re- days from the date of the notice from
moval, including the reasons for it, in the accrediting organization. The pro-
the FEDERAL REGISTER. vider or supplier must also provide
(e) Notification of providers or sup- written notice to the SA that it has
pliers. An accrediting organization submitted an application for accredita-
whose CMS approval of its accreditation under another CMS-approved ac-
tion program has been withdrawn must creditation program within this same
notify, in writing, each of its accred- 60-calendar day timeframe. Failure to
ited providers or suppliers of the with- comply with the timeframe require-
drawal of CMS approval and the impli- ments specified in this section will
cations in accordance with paragraph place the provider or supplier under the
(g)(1) of this section for the providers’ SAs authority for continued participa-
or suppliers’ deemed status no later tion in Medicare and on-going moni-
than 30 calendar days after the notice toring.
is published in the FEDERAL REGISTER. (h) Onsite observations of accrediting
(f) Request for reconsideration. Any ac- organization operations. As part of the
crediting organization dissatisfied with application review process, the ongoing
a determination to withdraw CMS ap- review process, or the continuing over-
proval of its accreditation program sight of an accrediting organization’s
may request a reconsideration of that performance, CMS may conduct at any
determination in accordance with sub- time an onsite inspection of the ac-
part D of this part. crediting organization’s operations and
(g) Continuation of deemed status—(1) offices to verify the organization’s rep-
Involuntary termination. After CMS re- resentations and to assess the organi-
moves approval of an accrediting orga- zation’s compliance with its own poli-
nization’s accreditation program, an cies and procedures. The onsite inspec-
affected provider’s or supplier’s deemed tion may include, but is not limited to,
status continues in effect for 180 cal- the review of documents, auditing
endar days after the removal of the ap- meetings concerning the accreditation
proval if the provider or supplier sub- process, observation of surveys, the
mits an application to another CMS- evaluation of survey results or the ac-
approved accreditation program within creditation decision-making process,
60 calendar days from the date of publi- and interviews with the organization’s
cation of the removal notice in the staff.
FEDERAL REGISTER. The provider or
supplier must also provide written no- [80 FR 29837, May 22, 2015]
tice to the SA that it has submitted an
§ 488.9 Validation surveys.
application for accreditation under an-
other CMS-approved accreditation pro- (a) Basis for survey. CMS may require
gram within this same 60-calendar day a survey of an accredited provider or
timeframe. Failure to comply with the supplier to validate the accrediting or-
timeframe requirements specified in ganization’s CMS-approved accredita-
this section will place the provider or tion process. These surveys are con-
supplier under the SAs authority for ducted on a representative sample
continued participation in Medicare basis, or in response to substantial al-
and on-going monitoring. legations of non-compliance.
(2) Voluntary termination by accred- (1) For a representative sample, the
iting organization. When an accrediting survey may be comprehensive and ad-
organization has voluntarily termi- dress all Medicare conditions or re-
nated its CMS-approved accreditation quirements, or it may be focused on a
program and provides its accredited specific condition(s) as determined by
providers and suppliers the notice re- CMS.
322
(2) For a substantial allegation of to release a copy of the provider’s or

noncompliance, the SA surveys for any supplier’s current accreditation survey.
condition(s) or requirement(s) that (2) It withdraws any prior refusal to
CMS determines is related to the alle- allow a validation survey, if applicable.
gations. (3) CMS finds that the provider or
(b) Selection for survey. (1) A provider supplier meets all applicable Medicare
or supplier selected for a validation CoP, CfC, conditions of certification, or
survey must cooperate with the SA requirements.
that performs the validation survey. (e) Impact of adverse actions. The ex-
(2) If a provider or supplier selected istence of any performance review,
for a validation survey fails to cooper- comparability review, deemed status
ate with the SA, it will no longer be review, probationary period, or any
deemed to meet the Medicare condi- other action by CMS, does not affect or
tions or requirements, but will be sub- limit conducting any validation sur-
ject to a review by the SA in accord- vey.
ance with § 488.10(a), and may be sub-
ject to termination of its provider [80 FR 29839, May 22, 2015]
agreement under § 489.53 of this chap-
ter. § 488.10 State survey agency review:
(c) Consequences of a finding of non- Statutory provisions.
compliance. (1) If a CMS validation sur- (a) Section 1864(a) of the Act requires
vey results in a finding that the pro- the Secretary to enter into an agree-
vider or supplier is out of compliance ment with any State that is able and
with one or more Medicare conditions willing to do so, under which appro-
or requirements, the provider or sup- priate State or local survey agencies
plier will no longer be deemed to meet will determine whether:
the Medicare conditions or require- (1) Providers or prospective providers
ments and will be subject to ongoing meet the Medicare conditions of par-
review by the SA in accordance with ticipation or requirements (for SNFs
§ 488.10(a) until the provider or supplier and NFs);
demonstrates compliance. (2) Suppliers meet the conditions for
(2) CMS may take actions for the de- coverage; and
ficiencies identified in the state valida-
(3) Rural health clinics meet the con-
tion survey in accordance with § 488.24,
ditions of certification.
or may first direct the SA to conduct
another survey of the provider’s or sup- (b) Section 1865(a) of the Act provides
plier’s compliance with specified Medi- that if an institution is accredited by a
care conditions or requirements before national accrediting organization rec-
taking the enforcement actions pro- ognized by the Secretary, it may be
vided for at § 488.24. deemed to have met the applicable con-
(3) If CMS determines that a provider ditions or requirements.
or supplier is not in compliance with (c) Section 1864(c) of the Act author-
applicable Medicare conditions or re- izes the Secretary to enter into agree-
quirements, the provider or supplier ments with state survey agencies for
may be subject to termination of the the purpose of conducting validation
provider or supplier agreement under surveys in institutions accredited by
§ 489.53 of this chapter or of the supplier an accreditation program recognized
agreement in accordance with the ap- by the Secretary.
plicable supplier conditions and any (d) Section 1865(c) provides that an
other applicable intermediate sanc- accredited institution that is found
tions and remedies. after a validation survey to have sig-
(d) Re-instating deemed status. An ac- nificant deficiencies related to health
credited provider or supplier will be and safety of patients will no longer
deemed to meet the applicable Medi- meet the applicable conditions or re-
care conditions or requirements in ac- quirements.
cordance with this section if all of the [53 FR 22859, June 17, 1988, as amended at 56
following requirements are met: FR 48879, Sept. 26, 1991; 58 FR 61842, Nov. 23,
(1) It withdraws any prior refusal to 1993; 62 FR 46037, Aug. 29, 1997; 80 FR 29839,
authorize its accrediting organization May 22, 2015]
323
§ 488.11 42 CFR Ch. IV (10–1–24 Edition)
§ 488.11 State survey agency functions. and evaluation activities required of

State and local agencies that have health care institutions under sections
agreements under section 1864(a) of the 1861(e)(6), and 1861(k) of the Act.
Act perform the following functions: [59 FR 56237, Nov. 10, 1994]
(a) Survey and make recommenda-
tions regarding the issues listed in § 488.18 Documentation of findings.
§ 488.10. (a) The findings of the State agency
(b) Conduct validation surveys of with respect to each of the conditions
deemed status providers and suppliers of participation, requirements (for
as provided in § 488.9. SNFs and NFs), or conditions for cov-
(c) Perform other surveys and carry erage must be adequately documented.
out other appropriate activities and When the State agency certifies to the
certify their findings to CMS. Secretary that a provider or supplier is
(d) Make recommendations regarding not in compliance with the conditions
the effective dates of provider agree-
or requirements (for SNFs and NFs),
ments and supplier approvals in ac-
and therefore not eligible to partici-
cordance with § 489.13 of this chapter.
pate in the program, such documenta-
[62 FR 43936, Aug. 18, 1997, as amended at 80 tion includes, in addition to the de-
FR 29839, May 22, 2015] scription of the specific deficiencies
which resulted in the agency’s rec-
§ 488.12 Effect of survey agency certifi- ommendation, any provider or supplier
cation.
response.
Certifications by the State survey (b) If a provider or supplier is cer-
agency represent recommendations to tified by the State agency as in compli-
CMS. ance with the conditions or participa-
(a) On the basis of these rection requirements (for SNFs and NFs)
ommendations, CMS will determine or as meeting the requirements for spe-
whether: cial certification (see § 488.54), with de-
(1) A provider or supplier is eligible ficiencies not adversely affecting the
to participate in or be covered under health and safety of patients, the fol-
the Medicare program; or lowing information will be incor-
(2) A provider or supplier accredited porated into the finding:
under a CMS-approved accreditation
(1) A statement of the deficiencies
program remains deemed to meet the
that were found.
Medicare conditions or requirements,
(2) A description of further action
or will be placed under the jurisdiction
of the SA and subject to further en- that is required to remove the defi-
forcement actions in accordance with ciencies.
the provisions at § 488.9. (3) A time-phased plan of correction
(b) Notice of CMS’s determination developed by the provider and supplier
will be sent to the provider or supplier. and concurred with by the State agen-
cy.
[53 FR 22859, June 17, 1988, as amended at 80 (4) A scheduled time for a resurvey of
FR 29839, May 22, 2015]
the institution or agency to be con-
§ 488.13 Loss of accreditation. ducted by the State agency within 90
days following the completion of the
If an accrediting organization noti- survey.
fies CMS that it is terminating a pro- (c) If, on the basis of the State cer-
vider or supplier due to non-compli- tification, the Secretary determines
ance with its CMS-approved accredita- that the provider or supplier is eligible
tion requirements, the SA will conduct to participate, the information de-
a full review in a timely manner. scribed in paragraph (b) of this section
[80 FR 29839, May 22, 2015] will be incorporated into a notice of
eligibility to the provider or supplier.
§ 488.14 Effect of QIO review. (d) If the State agency receives infor-
When a QIO is conducting review ac- mation to the effect that a hospital or
tivities under section 1154 of the Act a critical access hospital (as defined in
and part 466 of this chapter, its activi- section 1861(mm)(1) of the Act) or a
ties are in lieu of the utilization review rural emergency hospital (as defined in
324
section 1861(kkk)(2) of the Act) has vio- State survey agency’s previous certifi-
lated § 489.24 of this chapter, the State cation.
agency is to report the information to (Secs. 1102, 1814, 1861, 1863 through 1866, 1871,
CMS promptly. and 1881; 42 U.S.C. 1302, 1395f, 1395x, 1395z
through 1395cc, 1395hh, and 1395rr)
FR 11419, Mar. 28, 1974, and further redesig- [45 FR 74833, Nov. 12, 1981. Redesignated and
nated at 42 FR 52826, Sept. 30, 1977. Redesig- amended at 53 FR 23100, June 17, 1988, and
nated at 53 FR 23100, June 17, 1988; 59 FR further amended at 54 FR 5373, Feb. 2, 1989; 56
32120, June 22, 1994; 59 FR 56237, Nov. 10, 1994; FR 48879, Sept. 26, 1991; 59 FR 56237, Nov. 10,
62 FR 46037, Aug. 29, 1997; 88 FR 59335, Aug. 1994]
28, 2023]
§ 488.24 Certification of noncompli-
§ 488.20 Periodic review of compliance ance.
and approval. (a) Special rules for certification of
(a) Determinations by CMS to the ef- noncompliance for SNFs and NFs are
fect that a provider or supplier is in set forth in § 488.330.
compliance with the conditions of par- (b) The State agency will certify that
ticipation, or requirements (for SNFs a provider or supplier is not or is no
and NFs), or the conditions for cov- longer in compliance with the condi-
erage are made as often as CMS deems tions of participation or conditions for
coverage where the deficiencies are of
necessary and may be more or less
such character as to substantially
than a 12-month period, except for
limit the provider’s or supplier’s capac-
SNFs, NFs and HHAs. (See § 488.308 for ity to furnish adequate care or which
special rules for SNFs and NFs.) adversely affect the health and safety
(b) The responsibilities of State sur- of patients; or
vey agencies in the review and certifi- (c) If CMS determines that an insti-
cation of compliance are as follows: tution or agency does not qualify for
(1) Resurvey providers or suppliers as participation or coverage because it is
frequently as necessary to ascertain not in compliance with the conditions
compliance and confirm the correction of participation or conditions for cov-
of deficiencies; erage, or if a provider’s agreement is
(2) Review reports prepared by a Pro- terminated for that reason, the institu-
fessional Standards Review Organiza- tion or agency has the right to request
tion (authorized under Part B Title XI that the determination be reviewed.
of the Act) or a State inspection of (Appeals procedures are set forth in
care team (authorized under Title XIX part 498 of this chapter.)
of the Act) regarding the quality of a [59 FR 56237, Nov. 10, 1994]
facility’s care;
(3) Evaluate reports that may pertain § 488.26 Determining compliance.
to the health and safety of patients; (a) Additional rules for certification
and of compliance for SNFs and NFs are set
(4) Take appropriate actions that forth in § 488.330.
may be necessary to achieve compli- (b) The decision as to whether there
ance or certify noncompliance to CMS. is compliance with a particular re-
(c) A State survey agency certifi- quirement, condition of participation,
cation to CMS that a provider or sup- or condition for coverage depends upon
plier is no longer in compliance with the manner and degree to which the
the conditions of participation or re- provider or supplier satisfies the var-
quirements (for SNFs and NFs) or con- ious standards within each condition.
ditions for coverage will supersede the Evaluation of a provider’s or supplier’s
performance against these standards
enables the State survey agency to
document the nature and extent of de-
ficiencies, if any, with respect to a par-
ticular function, and to assess the need
for improvement in relation to the pre-
scribed conditions.
325
§ 488.28 42 CFR Ch. IV (10–1–24 Edition)
(c) The State survey agency must ad- shorter time period for achieving com-
here to the following principles in de- pliance.
termining compliance with participa- (b) The existing deficiencies noted ei-
tion requirements: ther individually or in combination
(1) The survey process is the means neither jeopardize the health and safe-
to assess compliance with Federal ty of patients nor are of such character
health, safety and quality standards; as to seriously limit the provider’s ca-
(2) The survey process uses resident pacity to render adequate care.
and patient outcomes as the primary (c)(1) If it is determined during a sur-
means to establish the compliance vey that a provider or supplier is not in
process of facilities and agencies. Spe- compliance with one or more of the
cifically, surveyors will directly ob- standards, it is granted a reasonable
serve the actual provision of care and time to achieve compliance.
services to residents and/or patients, (2) The amount of time depends upon
and the effects of that care, to assess the—
whether the care provided meets the (i) Nature of the deficiency; and
needs of individual residents and/or pa- (ii) State survey agency’s judgment
tients. as to the capabilities of the facility to
(3) Surveyors are professionals who provide adequate and safe care.
use their judgment, in concert with
(d) Ordinarily a provider or supplier
Federal forms and procedures, to deter-
is expected to take the steps needed to
mine compliance;
achieve compliance within 60 days of
(4) Federal procedures are used by all
being notified of the deficiencies but
surveyors to ensure uniform and con-
the State survey agency may rec-
sistent application and interpretation
ommend that additional time be grant-
of Federal requirements;
ed by the Secretary in individual situa-
(5) Federal forms are used by all sur-
tions, if in its judgment, it is not rea-
veyors to ensure proper recording of
sonable to expect compliance within 60
findings and to document the basis for
days, for example, a facility must ob-
the findings.
tain the approval of its governing body,
(d) The State survey agency must use
or engage in competitive bidding.
the survey methods, procedures, and
forms that are prescribed by CMS. [59 FR 56237, Nov. 10, 1994, as amended at 77
(e) The State survey agency must en- FR 67164, Nov. 8, 2012; 80 FR 29839, May 22,
sure that a facility’s or agency’s actual 2015; 86 FR 62425, Nov. 9, 2021]
provision of care and services to resi-
dents and patients and the effects of § 488.30 Revisit user fee for revisit sur-
that care on such residents and pa- veys.
tients are assessed in a systematic (a) Definitions. As used in this sec-
manner. tion, the following definitions apply:
[59 FR 56237, Nov. 10, 1994, as amended at 77 Certification (both initial and recer-
FR 67164, Nov. 8, 2012] tification) means those activities as
defined in § 488.1.
§ 488.28 Providers or suppliers, other Complaint surveys means those sur-
than SNFs, NFs, HHAs, and Hospice veys conducted on the basis of a sub-
programs with deficiencies. stantial allegation of noncompliance,
(a) If a provider or supplier is found as defined in § 488.1. The requirements
to be deficient in one or more of the of sections 1819(g)(4) and 1919(g)(4) of
standards in the conditions of partici- the Social Security Act and § 488.332
pation, conditions for coverage, or con- apply to complaint surveys.
ditions for certification or require- Provider of services, provider, or sup-
ments, it may participate in, or be cov- plier has the meaning defined in § 488.1,
ered under, the Medicare program only and ambulatory surgical centers,
if the provider or supplier has sub- transplant programs, and religious
mitted an acceptable plan of correction nonmedical health care institutions
for achieving compliance within a rea- subject to §§ 416.2, 482.70, and 403.702
sonable period of time acceptable to [C8] of this chapter, respectively, will
CMS. In the case of an immediate jeop- be subject to user fees unless otherwise
ardy situation, CMS may require a exempted.
326
Revisit survey means a survey per- agencies pursuant to section 1864 of the
formed with respect to a provider or Act or by CMS, and will be available
supplier cited for deficiencies during an for CMS until expended. CMS may de-
initial certification, recertification, or vise other collection methods as it
substantiated complaint survey and deems appropriate. In determining
that is designed to evaluate the extent these methods, CMS will consider effi-
to which previously-cited deficiencies ciency, effectiveness, and convenience
have been corrected and the provider or for the providers, suppliers, and CMS.
supplier is in substantial compliance CMS may consider any method allowed
with applicable conditions of participa- by law, including: Credit card; elec-
tion, requirements, or conditions for tronic fund transfer; check; money
coverage. Revisit surveys include both order; and offset collections from
offsite and onsite review. claims submitted.
Substantiated complaint survey means (2) Fees for revisit surveys under this
a complaint survey that results in the section are not allowable items on a
proof or finding of noncompliance at cost report, as identified in part 413,
the time of the survey, a finding that subpart B of this chapter, under title
noncompliance was proven to exist, but XVIII of the Act.
was corrected prior to the survey, and (3) Fees for revisit surveys will be
includes any deficiency that is cited due for any revisit surveys conducted
during a complaint survey, whether or during the time period for which au-
not the cited deficiency was the origi- thority to levy a revisit user fee exists.
nal subject of the complaint. (e) Reconsideration process for revisit
(b) Criteria for determining the fee. (1) user fees. (1) CMS will review a request
The provider or supplier will be as- for reconsideration of an assessed re-
sessed a revisit user fee based upon one visit user fee—
or more of the following: (i) If a provider or supplier believes
(i) The average cost per provider or an error of fact has been made in the
supplier type. application of the revisit user fee, such
(ii) The type of revisit survey con- as clerical errors, billing for a fee al-
ducted (onsite or offsite). ready paid, or assessment of a fee when
(iii) The size of the provider or sup- there was no revisit conducted, and
plier. (ii) If the request for reconsideration
(iv) The number of follow-up revisits is received by CMS within 14 calendar
resulting from uncorrected defi- days from the date identified on the re-
ciencies. visit user fee assessment notice.
(v) The seriousness and number of de- (2) CMS will issue a credit toward
ficiencies. any future revisit surveys conducted, if
(2) CMS may adjust the fees to ac- the provider or supplier has remitted
count for any regional differences in an assessed revisit user fee and for
cost. which a reconsideration request is
(c) Fee schedule. CMS must publish in found in favor of the provider or sup-
the FEDERAL REGISTER the proposed plier. If in the event that CMS judges
and final notices of a uniform fee that a significant amount of time has
schedule before it assesses revised re- elapsed before such a credit is used,
visit user fees. The notices must set CMS will refund the assessed revisit
forth which criteria will be used and user fee amount paid to the provider or
how, as well as the amounts of the as- supplier.
sessed fees based on the criteria as (3) CMS will not reconsider the as-
identified in paragraph (b) of this sub- sessment of revisit user fees that re-
part. quest reconsideration of the survey
(d) Collection of fees. (1) Fees for re- findings or deficiency citations that
visit surveys under this section may be may have given rise to the revisit, the
deducted from amounts otherwise pay- revisit findings, the need for the revisit
able to the provider or supplier. As itself, or other similarly identified
they are collected, fees will be depos- basis for the assessment of the revisit
ited as an offset collection to be used user fee.
exclusively for survey and certification (f) Enforcement. If the full revisit user
activities conducted by State survey fee payment is not received within 30
327
§ 488.52 42 CFR Ch. IV (10–1–24 Edition)
calendar days from the date identified relating to the exception in section
on the revisit user fee assessment no- 1861(e)(5) of the Act, see paragraph (c)
tice, CMS may terminate the facility’s of this section.)
provider agreement (pursuant to (c) Temporary waiver of 24-hour nurs-
§ 489.53(a)(16) of this chapter) and ening requirement of 24-hour registered
rollment in the Medicare program or nurse requirement. CMS may waive the
the supplier’s enrollment and partici- requirement contained in section
pation in the Medicare program (pursu- 1861(e)(5) that a hospital must provide
ant to § 424.535(a)(1) of this chapter). 24-hour nursing service furnished or su-
[72 FR 53648, Sept. 19, 2007, as amended at 82 pervised by a registered nurse. Such a
FR 36635, Aug. 4, 2017; 84 FR 51831, Sept. 30, waiver may be granted when the fol-
2019] lowing criteria are met:
(1) The hospital’s failure to comply
Subpart B—Special Requirements fully with the 24-hour nursing require-
ment is attributable to a temporary
§ 488.52 [Reserved] shortage of qualified nursing personnel
in the area in which the hospital is lo-
§ 488.54 Temporary waivers applicable cated.
to hospitals. (2) A registered nurse is present on
(a) General provisions. If a hospital is the premises to furnish or supervise
found to be out of compliance with one the nursing services during at least the
or more conditions of participation for daytime shift, 7 days a week.
hospitals, as specified in part 482 of (3) The hospital has in charge, on all
this chapter, a temporary waiver may tours of duty not covered by a reg-
be granted by CMS. CMS may extend a istered nurse, a licensed practical (vo-
temporary waiver only if such a waiver cational) nurse.
would not jeopardize or adversely af- (4) The hospital complies with all re-
fect the health and safety of patients. quirements specified in paragraph (a)
The waiver may be issued for any one of this section.
year period or less under certain cir- (d) Temporary waiver for technical per-
cumstances. The waiver may be with- sonnel. CMS may waive technical per-
drawn earlier if CMS determines this sonnel requirements, issued under sec-
action is necessary to protect the tion 1861(e)(9) of the Act, contained in
health and safety of patients. A waiver the Conditions of Participation; Hos-
may be granted only if: pitals (part 482 of this chapter). Such a
(1) The hospital is located in a rural waiver must take into account the
area. This includes all areas not delin- availability of technical personnel and
eated as ‘‘urban’’ by the Bureau of the the educational opportunities for tech-
Census, based on the most recent cen- nical personnel in the area in which
sus; the hospital is located. CMS may also
(2) The hospital has 50 or fewer inpa- limit the scope of services furnished by
tient hospital beds; a hospital in conjunction with the
(3) The character and seriousness of waiver in order not to adversely affect
the deficiencies do not adversely affect the health and safety of the patients.
the health and safety of patients; and In addition, the hospital must also
(4) The hospital has made and con- comply with all requirements specified
tinues to make a good faith effort to in paragraph (a) of this section.
comply with personnel requirements
consistent with any waiver.
FR 11419, Mar. 28, 1974, and amended at 41 FR
(b) Minimum compliance requirements. 27962, July 8, 1976. Further redesignated at 42
Each case will have to be decided on its FR 52826, Sept. 30, 1977, and amended at 47
individual merits, and while the degree FR 31531, July 20, 1982; 51 FR 22041, June 17,
and extent of compliance will vary, the 1986. Redesignated at 53 FR 23100, June 17,
institution must, as a minimum, meet 1988]
all of the statutory conditions in sec-
tion 1861(e)(1)–(8), in addition to meet- § 488.56 Temporary waivers applicable
ing such other requirements as the to skilled nursing facilities.
Secretary finds necessary under sec- (a) Waiver of 7-day registered nurse re-
tion 1861(e)(9). (For further information quirement. To the extent that § 483.35 of
328
this chapter requires any skilled nurs- unavailability of physicians in the

ing facility to engage the services of a area.
registered nurse more than 40 hours a [39 FR 35777, Oct. 3, 1974. Redesignated and
week, the Secretary may waive such amended at 42 FR 52826, Sept. 30, 1977. Fur-
requirement for such periods as he ther redesignated and amended at 53 FR
deems appropriate if, based upon docu- 23100, June 17, 1988, and further amended at
mented findings of the State agency, 56 FR 48879, Sept. 26, 1991; 57 FR 43925, Sept.
he determines that: 23, 1992; 81 FR 68871, Oct. 4, 2016; 82 FR 32260,
July 13, 2017]
(1) Such facility is located in a rural
area and the supply of skilled nursing § 488.60 Special procedures for ap-
facility services in such area is not suf- proving end stage renal disease fa-
ficient to meet the needs of individual cilities.
patients therein, (a) Consideration for approval. An
(2) Such facility has at least one ESRD facility that wishes to be ap-
fulltime registered nurse who is regu- proved or that wishes an expansion of
larly on duty at such facility 40 hours dialysis services to be approved for
a week, and coverage, in accordance with part 494
(3) Such facility (i) has only patients of this chapter, must secure a deter-
whose attending physicians have indi- mination by the Secretary. To secure a
cated (through physicians’ orders or determination, the facility must sub-
admission notes) that each such pa- mit the following documents and data
tient does not require the services of a for consideration by the Secretary:
registered nurse for a 48-hour period, or (1) Certification by the State agency
(ii) has made arrangements for a reg- referred to in § 488.12 of this part.
istered nurse or a physician to spend (2) Data furnished by ESRD network
such time at the facility as is deter- organizations and recommendations of
mined necessary by the patient’s at- the Public Health Service concerning
tending physician to provide necessary the facility’s contribution to the ESRD
services on days when the regular services of the network.
fulltime registered nurse is not on (3) Data concerning the facility’s
duty. compliance with professional norms
(4) Such facility has made and con- and standards.
tinues to make a good faith effort to (4) Data pertaining to the facility’s
comply with the more than 40-hour qualifications for approval or for any
registered nurse requirement, but such expansion of services.
compliance is impeded by the unavail- (b) Determining compliance with mini-
ability of registered nurses in the area. mal utilization rates: Time limitations—(1)
Unconditional status. A facility which
(b) Waiver of medical director require-
meets minimal utilization require-
ment. To the extent that § 483.70(h) of
ments will be assigned this status as
this chapter requires any skilled nurs- long as it continues to meet these re-
ing facility to engage the services of a quirements.
medical director either part-time or (2) Conditional status. A conditional
full-time, the Secretary may waive status may be granted to a facility for
such requirement for such periods as he not more than four consecutive cal-
deems appropriate if, based upon docu- endar years and will not be renewable
mented findings of the State agency, (see § 405.2122(b) of this chapter). Its
he determines that: status may be examined each calendar
(1) Such facility is located in an area year to ascertain its compliance with
where the supply of physicians is not Subpart U.
sufficient to permit compliance with (3) Exception status. Under unusual
this requirement without seriously re- circumstances (see § 405.2122 (b) of this
ducing the availability of physician chapter) the Secretary may grant a
services within the area, and time-limited exception to a facility
(2) Such facility has made and con- which is not in compliance with the
tinues to make a good faith effort to minimal utilization rate(s) for either
comply with § 483.70(h) of this chapter, unconditional status or conditional
but such compliance is impeded by the status. This exception status may be
329
§ 488.61 42 CFR Ch. IV (10–1–24 Edition)
granted, and may be renewed on an an- procedures described at 42 CFR part

nual basis, under circumstances where 488, subpart A apply to transplant pro-
rigid application of minimal utilization grams, including the periodic review of
rate requirements would adversely af- compliance and approval described at
fect the achievement of ESRD program § 488.20.
objectives. (a) Initial approval procedures for
(c) New applicant. A facility which transplant programs that are not Medi-
has not previously participated in the care-approved as of June 28, 2007. A
ESRD program must submit a plan de- transplant program, including a kidney
tailing how it expects to meet the con- transplant program, may submit a re-
ditional minimal utilization rate sta- quest to CMS for Medicare approval at
tus by the end of the second calendar any time.
year of its operation under the pro- (1) The request, signed by a person
gram and meet the unconditional mini- authorized to represent the center (for
mal utilization rate status by the end example, a chief executive officer),
of the fourth calendar year of its oper- must include:
ation under the program. (i) The hospital’s Medicare provider
(d) Notification. The Secretary will I.D. number;
notify each facility and its network co- (ii) Name(s) of the designated pri-
ordinating council of its initial and its mary transplant surgeon and primary
subsequent minimal utilization rate transplant physician; and,
classification. (iii) A statement from the OPTN that
(e) Failure to meet minimal utilization the center has complied with all data
rate. A facility failing to meet stand- submission requirements.
ards for unconditional status or condi- (2) To determine compliance with the
tional status, or if applicable, for ex- clinical experience and outcome re-
ception status, will be so notified at quirements at §§ 482.80(b) and 482.80(c),
the time of such classification. CMS will review the data contained in
(f) Interim regulations participant. A the most recent OPTN Data Report and
facility previously participating under 1-year patient and graft survival data
the interim regulations will not be ap- contained in the most recent Scientific
proved under the program established Registry of Transplant Recipient
by subpart U until it has demonstrated (SRTR) program-specific report.
that it meets all the applicable re- (3) If CMS determines that a trans-
quirements of this subpart, including plant center has not met the data sub-
the appropriate minimal utilization mission, clinical experience, or out-
rate. It may continue under the income requirements, CMS may deny the
terim program only for a period not to request for approval or may review the
exceed 1 year from the effective date of center’s compliance with the condi-
these amendments (see § 405.2100(c) of tions of participation at §§ 482.72
this chapter). During this period it through 482.76 and §§ 482.90 through
may demonstrate its ability to meet 482.104 of this chapter, using the proce-
the appropriate minimal utilization dures described at 42 CFR part 488, sub-
rate. Failure to qualify under this subpart A, to determine whether the cen-
part will automatically terminate cov- ter’s request will be approved. CMS
erage of such facility’s services under will notify the transplant center in
the ESRD program at the end of such writing whether it is approved and, if
year. approved, of the effective date of its
approval.
[41 FR 22510, June 3, 1976. Redesignated at 42
FR 52826, Sept. 30, 1977, and further amended
(4) CMS will consider mitigating fac-
at 45 FR 58124, Sept. 2, 1980. Redesignated tors in accordance with paragraphs (f),
and amended at 53 FR 23100, June 17, 1988; 73 (g), and (h) of this section.
FR 20474, Apr. 15, 2008] (5) If CMS determines that a trans-
plant program has met the data sub-
§ 488.61 Special procedures for ap- mission, clinical experience, and out-
proval and re-approval of organ come requirements, CMS will review
transplant programs. the program’s compliance with the
For the purposes of this subpart, the conditions of participation contained
survey, certification, and enforcement at §§ 482.72 through 482.76 and §§ 482.90
330
through 482.104 of this chapter using (4) If a transplant center that is

the procedures described in subpart A Medicare approved as of June 28, 2007
of this part. If the transplant program submits a request for approval under
is found to be in compliance with all the CoPs at §§ 482.72 through 482.104 of
the conditions of participation at this chapter but CMS does not approve
§§ 482.72 through 482.104 of this chapter, the transplant center, or if the trans-
CMS will notify the transplant pro- plant center does not submit its re-
gram in writing of the effective date of quest to CMS for Medicare approval
its Medicare-approval. CMS will notify under the CoPs by December 26, 2007,
the transplant program in writing if it CMS will revoke the transplant cen-
is not Medicare-approved. ter’s approval under the conditions for
(6) A kidney transplant center may coverage for kidney transplant centers
submit a request for initial approval or the national coverage decisions for
after performing at least 3 transplants extra-renal transplant centers, as ap-
over a 12-month period. plicable, and the transplant center will
(b) Initial approval procedures for no longer be reimbursed for services
transplant centers, including kidney provided to Medicare beneficiaries.
transplant centers, that are Medicare ap- CMS will notify the transplant center
proved as of June 28, 2007. (1) A trans- in writing of the effective date of its
plant center that wants to continue to loss of Medicare approval.
be Medicare approved must be in com- (c) Loss of Medicare approval. Pro-
pliance with the conditions of partici- grams that have lost their Medicare
pation at §§ 482.72 through 482.104 as of approval may seek re-entry into the
June 28, 2007 and submit a request to Medicare program at any time. A pro-
CMS for Medicare approval under the gram that has lost its Medicare ap-
conditions of participation no later proval must:
than December 26, 2007, using the proc-
(1) Request initial approval using the
ess described in paragraph (a)(1) of the
procedures described in paragraph (a)
section.
of this section;
(2) CMS will determine whether to
(2) Be in compliance with §§ 482.72
approve the transplant center, using
through 482.104 of this chapter at the
the procedures described in paragraphs
(a)(2) through (a)(5) of this section. time of the request for Medicare ap-
Until CMS makes a determination proval; and
whether to approve the transplant cen- (3) Submit a report to CMS docu-
ter under the conditions of participa- menting any changes or corrective ac-
tion at §§ 482.72 through 482.104, the tions taken by the program as a result
transplant center will continue to be of the loss of its Medicare approval sta-
Medicare approved under the end stage tus.
renal disease (ESRD) conditions for (d) Transplant program inactivity. A
coverage (CfCs) in part 405, subpart U transplant program may remain inac-
of this chapter for kidney transplant tive and retain its Medicare approval
centers or the pertinent national cov- for a period not to exceed 12 months. A
erage decisions (NCDs) for extra-renal transplant program must notify CMS
organ transplant centers, as applicable, upon its voluntary inactivation as re-
and the transplant center will continue quired by § 482.74(a)(3) of this chapter.
to be reimbursed for services provided (e) Consideration of mitigating factors
to Medicare beneficiaries. in initial approval survey, certification,
(3) Once CMS approves a kidney and enforcement actions for transplant
transplant center under the conditions programs—(1) Factors. Except for situa-
of participation, the ESRD CfCs no tions of immediate jeopardy or defi-
longer apply to the center as of the ciencies other than failure to meet re-
date of its approval. Once CMS ap- quirements at § 482.80 of this chapter,
proves an extra-renal organ transplant CMS will consider such mitigating fac-
center under the conditions of partici- tors as may be appropriate in light of
pation, the NCDs no longer apply to the nature of the deficiency and cir-
the center as of the date of its ap- cumstances, including (but not limited
proval. to) the following, in making a decision
331
§ 488.61 42 CFR Ch. IV (10–1–24 Edition)
of initial approval of a transplant pro- asters, the recovery actions planned.

gram that does not meet the data sub- Examples of information to be sub-
mission, clinical experience, or out- mitted with each request include (but
come requirements: are not limited to) the following:
(i) The extent to which outcome (i) The name and contact information
measures are not met or exceeded; for the transplant hospital and the
(ii) Availability of Medicare-approved names and roles of key personnel of the
transplant centers in the area; transplant program;
(iii) Extenuating circumstances (for (ii) The type of organ transplant pro-
example, natural disaster) that have a gram(s) for which approval is re-
temporary effect on meeting the condi- quested;
tions of participation; (iii) The conditions of participation
(iv) Program improvements that sub- that the program does not meet for
stantially address root causes of graft which the transplant center is request-
failures or patient deaths, that have ing CMS’ review for mitigating factors;
been implemented and institutional- (iv) The program’s organizational
ized on a sustainable basis, and that chart with full-time equivalent levels,
are supported by outcomes more recent roles, and structure for reporting to
than the latest available SRTR report, hospital leadership;
for which there is a sufficient post- (v) For applications involving sub-
transplant patient and graft survival standard patient or graft survival, the
period and a sufficient number of rationale and supporting evidence for
transplants such that CMS finds that CMS’ review includes, but is not lim-
the program demonstrates present-day ited to—
compliance with the requirements at (A) Root Cause Analysis for patient
§ 482.80(c)(2)(ii)(C) of this chapter; deaths and graft failures, including fac-
(v) Whether the program has made tors the program has identified as like-
extensive use of innovative transplan- ly causal or contributing factors for
tation practices relative to other patient deaths and graft failures;
transplant programs, such as a high
(B) Program improvements that have
rate of transplantation of individuals
been implemented and improvements
who are highly sensitized or children
that are planned;
who have undergone a Fontan proce-
(C) Patient and donor/organ selection
dure compared to most other trans-
criteria and evaluation protocols, in-
plant programs, where CMS finds that
cluding methods for pre-transplant pa-
the innovative practices are supported
tient evaluation by cardiologists, he-
by evidence-based published research
matologists, nephrologists, and psychi-
literature or nationally recognized
atrists or psychologists to the extent
standards or Institution Review Board
applicable;
(IRB) approvals, and the SRTR risk-ad-
justment methodology does not take (D) Waitlist management protocols
the relevant key factors into consider- and practices relevant to outcomes;
ation; and (E) Pre-operative management proto-
(vi) Whether the program’s perform- cols and practices;
ance, based on the OPTN method of (F) Immunosuppression/infection pro-
calculating patient and graft survival, phylaxis protocols;
is within the OPTN’s thresholds for ac- (G) Post-transplant monitoring and
ceptable performance and does not flag management protocols and practices;
OPTN performance review under the (H) Quality Assessment and Perform-
applicable OPTN policy. ance Improvement (QAPI) Program
(2) Content. A request for consider- meeting minutes from the most recent
ation of mitigating factors must in- four meetings and attendance rosters
clude sufficient information to permit from the most recent 12 months;
an adequate review and understanding (I) Quality dashboard and other per-
of the transplant program, the factors formance indicators; and
that have contributed to outcomes, (J) The most recent data regarding
program improvements or innovations transplants that have been made and
that have been implemented or for outcomes in terms of both patient
planned, and in the case of natural dis- survival and graft survival;
332
(vi) For mitigating factors requests with paragraph (g) of this section,
based on innovative practice: when a transplant program has waived
(A) A description of the innovations its appeal rights, has implemented sub-
that have been implemented and iden- stantial program improvements that
tification of the specific cases for address root causes and are institution-
which the innovative practices are rel- ally supported by the hospital’s gov-
evant so as to enable the patient and erning body on a sustainable basis, and
graft survival data for such cases to be has requested more time to design or
compared with all other transplants for implement additional improvements or
at least the period covered by the lat- demonstrate compliance with CMS
est available SRTR report. outcome requirements. Upon comple-
(B) The literature, research, or other tion of the Systems Improvement
evidentiary basis that supports consid- Agreement or a CMS finding that the
eration of the practice(s) as innovative. hospital has failed to meet the terms of
(vii) For requests based on natural the Agreement, CMS makes a final de-
disasters or public health emergency: termination of whether to approve or
(A) A description of the disaster or deny a program’s request for Medicare
emergency, the specific impact on the approval based on mitigating factors. A
program, the time periods of the Systems Improvement Agreement fol-
event(s) and of its immediate recovery lows the process specified in paragraph
aftermath; (g) of this section.
(B) Identification of the transplants (2) Limitation. CMS will not approve
that occurred during the period for any program with a condition-level de-
which the request is being made; and ficiency. However, CMS may approve a
(C) The approximate date when the program with a standard-level defi-
program believes it substantially re- ciency upon receipt of an acceptable
covered from the event(s), or believes plan of correction.
it will recover if substantial recovery (g) Transplant Systems Improvement
has not been accomplished at the time Agreement. A Systems Improvement
of the request. Agreement is a binding agreement, en-
(3) Timing. Within 14 calendar days tered into voluntarily by the hospital
after CMS has issued formal written and CMS, through which CMS extends
notice of a condition-level deficiency a prospective Medicare termination
to the program, CMS must receive no- date and offers the program additional
tification of the program’s intent to time to achieve compliance with the
seek mitigating factors approval, and conditions of participation, contingent
receive all information for consider- on the hospital’s agreement to partici-
ation of mitigating factors within 120 pate in a structured regimen of quality
calendar days of the CMS written noti- improvement activities, demonstrate
fication for a deficiency due to data improved outcomes, and waive the
submission, clinical experience or out- right to appeal termination based on
comes at § 482.80 of this chapter. Fail- the identified deficiency or deficiencies
ure to meet these timeframes may be (that led to the Agreement) in consid-
the basis for denial of mitigating fac- eration for more time to demonstrate
tors. CMS may permit an extension of compliance. In some cases, transplant
the timeline for good cause, such as a programs may enter a period of inac-
declared public health emergency. tivity—voluntarily, or imposed as a
(f) Results of mitigating factors review— condition of the Systems Improvement
(1) Actions. Upon review of the request Agreement.
to consider mitigating factors, CMS (1) Content. In exchange for the addi-
may take the following actions: tional time to initiate or continue ac-
(i) Approve initial approval of a pro- tivities to achieve compliance with the
gram’s Medicare participation based conditions of participation, the hos-
upon approval of mitigating factors. pital must agree to a regimen of speci-
(ii) Deny the program’s request for fied activities, including (but not lim-
Medicare approval based on mitigating ited to) all of the following:
factors. (i) Patient notification about the de-
(iii) Offer a time-limited Systems Im- gree and type of noncompliance by the
provement Agreement, in accordance program, an explanation of what the
333
§ 488.61 42 CFR Ch. IV (10–1–24 Edition)
program improvement efforts mean for in areas of endeavor that are relevant
patients, and financial assistance to to the center’s current quality im-
defray the out-of-pocket costs of co- provement needs;
payments and testing expenses for any (vi) Development of increased pro-
wait-listed individual who wishes to be ficiency, or demonstration of current
listed with another program; proficiency, with patient-level data
(ii) An external independent peer re- from the Scientific Registry of Trans-
view team that conducts an onsite as- plant Recipients and the use of registry
sessment of the program. The peer re- data to analyze outcomes and inform
view must include— quality improvement efforts;
(A) Review of policies, staffing, oper- (vii) A staffing analysis that exam-
ations, relationship to hospital serv- ines the level, type, training, and skill
ices, and factors that contribute to of staff in order to inform transplant
program outcomes; center efforts to ensure the engage-
(B) Suggestions for quality improvement and appropriate training and
ments the hospital should consider; credentialing of staff;
(C) Both verbal and written feedback (viii) Activities to strengthen per-
provided directly to the hospital; formance of the Quality Assessment
(D) Verbal debriefing provided di- and Performance Improvement Pro-
rectly to CMS; neither the hospital nor gram to ensure full compliance with
the peer review team is required to pro-
the requirements of § 482.96 and § 482.21
vide a written report to CMS; and
of this chapter;
(E) Onsite review by a multidisci-
(ix) Monthly (unless otherwise speci-
plinary team that includes a trans-
plant surgeon with expertise in the rel- fied) reporting and conference calls
evant organ type(s), a transplant ad- with CMS regarding the status of pro-
ministrator, an individual with exper- grammatic improvements, results of
tise in transplant QAPI systems, a so- the deliverables in the Systems Im-
cial worker or psychologist or psychia- provement Agreement, and the number
trist, and a specialty physician with of transplants, deaths, and graft fail-
expertise in conditions particularly ures that occur within 1 year post-
relevant to the applicable organ transplant; and
types(s) such as a cardiologist, (x) Additional or alternative require-
nephrologist, or hepatologist. Except ments specified by CMS, tailored to the
for the transplant surgeon, CMS may transplant program type and cir-
permit substitution of one type of ex- cumstances. CMS may waive the con-
pertise for another individual who has tent elements at paragraph (g)(1)(v),
expertise particularly needed for the (vi), (vii) or (viii) of this section if it
type of challenges experienced by the finds that the program has already ade-
program, such as substitution of an in- quately conducted the activity, the
fection control specialist in lieu of, or program is already proficient in the
in addition to, a social worker; function, or the activity is clearly in-
(iii) An action plan that addresses applicable to the deficiencies that led
systemic quality improvements and is to the Agreement.
updated after the onsite peer review; (2) Timeframe. A Systems Improve-
(iv) An onsite consultant whose ment Agreement will be established for
qualifications are approved by CMS, up to a 12-month period, subject to
and who provides services for 8 days CMS’ discretion to determine if a
per month on average for the duration shorter timeframe may suffice. At the
of the agreement, except that CMS hospital’s request, CMS may extend
may permit a portion of the time to be the agreement for up to an additional
spent offsite and may agree to fewer 6-month period. A signed Systems Im-
consultant days each month after the provement Agreement remains in force
first 3 months of the Systems Improve- even if a subsequent SRTR report indi-
ment Agreement; cates that the program has restored
(v) A comparative effectiveness anal- compliance with the CMS conditions of
ysis that compares policies, proce- participation, except that CMS in its
dures, and protocols of the transplant sole discretion may shorten the time-
program with those of other programs frame or allow modification to any
334
portion of the elements of the Agree- (d) The request shall include an as-
ment in such a case. surance by the requesting facility that
it will continue its good faith efforts to
FR 27156, May 12, 2014; 79 FR 50359, Aug. 22,
meet the requirements contained in
2014; 81 FR 79881, Nov. 14, 2016; 84 FR 51831, § 405.1137 of this chapter or § 482.30 of
Sept. 30, 2019] this chapter, as applicable.
(e) A revised utilization review plan
§ 488.64 Remote facility variances for for the requesting facility shall be sub-
utilization review requirements. mitted concurrently with the request
(a) As used in this section: for a variance. The revised plan shall
specify the methods and procedures
(1) An ‘‘available’’ individual is one
which the requesting facility will use,
who:
if a variance is granted, to assure:
(i) Possesses the necessary profes-
(1) That effective and timely control
sional qualifications;
will be maintained over the utilization
(ii) Is not precluded from partici- of services; and
pating by reason of financial interest (2) That reviews will be conducted so
in any such facility or direct responsi- as to improve the quality of care pro-
bility for the care of the patients being vided to patients.
reviewed or, in the case of a skilled (f) The request for a variance shall
nursing facility, employment by the fa- include:
cility; and (1) The name, location, and type (e.g.,
(iii) Is not precluded from effective hospital, skilled nursing facility) of the
participation by the distance between facility for which the variance is re-
the facility and his residence, office, or quested;
other place of work. An individual (2) The total number of patient ad-
whose residence, office, or other place missions and average daily patient cen-
of work is more than approximately sus at the facility within the previous
one hour’s travel time from the facility six months;
shall be considered precluded from ef- (3) The total number of title XVIII
fective participation. and title XIX patient admissions and
(2) ‘‘Adjacent facility’’ means a the average daily patient census of
health care facility located within a 50- title XVIII and title XIX patients in
mile radius of the facility which re- the facility within the previous six
quests a variance. months;
(b) The Secretary may grant a re- (4) As relevant to the request, the
questing facility a variance from the names of all physicians on the active
time frames set forth in §§ 405.1137(d) of staff of the facility and the names of
this chapter and 482.30 as applicable, all other professional personnel on the
within which reviews all of cases must staff of the facility, or both;
be commenced and completed, upon a (5) The name, location, and type of
showing satisfactory to the Secretary each adjacent facility (e.g., hospital,
that the requesting facility has been skilled nursing facility);
unable to meet one or more of the re- (6) The distance and average travel
quirements of § 405.1137 of this chapter time between the facility and each ad-
or § 482.30 of this chapter, as applicable, jacent facility;
by reason of insufficient medical and (7) As relevant to the request, the lo-
other professional personnel available cation of practice of available physi-
to conduct the utilization review re- cians and the estimated number of
quired by § 405.1137 of this chapter or other available professional personnel,
§ 482.30 of this chapter, as applicable. or both (see paragraph (a)(1)(iii) of this
(c) The request for variance shall section);
document the requesting facility’s in- (8) Documentation by the facility of
ability to meet the requirements for its attempt to obtain the services of
which a variance is requested and the available physicians or other profes-
facility’s good faith efforts to comply sional personnel, or both; and
with the requirements contained in (9) A statement of whether a QIO ex-
§ 405.1137 of this chapter or § 482.30 of ists in the area where the facility is lo-
this chapter, as applicable. cated.
335
§ 488.68 42 CFR Ch. IV (10–1–24 Edition)
(g) The Secretary shall promptly no- (1) Upon receipt of data from an
tify the facility of the action taken on HHA, edit the data as specified by CMS
the request. Where a variance is in ef- and ensure that the HHA resolves er-
fect, the validation of utilization re- rors within the limits specified by
view pursuant to § 405.1137 of this chap- CMS;
ter or § 482.30 shall be made with ref- (2) At least monthly, make available
erence to the revised utilization review for retrieval by CMS all edited OASIS
plan submitted with the request for records received during that period, ac-
variance. cording to formats specified by CMS,
(h) The Secretary, in granting a vari- and correct and retransmit previously
ance, will specify the period for which
rejected data as needed; and
the variance has been granted; such pe-
riod will not exceed one year. A request (3) Analyze data and generate reports
for a renewal shall be submitted not as specified by CMS.
later than 30 days prior to the expira- (c) Ensure accuracy of OASIS data.
tion of the variance and shall contain The State agency must audit the accu-
all information required by paragraphs racy of the OASIS data through the
(c), (d), and (f) of this section. Renewal survey process.
of the variance will be contingent upon (d) Restrict access to OASIS data. The
the facility’s continuing to meet the State agency or other entity des-
provisions of this section. ignated by CMS must do the following:
[40 FR 30818, July 23, 1975. Redesignated at 42 (1) Ensure that access to data is re-
FR 52826, Sept. 30, 1977; 51 FR 22041, June 17, stricted except for the transmission of
1986; 51 FR 27847, Aug. 4, 1986; 51 FR 43197, data and reports to—
Dec. 1, 1986. Redesignated and amended at 53 (i) CMS;
FR 23100, June 17, 1988] (ii) The State agency component that
§ 488.68 State Agency responsibilities conducts surveys for purposes related
for OASIS collection and data base to this function; and
requirements. (iii) Other entities if authorized by
As part of State agency survey re- CMS.
sponsibilities, the State agency or (2) Ensure that patient identifiable
other entity designated by CMS has OASIS data is released only to the ex-
overall responsibility for fulfilling the tent that it is permitted under the Pri-
following requirements for operating vacy Act of 1974.
the OASIS system: (e) Provide training and technical sup-
(a) Establish and maintain an OASIS port for HHAs. The State agency or
database. The State agency or other en- other entity designated by CMS must—
tity designated by CMS must— (1) Instruct each HHA on the admin-
(1) Use a standard system developed istration of the data set, privacy/con-
or approved by CMS to collect, store, fidentiality of the data set, and inte-
and analyze data; gration of the OASIS data set into the
(2) Conduct basic system manage- facility’s own record keeping system;
ment activities including hardware and (2) Instruct each HHA on the use of
software maintenance, system back-up, software to encode and transmit OASIS
and monitoring the status of the data-
data to the State;
base; and
(3) Obtain CMS approval before modi- (3) Specify to a facility the method of
fying any parts of the CMS standard transmission of data to the State, and
system including, but not limited to, instruct the facility on this method.
standard CMS-approved— (4) Monitor each HHA’s ability to
(i) OASIS data items; transmit OASIS data.
(ii) Record formats and validation (5) Provide ongoing technical assist-
edits; and ance and general support to HHAs in
(iii) Agency encoding and trans- implementing the OASIS reporting re-
mission methods. quirements specified in the conditions
(b) Analyze and edit OASIS data. The of participation for home health agen-
State agency or other entity des- cies; and
ignated by CMS must—
336
(6) Carry out any other functions as vider will retain, modify, add, and dis-
designated by CMS necessary to main- continue as an REH.
tain OASIS data on the standard State (c) Other outpatient medical and health
system. services. The provider must submit a
detailed description of the other med-
[64 FR 3763, Jan. 25, 1999]
ical and health services that it intends
§ 488.70 Special requirements for rural to furnish on an outpatient basis as an
emergency hospitals (REHs). REH.
(d) Use of additional facility payment.
An eligible facility submitting an ap- The provider must submit information
plication for enrollment under section regarding how the provider intends to
1866(j) of the Act to become a rural use the additional facility payment
emergency hospital (REH) (as defined provided in accordance with section
in § 485.502 of this chapter) must also 1834(x)(2) of the Act, including a de-
submit an action plan containing the scription of the services that the addi-
following additional information: tional facility payment would be sup-
(a) Plan for provision of services. The porting, such as the operation and
provider must submit an action plan maintenance of the facility and the
for initiating rural emergency hospital furnishing of covered services (for ex-
(REH) services (as defined in § 485.502 of ample, telehealth services, and ambu-
this chapter, and which must include lance services).
the provision of emergency department
services and observation care). [88 FR 59335, Aug. 28, 2023]
(b) Transition plan. The provider must
submit a detailed transition plan that Subpart C—Survey Forms and
lists the specific services that the pro- Procedures
337
§ 488.100 42 CFR Ch. IV (10–1–24 Edition)
§ 488.100 Long term care survey forms, Part A.
338
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§ 488.100 42 CFR Ch. IV (10–1–24 Edition)
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§ 488.100 42 CFR Ch. IV (10–1–24 Edition)
342
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§ 488.100 42 CFR Ch. IV (10–1–24 Edition)
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§ 488.100 42 CFR Ch. IV (10–1–24 Edition)
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§ 488.100 42 CFR Ch. IV (10–1–24 Edition)
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§ 488.100 42 CFR Ch. IV (10–1–24 Edition)
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§ 488.100 42 CFR Ch. IV (10–1–24 Edition)
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§ 488.100 42 CFR Ch. IV (10–1–24 Edition)
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§ 488.100 42 CFR Ch. IV (10–1–24 Edition)
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§ 488.100 42 CFR Ch. IV (10–1–24 Edition)
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§ 488.100 42 CFR Ch. IV (10–1–24 Edition)
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§ 488.100 42 CFR Ch. IV (10–1–24 Edition)
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§ 488.110 Procedural guidelines. resident, is actually being provided in

nursing homes. Although the onsite re-
SNF/ICF Survey Process. The purpose
view procedures have been changed, fa-
for implementing a new SNF/ICF sur-
cilities must continue to meet all ap-
vey process is to assess whether the
plicable Conditions/Standards, in order
quality of care, as intended by the law to participate in Medicare/Medicaid
and regulations, and as needed by the programs. That is, the methods used to
431
§ 488.110 42 CFR Ch. IV (10–1–24 Edition)
compile information about compliance CMS–519), along with the related work-
with law and regulations are changed; sheets (CMS–520 through 524).
the law and regulations themselves are Use this survey process for all sur-
not changed. The new process differs veys of SNFs and ICFs—whether free-
from the traditional process, prin- standing, distinct parts, or dually cer-
cipally in terms of its emphasis on resi- tified. Do not use this process for sur-
dent outcomes. In ascertaining wheth- veys of Intermediate Care Facilities for
er residents grooming and personal hy- Mentally Retarded (ICFs/IID), swing-
giene needs are met, for example, sur- bed hospitals or skilled nursing sec-
veyors will no longer routinely evalu- tions of hospitals that are not sepa-
ate a facility’s written policies and rately certified as SNF distinct parts.
procedures. Instead, surveyors will ob- Do not announce SNF/ICF surveys
serve residents in order to make that ahead of time.
determination. In addition, surveyors (b) The Survey Tasks. Listed below are
will confirm, through interviews with the survey tasks for easy reference:
residents and staff, that such needs are • Task 1. Entrance Conference.
indeed met on a regular basis. In most • Task 2. Resident Sample—Selection
reviews, then, surveyors will ascertain Methodology.
whether the facility is actually pro- • Task 3. Tour of the Facility. Resi-
viding the required and needed care dent Needs. Physical Environment.
and services, rather than whether the Meeting with Resident Council Rep-
facility is capable of providing the care resentatives. Tour Summation and
and services. Focus of Remaining Survey Activity.
• Task 4. Observation/Interview/Med-
THE OUTCOME-ORIENTED SURVEY PROCESS— ical Record. Review of Each Individual
SKILLED NURSING FACILITIES (SNFS) AND
INTERMEDIATE CARE FACILITIES (ICFS)
in the Resident Sample (including drug
regimen review).
(a) General. • Task 5. Drug Pass Observation.
(b) The Survey Tasks. • Task 6. Dining Area and Eating As-
(c) Task 1—Entrance Conference. sistance Observation.
(d) Task 2—Resident Sample—Selection
• Task 7. Forming the Deficiency
Methodology.
(e) Task 3—Tour of the Facility.
Statement (if necessary).
(f) Task 4—Observation/Interview/Medical • Task 8. Exit Conference.
Record Review (including drug regimen re- (c) Task 1—Entrance Conference. Per-
view). form these activities during the en-
(g) Task 5—Drug Pass Observation. trance conference in every certifi-
(h) Task 6—Dining Area and Eating Assist- cation and recertification survey:
ance Observation. • Introduce all members of the team
(i) Task 7—Forming the Deficiency State- to the facility staff, if possible, even
ment. though the whole team may not be
(j) Task 8—Exit Conference.
present for the entire entrance con-
(k) Plan of Correction.
(l) Followup Surveys. ference. (All surveyors wear identifica-
(m) Role of Surveyor. tion tags.)
(n) Confidentiality and Respect for Resi- • Explain the SNF/ICF survey proc-
dent Privacy. ess as resident centered in focus, and
(o) Team Composition. outline the basic steps.
(p) Type of Facility-Application of SNF or • Ask the facility for a list showing
ICF Regulations. names of residents by room number
(q) Use of Part A and Part B of the Survey with each of the following care needs/
Report. treatments identified for each resident
(a) General. A complete SNF/ICF fa- to whom they apply:
cility survey consists of three compo- —Decubitus care
nents: —Restraints
• Life Safety Code requirements; —Catheters
• Administrative and structural re- —Injections
quirements (Part A of the Survey Re- —Parenteral fluids
port, Form CMS–525); and —Rehabilitation service
• Direct resident care requirements —Colostomy/ileostomy care
(Part B of the Survey Report, Form —Respiratory care
432
—Tracheostomy care Number of

residents in Number of residents in sample 1
—Suctioning facility
—Tube feeding
0–60 resi- 25% of residents (minimum—10).
Use this list for selecting the residents.
dent sample. 61–120 20% of residents (minimum—15).
residents.
• Ask the facility to complete page 2 121–200 15% of residents (minimum—24).
of Form CMS–519 (Resident Census) as residents.
soon as possible, so that the informa- 201 + resi- 10% of residents (minimum—30).
dents.
tion can further orient you to the fa-
1 Maximum—50.
cility’s population. In a survey of a
SNF with a distinct part ICF, you may Note that the calculation is based on
collect two sets of census data. How- the resident census, not beds. After de-
ever, consolidate the information when termining the appropriate sample size,
submitting it to the regional office. select residents for the sample in a ran-
You may modify the Resident Census dom manner. You may, for example, se-
Form to include the numbers of li- lect every fifth resident from the resi-
censed and certified beds, if necessary. dent census, beginning at a random po-
• Ask the facility to post signs on sition on the list. For surveys of dually
readily viewed areas (at least one on certified facilities or distinct part
each floor) announcing that State sur- SNFs/ICFs, first use the combined SNF/
veyors are in the facility performing an ICF population to calculate the size of
‘‘inspection,’’ and are available to meet the sample, and then select a sample
with residents in private. Also indicate that reflects the proportions of SNF
the name and telephone number of the and ICF residents in the facility’s over-
State agency. Hand-printed signs with all population.
(2) Special Care Needs/Treatments. The
legible, large letters are acceptable.
survey form specifies several care
• If the facility has a Resident Coun- needs/treatments that must always be
cil, make mutually agreeable arrange- reviewed when they apply to any facil-
ments to meet privately with the presi- ity residents. These include:
dent and officers and other individuals
• Decubitus Care
they might invite.
• Restraints
• Inform the facility that interviews • Catheters
with residents and Resident Councils • Injections, Parenteral Fluids, Colos-
are conducted privately, unless they tomy/Ileostomy, Respiratory Care,
independently request otherwise, in Tracheostomy Care, Suctioning,
order to enhance the development of Tube Feeding
rapport as well as to allay any resident • Rehabilitative Services (physical
anxiety. Tell the facility that informa- therapy, speech pathology and audi-
tion is gathered from interviews, the ology services, occupational therapy)
tour, observations, discussions, record Due to the relatively low prevalence
review, and facility officials. Point out of these care needs/treatments, appro-
that the facility will be given an oppor- priate residents may be either under-
tunity to respond to all findings. represented or entirely omitted from
(d) Task 2—Resident Sample—Selection the sample. Therefore, determine dur-
Methodology. This methodology is ing the tour how many residents in the
aimed at formulating a sample that re- random selection fall into each of these
flects the actual distribution of care care categories. Then, compare the
needs/treatments in the facility popu- number of such residents in the ran-
lation. dom selection with the total number of
Primarily performed on a random residents in the facility with each spec-
basis, it also ensures representation in ified care need/treatment (based on ei-
the sample of certain care needs and ther the resident census or other infor-
treatments that are assessed during mation provided by the facility).
the survey. Review no less than 25 percent of the
(1) Sample Size. Calculate the size of residents in each of these special care
the sample according to the following needs/treatments categories. For exam-
guide: ple, if the facility has 10 residents with
433
§ 488.110 42 CFR Ch. IV (10–1–24 Edition)
decubitus ulcers, but only one of these ily members/significant others (if
residents is selected randomly, review present), and staff, asking open-ended
two more residents with decubitis ul- questions in order to confirm observa-
cers (25% of 10 equals 2.5, so review a tions, obtain additional information, or
total of 3). Or, if the facility has two corroborate information, (e.g., acci-
residents who require tube feeding, nei- dents, odors, apparent inappropriate
ther of whom is in the random selec- dress, adequacy and appropriateness of
tion, review the care of at least one of activities). Converse sufficiently with
the these residents. This can be accom- residents selected for in-depth review
plished in the following manner: to ascertain whether they are willing
Conduct in-depth reviews of the ran- to be interviewed and are communica-
domly selected residents and then per- tive. Observe staff interactions with
form limited reviews of additional resi- other staff members as well as with
dents as needed to cover the specified residents for insight into matters such
care categories. Such reviews are lim- as resident rights and assignments of
ited to the care and services related to staff responsibilities.
the pertinent care areas only, e.g., Always knock and/or get permission
catheters, restraints, or colostomy. before entering a room or interrupting
Utilize those worksheets or portions of privacy. If you wish to inspect a resi-
worksheets which are appropriate to dent’s skin, observe a treatment proce-
the limited review. Refer to the Care dure, or observe a resident who is ex-
Guidelines, as a resource document, posed, courteously ask permission from
when appropriate. the resident if she/he comprehends, or
Always keep in mind that neither the ask permission from the staff nurse if
random selection approach nor the re- the resident cannot communicate. Do
view of residents within the specified not do ‘‘hands-on’’ monitoring such as
care categories precludes investigation removal of dressings; ask staff to re-
of other resident care situations that move a dressing or handle a resident.
you believe might pose a serious threat (3) Resident Needs. While touring,
to a resident’s health or safety. Add to focus on the residents’ needs—physical,
the sample, as appropriate. emotional, psychosocial, or spiritual—
(e) Task 3—Tour of the Facility—(1) and whether those needs are being met.
Purpose. Conduct the tour in order to: Refer to the following list as needed:
• Develop an overall picture of the —Personal hygiene, grooming, and ap-
types and patterns of care delivery propriate dress
present within the facility; —Position
• View the physical environment; —Assistive and other restorative de-
and vices
• Ascertain whether randomly se- —Rehabilitation issues
lected residents are communicative —Functional limitations in ADL
and willing to be interviewed. —Functional limitations in gait, bal-
(2) Protocol. You may tour the entire ance and coordination
facility as a team or separately, as —Hydration and nutritional status
long as all areas of the facility are ex- —Resident rights
amined by at least one team member. —Activity for time of day (appropriate
Success of the latter approach, how- or inappropriate)
ever, is largely dependent on open —Emotional status
intra-team communication and the —Level of orientation
ability of each team member to iden- —Awareness of surroundings
tify situations for further review by —Behaviors
the team member of the appropriate —Cleanliness of immediate environ-
discipline. You may conduct the tour ment (wheelchair, bed, bedside table,
with or without facility staff accom- etc.)
panying you, as you prefer. Facilities, —Odors
however, vary in staff member avail- —Adequate clothing and care supplies
ability. Record your notes on the Tour as well as maintenance and cleanli-
Notes Worksheet, Form CMS–521. ness of same
Allow approximately three hours for (4) Review of the Physical Environment.
the tour. Converse with residents, fam- As you tour each resident’s room and
434
auxiliary rooms, also examine them in • ‘‘What don’t you like? What do you
connection with the physical environ- like?’’
ment requirements. You need not docu- (6) Tour Summation and Focus of Re-
ment physical environment on the maining Survey Activity. When the tour
Tour Notes Worksheet. Instead, you is completed, review the resident cen-
may note any negative findings di- sus data provided by the facility. De-
rectly on the Survey Report Form in termine if the care categories specified
the remarks section. in the section on Resident Sample are
(5) Meeting With Resident Council Rep- sufficiently represented in the random
resentatives. If a facility has a Resident selection, make adjustments as needed,
Council, one or more surveyors meet and complete the listing of residents on
with the respresentatives in a private the worksheet labeled ‘‘Residents Se-
area. Facility staff members do not at- lected for In-depth Review’’, Form
tend unless specifically requested by CMS–520.
the Council. Explain the purpose of the Transcribe notes of a negative nature
survey and briefly outline the steps in onto the SRF in the ‘‘Remarks’’ col-
the survey process, i.e., entrance con- umn under the appropriate rule. Find-
ference * * * exit conference. Indicate ings from a later segment in the survey
your interest in learning about the or gathered by another surveyor may
strengths of the facility in addition to combine to substantiate a deficiency.
any complaints or shortcomings. State You need not check ‘‘met’’ or ‘‘not
that this meeting is one part of the in- met’’ at this point in the survey. Dis-
formation gathering; the findings have cuss significant impressions/conclu-
not yet been completed nor the conclusions at the completion of each subse-
sions formulated. Explain further, how- quent survey task, and transfer any
ever, that the official survey findings negative findings onto the Survey Re-
are usually available within three port Form in the Remarks section.
months after the completion of the sur- (f) Task 4—Observation/Interview/Med-
vey, and give the telephone number of ical Record Review (including drug regi-
the State agency office. men review). Perform the in-depth re-
Use this meeting to ascertain view of each individual in the resident
strengths and/or problems, if any, from sample in order to ascertain whether
the consumer’s perspective, as well as the facility is meeting resident needs.
to develop additional information Evaluate specific indicators for each
about aspects of care and services resident, utilizing the front and back of
gleaned during the tour that were pos- the ‘‘Observation/Interview/Record Re-
sibly substandard. view (OIRR)’’ worksheet, Form CMS–
Conduct the meeting in a manner 524. You may prefer to perform the
that allows for comments about any record review first, complete resident/
aspect of the facility. (See the section staff/family observations and inter-
on Interview Procedures.) Use open- views, and finally, return to the record
ended questions such as: for any final unresolved issues. On the
• ‘‘What is best about this home?’’ other hand, you may prefer to do the
• ‘‘What is worst?’’ interviews first. Either method is ac-
• ‘‘What would you like to change?’’ ceptable. Whenever possible, however,
In order to get more detail, use ques- complete one resident’s observation/
tions such as: interview/medical record review and
document the OIRR before moving
• ‘‘Can you be more specific?’’ onto another resident. If because of the
• ‘‘Can you give me an example?’’
facility layout, it is more efficient to
• ‘‘What can anyone else tell me
do more than one record review at a
about this?’’
time, limit such record review to two
If you wish to obtain information or three residents so your familiarity
about a topic not raised by the resi- with the particular resident and con-
dents, use an approach like the fol- tinuity of the OIRR are not com-
lowing: promised.
• ‘‘Tell me what you think about the (1) Observation. Conduct observations
food/staff/cleanliness here.’’ concurrently with interviews of resi-
• ‘‘What would make it better?’’ dents, family/significant others, and
435
§ 488.110 42 CFR Ch. IV (10–1–24 Edition)
discussions with direct care staff [of • Assure that you will strive for ano-
the various disciplines involved. In nymity for the resident and that the
multi-facility operations, whenever interview is used in addition to med-
possible, observe staff that is regularly ical records, observations, discussions,
assigned to the facility in order to gain etc., to capture an accurate picture of
an understanding of the care and serv- the treatment and care provided by the
ices usually provided.] Maintain re- facility. Explain that the official find-
spect for resident privacy. Minimize ings of the survey are usually available
disruption of the operations of the fa- to the public about three months after
cility or impositions upon any resident completion of the survey, but resident
as much as possible. Based upon your names are not given to the public.
observations of the residents’ needs, • When residents experience dif-
gather information about any of the ficulty expressing themselves:
following areas, as appropriate: —Avoid pressuring residents to ver-
Bowel and bladder training balize
Catheter care —Accept and respond to all commu-
Restraints nication
Injections —Ignore mistakes in word choice
Parenteral fluids —Allow time for recollection of words
Tube feeding/gastrostomy
—Encourage self-expression through
Colostomy/ileostomy any means available
Respiratory therapy
Tracheostomy care • When interviewing residents with
Suctioning decreased receptive capacity:
(2) Interviews. Interview each resident —Speak slowly and distinctly
in private unless he/she independently —Speak at conversational voice level
requests that a facility staff member or —Sit within the resident’s line of vi-
other individual be present. Conduct sion
the in-depth interview in a nonthreat- • Listen to all resident information/al-
ening and noninvasive fashion so as to legations without judgment. Infor-
decrease anxiety and defensiveness. mation gathered subsequently may
The open-ended approach described in substantiate or repudiate an allega-
the section on the Resident Council is tion.
also appropriate for the in-depth inter- The length of the interview varies,
view. While prolonged time expendi- depending on the condition and wishes
ture is not usually a worthwhile use of of the resident and the amount of in-
resources or the resident’s time, do formation supplied. Expect the average
allow time initially to establish rap- interview, however, to last approxi-
port. mately 15 minutes. Courteously termi-
At each interview: nate an interview whenever the resi-
• Introduce yourself. dent is unable or unwilling to continue,
• Address the resident by name. or is too confused or disoriented to
• Explain in simple terms the reason continue. Do, however, perform the
for your visit (e.g., to assure that the other activities of this task (observa-
care and services are adequate and ap- tion and record review). If, in spite of
propriate for each resident). your conversing during the tour, you
• Briefly outline the process—en- find that less than 40 percent of the
trance conference, tour, interviews, ob- residents in your sample are suffi-
servations, review of medical records, ciently alert and willing to be inter-
resident interviews, and exit con- viewed, try to select replacements so
ference. that a complete OIRR is performed for
• Mention that the selection of a par- a group this size, if possible. There may
ticular resident for an interview is not be situations, however, where the resi-
meant to imply that his/her care is dent population has a high percentage
substandard or that the facility proof confused individuals and this per-
vides substandard care. Also mention centage is not achievable. Expect that
that most of those interviewed are se- the information from confused individ-
lected randomly. uals can be, but is not necessarily, less
436
reliable than that from more alert indi- • The interventions have been car-
viduals. ried out.
Include the following areas in the • The resident has been evaluated to
interview of each resident in the sam- determine the effectiveness of the
ple: interventions.
Activities of daily living For example, if a resident has devel-
Grooming/hygiene oped a decubitus ulcer while in the fa-
Nutrition/dietary cility, record review can validate staff
Restorative/rehabilitation care and and resident interviews regarding the
services facility’s attempts at prevention. Use
Activities your own judgment; review as much of
Social services the record(s) as necessary to evaluate
Resident rights the care planning. Note that facilities
need not establish specific areas in the
Refer to the Care Guidelines ‘‘eval-
record stating ‘‘Assessment,’’ ‘‘Plan,’’
uation factors’’ as a resource for pos-
‘‘Intervention,’’ or ‘‘Evaluation’’ in
sible elements to consider when focus-
order for the documentation to be con-
ing on particular aspects of care and
sidered adequate.
resident needs.
(ii) Reconciling the record with itself.
Document information obtained from Determine:
the interviews/observations on the
OIRR Worksheet. Record in the • If the resident has been properly as-
‘‘Notes’’ section any additional infor- sessed for all his/her needs.
mation you may need in connection • That normal and routine nursing
with substandard care or services. Un- practices such as periodic weights,
less the resident specifically requests temperatures, blood pressures, etc., are
that he/she be identified, do not reveal performed as required by the resident’s
the source of the information gleaned conditions.
from the interview. (iii) Performing the drug regimen re-
(3) Medical Record Review. The med- view. The purpose of the drug regimen
ical record review is a three-part proc- review is to determine if the phar-
ess, which involves first reconciling the macist has reviewed the drug regimen
observation/interview findings with the on a monthly basis. Follow the proce-
record, then reconciling the record dures in Part One of Appendix N, Sur-
against itself, and lastly performing veyor Procedures for Pharmaceutical
the drug regimen review. Service Requirements in Long-Term
Document your findings on the OIRR Care Facilities. Fill in the appropriate
Worksheet, as appropriate, and summa- boxes on the top left hand corner of the
rize on the Survey Report Form the reverse side of the OIRR Worksheet,
findings that are indicative of problem- Form CMS–524. Appendix N lists many
atic or substandard care. Be alert for irregularities that can occur. Review
repeated similar instances of sub- at least six different indicators on each
standard care developing as the num- survey. However, the same six indica-
ber of completed OIRR Worksheets in- tors need not be reviewed on every sur-
creases. vey.
NOTE: The problems related to a particular NOTE: If you detect irregularities and the
standard or condition could range from iden- documentation demonstrates that the phar-
tical (e.g., meals not in accordance with die- macist has notified the attending physician,
tary plan) to different but related (e.g., nurs- do not cite a deficiency. Do, however, bring
ing services—lapse in care provided to resi- the irregularity to the attention of the med-
dents with catheters, to residents with con- ical director or other facility official, and
tractures, to residents needing assistance for note the official’s name and date of notifica-
personal hygiene and residents with improp- tion on the Survey Report Form.
erly applied restraints). (g) Task 5—Drug Pass Observation. The
purpose of the drug pass observation is
(i) Reconciling the observation/interview to observe the actual preparation and
findings with the record. Determine if: administration of medications to resi-
• An assessment has been performed. dents. With this approach, there is no
• A plan with goals has been devel- doubt that the errors detected, if any,
oped. are errors in drug administration, not
437
§ 488.110 42 CFR Ch. IV (10–1–24 Edition)
documentation. Follow the procedure help alleviate resident anxiety over the
in Part Two of Appendix N, Surveyor observation process.
Procedures for Pharmaceutical Service Select a minimum of five residents
Requirements in Long-Term Care Fa- for each meal observation and include
cilities, and complete the Drug Pass residents who have their meals in their
Worksheet, Form CMS–522. Be as neu- rooms. Residents selected for the in-
tral and unobtrusive as possible during depth review need not be included in
the drug pass observation. Whenever the dining and eating assistance obser-
possible, select one surveyor, who is a vation; however, their whole or partial
Registered Nurse or a pharmacist, to inclusion is acceptable. Ascertain the
observe the drug pass of approximately extent to which the facility assesses,
20 residents. In facilities where fewer plans, and evaluates the nutritional
than 20 residents are receiving medica- care of residents and eating assistance
tions, review as many residents receiv- needs by reviewing the sample of 10 or
ing medications as possible. Residents more residents. If you are unable to de-
selected for the in-depth review need termine whether the facility meets the
not be included in the group chosen for standards from the sample reviewed,
the drug pass; however, their whole or expand the sample and focus on the
partial inclusion is acceptable. In order specific area(s) in question, until you
to get a balanced view of a facility’s can formulate a conclusion about the
practices, observe more than one per- extent of compliance. As with the
son administering a drug pass, if fea- other survey tasks, transfer the find-
sible. This might involve observing the
ings noted on the ‘‘Dining & Eating As-
morning pass one day in Wing A, for
sistance Observation’’ worksheet to the
example, and the morning pass the
Survey Report Form.
next day in Wing B.
Transfer findings noted on the ‘‘Drug (i) Task 7—Forming the Deficiency
Pass’’ worksheet to the SRF under the Statement—(1) General. The Survey Re-
appropriate rule. If your team con- port Form contains information about
cludes that the facility’s medication all of the negative findings of the sur-
error rate is 5 percent or more, cite the vey. Be sure to transfer to the Survey
deficiency under Nursing Services/Ad- Report Form data from the tour, drug
ministration of Drugs. Report the error pass observation, dining area and eat-
rate under F209. If the deficiency is at ing assistance observation, as well as
the standard level, cite it in Nursing in-depth review of the sample of resi-
Services, rather than Pharmacy. dents. Transfer only those findings
(h) Task 6—Dining Area and Eating As- which could possibly contribute to a
sistance Observation. The purpose of this determination that the facility is defi-
task is to ascertain the extent to which cient in a certain area.
the facility meets dietary needs, par- Meet as a group in a pre-exit con-
ticularly for those who require eating ference to discuss the findings and
assistance. This task also yields infor- make conclusions about the defi-
mation about staff interaction with ciencies, subject to information pro-
residents, promptness and appropriate- vided by facility officials that may fur-
ness of assistance, adaptive equipment ther explain the situation. Review the
usage and availability, as well as ap- summaries/conclusions from each task
propriateness of dress and hygiene for and decide whether any further infor-
meals. mation and/or documentation is nec-
For this task, use the worksheet en- essary to substantiate a deficiency. As
titled ‘‘Dining Area and Eating Assist- the facility for additional information
ance Observation’’ (Form CMS–523). for clarification about particular find-
Observe two meals; for a balanced view, ings, if necessary. Always consider in-
try to observe meals at different times formation provided by the facility. If
of the day. For example, try to observe the facility considers as acceptable,
a breakfast and a dinner rather than practices which you believe are not ac-
two breakfasts. Give particular care to ceptable, ask the facility to backup its
performing observations as unobtru- contention with suitable reference ma-
sively as possible. Chatting with resi- terial or sources and submit them for
dents and sitting down nearby may your consideration.
438
(2) Analysis. Analyze the findings on ascertain compliance, and cite accord-
the Survey Report Form for the degree ingly. Residents, family, or former em-
of severity, frequency of occurrence ployees may be helpful for information
and impact on delivery of care or qual- gathering.
ity of life. The threshold at which the (4) Composing the Deficiency Statement.
frequency of occurrences amounts to a Write the deficiency statement in
deficiency varies from situation to sit- terms specific enough to allow a rea-
uation. One occurrence directly related sonably knowledgeable person to un-
to a life-threatening or fatal outcome derstand the aspect(s) of the require-
can be cited as a deficiency. On the ment(s) that is (are) not met. Do not
other hand, a few sporadic occurrences delve into the facility’s policies and
may have so slight an impact on deliv- procedures to determine or speculate
ery of care or quality of life that they on the root cause of a deficiency, or
do not warrant a deficiency citation. sift through various alternatives in an
Review carefully all the information effort to prescribe an acceptable rem-
gathered. What may appear during ob- edy. Indicate the data prefix tag and
servation as a pattern, may or may not regulatory citation, followed by a sum-
be corroborated by records, staff, and mary of the deficiency and supporting
residents. For example, six of the 32 findings using resident identifiers, not
residents in the sample are dressed in resident names, as in the following ex-
mismatched, poorly buttoned clothes. ample.
A few of the six are wearing slippers F102 SNF 405.1123(b).—Each resident has
without socks. A few others are wear- not had a physician’s visit at least once
ing worn clothes. Six occurrences every 30 days for the first 90 days after ad-
might well be indicative of a pattern of mission. Resident #1602 has not been seen by
susbstandard care. Close scrutiny of a physician since she was admitted 50 days
records, discussions with staff, and ago. Her condition has deteriorated since
interviews reveal, however, that the six that time (formulation of decubiti, infec-
tions).
residents are participating in dressing
retraining programs. Those residents When the data prefix tag does not re-
who are without socks, chose to do so. peat the regulations, also include a
The worn clothing items were also cho- short phrase that describes the prefix
sen—they are favorites. tag (e.g., F117 decubitus ulcer care).
Combinations of substandard care List the data tags in numerical order,
such as poor grooming of a number of whenever possible.
residents, lack of ambulation of a num- (j) Task 8—Exit Conference. The pur-
ber of residents, lack of attention to pose of the exit conference is to inform
positioning, poor skin care, etc., can the facility of survey findings and to
yield a deficiency in nursing services arrange for a plan of correction, if
just as 10 out of 10 residents receiving needed. Keep the tone of the exit con-
substandard care for decubiti yields a ference consistent with the character
deficiency. of the survey process—inspection and
(3) Deficiencies Alleged by Staff or Resi- enforcement. Tactful, business-like,
dents. If staff or residents allege defi- professional presentation of the find-
ciencies, but records, interviews, and ings is of paramount importance. Rec-
observation fail to confirm the situa- ognize that the facility may wish to re-
tion, it is unlikely that a deficiency ex- spond to various findings. Although de-
ists. Care and services that are indeed ficiency statements continue to de-
confirmed by the survey to be in com- pend, in part, on surveyor professional
pliance with the regulatory require- judgment, support your conclusions
ments, but considered deficient by resi- with resident-specific examples (identi-
dents or staff, cannot be cited as defi- fiers other than names) whenever you
cient for certification purposes. On the can do so without compromising con-
other hand, if an allegation is of a very fidentiality. Before formally citing de-
serious nature (e.g., resident abuse) ficiencies, discuss any allegations or
and the tools of record review and ob- findings that could not be substan-
servation are not effective because the tiated during earlier tasks in the proc-
problem is concealed, obtain as much ess. For example, if information is
information as possible or necessary to gathered that suggests a newly hired
439
§ 488.110 42 CFR Ch. IV (10–1–24 Edition)
R.N. is not currently licensed, ask the day,’’ is not acceptable. An acceptable
facility officials to present current li- plan of correction would explain
censure information for the nurse in changes made to the facility’s staffing
question. Identify residents when the and scheduling in order to gurantee
substandard care is readily observed or that staff is available to provide all
discerned through record review. En- necessary services for all residents.
sure that the facility improves the care Acceptance of the plan of correction
provided to all affected residents, not does not absolve the facility of the re-
only the identified residents. Make sponsibility for compliance should the
clear to the facility that during a fol- implementation not result in correc-
low-up visit the surveyors may review tion and compliance. Acceptance indi-
residents other than those with signifi- cates the State agency’s acknowledge-
cant problems from the original sam- ment that the facility indicated a will-
ple, in order to see that the facility has ingness and ability to make correc-
corrected the problems overall. Do not tions adequately and timely.
disclose the source of information pro-
Allow the facility up to 10 days to
vided during interviews, unless the
prepare and submit the plan of correc-
resident has specifically requested you
tion to the State agency, however, fol-
to inform the facility of his/her com-
ments or complaints. In accordance low your SA policy if the timeframe is
with your Agency’s policy, present the shorter. Retain the various survey
Statement of Deficiencies, form CMS– worksheets as well as the Survey Re-
2567, on site or after supervisory report Form at the State agency. For-
view, no later than 10 calendar days ward the deficiency statement to the
following the survey. CMS regional office.
(k) Plan of Correction. Explain to the (l) Follow-up Surveys. The purpose of
facility that your role is to identify the follow-up survey is to re-evaluate
care and services which are not con- the specific types of care or care deliv-
sistent with the regulatory require- ery patterns that were cited as defi-
ments, rather than to ascertain the cient during the original survey. Ascer-
root causes of deficiencies. Each facil- tain the corrective status of all defi-
ity is expected to review its own care ciencies cited on the CMS–2567. Be-
delivery. Subsequent to the exit con- cause this survey process focuses on
ference, each facility is required to the actual provision of care and serv-
submit a plan of correction that identi- ices, revisits are almost always nec-
fies necessary changes in operation essary to ascertain whether the
that will assure correction of the cited deficienicies have indeed been cor-
deficiencies. In reviewing and accept- rected. The nature of the deficiencies
ing a proposed plan of correction, apply dictates the scope of the follow-up
these criteria: visit. Use as many tasks or portions of
• Does the facility have a reasonable the Survey Report Form(s) as needed
approach for correcting the defi- to ascertain compliance status. For ex-
ciencies? ample, you need not perform another
• Is there a high probability that the drug pass if no drug related deficiencies
planned action will result in compli- were cited on the initial survey. Simi-
ance? larly, you need not repeat the dining
• Is compliance expected timely? area and eating assistance observations
Plans of correction specific to resi- if no related problems were identified.
dents identified on the deficiency All or some of the aspects of the obser-
statement are acceptable only where vation/interview/medical record review,
the deficiency is determined to be however, are likely to be appropriate
unique to that resident and not indic- for the follow-up survey.
ative of a possible systemic problem. When selecting the resident sample
For example, as a result of an aide for the follow-up, determine the sample
being absent, two residents are not am- size using the same formula as used
bulated three times that day as called earlier in the survey, with the fol-
for in their care plans. A plan of cor- lowing exceptions:
rection that says ‘‘Ambulate John • The maximum sample size is 30
Jones and Mary Smith three times per residents, rather than 50.
440
• The minimum sample size of 10 ensure that the restriants are applied
residents does not apply if only one properly.
care category was cited as deficient A secondary role for the surveyor is
and the total number of residents in to provide general consultation to the
the facility in that category was less provider/consumer community. This in-
than 10 (e.g., deficiency cited under cludes meeting with provider/consumer
catheter care and only five residents associations and other groups as well
have catheters). as participating in seminars. It also in-
cludes informational activities, where-
Include in the sample those residents
by you respond to oral or written in-
who, in your judgment, are appropriate
quiries about required outcomes in
for reviewing vis-a-vis the cited sub-
care and services.
standard care. If possible, include some (n) Confidentiality and Respect for
residents identified as receiving sub- Resident Privacy. Conduct the survey in
standard care during the initial survey. a manner that allows for the greatest
If after completing the follow-up ac- degree of confidentiality for residents,
tivities you determine that the cited particularly regarding the information
deficiencies were not corrected, ini- gathered during the in-depth inter-
tiate adverse action procedures, as ap- views. When recording observations
propriate. about care and resident conditions,
(m) Role of Surveyor. The survey and protect the privacy of all residents. Use
certification process is intended to de- a code such as resident identifier num-
termine whether providers and sup- ber rather than names on worksheets
pliers meet program participation re- whenever possible. Never use a resi-
quirements. The primary role of the dent’s name on the Deficiency State-
surveyor, then, is to assess the quality ment, Form CMS–2567. Block out resi-
of care and services and to relate those dent names, if any, from any document
findings to statutory and regulatory that is disclosed to the facility, indi-
requirements for program participa- vidual or organization.
tion. When communicating to the facility
When you find substandard care or about substandard care, fully identify
services in the course of a survey, care- the resident(s) by name if the situation
fully document your findings. Explain was identified through observation or
the deficiency in sufficient detail so record review. Improperly applied re-
that the facility officials understand straints, expired medication, cold food,
your rationale. If the cause of the defi- gloves not worn for a sterile procedure,
ciency is obvious, share the informa- and diet inconsistent with order, are
tion with the provider. For example, if examples of problems which can be
you cite a deficiency for restraints identified to the facility by resident
(F118), indicate that restraints were ap- name. Information about injuries due
plied backwards on residents 1621, 1634, to broken equipment, prolonged use of
1646, etc. restraints, and opened mail is less like-
ly to be obtained through observation
In those instances where the cause is
or record review. Do not reveal the
not obvious, do not delve into the fa-
source of information unless actually
cility’s policies and procedures to de-
observed, discovered in the record re-
termine the root cause of any defi-
view, or requested by the resident or
ciency. Do not recommend or prescribe
family.
an acceptable remedy. The provider is
(o) Team Composition. Whenever pos-
responsible for deciding on and imple-
sible, use the following survey team
menting the action(s) necessary for
model:
achieving compliance. For the re-
straint situation in the example above, SNF/ICF SURVEY TEAM MODEL
you would not ascertain whether the
improper application was due to im- In facilities with 200 beds or less, the
proper training or lack of training, nor team size may range from 2 to 4 mem-
would you attempt to identify the staff bers. If the team size is:
member who applied the restraints. It • 2 members: The team has at least
is the provider’s responsibility to make one RN plus another RN or a dietitian
the necessary changes or corrections to or a pharmacist.
441
§ 488.110 42 CFR Ch. IV (10–1–24 Edition)
• 3–4 member: In addition to the com- • When a terminated facility re-

position described above, the team has quests program participation 60 days or
one or two members of any discipline more after termination. Treat this sit-
such as a social worker, sanitarian, uation as a request for initial certifi-
etc. cation and complete Part A of the sur-
If the facility has over 200 beds and vey report in addition to Part B.
the survey will last more than 2 days, • If an ICF with a favorable compli-
the team size may be greater than 4 ance history requests to covert a num-
members. Select additional disciplines ber of beds to SNF level, complete both
as appropriate to the facility’s compli- Part A and Part B for compliance with
ance history. the SNF requirements. If distinct part
Average onsite time per survey: 60 status is at issue, also examine wheth-
person hours (Number of surveyors er it meets the criteria for certifi-
cation as a distinct part.
multiplied by the number of hours on
site) (i) Addendum for Outpatient Physical
Preferably, team members have ge- Therapy (OPT) or Speech Pathology Serv-
rontological training and experience. ices. Use the Outpatient Physical Ther-
Any member may serve as the team apy—Speech Pathology SRF (CMS–
leader, consistent with State agency 1893) as an addendum to Part A.
procedures. In followup surveys, select (ii) Resurvey of Participating Facilities.
disciplines based on major areas of cor- Do not use Part A for resurveys of par-
rection. Include a social worker, for ex- ticipating SNFs and ICFs. A deter-
ample, if the survey revealed major mination of compliance, based on docu-
psychosocial problems. This model mented examination of the written
does not consider integrated survey policies and procedures and other perti-
and Inspection of Care review teams, nent documents during the initial sur-
which typically would be larger. vey, establishes the facility’s compli-
(p) Type of Facility—Application of ance status with Part A requirements.
SNF or ICF Regulations. Apply the regu- This does not preclude citing defi-
lations to the various types of facilities ciencies if they pertain to administra-
in the following manner: tive or structural requirements from
• Freestanding Skilled Nurs- Apply SNF regulations.
Part A that are uncovered incidental
ing Facility (SNF) to a Part B survey. As an assurance
• Freestanding Intermediate Apply ICF regulations. measure, however, each facility at the
Care Facility (ICF) time of recertification must complete
• SNF Distinct Part of a Hos- Apply SNF regulations.
pital an affidavit (on the CMS–1516) attest-
• ICF Distinct Part of a Hos- Apply ICF regulations. ing that no substantive changes have
pital occurred that would affect compliance.
• Dually Certified SNF/ICF Apply SNF regulations and Each facility must also agree to notify
442.346(b).
• Freestanding SNF with ICF Apply SNF regulations for the State agency immediately of any
Distinct Part (Regardless of SNF unit. upcoming changes in its organization
the proportion of SNF and Apply ICF regulations for ICF or management which may affect its
ICF beds, the facility type distinct part.
is determined by the higher Apply both SNF and ICF reg-
compliance status. If a new adminis-
level of care. Therefore, ulations for shared services trator is unable to complete the affi-
LTC facilities with distinct (e.g., dietary). davit, proceed with the survey using
parts are defined as SNFs If the same deficiency occurs the Part B form and worksheets; do not
with ICF distinct parts.) in both the SNF and ICF
components of the facility, use the Part A form. The survey cannot
cite both SNF and ICF reg- be considered complete, however, until
ulations. the affidavit is signed. If the facility
If the deficiency occurs in the
SNF part only, cite only the
fails to complete the affidavit, it can-
SNF regulation. not participate in the program.
If the deficiency occurs in the (iii) Substantial Changes in a Facility’s
ICF part only, cite only the Organization and Management. If you
ICF regulation.
receive such information, review the
(q) Use of Part A and Part B of the Sur- changes to ensure compliance with the
vey Report—(1) Use of Part A (CMS–525). regulations. Request copies of the ap-
Use Part A for initial certification sur- propriate documents (e.g., written poli-
veys only, except under the following cies and procedures, personnel quali-
circumstances: fications, or agreements) if they were
442
not submitted. If the changes have • CMS–523—Dining Area and Eating

made continued compliance seem Assistance Worksheet
doubtful, determine through a Part B • CMS–5245—Observation/Interview/
survey whether deficiencies have re- Record Review Worksheet
sulted. Cite any deficiencies on the For complaint investigations, per-
CMS–2567 and follow the usual proce- form a full or partial Part B survey
dures. based on the extent of the allegations.
(2) Use of Part B (CMS–519). Use Part If the complaint alleges substandard
B and the worksheets for all types of care in a general fashion or in a variety
SNF and ICF surveys—initials, recer- of services and care areas, perform sev-
tifications, followup, complaints, etc. eral tasks or a full Part B survey, as
The worksheets are: needed. If the complaint is of a more
specific nature, such as an allegation of
• CMS–520—Residents Selected for In- improper medications, perform an ap-
depth Review propriate partial Part B survey, such
• CMS–521—Tour Notes Worksheet as a drug pass review and a review of
• CMS–522—Drug Pass Worksheet selected medical records.
443
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
§ 488.115 Care guidelines.
444
445
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
446
447
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
448
449
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
450
451
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
452
453
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
454
455
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
456
457
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
458
459
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
460
461
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
462
463
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
464
465
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
466
467
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
468
469
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
470
471
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
472
473
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
474
475
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
476
477
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
478
479
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
480
481
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
482
483
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
484
485
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
486
487
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
488
489
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
490
491
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
492
493
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
494
495
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
496
497
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
498
499
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
500
501
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
502
503
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
504
505
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
506
507
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
508
509
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
510
511
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
512
513
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
514
515
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
516
517
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
518
519
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
520
521
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
522
523
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
524
525
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
526
527
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
528
529
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
530
531
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
532
533
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
534
535
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
536
537
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
538
539
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
540
541
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
542
543
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
544
545
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
546
547
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
548
549
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
550
551
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
552
553
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
554
555
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
556
557
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
558
559
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
560
561
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
562
563
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
564
565
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
566
567
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
568
569
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
570
571
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
572
573
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
574
575
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
576
577
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
578
579
§ 488.115 42 CFR Ch. IV (10–1–24 Edition)
580
Subpart D—Reconsideration of quirements, may request a reconsider-

Adverse Determinations— ation of the determination by filing a
request with CMS either directly by its
Deeming Authority for Ac- authorized officials or through its legal
creditation Organizations and representative. The request must be
CLIA Exemption of Labora- filed within 60 days of the receipt of no-
tories Under State Programs tice of an adverse determination or
nonrenewal as provided in subpart A of
SOURCE: 57 FR 34012, July 31, 1992, unless part 488 or subpart E of part 493, as ap-
otherwise noted. plicable.
(2) Reconsideration procedures are
§ 488.201 Reconsideration. available after the effective date of the
(a) Right to reconsideration. (1) A na- decision to deny, remove, or not renew
tional accreditation organization dis- the approval of an accreditation orga-
satisfied with a determination that its nization or State laboratory program.
accreditation requirements do not pro- (d) Content of request. The request for
vide (or do not continue to provide) reconsideration must specify the find-
reasonable assurance that the entities ings or issues with which the accredita-
accredited by the accreditation organi- tion organization or State disagrees
zation meet the applicable long-term and the reasons for the disagreement.
care requirements, conditions for cov-
[57 FR 34012, July 31, 1992, as amended at 58
erage, conditions of certification, con-
FR 61843, Nov. 23, 1993]
ditions of participation, or CLIA condi-
tion level requirements is entitled to a § 488.203 Withdrawal of request for re-
reconsideration as provided in this sub- consideration.
part.
A requestor may withdraw its re-
(2) A State dissatisfied with a deter-
quest for reconsideration at any time
mination that the requirements it im-
before the issuance of a reconsideration
poses on laboratories in that State and
determination.
under the laws of that State do not
provide (or do not continue to provide) § 488.205 Right to informal hearing.
reasonable assurance that laboratories
licensed or approved by the State meet In response to a request for reconsid-
applicable CLIA requirements is enti- eration, CMS will provide the accredi-
tled to a reconsideration as provided in tation organization or the State lab-
this subpart. oratory program the opportunity for
(b) Eligibility for reconsideration. CMS an informal hearing as described in
will reconsider any determination to § 488.207 that will—
deny, remove or not renew the ap- (a) Be conducted by a hearing officer
proval of deeming authority to private appointed by the Administrator of
accreditation organizations, or any de- CMS; and
termination to deny, remove or not (b) Provide the accreditation organi-
renew the approval of a State labora- zation or State laboratory program the
tory program for the purpose of ex- opportunity to present, in writing or in
empting the State’s laboratories from person, evidence or documentation to
CLIA requirements, if the accredita- refute the determination to deny ap-
tion organization or State files a writ- proval, or to withdraw or not renew
ten request for a reconsideration in ac- deeming authority or the exemption of
cordance with paragraphs (c) and (d) of a State’s laboratories from CLIA re-
this section. quirements.
(c) Manner and timing of request for re-
consideration. (1) A national accredita- § 488.207 Informal hearing procedures.
tion organization or a State laboratory (a) CMS will provide written notice
program described in paragraph (b), of the time and place of the informal
dissatisfied with a determination with hearing at least 10 days before the
respect to its deeming authority, or, in scheduled date.
the case of a State, a determination (b) The informal reconsideration
with respect to the exemption of the hearing will be conducted in accord-
laboratories in the State from CLIA re- ance with the following procedures—
581
§ 488.209 42 CFR Ch. IV (10–1–24 Edition)
(1) The hearing is open to CMS and (d) The reconsideration determina-
the organization requesting the recon- tion of the Administrator is final.
sideration, including— (e) A final reconsideration deter-
(i) Authorized representatives; mination against an accreditation or-
(ii) Technical advisors (individuals ganization or State laboratory pro-
with knowledge of the facts of the case gram will be published by CMS in the
or presenting interpretation of the FEDERAL REGISTER.
facts); and
(iii) Legal counsel; Subpart E—Survey and Certifi-
(2) The hearing is conducted by the cation of Long-Term Care Fa-
hearing officer who receives testimony cilities
and documents related to the proposed
action;
SOURCE: 59 FR 56238, Nov. 10, 1994, unless
(3) Testimony and other evidence otherwise noted.
may be accepted by the hearing officer
even though it would be inadmissable § 488.300 Statutory basis.
under the usual rules of court proce-
Sections 1819 and 1919 of the Act es-
dures;
tablish requirements for surveying
(4) Either party may call witnesses
SNFs and NFs to determine whether
from among those individuals specified
they meet the requirements for partici-
in paragraph (b)(1) of this section; and
pation in the Medicare and Medicaid
(5) The hearing officer does not have programs.
the authority to compel by subpoena
the production of witnesses, papers, or § 488.301 Definitions.
other evidence.
§ 488.209 Hearing officer’s findings. Abbreviated standard survey means a
survey other than a standard survey
(a) Within 30 days of the close of the that gathers information primarily
hearing, the hearing officer will through resident-centered techniques
present the findings and recommenda- on facility compliance with the re-
tions to the accreditation organization quirements for participation. An abbre-
or State laboratory program that re- viated standard survey may be pre-
quested the reconsideration. mised on complaints received; a change
(b) The written report of the hearing of ownership, management, or director
officer will include— of nursing; or other indicators of spe-
(1) Separate numbered findings of cific concern. Abbreviated standard
fact; and surveys conducted to investigate a
(2) The legal conclusions of the hear- complaint or to conduct on-site moni-
ing officer. toring to verify compliance with par-
ticipation requirements are subject to
§ 488.211 Final reconsideration deter- the requirements of § 488.332. Other
mination.
premises for abbreviated standard sur-
(a) The hearing officer’s decision is veys would follow the requirements of
final unless the Administrator, within § 488.314.
30 days of the hearing officer’s deci- Abuse is the willful infliction of in-
sion, chooses to review that decision. jury, unreasonable confinement, in-
(b) The Administrator may accept, timidation, or punishment with result-
reject or modify the hearing officer’s ing physical harm, pain or mental an-
findings. guish. Abuse also includes the depriva-
(c) Should the Administrator choose tion by an individual, including a care-
to review the hearing officer’s decision, taker, of goods or services that are nec-
the Administrator will issue a final re- essary to attain or maintain physical,
consideration determination to the ac- mental, and psychosocial well-being.
creditation organization or State lab- Instances of abuse of all residents, irre-
oratory program on the basis of the spective of any mental or physical con-
hearing officer’s findings and rec- dition, cause physical harm, pain or
ommendations and other relevant in- mental anguish. It includes verbal
formation. abuse, sexual abuse, physical abuse,
582
and mental abuse including abuse fa- facility, or who is used under an ar-
cilitated or enabled through the use of rangement with another agency or or-
technology. Willful, as used in this defi- ganization.
nition of abuse, means the individual Partial extended survey means a sur-
must have acted deliberately, not that vey that evaluates additional partici-
the individual must have intended to pation requirements subsequent to
inflict injury or harm. finding substandard quality of care
Deficiency means a SNF’s or NF’s during an abbreviated standard survey.
failure to meet a participation require- Skilled nursing facility (SNF) means a
ment specified in the Act or in part 483, Medicare nursing facility.
subpart B of this chapter. Standard survey means a periodic,
Dually participating facility means a resident-centered inspection which
facility that has a provider agreement gathers information about the quality
in both the Medicare and Medicaid proof service furnished in a facility to de-
grams. termine compliance with the require-
Extended survey means a survey that ments for participation.
evaluates additional participation re-
Substandard quality of care means one
quirements subsequent to finding sub-
or more deficiencies related to partici-
standard quality of care during a
pation requirements under § 483.10
standard survey.
‘‘Resident rights’’, paragraphs (a)(1)
Facility means a SNF or NF, or a dis-
through (a)(2), (b)(1) through (b)(2), (e)
tinct part SNF or NF, in accordance
(except for (e)(2), (e)(7), and (e)(8)),
with § 483.5 of this chapter.
(f)(1) through (f)(3), (f)(5) through (f)(8),
Immediate family means husband or
and (i) of this chapter; § 483.12 of this
wife; natural or adoptive parent, child
chapter ‘‘Freedom from abuse, neglect,
or sibling; stepparent, stepchild, step-
and exploitation’’; § 483.24 of this chap-
brother, or stepsister; father-in-law,
ter ‘‘Quality of life’’; § 483.25 of this
mother-in-law, son-in-law, daughter-in-
chapter ‘‘Quality of care’’; § 483.40 ‘‘Be-
law, brother-in-law, or sister-in-law;
havioral health services’’, paragraphs
grandparent or grandchild.
(b) and (d) of this chapter; § 483.45
Immediate jeopardy means a situation
‘‘Pharmacy services’’, paragraphs (d),
in which the provider’s noncompliance
(e), and (f) of this chapter; § 483.70 ‘‘Ad-
with one or more requirements of par-
ministration’’, paragraph (p) of this
ticipation has caused, or is likely to
chapter, and § 483.80 ‘‘Infection con-
cause, serious injury, harm, impair-
trol’’, paragraph (d) of this chapter,
ment, or death to a resident.
which constitute either immediate
Misappropriation of resident property
jeopardy to resident health or safety; a
means the deliberate misplacement,
pattern of or widespread actual harm
exploitation, or wrongful, temporary or
that is not immediate jeopardy; or a
permanent use of a resident’s belong-
widespread potential for more than
ings or money without the resident’s
minimal harm, but less than imme-
consent.
diate jeopardy, with no actual harm.
Neglect is the failure of the facility,
its employees or service providers to Substantial compliance means a level
provide goods and services to a resident of compliance with the requirements of
that are necessary to avoid physical participation such that any identified
harm, pain, mental anguish, or emo- deficiencies pose no greater risk to
tional distress. resident health or safety than the po-
Noncompliance means any deficiency tential for causing minimal harm.
that causes a facility to not be in sub- Validation survey means a survey con-
stantial compliance. ducted by the Secretary within 2
Nurse aide means an individual, as de- months following a standard survey,
fined in § 483.5 of this chapter. abbreviated standard survey, partial
Nursing facility (NF) means a Med- extended survey, or extended survey
icaid nursing facility. for the purpose of monitoring State
Paid feeding assistant means an indi- survey agency performance.
vidual who meets the requirements [59 FR 56238, Nov. 10, 1994, as amended at 68
specified in § 483.60(h)(1) of this chapter FR 55539, Sept. 26, 2003; 81 FR 68871, Oct. 4,
and who is paid to feed residents by a 2016; 82 FR 36635, Aug. 4, 2017]
583
§ 488.303 42 CFR Ch. IV (10–1–24 Edition)
§ 488.303 State plan requirement. ance and correcting deficiencies as the

(a) A State plan must provide that remedies listed in paragraphs (d) and
the requirements of this subpart and (e) of this section.
subpart F of this part are met, to the [59 FR 56238, Nov. 10, 1994; 60 FR 50118, Sept.
extent that those requirements apply 28, 1995]
to the Medicaid program.
(b) A State may establish a program § 488.305 Standard surveys.
to reward, through public recognition, (a) For each SNF and NF, the State
incentive payments, or both, nursing survey agency must conduct standard
facilities that provide the highest qual- surveys that include all of the fol-
ity care to Medicaid residents. For pur- lowing:
poses of section 1903(a)(7) of the Social (1) A case-mix stratified sample of
Security Act, proper expenses incurred residents;
by a State in carrying out such a pro- (2) A survey of the quality of care
gram are considered to be expenses furnished, as measured by indicators of
necessary for the proper and efficient medical, nursing, and rehabilitative
administration of the State plan. care, dietary and nutrition services, ac-
(c) A State must conduct periodic tivities and social participation, and
educational programs for the staff and sanitation, infection control, and the
residents (and their representatives) of physical environment;
NFs in order to present current regula- (3) An audit of written plans of care
tions, procedures, and policies under and residents’ assessments to deter-
this subpart and subpart F of this part. mine the accuracy of such assessments
(d) Required remedies for a non-State and the adequacy of such plans of care;
operated NF. A State must establish, and
in addition to termination of the pro- (4) A review of compliance with resi-
vider agreement, the following rem- dents’ rights requirements set forth in
edies or an approved alternative to the sections 1819(c) and 1919(c) of the Act.
following remedies for imposition (b) The State survey agency’s failure
against a non-State operated NF: to follow the procedures set forth in
(1) Temporary management. this section will not invalidate other-
(2) Denial of payment for new admis- wise legitimate determinations that a
sions. facility’s deficiencies exist.
(3) Civil money penalties.
(4) Transfer of residents. § 488.307 Unannounced surveys.
(5) Closure of the facility and trans- (a) Basic rule. All standard surveys
fer of residents. must be unannounced.
(6) State monitoring. (b) Review of survey agency’s sched-
(e) Optional remedies for a non-State uling and surveying procedures. (1) CMS
operated NF. A State may establish reviews on an annual basis each State
the following remedies for imposition survey agency’s scheduling and sur-
against a non-State operated NF: veying procedures and practices to en-
(1) Directed plan of correction. sure that survey agencies avoid giving
(2) Directed in-service training. notice of a survey through the sched-
(3) Alternative or additional State uling procedures and the conduct of the
remedies. surveys.
(f) Alternative or additional State (2) CMS takes corrective action in
remedies. If a State uses remedies that accordance with the nature and com-
are in addition to those specified in plexity of the problem when survey
paragraph (d) or (e) of this section, or agencies are found to have notified a
alternative to those specified in para- SNF or NF through their scheduling or
graph (d) of this section (other than procedural policies. Sanctions for inad-
termination of participation), it equate survey performance are in ac-
must— cordance with § 488.320.
(1) Specify those remedies in the (c) Civil money penalties. An indi-
State plan; and vidual who notifies a SNF or NF, or
(2) Demonstrate to CMS’s satisfac- causes a SNF or NF to be notified, of
tion that those alternative remedies the time or date on which a standard
are as effective in deterring noncompli- survey is scheduled to be conducted is
584
subject to a Federal civil money pen- quirements by SNFs and NFs if its re-
alty not to exceed $2,000 as adjusted an- view of the allegation concludes that—
nually under 45 CFR part 102. (i) A deficiency in one or more of the
requirements may have occurred; and
(ii) Only a survey can determine
FR 61563, Sept. 6, 2016]
whether a deficiency or deficiencies
§ 488.308 Survey frequency. exist.
(2) The survey agency does not con-
(a) Basic period. The survey agency duct a survey if the complaint raises
must conduct a standard survey of issues that are outside the purview of
each SNF and NF not later than 15 Federal participation requirements.
months after the last day of the pre-
vious standard survey. [53 FR 22859, June 17, 1988, as amended at 82
FR 36635, Aug. 4, 2017]
(b) Statewide average interval. (1) The
statewide average interval between § 488.310 Extended survey.
standard surveys must be 12 months or
less, computed in accordance with (a) Purpose of survey. The purpose of
paragraph (d) of this section. an extended survey is to identify the
(2) CMS takes corrective action in policies and procedures that caused the
accordance with the nature of the facility to furnish substandard quality
of care.
State survey agency’s failure to ensure
(b) Scope of extended survey. An ex-
that the 12-month statewide average
tended survey includes all of the fol-
interval requirement is met. CMS’s
lowing:
corrective action is in accordance with
(1) Review of a larger sample of resi-
§ 488.320.
dent assessments than the sample used
(c) Other surveys. The survey agency in a standard survey.
may conduct a survey as frequently as (2) Review of the staffing and in-serv-
necessary to— ice training.
(1) Determine whether a facility com- (3) If appropriate, examination of the
plies with the participation require- contracts with consultants.
ments; and (4) A review of the policies and proce-
(2) Confirm that the facility has cor- dures related to the requirements for
rected deficiencies previously cited. which deficiencies exist.
(d) Computation of statewide average (5) Investigation of any participation
interval. The statewide average interval requirement at the discretion of the
is computed at the end of each Federal survey agency.
fiscal year by comparing the last day (c) Timing and basis for survey. The
of the most recent standard survey for survey agency must conduct an ex-
each participating facility to the last tended survey not later than 14 cal-
day of each facility’s previous standard endar days after completion of a stand-
survey. ard survey which found that the facil-
(e) Special surveys. (1) The survey ity had furnished substandard quality
agency may conduct a standard or an of care.
abbreviated standard survey to deter-
mine whether certain changes have § 488.312 Consistency of survey re-
caused a decline in the quality of care sults.
furnished by a SNF or a NF, within 60 CMS does and the survey agency
days of a change in the following: must implement programs to measure
(i) Ownership; accuracy and improve consistency in
(ii) Entity responsible for manage- the application of survey results and
ment of a facility (management firm); enforcement remedies.
(iii) Nursing home administrator; or
(iv) Director of nursing. § 488.314 Survey teams.
(2) [Reserved] (a) Team composition. (1) Surveys
(f) Investigation of complaints. (1) The under sections 1819(g)(2) and 1919(g)(2)
survey agency must review all com- of the Social Security Act must be con-
plaint allegations and conduct a stand- ducted by an interdisciplinary team of
ard or an abbreviated survey to inves- professionals, which must include a
tigate complaints of violations of re- registered nurse.
585
§ 488.318 42 CFR Ch. IV (10–1–24 Edition)
(2) Examples of professionals include, survey as a trainee if accompanied on-

but are not limited to, physicians, phy- site by a surveyor who has successfully
sician assistants, nurse practitioners, completed the required training and
physical, speech, or occupational testing program.
therapists, registered professional
[59 FR 56238, Nov. 10, 1994; 60 FR 50118, Sept.
nurses, dieticians, sanitarians, engi-
28, 1995 as amended at 82 FR 36636, Aug. 4,
neers, licensed practical nurses, or so- 2017]
cial workers.
(3) The State determines what con- § 488.318 Inadequate survey perform-
stitutes a professional, subject to CMS ance.
approval.
(a) CMS considers survey perform-
(4) Any of the following cir-
cumstances disqualifies a surveyor for ance to be inadequate if the State sur-
surveying a particular facility: vey agency—
(i) The surveyor currently works, or, (1) Indicates a pattern of failure to—
within the past two years, has worked (i) Identify deficiencies and the fail-
as an employee, as employment agency ure cannot be explained by changed
staff at the facility, or as an officer, conditions in the facility or other case
consultant, or agent for the facility to specific factors;
be surveyed. (ii) Cite only valid deficiencies;
(ii) The surveyor has any financial (iii) Conduct surveys in accordance
interest or any ownership interest in with the requirements of this subpart;
the facility. or
(iii) The surveyor has an immediate (iv) Use Federal standards, protocols,
family member who has a relationship and the forms, methods and procedures
with a facility described in paragraphs specified by CMS in manual instruc-
(a)(4)(i) or paragraph (a)(4)(ii) of this tions; or
section. (2) Fails to identify an immediate
(iv) The surveyor has an immediate jeopardy situation.
family member who is a resident in the (b) Inadequate survey performance
facility to be surveyed. For purposes of does not—
this section, an immediate family (1) Relieve a SNF or NF of its obliga-
member is defined at § 488.301 of this tion to meet all requirements for pro-
part. gram participation; or
(b) CMS training. CMS provides com-
(2) Invalidate adequately documented
prehensive training to surveyors, in-
deficiencies.
cluding at least the following:
(1) Application and interpretation of § 488.320 Sanctions for inadequate sur-
regulations for SNFs and NFs. vey performance.
(2) Techniques and survey procedures
for conducting standard and extended (a) Annual assessment of survey per-
surveys. formance. CMS assesses the perform-
(3) Techniques for auditing resident ance of the State’s survey and certifi-
assessments and plans of care. cation program annually.
(c) Required surveyor training. (1) Ex- (b) Sanctions for inadequate survey per-
cept as specified in paragraph (c)(3) of formance. When a State demonstrates
this section, the survey agency may inadequate survey performance, as
not permit an individual to serve as a specified in § 488.318, CMS notifies the
member of a survey team unless the in- survey agency of the inadequacy and
dividual has successfully completed a takes action in accordance with para-
training and testing program pre- graphs (c) and (d) of this section.
scribed by the Secretary. (c) Medicaid facilities. (1) For a pat-
(2) The survey agency must have a tern of failure to identify deficiencies
mechanism to identify and respond to in Medicaid facilities, CMS—
in-service training needs of the sur- (i) Reduces FFP, as specified in para-
veyors. graph (e) of this section, and if appro-
(3) The survey agency may permit an priate;
individual who has not completed a (ii) Provides for training of survey
training program to participate in a teams.
586
(2) For other survey inadequacies in (5) Final appeal results.

Medicaid facilities, CMS provides for (6) Notice of termination of a facil-
training of survey teams. ity.
(d) Medicare facilities. For all survey (7) Medicare and Medicaid cost re-
inadequacies in Medicare facilities, ports.
CMS— (8) Names of individuals with direct
(1) Requires that the State survey or indirect ownership interest in a SNF
agency submit a plan of correction; or NF, as defined in § 420.201 of this
(2) Provides for training of survey chapter.
teams; (9) Names of individuals with direct
(3) Provides technical assistance on or indirect ownership interest in a SNF
scheduling and procedural policies; or NF, as defined in § 420.201 of this
(4) Provides CMS-directed sched- chapter, who have been found guilty by
uling; or a court of law of a criminal offense in
(5) Initiates action to terminate the violation of Medicare or Medicaid law.
agreement between the Secretary and (b) Charge to public for information.
the State under section 1864 of the Act, CMS and the State may charge the
either in whole or in part. public for specified services with re-
(e) Reduction of FFP. In reducing FFP spect to requests for information in ac-
for inadequate survey performance, cordance with—
CMS uses the formula specified in sec- (1) Section 401.140 of this chapter, for
tion 1919(g)(3)(C) of the Act, that is 33 Medicare; or
percent multiplied by a fraction— (2) State procedures, for Medicaid.
(1) The numerator of which is equal (c) How public can request information.
to the total number of residents in the The public may request information in
NFs that CMS found to be noncompli- accordance with disclosure procedures
ant during validation surveys for that specified in 45 CFR part 5.
quarter; and (d) When information must be disclosed.
(2) The denominator of which is equal The disclosing agency must make
to the total number of residents in the available to the public, upon the
NFs in which CMS conducted valida- public’s request, information con-
tion surveys during that quarter. cerning all surveys and certifications
(f) Appeal of FFP reduction. When a of SNFs and NFs, including statements
State is dissatisfied with CMS’s deter- of deficiencies, separate listings of any
mination to reduce FFP, the State isolated deficiencies that constitute no
may appeal the determination to the actual harm, with the potential for
Departmental Appeals Board, using the minimal harm, and plans of correction
procedures specified in 45 CFR part 16. (which contain any provider response
to the deficiency statement) within 14
§ 488.325 Disclosure of results of sur- calendar days after each item is made
veys and activities. available to the facility.
(a) Information which must be provided (e) Procedures for responding to re-
to public. As provided in sections quests. The procedures and time periods
1819(g)(5) and 1919(g)(5) of the Act, the for responding to requests are in ac-
following information must be made cordance with—
available to the public, upon the (1) Section 401.136 of this chapter for
public’s request, by the State or CMS documents maintained by CMS; and
for all surveys and certifications of (2) State procedures for documents
SNFs and NFs: maintained by the State.
(1) Statements of deficiencies and (f) Information that must be provided to
providers’ comments. the State’s long-term care ombudsman.
(2) A list of isolated deficiencies that The State must provide the State’s
constitute no actual harm, with the po- long-term care ombudsman with the
tential for minimal harm. following:
(3) Approved plans of correction. (1) A statement of deficiencies re-
(4) Statements that the facility did flecting facility noncompliance, includ-
not submit an acceptable plan of cor- ing a separate list of isolated defi-
rection or failed to comply with the ciencies that constitute no harm with
conditions of imposed remedies. the potential for minimal harm.
587
§ 488.330 42 CFR Ch. IV (10–1–24 Edition)
(2) Reports of adverse actions speci- (A) The State certifies the compli-
fied at § 488.406 imposed on a facility. ance or noncompliance of non-State
(3) Written response by the provider. operated NFs. Regardless of the State
(4) A provider’s request for an appeal entity doing the certification, it is
and the results of any appeal. final, except in the case of a complaint
(g) Information which must be provided or validation survey conducted by
to State by a facility with substandard CMS, or CMS review of the State’s
quality of care. (1) To provide for the findings.
notice to physicians required under (B) CMS certifies the compliance or
sections 1819(g)(5)(C) and 1919(g)(5)(C) of noncompliance of all State-operated fa-
the Act, not later than 10 working days cilities.
after receiving a notice of substandard (C) The State survey agency certifies
quality of care, a SNF or NF must pro- the compliance or noncompliance of a
vide the State with a list of— non-State operated SNF, subject to the
(i) Each resident in the facility with approval of CMS.
respect to which such finding was (D) The State survey agency certifies
made; and compliance or noncompliance for a du-
(ii) The name and address of his or ally participating SNF/NF. In the case
her attending physician. of a disagreement between CMS and
(2) Failure to disclose the informa- the State survey agency, a finding of
tion timely will result in termination noncompliance takes precedence over
of participation or imposition of alter- that of compliance.
native remedies. (ii) In the case of a validation survey,
(h) Information the State must provide the Secretary’s determination as to the
to attending physician and State board. facility’s noncompliance is binding,
Not later than 20 calendar days after a and takes precedence over a certifi-
SNF or NF complies with paragraph (g) cation of compliance resulting from
of this section, the State must provide the State survey.
written notice of the noncompliance (2) Basis for certification. (i) Certifi-
to— cation by the State is based on the sur-
(1) The attending physician of each vey agency findings.
resident in the facility with respect to (ii) Certification by CMS is based on
which a finding of substandard quality either the survey agency findings (in
of care was made; and the case of State-operated facilities),
(2) The State board responsible for li- or, in the case of a validation survey,
censing the facility’s administrator. on CMS’s own survey findings.
(i) Access to information by State Med- (b) Effect of certification—(1) Certifi-
icaid fraud control unit. The State must cation of compliance. A certification of
provide access to any survey and cer- compliance constitutes a determina-
tification information incidental to a tion that the facility is in substantial
SNF’s or NF’s participation in Medi- compliance and is eligible to partici-
care or Medicaid upon written request pate in Medicaid as a NF, or in Medi-
by the State Medicaid fraud control care as a SNF, or in Medicare and Med-
unit established under part 1007, of this icaid as a dually participating facility.
title, consistent with current State (2) Certification of noncompliance. A
laws. certification of noncompliance requires
[59 FR 56238, Nov. 10, 1994; 60 FR 50118, Sept. denial of participation for prospective
28, 1995] providers and enforcement action for
current providers in accordance with
§ 488.330 Certification of compliance subpart F of this part. Enforcement ac-
or noncompliance. tion must include one of the following:
(a) General rules—(1) Responsibility for (i) Termination of any Medicare or
certification. (i) The State survey agen- Medicaid provider agreements that are
cy surveys all facilities for compliance in effect.
or noncompliance with requirements (ii) Application of alternative rem-
for long term care facilities. The sur- edies instead of, or in addition to, ter-
vey by the State survey agency may be mination procedures.
followed by a Federal validation sur- (c) Notice of certification of noncompli-
vey. ance and resulting action. The notice of
588
certification of noncompliance is sent (ii) SNFs and dually participating

in accordance with the timeframes SNF/NFs; and
specified in § 488.402(f), and resulting (iii) Any other facilities subject to a
action is issued by CMS, except when CMS validation survey or CMS review
the State is taking the action for a of the State’s findings.
non-State operated NF. (4) The provisions of part 431 of this
(d) Content of notice of certification of chapter apply when a non-State oper-
noncompliance. The notice of certifi- ated Medicaid NF, which has not re-
cation of noncompliance is sent in ac- ceived a CMS validation survey or CMS
cordance with the timeframes specified review of the State’s findings, requests
in § 488.402(f) and includes information a hearing on the State’s denial of par-
on all of the following: ticipation, termination of provider
(1) Nature of noncompliance. agreement, or certification of non-
(2) Any alternative remedies to be compliance leading to an alternative
imposed under subpart F of this part. remedy, except State monitoring.
(3) Any termination or denial of par- (f) Provider agreements. CMS or the
ticipation action to be taken under Medicaid agency may execute a pro-
this part. vider agreement when a prospective
(4) The appeal rights available to the provider is in substantial compliance
facility under this part. with all the requirements for participa-
(5) Timeframes to be met by the pro- tion for a SNF or NF, respectively.
vider and certifying agency with regard (g) Special rules for Federal validation
to each of the enforcement actions or surveys. (1) CMS may make inde-
appeal procedures addressed in the no- pendent certifications of a NF’s, SNF’s,
tice. or dually participating facility’s non-
(e) Appeals. (1) Notwithstanding any compliance based on a CMS validation
provision of State law, the State must survey.
impose remedies promptly on any pro- (2) CMS issues the notice of actions
vider of services participating in the affecting facilities for which CMS did
Medicaid program— validation surveys.
(i) After promptly notifying the facil- (3) For non-State-operated NFs and
ity of the deficiencies and impending non-State-operated dually partici-
remedy or remedies; and pating facilities, any disagreement be-
(ii) Except for civil money penalties, tween CMS and the State regarding the
during any pending hearing that may timing and choice of remedies is re-
be requested by the provider of serv- solved in accordance with § 488.452.
ices. (4) Either CMS or the survey agency,
(2) CMS imposes remedies promptly at CMS’s option, may revisit the facil-
on any provider of services partici- ity to ensure that corrections are
pating in the Medicare or Medicaid made.
program or any provider of services [59 FR 56238, Nov. 10, 1994; 60 FR 50118, Sept.
participating in both the Medicare and 28, 1995; 76 FR 15126, Mar. 18, 2011]
Medicaid programs—
(i) After promptly notifying the facil- § 488.331 Informal dispute resolution.
ity of the deficiencies and impending (a) Opportunity to refute survey find-
remedy or remedies; and ings. (1) For non-Federal surveys, the
(ii) Except for civil money penalties State must offer a facility an informal
imposed on NFs-only by the State, dur- opportunity, at the facility’s request,
ing any pending hearing that may be to dispute survey findings upon the fa-
requested by the provider of services. cility’s receipt of the official state-
(3) The provisions of part 498 of this ment of deficiencies.
chapter apply when the following pro- (2) For Federal surveys, CMS offers a
viders request a hearing on a denial of facility an informal opportunity, at the
participation, or certification of non- facility’s request, to dispute survey
compliance leading to an enforcement findings upon the facility’s receipt of
remedy (including termination of the the official statement of deficiencies.
provider agreement), except State (3) For SNFs, dually-participating
monitoring: SNF/NFs, and NF-only facilities that
(i) All State-operated facilities; have civil money penalties imposed by
589
§ 488.332 42 CFR Ch. IV (10–1–24 Edition)
CMS that will be placed in a CMS es- have a means of communicating infor-
crow account, CMS also offers the fa- mation among appropriate entities,
cility an opportunity for independent and the State survey agency retains re-
informal dispute resolution, subject to sponsibility for the investigation proc-
the terms of paragraphs (b), (c), and (d) ess.
of this section and of § 488.431. The fa- (4) If, after investigating a com-
cility must request independent infor- plaint, the State has reason to believe
mal dispute resolution in writing with- that an identifiable individual ne-
in 10 days of receipt of CMS’s offer. glected or abused a resident, or mis-
However, a facility may not use the appropriated a resident’s property, the
dispute resolution processes at both State survey agency must act on the
§§ 488.331 and 488.431 for the same defi- complaint in accordance with § 488.335.
ciency citation arising from the same (b) On-site monitoring. The State sur-
survey unless the informal dispute res- vey agency conducts on-site moni-
olution process at § 488.331 was com- toring on an as necessary basis when—
pleted prior to the imposition of the (1) A facility is not in substantial
civil money penalty. compliance with the requirements and
(b)(1) Failure of the State or CMS, as is in the process of correcting defi-
appropriate, to complete informal dis- ciencies;
pute resolution timely cannot delay (2) A facility has corrected defi-
the effective date of any enforcement ciencies and verification of continued
action against the facility. substantial compliance is needed; or
(2) A facility may not seek a delay of (3) The survey agency has reason to
any enforcement action against it on question the substantial compliance of
the grounds that informal dispute reso- the facility with a requirement of par-
lution has not been completed before ticipation.
the effective date of the enforcement (c) Composition of the investigative
action. team. A State may use a specialized
(c) If a provider is subsequently suc- team, which may include an attorney,
cessful, during the informal dispute auditor and appropriate health profes-
resolution process, at demonstrating sionals, to identify, survey, gather and
that deficiencies should not have been preserve evidence, and administer rem-
cited, the deficiencies are removed edies to noncompliant facilities.
from the statement of deficiencies and
any enforcement actions imposed sole- § 488.334 Educational programs.
ly as a result of those cited deficiencies A State must conduct periodic edu-
are rescinded. cational programs for the staff and
(d) Notification. Upon request, CMS residents (and their representatives) of
does and the State must provide the fa- SNFs and NFs in order to present cur-
cility with written notification of the rent regulations, procedures, and poli-
informal dispute resolution process. cies on the survey, certification and
[59 FR 56238, Nov. 10, 1994, as amended at 76 enforcement process under this subpart
FR 15126, Mar. 18, 2011] and subpart F of this part.
§ 488.332 Investigation of complaints § 488.335 Action on complaints of resi-

of violations and monitoring of dent neglect and abuse, and mis-
compliance. appropriation of resident property.
(a) Investigation of complaints. (1) The (a) Investigation. (1) The State must
State survey agency must establish review all allegations of resident ne-
procedures and maintain adequate staff glect and abuse, and misappropriation
to investigate complaints of violations of resident property and follow proce-
of participation requirements. dures specified in § 488.332.
(2) The State survey agency takes ap- (2) If there is reason to believe, either
propriate precautions to protect a com- through oral or written evidence that
plainant’s anonymity and privacy, if an individual used by a facility to pro-
possible. vide services to residents could have
(3) If arrangements have been made abused or neglected a resident or mis-
with other State components for inves- appropriated a resident’s property, the
tigation of complaints, the State must State must investigate the allegation.
590
(3) The State must have written pro- (e) Factors beyond the individual’s con-
cedures for the timely review and in- trol. A State must not make a finding
vestigation of allegations of resident that an individual has neglected a resi-
abuse and neglect, and misappropria- dent if the individual demonstrates
tion of resident property. that such neglect was caused by factors
(b) Source of complaints. The State beyond the control of the individual.
must review all allegations regardless (f) Report of findings. If the finding is
of the source. that the individual has neglected or
(c) Notification—(1) Individuals to be abused a resident or misappropriated
notified. If the State makes a prelimi- resident property or if the individual
nary determination, based on oral or waives the right to a hearing, the State
written evidence and its investigation, must report the findings in writing
that the abuse, neglect or misappro- within 10 working days to—
priation of property occurred, it must (1) The individual;
notify in writing— (2) The current administrator of the
(i) The individuals implicated in the facility in which the incident occurred;
investigation; and and
(ii) The current administrator of the (3) The administrator of the facility
facility in which the incident occurred. that currently employs the individual,
(2) Timing of the notice. The State if different than the facility in which
must notify the individuals specified in the incident occurred;
paragraph (c)(1) of this section in writ-
(4) The licensing authority for indi-
ing within 10 working days of the
viduals used by the facility other than
State’s investigation.
nurse aides, if applicable; and
(3) Contents of the notice. The notice
(5) The nurse aide registry for nurse
must include the—
aides. Only the State survey agency
(i) Nature of the allegation(s);
may report the findings to the nurse
(ii) Date and time of the occurrence; aide registry, and this must be done
(iii) Right to a hearing; within 10 working days of the findings,
(iv) Intent to report the substan- in accordance with § 483.156(c) of this
tiated findings in writing, once the in- chapter. The State survey agency may
dividual has had the opportunity for a not delegate this responsibility.
hearing, to the nurse aide registry or (g) Contents and retention of report of
appropriate licensure authority; finding to the nurse aide registry. (1) The
(v) Fact that the individual’s failure report of finding must include informa-
to request a hearing in writing within tion in accordance with § 483.156(c) of
30 days from the date of the notice will this chapter.
result in reporting the substantiated
(2) The survey agency must retain
findings to the nurse aide registry or
the information as specified in para-
appropriate licensure authority.
graph (g)(1) of this section, in accord-
(vi) Consequences of waiving the
ance with the procedures specified in
right to a hearing;
§ 483.156(c) of this chapter.
(vii) Consequences of a finding
(h) Survey agency responsibility. (1)
through the hearing process that the
The survey agency must promptly re-
alleged resident abuse or neglect, or
view the results of all complaint inves-
misappropriation of resident property
did occur; and tigations and determine whether or not
a facility has violated any require-
(viii) Fact that the individual has the
ments in part 483, subpart B of this
right to be represented by an attorney
chapter.
at the individual’s own expense.
(d) Conduct of hearing. (1) The State (2) If a facility is not in substantial
must complete the hearing and the compliance with the requirements in
hearing record within 120 days from the part 483, subpart B of this chapter, the
day it receives the request for a hear- survey agency initiates appropriate ac-
ing. tions, as specified in subpart F of this
(2) The State must hold the hearing part.
at a reasonable place and time conven- [59 FR 56238, Nov. 10, 1994; 60 FR 50118, Sept.
ient for the individual. 28, 1995]
591
§ 488.400 42 CFR Ch. IV (10–1–24 Edition)
Subpart F—Enforcement of Com- § 488.402 General provisions.

pliance for Long-Term Care (a) Purpose of remedies. The purpose of
Facilities with Deficiencies remedies is to ensure prompt compli-
ance with program requirements.
SOURCE: 59 FR 56243, Nov. 10, 1994, unless (b) Basis for imposition and duration of
otherwise noted. remedies. When CMS or the State choos-
es to apply one or more remedies speci-
§ 488.400 Statutory basis. fied in § 488.406, the remedies are ap-
plied on the basis of noncompliance
Sections 1819(h) and 1919(h) of the Act
found during surveys conducted by
specify remedies that may be used by CMS or by the survey agency.
the Secretary or the State respectively (c) Number of remedies. CMS or the
when a SNF or a NF is not in substan- State may apply one or more remedies
tial compliance with the requirements for each deficiency constituting non-
for participation in the Medicare and compliance or for all deficiencies con-
Medicaid programs. These sections also stituting noncompliance.
provide for ensuring prompt compli- (d) Plan of correction requirement. (1)
ance and specify that these remedies Except as specified in paragraph (d)(2)
are in addition to any other available of this section, regardless of which
under State or Federal law, and, ex- remedy is applied, each facility that
cept, for civil money penalties imposed has deficiencies with respect to pro-
on NFs-only by the State, are imposed gram requirements must submit a plan
prior to the conduct of a hearing. of correction for approval by CMS or
the survey agency.
[76 FR 15126, Mar. 18, 2011]
(2) Isolated deficiencies. A facility is
§ 488.401 Definitions. not required to submit a plan of correc-
tion when it has deficiencies that are
As used in this subpart— isolated and have a potential for mini-
Instance or instances of noncompliance mal harm, but no actual harm has oc-
means a factual and temporal occur- curred.
rence(s) when a facility is not in sub- (e) Disagreement regarding remedies. If
stantial compliance with the require- the State and CMS disagree on the de-
ments for participation. Each instance cision to impose a remedy, the dis-
of noncompliance is sufficient to con- agreement is resolved in accordance
stitute a deficiency and a deficiency with § 488.452.
may comprise of multiple instances of (f) Notification requirements—(1) Ex-
noncompliance. cept when the State is taking action
New admission means a resident who against a non-State operated NF, CMS
is admitted to the facility on or after or the State (as authorized by CMS)
the effective date of a denial of pay- gives the provider notice of the rem-
ment remedy and, if previously admit- edy, including the—
ted, has been discharged before that ef- (i) Nature of the noncompliance;
fective date. Residents admitted before (ii) Which remedy is imposed;
the effective date of the denial of pay- (iii) Effective date of the remedy; and
ment, and taking temporary leave, are (iv) Right to appeal the determina-
not considered new admissions, nor tion leading to the remedy.
subject to the denial of payment. (2) When a State is taking action
against a non-State operated NF, the
Plan of correction means a plan devel-
State’s notice must include the same
oped by the facility and approved by
information required by CMS in para-
CMS or the survey agency that de-
graph (f)(1) of this section.
scribes the actions the facility will
(3) Immediate jeopardy—2 day notice.
take to correct deficiencies and speci-
Except for civil money penalties and
fies the date by which those defi- State monitoring imposed when there
ciencies will be corrected. is immediate jeopardy, for all remedies
[59 FR 56243, Nov. 10, 1994; 60 FR 50118, Sept. specified in § 488.406 imposed when
28, 1995, as amended at 89 FR 64162, Aug. 6, there is immediate jeopardy, the notice
2024] must be given at least 2 calendar days
592
before the effective date of the enforce- (2) The facility’s prior history of non-
ment action. compliance in general and specifically
(4) No immediate jeopardy—15 day no- with reference to the cited deficiencies.
tice. Except for civil money penalties
and State monitoring, notice must be § 488.406 Available remedies.
given at least 15 calendar days before (a) General. In addition to the remedy
the effective date of the enforcement of termination of the provider agree-
action in situations in which there is ment, the following remedies are avail-
no immediate jeopardy. able:
(5) Date of enforcement action. The 2- (1) Temporary management.
and 15-day notice periods begin when (2) Denial of payment including—
the facility receives the notice. (i) Denial of payment for all individ-
(6) Civil money penalties. For civil uals, imposed by CMS, to a—
money penalties, the notices must be (A) Skilled nursing facility, for Medi-
given in accordance with the provisions care;
of §§ 488.434 and 488.440. (B) State, for Medicaid; or
(7) State monitoring. For State moni- (ii) Denial of payment for all new ad-
toring, no prior notice is required. missions.
[59 FR 56243, Nov. 10, 1994; 60 FR 50118, Sept. (3) Civil money penalties.
28, 1995, as amended at 64 FR 13360, Mar. 18, (4) State monitoring.
1999] (5) Transfer of residents.
(6) Closure of the facility and trans-
§ 488.404 Factors to be considered in fer of residents.
selecting remedies. (7) Directed plan of correction.
(a) Initial assessment. In order to se- (8) Directed in-service training.
lect the appropriate remedy, if any, to (9) Alternative or additional State
apply to a facility with deficiencies, remedies approved by CMS.
CMS and the State determine the seri- (b) Remedies that must be established.
ousness of the deficiencies. At a minimum, and in addition to ter-
(b) Determining seriousness of defi- mination of the provider agreement,
ciencies. To determine the seriousness the State must establish the following
of the deficiency, CMS considers and remedies or approved alternatives to
the State must consider at least the the following remedies:
following factors: (1) Temporary management.
(1) Whether a facility’s deficiencies (2) Denial of payment for new admis-
constitute— sions.
(i) No actual harm with a potential (3) Civil money penalties.
for minimal harm; (4) Transfer of residents.
(ii) No actual harm with a potential (5) Closure of the facility and trans-
for more than minimal harm, but not fer of residents.
immediate jeopardy; (6) State monitoring.
(iii) Actual harm that is not imme- (c) State plan requirement. If a State
diate jeopardy; or wishes to use remedies for noncompli-
(iv) Immediate jeopardy to resident ance that are either additional or al-
health or safety. ternative to those specified in para-
(2) Whether the deficiencies— graphs (a) or (b) of this section, it
(i) Are isolated; must—
(ii) Constitute a pattern; or (1) Specify those remedies in the
(iii) Are widespread. State plan; and
(c) Other factors which may be consid- (2) Demonstrate to CMS’s satisfac-
ered in choosing a remedy within a rem- tion that those remedies are as effec-
edy category. Following the initial as- tive as the remedies listed in paragraph
sessment, CMS and the State may con- (a) of this section, for deterring non-
sider other factors, which may include, compliance and correcting deficiencies.
but are not limited to the following: (d) State remedies in dually partici-
(1) The relationship of the one defi- pating facilities. If the State’s remedy is
ciency to other deficiencies resulting unique to the State plan and has been
in noncompliance. approved by CMS, then that remedy, as
593
§ 488.408 42 CFR Ch. IV (10–1–24 Edition)
imposed by the State under its Med- (2) CMS applies one or more of the
icaid authority, may be imposed by remedies in Category 2, or, except for
CMS against the Medicare provider denial of payment for all individuals,
agreement of a dually participating fa- the State must apply one or more of
cility. the remedies in Category 2 when there
[59 FR 56243, Nov. 10, 1994; 60 FR 50118, Sept. are—
28, 1995] (i) Widespread deficiencies that con-
stitute no actual harm with a potential
§ 488.408 Selection of remedies. for more than minimal harm but not
(a) Categories of remedies. In this sec- immediate jeopardy; or
tion, the remedies specified in (ii) One or more deficiencies that
§ 488.406(a) are grouped into categories constitute actual harm that is not im-
and applied to deficiencies according to mediate jeopardy.
how serious the noncompliance is. (3) CMS or the State may apply one
(b) Application of remedies. After con- or more of the remedies in Category 2
sidering the factors specified in to any deficiency except when—
§ 488.404, as applicable, if CMS and the (i) The facility is in substantial com-
State choose to impose remedies, as pliance; or
provided in paragraphs (c)(1), (d)(1) and (ii) CMS or the State imposes a civil
(e)(1) of this section, for facility non- money penalty for a deficiency that
compliance, instead of, or in addition constitutes immediate jeopardy, the
to, termination of the provider agree- penalty must be in the upper range of
ment, CMS does and the State must penalty amounts, as specified in
follow the criteria set forth in para- § 488.438(a).
graphs (c)(2), (d)(2), and (e)(2) of this (e) Category 3. (1) Category 3 remedies
section, as applicable. include the following:
(c) Category 1. (1) Category 1 remedies (i) Temporary management.
include the following: (ii) Immediate termination.
(i) Directed plan of correction. (iii) Civil money penalties of $3,050–
(ii) State monitoring. $10,000 as adjusted annually under 45
(iii) Directed in-service training. CFR part 102 per day.
(2) CMS does or the State must apply (iv) Civil money penalty of $1,000–
one or more of the remedies in Cat- $10,000 as adjusted annually under 45
egory 1 when there— CFR part 102 per instance of non-
(i) Are isolated deficiencies that con- compliance.
stitute no actual harm with a potential (2) When there are one or more defi-
for more than minimal harm but not ciencies that constitute immediate
immediate jeopardy; or jeopardy to resident health or safety—
(ii) Is a pattern of deficiencies that (i) CMS does and the State must do
constitutes no actual harm with a po- one or both of the following:
tential for more than minimal harm (A) Impose temporary management;
but not immediate jeopardy. or
(3) Except when the facility is in sub- (B) Terminate the provider agree-
stantial compliance, CMS or the State ment;
may apply one or more of the remedies (ii) For each instance of noncompli-
in Category 1 to any deficiency. ance, CMS and the State may impose a
(d) Category 2. (1) Category 2 remedies civil money penalty of $3,050–$10,000 (as
include the following: adjusted annually under 45 CFR part
(i) Denial of payment for new admis- 102) per day, $1,000–$10,000 (as adjusted
sions. annually under 45 CFR part 102) per in-
(ii) Denial of payment for all individ- stance of noncompliance, or both, in
uals imposed only by CMS. addition to imposing the remedies
(iii) Civil money penalties of $50–3,000 specified in paragraph (e)(2)(i) of this
as adjusted annually under 45 CFR part section. For multiple instances of non-
102 per day. compliance, CMS may impose any com-
(iv) Civil money penalty of $1,000- bination of per instance or per day civil
$10,000 as adjusted annually under 45 money penalties for each instance
CFR part 102 per instance of non- within the same survey. The aggregate
compliance. civil money penalty amount may not
594
exceed $10,000 (as adjusted annually survey, if the immediate jeopardy is

under 45 CFR part 102) for each day of not removed. In these cases, State
noncompliance. monitoring may be imposed pending
(3) When there are widespread defi- termination.
ciencies that constitute actual harm (3) If the facility relinquishes control
that is not immediate jeopardy, CMS to the temporary manager, the State
and the State may impose temporary must (and CMS does) notify the facility
management, in addition to Category 2 that, unless it removes the immediate
remedies. jeopardy, its provider agreement will
(f) Plan of correction. (1) Except as be terminated within 23 calendar days
specified in paragraph (f)(2) of this sec- of the last day of the survey.
tion, each facility that has a deficiency (4) CMS does and the State must ter-
with regard to a requirement for long minate the provider agreement within
term care facilities must submit a plan 23 calendar days of the last day of sur-
of correction for approval by CMS or vey if the immediate jeopardy has not
the State, regardless of— been removed.
(i) Which remedies are imposed; or (b) CMS or the State may also im-
(ii) The seriousness of the defi- pose other remedies, as appropriate.
ciencies. (c)(1) In a NF or dually participating
(2) When there are only isolated defi- facility, if either CMS or the State
ciencies that CMS or the State deter- finds that a facility’s noncompliance
mines constitute no actual harm with poses immediate jeopardy to resident
a potential for minimal harm, the fa- health or safety, CMS or the State
cility need not submit a plan of correc- must notify the other of such a finding.
tion. (2) CMS will or the State must do one
(g) Appeal of a certification of non- or both of the following:
compliance. (1) A facility may appeal a (i) Take immediate action to remove
certification of noncompliance leading the jeopardy and correct the non-
to an enforcement remedy. compliance through temporary man-
(2) A facility may not appeal the agement.
choice of remedy, including the factors
(ii) Terminate the facility’s partici-
considered by CMS or the State in se-
pation under the State plan. If this is
lecting the remedy, specified in
done, CMS will also terminate the fa-
§ 488.404.
cility’s participation in Medicare if it
[59 FR 56243, Nov. 10, 1994; 60 FR 50118, Sept. is a dually participating facility.
28, 1995, as amended at 64 FR 13360, Mar. 18, (d) The State must provide for the
1999; 81 FR 61563, Sept. 6, 2016; 89 FR 64162, safe and orderly transfer of residents
Aug. 6, 2024]
when the facility is terminated.
§ 488.410 Action when there is imme- (e) If the immediate jeopardy is also
diate jeopardy. substandard quality of care, the State
survey agency must notify attending
(a) If there is immediate jeopardy to
physicians and the State board respon-
resident health or safety, the State
sible for licensing the facility adminis-
must (and CMS does) either terminate
trator of the finding of substandard
the provider agreement within 23 cal-
quality of care, as specified in
endar days of the last date of the sur-
§ 488.325(h).
vey or appoint a temporary manager to
remove the immediate jeopardy. The [59 FR 56243, Nov. 10, 1994; 60 FR 50118, Sept.
rules for appointment of a temporary 28, 1995]
manager in an immediate jeopardy sit-
uation are as follows: § 488.412 Action when there is no im-
(1) CMS does and the State must no- mediate jeopardy.
tify the facility that a temporary man- (a) If a facility’s deficiencies do not
ager is being appointed. pose immediate jeopardy to residents’
(2) If the facility fails to relinquish health or safety, and the facility is not
control to the temporary manager, in substantial compliance, CMS or the
CMS does and the State must termi- State may terminate the facility’s pro-
nate the provider agreement within 23 vider agreement or may allow the fa-
calendar days of the last day of the cility to continue to participate for no
595
§ 488.414 42 CFR Ch. IV (10–1–24 Edition)
longer than 6 months from the last day quirements and will remain in substan-
of the survey if— tial compliance with all requirements.
(1) The State survey agency finds (b) Repeated noncompliance. For pur-
that it is more appropriate to impose poses of this section, repeated non-
alternative remedies than to terminate compliance is based on the repeated
the facility’s provider agreement; finding of substandard quality of care
(2) The State has submitted a plan and not on the basis that the substance
and timetable for corrective action ap- of the deficiency or the exact tag num-
proved by CMS; and ber for the deficiency was repeated.
(3) The facility in the case of a Medi- (c) Standard surveys to which this pro-
care SNF or the State in the case of a vision applies. Standard surveys com-
Medicaid NF agrees to repay to the pleted by the State survey agency on
Federal government payments received or after October 1, 1990, are used to de-
after the last day of the survey that termine whether the threshold of three
first identified the deficiencies if cor- consecutive standard surveys is met.
rective action is not taken in accord- (d) Program participation. (1) The de-
ance with the approved plan of correc- termination that a certified facility
tion. has repeated instances of substandard
(b) If a facility does not meet the cri- quality of care is made without regard
teria for continuation of payment to any variances in the facility’s pro-
under paragraph (a) of this section, gram participation (that is, any stand-
CMS will and the State must terminate ard survey completed for Medicare,
the facility’s provider agreement. Medicaid or both programs will be con-
(c) CMS does and the State must sidered).
deny payment for new admissions when (2) Termination would allow the
a facility is not in substantial compli- count of repeated substandard quality
ance 3 months after the last day of the of care surveys to start over.
survey. (3) Change of ownership. (i) A facility
(d) CMS terminates the provider may not avoid a remedy on the basis
agreement for SNFs and NFs, and stops that it underwent a change of owner-
FFP to a State for a NF for which par- ship.
ticipation was continued under para- (ii) In a facility that has undergone a
graph (a) of this section, if the facility change of ownership, CMS does not and
is not in substantial compliance within the State may not restart the count of
6 months of the last day of the survey. repeated substandard quality of care
[59 FR 56243, Nov. 10, 1994; 60 FR 50118, Sept. surveys unless the new owner can dem-
28, 1995] onstrate to the satisfaction of CMS or
the State that the poor past perform-
§ 488.414 Action when there is re- ance no longer is a factor due to the
peated substandard quality of care. change in ownership.
(a) General. If a facility has been (e) Facility alleges corrections or
found to have provided substandard achieves compliance after repeated sub-
quality of care on the last three con- standard quality of care is identified. (1)
secutive standard surveys, as defined in If a penalty is imposed for repeated
§ 488.305, regardless of other remedies substandard quality of care, it will con-
provided— tinue until the facility has dem-
(1) CMS imposes denial of payment onstrated to the satisfaction of CMS or
for all new admissions, as specified in the State that it is in substantial com-
§ 488.417, or denial of all payments, as pliance with the requirements and that
specified in § 488.418; it will remain in substantial compli-
(2) The State must impose denial of ance with the requirements for a period
payment for all new admissions, as of time specified by CMS or the State.
specified in § 488.417; and (2) A facility will not avoid the impo-
(3) CMS does and the State survey sition of remedies or the obligation to
agency must impose State monitoring, demonstrate that it will remain in
as specified in § 488.422, until the facil- compliance when it—
ity has demonstrated to the satisfac- (i) Alleges correction of the defi-
tion of CMS or the State, that it is in ciencies cited in the most recent stand-
substantial compliance with all re- ard survey; or
596
(ii) Achieves compliance before the terminate the provider agreement in

effective date of the remedies. accordance with § 488.456.
(2) Failure to pay salary of temporary
§ 488.415 Temporary management. manager. A facility’s failure to pay the
(a) Definition. Temporary manage- salary of the temporary manager is
ment means the temporary appoint- considered a failure to relinquish au-
ment by CMS or the State of a sub- thority to temporary management.
stitute facility manager or adminis- (e) Duration of temporary management.
trator with authority to hire, termi- Temporary management ends when the
nate or reassign staff, obligate facility facility meets any of the conditions
funds, alter facility procedures, and specified in § 488.454(c).
manage the facility to correct defi-
ciencies identified in the facility’s op- § 488.417 Denial of payment for all new
eration. admissions.
(b) Qualifications. The temporary (a) Optional denial of payment. Except
manager must— as specified in paragraph (b) of this sec-
(1) Be qualified to oversee correction tion, CMS or the State may deny pay-
of deficiencies on the basis of experi- ment for all new admissions when a fa-
ence and education, as determined by cility is not in substantial compliance
the State; with the requirements, as defined in
(2) Not have been found guilty of mis- § 488.401, as follows:
conduct by any licensing board or pro- (1) Medicare facilities. In the case of
fessional society in any State; Medicare facilities, CMS may deny
(3) Have, or a member of his or her payment to the facility.
immediate family have, no financial (2) Medicaid facilities. In the case of
ownership interest in the facility; and Medicaid facilities—
(4) Not currently serve or, within the (i) The State may deny payment to
past 2 years, have served as a member the facility; and
of the staff of the facility. (ii) CMS may deny payment to the
(c) Payment of salary. The temporary State for all new Medicaid admissions
manager’s salary— to the facility.
(1) Is paid directly by the facility (b) Required denial of payment. CMS
while the temporary manager is as- does or the State must deny payment
signed to that facility; and for all new admissions when—
(2) Must be at least equivalent to the (1) The facility is not in substantial
sum of the following— compliance, as defined in § 488.401, 3
(i) The prevailing salary paid by pro- months after the last day of the survey
viders for positions of this type in what identifying the noncompliance; or
the State considers to be the facility’s (2) The State survey agency has cited
geographic area; a facility with substandard quality of
(ii) Additional costs that would have care on the last three consecutive
reasonably been incurred by the pro- standard surveys.
vider if such person had been in an em- (c) Resumption of payments: Repeated
ployment relationship; and instances of substandard quality of care.
(iii) Any other costs incurred by such When a facility has repeated instances
a person in furnishing services under of substandard quality of care, pay-
such an arrangement or as otherwise ments to the facility or, under Med-
set by the State. icaid, CMS payments to the State on
(3) May exceed the amount specified behalf of the facility, resume on the
in paragraph (c)(2) of this section if the date that—
State is otherwise unable to attract a (1) The facility achieves substantial
qualified temporary manager. compliance as indicated by a revisit or
(d) Failure to relinquish authority to written credible evidence acceptable to
temporary management—(1) Termination CMS (for all facilities except non-State
of provider agreement. If a facility fails operated NFs against which CMS is im-
to relinquish authority to the tem- posing no remedies) or the State (for
porary manager as described in this non-State operated NFs against which
section, CMS will or the State must CMS is imposing no remedies); and
597
§ 488.418 42 CFR Ch. IV (10–1–24 Edition)
(2) CMS (for all facilities except non- (1) Denial of payment was imposed;
State operated NFs against which CMS and
is imposing no remedies) or the State (2) CMS verifies as the date that the
(for non-State operated NFs against facility achieved substantial compli-
which CMS is imposing no remedies) ance.
believes that the facility is capable of (d) Retroactive resumption of payment.
remaining in substantial compliance. Except when a facility has repeated in-
(d) Resumption of payments: No re- stances of substandard quality of care,
peated instances of substandard quality of as specified in paragraph (e) of this sec-
care. When a facility does not have re- tion, when CMS or the State finds that
peated instances of substandard qual- the facility was in substantial compli-
ity of care, payments to the facility or, ance before the date of the revisit, or
under Medicaid, CMS payments to the before CMS or the survey agency re-
State on behalf of the facility, resume ceived credible evidence of such com-
prospectively on the date that the fa- pliance, payment is resumed on the
cility achieves substantial compliance, date that substantial compliance was
as indicated by a revisit or written achieved, as determined by CMS.
credible evidence acceptable to CMS (e) Resumption of payment—repeated
(under Medicare) or the State (under instances of substandard care. When
Medicaid). CMS denies payment for all Medicare
(e) Restriction. No payments to a fa- residents for repeated instances of sub-
cility or, under Medicaid, CMS pay- standard quality of care, payment is
ments to the State on behalf of the fa- resumed when—
cility, are made for the period between (1) The facility achieved substantial
the date that the— compliance, as indicated by a revisit or
(1) Denial of payment remedy is im- written credible evidence acceptable to
posed; and CMS; and
(2) Facility achieves substantial com- (2) CMS believes that the facility will
pliance, as determined by CMS or the remain in substantial compliance.
State. § 488.422 State monitoring.
[59 FR 56243, Nov. 10, 1994; 60 FR 50119, Sept. (a) A State monitor—
28, 1995] (1) Oversees the correction of defi-
ciencies specified by CMS or the State
§ 488.418 Secretarial authority to deny survey agency at the facility site and
all payments.
protects the facility’s residents from
(a) CMS option to deny all payment. If harm;
a facility has not met a requirement, (2) Is an employee or a contractor of
in addition to the authority to deny the survey agency;
payment for all new admissions as (3) Is identified by the State as an ap-
specified in § 488.417, CMS may deny propriate professional to monitor cited
any further payment for all Medicare deficiencies;
residents in the facility and to the (4) Is not an employee of the facility;
State for all Medicaid residents in the (5) Does not function as a consultant
facility. to the facility; and
(b) Prospective resumption of payment. (6) Does not have an immediate fam-
Except as provided in paragraphs (d) ily member who is a resident of the fa-
and (e) of this section, if the facility cility to be monitored.
achieves substantial compliance, CMS (b) A State monitor must be used
resumes payment prospectively from when a survey agency has cited a facil-
the date that it verifies as the date ity with substandard quality of care
that the facility achieved substantial deficiencies on the last 3 consecutive
compliance. standard surveys.
(c) Restriction on payment after denial (c) State monitoring is discontinued
of payment is imposed. If payment to the when—
facility or to the State resumes after (1) The facility has demonstrated
denial of payment for all residents, no that it is in substantial compliance
payment is made for the period be- with the requirements, and, if imposed
tween the date that— for repeated instances of substandard
598
quality of care, will remain in compli- (c) Required notifications when a facili-
ance for a period of time specified by ty’s provider agreement is terminated.
CMS or the State; or When the State or CMS terminates a
(2) Termination procedures are com- facility’s provider agreement, CMS de-
pleted. termines the appropriate date for noti-
fication, in accordance with § 483.70(l)
[59 FR 56243, Nov. 10, 1994; 60 FR 50119, Sept.
28, 1995] of this chapter.
[59 FR 56243, Nov. 10, 1994; 60 FR 50119, Sept.
§ 488.424 Directed plan of correction. 28, 1995, as amended at 76 FR 9511, Feb. 18,
CMS, the State survey agency, or the 2011; 81 FR 68872, Oct. 4, 2016]
temporary manager (with CMS or
State approval) may develop a plan of § 488.430 Civil money penalties: Basis
for imposing penalty.
correction and CMS, the State, or the
temporary manager require a facility (a) CMS or the State may impose a
to take action within specified time- civil money penalty for the number of
frames. days a facility is not in substantial
compliance with one or more participa-
§ 488.425 Directed inservice training. tion requirements or for each instance
(a) Required training. CMS or the that a facility is not in substantial
State agency may require the staff of a compliance, or both, regardless of
facility to attend an inservice training whether or not the deficiencies con-
program if— stitute immediate jeopardy. When a
(1) The facility has a pattern of defi- survey contains multiple instances of
ciencies that indicate noncompliance; noncompliance, CMS or the State may
and impose any combination of per in-
(2) Education is likely to correct the stance or per day civil money penalties
deficiencies. for each instance of noncompliance
(b) Action following training. After the within the same survey.
staff has received inservice training, if (b) CMS or the State may impose a
the facility has not achieved substan- civil money penalty for the number of
tial compliance, CMS or the State may days or instances of previously cited
impose one or more other remedies noncompliance, including the number
specified in § 488.406. of days of immediate jeopardy, since
(c) Payment. The facility pays for di- the last three standard surveys.
rected inservice training. [89 FR 64163, Aug. 6, 2024]
[59 FR 56243, Nov. 10, 1994; 60 FR 50119, Sept.
28, 1995] § 488.431 Civil money penalties im-
posed by CMS and independent in-
§ 488.426 Transfer of residents, or clo- formal dispute resolution: for SNFS,
sure of the facility and transfer of dually-participating SNF/NFs, and
residents. NF-only facilities.
(a) Transfer of residents, or closure of (a) Opportunity for independent review.
the facility and transfer of residents in an CMS retains ultimate authority for the
emergency. In an emergency, the State survey findings and imposition of civil
has the authority to— money penalties, but provides an op-
(1) Transfer Medicaid and Medicare portunity for independent informal dis-
residents to another facility; or pute resolution within 30 days of notice
(2) Close the facility and transfer the of imposition of a civil money penalty
Medicaid and Medicare residents to an- that will be placed in escrow in accord-
other facility. ance with paragraph (b) of this section.
(b) Required transfer when a facility’s An independent informal dispute reso-
provider agreement is terminated. When lution will—
the State or CMS terminates a facili- (1) Be completed within 60 days of fa-
ty’s provider agreement, the State will cility’s request if an independent infor-
arrange for the safe and orderly trans- mal dispute resolution is timely re-
fer of all Medicare and Medicaid resi- quested by the facility.
dents to another facility, in accordance (2) Generate a written record prior to
with § 483.70(l) of this chapter. the collection of the penalty.
599
§ 488.431 42 CFR Ch. IV (10–1–24 Edition)
(3) Include notification to an in- amount of the civil money penalty im-
volved resident or resident representa- posed.
tive, as well as the State’s long term (3) CMS may provide for an escrow
care ombudsman, to provide oppor- payment schedule that differs from the
tunity for written comment. collection times of paragraph (1) of this
(4) Be approved by CMS and con- subsection in any case in which CMS
ducted by the State under section 1864 determines that more time is necessary
of the Act, or by an entity approved by for deposit of the total civil money
the State and CMS, or by CMS or its penalty into an escrow account, not to
agent in the case of surveys conducted exceed 12 months, if CMS finds that im-
only by federal surveyors where the mediate payment would create sub-
State independent dispute resolution stantial and undue financial hardship
process is not used, and which has no on the facility.
conflict of interest, such as: (4) If the full civil money penalty is
(i) A component of an umbrella State not placed in an escrow account within
agency provided that the component is 30 calendar days from the date the pro-
organizationally separate from the vider receives notice of collection, or
State survey agency. within 30 calendar days of any due date
(ii) An independent entity with a spe- established pursuant to a hardship
cific understanding of Medicare and finding under paragraph (b)(3), CMS
Medicaid program requirements se- may deduct the amount of the civil
lected by the State and approved by money penalty from any sum then or
CMS. later owed by CMS or the State to the
(5) Not include the survey findings facility in accordance with § 488.442(c).
that have already been the subject of (5) For any civil money penalties
an informal dispute resolution under that are not collected and placed into
§ 488.331 for the particular deficiency cian escrow account under this section,
tations at issue in the independent CMS will collect such civil money pen-
process under § 488.431, unless the infor- alties in the same manner as the State
mal dispute resolution under § 488.331 in accordance with § 488.432.
was completed prior to the imposition (c) Maintenance of escrowed funds.
of the civil money penalty. CMS will maintain collected civil
(b) Collection and placement in escrow money penalties in an escrow account
account. (1) For both per day and per pending the resolution of any adminis-
instance civil money penalties, CMS trative appeal of the deficiency find-
may collect and place the imposed civil ings that comprise the basis for the
money penalties in an escrow account civil monetary penalty imposition.
on whichever of the following occurs CMS will retain the escrowed funds on
first: an on-going basis and, upon a final ad-
(i) The date on which the inde- ministrative decision, will either re-
pendent informal dispute resolution turn applicable funds in accordance
process is completed under paragraph with paragraph (d)(2) of this section or,
(a) of this section. in the case of an unsuccessful adminis-
(ii) The date that is 90 days after the trative appeal, will periodically dis-
date of the notice of imposition of the burse the funds to States or other enti-
penalty. ties in accordance with § 488.433.
(2) For collection and placement in (d) When a facility requests a hearing.
escrow accounts of per day civil money (1) A facility must request a hearing on
penalties, CMS may collect the portion the determination of the noncompli-
of the per day civil money penalty that ance that is the basis for imposition of
has accrued up to the time of collec- the civil money penalty as specified in
tion as specified in paragraph (b)(1) of § 498.40 of this chapter.
this section. CMS may make additional (2) If the administrative law judge re-
collections periodically until the full verses deficiency findings that com-
amount is collected, except that the prise the basis of a civil money penalty
full balance must be collected once the in whole or in part, the escrowed
facility achieves substantial compli- amounts continue to be held pending
ance or is terminated from the pro- expiration of the time for CMS to ap-
gram and CMS determines the final peal the decision or, where CMS does
600
appeal, a Departmental Appeals Board the penalty when the time frame for
decision affirming the reversal of the requesting a hearing expires.
pertinent deficiency findings. Any col- (c) When a facility waives a hearing. (1)
lected civil money penalty amount If a facility waives its right to a hear-
owed to the facility based on a final ad- ing as specified in § 488.436, the State
ministrative decision will be returned initiates collection of civil money pen-
to the facility with applicable interest alty imposed per day of noncompliance
as specified in section 1878(f)(2) of the after 60 days from the date of the no-
Act. tice imposing the penalty and the
[76 FR 15126, Mar. 18, 2011] State has not received a timely request
for a hearing.
§ 488.432 Civil money penalties im- (2) If a facility waives its right to a
posed by the State: NF-only. hearing as specified in § 488.436, the
(a) When a facility requests a hearing. State initiates collection of civil
(1) When the State imposes a civil money penalty imposed per instance of
money penalty against a non-State op- noncompliance after 60 days from the
erated NF that is not subject to impo- date of the notice imposing the penalty
sition of remedies by CMS, the facility and the State has not received a timely
must request a hearing on the deter- request for a hearing.
mination of noncompliance that is the (d) Accrual and computation of pen-
basis for imposition of the civil money alties for a facility that—
penalty within the time specified in (1) Requests a hearing or does not re-
§ 431.153 of this chapter. quest a hearing are specified in
(2)(i) If a facility requests a hearing § 488.440;
within the time frame specified in (2) Waives its right to a hearing in
paragraph (a)(1) of this section, for a writing, are specified in §§ 488.436(b) and
civil money penalty imposed per day, 488.440.
the State initiates collection of the
[59 FR 56243, Nov. 10, 1994; 60 FR 50119, Sept.
penalty when there is a final adminis- 28, 1995, as amended at 64 FR 13360, Mar. 18,
trative decision that upholds the 1999; 76 FR 15127, Mar. 18, 2011; 88 FR 53347,
State’s determination of noncompli- Aug. 7, 2023]
ance after the facility achieves sub-
stantial compliance or is terminated. § 488.433 Civil money penalties: Uses
(ii) If a facility requests a hearing for and approval of civil money pen-
a civil money penalty imposed per in- alties imposed by CMS.
stance of noncompliance within the (a) Ten percent of the collected civil
time specified in paragraph (a)(1) of money penalty funds that are required
this section, the State initiates collec- to be held in escrow pursuant to
tion of the penalty when there is a § 488.431 and that remain after a final
final administrative decision that up- administrative decision will be depos-
holds the State’s determination of non- ited with the Department of the Treas-
compliance. ury in accordance with § 488.442(f). The
(b) When a facility does not request a remaining ninety percent of the col-
hearing for a civil money penalty imposed lected civil money penalty funds that
per day. (1) If a facility does not re- are required to be held in escrow pursu-
quest a hearing in accordance with ant to § 488.431 and that remain after a
paragraph (a) of this section, the State final administrative decision must be
initiates collection of the penalty when used entirely for activities that protect
the facility— or improve the quality of care or qual-
(i) Achieves substantial compliance; ity of life for residents consistent with
or paragraph (b) of this section and may
(ii) Is terminated. not be used for survey and certification
(2) When a facility does not request a operations or State expenses, except
hearing for a civil money penalty imposed that reasonable expenses necessary to
per instance of noncompliance. If a facil- administer, monitor, or evaluate the
ity does not request a hearing in ac- effectiveness of projects utilizing civil
cordance with paragraph (a) of this sec- money penalty funds may be per-
tion, the State initiates collection of mitted.
601
§ 488.434 42 CFR Ch. IV (10–1–24 Edition)
(b) All activities and plans for uti- including a description of methods by
lizing civil money penalty funds, in- which the State will:
cluding any expense used to administer (1) Solicit, accept, monitor, and
grants utilizing civil money penalty track projects utilizing civil money
funds, must be approved in advance by penalty funds including any funds used
CMS and may include, but are not lim- for state administration.
ited to: (2) Make information about the use
(1) Support and protection of resi- of civil money penalty funds publicly
dents of a facility that closes (volun- available, including about the dollar
tarily or involuntarily). amount awarded for approved projects,
(2) Time-limited expenses incurred in the grantee or contract recipients, the
the process of relocating residents to results of projects, and other key infor-
home and community-based settings or mation.
another facility when a facility is (3) Ensure that:
closed (voluntarily or involuntarily) or (i) A core amount of civil money pen-
downsized pursuant to an agreement alty funds will be held in reserve for
with the State Medicaid agency. emergencies, such as relocation of resi-
(3) Projects that support resident and dents pursuant to an involuntary ter-
family councils and other consumer in- mination from Medicare and Medicaid.
volvement in assuring quality care in (ii) A reasonable amount of funds, be-
facilities. yond those held in reserve under para-
(4) Facility improvement initiatives, graph (e)(3)(i) of this section, will be
such as joint training of facility staff awarded or contracted each year for
and surveyors or technical assistance the purposes specified in this section.
for facilities implementing quality as- (f) If CMS finds that a State has not
surance and performance improvement spent civil money penalty funds in ac-
programs. cordance with this section, or fails to
(5) Development and maintenance of make use of funds to benefit the qual-
temporary management or receivership ity of care or life of residents, or fails
capability such as but not limited to, to maintain an acceptable plan for the
recruitment, training, retention or use of funds that is approved by CMS,
other system infrastructure expenses. then CMS may withhold future dis-
However, as specified in § 488.415(c), a bursements of civil money penalty
temporary manager’s salary must be funds to the State until the State has
paid by the facility. In rare situations, submitted an acceptable plan to com-
if the facility is closing, CMS plans to ply with this section.
stop or suspend continued payments to
the facility under § 489.55 of this chap- [79 FR 45658, Aug. 5, 2014]
ter during the temporary manager’s
duty period, and CMS determines that § 488.434 Civil money penalties: Notice
of penalty.
extraordinary action is necessary to
protect the residents until relocation (a) CMS notice of penalty. (1) CMS
efforts are successful, civil money pen- sends a written notice of the penalty to
alty funds may be used to pay the man- the facility for all facilities except
ager’s salary. non-State operated NFs when the State
(c) At a minimum, proposed activi- is imposing the penalty.
ties submitted to CMS for prior ap- (2) Content of notice. The notice that
proval must include a description of CMS sends includes—
the intended outcomes, deliverables, (i) The nature of the noncompliance;
and sustainability; and a description of (ii) The statutory basis for the pen-
the methods by which the activity re- alty;
sults will be assessed, including spe- (iii) Either the amount of penalty per
cific measures. day of noncompliance or the amount of
(d) Civil money penalty funds may the penalty per instance of noncompli-
not be used for activities that have ance or both;
been disapproved by CMS. (iv) Any factors specified in
(e) The State must maintain an ac- § 488.438(f) that were considered when
ceptable plan, approved by CMS, for determining the amount of the pen-
the effective use of civil money funds, alty;
602
(v) The date(s) of the instance(s) of (i) Upper range. Penalties in the
noncompliance or the date on which range of $3,050–$10,000 as adjusted annu-
the penalty begins to accrue; ally under 45 CFR part 102 per day are
(vi) When the penalty stops accruing, imposed for deficiencies constituting
if applicable; immediate jeopardy, and as specified in
(vii) When the penalty is collected; paragraph (d)(2) of this section.
and (ii) Upper range. Penalties in the
(viii) Instructions for responding to range of $50–$3,000 as adjusted annually
the notice, including a statement of under 45 CFR part 102 per day are im-
the facility’s right to a hearing, and posed for deficiencies that do not con-
the implication of waiving a hearing, stitute immediate jeopardy, but either
as provided in § 488.436. caused actual harm, or caused no ac-
(b) State notice of penalty. (1) The tual harm, but have the potential for
State must notify the facility in ac- more than minimal harm.
cordance with State procedures for all (2) Per instance penalty. When pen-
non-State operated NFs when the State alties are imposed for an instance of
takes the action. noncompliance, the penalties will be in
(2) The State’s notice must—
the range of $1,000-$10,000 as adjusted
(i) Be in writing; and
annually under 45 CFR part 102 per in-
(ii) Include, at a minimum, the infor-
stance.
mation specified in paragraph (a)(2) of
this section. (b) Basis for penalty amount. The
amount of penalty is based on CMS’s or
[59 FR 56243, Nov. 10, 1994; 60 FR 50119, Sept. the State’s assessment of factors listed
28, 1995, as amended at 64 FR 13360, Mar. 18, in paragraph (f) of this section.
1999; 89 FR 64163, Aug. 6, 2024]
(c) Decreased penalty amounts. (1) Ex-
§ 488.436 Civil money penalties: Waiv- cept as specified in paragraph (d)(2) of
er of hearing, reduction of penalty this section, if immediate jeopardy is
amount. removed, but the noncompliance con-
(a) Constructive waiver of a hearing. A tinues, CMS or the State will shift the
facility is considered to have waived penalty amount imposed per day to the
its right to a hearing after 60 days from lower range.
the date of the notice imposing the (2) When CMS determines that a
civil money penalty if CMS has not re- SNF, dually-participating SNF/NF, or
ceived a request for a hearing from the NF-only facility subject to a civil
facility. money penalty imposed by CMS self-re-
(b) Reduction of penalty amount. (1) If ports and promptly corrects the non-
the facility waives its right to a hear- compliance for which the civil money
ing in accordance with the procedures penalty was imposed, CMS will reduce
specified in paragraph (a) of this sec- the amount of the penalty by 50 per-
tion, CMS or the State reduces the cent, provided that all of the following
civil money penalty by 35 percent, as apply —
long as the civil money penalty has not (i) The facility self-reported the non-
also been reduced by 50 percent under compliance to CMS or the State before
§ 488.438. it was identified by CMS or the State
(2) If the facility does not waive its and before it was reported to CMS or
right to a hearing in accordance with the State by means of a complaint
the procedures specified in paragraph lodged by a person other than an offi-
(a) of this section, the civil money pen- cial representative of the nursing
alty is not reduced by 35 percent. home;
[59 FR 56243, Nov. 10, 1994; 62 FR 44221, Aug.
(ii) Correction of the self-reported
20, 1997, as amended at 76 FR 15127, Mar. 18, noncompliance occurred on whichever
2011; 88 FR 53347, Aug. 7, 2023] of the following occurs first:
(A) 15 calendar days from the date of
§ 488.438 Civil money penalties: the circumstance or incident that later
Amount of penalty. resulted in a finding of noncompliance;
(a) Amount of penalty. (1) The pen- or
alties are within the following ranges, (B) 10 calendar days from the date
set at $50 increments: the civil money penalty was imposed;
603
§ 488.440 42 CFR Ch. IV (10–1–24 Edition)
(iii) The facility waives its right to a (2) Review the exercise of discretion
hearing under § 488.436; by CMS or the State to impose a civil
(iv) The noncompliance that was self- money penalty; and
reported and corrected did not con- (3) Consider any factors in reviewing
stitute a pattern of harm, widespread the amount of the penalty other than
harm, immediate jeopardy, or result in those specified in paragraph (f) of this
the death of a resident; section.
(v) The civil money penalty was not (f) Factors affecting the amount of pen-
imposed for a repeated deficiency, as alty. In determining the amount of pen-
defined in paragraph (d)(3) of this sec- alty, CMS does or the State must take
tion, that was the basis of a civil into account the following factors:
money penalty that previously re- (1) The facility’s history of non-
ceived a reduction under this section; compliance, including repeated defi-
and ciencies.
(vi) The facility has met mandatory (2) The facility’s financial condition.
reporting requirements for the incident (3) The factors specified in § 488.404.
or circumstance upon which the civil (4) The facility’s degree of culpability.
money penalty is based, as required by Culpability for purposes of this para-
Federal and State law. graph includes, but is not limited to,
(3) Under no circumstances will a fa- neglect, indifference, or disregard for
cility receive both the 50 percent civil resident care, comfort or safety. The
money penalty reduction for self-re- absence of culpability is not a miti-
porting and correcting under this sec- gating circumstance in reducing the
tion and the 35 percent civil money amount of the penalty.
penalty reduction for waiving its right [59 FR 56243, Nov. 10, 1994, as amended at 64
to a hearing under § 488.436. FR 13360, Mar. 18, 1999; 68 FR 46072, Aug. 4,
(d) Increased penalty amounts. (1) Be- 2003; 76 FR 15127, Mar. 18, 2011; 81 FR 61563,
fore a hearing requested in accordance Sept. 6, 2016]
with § 488.431(d) or § 488.432(a), CMS or
the State may propose to increase the § 488.440 Civil money penalties: Effec-
per day penalty amount for facility tive date and duration of penalty.
noncompliance which, after imposition (a)(1) The per day civil money pen-
of a lower level penalty amount, be- alty may start accruing as early as the
comes sufficiently serious to pose im- date that the facility was first out of
mediate jeopardy. compliance, as determined by CMS or
(2) CMS does and the State must in- the State.
crease the per day penalty amount for (2) A civil money penalty for each in-
any repeated deficiencies for which a stance of noncompliance is imposed in
lower level penalty amount was pre- a specific amount per instance.
viously imposed, regardless of whether (b) The per day civil money penalty
the increased penalty amount would is computed and collectible, as speci-
exceed the range otherwise reserved for fied in §§ 488.431, 488.432, and 488.442 for
nonimmediate jeopardy deficiencies. the number of days of noncompliance
(3) Repeated deficiencies are defi- until the date the facility achieves sub-
ciencies in the same regulatory group- stantial compliance, or, if applicable,
ing of requirements found at the last the date of termination when —
survey, subsequently corrected, and (1) The determination of noncompli-
found again at the next survey. ance is upheld after a final administra-
(e) Review of the penalty. When an ad- tive decision for NFs-only subject to
ministrative law judge or State hear- civil money penalties imposed by the
ing officer (or higher administrative state or for civil money penalties im-
review authority) finds that the basis posed by CMS that are not collected
for imposing a civil money penalty ex- and placed into an escrow account;
ists, as specified in § 488.430, the admin- (2) The facility waives its right to a
istrative law judge or State hearing of- hearing in accordance with § 488.436; or
ficer (or higher administrative review (3) The time for requesting a hearing
authority) may not— has expired and CMS or the State has
(1) Set a penalty of zero or reduce a not received a hearing request from the
penalty to zero; facility.
604
(c)(1) For NFs-only subject to civil prior to the notice specified in § 488.434
money penalties imposed by the State and an additional period of no longer
and for civil money penalties imposed than 6 months following the last day of
by CMS that may not be placed in an the survey.
escrow account, the entire penalty, (2) After the period specified in para-
whether imposed on a per day or per in- graph (f)(1) of this section, if the facil-
stance basis, is due and collectible as ity has not achieved substantial com-
specified in the notice sent to the pro- pliance, CMS terminates the provider
vider under paragraphs (d) and (e) of agreement and the State may termi-
this section. nate the provider agreement.
(2) For SNFs, dually-participating (g)(1) In a case when per day civil
SNF/NFs, or NFs subject to civil money penalties are imposed, when a
money penalties imposed by CMS, col- facility has deficiencies that pose im-
lection is made in accordance with mediate jeopardy, CMS does or the
§ 488.431. State must terminate the provider
(d)(1) When a civil money penalty is agreement within 23 calendar days
imposed on a per day basis and the fa- after the last day of the survey if the
cility achieves substantial compliance, immediate jeopardy remains.
CMS does or the State must send a sep- (2) The accrual of the civil money
arate notice to the facility containing penalty imposed on a per day basis
the following information: stops on the day the provider agree-
(i) The amount of penalty per day. ment is terminated.
(ii) The number of days involved. (h)(1) If an on-site revisit is necessary
(iii) The total amount due. to confirm substantial compliance and
(iv) The due date of the penalty. the provider can supply documentation
(v) The rate of interest assessed on acceptable to CMS or the State agency
the unpaid balance beginning on the that substantial compliance was
due date, as provided in § 488.442. achieved on a date preceding the re-
(2) When a civil money penalty is im- visit, penalties imposed on a per day
posed for an instance of noncompli- basis only accrue until that date of
ance, CMS does or the State must send correction for which there is written
a separate notice to the facility con- credible evidence.
taining the following information: (2) If an on-site revisit is not nec-
(i) The amount of the penalty. essary to confirm substantial compli-
(ii) The total amount due. ance, penalties imposed on a per day
(iii) The due date of the penalty. basis only accrue until the date of cor-
(iv) The rate of interest assessed on rection for which CMS or the State re-
the unpaid balance beginning on the ceives and accepts written credible evi-
due date, as provided in § 488.442. dence.
(e) In the case of a facility for which [59 FR 56243, Nov. 10, 1994, as amended at 64
the provider agreement has been termi- FR 13361, Mar. 18, 1999; 76 FR 15128, Mar. 18,
nated and on which a civil money pen- 2011; 89 FR 64163, Aug. 6, 2024]
alty was imposed on a per day basis,
CMS does or the State must send this § 488.442 Civil money penalties: Due
penalty information after the— date for payment of penalty.
(1) Final administrative decision is (a) When payments are due for a civil
made; money penalty. (1) Payment for a civil
(2) Facility has waived its right to a money penalty is due in accordance
hearing in accordance with § 488.436; or with § 488.431 of this chapter for CMS-
(3) Time for requesting a hearing has imposed penalties and 15 days after the
expired and CMS or the state has not State initiates collection pursuant to
received a hearing request from the fa- § 488.432 of this chapter for State-im-
cility. posed penalties, except as provided in
(f) Accrual of penalties when there is no paragraphs (a)(2) and (3) of this section.
immediate jeopardy. (1) In the case of (2) After the facility waives its right to
noncompliance that does not pose im- a hearing in accordance with § 488.436(a).
mediate jeopardy, the daily accrual of Except as provided for in § 488.431, a
per day civil money penalties is im- civil money penalty is due 75 days after
posed for the days of noncompliance the notice of the penalty in accordance
605
§ 488.444 42 CFR Ch. IV (10–1–24 Edition)
with § 488.436 and a hearing request was (g) Penalties collected by the State.
not received when: Civil money penalties collected by the
(i) The facility achieved substantial State must be applied to the protection
compliance before the hearing request of the health or property of residents of
was due; or facilities that the State or CMS finds
(ii) The effective date of termination noncompliant, such as—
occurs before the hearing request was (1) Payment for the cost of relocating
due. residents to other facilities;
(3) After the effective date of termi- (2) State costs related to the oper-
nation. A civil money penalty payment ation of a facility pending correction of
is due 15 days after the effective date of deficiencies or closure; and
termination, if that date is earlier than (3) Reimbursement of residents for
the date specified in paragraph (a)(1)of
personal funds or property lost at a fa-
this section.
cility as a result of actions by the fa-
(b) [Reserved]
cility or by individuals used by the fa-
(c) Deduction of penalty from amount
cility to provide services to residents.
owed. The amount of the penalty, when
determined, may be deducted from any [59 FR 56243, Nov. 10, 1994; 60 FR 50119, Sept.
sum then or later owing by CMS or the 28, 1995, as amended at 64 FR 13361, Mar. 18,
State to the facility. 1999; 76 FR 15128, Mar. 18, 2011; 88 FR 53347,
(d) Interest—(1) Assessment. Interest is Aug. 7, 2023]
assessed on the unpaid balance of the
penalty, beginning on the due date. § 488.444 Civil money penalties: Settle-
(2) Medicare interest. Medicare rate of ment of penalties.
interest is the higher of— (a) CMS has authority to settle cases
(i) The rate fixed by the Secretary of at any time prior to a final administra-
the Treasury after taking into consid- tive decision for Medicare-only SNFs,
eration private consumer rates of in- State-operated facilities, or other fa-
terest prevailing on the date of the no- cilities for which CMS’s enforcement
tice of the penalty amount due (pub- action prevails, in accordance with
lished quarterly in the FEDERAL REG- § 488.330.
ISTER by HHS under 45 CFR 30.13(a)); or (b) The State has the authority to
(ii) The current value of funds (pub- settle cases at any time prior to the
lished annually in the FEDERAL REG- evidentiary hearing decision for all
ISTER by the Secretary of the Treasury, cases in which the State’s enforcement
subject to quarterly revisions). action prevails.
(3) Medicaid interest. The interest rate
for Medicaid is determined by the § 488.446 Administrator sanctions:
State. long-term care facility closures.
(e) Penalties collected by CMS. Civil Any individual who is or was the ad-
money penalties and corresponding in- ministrator of a facility and fails or
terest collected by CMS from— failed to comply with the requirements
(1) Medicare-participating facilities at § 483.70(l) of this chapter—
are deposited and disbursed in accord-
(a) Will be subject to a civil mone-
ance with § 488.433; and
tary penalty as follows:
(2) Medicaid-participating facilities
are returned to the State. (1) A minimum of $500 as adjusted an-
(f) Collection from dually participating nually under 45 CFR part 102 for the
facilities. Civil money penalties col- first offense.
lected from dually participating facili- (2) A minimum of $1,500 as adjusted
ties are deposited and disbursed in ac- annually under 45 CFR part 102 for the
cordance with § 488.433 and returned to second offense.
the State in proportion commensurate (3) A minimum of $3,000 as adjusted
with the relative proportions of Medi- annually under 45 CFR part 102 for the
care and Medicaid beds at the facility third and subsequent offenses.
actually in use by residents covered by (b) May be subject to exclusion from
the respective programs on the date participation in any Federal health
the civil money penalty begins to ac- care program (as defined in section
crue. 1128B(f) of the Act); and
606
(c) Will be subject to any other pen- the approved plan and timetable for
alties that may be prescribed by law. corrective action.
[76 FR 9511, Feb. 18, 2011, as amended at 81 (2) CMS or the State may terminate
FR 61563, Sept. 6, 2016; 81 FR 68872, Oct. 4, the SNF or NF agreement before the
2016] end of the correction period if the cri-
teria in paragraph (a)(1) of this section
§ 488.447 Civil Money Penalties im- are not met.
posed for failure to comply with 42 (b) Cessation of payments. If termi-
CFR 483.80(g)(1) and (2).
nation is not sought, either by itself or
(a) CMS may impose a civil money along with another remedy or rem-
penalty for noncompliance with the re- edies, or any of the criteria set forth in
quirements at § 483.80(g)(1) and (2) of paragraph (a)(1) of this section are not
this chapter as follows: met or agreed to by either the facility
(1) Minimum. A minimum of $1,000 for or the State, the facility or State will
the first occurrence.
receive no Medicare or Federal Med-
(2) Increased amount. An amount
icaid payments, as applicable, from the
equal to $500 added to the previously
last day of the survey.
imposed civil money penalty amount
for each subsequent occurrence, not to (c) Period of continued payments—(1)
exceed the maximum amount set forth Non-compliance. If the conditions in
in § 488.408(d)(1)(iii). paragraph (a)(1) of this section are met,
(b) The penalty amounts in this sec- CMS may continue payments to a
tion will be adjusted annually under 45 Medicare facility or the State for a
CFR part 102. Medicaid facility with noncompliance
(c) Compliance with the require- that does not constitute immediate
ments at § 483.80(g)(1) and (2) of this jeopardy for up to 6 months from the
chapter will be assessed weekly. Facili- last day of the survey.
ties found out of compliance with (2) Facility closure. In the case of a fa-
§ 483.80(g)(1) and (2) of this chapter are cility closure, the Secretary may, as
not required to submit a plan of correc- the Secretary determines appropriate,
tion as indicated in § 488.408(f)(1). continue to make payments with re-
(d) This section is in effect during spect to residents of a long-term care
and the Public Health Emergency facility that has submitted a notifica-
(PHE), as defined in § 400.200 of this tion of closure during the period begin-
chapter, and will continue for up to one ning on the date such notification is
year after the end of the PHE. submitted to CMS and ending on the
[85 FR 54873, Sept. 2, 2020] date on which the residents are suc-
cessfully relocated.
§ 488.450 Continuation of payments to (d) Failure to achieve substantial com-
a facility with deficiencies. pliance. If the facility does not achieve
(a) Criteria. (1) CMS may continue substantial compliance by the end of
payments to a facility not in substan- the period specified in paragraph (c) of
tial compliance for the periods speci- this section,
fied in paragraph (c) of this section if (1) CMS will—
the following criteria are met: (i) Terminate the provider agreement
(i) The State survey agency finds of the Medicare SNF in accordance
that it is more appropriate to impose with § 488.456; or
alternative remedies than to terminate (ii) Discontinue Federal funding to
the facility;
the SNF for Medicare; and
(ii) The State has submitted a plan
(iii) Discontinue FFP to the State for
and timetable for corrective action ap-
proved by CMS; and the Medicaid NF.
(iii) The facility, in the case of a (2) The State may terminate the pro-
Medicare SNF, or the State, in the case vider agreement for the NF.
of a Medicaid NF, agrees to repay the [59 FR 56243, Nov. 10, 1994; 60 FR 50119, Sept.
Federal government payments received 28, 1995, as amended at 76 FR 9511, Feb. 18,
under this provision if corrective ac- 2011; 78 FR 16805, Mar. 19, 2013]
tion is not taken in accordance with
607
§ 488.452 42 CFR Ch. IV (10–1–24 Edition)
§ 488.452 State and Federal disagree- (i) The State, but not CMS, finds that
ments involving findings not in a NF’s participation should be termi-
agreement in non-State operated nated; and
NFs and dually participating facili- (ii) The State’s effective date for the
ties when there is no immediate termination of the NF’s provider agree-
jeopardy. ment is no later than 6 months after
The following rules apply when CMS the last day of survey.
and the State disagree over findings of (c) Disagreement over timing of termi-
noncompliance or application of rem- nation of facility. The State’s timing of
edies in a non-State operated NF or du- termination takes precedence if it does
ally participating facility: not occur later than 6 months after the
(a) Disagreement over whether facility last day of the survey when both CMS
has met requirements. (1) The State’s and the State find that—
finding of noncompliance takes prece- (1) A facility is not in substantial
dence when— compliance; and
(i) CMS finds that a NF or a dually (2) The facility’s participation should
participating facility is in substantial be terminated.
compliance with the participation re- (d) Disagreement over remedies. (1)
quirements; and When CMS or the State, but not both,
(ii) The State finds that a NF or du- establishes one or more remedies, in
ally participating facility has not addition to or as an alternative to ter-
achieved substantial compliance. mination, the additional or alternative
(2) CMS’s findings of noncompliance remedies will also apply when—
take precedence when— (i) Both CMS and the State find that
(i) CMS finds that a NF or a dually a facility has not achieved substantial
participating facility has not achieved compliance; and
substantial compliance; and (ii) Both CMS and the State find that
(ii) The State finds that a NF or a du- no immediate jeopardy exists.
ally participating facility is in sub- (2) Overlap of remedies. When CMS and
stantial compliance with the participa- the State establish one or more rem-
tion requirements. edies, in addition to or as an alter-
(3) When CMS’s survey findings take native to termination, only the CMS
precedence, CMS may— remedies apply when both CMS and the
(i) Impose any of the alternative State find that a facility has not
remedies specified in § 488.406; achieved substantial compliance.
(ii) Terminate the provider agree- (e) Regardless of whether CMS’s or
ment subject to the applicable condi- the State’s decision controls, only one
tions of § 488.450; and noncompliance and enforcement deci-
(iii) Stop FFP to the State for a NF. sion is applied to the Medicaid agree-
(b) Disagreement over decision to termi- ment, and for a dually participating fa-
nate. (1) CMS’s decision to terminate cility, that same decision will apply to
the participation of a facility takes the Medicare agreement.
precedence when—
(i) Both CMS and the State find that § 488.454 Duration of remedies.
the facility has not achieved substan- (a) Except as specified in paragraphs
tial compliance; and (b) and (d) of this section, alternative
(ii) CMS, but not the State, finds remedies continue until—
that the facility’s participation should (1) The facility has achieved substan-
be terminated. CMS will permit con- tial compliance, as determined by CMS
tinuation of payment during the period or the State based upon a revisit or
prior to the effective date of termi- after an examination of credible writ-
nation not to exceed 6 months, if the ten evidence that it can verify without
applicable conditions of § 488.450 are an on-site visit; or
met. (2) CMS or the State terminates the
(2) The State’s decision to terminate provider agreement.
a facility’s participation and the proce- (b) In the cases of State monitoring
dures for appealing such termination, and denial of payment imposed for re-
as specified in § 431.153(c) of this chap- peated substandard quality of care,
ter, takes precedence when— remedies continue until—
608
(1) CMS or the State determines that (2) CMS and the State terminate a fa-
the facility has achieved substantial cility’s provider agreement if a facil-
compliance and is capable of remaining ity—
in substantial compliance; or (i) Fails to relinquish control to the
(2) CMS or the State terminates the temporary manager, if that remedy is
provider agreement. imposed by CMS or the State; or
(c) In the case of temporary manage- (ii) Does not meet the eligibility cri-
ment, the remedy continues until— teria for continuation of payment as
(1) CMS or the State determines that set forth in § 488.412(a)(1).
the facility has achieved substantial (c) Notice of termination. Before termi-
compliance and is capable of remaining nating a provider agreement, CMS does
in substantial compliance; and the State must notify the facility
(2) CMS or the State terminates the and the public—
provider agreement; or (1) At least 2 calendar days before the
(3) The facility which has not effective date of termination for a fa-
achieved substantial compliance re- cility with immediate jeopardy defi-
assumes management control. In this ciencies; and
case, CMS or the State initiates termi- (2) At least 15 calendar days before
nation of the provider agreement and
the effective date of termination for a
may impose additional remedies.
facility with non-immediate jeopardy
(d) In the case of a civil money pen- deficiencies that constitute noncompli-
alty imposed for an instance of non-
ance.
compliance, the remedy is the specific
(d) Procedures for termination. (1) CMS
amount of the civil money penalty im-
posed for the particular deficiency. terminates the provider agreement in
accordance with procedures set forth in
(e) If the facility can supply docu-
mentation acceptable to CMS or the § 489.53 of this chapter; and
State survey agency that it was in sub- (2) The State must terminate the
stantial compliance and was capable of provider agreement of a NF in accord-
remaining in substantial compliance, if ance with procedures specified in parts
necessary, on a date preceding that of 431 and 442 of this chapter.
the revisit, the remedies terminate on
the date that CMS or the State can Subpart G [Reserved]
verify as the date that substantial
compliance was achieved and the facil- Subpart H—Termination of Medi-
ity demonstrated that it could main-
tain substantial compliance, if nec-
care Coverage and Alter-
essary. native Sanctions for End-
Stage Renal Disease (ESRD)
[59 FR 56243, Nov. 10, 1994; 60 FR 50119, Sept. Facilities
28, 1995, as amended at 64 FR 13361, Mar. 18,
1999]
SOURCE: 73 FR 20475, Apr. 15, 2008, unless
§ 488.456 Termination of provider otherwise noted.
agreement.
(a) Effect of termination. Termination § 488.604 Termination of Medicare cov-
erage.
of the provider agreement ends—
(1) Payment to the facility; and (a) Except as otherwise provided in
(2) Any alternative remedy. this subpart, failure of a supplier of
(b) Basis for termination. (1) CMS and ESRD services to meet one or more of
the State may terminate a facility’s the conditions for coverage set forth in
provider agreement if a facility— part 494 of this chapter will result in
(i) Is not in substantial compliance termination of Medicare coverage of
with the requirements of participation, the services furnished by the supplier.
regardless of whether or not immediate (b) If termination of coverage is
jeopardy is present; or based solely on a supplier’s failure to
(ii) Fails to submit an acceptable participate in network activities and
plan of correction within the time- pursue network goals, as required at
frame specified by CMS or the State. § 494.180(i) of this chapter, coverage
609
§ 488.606 42 CFR Ch. IV (10–1–24 Edition)
may be reinstated when CMS deter- § 488.608 Notice of alternative sanction

mines that the supplier is making rea- and appeal rights: Termination of
sonable and appropriate efforts to meet coverage.
that condition. (a) Notice of alternative sanction. CMS
(c) If termination of coverage is gives the supplier and the general pub-
based on failure to meet any of the lic notice of the alternative sanction
other conditions specified in part 494 of and of the effective date of the sanc-
this chapter, coverage will not be rein- tion. The effective date of the alter-
stated until CMS finds that the reason native sanction is at least 30 days after
for termination has been removed and the date of the notice.
there is reasonable assurance that it (b) Appeal rights. Termination of
will not recur. Medicare coverage of a supplier’s
ESRD services because the supplier no
§ 488.606 Alternative sanctions.
longer meets the conditions for cov-
(a) Basis for application of alternative erage of its services is an initial deter-
sanctions. CMS may, as an alternative mination appealable under part 498 of
to termination of Medicare coverage, this chapter.
impose one of the sanctions specified in
paragraph (b) of this section if CMS § 488.610 Notice of appeal rights: Alter-
finds that— native sanctions.
(1) The supplier fails to participate in If CMS proposes to apply an alter-
the activities and pursue the goals of native sanction specified in § 488.606(b),
the ESRD network that is designated the following rules apply:
to encompass the supplier’s geographic (a) CMS gives the facility notice of
area; and the proposed alternative sanction and
(2) This failure does not jeopardize 15 days in which to request a hearing.
patient health and safety. (b) If the facility requests a hearing,
(b) Alternative sanctions. The alter- CMS provides an informal hearing by a
native sanctions that CMS may apply CMS official who was not involved in
in the circumstances specified in para- making the appealed decision.
graph (a) of this section include the fol- (c) During the informal hearing, the
lowing: facility—
(1) Denial of payment for services (1) May be represented by counsel;
furnished to patients first accepted for (2) Has access to the information on
care after the effective date of the which the allegation was based; and
sanction as specified in the sanction (3) May present, orally or in writing,
notice. evidence and documentation to refute
(2) Reduction of payments, for all the finding of failure to participate in
ESRD services furnished by the sup- network activities and pursue network
plier, by 20 percent for each 30-day pe- goals.
riod after the effective date of the (d) If the written decision of the in-
sanction. formal hearing supports application of
(3) Withholding of all payments, the alternative sanction, CMS provides
without interest, for all ESRD services the facility and the public, at least 30
furnished by the supplier to Medicare days before the effective date of the al-
beneficiaries. ternative sanction, a written notice
(c) Duration of alternative sanction. An that specifies the effective date and the
alternative sanction remains in effect reasons for the alternative sanction.
until CMS finds that the supplier is in
substantial compliance with the re- Subpart I—Survey and Certifi-
quirement to cooperate in the network
plans and goals, or terminates coverage
cation of Home Health Agen-
of the supplier’s services for lack of cies
compliance.
otherwise noted.
610
§ 488.700 Basis and scope. cators related to medical, nursing, and

rehabilitative care.
Section 1891 of the Act establishes re-
quirements for surveying HHAs to de- Substandard care means noncompli-
termine whether they meet the Medi- ance with one or more conditions of
care conditions of participation. participation identified on a standard
survey, including deficiencies which
§ 488.705 Definitions. could result in actual or potential
harm to patients of an HHA.
Abbreviated standard survey means a Substantial compliance means compli-
focused survey other than a standard ance with all condition-level require-
survey that gathers information on an ments, as determined by CMS or the
HHA’s compliance with fewer specific State.
standards or conditions of participa-
§ 488.710 Standard surveys.
tion. An abbreviated standard survey
may be based on complaints received, a (a) For each HHA, the survey agency
change of ownership or management, must conduct a standard survey not
or other indicators of specific concern later than 36 months after the date of
such as reapplication for Medicare bill- the previous standard survey that in-
ing privileges following a deactivation. cludes, but is not limited to, all of the
Complaint survey means a survey that following (to the extent practicable):
is conducted to investigate specific al- (1) A case-mix stratified sample of in-
legations of noncompliance. dividuals furnished items or services by
Condition-level deficiency means non- the HHA.
compliance as described in § 488.24 of (2) Visits to the homes of patients,
this part. (the purpose of the home visit is to
Deficiency is a violation of the Act evaluate the extent to which the qual-
and regulations contained in part 484, ity and scope of services furnished by
subparts A through C of this chapter, is the HHA attained and maintained the
determined as part of a survey, and can highest practicable functional capacity
be either standard or condition-level. of each patient as reflected in the pa-
Extended survey means a survey that tient’s written plan of care and clinical
reviews additional conditions of par- records), but only with their consent,
ticipation not examined during a and, if determined necessary by CMS or
standard survey. It may be conducted the survey team, other forms of com-
at any time but must be conducted munication with patients including
when substandard care is identified. telephone calls.
Noncompliance means any deficiency
(3) Review of indicators that include
found at the condition-level or stand-
the outcomes of quality care and serv-
ard-level.
ices furnished by the agency as indi-
Partial extended survey means a sur-
cated by medical, nursing, and reha-
vey conducted to determine if defi-
bilitative care.
ciencies and/or deficient practice(s)
exist that were not fully examined dur- (4) Review of compliance with a se-
ing the standard survey. The surveyors lect number of regulations most re-
may review any additional require- lated to high-quality patient care.
ments which would assist in making a (b) The survey agency’s failure to fol-
compliance finding. low the procedures set forth in this sec-
Standard-level deficiency means non- tion will not invalidate otherwise le-
compliance with one or more of the gitimate determinations that defi-
standards that make up each condition ciencies exist at an HHA.
of participation for HHAs.
§ 488.715 Partial extended surveys.
Standard survey means a survey con-
ducted in which the surveyor reviews A partial extended survey is con-
the HHA’s compliance with a select ducted to determine if standard or con-
number of standards and/or conditions dition-level deficiencies are present in
of participation in order to determine the conditions of participation not
the quality of care and services fur- fully examined during the standard
nished by an HHA as measured by indi- survey and there are indications that a
611
§ 488.720 42 CFR Ch. IV (10–1–24 Edition)
more comprehensive review of condi- whether an HHA complies with the Act
tions of participation would determine and conditions of participation; and
if a deficient practice exists. (2) Confirm that the HHA has cor-
rected deficiencies that were pre-
§ 488.720 Extended surveys. viously cited.
(a) Purpose of survey. The purpose of (b) Change in HHA information. A
an extended survey is: standard survey or an abbreviated
(1) To review and identify the poli- standard survey may be conducted
cies and procedures that caused an within 2 months of a change, or knowl-
HHA to furnish substandard care. edge of a change, in any of the fol-
(2) To determine whether the HHA is lowing:
in compliance with one or more or all (1) Ownership;
additional conditions of participation (2) Administration; or,
not examined during the standard sur- (3) Management of the HHA.
vey. (c) Complaints. A standard survey, or
(b) Timing and basis for survey. An ex- abbreviated standard survey—
tended survey must be conducted not (1) Must be conducted of an HHA
later than 14 calendar days after com- within 2 months of when a significant
pletion of a standard survey which number of complaints against the HHA
found that a HHA was out of compli- are reported to CMS, the State, the
ance with a condition of participation. State or local agency responsible for
maintaining a toll-free hotline and in-
§ 488.725 Unannounced surveys. vestigative unit, or any other appro-
(a) Basic rule. All HHA surveys must priate Federal, State, or local agency;
be unannounced and conducted with or
procedures and scheduling that renders (2) As otherwise required to deter-
the onsite surveys as unpredictable in mine compliance with the conditions of
their timing as possible. participation such as the investigation
(b) State survey agency’s scheduling of a complaint.
and surveying procedures. CMS reviews
each survey agency’s scheduling and § 488.735 Surveyor qualifications.
surveying procedures and practices to (a) Minimum qualifications. Surveys
assure that the survey agency has must be conducted by individuals who
taken all reasonable steps to avoid giv- meet minimum qualifications pre-
ing notice of a survey through the scribed by CMS. In addition, before any
scheduling procedures and conduct of State or Federal surveyor may serve on
the surveys. an HHA survey team (except as a train-
(c) Civil money penalties. Any indi- ee), he/she must have successfully com-
vidual who notifies an HHA, or causes pleted the relevant CMS-sponsored
an HHA to be notified, of the time or Basic HHA Surveyor Training Course
date on which a standard survey is and any associated course pre-
scheduled to be conducted is subject to requisites. All surveyors must follow
a Federal civil money penalty not to the principles set forth in § 488.24
exceed $2,000 as adjusted annually through § 488.28 according to CMS poli-
under 45 CFR part 102. cies and procedures for determining
[77 FR 67164, Nov. 8, 2012, as amended at 81 compliance with the conditions of par-
FR 61563, Sept. 6, 2016] ticipation.
(b) Disqualifications. Any of the fol-
§ 488.730 Survey frequency and con- lowing circumstances disqualifies a
tent. surveyor from surveying a particular
(a) Basic period. Each HHA must be agency:
surveyed not later than 36 months after (1) The surveyor currently works for,
the last day of the previous standard or, within the past two years, has
survey. Additionally, a survey may be worked with the HHA to be surveyed
conducted as frequently as necessary as:
to— (i) A direct employee;
(1) Assure the delivery of quality (ii) An employment agency staff at
home health services by determining the agency; or
612
(iii) An officer, consultant, or agent submitting an acceptable plan of cor-

for the agency to be surveyed con- rection.
cerning compliance with conditions of
participation specified in or pursuant Subpart J—Alternative Sanctions
to sections 1861(o) or 1891(a) of the Act. for Home Health Agencies
(2) The surveyor has a financial in-
terest or an ownership interest in the
With Deficiencies
HHA to be surveyed.
(3) The surveyor has a family mem- SOURCE: 77 FR 67165, Nov. 8, 2012, unless
otherwise noted.
ber who has a relationship with the
HHA to be surveyed. § 488.800 Statutory basis.
(4) The surveyor has an immediate
family member who is a patient of the Section 1891(e) through (f) of the Act
HHA to be surveyed. authorizes the Secretary to take ac-
tions to remove and correct defi-
§ 488.740 Certification of compliance ciencies in an HHA through an alter-
or noncompliance. native sanction or termination or both.
Rules to be followed for certification, Furthermore, this section specifies
documentation of findings, periodic re- that these sanctions are in addition to
view of compliance and approval, cer- any others available under State or
tification of noncompliance, and deter- Federal law, and, except for the final
mining compliance of HHAs are set determination of civil money penalties,
forth, respectively, in §§ 488.12, 488.18, are imposed prior to the conduct of a
488.20, 488.24, and 488.26 of this part. hearing.
§ 488.745 Informal Dispute Resolution § 488.805 Definitions.

(IDR). As used in this subpart—
(a) Opportunity to refute survey find- Directed plan of correction means CMS
ings. Upon the provider’s receipt of an or the temporary manager (with CMS/
official statement of deficiencies, SA approval) may direct the HHA to
HHAs are afforded the option to re- take specific corrective action to
quest an informal opportunity to dis- achieve specific outcomes within spe-
pute condition-level survey findings. cific timeframes.
(b) Failure to conduct IDR timely. Fail- Immediate jeopardy means a situation
ure of CMS or the State, as appro- in which the provider’s noncompliance
priate, to complete IDR shall not delay with one or more requirements of par-
the effective date of any enforcement ticipation has caused, or is likely to
action. cause serious injury, harm, impair-
(c) Revised statement of deficiencies as ment, or death to a patient(s).
a result of IDR. If any findings are re- New admission means an individual
vised or removed by CMS or the State who becomes a patient or is readmitted
based on IDR, the official statement of to the HHA on or after the effective
deficiencies is revised accordingly and date of a suspension of payment sanc-
any enforcement actions imposed sole- tion.
ly as a result of those cited deficiencies Per instance means a single event of
are adjusted accordingly. noncompliance identified and corrected
(d) Notification. When the survey find- through a survey, for which the statute
ings indicate a condition-level defi- authorizes CMS to impose a sanction.
ciency, CMS or the State, as appro- Plan of correction means a plan devel-
priate, must provide the agency with oped by the HHA and approved by CMS
written notification of the opportunity that is the HHA’s written response to
for participating in an IDR process at survey findings detailing corrective ac-
the time the official statement of defi- tions to cited deficiencies and specifies
ciencies is issued. The request for IDR the date by which those deficiencies
must be submitted in writing to the will be corrected.
State or CMS, must include the spe- Repeat deficiency means a condition-
cific deficiencies that are disputed, and level citation that is cited on the cur-
must be made within the same 10 cal- rent survey and is substantially the
endar day period that the HHA has for same as or similar to, a finding of a
613
§ 488.810 42 CFR Ch. IV (10–1–24 Edition)
standard-level or condition-level defi- (g) Appeals. (1) The provisions of part

ciency citation cited on the most re- 498 of this chapter apply when the HHA
cent previous standard survey or on requests a hearing on a determination
any intervening survey since the most of noncompliance leading to the impo-
recent standard survey. sition of a sanction, including termi-
Temporary management means the nation of the provider agreement.
temporary appointment by CMS or by (2) A pending hearing does not delay
a CMS authorized agent, of a sub- the effective date of a sanction, includ-
stitute manager or administrator based ing termination, against an HHA.
upon qualifications described in Sanctions continue to be in effect re-
§§ 484.105(b) and 484.115 of this chapter. gardless of the timing of any appeals
The HHA’s governing body must ensure proceedings.
that the temporary manager has au-
thority to hire, terminate or reassign § 488.815 Factors to be considered in
staff, obligate funds, alter procedures, selecting sanctions.
and manage the HHA to correct defi- CMS bases its choice of sanction or
ciencies identified in the HHA’s oper- sanctions on consideration of one or
ation. more factors that include, but are not
[77 FR 67165, Nov. 8, 2012, as amended at 82 limited to, the following:
FR 4591, Jan. 13, 2017] (a) The extent to which the defi-
ciencies pose immediate jeopardy to
§ 488.810 General provisions. patient health and safety.
(a) Purpose of sanctions. The purpose (b) The nature, incidence, manner,
of sanctions is to ensure prompt com- degree, and duration of the deficiencies
pliance with program requirements in or noncompliance.
order to protect the health and safety (c) The presence of repeat defi-
of individuals under the care of an ciencies, the HHA’s overall compliance
HHA. history and any history of repeat defi-
(b) Basis for imposition of sanctions. ciencies at either the parent or branch
When CMS chooses to apply one or location.
more sanctions specified in § 488.820, (d) The extent to which the defi-
the sanctions are applied on the basis ciencies are directly related to a fail-
of noncompliance with one or more ure to provide quality patient care.
conditions of participation found (e) The extent to which the HHA is
through a survey and may be based on part of a larger organization with per-
failure to correct previous deficiency formance problems.
findings as evidenced by repeat defi- (f) An indication of any system-wide
ciencies. failure to provide quality care.
(c) Number of sanctions. CMS may
apply one or more sanctions for each § 488.820 Available sanctions.
deficiency constituting noncompliance
or for all deficiencies constituting non- In addition to termination of the pro-
compliance. vider agreement, the following alter-
(d) Extent of sanctions imposed. When native sanctions are available:
CMS imposes a sanction, the sanction (a) Civil money penalties.
applies to the parent HHA and its re- (b) Suspension of payment for all new
spective branch offices. admissions.
(e) Plan of correction requirement. Re- (c) Temporary management of the
gardless of which sanction is applied, a HHA.
non-compliant HHA must submit a (d) Directed plan of correction, as set
plan of correction for approval by CMS. out at § 488.850.
(f) Notification requirements—(1) No- (e) Directed in-service training, as
tice. CMS provides written notification set out at § 488.855.
to the HHA of the intent to impose the
sanction. § 488.825 Action when deficiencies
(2) Date of enforcement action. The no- pose immediate jeopardy.
tice periods specified in § 488.825(b) and (a) Immediate jeopardy. If there is im-
§ 488.830(b) begin the day after the HHA mediate jeopardy to the HHA’s patient
receives the notice. health or safety—
614
(1) CMS immediately terminates the action. The requirements of the notice
HHA provider agreement in accordance are set forth in § 488.810(f) of this part.
with § 489.53 of this chapter. (c) Not meeting criteria for continuation
(2) CMS terminates the HHA provider of payment. If an HHA does not meet
agreement no later than 23 days from the criteria for continuation of pay-
the last day of the survey, if the imme- ment under § 488.860(a) of this part,
diate jeopardy has not been removed by CMS will terminate the HHA’s provider
the HHA. agreement in accordance with § 488.865
(3) In addition to a termination, CMS of this part.
may impose one or more alternative (d) Termination time frame when there
sanctions, as appropriate. is no immediate jeopardy. CMS termi-
(b) 2-day notice. Except for civil nates an HHA within 6 months of the
money penalties, for all sanctions spec- last day of the survey, if the HHA is
ified in § 488.820 that are imposed when not in compliance with the conditions
there is immediate jeopardy, notice of participation, and the terms of the
must be given at least 2 calendar days plan of correction have not been met.
before the effective date of the enforce- (e) Transfer of care. An HHA, if its
ment action. provider agreement terminated, is re-
(c) Transfer of care. An HHA, if its sponsible for providing information, as-
provider agreement terminated, is resistance, and arrangements necessary
sponsible for providing information, as- for the proper and safe transfer of pa-
sistance, and arrangements necessary tients to another local HHA within 30
for the proper and safe transfer of pa- days of termination. The State must
tients to another local HHA within 30 assist the HHA in the safe and orderly
days of termination. The State must transfer of care and services for the pa-
assist the HHA in the safe and orderly tients to another local HHA.
transfer of care and services for the pa-
tients to another local HHA. § 488.835 Temporary management.
§ 488.830 Action when deficiencies are (a) Application. (1) CMS may impose
at the condition-level but do not temporary management of an HHA if it
pose immediate jeopardy. determines that an HHA has a condi-
(a) Noncompliance. If the HHA is no tion-level noncompliance and CMS de-
longer in compliance with the condi- termines that management limitations
tions of participation, either because or the deficiencies are likely to impair
the deficiency or deficiencies substan- the HHA’s ability to correct defi-
tially limit the provider’s capacity to ciencies and return the HHA to full
furnish adequate care but do not pose compliance with the conditions of par-
immediate jeopardy, have a condition- ticipation within the timeframe re-
level deficiency or deficiencies that do quired.
not pose immediate jeopardy, or be- (2) [Reserved]
cause the HHA has repeat noncompli- (b) Procedures. (1) CMS notifies the
ance that results in a condition-level HHA that a temporary manager is
deficiency based on the HHA’s failure being appointed.
to correct and sustain compliance, (2) If the HHA fails to relinquish au-
CMS will: thority and control to the temporary
(1) Terminate the HHA’s provider manager, CMS terminates the HHA’s
agreement; or provider agreement in accordance with
(2) Impose one or more alternative § 488.865.
sanctions set forth in § 488.820(a) (c) Duration and effect of sanction.
through (f) of this part as an alter- Temporary management continues
native to termination, for a period not until—
to exceed 6 months. (1) CMS determines that the HHA has
(b) 15-day notice. Except for civil achieved substantial compliance and
money penalties, for all sanctions spec- has the management capability to en-
ified in § 488.820 imposed when there is sure continued compliance with all the
no immediate jeopardy, notice must be conditions of participation;
given at least 15 calendar days before (2) CMS terminates the provider
the effective date of the enforcement agreement; or
615
§ 488.840 42 CFR Ch. IV (10–1–24 Edition)
(3) The HHA reassumes management the right to appeal the determination
control without CMS approval. In such leading to the sanction.
case, CMS initiates termination of the (ii) The HHA may not charge a newly
provider agreement and may impose admitted HHA patient who is a Medi-
additional sanctions. care beneficiary for services for which
(4) Temporary management will not Medicare payment is suspended unless
exceed a period of 6 months from the the HHA can show that, before initi-
date of the survey identifying non- ating care, it gave the patient or his or
compliance. her representative oral and written no-
(d) Payment of salary. (1) The tem- tice of the suspension of Medicare pay-
porary manager’s salary— ment in a language and manner that
(i) Is paid directly by the HHA while the beneficiary or representative can
the temporary manager is assigned to understand.
that HHA; and (2) Restriction. (i) Suspension of pay-
(ii) Must be at least equivalent to the ment for all new admissions sanction
sum of the following: may be imposed anytime an HHA is
(A) The prevailing salary paid by profound to be out of substantial compli-
viders for positions of this type in what ance.
the State considers to be the HHA’s ge- (ii) Suspension of payment for pa-
ographic area (prevailing salary based tients with new admissions will remain
on the Geographic Guide by the De- in place until CMS determines that the
partment of Labor (BLS Wage Data by HHA has achieved substantial compli-
Area and Occupation); ance or is involuntarily terminated
(B) Any additional costs that would with the conditions of participation, as
have reasonably been incurred by the determined by CMS.
HHA if such person had been in an em- (3) Resumption of payments. Payments
ployment relationship; and to the HHA resume prospectively on
(C) Any other costs incurred by such the date that CMS determines that the
a person in furnishing services under HHA has achieved substantial compli-
such an arrangement or as otherwise ance with the conditions of participa-
set by the State. tion.
(2) An HHA’s failure to pay the salary (c) Duration and effect of sanction.
and other costs of the temporary man- This sanction ends when—
ager described in paragraph (d)(1) of
(1) CMS determines that the HHA is
this section is considered a failure to
in substantial compliance with all of
relinquish authority and control to
the conditions of participation; or
temporary management.
(2) When the HHA is terminated or
§ 488.840 Suspension of payment for CMS determines that the HHA is not in
all new patient admissions. compliance with the conditions of par-
(a) Application. (1) CMS may suspend ticipation at a maximum of 6 months
payment for all new admissions if an from the date noncompliance was de-
HHA is found to have condition-level termined.
deficiencies, regardless of whether § 488.845 Civil money penalties.
those deficiencies pose immediate jeop-
ardy. (a) Application. (1) CMS may impose a
(2) CMS will consider this sanction civil money penalty against an HHA
for any deficiency related to poor pa- for either the number of days the HHA
tient care outcomes, regardless of is not in compliance with one or more
whether the deficiency poses imme- conditions of participation or for each
diate jeopardy. instance that an HHA is not in compli-
(b) Procedures—(1) Notices. (i) Before ance, regardless of whether the HHA’s
suspending payments for new admis- deficiencies pose immediate jeopardy.
sions, CMS provides the HHA notice of (2) CMS may impose a civil money
the suspension of payment for all new penalty for the number of days of im-
admissions as set forth in § 488.810(f). mediate jeopardy.
The CMS notice of suspension will in- (3) A per-day and a per-instance CMP
clude the nature of the noncompliance; may not be imposed simultaneously for
the effective date of the sanction; and the same deficiency.
616
(b) Amount of penalty—(1) Factors con- jeopardy and that result in actual
sidered. CMS takes into account the harm.
following factors in determining the (ii) $9,000 as adjusted annually under
amount of the penalty: 45 CFR part 102 per day for a deficiency
(i) The factors set out at § 488.815. or deficiencies that are immediate
(ii) The size of an agency and its re- jeopardy and that result in a potential
sources. for harm.
(iii) Accurate and credible resources, (iii) $8,500 as adjusted annually under
such as PECOS, Medicare cost reports 45 CFR part 102 per day for an isolated
and Medicare/Medicaid claims informa- incident of noncompliance in violation
tion that provide information on the of established HHA policy.
operation and resources of the HHA. (4) Middle range of penalty. Penalties
in the range of $1,500–$8,500 as adjusted
(iv) Evidence that the HHA has a
annually under 45 CFR part 102 per day
built-in, self-regulating quality assess-
of noncompliance are imposed for a re-
ment and performance improvement
peat and/or condition-level deficiency
system to provide proper care, prevent
that does not constitute immediate
poor outcomes, control patient injury,
jeopardy, but is directly related to poor
enhance quality, promote safety, and
quality patient care outcomes.
avoid risks to patients on a sustainable
(5) Lower range of penalty. Penalties
basis that indicates the ability to meet
in this range of $500–$4,000 as adjusted
the conditions of participation and to
annually under 45 CFR part 102 are im-
ensure patient health and safety.
posed for a repeat and/or condition-
(2) Adjustments to penalties. Based on level deficiency that does not con-
revisit survey findings, adjustments to stitute immediate jeopardy and that
penalties may be made after a review are related predominately to structure
of the provider’s attempted correction or process-oriented conditions (such as
of deficiencies. OASIS submission requirements) rath-
(i) CMS may increase a CMP in incre- er than directly related to patient care
ments based on a HHA’s inability or outcomes.
failure to correct deficiencies, the pres- (6) Per instance penalty. Penalty im-
ence of a system-wide failure in the posed per instance of noncompliance
provision of quality care, or a deter- may be assessed for one or more sin-
mination of immediate jeopardy with gular events of condition-level non-
actual harm versus immediate jeop- compliance that are identified and
ardy with potential for harm. where the noncompliance was cor-
(ii) CMS may also decrease a CMP in rected during the onsite survey. When
increments to the extent that it finds, penalties are imposed for per instance
pursuant to a revisit, that substantial of noncompliance, or more than one
and sustainable improvements have per instance of noncompliance, the
been implemented even though the penalties will be in the range of $1,000
HHA is not yet in full compliance with to $10,000 as adjusted annually under 45
the conditions of participation. CFR part 102 per instance, not to ex-
(iii) No penalty assessment will exceed $10,000 as adjusted annually under
ceed $10,000 as adjusted annually under 45 CFR part 102 each day of noncompli-
45 CFR part 102 for each day of non- ance.
compliance. (7) Decreased penalty amounts. If the
(3) Upper range of penalty. Penalties immediate jeopardy situation is re-
in the upper range of $8,500 to $10,000 as moved, but condition-level noncompli-
adjusted under 45 CFR part 102 per day ance continues, CMS will shift the pen-
of noncompliance are imposed for a alty amount imposed per day from the
condition-level deficiency that is im- upper range to the middle or lower
mediate jeopardy. The penalty in this range. An earnest effort to correct any
range will continue until compliance systemic causes of deficiencies and sus-
can be determined based on a revisit tain improvement must be evident.
survey. (8) Increased penalty amounts. (i) In
(i) $10,000 as adjusted annually under accordance with paragraph (b)(2) of
45 CFR part 102 per day for a deficiency this section, CMS will increase the per
or deficiencies that are immediate day penalty amount for any condition-
617
§ 488.845 42 CFR Ch. IV (10–1–24 Edition)
level deficiency or deficiencies which, (3) Duration of per day penalty when
after imposition of a lower-level pen- there is immediate jeopardy. (i) In the
alty amount, become sufficiently seri- case of noncompliance that poses im-
ous to pose potential harm or imme- mediate jeopardy, CMS must terminate
diate jeopardy. the provider agreement within 23 cal-
(ii) CMS increases the per day pen- endar days after the last day of the
alty amount for deficiencies that are survey if the immediate jeopardy is not
not corrected and found again at the removed.
time of revisit survey(s) for which a (ii) A penalty imposed per day of non-
lower-level penalty amount was pre- compliance will stop accruing on the
viously imposed. day the provider agreement is termi-
(iii) CMS may impose a more severe nated or the HHA achieves substantial
amount of penalties for repeated noncompliance, whichever occurs first.
compliance with the same condition- (4) Duration of penalty when there is
level deficiency or uncorrected defi- no immediate jeopardy. (i) In the case of
ciencies from a prior survey. noncompliance that does not pose im-
(c) Procedures—(1) Notice of intent. mediate jeopardy, the daily accrual of
CMS provides the HHA with written per day civil money penalties is im-
notice of the intent to impose a civil posed for the days of noncompliance
money penalty. The notice includes the prior to the notice specified in para-
amount of the CMP being imposed, the graph (c)(1) of this section and an addi-
basis for such imposition and the pro- tional period of no longer than 6
posed effective date of the sanction. months following the last day of the
(2) Appeals—(i) Appeals procedures. An survey.
HHA may request a hearing on the de- (ii) If the HHA has not achieved com-
termination of the noncompliance that pliance with the conditions of partici-
is the basis for imposition of the civil pation, CMS terminates the provider
money penalty. The request must meet agreement. The accrual of civil money
the requirements in § 498.40 of this penalty stops on the day the HHA
chapter. agreement is terminated or the HHA
(ii) Waiver of a hearing. An HHA may achieves substantial compliance,
waive the right to a hearing, in writ- whichever is earlier.
ing, within 60 days from the date of the (e) Computation and notice of total pen-
notice imposing the civil money penalty amount. (1) When a civil money
alty. If an HHA timely waives its right penalty is imposed on a per day basis
to a hearing, CMS reduces the penalty and the HHA achieves compliance with
amount by 35 percent, and the amount the conditions of participation as de-
is due within 15 days of the HHAs termined by a revisit survey, CMS
agreeing in writing to waive the hear- sends a final notice to the HHA con-
ing. If the HHA does not waive its right taining all of the following informa-
to a hearing in accordance to the pro- tion:
cedures specified in this subsection, the (i) The amount of penalty assessed
civil money penalty is not reduced by per day.
35 percent. (ii) The total number of days of non-
(d) Accrual and duration of penalty. compliance.
(1)(i) The per day civil money penalty (iii) The total amount due.
may start accruing as early as the be- (iv) The due date of the penalty.
ginning of the last day of the survey (v) The rate of interest to be assessed
that determines that the HHA was out on any unpaid balance beginning on
of compliance, as determined by CMS. the due date, as provided in paragraph
(ii) A civil money penalty for each (f)(4) of this section.
per instance of noncompliance is im- (2) When a civil money penalty is im-
posed in a specific amount for that par- posed for per instance of noncompli-
ticular deficiency, with a maximum of ance, CMS sends a notice to the HHA
$10,000 as adjusted annually under 45 containing all of the following infor-
CFR part 102 per day per HHA. mation:
(2) A penalty that is imposed per day (i) The amount of the penalty that
and per instance of noncompliance may was assessed.
not be imposed simultaneously. (ii) The total amount due.
618
(iii) The due date of the penalty. (ii) The effective date of termination
(iv) The rate of interest to be as- occurs before CMS received the written
sessed on any unpaid balance beginning waiver of hearing.
on the due date, as provided in para- (4) The period of noncompliance may
graph (f)(6) of this section. not extend beyond 6 months from the
(3) In the case of an HHA for which last day of the survey.
the provider agreement has been invol- (5) The amount of the penalty, when
untarily terminated and for which a determined, may be deducted (offset)
civil money penalty was imposed on a from any sum then or later owing by
per day basis, CMS sends this penalty CMS or State Medicaid to the HHA.
information after one of the following (6) Interest is assessed and accrues on
actions has occurred: the unpaid balance of a penalty, begin-
(i) Final administrative decision is ning on the due date. Interest is com-
made. puted at the rate specified in § 405.378(d)
(ii) The HHA has waived its right to of this chapter.
a hearing in accordance with paragraph (g) Penalties collected by CMS—(1) Dis-
(c)(2)(ii) of this section. bursement of CMPs. Civil money pen-
(iii) Time for requesting a hearing alties and any corresponding interest
has expired and CMS has not received a collected by CMS from Medicare and
hearing request from the HHA. Medicaid participating HHAs are dis-
(f) Due date for payment of penalty. A bursed in proportion to average dollars
penalty is due and payable 15 days from spent by Medicare and Medicaid at the
notice of the final administrative deci- national level based on MSIS and HHA
sion. PPS data for a three year fiscal period.
(1) Payments are due for all civil (i) Based on expenditures for the FY
2007–2009 period, the initial proportions
money penalties within 15 days:
to be disbursed are 63 percent returned
(i) After a final administrative deci-
to the U.S. Treasury and 37 percent re-
sion when the HHA achieves substan- turned to the State Medicaid agency.
tial compliance before the final deci-
(ii) Beginning one year after the ef-
sion or the effective date of termi-
fective date of this section, CMS shall
nation before final decision,
annually update these proportions
(ii) After the time to appeal has ex- based on the most recent 3-year fiscal
pired and the HHA does not appeal or period, prior to the year in which the
fails to timely appeal the initial deter- CMP is imposed, for which CMS deter-
mination, mines that the relevant data are essen-
(iii) After CMS receives a written re- tially complete.
quest from the HHA requesting to (iii) The portion corresponding to the
waive its right to appeal the deter- Medicare payments is returned to the
minations that led to the imposition of U.S. Department of Treasury as mis-
a sanction, cellaneous receipts.
(iv) After substantial compliance is (iv) The portion corresponding to the
achieved, or Medicaid payments is returned to the
(v) After the effective date of termi- State Medicaid agency.
nation. (2) Penalties may not be used for Sur-
(2) A request for hearing does not vey and Certification operations nor as
delay the imposition of any penalty; it the State’s Medicaid non-Federal med-
only potentially delays the collection ical assistance or administrative
of the final penalty amount. match.
(3) If an HHA waives its right to a (h) Review of the penalty. When an ad-
hearing according to paragraph ministrative law judge or state hearing
(c)(2)(ii) of this section, CMS will apply officer (or higher administrative re-
a 35 percent reduction to the CMP view authority) finds that the basis for
amount when: imposing a civil monetary penalty ex-
(i) The HHA achieved compliance ists, as specified in this part, the ad-
with the conditions of participation be- ministrative law judge, State hearing
fore CMS received the written waiver officer (or higher administrative re-
of hearing; or view authority) may not—
619
§ 488.850 42 CFR Ch. IV (10–1–24 Edition)
(1) Set a penalty of zero or reduce a (b) Procedures—(1) Action following

penalty to zero; training. After the HHA staff has re-
(2) Review the exercise of discretion ceived in-service training, if the HHA
by CMS to impose a civil monetary has not achieved compliance, CMS may
penalty; and impose one or more other sanctions
(3) Consider any factors in reviewing specified in § 488.820.
the amount of the penalty other than (2) Payment. The HHA pays for the di-
those specified in paragraph (b) of this rected in-service training for its staff.
section.
[77 FR 67165, Nov. 8, 2012, as amended at 79 § 488.860 Continuation of payments to
FR 66118, Nov. 6, 2014; 81 FR 61563, Sept. 6, an HHA with deficiencies.
2016] (a) Continued payments. CMS may
continue payments to an HHA with
§ 488.850 Directed plan of correction. condition-level deficiencies that do not
(a) Application. CMS may impose a di- constitute immediate jeopardy for up
rected plan of correction when an HHA: to 6 months from the last day of the
(1) Has one or more deficiencies that survey if the criteria in paragraph
warrant directing the HHA to take spe- (a)(1) of this section are met.
cific actions; or (1) Criteria. CMS may continue pay-
(2) Fails to submit an acceptable plan ments to an HHA not in compliance
of correction. with the conditions of participation for
(b) Procedures. (1) Before imposing the period specified in paragraph (a) of
this sanction, CMS provides the HHA this section if all of the following cri-
notice of the impending sanction. teria are met:
(2) CMS or the temporary manager (i) The HHA has been imposed an al-
(with CMS approval) may direct the ternative sanction or sanctions and
HHA to take corrective action to termination has not been imposed.
achieve specific outcomes within spe-
(ii) The HHA has submitted a plan of
cific timeframes.
correction approved by CMS.
(c) Duration and effect of sanction. If
(iii) The HHA agrees to repay the
the HHA fails to achieve compliance
with the conditions of participation Federal government payments received
within the timeframes specified in the under this provision if corrective ac-
directed plan of correction, CMS: tion is not taken in accordance with
(1) May impose one or more other the approved plan and timetable for
sanctions set forth in § 488.820; or corrective action.
(2) Terminates the provider agree- (2) CMS may terminate the HHA’s
ment. provider agreement any time if the cri-
teria in paragraph (a)(1) of this section
§ 488.855 Directed in-service training. are not met.
(a) Application. CMS may require the (b) Cessation of payments for new ad-
staff of an HHA to attend in-service missions. If termination is imposed, ei-
training program(s) if CMS determines ther on its own or in addition to an al-
that— ternative sanction or sanctions, or if
(1) The HHA has deficiencies that in- any of the criteria set forth in para-
dicate noncompliance; graph (a)(1) of this section are not met,
(2) Education is likely to correct the the HHA will receive no Medicare pay-
deficiencies; and ments, as applicable, for new admis-
(3) The programs are conducted by sions following the last day of the sur-
established centers of health education vey.
and training or consultants with back- (c) Failure to achieve compliance with
ground in education and training with the conditions of participation. If the
Medicare Home Health Providers, or as HHA does not achieve compliance with
deemed acceptable by CMS and/or the the conditions of participation by the
State (by review of a copy of cur- end of the period specified in paragraph
riculum vitas and/or resumes/ref- (a) of this section, CMS will terminate
erences to determine the educator’s the provider agreement of the HHA in
qualifications). accordance with § 488.865.
620
§ 488.865 Termination of provider (2) Section 1834(u)(5) of the Act re-

agreement. quire the Secretary to designate and
(a) Effect of termination by CMS. Ter- approve independent organizations for
mination of the provider agreement the purposes of accrediting qualified
ends— home infusion therapy suppliers.
(1) Payment to the HHA; and (c) Scope. This subpart sets forth the
(2) Any alternative sanction(s). following:
(b) Basis for termination. CMS termi- (1) Application and reapplication pro-
nates an HHA’s provider agreement cedures for national accrediting orga-
under any one of the following condi- nizations seeking approval or re-ap-
tions— proval of authority to accredit quali-
(1) The HHA is not in compliance fied home infusion therapy suppliers.
with the conditions of participation. (2) Ongoing CMS oversight processes
(2) The HHA fails to submit an ac- for approved accrediting organizations
ceptable plan of correction within the that accredit qualified home infusion
timeframe specified by CMS. therapy suppliers.
(3) Appeal procedures for accrediting
(3) The HHA fails to relinquish con-
organizations that accredit qualified
trol to the temporary manager, if that
home infusion therapy suppliers.
sanction is imposed by CMS.
(4) The HHA fails to meet the eligi- § 488.1005 Definitions.
bility criteria for continuation of pay-
ment as set forth in § 488.860(a)(1). As used in this subpart—
(c) Notice. CMS notifies the HHA and Immediate jeopardy means a situation
the public of the termination, in ac- in which the provider’s or supplier’s
cordance with procedures set forth in non-compliance with one or more
§ 489.53 of this chapter. Medicare accreditation requirements
(d) Procedures for termination. CMS has caused, or is likely to cause, seri-
terminates the provider agreement in ous injury, harm, impairment, or death
accordance with procedures set forth in to a patient.
§ 489.53 of this chapter. National accrediting organization
(e) Appeal. An HHA may appeal the means an organization that accredits
termination of its provider agreement provider or supplier entities under a
by CMS in accordance with part 498 of specific program and whose accredited
this chapter. provider or supplier entities under each
program are widely dispersed geo-
graphically across the United States.
Subpart K—[Reserved] In addition, the specific program is ac-
tive, fully implemented, and oper-
Subpart L—Accreditation of Home ational.
Infusion Therapy Suppliers National in scope means a program is
fully implemented, operational, and
SOURCE: 83 FR 56631, Nov. 13, 2018, unless widely dispersed geographically
otherwise noted. throughout the country.
Qualified home infusion therapy sup-
GENERAL PROVISIONS plier means a supplier of home infusion
therapy that meets the all of the fol-
§ 488.1000 Basis and scope. lowing criteria which are set forth at
(a) Regulatory basis for home infusion section 1861(iii)(3)(D)(i) of the Act:
therapy services. The home infusion (1) Furnishes infusion therapy to in-
therapy health and safety regulations dividuals with acute or chronic condi-
are codified at part 486, subpart I, of tions requiring administration of home
this chapter. infusion drugs.
(b) Statutory basis for the accreditation (2) Ensures the safe and effective pro-
of home infusion therapy suppliers. (1) vision and administration of home in-
Sections 1102 and 1871 of the Act re- fusion therapy on a 7-day-a-week, 24-
quire that the Secretary prescribe such hour-a-day basis.
regulations as may be necessary to (3) Is accredited by an organization
carry out the administration of the designated by the Secretary in accord-
Medicare program. ance with section 1834(u)(5) of the Act.
621
§ 488.1010 42 CFR Ch. IV (10–1–24 Edition)
(4) Meets such other requirements as (4) Information that demonstrates

the Secretary determines appropriate. the home infusion therapy accrediting
Reasonable assurance means an ac- organization’s knowledge, expertise,
crediting organization has dem- and experience in home infusion ther-
onstrated to CMS’ satisfaction that its apy.
accreditation program requirements (5) A detailed crosswalk (in table for-
meet or exceed the Medicare program mat) that identifies, for each of the ap-
requirements. plicable Medicare requirements, the
Rural area as defined at section exact language of the organization’s
1886(d)(2)(D) of the Act. comparable accreditation requirements
Substantial allegation of non-compli- and standards.
ance means a complaint from any of a (6) A detailed description of the home
variety of sources (such as patient, rel- infusion therapy accrediting organiza-
ative, or third party), including com- tion’s survey processes to confirm that
plaints submitted in person, by tele- a home infusion therapy supplier’s
phone, through written correspond- processes are comparable to those of
ence, or in the newspaper, magazine ar- Medicare. This description must in-
ticles or other media, that would, if clude all of the following:
found to be present, adversely affect (i) The types and frequency of sur-
the health and safety of patients and veys performed, and a rationale for
raises doubts as to a qualified home in- which accreditation requirements will
fusion therapy supplier’s compliance be evaluated via onsite surveys and
with the applicable Medicare accredita- which will be evaluated via offsite au-
tion requirements. dits, or other strategies for ensuring
accredited home infusion therapy sup-
APPROVAL AND OVERSIGHT OF HOME IN-
pliers maintain adherence to the home
FUSION THERAPY SUPPLIER ACCRED-
infusion therapy accreditation program
ITING ORGANIZATIONS
requirements, including an explanation
§ 488.1010 Application and reapplica- of how the accrediting organization
tion procedures for national home will maintain the schedule it proposes.
infusion therapy accrediting orga- (ii) Copies of the home infusion ther-
nizations. apy accrediting organizations survey
(a) Information submitted with applica- and audit forms, guidelines, and in-
tion. A national home infusion therapy structions to surveyors.
accrediting organization applying to (iii) Documentation demonstrating
CMS for approval or re-approval of a that the home infusion therapy accred-
designated home infusion therapy ac- iting organization’s onsite survey or
creditation program must furnish CMS offsite audit reports identify, for each
with information and materials that finding of non-compliance with accred-
demonstrate that its home infusion itation standards, the comparable
therapy accreditation program require- Medicare home infusion therapy ac-
ments meet or exceed the applicable creditation requirements, as applica-
Medicare requirements for accrediting ble.
organizations, including the following: (iv) A description of the home infu-
(1) Documentation that demonstrates sion therapy accrediting organization’s
the organization meets the definition accreditation survey review process.
of a national accrediting organization (v) A description of the home infu-
under § 488.1005 as it relates to the ac- sion therapy accrediting organization’s
creditation program. procedures and timelines for notifying
(2) The Medicare provider or supplier a surveyed or audited home infusion
type for which the organization is re- therapy supplier of non-compliance
questing approval or reapproval. with the home infusion therapy accred-
(3) Documentation that demonstrates itation program’s standards.
the home infusion therapy accrediting (vi) A description of the home infu-
organization’s ability to take into ac- sion therapy accrediting organization’s
count the capacities of rural home in- procedures and timelines for moni-
fusion therapy suppliers (as required by toring the home infusion therapy sup-
section 1834(u)(5)(A)(ii) of the Act). plier’s correction of identified non-
622
compliance with the accreditation pro- tions to be surveyed using an onsite

gram’s standards. survey.
(vii) The ability of the home infusion (ii) The number of home infusion
therapy accrediting organization to therapy suppliers to be surveyed using
conduct timely reviews of accredita- off-site audits.
tion applications. (iii) A description of other types of
(viii) A statement acknowledging home infusion therapy accreditation
that, as a condition for CMS approval review activities to be used.
of a national accrediting organization’s (iv) The reasons for each type of sur-
accreditation program, the home infu- vey (that is, initial accreditation sur-
sion therapy accrediting organization vey, reaccreditation survey, and com-
agrees to provide CMS with informa- plaint survey).
tion extracted from each home infusion (9) The overall adequacy of the num-
therapy accreditation onsite survey, ber of the home infusion therapy ac-
offsite audit or other evaluation strate- crediting organization’s surveyors,
gies as part of its data submissions re- auditors, and other staff available to
quired under paragraph (a)(19) of this perform survey related activities, in-
section, and, upon request from CMS, a cluding how the organization will in-
copy of the most recent accreditation crease the size of the survey, audit, and
onsite survey, offsite audit, or other other evaluation staff to match growth
evaluation strategy together with any in the number of accredited facilities
other information related to the survey or programs while maintaining re-ac-
as CMS may require (including correc- creditation intervals for existing ac-
tive action plans). credited facilities or programs.
(ix) A statement acknowledging that
(10) Detailed information about the
the home infusion therapy accrediting
individuals who perform onsite sur-
organization will provide timely notifi-
veys, offsite audits or other strategies
cation to CMS when an accreditation
for ensuring accredited home infusion
survey or complaint investigation iden-
therapy suppliers maintain adherence
tifies an immediate jeopardy as that
to the home infusion therapy accredi-
term is defined at § 488.1005. Using the
tation program requirements, includ-
format specified by CMS, the home in-
ing all of the following information:
fusion therapy accrediting organiza-
(i) The number and types of profes-
tion must notify CMS within 2 business
sional and technical staff available for
days from the date the accrediting or-
conducting onsite surveys, offsite au-
ganization identifies the immediate
dits, or other strategies for ensuring
jeopardy.
accredited home infusion therapy sup-
(7) Procedures to ensure that—
pliers maintain adherence to the home
(i) Unannounced onsite surveys, as
infusion therapy accreditation program
appropriate, will be conducted periodi-
requirements.
cally, including procedures that pro-
tect against unannounced surveys be- (ii) The education, employment, and
coming known to the provider or sup- experience requirements surveyors and
plier in advance of the visit; or auditors must meet.
(ii) Offsite survey audits are per- (iii) The content and length of the
formed to evaluate the quality of serv- orientation program.
ices provided which may be followed up (11) The content, frequency and types
with periodic onsite visits. of in-service training provided to sur-
(8) The criteria for determining the vey and audit personnel.
size and composition of the home infu- (12) The evaluation systems used to
sion therapy accrediting organization’s monitor the performance of individual
survey, audit and other evaluation surveyors, auditors and survey teams.
strategy teams for individual supplier (13) The home infusion therapy ac-
onsite surveys. The home infusion crediting organization’s policies and
therapy accrediting organization’s cri- procedures to avoid conflicts of inter-
teria should include, but not be limited est, including the appearance of con-
to the following information: flicts of interest, involving individuals
(i) The expected number of individual who conduct surveys, audits or partici-
home infusion therapy supplier loca- pate in accreditation decisions.
623
§ 488.1010 42 CFR Ch. IV (10–1–24 Edition)
(14) The policies and procedures used (18) A list of all currently accredited
when a home infusion therapy supplier home infusion therapy suppliers, the
has a dispute regarding survey or audit type and category of accreditation,
findings, or an adverse decision. currently held by each, and the expira-
(15) Procedures for the home infusion tion date for each home infusion ther-
therapy supplier to use to notify the apy supplier’s current accreditation.
home infusion therapy accrediting or- (19) A schedule of all survey activity
ganization when the accredited home (such as onsite surveys, offsite audits
infusion therapy supplier does the ei- and other types if survey strategies)
ther of the following: expected to be conducted by the orga-
(i) Removes or ceases furnishing serv- nization during the 6-month period fol-
ices for which they are accredited. lowing submission of an initial or re-
(ii) Adds services for which they are newal application.
not accredited. (20) A written presentation that dem-
(16) The home infusion therapy ac- onstrates the organization’s ability to
crediting organization’s procedures for furnish CMS with electronic data.
responding to, and investigating com- (21) A description of the home infu-
plaints against accredited facilities, in- sion therapy accrediting organization’s
cluding policies and procedures regard- data management and analysis system
ing referrals, when applicable, to ap- with respect to its surveys and accredi-
propriate licensing bodies, ombudsmen tation decisions, including all of the
offices, and CMS. following:
(17) A description of the home infu- (i) A detailed description of how the
sion therapy accrediting organization’s home infusion therapy accrediting or-
accreditation status decision-making ganization uses its data to assure the
process. The home infusion therapy ac- compliance of its home infusion ther-
crediting organization must furnish apy accreditation program with the
the following: Medicare home infusion therapy ac-
(i) Its process for addressing defi- creditation program requirements.
ciencies identified with accreditation (ii) A written statement acknowl-
program requirements, and the proce- edging that the home infusion therapy
dures used to monitor the correction of accrediting organization agrees to sub-
deficiencies identified during an ac- mit timely, accurate, and complete
creditation survey and audit process. data that CMS has determined is both
(ii) A description of all types and cat- necessary to evaluate the accrediting
egories of accreditation decisions asso- organization’s performance and is not
ciated with the program, including the unduly burdensome for the accrediting
duration of each of the organization’s organization to submit.
accreditation decisions. (A) The organization must submit
(iii) Its policies and procedures for necessary data according to the in-
the granting, withholding or removal structions and timeframes CMS speci-
of accreditation status for facilities fies.
that fail to meet the accrediting orga- (B) Data to be submitted includes the
nization’s standards or requirements, following:
assignment of less than full accredita- (1) Accredited home infusion therapy
tion status or other actions taken by supplier identifying information.
the organization in response to non- (2) Survey findings.
compliance with its standards and re- (3) Quality measures.
quirements. (4) Notices of accreditation decisions.
(iv) A statement acknowledging that (22) The three most recent annual au-
the home infusion therapy accrediting dited financial statements of the home
organization agrees to notify CMS (in a infusion therapy accrediting organiza-
manner CMS specifies) of any decision tion that demonstrate that the organi-
to revoke, terminate, or revise the ac- zation’s staffing, funding, and other re-
creditation status of a home infusion sources are adequate to perform the re-
therapy supplier, within 3 business quired surveys, audits, and related ac-
days from the date the organization tivities to maintain the accreditation
takes an action. program.
624
(23) A written statement acknowl- (D) Withdrawals.

edging that, as a condition for ap- (E) Denials.
proval, the home infusion therapy ac- (F) Accreditation decisions.
crediting organization agrees to the (G) Other survey-related activities as
following: specified by CMS.
(i) Voluntary termination. Provide (iv) Termination of an accreditation or-
written notification to CMS and all ganization. If CMS terminates a home
home infusion therapy suppliers ac- infusion therapy accrediting organiza-
credited under its CMS-approved home tion’s approved status, the home infu-
infusion therapy accreditation program sion therapy accrediting organization
at least 180 calendar days in advance of must work collaboratively with CMS
the effective date of a decision by the to direct its accredited home infusion
home infusion therapy accrediting or- therapy suppliers to the remaining
ganization to voluntarily terminate its
CMS-approved accrediting organiza-
CMS-approved home infusion therapy
tions within a reasonable period of
accreditation program and the implica-
time.
tions for the suppliers’ payment status
once their current term of accredita- (v) Notification of proposed changes.
tion expires in accordance with the re- Notify CMS at least 60 days in advance
quirements at § 488.1045(a). of the implementation date of any sig-
(ii) Involuntary termination. Provide nificant proposed changes in its CMS-
written notification to all accredited approved home infusion therapy ac-
home infusion therapy suppliers accreditation program and that it agrees
credited under its CMS-approved home not to implement the proposed changes
infusion therapy accreditation program without prior written notice of contin-
no later than 30 calendar days after the ued program approval from CMS, ex-
notice is published in the FEDERAL cept as provided for at § 488.1040(b)(2).
REGISTER announcing that CMS is (vi) Response to a written notice from
withdrawing its approval of its accredi- CMS. A statement acknowledging that,
tation program and the implications in response to a written notice from
for the home infusion therapy sup- CMS to the home infusion therapy ac-
plier’s payment status in accordance crediting organization of a change in
with the requirements at § 488.1045(b) the applicable home infusion therapy
once their current term of accredita- accreditation requirements or survey
tion expires. process, the organization will provide
(A) For both voluntary and involun- CMS with proposed corresponding
tary terminations, provide a second changes in the accrediting organiza-
written notification to all accredited tion’s home infusion therapy accredita-
home infusion therapy suppliers 10 cal- tion requirements for its CMS-ap-
endar days prior to the organization’s proved home infusion therapy accredi-
accreditation program effective date of tation program to ensure that its ac-
termination. creditation standards continue to meet
(B) Notify CMS, in writing (electroni- or exceed those of Medicare, or survey
cally or hard copy), within 2 business process remains comparable with that
days of a deficiency identified in any of Medicare. The home infusion ther-
accredited home infusion therapy sup- apy accrediting organization must
plier from any source where the defi- comply with the following require-
ciency poses an immediate jeopardy to ments:
the home infusion therapy supplier’s (A) The proposed changes must be
beneficiaries or a hazard to the general submitted within 30 calendar days of
public. the date of the written CMS notice to
(iii) Summary accreditation activity the home infusion therapy accrediting
data and trends. Provide, on an annual organization or by a date specified in
basis, summary accreditation activity the notice, whichever is later. CMS
data and trends including the fol- gives due consideration to a home infu-
lowing: sion therapy accrediting organization’s
(A) Deficiencies. request for an extension of the deadline
(B) Complaints. as long as it is submitted prior to the
(C) Terminations. due date.
625
§ 488.1015 42 CFR Ch. IV (10–1–24 Edition)
(B) The proposed changes are not to cation, may resubmit its application if
be implemented without prior written the home infusion therapy accrediting
notice of continued program approval organization satisfies all of the fol-
from CMS, except as provided for at lowing requirements:
§ 488.1040(b)(2)(ii). (1) Revises its home infusion therapy
(24) The organization’s proposed fees accreditation program to address the
for accreditation, including any plans issues related to the denial of its pre-
for reducing the burden and cost of ac- vious request or its voluntary with-
creditation to small and rural sup- drawal.
pliers. (2) Resubmits the application in its
(b) Additional information needed. If entirety.
CMS determines that additional infor- (b) If a home infusion therapy accred-
mation is necessary to make a deter- iting organization has requested, in ac-
mination for approval or denial of the cordance with § 488.1050, a reconsider-
home infusion therapy accrediting or- ation of CMS’s disapproval, it may not
ganization’s initial application or resubmit a new application for approval
application for CMS-approval of an ac- of a home infusion therapy accredita-
creditation program, CMS requires tion program until such reconsider-
that the home infusion therapy accred- ation is administratively final.
iting organization s submit any spe-
cific documentation requirements and § 488.1020 Public notice and comment.
attestations as a condition of approval CMS publishes a notice in the FED-
of accreditation status. CMS notifies ERAL REGISTER when the following con-
the home infusion therapy accrediting ditions are met:
organization and afford it an oppor- (a) Proposed notice. CMS publishes a
tunity to provide the additional infor- notice after the receipt of a completed
mation. application from a national home infu-
(c) Withdrawing an application. A sion therapy accrediting organization
home infusion therapy accrediting or- seeking CMS’s approval of a home infu-
ganization may withdraw its initial ap- sion therapy accreditation program.
plication for CMS’ approval of its home The notice identifies the home infusion
infusion therapy accreditation program therapy accrediting organization, the
at any time before CMS publishes the type of suppliers covered by the home
final notice described in § 488.1025(b). infusion therapy accreditation pro-
(d) Notice of approval or disapproval of gram, and provides at least a 30 day
application. CMS sends a notice of its public comment period (beginning on
decision to approve or disapprove the the date of publication).
home infusion therapy accrediting or- (b) Final notice. The final notice an-
ganization’s application within 210 cal- nounces CMS decision to approve or
endar days from the date CMS deter- deny a national accrediting organiza-
mines the home infusion therapy action application. The notice specifies
crediting organization’s application is the basis for the CMS decision.
complete. The final notice specifies the (1) Approval or re-approval. If CMS ap-
following: proves or re-approves the home infu-
(1) The basis for the decision. sion therapy accrediting organization’s
(2) The effective date. home infusion therapy accreditation
(3) The term of the approval (not ex- program, the final notice at a min-
ceed 6 years). imum includes the following informa-
tion:
§ 488.1015 Resubmitting a request for (i) A description of how the home in-
reapproval. fusion therapy accreditation program
(a) Except as provided in paragraph meets or exceeds Medicare home infu-
(b) of this section, a home infusion sion therapy accreditation program re-
therapy accrediting organization whose quirements.
request for CMS’s approval or re-ap- (ii) The effective date of approval (no
proval of an accreditation program has later than the publication date of the
been denied, or a home infusion ther- notice).
apy accrediting organization that has (iii) The term of the approval (6 years
voluntarily withdrawn an initial appli- or less).
626
(2) Denial. If CMS does not approve therapy accrediting organization’s

the home infusion therapy accrediting CMS-approved program requirements
organization’s accreditation program, with the comparable Medicare home
the final notice describes the following: infusion therapy accreditation require-
(i) How the home infusion therapy ments after CMS imposes new or re-
accrediting organization fails to meet vised Medicare accreditation require-
Medicare home infusion therapy ac- ments. When this occurs, the following
creditation program requirements. takes place:
(ii) The effective date of the decision. (1) CMS provides the home infusion
therapy accrediting organizations with
§ 488.1025 Release and use of home in-
fusion therapy accreditation sur- written notice of the changes to the to
veys. the Medicare home infusion therapy
accreditation requirements.
The home infusion therapy accred-
iting organization must include, in its (2) The home infusion therapy ac-
accreditation agreement with each crediting organization must make revi-
supplier, an acknowledgement that the sions to its home infusion therapy ac-
supplier agrees to release to CMS a creditation standards or survey proc-
copy of its most current accreditation esses which incorporate the new or re-
survey and any information related to vised Medicare accreditation require-
the survey that CMS may require, cor- ments.
rective action plans. (3) In the written notice, CMS speci-
(a) CMS may determine that a home fies the deadline (no less than 30 cal-
infusion therapy supplier does not endar days) by which the home infu-
meet the applicable Medicare condi- sion therapy accrediting organization
tions or requirements on the basis of must submit its proposed revised home
its own investigation of the accredita- infusion therapy accreditation stand-
tion survey or any other information ard or survey process revisions, and the
related to the survey. timeframe(s) for implementation of
(b) With the exception of home these revised home infusion therapy
health agency surveys, general disclo- accreditation standards.
sure of an accrediting organization’s (4) CMS may extend the submission
survey information is prohibited under deadline by which the accrediting orga-
section 1865(b) of the Act. CMS may nization must submit its proposed re-
publically disclose an accreditation vised home infusion therapy accredita-
survey and information related to the tion standards and survey processes, if
survey, upon written request, to the both of the following occur:
extent that the accreditation survey (i) The accrediting organization sub-
and survey information are related to mits a written request for an extension
an enforcement action taken by CMS. of the submission deadline.
§ 488.1030 Ongoing review of home in- (ii) The request for extension is sub-
fusion therapy accrediting organi- mitted prior to the original submission
zations. deadline.
(a) Performance review. CMS evaluates (5) After completing the com-
the performance of each CMS-approved parability review of the home infusion
home infusion therapy accreditation therapy accrediting organizations re-
program on an ongoing basis. This revised home infusion therapy accredita-
view includes the review of the fol- tion standards and survey processes,
lowing: CMS shall provide written notification
(1) The home infusion therapy ac- to the home infusion therapy accred-
crediting organization’s survey activ- iting organization regarding whether
ity. or not its home infusion therapy ac-
(2) The home infusion therapy accreditation program, including the pro-
crediting organization’s continued ful- posed revised home infusion therapy
fillment of the requirements at accreditation standards and implemen-
§§ 488.1010 and 488.1035. tation timeframe(s), continues to meet
(b) Comparability review. CMS assesses or exceed all applicable Medicare re-
the equivalency of a home infusion quirements.
627
§ 488.1030 42 CFR Ch. IV (10–1–24 Edition)
(6) If, no later than 60 calendar days ganization’s home infusion therapy ac-
after receipt of the home infusion ther- creditation standards, requirements
apy accrediting organization’s pro- and survey processes.
posed changes, CMS does not provide (ii) A detailed crosswalk (in table for-
the written notice to the home infusion mat) that states the exact language of
therapy accrediting organization re- the organization’s revised accredita-
quired, then the revised home infusion tion requirements and the applicable
therapy accreditation standards and Medicare requirements for each.
program is deemed to meet or exceed (4) CMS must provide a written no-
all applicable Medicare requirements tice to the home infusion therapy ac-
and to have continued CMS-approval. crediting organization which states
(7) If a home infusion therapy accred-
whether the home infusion therapy ac-
iting organization is required to sub-
creditation program, including the pro-
mit a new application because CMS im-
posed revisions, continues or does not
poses new home infusion therapy regu-
lations or makes significant sub- continue to meet or exceed all applica-
stantive revisions to the existing home ble Medicare home infusion therapy re-
infusion therapy regulations, CMS pro- quirements within 60 days of receipt of
vides notice of the decision to approve the home infusion therapy accrediting
or disapprove the new application sub- organization’s proposed changes. If
mitted by the home infusion therapy CMS has made a finding that the home
accrediting organization within the infusion therapy accrediting organiza-
time period specified in § 488.1010(d). tion’s home infusion therapy accredita-
(8) If a home infusion therapy accred- tion program, accreditation require-
iting organization fails to submit its ments and survey processes, including
proposed changes to its home infusion the proposed revisions does not con-
therapy accreditation standards and tinue to meet or exceed all applicable
survey processes within the required Medicare home infusion therapy re-
timeframe, or fails to implement the quirements. CMS must state the rea-
proposed changes that have been deter- sons for these findings.
mined or deemed by CMS to be com- (5) If, no later than 60 calendar days
parable, CMS may open an accredita- after receipt of the home infusion ther-
tion program review in accordance apy accrediting organization’s pro-
with paragraph (d) of this section. posed changes, CMS does not provide
(c) Review of revised home infusion written notice to the home infusion
therapy accreditation standards submitted therapy accrediting organization that
to CMS by an accrediting organization. the home infusion therapy accredita-
When a home infusion therapy accred- tion program, including the proposed
iting organization proposes to adopt revisions, continues or does not con-
new or revised accreditation standards, tinue to meet or exceed all applicable
requirements or changes in its survey
Medicare home infusion therapy re-
process, the home infusion therapy ac-
quirements, then the revised home in-
crediting organization must do the fol-
fusion therapy accreditation program
lowing:
(1) Provide CMS with written notice is deemed to meet or exceed all appli-
of any proposed changes in home infu- cable Medicare home infusion therapy
sion therapy accreditation standards, requirements and to have continued
requirements or survey process at least CMS approval.
60 days prior to the proposed imple- (6) If a home infusion therapy accred-
mentation date of the proposed iting organization implements changes
changes. that have neither been determined nor
(2) Not implement any of the pro- deemed by CMS to be comparable to
posed changes before receiving CMS’s the applicable Medicare home infusion
approval, except as provided in para- therapy requirements, CMS may open a
graph (c)(4) of this section. home infusion therapy accreditation
(3) Provide written notice to CMS program review in accordance with
that includes all of the following: paragraph (d) of this section.
(i) A detailed description of the (d) CMS-approved home infusion ther-
changes that are to be made to the or- apy accreditation program review. If a
628
comparability, performance, or stand- (4) If CMS determines, as a result of

ards review reveals evidence of sub- the home infusion therapy accredita-
stantial non-compliance of a home in- tion program review or a review of an
fusion therapy accrediting organiza- application for renewal of the accred-
tion’s CMS-approved home infusion iting organizations existing CMS-ap-
therapy accreditation program with proved home infusion therapy accredi-
the requirements of this subpart, CMS tation program, that the home infusion
may initiate a home infusion therapy therapy accrediting organization has
accreditation program review. failed to meet any of the requirements
(1) If a home infusion therapy accred- of this subpart, CMS may place the
itation program review is initiated, home infusion therapy accrediting or-
CMS will provide written notice to the ganization’s CMS-approved home infu-
home infusion therapy accrediting or- sion therapy accreditation program on
ganization indicating that its CMS-ap- an additional probation period of up to
proved accreditation program approval 180 calendar days subsequent to the
may be in jeopardy and that a home in- 180-day probation period described in
fusion therapy accreditation program paragraph (d)(1)(v) of this section to
review is being initiated. The notice implement additional corrective ac-
will provide all of the following infor- tions or demonstrate sustained compli-
mation: ance, not to exceed the home infusion
(i) A statement of the instances, therapy accrediting organization’s cur-
rates or patterns of non-compliance rent term of approval. In the case of a
identified, as well as other related in- renewal application where CMS has al-
formation, if applicable. ready placed the home infusion therapy
(ii) A description of the process to be accreditation program on probation,
followed during the review, including a CMS indicates that any approval of the
description of the opportunities for the application is conditional while the
home infusion therapy accrediting or- program is placed on probation.
ganization to offer factual information
(i) Within 60 calendar days after the
related to CMS’ findings.
end of any probationary period, CMS
(iii) A description of the possible ac-
issues a written determination to the
tions that may be imposed by CMS
home infusion therapy accrediting or-
based on the findings of the home infu-
sion therapy accreditation program re- ganization as to whether or not its
view. CMS-approved home infusion therapy
(iv) The actions the home infusion accreditation program continues to
therapy accrediting organization must meet the requirements of this subpart,
take to address the identified defi- including the reasons for the deter-
ciencies mination.
(v) The length of the accreditation (ii) If CMS determines that the home
program review probation period, infusion therapy accrediting organiza-
which will include monitoring of the tion does not meet the requirements,
home infusion therapy accrediting or- CMS may withdraw approval of the
ganization’s performance and imple- CMS-approved home infusion therapy
mentation of the corrective action accreditation program. The notice of
plan. The probation period is not to ex- determination provided to the home in-
ceed 180 calendar days from the date fusion therapy accrediting organiza-
that CMS approves the AOs corrective tion includes notice of the removal of
action plan. approval, reason for the removal, in-
(2) CMS will review and approve the cluding the effective date determined
home infusion therapy accrediting or- in accordance with paragraph (d)(4)(iii)
ganization’s plan of correction for ac- of this section.
ceptability within 30 days after receipt. (iii) CMS publishes in the FEDERAL
(3) CMS will monitor the AO’s per- REGISTER a notice of its decision to
formance and implementation of the withdraw approval of a CMS-approved
plan of correction during the probation accreditation program, including the
period which is not to exceed 180 days reasons for the withdrawal, effective 60
from the date of approval of the plan of calendar days after the date of publica-
correction. tion of the notice.
629
§ 488.1035 42 CFR Ch. IV (10–1–24 Edition)
(e) Immediate jeopardy. If at any time (2) Notice of all accreditation deci-
CMS determines that the continued ap- sions.
proval of a CMS-approved home infu- (3) Notice of all complaints related to
sion therapy accreditation program of providers or suppliers.
any home infusion therapy accrediting (4) Information about all home infu-
organization poses an immediate jeop- sion therapy accredited suppliers
ardy to the patients of the suppliers ac- against which the home infusion ther-
credited under the program, or the con- apy accreditation organization has
tinued approval otherwise constitutes taken remedial or adverse action, in-
a significant hazard to the public cluding revocation, withdrawal, or re-
health, CMS may immediately with- vision of the providers or suppliers ac-
draw the approval of a CMS-approved creditation.
home infusion therapy accreditation (5) The home infusion therapy ac-
program of that home infusion therapy crediting organization must provide,
accrediting organization and publish a
on an annual basis, summary data
notice of the removal, including the
specified by CMS that relate to the
reasons for it, in the FEDERAL REG-
past year’s accreditation activities and
ISTER.
trends.
(f) Notification to home infusion ther-
apy suppliers of withdrawal of CMS ap- (6) Notice of any proposed changes in
proval status. A home infusion therapy the home infusion therapy accrediting
accrediting organization whose CMS organization’s accreditation standards
approval of its home infusion therapy or requirements or survey process. If
accreditation program has been with- the home infusion therapy accrediting
drawn must notify each of its accred- organization implements the changes
ited home infusion therapy suppliers, before or without CMS’ approval, CMS
in writing, of the withdrawal of CMS may withdraw its approval of the ac-
approval status no later than 30 cal- crediting organization.
endar days after the notice is published (b) Within 30 calendar days after a
in the FEDERAL REGISTER. The notifica- change in CMS requirements, the home
tion to the accredited home infusion infusion therapy accrediting organiza-
therapy suppliers must inform them of tion must submit an acknowledgment
the implications for their payment sta- of receipt of CMS’ notification to CMS.
tus once their current term of accredi- (c) The home infusion therapy ac-
tation expires. crediting organization must permit its
(g) Change of ownership. An accred- surveyors to serve as witnesses if CMS
iting organization that wishes to un- takes an adverse action based on ac-
dergo a change of ownership is subject creditation findings.
to the requirements set out at § 488.5(f). (d) Within 2 business days of identi-
fying a deficiency of an accredited
FR 25428, Apr. 29, 2022] home infusion therapy supplier that
poses immediate jeopardy to a bene-
§ 488.1035 Ongoing responsibilities of ficiary or to the general public, the
a CMS-approved home infusion home infusion therapy accrediting or-
therapy accrediting organization. ganization must provide CMS with
A home infusion therapy accredita- written notice of the deficiency and
tion organization approved by CMS any adverse action implemented by the
must carry out the following activities accrediting organization.
on an ongoing basis: (e) Within 10 calendar days after
(a) Provide CMS with all of the fol- CMS’ notice to a CMS-approved home
lowing in written format (either elec- infusion therapy accrediting organiza-
tronic or hard copy): tion that CMS intends to withdraw ap-
(1) Copies of all home infusion ther- proval of the home infusion therapy ac-
apy accreditation surveys, together crediting organization, the home infu-
with any survey-related information sion therapy accrediting organization
that CMS may require (including cor- must provide written notice of the
rective action plans and summaries of withdrawal to all of the home infusion
findings with respect to unmet CMS re- therapy accrediting organization’s ac-
quirements). credited suppliers.
630
§ 488.1040 Onsite observations of home written notification to all suppliers ac-

infusion therapy accrediting orga- credited under its CMS-approved home
nization operations. infusion therapy accreditation program
(a) As part of the application review no later than 30 calendar days after the
process, the ongoing review process, or notice is published in the FEDERAL
the continuing oversight of a home in- REGISTER announcing that CMS is
fusion therapy accrediting organiza- withdrawing its approval of its home
tion’s performance, CMS may conduct infusion therapy accreditation program
onsite inspections of the home infusion and the implications for the home infu-
therapy accrediting organization’s op- sion therapy suppliers payment status
erations and offices at any time to in accordance with the requirements at
verify the home infusion therapy ac- § 488.1010(f) once their current term of
crediting organization’s representa- accreditation expires.
tions and to assess the home infusion (c) Voluntary and involuntary termi-
therapy accrediting organization’s nations. For both voluntary and invol-
compliance with its own policies and untary terminations—
procedures. (1) The accreditation status of af-
(b) Activities to be performed by fected home infusion therapy suppliers
CMS staff during the onsite inspections is considered to remain in effect until
may include, but are not limited to the their current term of accreditation ex-
following: pires;
(1) Interviews with various accred- (2) If the home infusion therapy sup-
iting organization staff. plier wishes to avoid a suspension of
(2) Review of documents, survey files, payment, it must provide written no-
audit tools, and related records. tice to CMS at least 60-calendar days
(3) Observation of meetings con- prior to its accreditation expiration
cerning the home infusion therapy ac- date that it has submitted an applica-
creditation process. tion for home infusion therapy accredi-
(4) Auditing meetings concerning the
tation under another CMS-approved
accreditation process.
home infusion therapy accreditation
(5) Observation of in-progress surveys
program. Failure to comply with this
and audits.
60-calendar day requirement prior to
(6) Evaluation of the accrediting or-
expiration of their current home infu-
ganization’s survey results and accredi-
sion therapy accreditation stations
tation decision-making process.
within could result in a suspension of
§ 488.1045 Voluntary and involuntary payment; and
termination. (3) The home infusion therapy ac-
(a) Voluntary termination by a CMS- crediting organization provides a sec-
approved accrediting program. In accord- ond written notification to all accred-
ance with § 488.1010(a)(23), a home infu- ited home infusion therapy suppliers
sion therapy accrediting organization ten calendar days prior to the organi-
that decides to voluntarily terminate zation’s accreditation program effec-
its CMS-approved home infusion ther- tive date of termination.
apy accreditation program must pro- (d) Voluntary withdrawal from accredi-
vide written notice at least 180 days in tation requested by a home infusion ther-
advance of the effective date of the ter- apy supplier. If a voluntary withdrawal
mination to CMS and each of its ac- from accreditation is requested by the
credited home infusion therapy sup- home infusion therapy supplier, the
pliers. withdrawal may not become effective
(b) Involuntary termination of an ac- until the accrediting organization com-
crediting organization’s approval by CMS. pletes all of the following steps:
Once CMS publishes the notice in the (1) The accrediting organization must
FEDERAL REGISTER announcing its de- contact the home infusion therapy sup-
cision terminate the home infusion plier to seek written confirmation that
therapy accrediting organization’s the home infusion therapy supplier in-
home infusion therapy accreditation tends to voluntarily withdraw from the
program, the home infusion therapy home infusion therapy accreditation
accrediting organization must provide program.
631
§ 488.1050 42 CFR Ch. IV (10–1–24 Edition)
(2) The home infusion therapy ac- (2) Written notice of the time and
crediting organization must advise the place of the hearing at least 10 business
home infusion therapy supplier, in days before the scheduled date.
writing, of the statutory requirement (d) Hearing requirements and rules. (1)
for accreditation for all home infusion The reconsideration hearing is a public
therapy suppliers and the possible pay- hearing open to all of the following:
ment consequences for a lapse in ac- (i) Authorized representatives and
creditation status. staff from CMS, including, but not lim-
(3) The home infusion therapy ac- ited to, the following:
crediting organization must submit (A) Technical advisors (individuals
their final notice of the voluntary with knowledge of the facts of the case
withdrawal of accreditation by the or presenting interpretation of the
home infusion therapy supplier to CMS facts).
by 5 business days after the request for (B) Legal counsel.
voluntary withdrawal is ultimately (C) Non-technical witnesses with per-
processed and effective. sonal knowledge of the facts of the
case.
§ 488.1050 Reconsideration. (ii) Representatives from the accred-
(a) General rule. A home infusion iting organization requesting the re-
therapy accrediting organization dis- consideration including, but not lim-
satisfied with a determination that its ited to, the following:
home infusion therapy accreditation (A) Authorized representatives and
requirements do not provide or do not staff from the accrediting organization.
continue to provide reasonable assur- (B) Technical advisors (individuals
ance that the suppliers accredited by with knowledge of the facts of the case
the home infusion therapy accrediting or presenting interpretation of the
organization meet the applicable qual- facts).
ity standards is entitled to reconsider- (C) Legal counsel.
ation. (D) Non-technical witnesses, such as
(b) Filing requirements. (1) A written patients and family members that have
request for reconsideration must be personal knowledge of the facts of the
filed within 30 calendar days of the re- case.
ceipt of CMS notice of an adverse de- (2) The hearing is conducted by the
termination or non-renewal. hearing officer who receives testimony
(2) The written request for reconsid- and documents related to the proposed
eration must specify the findings or action.
issues with which the home infusion (3) Testimony and other evidence
therapy accrediting organization dis- may be accepted by the hearing officer
agrees and the reasons for the disagree- even though such evidence may be in-
ment. admissible under the Federal Rules of
(3) A requestor may withdraw its Civil Procedure.
written request for reconsideration at (4) The hearing officer does not have
any time before the issuance of a re- the authority to compel by subpoena
consideration determination. the production of witnesses, papers, or
(c) CMS response to a request for recon- other evidence.
sideration. In response to a request for (5) Within 45 calendar days after the
reconsideration, CMS provides the ac- close of the hearing, the hearing officer
crediting organization with— will present the findings and rec-
(1) The opportunity for a hearing to ommendations to the accrediting orga-
be conducted by a hearing officer ap- nization that requested the reconsider-
pointed by the Administrator of CMS ation.
and provide the accrediting organiza- (6) The written report of the hearing
tion the opportunity to present, in officer will include separate numbered
writing and in person, evidence or doc- findings of fact and the legal conclu-
umentation to refute the determina- sions of the hearing officer.
tion to deny approval, or to withdraw (7) The hearing officer’s decision is
or not renew designation; and final.
632
Subpart M—Survey and (3) Level 3—terminated from the

Certification of Hospice Programs Medicare program.
SFP survey means a standard survey
as defined in this section and is per-
SOURCE: 86 FR 62425, Nov. 9, 2021, unless formed after a hospice is selected for
otherwise noted.
the SFP and is conducted every 6
§ 488.1100 Basis and scope. months, up to 3 occurrences.
Standard-level deficiency means non-
Sections 1812, 1814, 1822, 1861, 1864, compliance with one or more of the
and 1865 of the Act establish require- standards that make up each condition
ments for Hospice programs and to au- of participation for hospice programs.
thorize surveys to determine whether Standard survey means a survey con-
they meet the Medicare conditions of ducted in which the surveyor reviews
participation. the hospice program’s compliance with
a select number of standards or condi-
§ 488.1105 Definitions. tions of participation or both to deter-
As used in this subpart— mine the quality of care and services
Abbreviated standard survey means a furnished by a hospice program.
focused survey other than a standard Substantial compliance means compli-
survey that gathers information on ance with all condition-level require-
hospice program’s compliance with ments, as determined by CMS or the
specific standards or conditions of par- State.
ticipation. An abbreviated standard
survey may be based on complaints re- FR 77879, Nov. 13, 2023]
ceived or other indicators of specific
concern. § 488.1110 Hospice program: surveys
Complaint survey means a survey that and hotline.
is conducted to investigate substantial (a) Basic period. Each hospice pro-
allegations of noncompliance as de- gram as defined in section 1861(dd) of
fined in § 488.1. the Act is subject to a standard survey
Condition-level deficiency means non- by an appropriate State or local survey
compliance as described in § 488.24. agency, or an approved accreditation
Deficiency is a violation of the Act agency, as determined by the Sec-
and regulations contained in part 418, retary, not less frequently than once
subparts C and D, of this chapter, is de- every 36 months. Additionally, a sur-
termined as part of a survey, and can vey may be conducted as frequently as
be either standard or condition-level. necessary to –
Hospice Special Focus Program (SFP) (1) Assure the delivery of quality hos-
means a program conducted by CMS to pice program services by determining
identify hospices as poor performers, whether a hospice program complies
based on defined quality indicators, in with the Act and conditions of partici-
which CMS selects hospices for in- pation; and
creased oversight to ensure that they (2) Confirm that the hospice program
meet Medicare requirements. Selected has corrected deficiencies that were
hospices either successfully complete previously cited.
the SFP program or are terminated (b) Complaints. A standard survey, or
from the Medicare program. abbreviated standard survey-
IDR stands for informal dispute reso- (1) Must be conducted of a hospice
lution. program when complaints against the
Noncompliance means any deficiency hospice program are reported to CMS,
found at the condition-level or stand- the State, or local agency.
ard-level. (2) The State, or local agency is re-
SFP status means the status of a hos- sponsible for maintaining a toll-free
pice provider in the SFP with respect hotline to collect, maintain, and con-
to the provider’s progress in the SFP, tinually update information on Medi-
which is indicated by one of the fol- care-participating hospice programs in-
lowing status levels: cluding significant deficiencies found
(1) Level 1—in progress. regarding patient care, corrective ac-
(2) Level 2—completed successfully. tions, and remedy activity during its
633
§ 488.1115 42 CFR Ch. IV (10–1–24 Edition)
most recent survey, and to receive care and identified as professionals

complaints and answer questions about providing hospice core services at
hospice programs. The State or local § 418.64 of this chapter. The multidisci-
agency is also responsible for main- plinary team must include a registered
taining a unit for investigating such nurse. Surveys conducted by a single
complaints. surveyor, must be conducted by a reg-
istered nurse.
§ 488.1115 Surveyor qualifications and
prohibition of conflicts of interest. § 488.1125 Consistency of survey re-
(a) Minimum qualifications. Surveyors sults.
must meet minimum qualifications A survey agency or accrediting orga-
prescribed by CMS. Before any accred- nization must provide a corrective ac-
iting organization, State or Federal tion plan to CMS for any disparity
surveyor may serve on a hospice survey rates that are greater than the thresh-
team (except as a trainee), he/she must old established by CMS.
have successfully completed the rel-
evant CMS–sponsored Basic Hospice § 488.1130 Informal dispute resolution
(IDR).
Surveyor Training Course, and addi-
tional training as specified by CMS. (a) Opportunity to refute survey find-
(b) Disqualifications. Surveyor(s) must ings. Upon the provider’s receipt of an
disclose actual or perceived conflicts of official statement of deficiencies, hos-
interest prior to participating in a hospice programs can request an informal
pice program survey and be provided opportunity to dispute condition-level
the opportunity to recuse themselves survey findings.
as necessary. Any of the following cir- (b) Failure to conduct IDR timely. Fail-
cumstances disqualifies a surveyor ure of CMS, the State, or the AO, as
from surveying a particular hospice appropriate, to complete IDR must not
program: delay the effective date of any enforce-
(1) The surveyor currently serves, or, ment action.
within the previous 2 years has served, (c) Revised statement of deficiencies as
with the hospice program to be sur- a result of IDR. If any findings are re-
veyed as one of the following: vised or removed by CMS, the State, or
(i) A direct employee. the AO based on IDR, the official state-
(ii) An employment agency staff at ment of deficiencies is revised accord-
the hospice program. ingly, and any enforcement actions im-
(iii) An officer, consultant, or agent posed solely as a result of those cited
for the hospice program to be surveyed deficiencies are adjusted accordingly.
concerning compliance with conditions (d) Notification. (1) If the survey find-
of participation specified in or in ac- ings indicate a condition-level defi-
cordance with sections 1861(dd) of the ciency, the hospice program is notified
Act. in writing of its opportunity for par-
(2) The surveyor has a financial in- ticipating in an IDR process at the
terest or an ownership interest in the time the official statement of defi-
hospice program to be surveyed. ciencies is issued.
(3) The surveyor has an immediate (2) The request for IDR must—
family member, as defined at § 411.351 (i) Be submitted in writing;
of this chapter, who has a financial in- (ii) Include the specific deficiencies
terest or an ownership interest with that are disputed; and
the hospice program to be surveyed. (iii) Be made within the same 10 cal-
(4) The surveyor has an immediate endar day period that the hospice pro-
family member, as defined at § 411.351 gram has for submitting an acceptable
of this chapter, who is a patient of the plan of correction.
hospice program to be surveyed. [88 FR 77879, Nov. 13, 2023]
§ 488.1120 Survey teams. § 488.1135 Hospice Special Focus Pro-

Standard surveys conducted by more gram (SFP).
than one surveyor must be conducted (a) Applicability. (1) The provisions of
by a multidisciplinary team of profes- this section are effective on or after
sionals typically involved in hospice January 1, 2024. ; and
634
(2) SFP selection begins in CY 2024. Subpart N—Enforcement Rem-

(b) Selection criteria. (1) Selection of edies for Hospice Programs
hospices for the SFP is made based on With Deficiencies
the highest aggregate scores based on
the algorithm used by CMS.
(2) Hospice programs with accred- otherwise noted.
iting organization deemed status
placed in the SFP— § 488.1200 Statutory basis.
(i) Do not retain deemed status; and
Section 1822 of the Act authorizes the
(ii) Are placed under CMS or State
Secretary to take actions to remove
survey agency jurisdiction until com-
and correct deficiencies in a hospice
pletion of the SFP or termination.
program through an enforcement rem-
(c) Survey and enforcement criteria. A edy or termination or both. This sec-
hospice in the SFP— tion specifies that these remedies are
(1) Is surveyed not less than once in addition to any others available
every 6 months by CMS or the State under State or Federal law, and, except
agency; and for the final determination of civil
(2) With condition level deficiencies money penalties, are imposed prior to
on any survey is subject to standard the conduct of a hearing.
enforcement actions and may be sub-
ject to progressive enforcement rem- § 488.1205 Definitions.
edies at the discretion of CMS. As used in this subpart—
(d) Completion criteria. A hospice in Directed plan of correction means CMS
the SFP that has two SFP surveys or the temporary manager (with CMS/
within 18 months with no condition- survey agency (SA) approval) may di-
level deficiencies, and that has no rect the hospice program to take spe-
pending complaint survey triaged at an cific corrective action to achieve spe-
immediate jeopardy or condition level, cific outcomes within specific time-
or that has returned to substantial frames.
compliance with all requirements may Immediate jeopardy means a situation
complete the SFP. in which the provider’s noncompliance
(e) Termination criteria. (1) A hospice with one or more requirements of par-
in the SFP that does not meet the SFP ticipation has caused, or is likely to
completion requirements in paragraph cause, serious injury, harm, impair-
(d) of this section is considered for ter- ment, or death to a patient(s).
mination from the Medicare program New admission means an individual
in accordance with 42 CFR 489.53. who becomes a patient or is readmitted
(2) CMS may consider termination to the hospice program on or after the
from the Medicare program in accord- effective date of a suspension of pay-
ance with § 488.1225 if any survey re- ment remedy.
sults in an immediate jeopardy cita- Per instance means a single event of
tion while the hospice is in the SFP. noncompliance identified and corrected
(f) Public reporting. CMS posts all of during a survey, for which the statute
the following at least annually on a authorizes CMS to impose a remedy.
CMS public-facing website: Plan of correction means a plan devel-
(1) A subset of 10 percent of hospice oped by the hospice program and ap-
programs based on the highest aggre- proved by CMS that is the hospice pro-
gate scores as determined by the algo- gram’s written response to survey find-
rithm used by CMS. ings detailing corrective actions to
(2) Hospice SFP selection from the cited deficiencies and specifies the date
list in paragraph (f)(1) of this section as by which those deficiencies will be cor-
determined by CMS. rected.
(3) SFP status as defined in § 488.1105. Repeat deficiency means a condition-
level deficiency that is cited on the
[88 FR 77879, Nov. 13, 2023]
current survey and is substantially the
same as or similar to, a finding of a
635
§ 488.1210 42 CFR Ch. IV (10–1–24 Edition)
standard-level or condition-level defi- gram, as set forth in § 488.1245(e), once

ciency cited on the most recent pre- the administrative determination is
vious standard survey or on any inter- final.
vening survey since the most recent (3) Date of enforcement action. The no-
standard survey. Repeated non-compli- tice periods specified in §§ 488.1225(b)
ance is not on the basis that the exact and 488.1230(b) begin the day after the
regulation (that is, tag number) for the hospice receives the notice of intent.
deficiency was repeated. (f) Appeals. (1) The hospice program
Temporary management means the may request a hearing on a determina-
temporary appointment by CMS or by tion of noncompliance leading to the
a CMS authorized agent, of a sub- imposition of a remedy, including ter-
stitute manager or administrator. The mination of the provider agreement,
hospice program’s governing body must under the provisions of part 498 of this
ensure that the temporary manager chapter.
has authority to hire, terminate or re- (2) A pending hearing does not delay
assign staff, obligate funds, alter proce- the effective date of a remedy, includ-
dures, and manage the hospice program ing termination, against a hospice pro-
to correct deficiencies identified in the gram. Remedies continue to be in ef-
hospice program’s operation. fect regardless of the timing of any ap-
peals proceedings.
§ 488.1210 General provisions.
(a) Purpose of remedies. The purpose of § 488.1215 Factors to be considered in
remedies is to ensure prompt compli- selecting remedies.
ance with program requirements in CMS bases its choice of remedy or
order to protect the health and safety remedies on consideration of one or
of individuals under the care of a hos- more factors that include, but are not
pice program. limited to, the following:
(b) Basis for imposition of remedies. (a) The extent to which the defi-
When CMS chooses to apply one or ciencies pose immediate jeopardy to
more remedies specified in § 488.1220, patient health and safety.
the remedies are applied on the basis of (b) The nature, incidence, manner,
noncompliance with one or more condi- degree, and duration of the deficiencies
tions of participation and may be based or noncompliance.
on failure to correct previous defi-
(c) The presence of repeat defi-
ciency findings as evidenced by repeat
ciencies, the hospice program’s overall
condition-level deficiencies.
compliance history and any history of
(c) Number of remedies. CMS may im-
repeat deficiencies at either the parent
pose one or more remedies specified in
hospice program or any of its multiple
§ 488.1220 for each condition-level defi-
locations.
ciency constituting noncompliance.
(d) The extent to which the defi-
(d) Plan of correction requirement. Re-
ciencies are directly related to a fail-
gardless of which remedy is applied, a
ure to provide quality patient care.
non-compliant hospice program must
submit a plan of correction for ap- (e) The extent to which the hospice
proval by CMS or the State Survey program is part of a larger organiza-
Agency. tion with performance problems.
(e) Notification requirements—(1) Notice (f) An indication of any system-wide
of intent. CMS provides written notifi- failure to provide quality care.
cation to the hospice program of the
§ 488.1220 Available remedies.
intent to impose the remedy, the statu-
tory basis for the remedy, the nature of The following enforcement remedies
the noncompliance, the proposed effec- are available instead of, or in addition
tive date of the sanction, and the ap- to, termination of the hospice pro-
peal rights. For civil money penalties, gram’s provider agreement under
the notice of intent would also include § 489.53 of this chapter, for a period not
the amount being imposed. to exceed 6 months:
(2) Final notice. With respect to civil (a) Civil money penalties.
money penalties, CMS provides a writ- (b) Suspension of payment for all new
ten final notice to the hospice pro- patient admissions.
636
(c) Temporary management of the (2) Imposes one or more enforcement

hospice program. remedies set forth in § 488.1220(a)
(d) Directed plan of correction. through (e) in lieu of termination, for a
(e) Directed in-service training. period not to exceed 6 months.
(b) 15-calendar day notice. Except for
§ 488.1225 Action when deficiencies civil money penalties, for all remedies
pose immediate jeopardy. specified in § 488.1220 imposed when
(a) Immediate jeopardy. If there is im- there is no immediate jeopardy, notice
mediate jeopardy to the hospice pro- must be given at least 15 calendar days
gram’s patient health or safety, the before the effective date of the enforce-
following rules apply: ment action. The requirements of the
notice are set forth in § 488.1210(e).
(1) CMS immediately terminates the
(c) Not meeting criteria for continuation
hospice program provider agreement in
of payment. If a hospice program does
accordance with § 489.53 of this chapter.
not meet the criteria for continuation
(2) CMS terminates the hospice proof payment under § 488.1260(a), CMS ter-
gram provider agreement no later than minates the hospice program’s provider
23 calendar days from the last day of agreement in accordance with
the survey, if the immediate jeopardy § 488.1265.
has not been removed by the hospice (d) Termination timeframe when there is
program. no immediate jeopardy. CMS terminates
(3) In addition to a termination, CMS a hospice program within 6 months of
may impose one or more enforcement the last day of the survey, if the hos-
remedies, as appropriate. pice program is not in compliance with
(b) 2-calendar day notice. Except for the conditions of participation, and the
civil money penalties, for all remedies terms of the plan of correction have
specified in § 488.1220 imposed when not been met.
there is immediate jeopardy, notice (e) Transfer of care. A hospice pro-
must be given at least 2 calendar days gram, if its provider agreement termi-
before the effective date of the enforce- nated, is responsible for providing in-
ment action. The requirements of the formation, assistance, and arrange-
notice are set forth in § 488.1210(e). ments necessary for the proper and safe
(c) Transfer of care. A hospice pro- transfer of patients to another local
gram, if its provider agreement is ter- hospice program within 30 calendar
minated, is responsible for providing days of termination. The State must
information, assistance, and arrange- assist the hospice program in the safe
ments necessary for the proper and safe and orderly transfer of care and serv-
transfer of patients to another local ices for the patients to another local
hospice program within 30 calendar hospice program.
days of termination.
§ 488.1235 Temporary management.
§ 488.1230 Action when deficiencies (a) Application. CMS may impose
are at the condition-level but do not temporary management of a hospice
pose immediate jeopardy.
program if it determines that a hospice
(a) Noncompliance with conditions of program has a condition-level defi-
participation. If the hospice program is ciency and CMS determines that man-
no longer in compliance with the con- agement limitations or the deficiencies
ditions of participation, either because are likely to impair the hospice pro-
the condition-level deficiency or defi- gram’s ability to correct the non-
ciencies substantially limit the pro- compliance and return the hospice pro-
vider’s capacity to furnish adequate gram to compliance with all of the con-
care but do not pose immediate jeop- ditions of participation within the
ardy, or the hospice program has re- timeframe required.
peat condition-level deficiencies based (b) Procedures—(1) Notice of intent. Be-
on the hospice program’s failure to cor- fore imposing the remedy in paragraph
rect and sustain compliance, CMS does (a) of this section, CMS notifies the
either of the following. hospice program in accordance with
(1) Terminates the hospice program’s § 488.1210(e) that a temporary manager
provider agreement. is being appointed.
637
§ 488.1240 42 CFR Ch. IV (10–1–24 Edition)
(2) Termination. If the hospice pro- § 488.1240 Suspension of payment for

gram fails to relinquish authority and all new patient admissions.
control to the temporary manager, (a) Application. (1) CMS may suspend
CMS terminates the hospice program’s payment for all new admissions to a
provider agreement in accordance with hospice program on or after the date on
§ 488.1265. which the Secretary determines that
(c) Duration and effect of remedy. Tem- remedies should be imposed.
porary management continues until (2) CMS considers the remedy in
one of the following occur: paragraph (a)(1) of this section for any
(1) CMS determines that the hospice deficiency related to poor patient care
program has achieved substantial com- outcomes, regardless of whether the de-
pliance and has the management capa- ficiency poses immediate jeopardy.
(b) Procedures—(1) Notice of intent. (i)
bility to ensure continued compliance
Before suspending payments for all new
with all the conditions of participa-
admissions, CMS provides the hospice
tion. program notice of the suspension of
(2) CMS terminates the provider payment in accordance with
agreement. § 488.1210(e).
(3) The hospice program resumes (ii) The hospice program may not
management control without CMS ap- charge a newly admitted hospice pa-
proval. In this case, CMS initiates ter- tient who is a Medicare beneficiary for
mination of the provider agreement services for which Medicare payment is
and may impose additional remedies. suspended unless the hospice program
(4) Temporary management will not can show that, before initiating care, it
exceed a period of 6 months from the gave the patient or his or her rep-
date of the survey identifying non- resentative oral and written notice of
compliance. the suspension of Medicare payment in
(d) Payment of salary. (1) The tem- a language and manner that the bene-
porary manager’s salary must meet the ficiary or representative can under-
following: stand.
(2) Restriction. (i) The suspension of
(i) Is paid directly by the hospice pro-
payment for all new admissions remedy
gram while the temporary manager is
may be imposed anytime a hospice pro-
assigned to that hospice program. gram is found to be out of substantial
(ii) Must be at least equivalent to the compliance with the conditions of par-
sum of the following: ticipation.
(A) The prevailing salary paid by pro- (ii) The suspension of payment for all
viders for positions of this type in what new admissions remains in place until
the State considers to be the hospice CMS determines that the hospice pro-
program’s geographic area (prevailing gram has achieved substantial compli-
salary based on the Bureau of Labor ance with the conditions of participa-
Statistics, National Occupational Em- tion or is terminated, as determined by
ployment and Wage Estimates). CMS.
(B) Any additional costs that would (3) Resumption of payments. Payments
have reasonably been incurred by the for all new admissions to the hospice
hospice program if such person had program resume prospectively on the
been in an employment relationship. date that CMS determines that the
(C) Any other costs incurred by such hospice program has achieved substan-
tial compliance with the conditions of
a person in furnishing services under
participation.
such an arrangement or as otherwise
(c) Duration and effect of remedy. The
set by the State. remedy in paragraph (a) of this section
(2) A hospice program’s failure to pay ends when any of the following occur—
the salary and other costs of the tem- (1) CMS determines that the hospice
porary manager described in paragraph program has achieved substantial com-
(d)(1) of this section is considered a pliance with all of the conditions of
failure to relinquish authority and con- participation.
trol to temporary management. (2) When the hospice program is ter-
minated or CMS determines that the
638
hospice program is not in compliance ardy with actual harm versus imme-
with the conditions of participation at diate jeopardy with potential for harm.
a maximum of 6 months from the date (ii) CMS may also decrease a CMP in
of the survey identifying the non- increments to the extent that it finds,
compliance. in accordance with a revisit, that sub-
stantial and sustainable improvements
§ 488.1245 Civil money penalties. have been implemented even though
(a) Application. (1) CMS may impose a the hospice program is not yet in com-
civil money penalty against a hospice pliance with the conditions of partici-
program for either the number of days pation.
the hospice program is not in compli- (iii) No penalty assessment exceeds
ance with one or more conditions of $10,000, as adjusted annually under 45
participation or for each instance that CFR part 102, for each day a hospice
a hospice program is not in compli- program is not in substantial compli-
ance, regardless of whether the hospice ance with one or more conditions of
program’s deficiencies pose immediate participation.
jeopardy. (3) Upper range of penalty. Penalties
(2) CMS may impose a civil money in the upper range of $8,500 to $10,000
penalty for the number of days of im- per day, as adjusted annually under 45
mediate jeopardy. CFR part 102, are imposed for a condi-
tion-level deficiency that is immediate
(3) A per-day and a per-instance civil
jeopardy. The penalty in this range
money penalty (CMP) may not be im-
continues until substantial compliance
posed simultaneously for the same de-
can be determined based on a revisit
ficiency in conjunction with a survey.
survey.
(4) CMS may impose a civil money
(i) $10,000, as adjusted annually under
penalty for the number of days of non-
45 CFR part 102, per day for a defi-
compliance since the last standard sur-
ciency or deficiencies that are imme-
vey, including the number of days of
diate jeopardy and that result in actual
immediate jeopardy.
harm.
(b) Amount of penalty—(1) Factors con- (ii) $9,000, as adjusted annually under
sidered. CMS takes into account the 45 CFR part 102, per day for a defi-
following factors in determining the ciency or deficiencies that are imme-
amount of the penalty: diate jeopardy and that result in a po-
(i) The factors set out at § 488.1215. tential for harm.
(ii) The size of a hospice program and (iii) $8,500, as adjusted annually
its resources. under 45 CFR part 102, per day for a de-
(iii) Evidence that the hospice proficiency based on an isolated incident
gram has a built-in, self-regulating in violation of established hospice pol-
quality assessment and performance icy.
improvement system to provide proper (4) Middle range of penalty. Penalties
care, prevent poor outcomes, control in the range of $1,500 up to $8,500, as ad-
patient injury, enhance quality, pro- justed annually under 45 CFR part 102,
mote safety, and avoid risks to paper day of noncompliance are imposed
tients on a sustainable basis that indi- for a repeat or condition-level defi-
cates the ability to meet the condi- ciency or both that does not constitute
tions of participation and to ensure pa- immediate jeopardy but is directly re-
tient health and safety. lated to poor quality patient care out-
(2) Adjustments to penalties. Based on comes.
revisit survey findings, adjustments to (5) Lower range of penalty. Penalties
penalties may be made after a review in this range of $500 to $4,000, as ad-
of the provider’s attempted correction justed annually under 45 CFR part 102,
of deficiencies. are imposed for a repeat or condition-
(i) CMS may increase a CMP in incre- level deficiency or both that does not
ments based on a hospice program’s in- constitute immediate jeopardy and
ability or failure to correct defi- that are related predominately to
ciencies, the presence of a system-wide structure or process-oriented condi-
failure in the provision of quality care, tions rather than directly related to
or a determination of immediate jeop- patient care outcomes.
639
§ 488.1245 42 CFR Ch. IV (10–1–24 Edition)
(6) Per instance penalty. Penalty im- the civil money penalty. If a hospice
posed per instance of noncompliance program timely waives its right to a
may be assessed for one or more sin- hearing, CMS reduces the penalty
gular events of condition-level defi- amount by 35 percent, and the amount
ciency that are identified and where is due within 15 calendar days of the
the noncompliance was corrected dur- hospice program agreeing in writing to
ing the onsite survey. When penalties waive the hearing. If the hospice pro-
are imposed for per instance of non- gram does not waive its right to a
compliance, or more than one per in- hearing in accordance to the proce-
stance of noncompliance, the penalties dures specified in this section, the civil
will be in the range of $1,000 to $10,000 money penalty is not reduced by 35 per-
per instance, not to exceed $10,000 each cent.
day of noncompliance, as adjusted an- (d) Accrual and duration of penalty—
nually under 45 CFR part 102. (1) Accrual of per day penalty. (i) The
(7) Decreased penalty amounts. If the per day civil money penalty may start
immediate jeopardy situation is re- accruing as early as the beginning of
moved, but a condition-level deficiency the last day of the survey that deter-
exists, CMS shifts the penalty amount mines that the hospice program was
imposed per day from the upper range out of compliance, as determined by
to the middle or lower range. An ear- CMS.
nest effort to correct any systemic (ii) A civil money penalty for each
causes of deficiencies and sustain im- per instance of noncompliance is im-
provement must be evident. posed in a specific amount for that par-
(8) Increased penalty amounts. (i) In ticular deficiency, with a maximum of
accordance with paragraph (b)(2) of $10,000 per day per hospice program.
this section, CMS increases the per day
(2) Duration of per day penalty when
penalty amount for any condition-level
there is immediate jeopardy. (i) In the
deficiency or deficiencies which, after
case of noncompliance that poses im-
imposition of a lower-level penalty
mediate jeopardy, CMS must terminate
amount, become sufficiently serious to
the provider agreement within 23 cal-
pose potential harm or immediate jeop-
ardy. endar days after the last day of the
(ii) CMS increases the per day pen- survey if the immediate jeopardy is not
alty amount for deficiencies that are removed.
not corrected and found again at the (ii) A penalty imposed per day of non-
time of revisit survey(s) for which a compliance will stop accruing on the
lower-level penalty amount was pre- day the provider agreement is termi-
viously imposed. nated or the hospice program achieves
(iii) CMS may impose a more severe substantial compliance, whichever oc-
amount of penalties for repeated non- curs first.
compliance with the same condition- (3) Duration of penalty when there is
level deficiency or uncorrected defi- no immediate jeopardy. (i) In the case of
ciencies from a prior survey. noncompliance that does not pose im-
(c) Procedures—(1) Notice of intent. mediate jeopardy, the daily accrual of
CMS provides the hospice program per day civil money penalties is im-
with written notice of the intent to imposed for the days of noncompliance
pose a civil money penalty in accord- prior to the notice of intent specified
ance with § 488.1210(e). in paragraph (c)(1) of this section and
(2) Appeals—(i) Appeals procedures. A an additional period of no longer than
hospice program may request a hearing 6 months following the last day of the
on the determination of the noncompli- survey.
ance that is the basis for imposition of (ii) If the hospice program has not
the civil money penalty. The request achieved compliance with the condi-
must meet the requirements in § 498.40 tions of participation within 6 months
of this chapter. following the last day of the survey,
(ii) Waiver of a hearing. A hospice pro- CMS terminates the provider agree-
gram may waive the right to a hearing, ment. The accrual of civil money pen-
in writing, within 60 calendar days alty stops on the day the hospice pro-
from the date of the notice imposing gram agreement is terminated or the
640
hospice program achieves substantial the final decision or the effective date
compliance, whichever is earlier. of termination occurs before the final
(e) Computation and notice of total pen- decision.
alty amount. (1) When a civil money (ii) After the time to appeal has ex-
penalty is imposed on a per day basis pired and the hospice program does not
and the hospice program achieves com- appeal or fails to timely appeal the ini-
pliance with the conditions of partici- tial determination.
pation as determined by a revisit sur- (iii) After CMS receives a written re-
vey, once the administrative deter- quest from the hospice program re-
mination is final, CMS sends a final no- questing to waive its right to appeal
tice to the hospice program containing the determinations that led to the im-
of the following information: position of a remedy.
(i) The amount of penalty assessed (iv) After the effective date of termi-
per day. nation.
(ii) The total number of days of non- (2) A request for hearing does not
compliance. delay the imposition of any penalty; it
(iii) The total amount due. only potentially delays the collection
(iv) The due date of the penalty. of the final penalty amount.
(v) The rate of interest to be assessed (3) If a hospice program waives its
on any unpaid balance beginning on right to a hearing according to para-
the due date, as provided in paragraph graph (c)(2)(ii) of this section, CMS ap-
(f)(6) of this section. plies a 35 percent reduction to the CMP
(2) When a civil money penalty is im- amount for any of the following:
posed per instance of noncompliance,
(i) The hospice program achieved
once the administrative determination
compliance with the conditions of par-
is final, CMS sends a final notice to the
ticipation before CMS received the
hospice program containing all of the
written waiver of hearing.
following information:
(ii) The effective date of termination
(i) The amount of the penalty that
occurs before CMS received the written
was assessed.
waiver of hearing.
(ii) The total amount due.
(iii) The due date of the penalty. (4) The period of noncompliance may
(iv) The rate of interest to be as- not extend beyond 6 months from the
sessed on any unpaid balance beginning last day of the survey.
on the due date, as provided in para- (5) The amount of the penalty, when
graph (f)(6) of this section. determined, may be deducted (offset)
(3) In the case of a hospice program from any sum then or later owing by
for which the provider agreement has CMS or State Medicaid to the hospice
been involuntarily terminated, CMS program.
sends the final notice after one of the (6) Interest is assessed and accrues on
following actions has occurred: the unpaid balance of a penalty, begin-
(i) The administrative determination ning on the due date. Interest is com-
is final. puted at the rate specified in § 405.378(d)
(ii) The hospice program has waived of this chapter.
its right to a hearing in accordance (g) Review of the penalty. When an ad-
with paragraph (c)(2)(ii) of this section. ministrative law judge finds that the
(iii) Time for requesting a hearing basis for imposing a civil monetary
has expired and the hospice program penalty exists, as specified in this part,
has not requested a hearing. the administrative law judge, may not
(f) Due date for payment of penalty. A do any of the following:
penalty is due and payable 15 calendar (1) Set a penalty of zero or reduce a
days from notice of the final adminis- penalty to zero.
trative decision. (2) Review the exercise of discretion
(1) Payments are due for all civil by CMS to impose a civil monetary
money penalties within 15 calendar penalty.
days of any of the following: (3) Consider any factors in reviewing
(i) After a final administrative deci- the amount of the penalty other than
sion when the hospice program those specified in paragraph (b) of this
achieves substantial compliance before section.
641
§ 488.1250 42 CFR Ch. IV (10–1–24 Edition)
§ 488.1250 Directed plan of correction. ance, CMS may impose one or more
(a) Application. CMS may impose a di- other remedies specified in § 488.1220.
rected plan of correction when a hos- (3) Payment. The hospice program
pice program— pays for the directed in-service train-
(1) Has one or more condition-level ing for its staff.
deficiencies that warrant directing the
hospice program to take specific ac- § 488.1260 Continuation of payments to
a hospice program with defi-
tions; or
ciencies.
(2) Fails to submit an acceptable plan
of correction. (a) Continued payments. CMS may
(b) Procedures. (1) Before imposing continue payments to a hospice pro-
the remedy in paragraph (a) of this sec- gram with condition-level deficiencies
tion, CMS notifies the hospice program that do not constitute immediate jeop-
in accordance with § 488.1210(e). ardy for up to 6 months from the last
(2) CMS or the temporary manager day of the survey if the criteria in
(with CMS approval) may direct the paragraph (a)(1) of this section are met.
hospice program to take corrective ac- (1) Criteria. CMS may continue pay-
tion to achieve specific outcomes with- ments to a hospice program not in
in specific timeframes. compliance with the conditions of par-
(c) Duration and effect of remedy. If ticipation for the period specified in
the hospice program fails to achieve paragraph (a) of this section if all of
compliance with the conditions of par- the following criteria are met:
ticipation within the timeframes speci- (i) An enforcement remedy, or rem-
fied in the directed plan of correction, edies, has been imposed on the hospice
which may not to exceed 6 months, program and termination has not been
CMS does one of the following:
imposed.
(1) May impose one or more other
remedies set forth in § 488.1220. (ii) The hospice program has sub-
(2) Terminates the provider agree- mitted a plan of correction approved by
ment. CMS.
(iii) The hospice program agrees to
§ 488.1255 Directed in-service training. repay the Federal Government pay-
(a) Application. CMS may require the ments received under this paragraph
staff of a hospice program to attend in- (a) if corrective action is not taken in
service training program(s) if CMS de- accordance with the approved plan and
termines all of the following: timetable for corrective action.
(1) The hospice program has condi- (2) Termination. CMS may terminate
tion-level deficiencies. the hospice program’s provider agree-
(2) Education is likely to correct the ment any time if the criteria in para-
deficiencies. graph (a)(1) of this section are not met.
(3) The programs are conducted by (b) Cessation of payments for new ad-
established centers of health education missions. If termination is imposed, ei-
and training or consultants with back- ther on its own or in addition to an en-
ground in education and training with forcement remedy or remedies, or if
Medicare hospice providers, or as any of the criteria set forth in para-
deemed acceptable by CMS or the graph (a)(1) of this section are not met,
State (by review of a copy of cur- the hospice program will receive no
riculum vitas or resumes and ref- Medicare payments, as applicable, for
erences to determine the educator’s new admissions following the last day
qualifications). of the survey.
(b) Procedures—(1) Notice of intent. Be- (c) Failure to achieve compliance with
fore imposing the remedy in paragraph the conditions of participation. If the
(a) of this section, CMS notifies the hospice program does not achieve com-
hospice program in accordance with pliance with the conditions of partici-
§ 488.1210(e). pation by the end of the period speci-
(2) Action following training. After the fied in paragraph (a) of this section,
hospice program staff has received in- CMS terminates the provider agree-
service training, if the hospice program ment of the hospice program in accord-
has not achieved substantial compliance with § 488.1265.
642
§ 488.1265 Termination of provider 489.13 Effective date of agreement or ap-

agreement. proval.
489.18 Change of ownership or leasing: Ef-
(a) Effect of termination by CMS. Ter- fect on provider agreement.
mination of the provider agreement
ends— Subpart B—Essentials of Provider
(1) Payment to the hospice program; Agreements
and
489.20 Basic commitments.
(2) Any enforcement remedy. 489.21 Specific limitations on charges.
(b) Basis for termination. CMS termi- 489.22 Special provisions applicable to pre-
nates a hospice program’s provider payment requirements.
agreement under any one of the fol- 489.23 Specific limitation on charges for
lowing conditions: services provided to certain enrollees of
(1) The hospice program is not in fee-for-service FEHB plans.
compliance with the conditions of par- 489.24 Special responsibilities of Medicare
hospitals in emergency cases.
ticipation. 489.25 Special requirements concerning
(2) The hospice program fails to sub- CHAMPUS and CHAMPVA programs.
mit an acceptable plan of correction 489.26 Special requirements concerning vet-
within the timeframe specified by erans.
CMS. 489.27 Beneficiary notice of discharge
(3) The hospice program fails to relin- rights.
quish control to the temporary man- 489.28 Special capitalization requirements
ager, if that remedy is imposed by for HHAs.
489.29 Special requirements concerning
CMS. beneficiaries served by the Indian Health
(4) The hospice program fails to meet Service, Tribal health programs, and
the eligibility criteria for continuation urban Indian organization health pro-
of payment as set forth in grams.
§ 488.1260(a)(1).
(c) Notice. CMS notifies the hospice Subpart C—Allowable Charges
program and the public of the termi- 489.30 Allowable charges: Deductibles and
nation, in accordance with procedures coinsurance.
set forth in § 489.53 of this chapter. 489.31 Allowable charges: Blood.
(d) Procedures for termination. CMS 489.32 Allowable charges: Noncovered and
terminates the provider agreement in partially covered services.
accordance with procedures set forth in 489.34 Allowable charges: Hospitals partici-
§ 489.53 of this chapter. pating in State reimbursement control
systems or demonstration projects.
(e) Payment post termination. Payment
489.35 Notice to intermediary.
is available for up to 30 calendar days
after the effective date of termination Subpart D—Handling of Incorrect
for hospice care furnished under a plan Collections
established before the effective date of
termination as set forth in § 489.55 of 489.40 Definition of incorrect collection.
489.41 Timing and methods of handling.
this chapter.
489.42 Payment of offset amounts to bene-
(f) Appeal. A hospice program may ficiary or other person.
appeal the termination of its provider
agreement by CMS in accordance with Subpart E—Termination of Agreement and
part 498 of this chapter. Reinstatement After Termination
489.52 Termination by the provider.
PART 489—PROVIDER AGREEMENTS 489.53 Termination by CMS.
AND SUPPLIER APPROVAL 489.54 Termination by the OIG.
489.55 Exceptions to effective date of termi-
Subpart A—General Provisions nation.
489.57 Reinstatement after termination.
Sec.
489.1 Statutory basis. Subpart F—Surety Bond Requirements for
489.2 Scope of part. HHAs
489.3 Definitions.
489.10 Basic requirements. 489.60 Definitions.
489.11 Acceptance of a provider as a partici- 489.61 Basic requirement for surety bonds.
pant. 489.62 Requirement waived for Government-
489.12 Decision to deny an agreement. operated HHAs.
643
§ 489.1 42 CFR Ch. IV (10–1–24 Edition)
489.63 Parties to the bond. be treated as meeting those require-
489.64 Authorized Surety and exclusion of ments. Section 1865(a)(2) of the Act re-
surety companies. quires the Secretary to consider when
489.65 Amount of the bond.
489.66 Additional requirements of the surety
making such a finding, among other
bond. things, the national accreditation
489.67 Term and type of bond. body’s accreditation requirements and
489.68 Effect of failure to obtain, maintain, survey procedures.
and timely file a surety bond. (4) Section 1871 of the Act authorizes
489.69 Evidence of compliance. the Secretary to prescribe regulations
489.70 Effect of payment by the Surety. for the administration of the Medicare
489.71 Surety’s standing to appeal Medicare
program.
determinations.
489.72 Effect of review reversing CMS’s de- (b) Although section 1866 of the Act
termination. speaks only to providers and provider
489.73 Effect of conditions of payment. agreements, the following rules in this
489.74 Incorporation into existing provider part also apply to the approval of sup-
agreements. plier entities that, for participation in
Medicare, are subject to a determina-
Subparts G–H [Reserved] tion by CMS on the basis of a survey
Subpart I—Advance Directives conducted by the SA or CMS surveyors;
or, in lieu of an SA or CMS-conducted
489.100 Definition. survey, accreditation by an accrediting
489.102 Requirements for providers. organization whose program has CMS
489.104 Effective dates. approval in accordance with the re-
AUTHORITY: 42 U.S.C. 1302, 1395i–3, 1395x, quirements of part 488 of this chapter
1395aa(m), 1395cc, 1395ff, and 1395hh. at the time of the accreditation survey
SOURCE: 45 FR 22937, Apr. 4, 1980, unless and accreditation decision, in accord-
otherwise noted. ance with the following:
(1) The definition of immediate jeop-
Subpart A—General Provisions ardy at § 489.3.
(2) The effective date rules specified
§ 489.1 Statutory basis. in § 489.13.
(3) The requirements specified in
(a) This part implements section 1866
§ 489.53(a)(2), (13), and (18), related to
of the Social Security Act (the Act).
Section 1866 of the Act specifies the termination by CMS of participation in
terms of provider agreements, the Medicare.
grounds for terminating a provider (c) Section 1861(o)(7) of the Act re-
agreement, the circumstances under quires each HHA to provide CMS with
which payment for new admissions a surety bond.
may be denied, and the circumstances [75 FR 50418, Aug. 16, 2010, as amended at 80
under which payment may be withheld FR 29839, May 22, 2015]
for failure to make timely utilization
review. The sections of the Act speci- § 489.2 Scope of part.
fied in paragraphs (a)(1) through (a)(4) (a) Subpart A of this part sets forth
of this section are also pertinent. the basic requirements for submittal
(1) Section 1861 of the Act defines the and acceptance of a provider agree-
services covered under Medicare and ment under Medicare. Subpart B of this
the providers that may be reimbursed part specifies the basic commitments
for furnishing those services. and limitations that the provider must
(2) Section 1864 of the Act provides agree to as part of an agreement to
for the use of State survey agencies to provide services. Subpart C specifies
ascertain whether certain entities the limitations on allowable charges to
meet the conditions of participation. beneficiaries for deductibles, coinsur-
(3) Section 1865(a)(1) of the Act pro- ance, copayments, blood, and services
vides that an entity accredited by a na- that must be part of the provider
tional accreditation body found by the agreement. Subpart D of this part
Secretary to satisfy the Medicare con- specifies how incorrect collections are
ditions of participation, conditions for to be handled. Subpart F sets forth the
coverage, or conditions of certification circumstances and procedures for de-
or requirements for participation shall nial of payments for new admissions
644
and for withholding of payment as an est in the hospital. The ownership or

alternative to termination of a pro- investment interest may be through
vider agreement. equity, debt, or other means, and in-
(b) The following providers are sub- cludes an interest in an entity that
ject to the provisions of this part: holds an ownership or investment in-
(1) Hospitals. terest in the hospital. This definition
(2) Skilled nursing facilities (SNFs). does not include a hospital with physi-
(3) Home health agencies (HHAs). cian ownership or investment interests
(4) Clinics, rehabilitation agencies, that satisfy the requirements at
and public health agencies. § 411.356(a) or (b) of this chapter.
(5) Comprehensive outpatient reha- Provider agreement means an agree-
bilitation facilities (CORFs). ment between CMS and one of the pro-
(6) Hospices. viders specified in § 489.2(b) to provide
(7) Critical access hospital (CAHs). services to Medicare beneficiaries and
(8) Community mental health centers to comply with the requirements of
(CMHCs). section 1866 of the Act.
(9) Religious nonmedical health care [48 FR 39837, Sept. 1, 1983, as amended at 51
institutions (RNHCIs). FR 24492, July 3, 1986; 54 FR 5373, Feb. 2, 1989;
(10) Opioid treatment programs 59 FR 56250, Nov. 10, 1994; 60 FR 50119, Sept.
(OTPs). 28, 1995; 72 FR 47412, Aug. 22, 2007; 73 FR 48757,
(11) Rural emergency hospitals Aug. 19, 2008; 80 FR 29840, May 22, 2015]
(REHs).
(c)(1) Clinics, rehabilitation agencies, § 489.10 Basic requirements.
and public health agencies may enter (a) Any of the providers specified in
into provider agreements only for fur- § 489.2 may request participation in
nishing outpatient physical therapy, Medicare. In order to be accepted, it
and speech pathology services. must meet the conditions of participa-
(2) CMHCs may enter into provider tion or requirements (for SNFs) set
agreements only to furnish partial hos- forth in this section and elsewhere in
pitalization services and intensive out- this chapter. The RNHCIs must meet
patient services. the conditions for coverage, conditions
(3) OTPs may enter into provider for participation and the requirements
agreements only to furnish opioid use set forth in this section and elsewhere
disorder treatment services. in this chapter. The OTPs must meet
the requirements set forth in this sec-
[45 FR 22937, Apr. 4, 1980, as amended at 47
FR 56297, Dec. 15, 1982; 48 FR 56036, Dec. 15,
tion and elsewhere in this chapter.
1983; 51 FR 24492, July 3, 1986; 58 FR 30676, (b) In order to participate in the
May 26, 1993; 59 FR 6578, Feb. 11, 1994; 62 FR Medicare program, the provider must
46037, Aug. 29, 1997; 68 FR 66720, Nov. 28, 2003; meet the applicable civil rights re-
84 FR 63204, Nov. 15, 2019; 87 FR 72309, Nov. 23, quirements of:
2022; 88 FR 82184, Nov. 22, 2023] (1) Title VI of the Civil Rights Act of
1964, as implemented by 45 CFR part 80,
§ 489.3 Definitions. which provides that no person in the
For purposes of this part— United States shall, on the ground of
Immediate jeopardy means a situation race, color, or national origin, be ex-
in which the provider’s or supplier’s cluded from participation in, be denied
non-compliance with one or more re- the benefits of, or be subject to dis-
quirements, conditions of participa- crimination under, any program or ac-
tion, conditions for coverage, or condi- tivity receiving Federal financial as-
tions for certification has caused, or is sistance (section 601);
likely to cause, serious injury, harm, (2) Section 504 of the Rehabilitation
impairment, or death to a resident or Act of 1973, as implemented by 45 CFR
patient. part 84, which provides that no quali-
Physician-owned hospital means any fied handicapped person shall, on the
participating hospital (as defined in basis of handicap, be excluded from
§ 489.24) in which a physician, or an im- participation in, be denied the benefits
mediate family member of a physician of, or otherwise be subject to discrimi-
(as defined in § 411.351 of this chapter), nation under any program or activity
has an ownership or investment inter- receiving Federal financial assistance;
645
§ 489.11 42 CFR Ch. IV (10–1–24 Edition)
(3) The Age Discrimination Act of (c) Notice of acceptance. If CMS ac-
1975, as implemented by 45 CFR part 90, cepts the agreement, it will return one
which is designed to prohibit discrimi- copy to the provider with a written no-
nation on the basis of age in programs tice that—
or activities receiving Federal finan- (1) Indicates the dates on which it
cial assistance. The Age Discrimina- was signed by the provider’s represent-
tion Act also permits federally assisted ative and accepted by CMS; and
programs and activities, and bene- (2) Specifies the effective date of the
ficiaries of Federal funds, to continue agreement.
to use certain age distinctions, and fac- [45 FR 22937, Apr. 4, 1980, as amended at 59
tors other than age, that meet the re- FR 56251, Nov. 10, 1994; 62 FR 43937, Aug. 18,
quirements of the Age Discrimination 1997]
Act and 45 CFR part 90; and
(4) Other pertinent requirements of § 489.12 Decision to deny an agree-
the Office of Civil Rights of HHS. ment.
(c) In order for a hospital, SNF, HHA, (a) Bases for denial. CMS may refuse
hospice, or RNHCI to be accepted, it to enter into an agreement for any of
must also meet the advance directives the following reasons:
requirements specified in subpart I of (1) Principals of the prospective pro-
this part. vider have been convicted of fraud (see
(d) The State survey agency will as- § 420.204 of this chapter);
certain whether the provider meets the (2) The prospective provider has
conditions of participation or require- failed to disclose ownership and control
ments (for SNFs) and make its rec- interests in accordance with § 420.206 of
ommendations to CMS. this chapter;
(e) In order for a home health agency (3) The prospective provider is a phy-
to be accepted, it must also meet the sician-owned hospital as defined in
surety bond requirements specified in § 489.3 and does not have procedures in
subpart F of this part. place for making physician ownership
(f) In order for a home health agency disclosures to patients in accordance
to be accepted as a new provider, it with § 489.20(u); or
must also meet the capitalization re- (4) The prospective provider is unable
quirements specified in subpart B of to give satisfactory assurance of com-
this part. pliance with the requirements of title
XVIII of the Act.
[58 FR 61843, Nov. 23, 1993, as amended at 59 (b) [Reserved]
FR 6578, Feb. 11, 1994; 63 FR 312, Jan. 5, 1998; (c) Compliance with civil rights require-
68 FR 66720, Nov. 28, 2003; 84 FR 63204, Nov. 15, ments. CMS will not enter into a pro-
2019] vider agreement if the provider fails to
comply with civil rights requirements
§ 489.11 Acceptance of a provider as a
participant. set forth in 45 CFR parts 80, 84, and 90,
subject to the provisions of § 489.10.
(a) Action by CMS. If CMS determines
that the provider meets the require- [45 FR 22937, Apr. 4, 1980, as amended at 51
FR 34833, Sept. 30, 1986; 54 FR 4027, Jan. 27,
ments, it will send the provider— 1989; 59 FR 6578, Feb. 11, 1994; 59 FR 56251,
(1) Written notice of that determina- Nov. 10, 1994; 72 FR 47413, Aug. 22, 2007]
tion; and
(2) Two copies of the provider agree- § 489.13 Effective date of agreement or
ment. approval.
(b) Action by provider. If the provider (a) Applicability—(1) General rule. Ex-
wishes to participate, it must return cept as provided in paragraph (a)(2) of
both copies of the agreement, duly this section, this section applies to
signed by an authorized official, to Medicare provider agreements with,
CMS, together with a written state- and supplier approval of, entities that,
ment indicating whether it has been as a basis for participation in Medicare
adjudged insolvent or bankrupt in any are subject to a determination by CMS
State or Federal court, or whether any on the basis of—
insolvency or bankruptcy actions are (i) A survey conducted by the State
pending. survey agency or CMS surveyors; or
646
(ii) In lieu of such State survey agen- (3) The applicable Medicare health
cy or CMS conducted survey, accredita- and safety standards, such as the appli-
tion by an accreditation organization cable conditions of participation, the
whose program has CMS approval in requirements for participation, the
accordance with section 1865 of the Act conditions for coverage, or the condi-
at the time of the accreditation survey tions for certification.
and accreditation decision. (c) All health and safety standards are
(2) Exceptions. (i) For an agreement not met on the date of survey. If, on the
with a community mental health cen- date the survey is completed, the pro-
ter (CMHC) or a federally qualified vider or supplier has failed to meet any
health center (FQHC), the effective one of the applicable health and safety
date is the date on which CMS accepts standards, the following rules apply for
a signed agreement which assures that determining the effective date of the
the CMHC or FQHC meets all Federal provider agreement or supplier ap-
requirements. proval, assuming that no other Federal
(ii) A Medicare supplier approval of a requirements remain to be satisfied.
laboratory is effective only while the However, if other Federal requirements
laboratory has in effect a valid CLIA remain to be satisfied, notwithstanding
certificate issued under part 493 of this the provisions of paragraphs (c)(1)
chapter, and only for the specialty and through (c)(3) of this section, the effec-
subspecialty tests it is authorized to tive date of the agreement or approval
perform. may not be earlier than the latest of
(iii) For an agreement with an opioid the dates on which CMS determines
treatment program (OTP), the effective that each applicable Federal require-
date is the effective date of billing as ment is met.
established under § 424.520(d) or (1) For an agreement with an SNF,
§ 424.521(a), as applicable. the effective date is the date on
(b) All health and safety standards are which—
met on the date of survey. The agree- (i) The SNF is in substantial compli-
ment or approval is effective on the ance (as defined in § 488.301 of this chap-
date the State agency, CMS, or the ter) with the requirements for partici-
CMS contractor survey (including the pation; and
Life Safety Code survey, if applicable) (ii) CMS or the State survey agency
is completed, or on the effective date of receives from the SNF, if applicable, an
the accreditation decision, as applica- approvable waiver request.
ble, if on that date the provider or sup- (2) For an agreement with, or an ap-
plier meets all applicable Federal re- proval of, any other provider or sup-
quirements as set forth in this chapter. plier, (except those specified in para-
(If the agreement or approval is time- graph (a)(2) of this section), the effec-
limited, the new agreement or approval tive date is the earlier of the following:
is effective on the day following the ex- (i) The date on which the provider or
piration of the current agreement or supplier meets all applicable condi-
approval.) However, the effective date tions of participation, conditions for
of the agreement or approval may not coverage, or conditions for certifi-
be earlier than the latest of the dates cation; or, if applicable, the date of a
on which CMS determines that each CMS-approved accreditation organiza-
applicable Federal requirement is met. tion program’s positive accreditation
Federal requirements include, but are decision, issued after the accreditation
not limited to— organization has determined that the
(1) Enrollment requirements estab- provider or supplier meets all applica-
lished in part 424, subpart P, of this ble conditions.
chapter. CMS determines, based upon (ii) The date on which a provider or
its review and verification of the pro- supplier is found to meet all conditions
spective provider’s or supplier’s enroll- of participation, conditions for cov-
ment application, the date on which erage, or conditions for certification,
enrollment requirements have been but has lower-level deficiencies, and—
met; (A) CMS or the State survey agency
(2) The requirements identified in receives an acceptable plan of correc-
§§ 489.10 and 489.12; and tion for the lower-level deficiencies
647
§ 489.18 42 CFR Ch. IV (10–1–24 Edition)
(the date of receipt is the effective date (c) Assignment of agreement. When
regardless of when the plan of correc- there is a change of ownership as speci-
tion is approved); or, if applicable, a fied in paragraph (a) of this section,
CMS-approved accreditation organiza- the existing provider agreement will
tion program issues a positive accredi- automatically be assigned to the new
tation decision after it receives an ac- owner.
ceptable plan of correction for the (d) Conditions that apply to assigned
lower-level deficiencies; or agreements. An assigned agreement is
(B) CMS receives an approvable waiv- subject to all applicable statutes and
er request (the date of receipt is the ef- regulations and to the terms and condi-
fective date regardless of when CMS tions under which it was originally
approves the waiver request). issued including, but not limited to,
(3) For an agreement with any other the following:
provider or an approval of any other (1) Any existing plan of correction.
supplier (except those specified in para- (2) Compliance with applicable health
graph (a)(2) of this section) that is and safety standards.
found to meet all conditions of partici-
(3) Compliance with the ownership
pation, conditions for coverage, or con-
and financial interest disclosure re-
ditions for certification, but has lower-
quirements of part 420, subpart C, of
level deficiencies and has submitted
this chapter.
both an approvable plan of correction/
positive accreditation decision and an (4) Compliance with civil rights re-
approvable waiver request, the effec- quirements set forth in 45 CFR parts 80,
tive date is the later of the dates that 84, and 90.
result when calculated in accordance (e) Effect of leasing. The provider
with paragraph (c)(2)(ii)(A) or agreement will be assigned to the les-
(c)(2)(ii)(B) of this section. see only to the extent of the leased por-
tion of the facility.
[75 FR 50418, Aug. 16, 2010, as amended at 84
FR 63204, Nov. 15, 2019] [45 FR 22937, Apr. 4, 1980, as amended at 59
FR 56251, Nov. 10, 1994]
§ 489.18 Change of ownership or leas-
ing: Effect on provider agreement.
Subpart B—Essentials of Provider
(a) What constitutes change of owner- Agreements
ship—(1) Partnership. In the case of a
partnership, the removal, addition, or § 489.20 Basic commitments.
substitution of a partner, unless the
partners expressly agree otherwise, as The provider agrees to the following:
permitted by applicable State law, con- (a) To limit its charges to bene-
stitutes change of ownership. ficiaries and to other individuals on
(2) Unincorporated sole proprietorship. their behalf, in accordance with provi-
Transfer of title and property to an- sions of subpart C of this part.
other party constitutes change of own- (b) To comply with the requirements
ership. of subpart D of this part for the return
(3) Corporation. The merger of the or other disposition of any amounts in-
provider corporation into another cor- correctly collected from a beneficiary
poration, or the consolidation of two or or any other person in his or her be-
more corporations, resulting in the cre- half.
ation of a new corporation constitutes (c) To comply with the requirements
change of ownership. Transfer of cor- of § 420.203 of this chapter when it hires
porate stock or the merger of another certain former employees of inter-
corporation into the provider corpora- mediaries.
tion does not constitute change of own- (d) In the case of a hospital or a CAH
ership. that furnishes services to Medicare
(4) Leasing. The lease of all or part of beneficiaries, either to furnish directly
a provider facility constitutes change or to make arrangements (as defined in
of ownership of the leased portion. § 409.3 of this chapter) for all Medicare-
(b) Notice to CMS. A provider who is covered services to inpatients and out-
contemplating or negotiating a change patients of a hospital or a CAH except
of ownership must notify CMS. the following:
648
(1) Physicians’ services that meet the claim and received payment based on
criteria of § 415.102(a) of this chapter for such a claim; and
payment on a reasonable charge basis. (ii) An amount equal to any primary
(2) Physician assistant services, as payment reduction attributable to fail-
defined in section 1861(s)(2)(K)(i) of the ure to file a proper claim, but only if
Act, that are furnished after December the provider can show that—
31, 1990. (A) It failed to file a proper claim
(3) Nurse practitioner and clinical solely because the beneficiary, for any
nurse specialist services, as defined in reason other than mental or physical
section 1861(s)(2)(K)(ii) of the Act. incapacity, failed to give the provider
(4) Certified nurse-midwife services, the necessary information; or
as defined in section 1861(ff) of the Act, (B) The beneficiary, who was respon-
that are furnished after December 31, sible for filing a proper claim, failed to
1990.
do so for any reason other than mental
(5) Qualified psychologist services, as or physical incapacity.
defined in section 1861(ii) of the Act,
(j) In the State of Oregon, because of
that are furnished after December 31,
a court decision, and in the absence of
1990.
a reversal on appeal or a statutory
(6) Services of an anesthetist, as de-
clarification overturning the decision,
fined in § 410.69 of this chapter.
hospitals may bill liability insurers
(e) In the case of a hospital or CAH
first. However, if the liability insurer
that furnishes inpatient hospital serv-
ices or inpatient CAH services for does not pay ‘‘promptly’’, as defined in
which payment may be made under § 411.50 of this chapter, the hospital
Medicare, to maintain an agreement must withdraw its claim or lien and
with a QIO for that organization to re- bill Medicare for covered services.
view the admissions, quality, appro- (k) In the case of home health agen-
priateness, and diagnostic information cies that provide home health services
related to those inpatient services. The to Medicare beneficiaries under sub-
requirement of this paragraph (e) ap- part E of part 409 and subpart C f part
plies only if, for the area in which the 410 of this chapter, to offer to furnish
hospital or CAH is located, there is a catheters, catheter supplies, ostomy
QIO that has a contract with CMS bags, and supplies related to ostomy
under part B of title XI of the Act. care to any individual who requires
(f) To maintain a system that, during them as part of their furnishing of
the admission process, identifies any home health services.
primary payers other than Medicare, so (l) In the case of a hospital as defined
that incorrect billing and Medicare in § 489.24(b) to comply with § 489.24.
overpayments can be prevented. (m) In the case of a hospital as de-
(g) To bill other primary payers be- fined in § 489.24(b), to report to CMS or
fore Medicare. the State survey agency any time it
(h) If the provider receives payment has reason to believe it may have re-
for the same services from Medicare ceived an individual who has been
and another payer that is primary to transferred in an unstable emergency
Medicare, to reimburse Medicare any
medical condition from another hos-
overpaid amount within 60 days.
pital in violation of the requirements
(i) If the provider receives, from a
of § 489.24(e).
payer that is primary to Medicare, a
(n) In the case of inpatient hospital
payment that is reduced because the
provider failed to file a proper claim— services, to participate in any health
(1) To bill Medicare for an amount no plan contracted for under 10 U.S.C. 1079
greater than would have been payable or 1086 or 38 U.S.C. 613, in accordance
as secondary payment if the primary with § 489.25.
insurer’s payment had been based on a (o) In the case of inpatient hospital
proper claim; and services, to admit veterans whose ad-
(2) To charge the beneficiary only: (i) mission has been authorized under 38
The amount it would have been enti- U.S.C. 603, in accordance with § 489.26.
tled to charge if it had filed a proper
649
§ 489.20 42 CFR Ch. IV (10–1–24 Edition)
(p) To comply with § 489.27 of this (s) In the case of an SNF, either to
part concerning notification of Medi- furnish directly or make arrangements
care beneficiaries of their rights asso- (as defined in § 409.3 of this chapter) for
ciated with the termination of Medi- all Medicare-covered services furnished
care services. to a resident (as defined in § 411.15(p)(3)
(q) In the case of a hospital as defined of this chapter) of the SNF, except the
in § 489.24(b)— following:
(1) To post conspicuously in any (1) Physicians’ services that meet the
emergency department or in a place or criteria of § 415.102(a) of this chapter for
places likely to be noticed by all indi- payment on a fee schedule basis.
viduals entering the emergency depart- (2) Services performed under a physi-
ment, as well as those individuals wait- cian’s supervision by a physician as-
ing for examination and treatment in sistant who meets the applicable defi-
areas other than traditional emergency nition in section 1861(aa)(5) of the Act.
departments (that is, entrance, admit- (3) Services performed by a nurse
ting area, waiting room, treatment practitioner or clinical nurse specialist
area), a sign (in a form specified by the who meets the applicable definition in
Secretary) specifying rights of individ- section 1861(aa)(5) of the Act and is
uals under Section 1867 of the Act with working in collaboration (as defined in
respect to examination and treatment section 1861(aa)(6) of the Act) with a
for emergency medical conditions and physician.
women in labor; and (4) Services performed by a certified
nurse-midwife, as defined in section
(2) To post conspicuously (in a form
1861(gg) of the Act.
specified by the Secretary) information
(5) Services performed by a qualified
indicating whether or not the hospital
psychologist, as defined in section
or rural primary care hospital partici-
1861(ii) of the Act.
pates in the Medicaid program under a
(6) Services performed by a marriage
State plan approved under title XIX.
and family therapist, as defined in sec-
(r) In the case of a hospital as defined tion 1861(lll)(2) of the Act.
in § 489.24(b) (including both the trans- (7) Services performed by a mental
ferring and receiving hospitals), to health counselor, as defined in section
maintain— 1861(lll)(4) of the Act.
(1) Medical and other records related (8) Services performed by a certified
to individuals transferred to or from registered nurse anesthetist, as defined
the hospital for a period of 5 years from in section 1861(bb) of the Act.
the date of the transfer; (9) Dialysis services and supplies, as
(2) An on-call list of physicians who defined in section 1861(s)(2)(F) of the
are on the hospital’s medical staff or Act, and those ambulance services that
who have privileges at the hospital, or are furnished in conjunction with
who are on the staff or have privileges them.
at another hospital participating in a (10) Erythropoietin (EPO) for dialysis
formal community call plan, in accord- patients, as defined in section
ance with § 489.24(j)(2)(iii), available to 1861(s)(2)(O) of the Act.
provide treatment necessary after the (11) Hospice care, as defined in sec-
initial examination to stabilize indi- tion 1861(dd) of the Act.
viduals with emergency medical condi- (12) An ambulance trip that initially
tions who are receiving services re- conveys an individual to the SNF to be
quired under § 489.24 in accordance with admitted as a resident, or that conveys
the resources available to the hospital; an individual from the SNF in connec-
and tion with one of the circumstances
(3) A central log on each individual specified in § 411.15(p)(3)(i) through
who comes to the emergency depart- (p)(3)(iv) of this chapter as ending the
ment, as defined in § 489.24(b), seeking individual’s status as an SNF resident.
assistance and whether he or she re- (13) The transportation costs of elec-
fused treatment, was refused treat- trocardiogram equipment (HCPCS code
ment, or whether he or she was trans- R0076), but only with respect to those
ferred, admitted and treated, stabilized electrocardiogram test services fur-
and transferred, or discharged. nished during 1998.
650
(14) Services described in paragraphs Health Act of 1970 (or a State occupa-
(s)(1) through (8) of this section when tional safety and health plan that is
furnished via telehealth under section approved under section 18(b) of the Oc-
1834(m)(4)(C)(ii)(VII) of the Act. cupational Safety and Health Act)
(15) Those chemotherapy items iden- must comply with the bloodborne
tified, as of July 1, 1999, by HCPCS pathogens (BBP) standards under 29
codes J9000–J9020, J9040–J9151, J9170– CFR 1910.1030. A hospital that fails to
J9185, J9200–J9201, J9206–J9208, J9211, comply with the BBP standards may be
J9230–J9245, and J9265–J9600, and as of subject to a civil money penalty in ac-
January 1, 2004, by HCPCS codes A9522, cordance with section 17 of the Occupa-
A9523, A9533, and A9534 (as subse- tional Safety and Health Act of 1970,
quently modified by CMS), and any ad- including any adjustments of the civil
ditional chemotherapy items identified money penalty amounts under the Fed-
by CMS. eral Civil Penalties Inflation Adjust-
(16) Those chemotherapy administra- ment Act, for a violation of the BBP
tion services identified, as of July 1, standards. A civil money penalty will
1999, by HCPCS codes 36260–36262, 36489, be imposed and collected in the same
36530–36535, 36640, 36823, and 96405–96542 manner as civil money penalties under
(as subsequently modified by CMS), section 1128A(a) of the Social Security
and any additional chemotherapy ad- Act.
ministration services identified by (u) Except as provided in paragraph
CMS. (v) of this section, in the case of a phy-
(17) Those radioisotope services iden- sician-owned hospital as defined at
tified, as of July 1, 1999, by HCPCS § 489.3—
codes 79030–79440 (as subsequently (1) To furnish written notice to each
modified by CMS), and any additional patient at the beginning of the pa-
radioisotope services identified by tient’s hospital stay or outpatient visit
CMS. that the hospital is a physician-owned
(18) Those customized prosthetic de- hospital, in order to assist the patient
vices (including artificial limbs and in making an informed decision regard-
their components) identified, as of July ing his or her care, in accordance with
1, 1999, by HCPCS codes L5050–L5340, § 482.13(b)(2) of this subchapter. The no-
L5500–L5611, L5613–L5986, L5988, L6050– tice should disclose, in a manner rea-
L6370, L6400–6880, L6920–L7274, and sonably designed to be understood by
L7362–L7366 (as subsequently modified all patients, the fact that the hospital
by CMS) and any additional customized meets the Federal definition of a physi-
prosthetic devices identified by CMS, cian-owned hospital specified in § 489.3
which are delivered for a resident’s use and that the list of the hospital’s own-
during a stay in the SNF and intended ers or investors who are physicians or
to be used by the resident after dis- immediate family members (as defined
charge from the SNF. at § 411.351 of this chapter) of physi-
(19) Those blood clotting factors indi- cians is available upon request and
cated for the treatment of patients must be provided to the patient at the
with hemophilia and other bleeding time the request for the list is made by
disorders identified, as of July 1, 2020, or on behalf of the patient. For pur-
by HCPCS codes J7170, J7175, J7177– poses of this paragraph (u)(1), the hos-
J7183, J7185–J7190, J7192–J7195, J7198– pital stay or outpatient visit begins
J7203, J7205, and J7207–J7211 (as subse- with the provision of a package of in-
quently modified by CMS) and items formation regarding scheduled
and services related to the furnishing preadmission testing and registration
of such factors, and any additional for a planned hospital admission for in-
blood clotting factors identified by patient care or an outpatient service.
CMS and items and services related to (2) To require each physician who is a
the furnishing of such factors. member of the hospital’s medical staff
(20) Those RHC and FQHC services to agree, as a condition of continued
that are described in § 405.2411(b)(2) of medical staff membership or admitting
this chapter. privileges, to disclose, in writing, to all
(t) Hospitals that are not otherwise patients the physician refers to the
subject to the Occupational Safety and hospital any ownership or investment
651
§ 489.20 42 CFR Ch. IV (10–1–24 Edition)
interest in the hospital that is held by (3) The written notice must state
the physician or by an immediate fam- that the hospital does not have a doc-
ily member (as defined at § 411.351 of tor of medicine or a doctor of osteop-
this chapter) of the physician. Disclo- athy present in the hospital 24 hours
sure must be required at the time the per day, 7 days per week, and must in-
referral is made. dicate how the hospital will meet the
(v) The requirements of paragraph (u) medical needs of any patient who de-
of this section do not apply to any phy- velops an emergency medical condi-
sician-owned hospital that does not tion, as defined in § 489.24(b), at a time
have at least one referring physician when there is no doctor of medicine or
(as defined at § 411.351 of this chapter) doctor of osteopathy present in the
who has an ownership or investment hospital.
interest in the hospital or who has an (4) Before admitting a patient or pro-
immediate family member who has an viding an outpatient service to out-
ownership or investment interest in patients for whom a notice is required,
the hospital, provided that such hos- the hospital must receive a signed ac-
pital signs an attestation statement to knowledgment from the patient stating
that effect and maintains such attesta- that the patient understands that a
tion in its records. doctor of medicine or doctor of osteop-
(w)(1) In the case of a hospital as de- athy may not be present during all
fined in § 489.24(b), to furnish written hours services are furnished to the pa-
notice to all patients at the beginning tient.
of their planned or unplanned inpatient (5) Each dedicated emergency depart-
hospital stay or at the beginning of ment, as that term is defined in
any planned or unplanned outpatient § 489.24(b), in a hospital in which a doc-
visit for observation, surgery or any tor of medicine or doctor of osteopathy
other procedure requiring anesthesia, if is not present 24 hours per day, 7 days
a doctor of medicine or a doctor of os- per week must post a notice conspicu-
teopathy is not present in the hospital ously in a place or places likely to be
24 hours per day, 7 days per week, in noticed by all individuals entering the
order to assist the patients in making dedicated emergency department. The
informed decisions regarding their posted notice must state that the hos-
care, in accordance with § 482.13(b)(2) of pital does not have a doctor of medi-
this subchapter. For purposes of this cine or a doctor of osteopathy present
paragraph, a planned hospital stay or in the hospital 24 hours per day, 7 days
outpatient visit begins with the provi- per week, and must indicate how the
sion of a package of information re- hospital will meet the medical needs of
garding scheduled preadmission testing any patient with an emergency medical
and registration for a planned hospital condition, as defined in § 489.24(b), at a
admission for inpatient care or out- time when there is no doctor of medi-
patient service. An unplanned hospital cine or doctor of osteopathy present in
stay or outpatient visit begins at the the hospital.
earliest point at which the patient pre- (x) To comply with § 488.30 of this
sents to the hospital. chapter, to pay revisit user fees when
(2) In the case of a hospital that is a and if assessed.
main provider and has one or more re- (y) In the case of a hospital or crit-
mote locations of a hospital or one or ical access hospital, to provide notice,
more satellites, as these terms are de- as specified in paragraphs (y)(1) and (2)
fined in § 413.65(a)(2), § 412.22(h), or of this section, to each individual enti-
§ 412.25(e) of this chapter, as applicable, tled to Medicare benefits under Title
the determination is made separately XVIII of the Act when such individual
for the main provider and each remote receives observation services as an out-
location or satellite whether notice to patient for more than 24 hours. Notice
patients is required. Notice is required must be provided to the individual not
at each location at which inpatient later than 36 hours after observation
services are furnished at which a doc- services are initiated or sooner if the
tor of medicine or doctor of osteopathy individual is transferred, discharged, or
is not present 24 hours per day, 7 days admitted. Notice may be provided be-
per week. fore such individual receives 24 hours
652
of observation services as an outcome effective until approval has been given
patient. by the Office of Management and Budget.
(1) Written notice. Hospitals and crit-
§ 489.21 Specific limitations on
ical access hospitals must use a stand- charges.
ardized written notice, as specified by
the Secretary, which includes the fol- Except as specified in subpart C of
lowing information: this part, the provider agrees not to
(i) An explanation of the status of charge a beneficiary for any of the fol-
the individual as an outpatient receiv- lowing:
ing observation services and not as an (a) Services for which the beneficiary
inpatient of the hospital or critical ac- is entitled to have payment made
cess hospital and the reason for status under Medicare.
as an outpatient receiving observation (b) Services for which the beneficiary
services; and would be entitled to have payment
(ii) An explanation of the implica- made if the provider—
tions of such status as an outpatient on (1) Had in its files the required cer-
services furnished by the hospital or tification and recertification by a phy-
critical access hospital (including serv- sician relating to the services fur-
ices furnished on an inpatient basis), nished to the beneficiary;
such as Medicare cost-sharing require- (2) Had furnished the information re-
ments, and subsequent eligibility for quired by the intermediary in order to
Medicare coverage for skilled nursing determine the amount due the provider
on behalf of the individual for the pe-
facility services.
(2) Oral notice. The hospital must give riod with respect to which payment is
to be made or any prior period;
an oral explanation of the written noti-
(3) Had complied with the provisions
fication described in paragraph (y)(1) of
requiring timely utilization review of
this section.
long stay cases so that a limitation on
(3) Signature requirements. The writ-
days of service has not been imposed
ten notice specified in paragraph (y)(1)
under section 1866(d) of the Act (see
of this section must either—
subpart K of part 405 and part 482 of
(i) Be signed by the individual who
this chapter for utilization review re-
receives observation services as an out-
quirements); and
patient or a person acting on the indi-
(4) Had obtained, from the bene-
vidual’s behalf to acknowledge receipt
ficiary or a person acting on his or her
of such notification; or
behalf, a written request for payment
(ii) If the individual who receives ob-
to be made to the provider, and had
servation services as an outpatient or
properly filed that request. (If the ben-
the person acting on behalf of the indi- eficiary or person on his or her behalf
vidual refuses to provide the signature refuses to execute a written request,
described in paragraph (y)(1) of this the provider may charge the bene-
section, is signed by the staff member ficiary for all services furnished to him
of the hospital or critical access hos- or her.)
pital who presented the written notifi- (c) Inpatient hospital services fur-
cation and includes the name and title nished to a beneficiary who exhausted
of the staff member, a certification his or her Part A benefits, if CMS reim-
that the notification was presented, burses the provider for those services.
and the date and time the notification (d) Custodial care and services not
was presented. reasonable and necessary for the diag-
[45 FR 22937, Apr. 4, 1980] nosis or treatment of illness or injury,
if—
EDITORIAL NOTE: For FEDERAL REGISTER ci-
tations affecting § 489.20, see the List of CFR (1) The beneficiary was without fault
Sections Affected, which appears in the in incurring the expenses; and
Finding Aids section of the printed volume (2) The determination that payment
and at www.govinfo.gov. was incorrect was not made until after
EFFECTIVE DATE NOTE: At 59 FR 32120, June
the third year following the year in
22, 1994, § 489.20(l) through (r) were added. which the payment notice was sent to
Paragraphs (m), (r)(2), and (r)(3) of this sec- the beneficiary.
tion contain information collection and rec- (e) Inpatient hospital services for
ordkeeping requirements and will not be- which a beneficiary would be entitled
653
§ 489.22 42 CFR Ch. IV (10–1–24 Edition)
to have payment made under Part A of ability to pay a deductible or a coin-

Medicare but for a denial or reduction surance amount required under Medi-
in payments under regulations at care.
§ 412.48 of this chapter or under section (d) A provider may not charge an in-
1886(f) of the Act. dividual for (1) its agreement to admit
(f) Items and services furnished to a or readmit the individual on some
hospital inpatient (other than physi- specified future date for covered inpa-
cians’ services as described in tient services; or (2) for failure to re-
§ 415.102(a) of this chapter or the serv- main an inpatient for any agreed-upon
ices of an anesthetist as described in length of time or for failure to give ad-
§ 405.553(b)(4) of this chapter) for which
vance notice of departure from the pro-
Medicare payment would be made if
vider’s facilities.
furnished by the hospital or by other
providers or suppliers under arrange- [45 FR 22937, Apr. 4, 1980, as amended at 68
ments made with them by the hospital. FR 46072, Aug. 4, 2003]
For this purpose, a charge by another
provider or supplier for such an item or § 489.23 Specific limitation on charges
service is treated as a charge by the for services provided to certain en-
hospital for the item or service, and is rollees of fee-for-service FEHB
also prohibited. plans.
(g) [Reserved] A provider that furnishes inpatient
(h) Items and services (other than hospital services to a retired Federal
those described in § 489.20(s)(1) through worker age 65 or older who is enrolled
(15)) required to be furnished under in a fee-for-service FEHB plan and who
§ 489.20(s) to a resident of an SNF (de- is not covered under Medicare Part A,
fined in § 411.15(p) of this chapter), for must accept, as payment in full, an
which Medicare payment would be amount that approximates as closely
made if furnished by the SNF or by as possible the Medicare inpatient hos-
other providers or suppliers under ar-
pital prospective payment system
rangements made with them by the
(PPS) rate established under part 412.
SNF. For this purpose, a charge by an-
The payment to the provider is com-
other provider or supplier for such an
item or service is treated as a charge posed of a payment from the FEHB
by the SNF for the item or service, and plan and a payment from the enrollee.
is also prohibited. This combined payment approximates
the Medicare PPS rate. The payment
[49 FR 324, Jan. 3, 1984, as amended at 51 FR from the FEHB plan approximates, as
22052, June 17, 1986; 52 FR 27765, July 23, 1987;
60 FR 63189, Dec. 8, 1995; 64 FR 41683, July 30,
closely as possible, the Medicare PPS
1999; 65 FR 46796, July 31, 2000; 65 FR 62646, rate minus any applicable enrollee de-
Oct. 19, 2000; 66 FR 39601, July 31, 2001] ductible, coinsurance, or copayment
amount. The payment from the en-
§ 489.22 Special provisions applicable rollee is equal to the applicable deduct-
to prepayment requirements. ible, coinsurance, or copayment
(a) A provider may not require an in- amount.
dividual entitled to hospital insurance
[62 FR 56111, Oct. 29, 1997]
benefits to prepay in part or in whole
for inpatient services as a condition of
§ 489.24 Special responsibilities of
admittance as an inpatient, except Medicare hospitals in emergency
where it is clear upon admission that cases.
payment under Medicare, Part A can-
not be made. (a) Applicability of provisions of this
(b) A provider may not deny covered section. (1) In the case of a hospital that
inpatient services to an individual en- has an emergency department, if an in-
titled to have payment made for those dividual (whether or not eligible for
services on the ground of inability or Medicare benefits and regardless of
failure to pay a requested amount at or ability to pay) ‘‘comes to the emer-
before admission. gency department’’, as defined in para-
(c) A provider may not evict, or graph (b) of this section, the hospital
threaten to evict, an individual for in- must—
654
(i) Provide an appropriate medical upon the implementation of a hospital

screening examination within the capa- disaster protocol, except that, if a pub-
bility of the hospital’s emergency de- lic health emergency involves a pan-
partment, including ancillary services demic infectious disease (such as pan-
routinely available to the emergency demic influenza), the waiver will con-
department, to determine whether or tinue in effect until the termination of
not an emergency medical condition the applicable declaration of a public
exists. The examination must be con- health emergency, as provided under
ducted by an individual(s) who is deter- section 1135(e)(1)(B) of the Act.
mined qualified by hospital bylaws or (b) Definitions. As used in this sub-
rules and regulations and who meets part—
the requirements of § 482.55 of this Capacity means the ability of the hos-
chapter concerning emergency services pital to accommodate the individual
personnel and direction; and requesting examination or treatment
(ii) If an emergency medical condi- of the transferred individual. Capacity
tion is determined to exist, provide any encompasses such things as numbers
necessary stabilizing treatment, as de- and availability of qualified staff, beds
fined in paragraph (d) of this section, and equipment and the hospital’s past
or an appropriate transfer as defined in practices of accommodating additional
paragraph (e) of this section. If the hos- patients in excess of its occupancy lim-
pital admits the individual as an inpa- its.
tient for further treatment, the hos- Comes to the emergency department
pital’s obligation under this section means, with respect to an individual
ends, as specified in paragraph (d)(2) of who is not a patient (as defined in this
this section. section), the individual—
(2)(i) When a waiver has been issued (1) Has presented at a hospital’s dedi-
in accordance with section 1135 of the cated emergency department, as de-
Act that includes a waiver under sec- fined in this section, and requests ex-
tion 1135(b)(3) of the Act, sanctions amination or treatment for a medical
under this section for an inappropriate condition, or has such a request made
transfer or for the direction or reloca- on his or her behalf. In the absence of
tion of an individual to receive medical such a request by or on behalf of the
screening at an alternate location do individual, a request on behalf of the
not apply to a hospital with a dedi- individual will be considered to exist if
cated emergency department if the fol- a prudent layperson observer would be-
lowing conditions are met: lieve, based on the individual’s appear-
(A) The transfer is necessitated by ance or behavior, that the individual
the circumstances of the declared needs examination or treatment for a
emergency in the emergency area dur- medical condition;
ing the emergency period. (2) Has presented on hospital prop-
(B) The direction or relocation of an erty, as defined in this section, other
individual to receive medical screening than the dedicated emergency depart-
at an alternate location is pursuant to ment, and requests examination or
an appropriate State emergency pre- treatment for what may be an emer-
paredness plan or, in the case of a pub- gency medical condition, or has such a
lic health emergency that involves a request made on his or her behalf. In
pandemic infectious disease, pursuant the absence of such a request by or on
to a State pandemic preparedness plan. behalf of the individual, a request on
(C) The hospital does not discrimi- behalf of the individual will be consid-
nate on the basis of an individual’s ered to exist if a prudent layperson ob-
source of payment or ability to pay. server would believe, based on the indi-
(D) The hospital is located in an vidual’s appearance or behavior, that
emergency area during an emergency the individual needs emergency exam-
period, as those terms are defined in ination or treatment;
section 1135(g)(1) of the Act. (3) Is in a ground or air ambulance
(E) There has been a determination owned and operated by the hospital for
that a waiver of sanctions is necessary. purposes of examination and treatment
(ii) A waiver of these sanctions is for a medical condition at a hospital’s
limited to a 72-hour period beginning dedicated emergency department, even
655
§ 489.24 42 CFR Ch. IV (10–1–24 Edition)
if the ambulance is not on hospital (2) It is held out to the public (by
grounds. However, an individual in an name, posted signs, advertising, or
ambulance owned and operated by the other means) as a place that provides
hospital is not considered to have care for emergency medical conditions
‘‘come to the hospital’s emergency de- on an urgent basis without requiring a
partment’’ if— previously scheduled appointment; or
(i) The ambulance is operated under (3) During the calendar year imme-
communitywide emergency medical diately preceding the calendar year in
service (EMS) protocols that direct it which a determination under this sec-
to transport the individual to a hos- tion is being made, based on a rep-
pital other than the hospital that owns resentative sample of patient visits
the ambulance; for example, to the that occurred during that calendar
closest appropriate facility. In this year, it provides at least one-third of
case, the individual is considered to all of its outpatient visits for the treat-
have come to the emergency department of emergency medical conditions
ment of the hospital to which the indi- on an urgent basis without requiring a
vidual is transported, at the time the previously scheduled appointment.
individual is brought onto hospital Emergency medical condition means—
property; (1) A medical condition manifesting
(ii) The ambulance is operated at the itself by acute symptoms of sufficient
direction of a physician who is not em- severity (including severe pain, psy-
ployed or otherwise affiliated with the chiatric disturbances and/or symptoms
hospital that owns the ambulance; or of substance abuse) such that the ab-
(4) Is in a ground or air nonhospital- sence of immediate medical attention
owned ambulance on hospital property could reasonably be expected to result
for presentation for examination and in—
treatment for a medical condition at a (i) Placing the health of the indi-
hospital’s dedicated emergency depart- vidual (or, with respect to a pregnant
ment. However, an individual in a non- woman, the health of the woman or her
hospital-owned ambulance off hospital unborn child) in serious jeopardy;
property is not considered to have (ii) Serious impairment to bodily
come to the hospital’s emergency de- functions; or
partment, even if a member of the am- (iii) Serious dysfunction of any bod-
bulance staff contacts the hospital by ily organ or part; or
telephone or telemetry communica- (2) With respect to a pregnant woman
tions and informs the hospital that who is having contractions—
they want to transport the individual (i) That there is inadequate time to
to the hospital for examination and effect a safe transfer to another hos-
treatment. The hospital may direct the pital before delivery; or
ambulance to another facility if it is in (ii) That transfer may pose a threat
‘‘diversionary status,’’ that is, it does to the health or safety of the woman or
not have the staff or facilities to ac- the unborn child.
cept any additional emergency pa- Hospital includes a critical access
tients. If, however, the ambulance staff hospital as defined in section
disregards the hospital’s diversion in- 1861(mm)(1) of the Act and a rural
structions and transports the indi- emergency hospital as defined in sec-
vidual onto hospital property, the indi- tion 1861(kkk)(2).
vidual is considered to have come to Hospital property means the entire
the emergency department. main hospital campus as defined in
Dedicated emergency department means § 413.65(b) of this chapter, including the
any department or facility of the hos- parking lot, sidewalk, and driveway,
pital, regardless of whether it is lo- but excluding other areas or structures
cated on or off the main hospital cam- of the hospital’s main building that are
pus, that meets at least one of the fol- not part of the hospital, such as physi-
lowing requirements: cian offices, rural health centers,
(1) It is licensed by the State in skilled nursing facilities, or other enti-
which it is located under applicable ties that participate separately under
State law as an emergency room or Medicare, or restaurants, shops, or
emergency department; other nonmedical facilities.
656
Hospital with an emergency department section under paragraph (2) of that def-
means a hospital with a dedicated inition, that the woman has delivered
emergency department as defined in the child and the placenta.
this paragraph (b). To stabilize means, with respect to an
Inpatient means an individual who is ‘‘emergency medical condition’’ as de-
admitted to a hospital for bed occu- fined in this section under paragraph
pancy for purposes of receiving inpa- (1) of that definition, to provide such
tient hospital services as described in medical treatment of the condition
§ 409.10(a) of this chapter with the ex- necessary to assure, within reasonable
pectation that he or she will remain at medical probability, that no material
least overnight and occupy a bed even deterioration of the condition is likely
though the situation later develops to result from or occur during the
that the individual can be discharged transfer of the individual from a facil-
or transferred to another hospital and ity or that, with respect to an ‘‘emer-
does not actually use a hospital bed gency medical condition’’ as defined in
overnight. this section under paragraph (2) of that
Labor means the process of childbirth definition, the woman has delivered the
beginning with the latent or early child and the placenta.
phase of labor and continuing through Transfer means the movement (in-
the delivery of the placenta. A woman cluding the discharge) of an individual
experiencing contractions is in true outside a hospital’s facilities at the di-
labor unless a physician, certified rection of any person employed by (or
nurse-midwife, or other qualified med- affiliated or associated, directly or in-
ical person acting within his or her directly, with) the hospital, but does
scope of practice as defined in hospital not include such a movement of an in-
medical staff bylaws and State law, dividual who (i) has been declared dead,
certifies that, after a reasonable time or (ii) leaves the facility without the
of observation, the woman is in false
permission of any such person.
labor.
(c) Use of dedicated emergency depart-
Participating hospital means:
ment for nonemergency services. If an in-
(i) A hospital;
(ii) A critical access hospital as de- dividual comes to a hospital’s dedi-
fined in section 1861(mm)(1) of the Act cated emergency department and a re-
that has entered into a Medicare pro- quest is made on his or her behalf for
vider agreement under section 1866 of examination or treatment for a med-
the Act; or ical condition, but the nature of the re-
(iii) A rural emergency hospital as quest makes it clear that the medical
defined in section 1861(kkk)(2) of the condition is not of an emergency na-
Act. ture, the hospital is required only to
Patient means— perform such screening as would be ap-
(1) An individual who has begun to propriate for any individual presenting
receive outpatient services as part of in that manner, to determine that the
an encounter, as defined in § 410.2 of individual does not have an emergency
this chapter, other than an encounter medical condition.
that the hospital is obligated by this (d) Necessary stabilizing treatment for
section to provide; emergency medical conditions—(1) Gen-
(2) An individual who has been admit- eral. Subject to the provisions of para-
ted as an inpatient, as defined in this graph (d)(2) of this section, if any indi-
section. vidual (whether or not eligible for
Stabilized means, with respect to an Medicare benefits) comes to a hospital
‘‘emergency medical condition’’ as de- and the hospital determines that the
fined in this section under paragraph individual has an emergency medical
(1) of that definition, that no material condition, the hospital must provide ei-
deterioration of the condition is likely, ther—
within reasonable medical probability, (i) Within the capabilities of the staff
to result from or occur during the and facilities available at the hospital,
transfer of the individual from a facil- for further medical examination and
ity or, with respect to an ‘‘emergency treatment as required to stabilize the
medical condition’’ as defined in this medical condition.
657
§ 489.24 42 CFR Ch. IV (10–1–24 Edition)
(ii) For transfer of the individual to individual’s method of payment or in-

another medical facility in accordance surance status.
with paragraph (e) of this section. (ii) A participating hospital may not
(2) Exception: Application to inpatients. seek, or direct an individual to seek,
(i) If a hospital has screened an indi- authorization from the individual’s in-
vidual under paragraph (a) of this sec- surance company for screening or sta-
tion and found the individual to have bilization services to be furnished by a
an emergency medical condition, and hospital, physician, or nonphysician
admits that individual as an inpatient practitioner to an individual until
in good faith in order to stabilize the after the hospital has provided the ap-
emergency medical condition, the hos- propriate medical screening examina-
pital has satisfied its special respon- tion required under paragraph (a) of
sibilities under this section with re- this section, and initiated any further
spect to that individual. medical examination and treatment
(ii) This section is not applicable to that may be required to stabilize the
an inpatient who was admitted for emergency medical condition under
elective (nonemergency) diagnosis or paragraph (d)(1) of this section.
treatment. (iii) An emergency physician or non-
(iii) A hospital is required by the con- physician practitioner is not precluded
ditions of participation for hospitals from contacting the individual’s physi-
cian at any time to seek advice regard-
under part 482 of this chapter to pro-
ing the individual’s medical history
vide care to its inpatients in accord-
and needs that may be relevant to the
ance with those conditions of partici-
medical treatment and screening of the
pation.
patient, as long as this consultation
(3) Refusal to consent to treatment. A does not inappropriately delay services
hospital meets the requirements of required under paragraph (a) or para-
paragraph (d)(1)(i) of this section with graphs (d)(1) and (d)(2) of this section.
respect to an individual if the hospital (iv) Hospitals may follow reasonable
offers the individual the further med- registration processes for individuals
ical examination and treatment de- for whom examination or treatment is
scribed in that paragraph and informs required by this section, including ask-
the individual (or a person acting on ing whether an individual is insured
the individual’s behalf) of the risks and and, if so, what that insurance is, as
benefits to the individual of the exam- long as that inquiry does not delay
ination and treatment, but the indi- screening or treatment. Reasonable
vidual (or a person acting on the indi- registration processes may not unduly
vidual’s behalf) does not consent to the discourage individuals from remaining
examination or treatment. The med- for further evaluation.
ical record must contain a description (5) Refusal to consent to transfer. A
of the examination, treatment, or both hospital meets the requirements of
if applicable, that was refused by or on paragraph (d)(1)(ii) of this section with
behalf of the individual. The hospital respect to an individual if the hospital
must take all reasonable steps to se- offers to transfer the individual to an-
cure the individual’s written informed other medical facility in accordance
refusal (or that of the person acting on with paragraph (e) of this section and
his or her behalf). The written docu- informs the individual (or a person act-
ment should indicate that the person ing on his or her behalf) of the risks
has been informed of the risks and ben- and benefits to the individual of the
efits of the examination or treatment, transfer, but the individual (or a per-
or both. son acting on the individual’s behalf)
(4) Delay in examination or treatment. does not consent to the transfer. The
(i) A participating hospital may not hospital must take all reasonable steps
delay providing an appropriate medical to secure the individual’s written in-
screening examination required under formed refusal (or that of a person act-
paragraph (a) of this section or further ing on his or her behalf). The written
medical examination and treatment re- document must indicate the person has
quired under paragraph (d)(1) of this been informed of the risks and benefits
section in order to inquire about the of the transfer and state the reasons
658
for the individual’s refusal. The med- that minimizes the risks to the individ-
ical record must contain a description ual’s health and, in the case of a
of the proposed transfer that was re- woman in labor, the health of the un-
fused by or on behalf of the individual. born child;
(e) Restricting transfer until the indi- (ii) The receiving facility—
vidual is stabilized—(1) General. If an in- (A) Has available space and qualified
dividual at a hospital has an emer- personnel for the treatment of the indi-
gency medical condition that has not vidual; and
been stabilized (as defined in paragraph (B) Has agreed to accept transfer of
(b) of this section), the hospital may the individual and to provide appro-
not transfer the individual unless— priate medical treatment;
(i) The transfer is an appropriate (iii) The transferring hospital sends
transfer (within the meaning of para- to the receiving facility all medical
graph (e)(2) of this section); and records (or copies thereof) related to
(ii)(A) The individual (or a legally re- the emergency condition which the in-
sponsible person acting on the individ- dividual has presented that are avail-
ual’s behalf) requests the transfer, able at the time of the transfer, includ-
after being informed of the hospital’s ing available history, records related
obligations under this section and of to the individual’s emergency medical
the risk of transfer. The request must condition, observations of signs or
be in writing and indicate the reasons symptoms, preliminary diagnosis, re-
for the request as well as indicate that sults of diagnostic studies or telephone
he or she is aware of the risks and ben- reports of the studies, treatment pro-
efits of the transfer; vided, results of any tests and the in-
(B) A physician (within the meaning formed written consent or certification
of section 1861(r)(1) of the Act) has (or copy thereof) required under para-
signed a certification that, based upon graph (e)(1)(ii) of this section, and the
the information available at the time name and address of any on-call physi-
of transfer, the medical benefits rea- cian (described in paragraph (g) of this
sonably expected from the provision of section) who has refused or failed to
appropriate medical treatment at an- appear within a reasonable time to pro-
other medical facility outweigh the in- vide necessary stabilizing treatment.
creased risks to the individual or, in Other records (e.g., test results not yet
the case of a woman in labor, to the available or historical records not
woman or the unborn child, from being readily available from the hospital’s
transferred. The certification must files) must be sent as soon as prac-
contain a summary of the risks and ticable after transfer; and
benefits upon which it is based; or (iv) The transfer is effected through
(C) If a physician is not physically qualified personnel and transportation
present in the emergency department equipment, as required, including the
at the time an individual is trans- use of necessary and medically appro-
ferred, a qualified medical person (as priate life support measures during the
determined by the hospital in its by- transfer.
laws or rules and regulations) has (3) A participating hospital may not
signed a certification described in penalize or take adverse action against
paragraph (e)(1)(ii)(B) of this section a physician or a qualified medical per-
after a physician (as defined in section son described in paragraph (e)(1)(ii)(C)
1861(r)(1) of the Act) in consultation of this section because the physician or
with the qualified medical person, qualified medical person refuses to au-
agrees with the certification and subse- thorize the transfer of an individual
quently countersigns the certification. with an emergency medical condition
The certification must contain a sum- that has not been stabilized, or against
mary of the risks and benefits upon any hospital employee because the em-
which it is based. ployee reports a violation of a require-
(2) A transfer to another medical fa- ment of this section.
cility will be appropriate only in those (f) Recipient hospital responsibilities. A
cases in which— participating hospital that has special-
(i) The transferring hospital provides ized capabilities or facilities (includ-
medical treatment within its capacity ing, but not limited to, facilities such
659
§ 489.24 42 CFR Ch. IV (10–1–24 Edition)
as burn units, shock-trauma units, neo- for consultation under paragraph (h)(1)
natal intensive case units, or, with re- of this section, the following provisions
spect to rural areas, regional referral apply—
centers (which, for purposes of this (i) The QIO reviews the case before
subpart, mean hospitals meeting the the 15th calendar day and makes its
requirements of referral centers found tentative findings.
at § 412.96 of this chapter)) may not (ii) Within 15 calendar days of receiv-
refuse to accept from a referring hos- ing the case, the QIO gives written no-
pital within the boundaries of the tice, sent by certified mail, return re-
United States an appropriate transfer ceipt requested, to the physician or the
of an individual who requires such spe- hospital (or both if applicable).
cialized capabilities or facilities if the (iii)(A) The written notice must con-
receiving hospital has the capacity to tain the following information:
treat the individual. (1) The name of each individual who
(1) The provisions of this paragraph may have been the subject of the al-
(f) apply to any participating hospital leged violation.
with specialized capabilities, regardless (2) The date on which each alleged
of whether the hospital has a dedicated violation occurred.
emergency department. (3) An invitation to meet, either by
(2) The provisions of this paragraph telephone or in person, to discuss the
(f) do not apply to an individual who case with the QIO, and to submit addi-
has been admitted to a referring hos- tional information to the QIO within 30
pital under the provisions of paragraph calendar days of receipt of the notice,
(d)(2)(i) of this section. and a statement that these rights will
(g) Termination of provider agreement. be waived if the invitation is not ac-
If a hospital fails to meet the require- cepted. The QIO must receive the infor-
ments of paragraph (a) through (f) of mation and hold the meeting within
this section, CMS may terminate the the 30-day period.
provider agreement in accordance with (4) A copy of the regulations at 42
§ 489.53. CFR 489.24.
(h) Consultation with Quality Improve- (B) For purposes of paragraph
ment Organizations (QIOs)—(1) General. (h)(2)(iii)(A) of this section, the date of
Except as provided in paragraph (h)(3) receipt is presumed to be 5 days after
of this section, in cases where a med- the certified mail date on the notice,
ical opinion is necessary to determine unless there is a reasonable showing to
a physician’s or hospital’s liability the contrary.
under section 1867(d)(1) of the Act, CMS (iv) The physician or hospital (or
requests the appropriate QIO (with a both where applicable) may request a
contract under Part B of title XI of the meeting with the QIO. This meeting is
Act) to review the alleged section not designed to be a formal adversarial
1867(d) violation and provide a report hearing or a mechanism for discovery
on its findings in accordance with para- by the physician or hospital. The meet-
graph (h)(2)(iv) and (v) of this section. ing is intended to afford the physician
CMS provides to the QIO all informa- and/or the hospital a full and fair op-
tion relevant to the case and within its portunity to present the views of the
possession or control. CMS, in con- physician and/or hospital regarding the
sultation with the OIG, also provides case. The following provisions apply to
to the QIO a list of relevant questions that meeting:
to which the QIO must respond in its (A) The physician and/or hospital has
report. the right to have legal counsel present
(2) Notice of review and opportunity for during that meeting. However, the QIO
discussion and additional information. may control the scope, extent, and
The QIO shall provide the physician manner of any questioning or any
and hospital reasonable notice of its re- other presentation by the attorney.
view, a reasonable opportunity for dis- The QIO may also have legal counsel
cussion, and an opportunity for the present.
physician and hospital to submit addi- (B) The QIO makes arrangements so
tional information before issuing its that, if requested by CMS or the OIG, a
report. When a QIO receives a request verbatim transcript of the meeting
660
may be generated. If CMS or OIG re- (3) If a delay would jeopardize the
quests a transcript, the affected physi- health or safety of individuals or when
cian and/or the affected hospital may there was no screening examination,
request that CMS provide a copy of the the QIO review described in this sec-
transcript. tion is not required before the OIG may
(C) The QIO affords the physician impose civil monetary penalties or an
and/or the hospital an opportunity to exclusion in accordance with section
present, with the assistance of counsel, 1867(d)(1) of the Act and 42 CFR part
expert testimony in either oral or writ- 1003 of this title.
ten form on the medical issues pre- (4) If the QIO determines after a pre-
sented. However, the QIO may reason- liminary review that there was an ap-
ably limit the number of witnesses and propriate medical screening examina-
length of such testimony if such testi- tion and the individual did not have an
mony is irrelevant or repetitive. The emergency medical condition, as de-
physician and/or hospital, directly or fined by paragraph (b) of this section,
through counsel, may disclose patient then the QIO may, at its discretion, re-
records to potential expert witnesses turn the case to CMS and not meet the
without violating any non-disclosure requirements of paragraph (h) except
requirements set forth in part 476 of for those in paragraph (h)(2)(v).
this chapter. (i) Release of QIO assessments. Upon
(D) The QIO is not obligated to con- request, CMS may release a QIO assess-
sider any additional information pro- ment to the physician and/or hospital,
or the affected individual, or his or her
vided by the physician and/or the hos-
representative. The QIO physician’s
pital after the meeting, unless, before
identity is confidential unless he or she
the end of the meeting, the QIO re-
consents to its release. (See §§ 476.132
quests that the physician and/or hos-
and 476.133 of this chapter.)
pital submit additional information to
(j) Availability of on-call physicians. In
support the claims. The QIO then al-
accordance with the on-call list re-
lows the physician and/or the hospital
quirements specified in § 489.20(r)(2), a
an additional period of time, not to ex-
hospital must have written policies and
ceed 5 calendar days from the meeting,
procedures in place—
to submit the relevant information to
(1) To respond to situations in which
the QIO. a particular specialty is not available
(v) Within 60 calendar days of receiv- or the on-call physician cannot respond
ing the case, the QIO must submit to because of circumstances beyond the
CMS a report on the QIO’s findings. physician’s control; and
CMS provides copies to the OIG and to (2) To provide that emergency serv-
the affected physician and/or the af- ices are available to meet the needs of
fected hospital. The report must con- individuals with emergency medical
tain the name of the physician and/or conditions if a hospital elects to—
the hospital, the name of the indi- (i) Permit on-call physicians to
vidual, and the dates and times the in- schedule elective surgery during the
dividual arrived at and was transferred time that they are on call;
(or discharged) from the hospital. The (ii) Permit on-call physicians to have
report provides expert medical opinion simultaneous on-call duties; and
regarding whether the individual in- (iii) Participate in a formal commu-
volved had an emergency medical con- nity call plan. Notwithstanding par-
dition, whether the individual’s emer- ticipation in a community call plan,
gency medical condition was stabilized, hospitals are still required to perform
whether the individual was transferred medical screening examinations on in-
appropriately, and whether there were dividuals who present seeking treat-
any medical utilization or quality of ment and to conduct appropriate trans-
care issues involved in the case. fers. The formal community plan must
(vi) The report required under para- include the following elements:
graph (h)(2)(v) of this section should (A) A clear delineation of on-call cov-
not state an opinion or conclusion as erage responsibilities; that is, when
to whether section 1867 of the Act or each hospital participating in the plan
§ 489.24 has been violated. is responsible for on-call coverage.
661
§ 489.25 42 CFR Ch. IV (10–1–24 Edition)
(B) A description of the specific geo- furnished to beneficiaries admitted on

graphic area to which the plan applies. or after January 1, 1987.
(C) A signature by an appropriate
[59 FR 32123, June 22, 1994]
representative of each hospital partici-
pating in the plan. § 489.26 Special requirements con-
(D) Assurances that any local and re- cerning veterans.
gional EMS system protocol formally
For inpatient services, a hospital
includes information on community
that participates in the Medicare pro-
on-call arrangements.
gram must admit any veteran whose
(E) A statement specifying that even
admission is authorized by the Depart-
if an individual arrives at a hospital
ment of Veterans Affairs under 38
that is not designated as the on-call
U.S.C. 603 and must meet the require-
hospital, that hospital still has an obli-
ments of 38 CFR part 17 concerning ad-
gation under § 489.24 to provide a med-
ical screening examination and stabi- missions practices and payment meth-
lizing treatment within its capability, odology and amounts. This section ap-
and that hospitals participating in the plies to services furnished to veterans
community call plan must abide by the admitted on and after July 1, 1987.
regulations under § 489.24 governing ap- [59 FR 32123, June 22, 1994]
propriate transfers.
(F) An annual assessment of the com- § 489.27 Beneficiary notice of dis-
munity call plan by the participating charge rights.
hospitals. (a) A hospital that participates in the
[59 FR 32120, June 22, 1994, as amended at 62 Medicare program must furnish each
FR 46037, Aug. 29, 1997; 65 FR 18548, Apr. 7, Medicare beneficiary or enrollee, (or an
2000; 65 FR 59748, Oct. 6, 2000; 66 FR 1599, Jan. individual acting on his or her behalf),
9, 2001; 66 FR 59923, Nov. 30, 2001; 68 FR 53262, timely notice as required by section
Sept. 9, 2003; 71 FR 48143, Aug. 18, 2006; 72 FR 1866(A)(1)(M) of the Act and in accord-
47413, Aug. 22, 2007; 73 FR 48758, Aug. 19, 2008;
ance with § 405.1205 and § 422.620. The
74 FR 44001, Aug. 27, 2009; 78 FR 50971, Aug.
19, 2013; 87 FR 72309, Nov. 23, 2022] hospital must be able to demonstrate
compliance with this requirement.
EFFECTIVE DATE NOTE: At 59 FR 32120, June (b) Notification by hospitals and other
22, 1994, § 489.24 was added. Paragraphs (d)
and (g) of this section contain information providers. Hospitals and other providers
collection and recordkeeping requirements (as identified at 489.2(b)) that partici-
and will not become effective until approval pate in the Medicare program must fur-
has been given by the Office of Management nish each Medicare beneficiary, or rep-
and Budget. resentative, applicable CMS notices in
advance of discharge or termination of
§ 489.25 Special requirements con- Medicare services, including the no-
cerning CHAMPUS and CHAMPVA
programs. tices required under § 405.1200, § 405.1202,
§ 405.1206, and § 422.624 of this chapter.
For inpatient services, a hospital
that participates in the Medicare pro- [71 FR 68724, Nov. 27, 2006]
gram must participate in any health
§ 489.28 Special capitalization require-
plan contracted under 10 U.S.C. 1079 or
ments for HHAs.
1086 (Civilian Health and Medical Pro-
gram of the Uniformed Services) and (a) Basic rule. An HHA entering the
under 38 U.S.C. 613 (Civilian Health and Medicare program on or after January
Medical Program of the Veterans Ad- 1, 1998, including a new HHA as a result
ministration) and accept the of a change of ownership, if the change
CHAMPUS/CHAMPVA-determined al- of ownership results in a new provider
lowable amount as payment in full, number being issued, must have avail-
less applicable deductible, patient cost- able sufficient funds, which we term
share, and noncovered items. Hospitals ‘‘initial reserve operating funds,’’ at
must meet the requirements of 32 CFR the time of application submission and
part 199 concerning program benefits at all times during the enrollment
under the Department of Defense. This process up to the expiration of the 3-
section applies to inpatient services month period following the conveyance
662
of Medicare billing privileges to oper- (2) [Reserved]

ate the HHA for the three-month pe- (d) Required proof of availability of ini-
riod after Medicare billing privileges tial reserve operating funds. The HHA
are conveyed by the Medicare con- must provide CMS with adequate proof
tractor, exclusive of actual or proof the availability of initial reserve op-
jected accounts receivable from Medi- erating funds. Such proof, at a min-
care. imum, will include a copy of the state-
(b) Standard. Initial reserve operating ment(s) of the HHA’s savings, check-
funds are sufficient to meet the re- ing, or other account(s) that contains
quirement of this section if the total the funds, accompanied by an attesta-
amount of such funds is equal to or tion from an officer of the bank or
greater than the product of the actual other financial institution (if the fi-
average cost per visit of three or more nancial institution offers such attesta-
similarly situated HHAs in their first tions) that the funds are in the ac-
year of operation (selected by CMS for count(s) and that the funds are imme-
comparative purposes) multiplied by diately available to the HHA. In some
the number of visits projected by the cases, an HHA may have all or part of
HHA for its first three months of oper- the initial reserve operating funds in
ation—or 22.5 percent (one fourth of 90 cash equivalents. For the purpose of
percent) of the average number of vis- this section, cash equivalents are
its reported by the comparison HHAs— short-term, highly liquid investments
whichever is greater. that are readily convertible to known
(c) Method. CMS, through the inter- amounts of cash and that present insig-
mediary, will determine the amount of nificant risk of changes in value. A
the initial reserve operating funds cash equivalent that is not readily con-
using reported cost and visit data from vertible to a known amount of cash as
submitted cost reports for the first full needed during the initial 3-month pe-
year of operation from at least three riod for which the initial reserve oper-
HHAs that the intermediary serves ating funds are required does not qual-
that are comparable to the HHA that is ify in meeting the initial reserve oper-
seeking to enter the Medicare program, ating funds requirement. Examples of
considering such factors as geographic cash equivalents for the purpose of this
location and urban/rural status, num- section are Treasury bills, commercial
ber of visits, provider-based versus paper, and money market funds. As
free-standing, and proprietary versus with funds in a checking, savings, or
non-proprietary status. The determina- other account, the HHA also must be
tion of the adequacy of the required able to document the availability of
initial reserve operating funds is based any cash equivalents. CMS later may
on the average cost per visit of the require the HHA to furnish another at-
comparable HHAs, by dividing the sum testation from the financial institution
of total reported costs of the HHAs in that the funds remain available, or, if
their first year of operation by the sum applicable, documentation from the
of the HHAs’ total reported visits. The HHA that any cash equivalents remain
resulting average cost per visit is then available, until a date when the HHA
multiplied by the projected visits for will have been surveyed by the State
the first three months of operation of agency or by an approved accrediting
the HHA seeking to enter the program, organization. The officer of the HHA
but not less than 90 percent of average who will be certifying the accuracy of
visits for a three month period for the the information on the HHA’s cost re-
HHAs used in determining the average port must certify what portion of the
cost per visit. required initial reserve operating funds
(1) In selecting the comparative is non-borrowed funds, including funds
HHAs as described in this paragraph invested in the business by the owner.
(c), the CMS contractor shall only se- That amount must be at least 50 per-
lect HHAs that have provided cost recent of the required initial reserve op-
ports to Medicare. When selecting cost erating funds. The remainder of the re-
reports for the comparative analysis, serve operating funds may be secured
CMS will exclude low utilization or no through borrowing or line of credit
utilization cost reports. from an unrelated lender.
663
§ 489.29 42 CFR Ch. IV (10–1–24 Edition)
(e) Borrowed funds. If borrowed funds § 489.29 Special requirements con-

are not in the same account(s) as the cerning beneficiaries served by the
HHA’s own non-borrowed funds, the Indian Health Service, Tribal health
HHA also must provide proof that the programs, and urban Indian organi-
zation health programs.
borrowed funds are available for use in
operating the HHA, by providing, at a (a) Hospitals (as defined in sections
minimum, a copy of the statement(s) 1861(e) and (f) of the Social Security
of the HHA’s savings, checking, or Act) and critical access hospitals (as
other account(s) containing the bor- defined in section 1861(mm)(1) of the
rowed funds, accompanied by an attes- Social Security Act) that participate
tation from an officer of the bank or in the Medicare program and furnish
inpatient hospital services must accept
other financial institution (if the fi-
the payment methodology and no more
nancial institution offers such attesta-
than the rates of payment established
tions) that the funds are in the ac-
under 42 CFR part 136, subpart D as
count(s) and are immediately available payment in full for the following pro-
to the HHA. As with the HHA’s own grams:
(that is, non-borrowed) funds, CMS (1) A contract health service (CHS)
later may require the HHA to establish program under 42 CFR part 136, subpart
the current availability of such bor- C, of the Indian Health Service (IHS);
rowed funds, including furnishing an (2) A CHS program under 42 CFR part
attestation from a financial institution 136, subpart C, carried out by an Indian
or other source, as may be appropriate, Tribe or Tribal organization pursuant
and to establish that such funds will to the Indian Self-Determination and
remain available until a date when the Education Assistance Act, as amended,
HHA will have been surveyed by the Public Law 93–638, 25 U.S.C. 450 et seq.;
State agency or by an approved accred- and
iting organization. (3) A program funded through a grant
(f) Line of credit. If the HHA chooses or contract by the IHS and operated by
to support the availability of a portion an urban Indian organization under
of the initial reserve operating funds which items and services are purchased
with a line of credit, it must provide for an eligible urban Indian (as those
CMS with a letter of credit from the terms are defined in 25 U.S.C. 1603 (f)
lender. CMS later may require the HHA and (h)).
to furnish an attestation from the (b) Hospitals and critical access hos-
lender that the HHA, upon its certifi- pitals may not refuse service to an in-
cation into the Medicare program, con- dividual on the basis that the payment
for such service is authorized under
tinues to be approved to borrow the
programs described in paragraph (a) of
amount specified in the letter of credit.
this section.
(g) Billing Privileges. (1) CMS may
deny Medicare billing privileges to an [72 FR 30711, June 4, 2007]
HHA unless the HHA meets the initial
reserve operating funds requirements Subpart C—Allowable Charges
of this section.
(2) CMS may revoke the Medicare § 489.30 Allowable charges:
Deductibles and coinsurance.
billing privileges of an HHA that fails
to maintain and comply with the ini- (a) Part A deductible and coinsurance.
tial reserve operating funds require- The provider may charge the bene-
ments of this section for the three- ficiary or other person on his or her be-
month period after it receives its Medi- half:
care billing privileges. (1) The amount of the inpatient hos-
pital deductible or, if less, the actual
[63 FR 312, Jan. 5, 1998, as amended at 75 FR charges for the services;
70465, Nov. 17, 2010; 86 FR 62430, Nov. 9, 2021] (2) The amount of inpatient hospital
coinsurance applicable for each day the
individual is furnished inpatient hos-
pital services after the 60th day, during
a benefit period; and
664
(3) The posthospital SNF care coin- the basic allowable charges are the
surance amount. Part B annual deductible and 20 per-
(4) In the case of durable medical cent of the inflation-adjusted payment
equipment (DME) furnished as a home amount for the rebatable drug in ex-
health service, 20 percent of the cus- cess of that deductible, which is ap-
tomary charge for the service. plied as a percent to the payment
(b) Part B deductible and coinsurance. amount for such calendar quarter.
(1) The basic allowable charges are the (7) In the case of insulin furnished on
Part B annual deductible and 20 per- or after July 1, 2023 through an item of
cent of the customary (insofar as rea- durable medical equipment covered
sonable) charges in excess of that de-
under section 1861(n) of the Act, the co-
ductible, except as specified in para-
insurance amount shall not exceed $35
graphs (b)(6) and (7) of this section.
(2) For hospital outpatient services, for a month’s supply of such insulin
the allowable deductible charges de- each calendar month. This limitation
pend on whether the hospital can de- on the coinsurance amount shall apply
termine the beneficiary’s deductible for the duration of the calendar month
status. in which the date of service (or serv-
(i) If the hospital is unable to deter- ices) occurs. In addition, the coinsur-
mine the deductible status, it may ance amount shall not exceed $105.00
charge the beneficiary its full cus- for 3 months’ supply of insulin. This
tomary charges up to $75. limitation on the coinsurance amount
(ii) If the beneficiary provides official shall apply for the duration of the cal-
information as to deductible status, endar month in which the date of serv-
the hospital may charge only the ice (or services) occurs and the 2 fol-
unmet portion of the deductible. lowing calendar months.
(3) In either of the cases discussed in
paragraph (b)(2) of this section, the FR 41350, Nov. 14, 1986; 88 FR 79552, Nov. 16,
hospital is required to file with the 2023]
intermediary, on a form prescribed by
CMS, information as to the services, § 489.31 Allowable charges: Blood.
charges, and amounts collected.
(4) The intermediary must reimburse (a) Limitations on charges. (1) A pro-
the beneficiary if reimbursement is au- vider may charge the beneficiary (or
thorized and credit the expenses to the other person on his or her behalf) only
beneficiary’s deductible if the deduct- for the first three pints of blood or
ible has not yet been met. units of packed red cells furnished
(5) In the case of DME furnished as a under Medicare Part A during a cal-
home health service under Medicare endar year, or furnished under Medi-
Part B, the coinsurance is 20 percent of care Part B during a calendar year.
the customary (insofar as reasonable) (2) The charges may not exceed the
charge for the services, with the fol- provider’s customary charges.
lowing exception: If the DME is used (3) The provider may not charge for
DME purchased by or on behalf of the any whole blood or packed red cells in
beneficiary at a price at least 25 per- any of the circumstances specified in
cent less than the reasonable charge § 409.87(c)(2) of this chapter.
for comparable new equipment, no co- (b) Offset for excessive charges. If the
insurance is required. charge exceeds the cost to the provider,
(6) In the case of a rebatable drug (as that excess will be deducted from any
defined in section 1847A(i)(2)(A) of the Medicare payments due the provider.
Act), including a selected drug (as de-
fined in section 1192(c) of the Act), fur- [56 FR 23022, May 20, 1991, as amended at 57
nished on or after April 1, 2023, in a cal- FR 36018, Aug. 12, 1992]
endar quarter in which the payment
amount for such drug as specified in § 489.32 Allowable charges: Non-
section 1847A(i)(3)(A)(ii)(I)(aa) or (bb), covered and partially covered serv-
ices.
as applicable, exceeds the inflation-ad-
justed amount (as defined in section (a) Services requested by beneficiary. If
1847A(i)(3)(C) of the Act) for such drug, services furnished at the request of a
665
§ 489.34 42 CFR Ch. IV (10–1–24 Edition)
beneficiary (or his or her representa- § 489.35 Notice to intermediary.

tive) are more expensive than, or in ex-
The provider must inform its inter-
cess of, services covered under Medi-
mediary of any amounts collected from
care—
a beneficiary or from other persons on
(1) A provider may charge the bene- his or her behalf.
ficiary an amount that does not exceed
the difference between—
(i) The provider’s customary charges Subpart D—Handling of Incorrect
for the services furnished; and Collections
(ii) The provider’s customary charges
§ 489.40 Definition of incorrect collec-
for the kinds and amounts of services tion.
that are covered under Medicare.
(2) A provider may not charge for the (a) As used in this subpart, ‘‘incor-
services unless they have been re- rect collections’’ means any amounts
quested by the beneficiary (or his or collected from a beneficiary (or some-
her representative) nor require a bene- one on his or her behalf) that are not
ficiary to request services as a condi- authorized under subpart C of this part.
tion of admission. (b) A payment properly made to a
(3) To avoid misunderstanding and provider by an individual not consid-
disputes, a provider must inform any ered entitled to Medicare benefits will
beneficiary who requests a service for be deemed to be an ‘‘incorrect collec-
which a charge will be made that there tion’’ when the individual is found to
will be a specified charge for that serv- be retroactively entitled to benefits.
ice.
§ 489.41 Timing and methods of han-
(b) Services not requested by the bene- dling.
ficiary. For special provisions that
apply when a provider customarily fur- (a) Refund. Prompt refund to the ben-
nishes more expensive services, see eficiary or other person is the preferred
§ 413.35 of this chapter. method of handling incorrect collec-
tions.
[45 FR 22937, Apr. 4, 1980, as amended at 51 (b) Setting aside. If the provider can-
FR 34833, Sept. 30, 1986] not refund within 60 days from the date
on the notice of incorrect collection, it
§ 489.34 Allowable charges: Hospitals
participating in State reimburse- must set aside an amount, equal to the
ment control systems or demonstra- amount incorrectly collected, in a sep-
tion projects. arate account identified as to the indi-
vidual to whom the payment is due.
A hospital receiving payment for a
This amount incorrectly collected
covered hospital stay under either a
must be carried on the provider’s
State reimbursement control system
records in this manner until final dis-
approved under 1886(c) of the Act or a
position is made in accordance with
demonstration project authorized
the applicable State law.
under section 402(a) of Pub. L. 90–248 (42
(c) Notice to, and action by, inter-
U.S.C. 1395b–1) or section 222(a) of Pub.
mediary. (1) The provider must notify
L. 92–603 (42 U.S.C. 1395b–1 (note)) and
the intermediary of the refund or set-
that would otherwise be subject to the
ting aside required under paragraphs
prospective payment system set forth
(a) and (b) of this section.
in part 412 of this chapter may charge
(2) If the provider fails to refund or
a beneficiary for noncovered services
set aside the required amounts, they
as follows:
may be offset against amounts other-
(a) For the custodial care and medi-
wise due the provider.
cally unnecessary services described in
§ 412.42(c) of this chapter, after the con- § 489.42 Payment of offset amounts to
ditions of § 412.42(c)(1) through (c)(4) are beneficiary or other person.
met; and
(a) In order to carry out the commit-
(b) For all other services in accord-
ment to refund amounts incorrectly
ance with the applicable rules of this
collected, CMS may determine that
subpart C.
amounts offset in accordance with
[54 FR 41747, Oct. 11, 1989] § 489.41 are to be paid directly to the
666
beneficiary or other person from whom (3) The notice may state the intended
the provider received the incorrect col- date of termination which must be the
lection, if: first day of the month.
(1) CMS finds that the provider has (b) Termination date. (1) If the notice
failed, following written request, to re- does not specify a date, or the date is
fund the amount of the incorrect col- not acceptable to CMS, CMS may set a
lection to the beneficiary or other per- date that will not be more than 6
son; and months from the date on the provider’s
(2) The provider agreement has been notice of intent.
terminated in accordance with the pro- (2) CMS may accept a termination
visions of subpart E of this part. date that is less than 6 months after
(b) Before making a determination to the date on the provider’s notice if it
make payment under paragraph (a) of determines that to do so would not un-
this section, CMS will give written no- duly disrupt services to the community
tice to the provider (1) explaining that or otherwise interfere with the effec-
tive and efficient administration of the
an incorrect collection was made and
Medicare program.
the amount; (2) requesting the provider
(3) A cessation of business is deemed
to refund the incorrect collection to
to be a termination by the provider, ef-
the beneficiary or other person; and (3)
fective with the date on which it
advising of CMS’s intention to make a
stopped providing services to the com-
determination under paragraph (a) of
munity.
this section. (4) A provider may request a retro-
(c) The notice will afford an author- active termination date if no Medicare
ized official of the provider an oppor- beneficiary received services from the
tunity to submit, within 20 days from facility on or after the requested ter-
the date on the notice, written state- mination date.
ment or evidence with respect to the (c) Public notice. (1) The provider
incorrect collection and/or offset must give notice to the public at least
amounts. CMS will consider any writ- 15 days before the effective date of ter-
ten statement or evidence in making a mination.
determination. (2) The notice must—
(d) Payment to a beneficiary or other (i) Specify the termination date; and
person under the provisions of para- (ii) Explain to what extent services
graph (a) of this section: may continue after that date, in ac-
(1) Will not exceed the amount of the cordance with the exceptions set forth
incorrect collection; and in § 489.55.
(2) May be considered as payment [45 FR 22937, Apr. 4, 1980, as amended at 76
made to the provider. FR 9512, Feb. 18, 2011; 81 FR 68872, Oct. 4, 2016;
82 FR 38516, Aug. 14, 2017; 88 FR 77880, Nov.
Subpart E—Termination of Agree- 13, 2023]
ment and Reinstatement After § 489.53 Termination by CMS.
Termination (a) Basis for termination of agreement.
§ 489.52 Termination by the provider. CMS may terminate the agreement
with any provider if CMS finds that
(a) Notice to CMS. (1) A provider that any of the following failings is attrib-
wishes to terminate its agreement, ex- utable to that provider, and may, in
cept for a SNF as specified in para- addition to the applicable require-
graph (a)(2) of this section, must send ments in this chapter governing the
CMS written notice of its intention in termination of agreements with sup-
accordance with paragraph (a)(3) of pliers, terminate the agreement with
this section. any supplier to which the failings in
(2) A SNF that wishes to terminate paragraphs (a)(2), (13) and (18) of this
its agreement due to closure of the fa- section are attributable:
cility must send CMS written notice of (1) It is not complying with the pro-
its intention at least 60 days prior to visions of title XVIII and the applica-
the date of closure, as required at ble regulations of this chapter or with
§ 483.70(l) of this chapter. the provisions of the agreement.
667
§ 489.53 42 CFR Ch. IV (10–1–24 Edition)
(2) The provider or supplier places re- other information by, or on behalf of,
strictions on the persons it will accept CMS, as necessary to determine or
for treatment and it fails either to ex- verify compliance with participation
empt Medicare beneficiaries from those requirements.
restrictions or to apply them to Medi- (14) The hospital knowingly and will-
care beneficiaries the same as to all fully fails to accept, on a repeated
other persons seeking care. basis, an amount that approximates
(3) It no longer meets the appropriate the Medicare rate established under
conditions of participation or require- the inpatient hospital prospective pay-
ments (for SNFs and NFs) set forth ment system, minus any enrollee
elsewhere in this chapter. In the case deductibles or copayments, as payment
of an RNHCI, it no longer meets the in full from a fee-for-service FEHB
conditions for coverage, conditions of plan for inpatient hospital services pro-
participation and requirements set vided to a retired Federal enrollee of a
forth elsewhere in this chapter. In the fee-for-service FEHB plan, age 65 or
case of an OTP, it no longer meets the older, who does not have Medicare Part
requirements set forth in this section A benefits.
and elsewhere in this chapter. (15) It had its enrollment in the Medi-
(4) It fails to furnish information care program revoked in accordance to
that CMS finds necessary for a deter- § 424.535 of this chapter.
mination as to whether payments are (16) It has failed to pay a revisit user
or were due under Medicare and the fee when and if assessed.
amounts due. (17) In the case of an HHA or hospice
(5) It refuses to permit examination program, it failed to correct any defi-
of its fiscal or other records by, or on ciencies within the required time
behalf of CMS, as necessary for frame.
verification of information furnished (18) The provider or supplier fails to
as a basis for payment under Medicare. grant immediate access upon a reason-
(6) It failed to furnish information on able request to a state survey agency
business transactions as required in or other authorized entity for the pur-
§ 420.205 of this chapter. pose of determining, in accordance
(7) It failed at the time the agree- with § 488.3, whether the provider or
ment was entered into or renewed to supplier meets the applicable require-
disclose information on convicted indi- ments, conditions of participation, con-
viduals as required in § 420.204 of this ditions for coverage, or conditions for
chapter. certification.
(8) It failed to furnish ownership in- (b) Termination of agreements with cer-
formation as required in § 420.206 of this tain hospitals. In the case of a hospital
chapter. or critical access hospital that has an
(9) It failed to comply with civil emergency department, as defined in
rights requirements set forth in 45 CFR § 489.24(b), CMS may terminate the pro-
parts 80, 84, and 90. vider agreement if—
(10) In the case of a hospital or a crit- (1) The hospital fails to comply with
ical access hospital as defined in sec- the requirements of § 489.24 (a) through
tion 1861(mm)(1) of the Act that has (e), which require the hospital to exam-
reason to believe it may have received ine, treat, or transfer emergency med-
an individual transferred by another ical condition cases appropriately, and
hospital in violation of § 489.24(d), the require that hospitals with specialized
hospital failed to report the incident to capabilities or facilities accept an ap-
CMS or the State survey agency. propriate transfer; or
(11) In the case of a hospital re- (2) The hospital fails to comply with
quested to furnish inpatient services to § 489.20(m), (q), and (r), which require
CHAMPUS or CHAMPVA beneficiaries the hospital to report suspected viola-
or to veterans, it failed to comply with tions of § 489.24(e), to post conspicu-
§ 489.25 or § 489.26, respectively. ously in emergency departments or in
(12) It failed to furnish the notice of a place or places likely to be noticed
discharge rights as required by § 489.27. by all individuals entering the emer-
(13) The provider or supplier refuses gency departments, as well as those in-
to permit copying of any records or dividuals waiting for examination and
668
treatment in areas other than tradi- least 2 days before the effective date of
tional emergency departments, (that termination of the provider agreement.
is, entrance, admitting area, waiting (iii) Home health agencies (HHAs). For
room, treatment area), signs specifying an HHA with deficiencies that pose im-
rights of individuals under this sub- mediate jeopardy to the health and
part, to post conspicuously informa- safety of patients, CMS gives notice to
tion indicating whether or not the hos- the HHA at least 2 days before the ef-
pital participates in the Medicaid pro- fective date of termination of the pro-
gram, and to maintain medical and vider agreement.
other records related to transferred in- (3) Notice of LTC facility closure. In the
dividuals for a period of 5 years, a list case of a facility where CMS termi-
of on-call physicians for individuals nates a facility’s participation under
with emergency medical conditions, Medicare or Medicaid in the absence of
and a central log on each individual immediate jeopardy, CMS determines
who comes to the emergency depart- the appropriate date for notification.
ment seeking assistance. (4) Content of notice. The notice states
(c) Termination of agreements with hos- the reasons for, and the effective date
pitals that fail to make required disclo- of, the termination, and explains the
sures. In the case of a physician-owned extent to which services may continue
hospital, as defined at § 489.3, CMS may after that date, in accordance with
terminate the provider agreement if § 489.55.
the hospital failed to comply with the (5) Notice to public. CMS concurrently
requirements of § 489.20(u) or (w). In the gives notice of the termination to the
case of other participating hospitals, as public.
defined at § 489.24, CMS may terminate (e) Appeal by the provider. A provider
the provider agreement if the partici- may appeal the termination of its pro-
pating hospital failed to comply with vider agreement by CMS in accordance
the requirements of § 489.20(w). with part 498 of this chapter.
(d) Notice of termination—(1) Timing: [51 FR 24492, July 3, 1986]
basic rule. Except as provided in para- EDITORIAL NOTE: For FEDERAL REGISTER ci-
graphs (d)(2) and (d)(3) of this section, tations affecting § 489.53, see the List of CFR
CMS gives the provider notice of termi- Sections Affected, which appears in the
nation at least 15 days before the effec- Finding Aids section of the printed volume
tive date of termination of the provider and at www.govinfo.gov.
agreement.
(2) Timing exceptions: Immediate jeop- § 489.54 Termination by the OIG.
ardy situations—(i) Hospitals. If CMS (a) Basis for termination. (1) The OIG
finds that a hospital is in violation of may terminate the agreement of any
§ 489.24(a) through (f), and CMS deter- provider if the OIG finds that any of
mines that the violation poses imme- the following failings can be attributed
diate jeopardy to the health or safety to that provider.
of individuals who present themselves (i) It has knowingly and willfully
to the hospital for emergency services, made, or caused to be made, any false
CMS— statement or representation of a mate-
(A) Gives the hospital a preliminary rial fact for use in an application or re-
notice indicating that its provider quest for payment under Medicare.
agreement will be terminated in 23 (ii) It has submitted, or caused to be
days if it does not correct the identi- submitted, requests for Medicare pay-
fied deficiencies or refute the finding; ment of amounts that substantially ex-
and ceed the costs it incurred in furnishing
(B) Gives a final notice of termi- the services for which payment is re-
nation, and concurrent notice to the quested.
public, at least 2 , but not more than 4, (iii) It has furnished services that the
days before the effective date of termi- OIG has determined to be substantially
nation of the provider agreement. in excess of the needs of individuals or
(ii) Skilled nursing facilities (SNFs). of a quality that fails to meet profes-
For an SNF with deficiencies that pose sionally recognized standards of health
immediate jeopardy to the health or care. The OIG will not terminate a pro-
safety of residents, CMS gives notice at vider agreement under paragraph (a) if
669
§ 489.55 42 CFR Ch. IV (10–1–24 Edition)
CMS has waived a disallowance with § 489.57 Reinstatement after termi-

respect to the services in question on nation.
the grounds that the provider and the When a provider agreement has been
beneficiary could not reasonably be ex- terminated by CMS under § 489.53, or by
pected to know that payment would the OIG under § 489.54, a new agreement
not be made. (The rules for deter- with that provider will not be accepted
mining such lack of knowledge are set unless CMS or the OIG, as appropriate,
forth in §§ 405.330 through 405.334 of this finds—
chapter.) (a) That the reason for termination
(b) Notice of termination. The OIG will of the previous agreement has been re-
give the provider notice of termination moved and there is reasonable assur-
at least 15 days before the effective ance that it will not recur; and
date of termination of the agreement, (b) That the provider has fulfilled, or
and will concurrently give notice of has made satisfactory arrangements to
termination to the public. fulfill, all of the statutory and regu-
(c) Appeal by the provider. A provider latory responsibilities of its previous
may appeal a termination of its agree- agreement.
ment by the OIG in accordance with
[51 FR 24493, July 3, 1986]
subpart O of part 405 of this chapter.
(d) Other applicable rules. The termi-
nation of a provider agreement by the Subpart F—Surety Bond
OIG is subject to the additional proce- Requirements for HHAs
dures specified in §§ 1001.105 through
1001.109 of this title for notice and ap- SOURCE: 63 FR 313, Jan. 5, 1998, unless oth-
peals. erwise noted.
[51 FR 24492, July 3, 1986, as amended at 51 § 489.60 Definitions.
FR 34788, Sept. 30, 1986]
As used in this subpart unless the
§ 489.55 Exceptions to effective date of context indicates otherwise—
termination. Assessment means a sum certain that
CMS may assess against an HHA in
(a) Payment is available for up to 30
lieu of damages under Titles XI, XVIII,
days after the effective date of termi-
or XXI of the Social Security Act or
nation for:
under regulations in this chapter.
(1) Inpatient hospital services (in- Assets includes but is not limited to
cluding inpatient psychiatric hospital any listing that identifies Medicare
services) and post hospital extended beneficiaries to whom home health
care services (except as specified in services were furnished by a partici-
paragraph (b) of this section with re- pating or formerly participating HHA.
spect to LTC facilities) furnished to a Civil money penalty means a sum cer-
beneficiary who was admitted before tain that CMS has the authority to im-
the effective date of termination; and pose on an HHA as a penalty under Ti-
(2) Home health services and hospice tles XI, XVIII, or XXI of the Social Se-
care furnished under a plan established curity Act or under regulations in this
before the effective date of termi- chapter.
nation. Participating home health agency
(b) The Secretary may, as the Sec- means a ‘‘home health agency’’ (HHA),
retary determines is appropriate, con- as that term is defined by section
tinue to make payments with respect 1861(o) of the Social Security Act, that
to residents of a long-term care facility also meets the definition of a ‘‘pro-
that has submitted a notification of vider’’ set forth at § 400.202 of this chap-
closure as required at § 483.70(l) of this ter.
chapter during the period beginning on Rider means a notice issued by a Sur-
the date such notification is submitted ety that a change in the bond has oc-
and ending on the date on which the curred or will occur.
residents are successfully relocated. Surety bond means one or more bonds
[76 FR 9512, Feb. 18, 2011, as amended at 78 issued by one or more surety compa-
FR 16805, Mar. 19, 2013; 81 FR 68872, Oct. 4, nies under 31 U.S.C. 9304 to 9308 and 31
2016] CFR parts 223, 224, and 225, provided
670
the bond otherwise meets the require- under State law, and CMS therefore
ments of this section. waives the requirements of this sub-
Unpaid civil money penalty or assess- part with respect to such an HHA if,
ment means a civil money penalty or during the preceding 5 years the HHA
assessment imposed by CMS on an has—
HHA under Titles XI, XVIII, or XXI of (a) Not had any unpaid claims or un-
the Social Security Act, plus accrued paid civil money penalties or assess-
interest, that, after the HHA or Surety ments; and
has exhausted all administrative ap- (b) Not had any of its claims referred
peals, remains unpaid (because the by CMS to the Department of Justice
civil money penalty or assessment has or the General Accounting Office in ac-
not been paid to, or offset or com- cordance with part 401 of this chapter.
promised by, CMS) and is not the sub- [63 FR 313, Jan. 5, 1998, as amended at 63 FR
ject of a written arrangement, accept- 29655, June 1, 1998]
able to CMS, for payment by the HHA.
In the event a written arrangement for § 489.63 Parties to the bond.
payment, acceptable to CMS, is made, The surety bond must name the HHA
an unpaid civil money penalty or assess- as Principal, CMS as Obligee, and the
ment also means such civil money pen- surety company (and its heirs, execu-
alty or assessment, plus accrued inter- tors, administrators, successors and as-
est, that remains due 60 days after the signees, jointly and severally) as Sur-
HHA’s default on such arrangement. ety.
Unpaid claim means a Medicare over-
payment for which the HHA is respon- § 489.64 Authorized Surety and exclu-
sible, plus accrued interest, that, 90 sion of surety companies.
days after the date of the agency’s no- (a) An HHA may obtain a surety bond
tice to the HHA of the overpayment, required under § 489.61 only from an au-
remains due (because the overpayment thorized Surety.
has not been paid to, or recouped or (b) An authorized Surety is a surety
compromised by, CMS) and is not the company that—
subject of a written arrangement, ac- (1) Has been issued a Certificate of
ceptable to CMS, for payment by the Authority by the U.S. Department of
HHA. In the event a written arrange- the Treasury in accordance with 31
ment for payment, acceptable to CMS, U.S.C. 9304 to 9308 and 31 CFR parts 223,
is made, an unpaid claim also means a 224, and 225 as an acceptable surety on
Medicare overpayment for which the Federal bonds and the Certificate has
HHA is responsible, plus accrued inter- neither expired nor been revoked; and
est, that remains due 60 days after the (2) Has not been determined by CMS
HHA’s default on such arrangement. to be an unauthorized Surety for the
[63 FR 313, Jan. 5, 1998, as amended at 63 FR purpose of an HHA obtaining a surety
29655, June 1, 1998] bond under this section.
(c) CMS determines that a surety
§ 489.61 Basic requirement for surety company is an unauthorized Surety
bonds. under this section—
Except as provided in § 489.62, each (1) If, upon request by CMS, the sur-
HHA that is a Medicare participating ety company fails to furnish timely
HHA, or that seeks to become a Medi- confirmation of the issuance of, and
care participating HHA, must obtain a the validity and accuracy of informa-
surety bond (and furnish to CMS a copy tion appearing on, a surety bond an
of such surety bond) that meets the re- HHA presents to CMS that shows the
quirements of this subpart F and surety company as Surety on the bond;
CMS’s instructions. (2) If, upon presentation by CMS to
the surety company of a request for
§ 489.62 Requirement waived for Gov- payment on a surety bond and of suffi-
ernment-operated HHAs. cient evidence to establish the surety
An HHA operated by a Federal, company’s liability on the bond, the
State, local, or tribal government surety company fails to timely pay
agency is deemed to have provided CMS in full the amount requested, up
CMS with a comparable surety bond to the face amount of the bond; or
671
§ 489.65 42 CFR Ch. IV (10–1–24 Edition)
(3) For other good cause. assets or the ownership interest of a

(d) Any determination CMS makes participating or formerly participating
under paragraph (c) of this section is HHA, the 15 percent is computed on the
effective immediately when notice of basis of Medicare payments made by
the determination is published in the CMS to the participating or formerly
FEDERAL REGISTER and remains in ef- participating HHA in the most recent
fect until a notice of reinstatement is fiscal year that a cost report has been
published in the FEDERAL REGISTER. accepted.
(e) Any determination CMS makes (d) Change of ownership. For an HHA
under paragraph (c) of this section does that undergoes a change of ownership
not affect the Surety’s liability under the 15 percent is computed on the basis
any surety bond issued by a surety of Medicare payments made by CMS to
company to an HHA before notice of the HHA for the most recently accept-
such determination is published in ac- ed cost report.
cordance with paragraph (d) of this sec- (e) An HHA that seeks to become a par-
tion. ticipating HHA without obtaining assets
(f) A determination by CMS that a or ownership interest. For an HHA that
surety company is an unauthorized seeks to become a participating HHA
Surety under this section is not a de- without purchasing the assets or the
barment, suspension, or exclusion for ownership interest of a participating or
the purposes of Executive Order No. formerly participating HHA, the 15 per-
12549 (3 CFR, 1986 comp., p. 189). cent computation does not apply.
(f) Exception to the basic rule. If an
§ 489.65 Amount of the bond. HHA’s overpayment in the most re-
(a) Basic rule. The amount of the sur- cently accepted cost report exceeds 15
ety bond must be $50,000 or 15 percent percent of annual payments, CMS may
of the Medicare payments made by require the HHA to secure a bond in an
CMS to the HHA in the HHA’s most re- amount up to or equal to the amount
cent fiscal year for which a cost report of overpayment, provided the amount
has been accepted by CMS, whichever of the bond is not less than $50,000.
is greater. (g) Expiration of the 15 percent provi-
(b) Computation of the 15 percent: Par- sion. For an annual surety bond, or for
ticipating HHA. The 15 percent is com- a rider on a continuous surety bond,
puted as follows: that is required to be submitted on or
(1) For the initial bond—on the basis after June 1, 2005, notwithstanding any
of Medicare payments made by CMS to reference in this subpart to 15 percent
the HHA in the HHA’s most recent fis- as a basis for determining the amount
cal year as shown in the HHA’s most of the bond, the amount of the bond or
recent cost report that has been ac- rider, as applicable, must be $50,000 or
cepted by CMS. If the initial bond will such amount as CMS specifies in ac-
cover less than a full fiscal year, the cordance with paragraph (f) of this sec-
computation of the 15 percent will be tion, whichever amount is greater.
based on the number of months of the [63 FR 313, Jan. 5, 1998, as amended at 63 FR
fiscal year that the bond will cover. 29655, June 1, 1998]
(2) For subsequent bonds—on the
basis of Medicare payments made by § 489.66 Additional requirements of
CMS in the most recent fiscal year for the surety bond.
which a cost report has been accepted. The surety bond that an HHA obtains
However, if payments in the first six under this subpart must meet the fol-
months of the current fiscal year differ lowing additional requirements:
from such an amount by more than 25 (a) The bond must guarantee that
percent, then the amount of the bond is within 30 days of receiving written no-
15 percent of such payments projected tice from CMS of an unpaid claim or
on an annualized basis. unpaid civil money penalty or assess-
(c) Computation of 15 percent: An HHA ment, which notice contains sufficient
that seeks to become a participating HHA evidence to establish the Surety’s li-
by obtaining assets or ownership interest. ability under the bond, the Surety will
For an HHA that seeks to become a pay CMS, up to the stated amount of
participating HHA by purchasing the the bond—
672
(1) The full amount of any unpaid HHA of action by the HHA to termi-
claim, plus accrued interest, for which nate or limit the scope of the bond, or
the HHA is responsible; and not later than 60 days before the effec-
(2) The full amount of any unpaid tive date of such action by the Surety;
civil money penalty or assessment im- or
posed by CMS on the HHA, plus ac- (ii) The HHA furnishes CMS with a
crued interest. new bond that meets the requirements
(b) The bond must provide the fol- of this subpart.
lowing: (2) The Surety’s failure to continue
(1) The Surety is liable for unpaid to meet the requirements of § 489.64(a)
claims, unpaid civil money penalties, or CMS’s determination that the sur-
and unpaid assessments that are dis- ety company is an unauthorized Surety
covered when the surety bond is in ef- under § 489.64(b).
fect, regardless of when the payment, (3) Termination of the HHA’s pro-
overpayment, or other event giving vider agreement.
rise to the claim, civil money penalty, (4) Any action by CMS to suspend,
or assessment occurred, provided CMS offset, or otherwise recover payments
makes a written demand for payment to the HHA.
from the Surety during, or within 90 (5) Any action by the HHA to—
days after, the term of the bond. (i) Cease operation;
(2) If the HHA fails to furnish a bond (ii) Sell or transfer any asset or own-
meeting the requirements of this sub- ership interest;
part F for the year following expiration (iii) File for bankruptcy; or
of the term of an annual bond, or if the (iv) Fail to pay the Surety.
HHA fails to submit a rider when a (6) Any fraud, misrepresentation, or
rider is required to be submitted under negligence by the HHA in obtaining the
this subpart, or if the HHA’s provider surety bond or by the Surety (or by the
agreement is terminated, the last bond Surety’s agent, if any) in issuing the
or rider, as applicable, submitted by surety bond, except that any fraud,
the HHA to CMS, which bond or appli- misrepresentation, or negligence by
cable rider meets the requirements of the HHA in identifying to the Surety
this subpart, remains effective and the (or to the Surety’s agent) the amount
Surety remains liable for unpaid of Medicare payments upon which the
claims, civil money penalties, and as- amount of the surety bond is deter-
sessments that— mined will not cause the Surety’s li-
(i) CMS determines or imposes on or ability to CMS to exceed the amount of
asserts against the HHA based on over- the bond.
payments or other events that took (7) The HHA’s failure to exercise
place during or prior to the term of the available appeal rights under Medicare
last bond or rider; and or to assign such rights to the Surety.
(ii) Were determined or imposed dur- (d) The bond must provide that ac-
ing the 2 years following the date the tions under the bond may be brought
HHA failed to submit a bond or re- by CMS or by CMS’s fiscal inter-
quired rider or the date the HHA’s pro- mediaries.
vider agreement is terminated, which- (e) The bond must provide the Sure-
ever is later. ty’s name, street address or post office
(c) The bond must provide that the box number, city, state, and zipcode to
Surety’s liability to CMS under the which the CMS notice provided for in
bond is not extinguished by any action paragraph (a) of this section is to be
of the HHA, the Surety, or CMS, in- sent.
cluding but not necessarily limited to [63 FR 313, Jan. 5, 1998, as amended at 63 FR
any of the following actions: 29655, June 1, 1998]
(1) Action by the HHA or the Surety
to terminate or limit the scope or term § 489.67 Term and type of bond.
of the bond. The Surety’s liability may (a) Each participating HHA that does
be extinguished, however, when— not meet the criteria for waiver under
(i) The Surety furnishes CMS with § 489.62 must submit to CMS in a form
notice of such action not later than 10 as CMS may specify, a surety bond for
days after receiving notice from the a term beginning January 1, 1998. If an
673
§ 489.68 42 CFR Ch. IV (10–1–24 Edition)
annual bond is submitted for the initial surety bond to CMS within 60 days
term, it must be effective through the after it receives notice from CMS that
end of the HHA’s current fiscal year. it no longer meets the criteria for
(b) Type of bond. The type of bond re- waiver.
quired to be submitted by an HHA (f) Change of Surety. An HHA that ob-
under this subpart may be either— tains a replacement surety bond from a
(1) An annual bond (that is, a bond different Surety to cover the remaining
that specifies an effective annual pe- term of a previously obtained bond
riod corresponding to the HHA’s fiscal must submit the new surety bond to
year); or CMS within 30 days of obtaining the
(2) A continuous bond (that is, a bond
bond from the new Surety.
that remains in full force and effect
from term to term unless it is termi- (Authority: Secs. 1102 and 1871 of the Social
nated or canceled as provided for in the Security Act (42 U.S.C. 1302 and 1395hh))
bond or as otherwise provided by law) [63 FR 315, Jan. 5, 1998, as amended at 63 FR
that is updated by the Surety, via the 10731, Mar. 4, 1998; 63 FR 29656, June 1, 1998;
issuance of a rider, for a particular fis- 63 FR 41171, July 31, 1998]
cal year for which the bond amount has
changed or will change. § 489.68 Effect of failure to obtain,
(c) HHA that seeks to become a partici- maintain, and timely file a surety
pating HHA. (1) An HHA that seeks to bond.
become a participating HHA must sub- (a) The failure of a participating
mit a surety bond with its enrollment HHA to obtain, file timely, and main-
application (Form CMS–855, OMB num-
tain a surety bond in accordance with
ber 0938–0685). The term of the initial
this subpart F and CMS’s instructions
surety bond must be effective from the
effective date of provider agreement as is sufficient under § 489.53(a)(1) for CMS
specified in § 489.13 of this part. How- to terminate the HHA’s provider agree-
ever, if the effective date of the pro- ment.
vider agreement is less than 30 days be- (b) The failure of an HHA seeking to
fore the end of the HHA’s current fiscal become a participating HHA to obtain
year, the HHA may obtain a bond effec- and file timely a surety bond in accord-
tive through the end of the next fiscal ance with this Subpart F and CMS’s in-
year, provided the amount of the bond structions is sufficient under
is the greater of $75,000 or 20 percent of § 489.12(a)(3) for CMS to refuse to enter
the amount determined from the com- into a provider agreement with the
putation specified in § 489.65(c) as appli- HHA.
cable.
(2) An HHA that seeks to become a § 489.69 Evidence of compliance.
participating HHA through the pur- (a) CMS may at any time require an
chase or transfer of assets or ownership HHA to make a specific showing of
interest of a participating or formerly
being in compliance with the require-
participating HHA must also ensure
ments of this Subpart F and may re-
that the surety bond is effective from
quire the HHA to submit such addi-
the date of such purchase or transfer.
(d) Change of ownership. An HHA that tional evidence as CMS considers suffi-
undergoes a change of ownership must cient to demonstrate the HHA’s com-
submit the surety bond to CMS not pliance.
later than the effective date of the (b) If requested by CMS to do so, the
change of ownership and the bond must failure of an HHA to timely furnish
be effective from the effective date of sufficient evidence to CMS to dem-
the change of ownership through the onstrate compliance with the require-
remainder of the HHA’s fiscal year. ments of this Subpart F is sufficient
(e) Government-operated HHA that for CMS to terminate the HHA’s pro-
loses its waiver. A government-operated vider agreement under § 489.53(a)(1) or
HHA that, as of January 1, 1998, meets to refuse to enter into a provider agree-
the criteria for waiver under § 489.62 ment with the HHA under § 489.12(a)(3),
but thereafter is determined by CMS to as applicable.
not meet such criteria, must submit a
674
§ 489.70 Effect of payment by the Sur- § 489.73 Effect of conditions of pay-

ety. ment.
A Surety’s payment to CMS under a If a Surety has paid an amount to
bond for an unpaid claim or an unpaid CMS on the basis of liability incurred
civil money penalty or assessment, under a bond obtained by an HHA
constitutes— under this subpart F, and CMS subse-
(a) Collection of the unpaid claim or quently collects from the HHA, in
unpaid civil money penalty or assess- whole or in part, on such unpaid claim,
civil money penalty, or assessment
ment (to the extent the Surety’s pay-
that was the basis for the Surety’s li-
ment on the bond covers such unpaid
ability, CMS reimburses the Surety
claim, civil money penalty, or assess-
such amount as CMS collected from
ment); and the HHA, up to the amount paid by the
(b) A basis for termination of the Surety to CMS, provided the Surety
HHA’s provider agreement under has no other liability to CMS under the
§ 489.53(a)(1). bond.
§ 489.71 Surety’s standing to appeal (Authority: Secs. 1102 and 1871 of the Social
Medicare determinations. Security Act (42 U.S.C. 1302 and 1395hh))
A Surety has standing to appeal any [63 FR 29656, June 1, 1998]

matter that the HHA could appeal, pro- § 489.74 Incorporation into existing
vided the Surety satisfies all jurisdic- provider agreements.
tional and procedural requirements
The requirements of this subpart F
that would otherwise have applied to
are deemed to be incorporated into ex-
the HHA, and provided the HHA is not, isting HHA provider agreements effec-
itself, actively pursuing its appeal tive January 1, 1998.
rights under this chapter, and provided
further that, with respect to unpaid [63 FR 315, Jan. 5, 1998. Redesignated at 63 FR
29656, June 1, 1998]
claims, the Surety has paid CMS all
amounts owed to CMS by the HHA on
such unpaid claims, up to the amount Subparts G–H [Reserved]
of the bond.
Subpart I—Advance Directives
[63 FR 29656, June 1, 1998]
§ 489.72 Effect of review reversing de- SOURCE: 57 FR 8203, Mar. 6, 1992, unless oth-
termination. erwise noted.
In the event a Surety has paid CMS § 489.100 Definition.

on the basis of liability incurred under For purposes of this part, advance di-
a bond obtained by an HHA under this rective means a written instruction,
subpart F, and to the extent the HHA such as a living will or durable power
that obtained such bond (or the Surety of attorney for health care, recognized
under § 489.71) is subsequently success- under State law (whether statutory or
ful in appealing the determination that as recognized by the courts of the
was the basis of the unpaid claim or State), relating to the provision of
unpaid civil money penalty or assess- health care when the individual is inca-
ment that caused the Surety to pay pacitated.
CMS under the bond, CMS will refund
to the Surety the amount the Surety § 489.102 Requirements for providers.
paid to CMS to the extent such amount (a) Hospitals, critical access hos-
relates to the matter that was success- pitals, rural emergency hospitals,
fully appealed by the HHA (or by the skilled nursing facilities, nursing fa-
Surety), provided all review, including cilities, home health agencies, pro-
judicial review, has been completed on viders of home health care (and for
such matter. Any additional amounts Medicaid purposes, providers of per-
owing as a result of the appeal will be sonal care services), hospices, and reli-
gious nonmedical health care institu-
paid to the HHA.
tions must maintain written policies
675
§ 489.102 42 CFR Ch. IV (10–1–24 Edition)
and procedures concerning advance di- State) regarding advance directives.

rectives with respect to all adult indi- The provider must inform individuals
viduals receiving medical care, or pa- that complaints concerning the ad-
tient care in the case of a patient in a vance directive requirements may be
religious nonmedical health care insti- filed with the State survey and certifi-
tution, by or through the provider and cation agency;
are required to: (5) Provide for education of staff con-
(1) Provide written information to cerning its policies and procedures on
such individuals concerning— advance directives; and
(i) An individual’s rights under State (6) Provide for community education
law (whether statutory or recognized regarding issues concerning advance
by the courts of the State) to make de- directives that may include material
cisions concerning such medical care, required in paragraph (a)(1) of this sec-
including the right to accept or refuse tion, either directly or in concert with
medical or surgical treatment and the other providers and organizations. Sep-
right to formulate, at the individual’s arate community education materials
option, advance directives. Providers may be developed and used, at the dis-
are permitted to contract with other cretion of providers. The same written
entities to furnish this information but materials do not have to be provided in
are still legally responsible for ensur- all settings, but the material should
ing that the requirements of this sec- define what constitutes an advance di-
tion are met. Providers are to update rective, emphasizing that an advance
and disseminate amended information directive is designed to enhance an in-
as soon as possible, but no later than 90 capacitated individual’s control over
days from the effective date of the medical treatment, and describe appli-
changes to State law; and cable State law concerning advance di-
(ii) The written policies of the pro- rectives. A provider must be able to
vider or organization respecting the
document its community education ef-
implementation of such rights, includ-
forts.
ing a clear and precise statement of
(b) The information specified in para-
limitation if the provider cannot im-
graph (a) of this section is furnished:
plement an advance directive on the
basis of conscience. At a minimum, a (1) In the case of a hospital, at the
provider’s statement of limitation time of the individual’s admission as
should: an inpatient.
(A) Clarify any differences between (2) In the case of a skilled nursing fa-
institution-wide conscience objections cility at the time of the individual’s
and those that may be raised by indi- admission as a resident.
vidual physicians; (3)(i) In the case of a home health
(B) Identify the state legal authority agency, in advance of the individual
permitting such objection; and coming under the care of the agency.
(C) Describe the range of medical The HHA may furnish advance direc-
conditions or procedures affected by tives information to a patient at the
the conscience objection. time of the first home visit, as long as
(2) Document in a prominent part of the information is furnished before
the individual’s current medical care is provided.
record, or patient care record in the (ii) In the case of personal care serv-
case of an individual in a religious non- ices, in advance of the individual com-
medical health care institution, wheth- ing under the care of the personal care
er or not the individual has executed services provider. The personal care
an advance directive; provider may furnish advance direc-
(3) Not condition the provision of tives information to a patient at the
care or otherwise discriminate against time of the first home visit, as long as
an individual based on whether or not the information is furnished before
the individual has executed an advance care is provided.
directive; (4) In the case of a hospice program,
(4) Ensure compliance with require- at the time of initial receipt of hospice
ments of State law (whether statutory care by the individual from the pro-
or recognized by the courts of the gram.
676
(5) In the case of a rural emergency PART 491—CERTIFICATION OF

hospital, at the time of the individual’s CERTAIN HEALTH FACILITIES
registration as a patient.
(c) The providers listed in paragraph Subpart A—Rural Health Clinics: Conditions
(a) of this section— for Certification; and FQHCs Conditions
(1) Are not required to provide care for Coverage
that conflicts with an advance direc-
Sec.
tive. 491.1 Purpose and scope.
(2) Are not required to implement an 491.2 Definitions.
advance directive if, as a matter of 491.3 Certification procedures.
conscience, the provider cannot imple- 491.4 Compliance with Federal, State and
ment an advance directive and State local laws.
491.5 Location of clinic.
law allows any health care provider or
491.6 Physical plant and environment.
any agent of such provider to conscien- 491.7 Organizational structure.
tiously object. 491.8 Staffing and staff responsibilities.
(d) Prepaid or eligible organizations 491.9 Provision of services.
(as specified in sections 1833(a)(1)(A) 491.10 Patient health records.
and 1876(b) of the Act) must meet the 491.11 Program evaluation.
491.12 Emergency preparedness.
requirements specified in § 417.436 of
this chapter. AUTHORITY: 42 U.S.C. 263a and 1302.
(e) If an adult individual is incapaci-
tated at the time of admission or at Subpart A—Rural Health Clinics:
the start of care and is unable to re- Conditions for Certification;
ceive information (due to the incapaci- and FQHCs Conditions for
tating conditions or a mental disorder) Coverage
or articulate whether or not he or she
has executed an advance directive, § 491.1 Purpose and scope.
then the provider may give advance di- This subpart sets forth the condi-
rective information to the individual’s tions that rural health clinics or
family or surrogate in the same man- FQHCs must meet in order to qualify
ner that it issues other materials about for reimbursement under Medicare
policies and procedures to the family of (title XVIII of the Social Security Act)
the incapacitated individual or to a and that rural health clinics must
surrogate or other concerned persons meet in order to qualify for reimburse-
in accordance with State law. The pro- ment under Medicaid (title XIX of the
vider is not relieved of its obligation to Act).
provide this information to the indi- [57 FR 24982, June 12, 1992]
vidual once he or she is no longer inca-
pacitated or unable to receive such in- § 491.2 Definitions.
formation. Follow-up procedures must As used in this subpart, unless the
be in place to provide the information context indicates otherwise:
to the individual directly at the appro- Certified nurse-midwife (CNM) means
priate time. an individual who meets the applicable
education, training, and other require-
[57 FR 8203, Mar. 6, 1992, as amended at 59 FR ments at § 410.77(a) of this chapter.
45403, Sept. 1, 1994; 60 FR 33294, June 27, 1995;
Clinical psychologist (CP) means an in-
62 FR 46037, Aug. 29, 1997; 64 FR 67052, Nov. 30,
1999; 68 FR 66720, Nov. 28, 2003; 88 FR 59336,
dividual who meets the applicable edu-
Aug. 28, 2023] cation, training, and other require-
ments of § 410.71(d) of this chapter.
§ 489.104 Effective dates. Clinical social worker means an indi-
vidual who meets the applicable edu-
These provisions apply to services cation, training, and other require-
furnished on or after December 1, 1991 ments at § 410.73(a) of this chapter.
payments made under section Direct services means services pro-
1833(a)(1)(A) of the Act on or after De- vided by the clinic’s staff.
cember 1, 1991, and contracts effective FQHC means an entity as defined in
on or after December 1, 1991. § 405.2401(b).
677
§ 491.2 42 CFR Ch. IV (10–1–24 Edition)
Marriage and family therapist means Physician assistant means a person

an individual who meets the applicable who meets the applicable State re-
education, training, and other require- quirements governing the qualifica-
ments at § 410.53 of this chapter. tions for assistants to primary care
Mental health counselor means an in- physicians, and who meets at least one
dividual who meets the applicable edu- of the following conditions:
cation, training, and other require- (1) Is currently certified by the Na-
ments at § 410.54 of this chapter. tional Commission on Certification of
Nurse practitioner means a person who Physician Assistants to assist primary
meets the applicable State require- care physicians; or
ments governing the qualifications for (2) Has satisfactorily completed a
nurse practitioners, and who meets at program for preparing physician’s as-
least one of the following conditions: sistants that:
(1) Is certified as a nurse practitioner
(i) Was at least 1 academic year in
by a recognized national certifying
length;
body that has established standards for
nurse practitioners and possesses a (ii) Consisted of supervised clinical
master’s or doctoral degree in nursing practice and at least 4 months (in the
practice; or aggregate) of classroom instruction di-
(2) Has satisfactorily completed a rected toward preparing students to de-
formal 1 academic year educational liver health care; and
program that: (iii) Was accredited by the American
(i) Prepares registered nurses to per- Medical Association’s Committee on
form an expanded role in the delivery Allied Health Education and Accredita-
of primary care; tion; or
(ii) Includes at least 4 months (in the (3) Has satisfactorily completed a
aggregate) of classroom instruction formal educational program (for pre-
and a component of supervised clinical paring physician assistants) that does
practice; and not meet the requirements of para-
(iii) Awards a degree, diploma, or cer- graph (2) of this definition and assisted
tificate to persons who successfully primary care physicians for a total of
complete the program; or 12 months during the 18-month period
(3) Has successfully completed a for- that ended on December 31, 1986.
mal educational program (for pre- Rural area means an area that is not
paring registered nurses to perform an delineated as an urbanized area by the
expanded role in the delivery of pri- Bureau of the Census.
mary care) that does not meet the re- Rural health clinic or clinic means a
quirements of paragraph (2) of this def- clinic that is located in a rural area
inition, and has been performing an ex- designated as a shortage area, is not a
panded role in the delivery of primary rehabilitation agency or a facility pri-
care for a total of 12 months during the marily for the care and treatment of
18-month period immediately preceding mental diseases, and meets all other
the effective date of this subpart. requirements of this subpart.
Physician means the following:
Shortage area means a defined geo-
(1) As it pertains to the supervision,
graphic area designated by the Depart-
collaboration, and oversight require-
ment as having either a shortage of
ments in sections 1861(aa)(2)(B) and
personal health services (under section
(aa)(3) of the Act, a doctor of medicine
1302(7) of the Public Health Service
or osteopathy legally authorized to
Act) or a shortage of primary medical
practice medicine or surgery in the
care manpower (under section 332 of
State in which the function is per-
that Act).
formed; and
(2) Within limitations as to the spe- Secretary means the Secretary of
cific services furnished, a doctor of Health and Human Services, or any of-
dental surgery or of dental medicine, a ficial to whom he has delegated the
doctor of optometry, a doctor of podia- pertinent authority.
try or surgical chiropody or a chiro- [71 FR 55345, Sept. 22, 2006, as amended at 79
practor (see section 1861(r) of the Act FR 27156, May 12, 2014; 88 FR 79552, Nov. 16,
for specific limitations). 2023]
678
§ 491.3 Certification procedures. (b) Exceptions. (1) CMS does not dis-
A rural health clinic will be certified qualify an RHC approved under this
for participation in Medicare in accord- subpart if the area in which it is lo-
ance with subpart S of 42 CFR part 405. cated subsequently fails to meet the
The Secretary will notify the State definition of a rural, shortage area.
Medicaid agency whenever he has cer- (2) A private, nonprofit facility that
tified or denied certification under meets all other conditions of this sub-
Medicare for a prospective rural health part except for location in a shortage
clinic in that State. A clinic certified area will be certified if, on July 1, 1977,
under Medicare will be deemed to meet it was operating in a rural area that is
the standards for certification under determined by the Secretary (on the
Medicaid. basis of the ratio of primary care phy-
[71 FR 55346, Sept. 22, 2006] sicians to the general population) to
have an insufficient supply of physi-
§ 491.4 Compliance with Federal, State cians to meet the needs of the area
and local laws. served.
The rural health clinic or FQHC and (3) Determinations on these excep-
its staff are in compliance with appli- tions will be made by the Secretary
cable Federal, State and local laws and upon application by the facility.
regulations. (c) Criteria for designation of rural
(a) Licensure of clinic or center. The areas. (1) Rural areas are areas not de-
clinic or center is licensed pursuant to lineated as urbanized areas in the last
applicable State and local law.
census conducted by the Census Bu-
(b) Licensure, certification or registra-
reau.
tion of personnel. Staff of the clinic or
center are licensed, certified or reg- (2) Excluded from the rural area clas-
istered in accordance with applicable sification are:
State and local laws. (i) Central cities of 50,000 inhabitants
or more;
[57 FR 24982, June 12, 1992]
(ii) Cities with at least 25,000 inhab-
§ 491.5 Location of clinic. itants which, together with contiguous
areas having stipulated population den-
(a) Basic requirements. (1) An RHC is
sity, have combined populations of
located in a rural area that is des-
ignated as a shortage area. 50,000 and constitute, for general eco-
(2) An FQHC is located in a rural or nomic and social purposes, single com-
urban area that is designated as either munities;
a shortage area or an area that has a (iii) Closely settled territories sur-
medically underserved population. rounding cities and specifically des-
(3) Both the RHC and the FQHC may ignated by the Census Bureau as urban.
be permanent or mobile units. (3) Included in the rural area classi-
(i) Permanent unit. The objects, equip- fication are those portions of extended
ment, and supplies necessary for the cities that the Census Bureau has de-
provision of the services furnished di- termined to be rural.
rectly by the clinic or center are (d) Criteria for designation of shortage
housed in a permanent structure. areas. (1) The criteria for determina-
(ii) Mobile unit. The objects, equip- tion of shortage of personal health
ment, and supplies necessary for the services (under section 1302(7) of the
provision of the services furnished di- Public Health Services Act), are:
rectly by the clinic or center are
(i) The ratio of primary care physi-
housed in a mobile structure, which
cians practicing within the area to the
has fixed, scheduled location(s).
(iii) Permanent unit in more than one resident population;
location. If clinic or center services are (ii) The infant mortality rate;
furnished at permanent units in more (iii) The percent of the population 65
than one location, each unit is inde- years of age or older; and
pendently considered for approval as a (iv) The percent of the population
rural health clinic or for approval as an with a family income below the pov-
FQHC. erty level.
679
§ 491.6 42 CFR Ch. IV (10–1–24 Edition)
(2) The criteria for determination of (3) The premises are clean and or-
shortage of primary medical care man- derly.
power (under section 332(a)(1)(A) of the [57 FR 24983, June 12, 1992, as amended at 81
Public Health Services Act) are: FR 64041, Sept. 16, 2016]
(i) The area served is a rational area
for the delivery of primary medical § 491.7 Organizational structure.
care services; (a) Basic requirements. (1) The clinic
(ii) The ratio of primary care physi- or center is under the medical direc-
cians practicing within the area to the tion of a physician, and has a health
resident population; and care staff that meets the requirements
(iii) The primary medical care man- of § 491.8.
power in contiguous areas is overuti- (2) The organization’s policies and its
lized, excessively distant, or inacces- lines of authority and responsibilities
sible to the population in this area. are clearly set forth in writing.
(e) Medically underserved population. (b) Disclosure. The clinic or center
A medically underserved population in- discloses the names and addresses of:
cludes the following: (1) Its owners, in accordance with
(1) A population of an urban or rural section 1124 of the Social Security Act
area that is designated by PHS as hav- (42 U.S.C. 132 A–3);
ing a shortage of personal health serv- (2) The person principally responsible
ices. for directing the operation of the clinic
(2) A population group that is des- or center; and
ignated by PHS as having a shortage of (3) The person responsible for med-
personal health services. ical direction.
(f) Requirements specific to FQHCs. An [57 FR 24983, June 12, 1992]
FQHC approved for participation in
Medicare must meet one of the fol- § 491.8 Staffing and staff responsibil-
lowing criteria: ities.
(1) Furnish services to a medically (a) Staffing. (1) The clinic or center
underserved population. has a health care staff that includes
(2) Be located in a medically under- one or more physicians. Rural health
served area, as demonstrated by an ap- clinic staffs must also include one or
plication approved by PHS. more physician’s assistants or nurse
practitioners.
CROSS REFERENCE: See 42 CFR 110.203(g) (41 (2) The physician member of the staff
FR 45718, Oct. 15, 1976) and 42 CFR Part 5 (42
FR 1586, Jan. 10, 1978).
may be the owner of the rural health
clinic, an employee of the clinic or cen-
[43 FR 5375, Feb. 8, 1978. Redesignated at 50 ter, or under agreement with the clinic
FR 33034, Aug. 16, 1985, and amended at 57 FR or center to carry out the responsibil-
24982, June 12, 1992; 61 FR 14658, Apr. 3, 1996; ities required under this section.
68 FR 74816, Dec. 24, 2003; 71 FR 55346, Sept.
22, 2006]
(3) The physician assistant, nurse
practitioner, certified nurse-midwife,
§ 491.6 Physical plant and environ- clinical social worker, clinical psychol-
ment. ogist, marriage and family therapist,
or mental health counselor member of
(a) Construction. The clinic or center the staff may be the owner or an em-
is constructed, arranged, and main- ployee of the clinic or center, or may
tained to insure access to and safety of furnish services under contract to the
patients, and provides adequate space clinic or center. In the case of a clinic,
for the provision of direct services. at least one physician assistant or
(b) Maintenance. The clinic or center nurse practitioner must be an em-
has a preventive maintenance program ployee of the clinic.
to ensure that: (4) The staff may also include ancil-
(1) All essential mechanical, elec- lary personnel who are supervised by
trical and patient-care equipment is the professional staff.
maintained in safe operating condition; (5) The staff is sufficient to provide
(2) Drugs and biologicals are appro- the services essential to the operation
priately stored; and of the clinic or center.
680
(6) A physician, nurse practitioner, transferred as required when patients

physician assistant, certified nurse- are referred.
midwife, clinical social worker, clinical [57 FR 24983, June 12, 1992, as amended at 61
psychologist, marriage and family FR 14658, Apr. 3, 1996; 68 FR 74817, Dec. 24,
therapist, or a mental health counselor 2003; 71 FR 55346, Sept. 22, 2006; 79 FR 25480,
is available to furnish patient care May 2, 2014; 79 FR 27156, May 12, 2014; 86 FR
services at all times the clinic or cen- 61626, Nov. 5, 2021; 88 FR 36510, June 5, 2023; 88
ter operates. In addition, for RHCs, a FR 79553, Nov. 16, 2023]
nurse practitioner, physician assistant,
or certified nurse-midwife is available § 491.9 Provision of services.
to furnish patient care services at least (a) Basic requirements. (1) All services
50 percent of the time the RHC oper- offered by the clinic or center are fur-
ates. nished in accordance with applicable
(b) Physician responsibilities. The phy- Federal, State, and local laws; and
sician performs the following: (2) The clinic or center is primarily
(1) Except for services furnished by a engaged in providing outpatient health
clinical psychologist in an FQHC, services and meets all other conditions
which State law permits to be provided of this subpart.
without physician supervision, pro- (3) The laboratory requirements in
vides medical direction for the clinic’s paragraph (c)(2) of this section apply to
or center’s health care activities and RHCs, but do not apply to FQHCs.
consultation for, and medical super- (b) Patient care policies. (1) The clin-
vision of, the health care staff. ic’s or center’s health care services are
(2) In conjunction with the physician furnished in accordance with appro-
assistant and/or nurse practitioner priate written policies which are con-
member(s), participates in developing, sistent with applicable State law.
executing, and periodically reviewing (2) The policies are developed with
the clinic’s or center’s written policies the advice of a group of professional
and the services provided to Federal personnel that includes one or more
program patients. physicians and one or more physician
(3) Periodically reviews the clinic’s assistants or nurse practitioners. At
or center’s patient records, provides least one member is not a member of
medical orders, and provides medical the clinic or center staff.
care services to the patients of the (3) The policies include:
clinic or center. (i) A description of the services the
clinic or center furnishes directly and
(c) Physician assistant and nurse prac-
those furnished through agreement or
titioner responsibilities. (1) The physician
arrangement.
assistant and the nurse practitioner
(ii) Guidelines for the medical man-
members of the clinic’s or center’s
agement of health problems which in-
staff:
clude the conditions requiring medical
(i) Participate in the development, consultation and/or patient referral,
execution and periodic review of the the maintenance of health care
written policies governing the services records, and procedures for the periodic
the clinic or center furnishes; review and evaluation of the services
(ii) Participate with a physician in a furnished by the clinic or center.
periodic review of the patients’ health (iii) Rules for the storage, handling,
records. and administration of drugs and
(2) The physician assistant or nurse biologicals.
practitioner performs the following (4) These policies are reviewed at
functions, to the extent they are not least biennially by the group of profes-
being performed by a physician: sional personnel required under para-
(i) Provides services in accordance graph (b)(2) of this section and re-
with the clinic’s or center’s policies; viewed as necessary by the RHC or
(ii) Arranges for, or refers patients FQHC.
to, needed services that cannot be pro- (c) Direct services—(1) General. The
vided at the clinic or center; and clinic or center staff furnishes those di-
(iii) Assures that adequate patient agnostic and therapeutic services and
health records are maintained and supplies that are commonly furnished
681
§ 491.10 42 CFR Ch. IV (10–1–24 Edition)
in a physician’s office or at the entry § 491.10 Patient health records.

point into the health care delivery sys-
(a) Records system. (1) The clinic or
tem. These include medical history,
physical examination, assessment of center maintains a clinical record sys-
health status, and treatment for a vari- tem in accordance with written poli-
ety of medical conditions. cies and procedures.
(2) Laboratory. These requirements (2) A designated member of the pro-
apply to RHCs but not to FQHCs. The fessional staff is responsible for main-
RHC provides laboratory services in ac- taining the records and for insuring
cordance with part 493 of this chapter, that they are completely and accu-
which implements the provisions of rately documented, readily accessible,
section 353 of the Public Health Service and systematically organized.
Act. The RHC provides basic labora- (3) For each patient receiving health
tory services essential to the imme- care services, the clinic or center
diate diagnosis and treatment of the maintains a record that includes, as
patient, including: applicable:
(i) Chemical examinations of urine (i) Identification and social data, evi-
by stick or tablet method or both (in- dence of consent forms, pertinent med-
cluding urine ketones); ical history, assessment of the health
(ii) Hemoglobin or hematocrit; status and health care needs of the pa-
(iii) Blood glucose; tient, and a brief summary of the epi-
(iv) Examination of stool specimens sode, disposition, and instructions to
for occult blood; the patient;
(v) Pregnancy tests; and (ii) Reports of physical examinations,
(vi) Primary culturing for trans- diagnostic and laboratory test results,
mittal to a certified laboratory. and consultative findings;
(3) Emergency. The clinic or center (iii) All physician’s orders, reports of
provides medical emergency procedures treatments and medications, and other
as a first response to common life-
pertinent information necessary to
threatening injuries and acute illness
monitor the patient’s progress;
and has available the drugs and
biologicals commonly used in life sav- (iv) Signatures of the physician or
ing procedures, such as analgesics, another health care professional.
esthetics (local), antibiotics, (b) Protection of record information. (1)
anticonvulsants, antidotes and The clinic or center maintains the con-
emetics, serums and toxoids. fidentiality of record information and
(d) Services provided through agree- provides safeguards against loss, de-
ments or arrangements. (1) The clinic or struction or unauthorized use.
center has agreements or arrangements (2) Written policies and procedures
with one or more providers or suppliers govern the use and removal of records
participating under Medicare or Med- from the clinic or center and the condi-
icaid to furnish other services to its pa- tions for release of information.
tients, including: (3) The patient’s written consent is
(i) Inpatient hospital care; required for release of information not
(ii) Physician(s) services (whether authorized to be released without such
furnished in the hospital, the office, consent.
the patient’s home, a skilled nursing (c) Retention of records. The records
facility, or elsewhere); and are retained for at least 6 years from
(iii) Additional and specialized diag- date of last entry, and longer if re-
nostic and laboratory services that are quired by State statute.
not available at the clinic or center.
(2) If the agreements are not in writ- (Secs. 1102, 1833 and 1902(a)(13), Social Secu-
ing, there is evidence that patients re- rity Act; 49 Stat. 647, 91 Stat. 1485 (42 U.S.C.
ferred by the clinic or center are being 1302, 13951 and 1396a(a)(13)))
accepted and treated. [43 FR 30529, July 14, 1978. Redesignated at 50
FR 33034, Aug. 16, 1985, as amended at 57 FR
24984, June 12, 1992]
FR 63536, Dec. 2, 1993; 84 FR 51832, Sept. 30,
2019]
682
§ 491.11 Program evaluation. tions of authority and succession

plans.
(a) The clinic or center carries out,
or arranges for, a biennial evaluation (4) Include a process for cooperation
of its total program. and collaboration with local, tribal, re-
(b) The evaluation includes review of:
(1) The utilization of clinic or center tain an integrated response during a
services, including at least the number disaster or emergency situation.
of patients served and the volume of
(b) Policies and procedures. The RHC
services;
or FQHC must develop and implement
(2) A representative sample of both emergency preparedness policies and
active and closed clinical records; and procedures, based on the emergency
(3) The clinic’s or center’s health plan set forth in paragraph (a) of this
care policies. section, risk assessment at paragraph
(c) The purpose of the evaluation is (a)(1) of this section, and the commu-
to determine whether: nication plan at paragraph (c) of this
(1) The utilization of services was ap- section. The policies and procedures
propriate; must be reviewed and updated at least
(2) The established policies were fol- every 2 years. At a minimum, the poli-
lowed; and cies and procedures must address the
(3) Any changes are needed. following:
(d) The clinic or center staff con- (1) Safe evacuation from the RHC/
siders the findings of the evaluation FQHC, which includes appropriate
and takes corrective action if nec- placement of exit signs; staff respon-
essary. sibilities and needs of the patients.
[71 FR 55346, Sept. 22, 2006, as amended at 84 (2) A means to shelter in place for pa-
FR 51832, Sept. 30, 2019] tients, staff, and volunteers who re-
main in the facility.
§ 491.12 Emergency preparedness. (3) A system of medical documenta-
The Rural Health Clinic/Federally tion that preserves patient informa-
Qualified Health Center (RHC/FQHC) tion, protects confidentiality of patient
must comply with all applicable Fed- information, and secures and main-
eral, State, and local emergency pre- tains the availability of records.
paredness requirements. The RHC/ (4) The use of volunteers in an emer-
FQHC must establish and maintain an gency or other emergency staffing
emergency preparedness program that strategies, including the process and
meets the requirements of this section. role for integration of State and Feder-
The emergency preparedness program ally designated health care profes-
must include, but not be limited to, the sionals to address surge needs during
following elements: an emergency.
(a) Emergency plan. The RHC or FQHC (c) Communication plan. The RHC or
must develop and maintain an emer- FQHC must develop and maintain an
gency preparedness plan that must be emergency preparedness communica-
reviewed and updated at least every 2 tion plan that complies with Federal,
years. The plan must do all of the fol- State, and local laws and must be re-
lowing: viewed and updated at least every 2
(1) Be based on and include a docu- years. The communication plan must
mented, facility-based and community- include all of the following:
based risk assessment, utilizing an all- (1) Names and contact information
hazards approach. for the following:
(2) Include strategies for addressing (i) Staff.
emergency events identified by the (ii) Entities providing services under
risk assessment. arrangement.
(3) Address patient population, in- (iii) Patients’ physicians.
cluding, but not limited to, the type of (iv) Other RHCs/FQHCs.
services the RHC/FQHC has the ability (v) Volunteers.
to provide in an emergency; and con- (2) Contact information for the fol-
tinuity of operations, including delega- lowing:
683
§ 491.12 42 CFR Ch. IV (10–1–24 Edition)
(i) Federal, State, tribal, regional, (A) When a community-based exer-

and local emergency preparedness cise is not accessible, an individual, fa-
staff. cility-based functional exercise every 2
(ii) Other sources of assistance. years; or.
(3) Primary and alternate means for (B) If the RHC or FQHC experiences
communicating with the following: an actual natural or man-made emer-
(i) RHC/FQHC’s staff. gency that requires activation of the
(ii) Federal, State, tribal, regional, emergency plan, the RHC or FQHC is
and local emergency management exempt from engaging in its next re-
agencies. quired full-scale community-based or
(4) A means of providing information individual, facility-based functional ex-
about the general condition and loca- ercise following the onset of the emer-
tion of patients under the facility’s gency event.
care as permitted under 45 CFR (ii) Conduct an additional exercise
164.510(b)(4). every 2 years, opposite the year the
(5) A means of providing information full-scale or functional exercise under
about the RHC/FQHC’s needs, and its paragraph (d)(2)(i) of this section is
ability to provide assistance, to the au- conducted, that may include, but is not
thority having jurisdiction or the Inci- limited to following:
dent Command Center, or designee. (A) A second full-scale exercise that
(d) Training and testing. The RHC or
is community-based or an individual,
FQHC must develop and maintain an
emergency preparedness training and
(B) A mock disaster drill; or
testing program that is based on the
emergency plan set forth in paragraph (C) A tabletop exercise or workshop
(a) of this section, risk assessment at that is led by a facilitator and includes
paragraph (a)(1) of this section, policies a group discussion, using a narrated,
and procedures at paragraph (b) of this clinically-relevant emergency scenario,
section, and the communication plan and a set of problem statements, di-
at paragraph (c) of this section. The rected messages, or prepared questions
training and testing program must be designed to challenge an emergency
reviewed and updated at least every 2 plan.
years. (iii) Analyze the RHC or FQHC’s re-
(1) Training program. The RHC/FQHC sponse to and maintain documentation
must do all of the following: of all drills, tabletop exercises, and
(i) Initial training in emergency pre- emergency events, and revise the RHC
paredness policies and procedures to all or FQHC’s emergency plan, as needed.
new and existing staff, individuals pro- (e) Integrated healthcare systems. If a
viding services under arrangement, and RHC/FQHC is part of a healthcare sys-
volunteers, consistent with their ex- tem consisting of multiple separately
pected roles, certified healthcare facilities that
(ii) Provide emergency preparedness elects to have a unified and integrated
training at least every 2 years. emergency preparedness program, the
(iii) Maintain documentation of the RHC/FQHC may choose to participate
training. in the healthcare system’s coordinated
(iv) Demonstrate staff knowledge of emergency preparedness program. If
emergency procedures. elected, the unified and integrated
(v) If the emergency preparedness emergency preparedness program must
policies and procedures are signifi- do all of the following:
cantly updated, the RHC/FQHC must (1) Demonstrate that each separately
conduct training on the updated poli- certified facility within the system ac-
cies and procedures. tively participated in the development
(2) Testing. The RHC or FQHC must of the unified and integrated emer-
conduct exercises to test the emergency preparedness program.
gency plan at least annually. The RHC (2) Be developed and maintained in a
or FQHC must do the following: manner that takes into account each
(i) Participate in a full-scale exercise separately certified facility’s unique
that is community-based every 2 years; circumstances, patient populations,
or and services offered.
684
(3) Demonstrate that each separately 493.41 Condition: Reporting of SARS–CoV–2

certified facility is capable of actively test results.
using the unified and integrated emer-
Subpart C—Registration Certificate, Certifi-
gency preparedness program and is in
cate for Provider-performed Micros-
compliance with the program.
copy Procedures, and Certificate of
(4) Include a unified and integrated Compliance
emergency plan that meets the require-
ments of paragraphs (a)(2), (3), and (4) 493.43 Application for registration certifi-
of this section. The unified and inte- cate, certificate for provider-performed
grated emergency plan must also be microscopy (PPM) procedures, and cer-
tificate of compliance.
based on and include all of the fol-
493.45 Requirements for a registration cer-
lowing: tificate.
(i) A documented community–based 493.47 Requirements for a certificate for
risk assessment, utilizing an all-haz- provider-performed microscopy (PPM)
ards approach. procedures.
(ii) A documented individual facility- 493.49 Requirements for a certificate of
based risk assessment for each sepa- compliance.
rately certified facility within the 493.51 Notification requirements for labora-
tories issued a certificate of compliance.
health system, utilizing an all-hazards
493.53 Notification requirements for labora-
approach. tories issued a certificate for provider-
(5) Include integrated policies and performed microscopy (PPM) procedures.
procedures that meet the requirements
set forth in paragraph (b) of this sec- Subpart D—Certificate of Accreditation
tion, a coordinated communication
493.55 Application for registration certifi-
plan, and training and testing pro- cate and certificate of accreditation.
grams that meet the requirements of 493.57 Requirements for a registration cer-
paragraphs (c) and (d) of this section, tificate.
respectively. 493.61 Requirements for a certificate of ac-
creditation.
[81 FR 64041, Sept. 16, 2016, as amended by 84
493.63 Notification requirements for labora-
FR 51832, Sept. 30, 2019]
tories issued a certificate of accredita-
tion.
PART 493—LABORATORY
REQUIREMENTS Subpart E—Accreditation by a Private,
Nonprofit Accreditation Organization
Subpart A—General Provisions or Exemption Under an Approved
State Laboratory Program
Sec.
493.551 General requirements for labora-
tories.
493.2 Definitions.
493.553 Approval process (application and
493.3 Applicability. reapplication) for accreditation organiza-
493.5 Categories of tests by complexity. tions and State licensure programs.
493.15 Laboratories performing waived 493.555 Federal review of laboratory require-
tests. ments.
493.17 Test categorization. 493.557 Additional submission requirements.
493.19 Provider-performed microscopy 493.559 Publication of approval of deeming
(PPM) procedures. authority or CLIA exemption.
493.20 Laboratories performing tests of 493.561 Denial of application or reapplica-
moderate complexity. tion.
493.25 Laboratories performing tests of high 493.563 Validation inspections—Basis and
complexity. focus.
493.565 Selection for validation inspection—
Subpart B—Certificate of Waiver laboratory responsibilities.
493.567 Refusal to cooperate with validation
493.35 Application for a certificate of waiv- inspection.
er. 493.569 Consequences of a finding of non-
493.37 Requirements for a certificate of compliance as a result of a validation in-
waiver. spection.
493.39 Notification requirements for labora- 493.571 Disclosure of accreditation, State
tories issued a certificate of waiver. and CMS validation inspection results.
685
493.573 Continuing Federal oversight of pri- 493.863 Standard; Compatibility testing.
vate nonprofit accreditation organiza- 493.865 Standard; Antibody identification.
tions and approved State licensure pro-
grams. Subpart I—Proficiency Testing Programs for
493.575 Removal of deeming authority or Nonwaived Testing
CLIA exemption and final determination
review. 493.901 Approval of proficiency testing pro-
grams.
Subpart F—General Administration 493.903 Administrative responsibilities.
493.905 Nonapproved proficiency testing pro-
493.602 Scope of subpart.
grams.
493.606 Applicability of subpart.
493.638 Certificate fees. PROFICIENCY TESTING PROGRAMS BY
493.639 Fees for revised and replacement SPECIALTY AND SUBSPECIALTY
certificates.
493.643 Additional fees applicable to labora- 493.909 Microbiology.
tories issued a certificate of compliance. 493.911 Bacteriology.
493.645 Additional fees applicable to labora- 493.913 Mycobacteriology.
tories issued a certificate of accredita- 493.915 Mycology.
tion, certificate of waiver, or certificate 493.917 Parasitology.
for PPM procedures. 493.919 Virology.
493.649 Additional fees applicable to ap- 493.921 Diagnostic immunology.
proved State laboratory programs. 493.923 Syphilis serology.
493.655 Payment of fees.
493.927 General immunology.
493.680 Methodology for determining the bi-
493.929 Chemistry.
ennial fee increase.
493.931 Routine chemistry.
Subpart G [Reserved] 493.933 Endocrinology.
493.937 Toxicology.
Subpart H—Participation in Proficiency 493.941 Hematology (including routine he-
Testing for Laboratories Performing matology and coagulation).
Nonwaived Testing 493.945 Cytology; gynecologic examinations.
493.959 Immunohematology.
493.801 Condition: Enrollment and testing of
samples. Subpart J—Facility Administration for
493.803 Condition: Successful participation. Nonwaived Testing
493.807 Condition: Reinstatement of labora-
tories performing nonwaived testing. 493.1100 Condition: Facility administration.
493.1101 Standard: Facilities.
PROFICIENCY TESTING BY SPECIALTY AND SUB- 493.1103 Standard: Requirements for trans-
SPECIALTY FOR LABORATORIES PERFORMING fusion services.
TESTS OF MODERATE COMPLEXITY (INCLUD- 493.1105 Standard: Retention requirements.
ING THE SUBCATEGORY), HIGH COMPLEXITY,
OR ANY COMBINATION OF THESE TESTS
Subpart K—Quality System for Nonwaived
493.821 Condition: Microbiology. Testing
493.823 Standard; Bacteriology.
493.825 Standard; Mycobacteriology. 493.1200 Introduction.
493.827 Standard; Mycology. 493.1201 Condition: Bacteriology.
493.829 Standard; Parasitology. 493.1202 Condition: Mycobacteriology.
493.831 Standard; Virology. 493.1203 Condition: Mycology.
493.833 Condition: Diagnostic immunology. 493.1204 Condition: Parasitology.
493.835 Standard; Syphilis serology. 493.1205 Condition: Virology.
493.837 Standard; General immunology. 493.1207 Condition: Syphilis serology.
493.839 Condition: Chemistry. 493.1208 Condition: General immunology.
493.841 Standard; Routine chemistry. 493.1210 Condition: Routine chemistry.
493.843 Standard; Endocrinology. 493.1211 Condition: Urinalysis.
493.845 Standard; Toxicology.
493.1212 Condition: Endocrinology.
493.849 Condition: Hematology.
493.1213 Condition: Toxicology.
493.851 Standard; Hematology.
493.853 Condition: Pathology. 493.1215 Condition: Hematology.
493.855 Standard; Cytology: gynecologic ex- 493.1217 Condition: Immunohematology.
aminations. 493.1219 Condition: Histopathology.
493.857 Condition: Immunohematology. 493.1220 Condition: Oral pathology.
493.859 Standard; ABO group and D (Rho) 493.1221 Condition: Cytology.
typing. 493.1225 Condition: Clinical cytogenetics.
493.861 Standard; Unexpected antibody de- 493.1226 Condition: Radiobioassay.
tection. 493.1227 Condition: Histocompatibility.
686
GENERAL LABORATORY SYSTEMS Subpart M—Personnel for Nonwaived
493.1230 Condition: General laboratory sys- Testing
tems.
493.1351 General.
493.1231 Standard: Confidentiality of patient
information. LABORATORIES PERFORMING PROVIDER-
493.1232 Standard: Specimen identification PERFORMED MICROSCOPY (PPM) PROCEDURES
and integrity.
493.1233 Standard: Complaint investiga- 493.1353 Scope.
tions. 493.1355 Condition: Laboratories performing
493.1234 Standard: Communications. PPM procedures; laboratory director.
493.1235 Standard: Personnel competency 493.1357 Standard; laboratory director quali-
assessment policies. fications.
493.1236 Standard: Evaluation of proficiency 493.1359 Standard; PPM laboratory director
testing performance. responsibilities.
493.1239 Standard: General laboratory sys- 493.1361 Condition: Laboratories performing
tems quality assessment. PPM procedures; testing personnel.
493.1363 Standard; PPM testing personnel
PREANALYTIC SYSTEMS qualifications.
493.1240 Condition: Preanalytic systems. 493.1365 Standard; PPM testing personnel
493.1241 Standard: Test request. responsibilities.
493.1242 Standard: Specimen submission,
handling, and referral. LABORATORIES PERFORMING MODERATE
493.1249 Standard: Preanalytic systems COMPLEXITY TESTING
quality assessment. 493.1403 Condition: Laboratories performing
moderate complexity testing; laboratory
ANALYTIC SYSTEMS
director.
493.1250 Condition: Analytic systems. 493.1405 Standard; Laboratory director
493.1251 Standard: Procedure manual. qualifications.
493.1252 Standard: Test systems, equipment, 493.1406 Standard; Laboratory director
instruments, reagents, materials, and qualifications on or before February 28,
supplies. 1992.
493.1253 Standard: Establishment and 493.1407 Standard; Laboratory director re-
verification of performance specifica- sponsibilities.
tions. 493.1409 Condition: Laboratories performing
493.1254 Standard: Maintenance and func- moderate complexity testing; technical
tion checks. consultant.
493.1255 Standard: Calibration and calibra- 493.1411 Standard; Technical consultant
tion verification procedures. qualifications.
493.1256 Standard: Control procedures. 493.1413 Standard; Technical consultant re-
493.1261 Standard: Bacteriology. sponsibilities.
493.1262 Standard: Mycobacteriology.
493.1415 Condition: Laboratories performing
493.1263 Standard: Mycology.
moderate complexity testing; clinical
493.1264 Standard: Parasitology.
consultant.
493.1265 Standard: Virology.
493.1417 Standard; Clinical consultant quali-
493.1267 Standard: Routine chemistry.
fications.
493.1269 Standard: Hematology.
493.1271 Standard: Immunohematology. 493.1419 Standard; Clinical consultant re-
493.1273 Standard: Histopathology. sponsibilities.
493.1274 Standard: Cytology. 493.1421 Condition: Laboratories performing
493.1276 Standard: Clinical cytogenetics. moderate complexity testing; testing
493.1278 Standard: Histocompatibility. personnel.
493.1281 Standard: Comparison of test re- 493.1423 Standard; Testing personnel quali-
sults. fications.
493.1282 Standard: Corrective actions. 493.1425 Standard; Testing personnel respon-
493.1283 Standard: Test records. sibilities.
493.1289 Standard: Analytic systems quality
assessment. LABORATORIES PERFORMING HIGH COMPLEXITY
TESTING
POSTANALYTIC SYSTEMS 493.1441 Condition: Laboratories performing
493.1290 Condition: Postanalytic systems. high complexity testing; laboratory di-
493.1291 Standard: Test report. rector.
493.1299 Standard: Postanalytic systems 493.1443 Standard; Laboratory director
quality assessment. qualifications.
493.1445 Standard; Laboratory director re-
Subpart L [Reserved] sponsibilities.
687
§ 493.1 42 CFR Ch. IV (10–1–24 Edition)
493.1447 Condition: Laboratories performing questing or issued a certificate of accred-
high complexity testing; technical super- itation.
visor.
493.1449 Standard; Technical supervisor Subpart R—Enforcement Procedures
qualifications.
493.1451 Standard; Technical supervisor re- 493.1800 Basis and scope.
sponsibilities. 493.1804 General considerations.
493.1453 Condition: Laboratories performing 493.1806 Available sanctions: All labora-
high complexity testing; clinical consult- tories.
ant. 493.1807 Additional sanctions: Laboratories
493.1455 Standard; Clinical consultant quali- that participate in Medicare.
fications. 493.1808 Adverse action on any type of CLIA
493.1457 Standard; Clinical consultant re- certificate: Effect on Medicare approval.
sponsibilities. 493.1809 Limitation on Medicaid payment.
493.1459 Condition: Laboratories performing 493.1810 Imposition and lifting of alter-
high complexity testing; general super- native sanctions.
visor. 493.1812 Action when deficiencies pose im-
493.1461 Standard; General supervisor quali- mediate jeopardy.
fications. 493.1814 Action when deficiencies are at the
493.1462 General supervisor qualifications condition level but do not pose imme-
on or before February 28, 1992. diate jeopardy.
493.1463 Standard; General supervisor re- 493.1816 Action when deficiencies are not at
sponsibilities. the condition level.
493.1467 Condition: Laboratories performing 493.1820 Ensuring timely correction of defi-
high complexity testing; cytology gen- ciencies.
eral supervisor. 493.1826 Suspension of part of Medicare pay-
493.1469 Standard; Cytology general super- ments.
visor qualifications. 493.1828 Suspension of all Medicare pay-
493.1471 Standard; Cytology general super- ments.
visor responsibilities. 493.1832 Directed plan of correction and di-
493.1481 Condition: Laboratories performing rected portion of a plan of correction.
high complexity testing; 493.1834 Civil money penalty.
cytotechnologist. 493.1836 State onsite monitoring.
493.1483 Standard; Cytotechnologist quali- 493.1838 Training and technical assistance
fications. for unsuccessful participation in pro-
493.1485 Standard; Cytotechnologist respon- ficiency testing.
sibilities. 493.1840 Suspension, limitation, or revoca-
493.1487 Condition: Laboratories performing tion of any type of CLIA certificate.
high complexity testing; testing per- 493.1842 Cancellation of Medicare approval.
sonnel. 493.1844 Appeals procedures.
493.1489 Standard; Testing personnel quali- 493.1846 Civil action.
fications. 493.1850 Laboratory registry.
493.1491 Technologist qualifications on or
before February 28, 1992. Subpart S [Reserved]
493.1495 Standard; Testing personnel respon-
sibilities. Subpart T—Consultations
Subparts N–P [Reserved] 493.2001 Establishment and function of the
Clinical Laboratory Improvement Advi-
Subpart Q—Inspection sory Committee.
493.1771 Condition: Inspection requirements AUTHORITY: 42 U.S.C. 263a, 1302, 1395x(e),

applicable to all CLIA-certified and 1395x(s)(3) and (s)(17).
CLIA-exempt laboratories. SOURCE: 55 FR 9576, Mar. 14, 1990, unless
493.1773 Standard: Basic inspection require- otherwise noted.
ments for all laboratories issued a CLIA
certificate and CLIA-exempt labora-
tories. Subpart A—General Provisions
493.1775 Standard: Inspection of laboratories
issued a certificate of waiver or a certifi- SOURCE: 57 FR 7139, Feb. 28, 1992, unless
cate for provider-performed microscopy otherwise noted.
procedures.
493.1777 Standard: Inspection of laboratories § 493.1 Basis and scope.
that have requested or have been issued
a certificate of compliance. This part sets forth the conditions
493.1780 Standard: Inspection of CLIA-ex- that all laboratories must meet to be
empt laboratories or laboratories re- certified to perform testing on human
688
specimens under the Clinical Labora- ALJ stands for Administrative Law
tory Improvement Amendments of 1988 Judge.
(CLIA). It implements sections 1861(e) Alternative sanctions means sanctions
and (j), the sentence following section that may be imposed in lieu of or in ad-
1861(s)(13), and 1902(a)(9) of the Social dition to principal sanctions. The term
Security Act, and section 353 of the is synonymous with ‘‘intermediate
Public Health Service Act, as amended sanctions’’ as used in section 1846 of
by section 2 of the Taking Essential the Act.
Steps for Testing Act of 2012. This part Analyte means a substance or con-
applies to all laboratories as defined stituent for which the laboratory con-
under ‘‘laboratory’’ in § 493.2 of this ducts testing.
part. This part also applies to labora- Approved accreditation organization for
tories seeking payment under the laboratories means a private, nonprofit
Medicare and Medicaid programs. The accreditation organization that has
requirements are the same for Medi- formally applied for and received
care approval as for CLIA certification. CMS’s approval based on the organiza-
tion’s compliance with this part.
FR 25480, May 2, 2014]
Approved State laboratory program
means a licensure or other regulatory
§ 493.2 Definitions. program for laboratories in a State,
the requirements of which are imposed
As used in this part, unless the con- under State law, and the State labora-
text indicates otherwise— tory program has received CMS ap-
Acceptance limit means the symmet- proval based on the State’s compliance
rical tolerance (plus and minus) around with this part.
the target value. Authorized person means an indi-
Accredited institution means a school vidual authorized under State law to
or program which— order tests or receive test results, or
(a) Admits as regular student only both.
persons having a certificate of gradua- Calibration means a process of testing
tion from a school providing secondary and adjusting an instrument or test
education, or the recognized equivalent system to establish a correlation be-
of such certificate; tween the measurement response and
(b) Is legally authorized within the the concentration or amount of the
State to provide a program of edu- substance that is being measured by
cation beyond secondary education; the test procedure.
(c) Provides an educational program Calibration verification means the as-
for which it awards a bachelor’s degree saying of materials of known con-
or provides not less than a 2-year pro- centration in the same manner as pa-
gram which is acceptable toward such tient samples to substantiate the in-
a degree, or provides an educational strument or test system’s calibration
program for which it awards a master’s throughout the reportable range for pa-
or doctoral degree; tient test results.
(d) Is accredited by a nationally rec- Challenge means, for quantitative
ognized accrediting agency or associa- tests, an assessment of the amount of
tion. substance or analyte present or meas-
This definition includes any foreign ured in a sample. For qualitative tests,
institution of higher education that a challenge means the determination
HHS or its designee determines meets of the presence or the absence of an
substantially equivalent requirements. analyte, organism, or substance in a
Accredited laboratory means a labora- sample.
tory that has voluntarily applied for CLIA means the Clinical Laboratory
and been accredited by a private, non- Improvement Amendments of 1988.
profit accreditation organization ap- CLIA certificate means any of the fol-
proved by CMS in accordance with this lowing types of certificates issued by
part; CMS or its agent:
Adverse action means the imposition (1) Certificate of compliance means a
of a principal or alternative sanction certificate issued to a laboratory after
by CMS. an inspection that finds the laboratory
689
§ 493.2 42 CFR Ch. IV (10–1–24 Edition)
to be in compliance with all applicable CMS agent means an entity with

condition level requirements, or re- which CMS arranges to inspect labora-
issued before the expiration date, pend- tories and assess laboratory activities
ing an appeal, in accordance with against CLIA requirements and may be
§ 493.49, when an inspection has found a State survey agency, a private, non-
the laboratory to be out of compliance profit organization other than an ap-
with one or more condition level re- proved accreditation organization, a
quirements. component of HHS, or any other gov-
(2) Certificate for provider-performed ernmental component CMS approves
microscopy (PPM) procedures means a for this purpose. In those instances
certificate issued or reissued before the where all of the laboratories in a State
expiration date, pending an appeal, in are exempt from CLIA requirements,
accordance with § 493.47, to a labora- based on the approval of a State’s ex-
tory in which a physician, midlevel emption request, the State survey
practitioner or dentist performs no agency is not the CMS agent.
tests other than PPM procedures and, Condition level deficiency means non-
if desired, waived tests listed in compliance with one or more condition
§ 493.15(c). level requirements.
(3) Certificate of accreditation means a Condition level requirements means
certificate issued on the basis of the any of the requirements identified as
laboratory’s accreditation by an ac- ‘‘conditions’’ in § 493.41 and subparts G
creditation organization approved by through Q of this part.
CMS (indicating that the laboratory is Confirmatory testing means testing
deemed to meet applicable CLIA re- performed by a second analytical pro-
quirements) or reissued before the ex- cedure that could be used to substan-
piration date, pending an appeal, in ac- tiate or bring into question the result
cordance with § 493.61, when a valida- of an initial laboratory test.
Credible allegation of compliance
tion or complaint survey has found the
means a statement or documentation
laboratory to be noncompliant with
that—
one or more CLIA conditions.
(1) Is made by a representative of a
(4) Certificate of registration or registra- laboratory that has a history of having
tion certificate means a certificate maintained a commitment to compli-
issued or reissued before the expiration ance and of taking corrective action
date, pending an appeal, in accordance when required;
with § 493.45, that enables the entity to (2) Is realistic in terms of its being
conduct moderate or high complexity possible to accomplish the required
laboratory testing or both until the en- corrective action between the date of
tity is determined to be in compliance the exit conference and the date of the
through a survey by CMS or its agent; allegation; and
or in accordance with § 493.57 to an en- (3) Indicates that the problem has
tity that is accredited by an approved been resolved.
accreditation organization. Dentist means a doctor of dental med-
(5) Certificate of waiver means a cer- icine or doctor of dental surgery li-
tificate issued or reissued before the censed by the State to practice den-
expiration date, pending an appeal, in tistry within the State in which the
accordance with § 493.37, to a labora- laboratory is located.
tory to perform only the waived tests Distributive testing means laboratory
listed at § 493.15(c). testing performed on the same speci-
CLIA-exempt laboratory means a lab- men, or an aliquot of it, that requires
oratory that has been licensed or ap- sharing it between two or more labora-
proved by a State where CMS has de- tories to obtain all data required to
termined that the State has enacted complete an interpretation or calcula-
laws relating to laboratory require- tion necessary to provide a final re-
ments that are equal to or more strin- portable result for the originally or-
gent than CLIA requirements and the dered test. When such testing occurs at
State licensure program has been ap- multiple locations with different CLIA
proved by CMS in accordance with sub- certificates, it is considered distribu-
part E of this part. tive testing.
690
Equivalency means that an accredita- or impairment of, or the assessment of

tion organization’s or a State labora- the health of, human beings. These ex-
tory program’s requirements, taken as aminations also include procedures to
a whole, are equal to or more stringent determine, measure, or otherwise de-
than the CLIA requirements estab- scribe the presence or absence of var-
lished by CMS, taken as whole. It is ac- ious substances or organisms in the
ceptable for an accreditation organiza- body. Facilities only collecting or pre-
tion’s or State laboratory program’s paring specimens (or both) or only
requirements to be organized dif- serving as a mailing service and not
ferently or otherwise vary from the performing testing are not considered
CLIA requirements, as long as laboratories.
(1) All of the requirements taken as a Midlevel practitioner means a nurse
whole would provide at least the same
midwife, nurse practitioner, or physi-
protection as the CLIA requirements
cian assistant, licensed by the State
taken as a whole; and
within which the individual practices,
(2) A finding of noncompliance with
if such licensing is required in the
respect to CLIA requirements taken as
a whole would be matched by a finding State in which the laboratory is lo-
of noncompliance with the accredita- cated.
tion or State requirements taken as a Nonwaived test means any test sys-
whole. tem, assay, or examination that has
FDA-cleared or approved test system not been found to meet the statutory
means a test system cleared or ap- criteria specified at section 353(d)(3) of
proved by the FDA through the pre- the Public Health Service Act.
market notification (510(k)) or pre- Operator means the individual or
market approval (PMA) process for in- group of individuals who oversee all
vitro diagnostic use. Unless otherwise facets of the operation of a laboratory
stated, this includes test systems ex- and who bear primary responsibility
empt from FDA premarket clearance for the safety and reliability of the re-
or approval. sults of all specimen testing performed
HHS means the Department of Health in that laboratory. The term includes—
and Human Services, or its designee. (1) A director of the laboratory if he
Immediate jeopardy means a situation or she meets the stated criteria; and
in which immediate corrective action (2) The members of the board of di-
is necessary because the laboratory’s rectors and the officers of a laboratory
noncompliance with one or more condi- that is a small corporation under sub-
tion level requirements has already chapter S of the Internal Revenue
caused, is causing, or is likely to cause, Code.
at any time, serious injury or harm, or Owner means any person who owns
death, to individuals served by the lab-
any interest in a laboratory except for
oratory or to the health or safety of
an interest in a laboratory whose stock
the general public. This term is syn-
and/or securities are publicly traded.
onymous with imminent and serious
(That is e.g., the purchase of shares of
risk to human health and significant
stock or securities on the New York
hazard to the public health.
Intentional violation means knowing Stock Exchange in a corporation own-
and willful noncompliance with any ing a laboratory would not make a per-
CLIA condition. son an owner for the purpose of this
Kit means all components of a test regulation.)
that are packaged together. Party means a laboratory affected by
Laboratory means a facility for the any of the enforcement procedures set
biological, microbiological, serological, forth in this subpart, by CMS or the
chemical, immunohematological, OIG, as appropriate.
hematological, biophysical, Peer group means a group of labora-
cytological, pathological, or other ex- tories whose testing process utilizes
amination of materials derived from similar instruments, methodologies,
the human body for the purpose of pro- and/or reagent systems and is not to be
viding information for the diagnosis, assigned using the reagent lot number
prevention, or treatment of any disease level.
691
§ 493.2 42 CFR Ch. IV (10–1–24 Edition)
Performance characteristic means a Thirty-eight divided by 200 equals a 19 per-

property of a test that is used to de- cent rate of disparity.
scribe its quality, e.g., accuracy, preci- Referee laboratory means a laboratory
sion, analytical sensitivity, analytical currently in compliance with applica-
specificity, reportable range, reference ble CLIA requirements, that has had a
range, etc.
record of satisfactory proficiency test-
Performance specification means a
ing performance for all testing events
value or range of values for a perform-
for at least one year for a specific test,
ance characteristic, established or
verified by the laboratory, that is used analyte, subspecialty, or specialty and
to describe the quality of patient test has been designated by an HHS ap-
results. proved proficiency testing program as
Physician means an individual with a a referee laboratory for analyzing pro-
doctor of medicine, doctor of osteop- ficiency testing specimens for the pur-
athy, or doctor of podiatric medicine pose of determining the correct re-
degree who is licensed by the State to sponse for the specimens in a testing
practice medicine, osteopathy, or po- event for that specific test, analyte,
diatry within the State in which the subspecialty, or specialty.
laboratory is located. Reference range means the range of
Principal sanction means the suspen- test values expected for a designated
sion, limitation, or revocation of any population of individuals, e.g., 95 per-
type of CLIA certificate or the can- cent of individuals that are presumed
cellation of the laboratory’s approval to be healthy (or normal).
to receive Medicare payment for its Reflex testing means confirmatory or
services. additional laboratory testing that is
Prospective laboratory means a labora- automatically requested by a labora-
tory that is operating under a registra- tory under its standard operating pro-
tion certificate or is seeking any of the cedures for patient specimens when the
three other types of CLIA certificates. laboratory’s findings indicate test re-
Rate of disparity means the percent- sults that are abnormal, are outside a
age of sample validation inspections predetermined range, or meet other
for a specific accreditation organiza- pre-established criteria for additional
tion or State where CMS, the State
testing.
survey agency or other CMS agent
Repeat proficiency testing referral
finds noncompliance with one or more
condition level requirements but no means a second instance in which a
comparable deficiencies were cited by proficiency testing sample, or a portion
the accreditation organization or the of a sample, is referred, for any reason,
State, and it is reasonable to conclude to another laboratory for analysis
that the deficiencies were present at prior to the laboratory’s proficiency
the time of the most recent accredita- testing program event cut-off date
tion organization or State licensure in- within the period of time encompassing
spection. the two prior survey cycles (including
initial certification, recertification, or
Example: Assume the State survey agency,
CMS or other CMS agent performs 200 sam-
the equivalent for laboratories sur-
ple validation inspections for laboratories veyed by an approved accreditation or-
accredited by a single accreditation organi- ganization).
zation or licensed in an exempt State during Replacement certificate means an ac-
a validation review period and finds that 60 tive CLIA certificate that is reissued
of the 200 laboratories had one or more con-
with no changes made.
dition level requirements out of compliance.
CMS reviews the validation and accredita- Reportable range means the span of
tion organization’s or State’s inspections of test result values over which the lab-
the validated laboratories and determines oratory can establish or verify the ac-
that the State or accreditation organization curacy of the instrument or test sys-
found comparable deficiencies in 22 of the 60 tem measurement response.
laboratories and it is reasonable to conclude
that deficiencies were present in the remain- Revised certificate means an active
ing 38 laboratories at the time of the accredi- CLIA certificate that is reissued with
tation organization’s or State’s inspection. changes to one or more fields displayed
692
on the certificate, such as the labora- standard deviations from the original
tory’s name, address, laboratory direc- mean, as applicable);
tor, or approved specialties/subspecial- (ii) The mean established by a defini-
ties. For purposes of this part, revised tive method or reference methods; or
certificates do not include the (iii) If a definitive method or ref-
issuance, renewal, change in certificate erence methods are not available, the
type, or reinstatement of a terminated mean of a peer group; or
certificate with a gap in service. (2) If the peer group consists of fewer
Sample in proficiency testing means
than 10 participants, the mean of all
the material contained in a vial, on a
participant responses after removal of
slide, or other unit that contains mate-
rial to be tested by proficiency testing outliers (as defined in paragraph (1) of
program participants. When possible, this definition) unless acceptable sci-
samples are of human origin. entific reasons are available to indi-
State includes, for purposes of this cate that such an evaluation is not ap-
part, each of the 50 States, the District propriate.
of Columbia, the Commonwealth of Test system means the instructions
Puerto Rico, the Virgin Islands and a and all of the instrumentation, equip-
political subdivision of a State where ment, reagents, and supplies needed to
the State, acting pursuant to State perform an assay or examination and
law, has expressly delegated powers to generate test results.
the political subdivision sufficient to Unsatisfactory proficiency testing per-
authorize the political subdivision to formance means failure to attain the
act for the State in enforcing require- minimum satisfactory score for an
ments equal to or more stringent than analyte, test, subspecialty, or specialty
CLIA requirements. for a testing event.
State licensure means the issuance of Unsuccessful participation in pro-
a license to, or the approval of, a lab- ficiency testing means any of the fol-
oratory by a State laboratory program
lowing:
as meeting standards for licensing or
approval established under State law. (1) Unsatisfactory performance for
State licensure program means a State the same analyte in two consecutive or
laboratory licensure or approval pro- two out of three testing events.
gram. (2) Repeated unsatisfactory overall
State survey agency means the State testing event scores for two consecu-
health agency or other appropriate tive or two out of three testing events
State or local agency that has an for the same specialty or subspecialty.
agreement under section 1864 of the So- (3) An unsatisfactory testing event
cial Security Act and is used by CMS score for those subspecialties not grad-
to perform surveys and inspections. ed by analyte (that is, bacteriology,
Substantial allegation of noncompliance mycobacteriology, virology,
means a complaint from any of a vari- parasitology, mycology, blood compat-
ety of sources (including complaints ibility, immunohematology, or syphilis
submitted in person, by telephone, serology) for the same subspecialty for
through written correspondence, or in two consecutive or two out of three
newspaper or magazine articles) that, testing events.
if substantiated, would have an impact (4) Failure of a laboratory performing
on the health and safety of the general gynecologic cytology to meet the
public or of individuals served by a lab-
standard at § 493.855.
oratory and raises doubts as to a lab-
oratory’s compliance with any condi- Unsuccessful proficiency testing per-
tion level requirement. formance means a failure to attain the
Target value for quantitative tests minimum satisfactory score for an
means: analyte, test, subspecialty, or specialty
(1) If the peer group consists of 10 for two consecutive or two of three
participants or greater: consecutive testing events.
(i) The mean of all participant re- Validation review period means the
sponses after removal of outliers (that one year time period during which CMS
is, those responses greater than three conducts validation inspections and
693
§ 493.2, Nt. 42 CFR Ch. IV (10–1–24 Edition)
evaluates the results of the most redefinition of a laboratory under this section
cent surveys performed by an accredi- and is not excepted under § 493.3(b).
tation organization or State laboratory
program. * * * * *
Waived test means a test system, Laboratory training or experience means that
assay, or examination that HHS has the training or experience must be obtained
determined meets the CLIA statutory in a facility that meets the definition of a
criteria as specified for waiver under laboratory under this section and is not ex-
section 353(d)(3) of the Public Health cepted under § 493.3(b).
Service Act. Midlevel practitioner means a nurse mid-
wife, nurse practitioner, nurse anesthetist,
[57 FR 7139, Feb. 28, 1992, as amended at 57 clinical nurse specialist, or physician assist-
FR 7236, Feb. 28, 1992; 57 FR 34013, July 31, ant licensed by the State within which the
1992; 57 FR 35761, Aug. 11, 1992; 58 FR 5220, individual practices, if such licensing is re-
Jan. 19, 1993; 58 FR 48323, Sept. 15, 1993; 60 FR quired in the State in which the laboratory
20043, Apr. 24, 1995; 63 FR 26732, May 14, 1998; is located.
68 FR 3702, Jan. 24, 2003; 68 FR 50723, Aug. 22,
2003; 79 FR 25480, May 2, 2014; 79 FR 27157,
May 12, 2014; 85 FR 54873, Sept. 2, 2020; 87 FR * * * * *
41232, July 11, 2022; 88 FR 90035, Dec. 28, 2023]
§ 493.3 Applicability.
EFFECTIVE DATE NOTE: At 88 FR 90035, Dec.
28, 2023, § 493.2 was amended by adding defini- (a) Basic rule. Except as specified in
tions for ‘‘Continuing education (CE) credit paragraph (b) of this section, a labora-
hours,’’ ‘‘Doctoral degree,’’ ‘‘Experience di- tory will be cited as out of compliance
recting or supervising,’’ and ‘‘Laboratory with section 353 of the Public Health
training or experience,’’ in alphabetical Service Act unless it—
order; and revising the definition of ‘‘Mid-
level practitioner,’’ effective Dec. 28, 2024. (1) Has a current, unrevoked or un-
For the convenience of the user, the added suspended certificate of waiver, reg-
and revised text is set forth as follows: istration certificate, certificate of
compliance, certificate for PPM proce-
§ 493.2 Definitions. dures, or certificate of accreditation
issued by HHS applicable to the cat-
* * * * * egory of examinations or procedures
Continuing education (CE) credit hours performed by the laboratory; or
means either continuing medical education (2) Is CLIA-exempt.
(CME) or continuing education units (CEUs). (b) Exception. These rules do not
The CE credit hours must cover the applica- apply to components or functions of—
ble laboratory director responsibilities and (1) Any facility or component of a fa-
be obtained prior to qualifying as a labora-
cility that only performs testing for fo-
tory director.
rensic purposes;
(2) Research laboratories that test
* * * * * human specimens but do not report pa-
Doctoral degree means an earned post-bac- tient specific results for the diagnosis,
calaureate degree with at least 3 years of prevention or treatment of any disease
graduate level study that includes research or impairment of, or the assessment of
related to clinical laboratory testing or ad- the health of individual patients; or
vanced study in clinical laboratory science,
medical laboratory science, or medical tech-
(3) Laboratories certified by the Sub-
nology. For purposes of this part, doctoral stance Abuse and Mental Health Serv-
degrees do not include doctors of medicine ices Administration (SAMHSA), in
(MD), doctors of osteopathy (DO), doctors of which drug testing is performed which
podiatric medicine (DPM), doctors of veteri- meets SAMHSA guidelines and regula-
nary medicine (DVM) degrees, or honorary tions. However, all other testing con-
degrees. ducted by a SAMHSA-certified labora-
tory is subject to this rule.
* * * * * (c) Federal laboratories. Laboratories
Experience directing or supervising means under the jurisdiction of an agency of
that the director or supervisory experience the Federal Government are subject to
must be obtained in a facility that meets the the rules of this part, except that the
694
Secretary may modify the application (1) Dipstick or Tablet Reagent Uri-
of such requirements as appropriate. nalysis (non-automated) for the fol-
lowing:
FR 5221, Jan. 19, 1993; 60 FR 20043, Apr. 24, (i) Bilirubin;
1995; 68 FR 3702, Jan. 24, 2003] (ii) Glucose;
(iii) Hemoglobin;
§ 493.5 Categories of tests by com- (iv) Ketone;
plexity. (v) Leukocytes;
(a) Laboratory tests are categorized (vi) Nitrite;
as one of the following: (vii) pH;
(viii) Protein;
(1) Waived tests.
(ix) Specific gravity; and
(2) Tests of moderate complexity, in-
(x) Urobilinogen.
cluding the subcategory of PPM proce-
(2) Fecal occult blood-non-auto-
dures.
mated;
(3) Tests of high complexity.
(3) Ovulation tests—visual color com-
(b) A laboratory may perform only parison tests for human luteinizing
waived tests, only tests of moderate hormone;
complexity, only PPM procedures, only (4) Urine pregnancy tests—visual
tests of high complexity or any com- color comparison tests;
bination of these tests. (5) Erythrocyte sedimentation rate—
(c) Each laboratory must be either non-automated;
CLIA-exempt or possess one of the fol- (6) Hemoglobin—copper sulfate—non-
lowing CLIA certificates, as defined in automated;
§ 493.2: (7) Blood glucose by glucose moni-
(1) Certificate of registration or reg- toring devices cleared by the FDA spe-
istration certificate. cifically for home use;
(2) Certificate of waiver. (8) Spun microhematocrit; and
(3) Certificate for PPM procedures. (9) Hemoglobin by single analyte in-
(4) Certificate of compliance. struments with self-contained or com-
(5) Certificate of accreditation. ponent features to perform specimen/
[60 FR 20043, Apr. 24, 1995] reagent interaction, providing direct
measurement and readout.
§ 493.15 Laboratories performing (d) Revisions to criteria for test cat-
waived tests. egorization and the list of waived tests.
(a) Requirement. Tests for certificate HHS will determine whether a labora-
of waiver must meet the descriptive tory test meets the criteria listed
criteria specified in paragraph (b) of under paragraph (b) of this section for
this section. a waived test. Revisions to the list of
(b) Criteria. Test systems are simple waived tests approved by HHS will be
laboratory examinations and proce- published in the FEDERAL REGISTER in
dures which— a notice with opportunity for com-
(1) Are cleared by FDA for home use; ment.
(2) Employ methodologies that are so (e) Laboratories eligible for a certifi-
simple and accurate as to render the cate of waiver must—
likelihood of erroneous results neg- (1) Follow manufacturers’ instruc-
ligible; or tions for performing the test; and
(3) Pose no reasonable risk of harm (2) Meet the requirements in subpart
to the patient if the test is performed B, Certificate of Waiver, of this part.
incorrectly. [57 FR 7139, Feb. 28, 1992, as amended at 58
(c) Certificate of waiver tests. A labora- FR 5221, Jan. 19, 1993; 82 FR 48773, Oct. 20,
tory may qualify for a certificate of 2017]
waiver under section 353 of the PHS
Act if it restricts the tests that it per- § 493.17 Test categorization.
forms to one or more of the following (a) Categorization by criteria. Notices
tests or examinations (or additional will be published in the FEDERAL REG-
tests added to this list as provided ISTER which list each specific test sys-
under paragraph (d) of this section) and tem, assay, and examination cat-
no others: egorized by complexity. Using the
695
§ 493.17 42 CFR Ch. IV (10–1–24 Edition)
seven criteria specified in this para- gravimetric or volumetric measure-

graph for categorizing tests of mod- ments.
erate or high complexity, each specific (4) Characteristics of operational steps—
laboratory test system, assay, and ex- (i) Score 1. Operational steps are either
amination will be graded for level of automatically executed (such as
complexity by assigning scores of 1, 2, pipetting, temperature monitoring, or
or 3 within each criteria. The score of timing of steps), or are easily con-
‘‘1’’ indicates the lowest level of com- trolled.
plexity, and the score of ‘‘3’’ indicates (ii) Score 3. Operational steps in the
the highest level. These scores will be testing process require close moni-
totaled. Test systems, assays or exami- toring or control, and may require spe-
nations receiving scores of 12 or less cial specimen preparation, precise tem-
will be categorized as moderate com- perature control or timing of proce-
plexity, while those receiving scores dural steps, accurate pipetting, or ex-
above 12 will be categorized as high tensive calculations.
complexity. (5) Calibration, quality control, and
NOTE: A score of ‘‘2’’ will be assigned to a proficiency testing materials—(i) Score 1.
criteria heading when the characteristics for (A) Calibration materials are stable
a particular test are intermediate between and readily available;
the descriptions listed for scores of ‘‘1’’ and (B) Quality control materials are sta-
‘‘3.’’ ble and readily available; and
(1) Knowledge—(i) Score 1. (A) Mini- (C) External proficiency testing ma-
mal scientific and technical knowledge terials, when available, are stable.
is required to perform the test; and (ii) Score 3. (A) Calibration materials,
(B) Knowledge required to perform if available, may be labile;
the test may be obtained through on- (B) Quality control materials may be
the-job instruction. labile, or not available; or
(ii) Score 3. Specialized scientific and (C) External proficiency testing ma-
technical knowledge is essential to per- terials, if available, may be labile.
form preanalytic, analytic or (6) Test system troubleshooting and
postanalytic phases of the testing. equipment maintenance—(i) Score 1. (A)
(2) Training and experience—(i) Score 1. Test system troubleshooting is auto-
(A) Minimal training is required for matic or self-correcting, or clearly de-
preanalytic, analytic and postanalytic scribed or requires minimal judgment;
phases of the testing process; and and
(B) Limited experience is required to (B) Equipment maintenance is pro-
perform the test. vided by the manufacturer, is seldom
(ii) Score 3. (A) Specialized training is needed, or can easily be performed.
essential to perform the preanalytic, (ii) Score 3. (A) Troubleshooting is
analytic or postanalytic testing proc- not automatic and requires decision-
ess; or making and direct intervention to re-
(B) Substantial experience may be solve most problems; or
necessary for analytic test perform- (B) Maintenance requires special
ance. knowledge, skills, and abilities.
(3) Reagents and materials prepara- (7) Interpretation and judgment—(i)
tion—(i) Score 1. (A) Reagents and ma- Score 1. (A) Minimal interpretation and
terials are generally stable and reli- judgment are required to perform
able; and preanalytic, analytic and postanalytic
(B) Reagents and materials are pre- processes; and
packaged, or premeasured, or require (B) Resolution of problems requires
no special handling, precautions or limited independent interpretation and
storage conditions. judgment; and
(ii) Score 3. (A) Reagents and mate- (ii) Score 3. (A) Extensive independent
rials may be labile and may require interpretation and judgment are re-
special handling to assure reliability; quired to perform the preanalytic, ana-
or lytic or postanalytic processes; and
(B) Reagents and materials prepara- (B) Resolution of problems requires
tion may include manual steps such as extensive interpretation and judgment.
696
(b) Revisions to the criteria for cat- quest, reviews the matter and notifies
egorization. The Clinical Laboratory the applicant of its decision. Test cat-
Improvement Advisory Committee, as egorization is effective as of the notifi-
defined in subpart T of this part, will cation to the applicant.
conduct reviews upon request of HHS (5) PHS will publish revisions peri-
and recommend to HHS revisions to odically to the list of moderate and
the criteria for categorization of tests. high complexity tests in the FEDERAL
(c) Process for device/test categorization REGISTER in a notice with opportunity
utilizing the scoring system under for comment.
§ 493.17(a). (1)(i) For new commercial [57 FR 7139, Feb. 28, 1992, as amended at 58
test systems, assays, or examinations, FR 5222, Jan. 19, 1993]
the manufacturer, as part of its 510(k)
and PMA application to FDA, will sub- § 493.19 Provider-performed micros-
mit supporting data for device/test cat- copy (PPM) procedures.
egorization. FDA will determine the (a) Requirement. To be categorized as
complexity category, notify the manu- a PPM procedure, the procedure must
facturers directly, and will simulta- meet the criteria specified in para-
neously inform both CMS and CDC of graph (b) of this section.
the device/test category. FDA will con- (b) Criteria. Procedures must meet
sult with CDC concerning test cat- the following specifications:
egorization in the following three situ- (1) The examination must be person-
ations: ally performed by one of the following
(A) When categorizing previously practitioners:
uncategorized new technology; (i) A physician during the patient’s
(B) When FDA determines it to be visit on a specimen obtained from his
necessary in cases involving a request or her own patient or from a patient of
for a change in categorization; and a group medical practice of which the
(C) If a manufacturer requests review physician is a member or an employee.
of a categorization decision by FDA in (ii) A midlevel practitioner, under
accordance with 21 CFR 10.75. the supervision of a physician or in
(ii) Test categorization will be effec- independent practice only if authorized
tive as of the notification to the appli- by the State, during the patient’s visit
cant. on a specimen obtained from his or her
(2) For test systems, assays, or ex- own patient or from a patient of a clin-
aminations not commercially avail- ic, group medical practice, or other
able, a laboratory or professional group health care provider of which the mid-
may submit a written request for cat- level practitioner is a member or an
egorization to PHS. These requests will employee.
be forwarded to CDC for evaluation; (iii) A dentist during the patient’s
CDC will determine complexity cat- visit on a specimen obtained from his
egory and notify the applicant, CMS, or her own patient or from a patient of
and FDA of the categorization deci- a group dental practice of which the
sion. In the case of request for a change dentist is a member or an employee.
of category or for previously (2) The procedure must be cat-
uncategorized new technology, PHS egorized as moderately complex.
will receive the request application and (3) The primary instrument for per-
forward it to CDC for categorization. forming the test is the microscope,
(3) A request for recategorization will limited to bright-field or phase-con-
be accepted for review if it is based on trast microscopy.
new information not previously sub- (4) The specimen is labile or delay in
mitted in a request for categorization performing the test could compromise
or recategorization by the same appli- the accuracy of the test result.
cant and will not be considered more (5) Control materials are not avail-
frequently than once per year. able to monitor the entire testing proc-
(4) If a laboratory test system, assay ess.
or examination does not appear on the (6) Limited specimen handling or
lists of tests in the FEDERAL REGISTER processing is required.
notices, it is considered to be a test of (c) Provider-performed microscopy
high complexity until PHS, upon re- (PPM) examinations. A laboratory may
697
§ 493.20 42 CFR Ch. IV (10–1–24 Edition)
qualify to perform tests under this sec- cluding the subcategory of PPM proce-
tion if it restricts PPM examinations dures.
to one or more of the following proce- (b) A laboratory that performs tests
dures (or additional procedures added or examinations of moderate com-
to this list as provided under paragraph plexity must meet the applicable re-
(d) of this section), waived tests and no quirements in subpart C or subpart D,
others: and subparts F, H, J, K, M, and Q of
(1) All direct wet mount preparations this part. Under a registration certifi-
for the presence or absence of bacteria, cate or certificate of compliance, lab-
fungi, parasites, and human cellular oratories also performing PPM proce-
elements. dures must meet the inspection re-
(2) All potassium hydroxide (KOH) quirements at §§ 493.1773 and 493.1777.
preparations. (c) If the laboratory also performs
(3) Pinworm examinations. waived tests, compliance with
(4) Fern tests. § 493.801(a) and (b)(7) and subparts J, K,
(5) Post-coital direct, qualitative ex- and M of this part is not applicable to
aminations of vaginal or cervical mu- the waived tests. However, the labora-
cous. tory must comply with the require-
(6) Urine sediment examinations. ments in §§ 493.15(e), 493.801(b)(1)
(7) Nasal smears for granulocytes. through (6), 493.1771, 493.1773, and
(8) Fecal leukocyte examinations. 493.1775.
(9) Qualitative semen analysis (lim- [60 FR 20044, Apr. 24, 1995, as amended at 68
ited to the presence or absence of FR 3702, Jan. 24, 2003; 68 FR 50723, Aug. 22,
sperm and detection of motility). 2003; 87 FR 41232, July 11, 2022]
(d) Revisions to criteria and the list of
PPM procedures. (1) The CLIAC con- § 493.25 Laboratories performing tests
ducts reviews upon HHS’ request and of high complexity.
recommends to HHS revisions to the (a) A laboratory must obtain a cer-
criteria for categorization of proce- tificate for tests of high complexity if
dures. it performs one or more tests that
(2) HHS determines whether a labora- meet the criteria for tests of high com-
tory procedure meets the criteria listed plexity as specified in § 493.17(a).
under paragraph (b) of this section for (b) A laboratory performing one or
a PPM procedure. Revisions to the list more tests of high complexity must
of PPM procedures proposed by HHS meet the applicable requirements of
are published in the FEDERAL REGISTER subpart C or subpart D, and subparts F,
as a notice with an opportunity for H, J, K, M, and Q of this part.
public comment. (c) If the laboratory also performs
(e) Laboratory requirements. Labora- tests of moderate complexity, the ap-
tories eligible to perform PPM exami- plicable requirements of subparts H, J,
nations must— K, M, and Q of this part must be met.
(1) Meet the applicable requirements Under a registration certificate or cer-
in subpart C or subpart D, and subparts tificate of compliance, PPM procedures
F, H, J, K, and M of this part. must meet the inspection requirements
(2) Be subject to inspection as speci- at §§ 493.1773 and 493.1777.
fied under subpart Q of this part. (d) If the laboratory also performs
[60 FR 20044, Apr. 24, 1995; 68 FR 50723, Aug. waived tests, compliance with
22, 2003] §§ 493.801(a) and 493.801(b)(7) and sub-
parts J, K, and M of this part are not
§ 493.20 Laboratories performing tests applicable to the waived tests. How-
of moderate complexity. ever, the laboratory must comply with
(a) A laboratory may qualify for a the requirements in §§ 493.15(e),
certificate to perform tests of mod- 493.801(b)(1) through (6), 493.1771,
erate complexity provided that it re- 493.1773, and 493.1775.
stricts its test performance to waived [57 FR 7139, Feb. 28, 1992, as amended at 60
tests or examinations and one or more FR 20044, Apr. 24, 1995; 68 FR 3702, Jan. 24,
tests or examinations meeting criteria 2003; 68 FR 50723, Aug. 22, 2003; 87 FR 41232,
for tests of moderate complexity in- July 11, 2022]
698
Subpart B—Certificate of Waiver (ii) The methodologies for each lab-

oratory test procedure or examination
performed, or both; and
SOURCE: 57 FR 7142, Feb. 28, 1992, unless
otherwise noted. (iii) The qualifications (educational
background, training, and experience)
§ 493.35 Application for a certificate of of the personnel directing and super-
waiver. vising the laboratory and performing
(a) Filing of application. Except as the laboratory examinations and test
specified in paragraph (b) of this sec- procedures.
tion, a laboratory performing only one (d) Access requirements. Laboratories
or more waived tests listed in § 493.15 that perform one or more waived tests
must file a separate application for listed in § 493.15(c) and no other tests
each laboratory location. must meet the following conditions:
(b) Exceptions. (1) Laboratories that (1) Make records available and sub-
are not at a fixed location, that is, lab- mit reports to HHS as HHS may rea-
oratories that move from testing site sonably require to determine compli-
to testing site, such as mobile units ance with this section and § 493.15(e);
providing laboratory testing, health (2) Agree to permit announced and
screening fairs, or other temporary unannounced inspections by HHS in ac-
testing locations may be covered under cordance with subpart Q of this part
the certificate of the designated pri- under the following circumstances:
mary site or home base, using its ad- (i) When HHS has substantive reason
dress. to believe that the laboratory is being
(2) Not-for-profit or Federal, State, operated in a manner that constitutes
or local government laboratories that an imminent and serious risk to human
engage in limited (not more than a health.
combination of 15 moderately complex (ii) To evaluate complaints from the
or waived tests per certificate) public public.
health testing may file a single appli- (iii) On a random basis to determine
cation. whether the laboratory is performing
(3) Laboratories within a hospital tests not listed in § 493.15.
that are located at contiguous build- (iv) To collect information regarding
ings on the same campus and under the appropriateness of waiver of tests
common direction may file a single ap- listed in § 493.15.
plication or multiple applications for
(e) Denial of application. If HHS deter-
the laboratory sites within the same
mines that the application for a certifi-
physical location or street address.
cate of waiver is to be denied, HHS
(c) Application format and contents.
will—
The application must—
(1) Provide the laboratory with a
(1) Be made to HHS or its designee on
written statement of the grounds on
a form or forms prescribed by HHS;
which the denial is based and an oppor-
(2) Be signed by an owner, or by an
tunity for appeal, in accordance with
authorized representative of the lab-
the procedures set forth in subpart R of
oratory who attests that the labora-
this part;
tory will be operated in accordance
with requirements established by the (2) Notify a laboratory that has its
Secretary under section 353 of the PHS application for a certificate of waiver
Act; and denied that it cannot operate as a lab-
(3) Describe the characteristics of the oratory under the PHS Act unless the
laboratory operation and the examina- denial is overturned at the conclusion
tions and other test procedures per- of the administrative appeals process
formed by the laboratory including— provided by subpart R; and
(i) The name and the total number of (3) Notify the laboratory that it is
test procedures and examinations per- not eligible for payment under the
formed annually (excluding tests the Medicare and Medicaid programs.
laboratory may run for quality control, [57 FR 7142, Feb. 28, 1992, as amended at 58
quality assurance or proficiency test- FR 5222, Jan. 19, 1993; 60 FR 20044, Apr. 24,
ing purposes; 1995]
699
§ 493.37 42 CFR Ch. IV (10–1–24 Edition)
§ 493.37 Requirements for a certificate (1) Complete the renewal application

of waiver. prescribed by HHS and return it to
(a) HHS will issue a certificate of HHS not less than 9 months nor more
waiver to a laboratory only if the lab- than 1 year before the expiration of the
oratory meets the requirements of certificate; and
§ 493.35. (2) Meet the requirements of §§ 493.35
(b) Laboratories issued a certificate and 493.37.
of waiver— (g) A laboratory with a certificate of
(1) Are subject to the requirements of waiver that wishes to perform exami-
this subpart and § 493.15(e) of subpart A nations or tests not listed in the waiv-
of this part; and er test category must meet the require-
(2) Must permit announced or unan- ments set forth in subpart C or subpart
nounced inspections by HHS in accord-
D of this part, as applicable.
ance with subpart Q of this part.
(c) Laboratories must remit the cer- [57 FR 7142, Feb. 28, 1992, as amended at 58
tificate of waiver fee specified in sub- FR 5222, Jan. 19, 1993; 60 FR 20045, Apr. 24,
part F of this part. 1995]
(d) In accordance with subpart R of
this part, HHS will suspend or revoke § 493.39 Notification requirements for
or limit a laboratory’s certificate of laboratories issued a certificate of
waiver for failure to comply with the waiver.
requirements of this subpart. In addi- Laboratories performing one or more
tion, failure to meet the requirements tests listed in § 493.15 and no others
of this subpart will result in suspension must notify HHS or its designee—
or denial of payments under Medicare (a) Before performing and reporting
and Medicaid in accordance with sub- results for any test or examination
part R of this part. that is not specified under § 493.15 for
(e)(1) A certificate of waiver issued which the laboratory does not have the
under this subpart is valid for no more
appropriate certificate as required in
than 2 years. In the event of a non-
subpart C or subpart D of this part, as
compliance determination resulting in
applicable; and
HHS action to revoke, suspend, or
limit the laboratory’s certificate of (b) Within 30 days of any change(s)
waiver, HHS will provide the labora- in—
tory with a statement of grounds on (1) Ownership;
which the determination of non-com- (2) Name;
pliance is based and offer an oppor- (3) Location; or
tunity for appeal as provided in sub- (4) Director.
part R of this part.
(2) If the laboratory requests a hear-
FR 20045, Apr. 24, 1995]
ing within the time specified by HHS,
it retains its certificate of waiver or re- § 493.41 Condition: Reporting of SARS–
issued certificate of waiver until a de- CoV–2 test results.
cision is made by an administrative
law judge, as specified in subpart R of During the Public Health Emergency,
this part, except when HHS finds that as defined in § 400.200 of this chapter,
conditions at the laboratory pose an each laboratory that performs a test
imminent and serious risk to human that is intended to detect SARS–CoV–2
health. or to diagnose a possible case of
(3) For laboratories receiving pay- COVID–19 (hereinafter referred to as a
ment from the Medicare or Medicaid ‘‘SARS–CoV–2 test’’) must report
program, such payments will be sus- SARS–CoV–2 test results to the Sec-
pended on the effective date specified retary in such form and manner, and at
in the notice to the laboratory of a such timing and frequency, as the Sec-
non-compliance determination even if retary may prescribe.
there has been no appeals decision
issued. [85 FR 54873, Sept. 2, 2020]
(f) A laboratory seeking to renew its
certificate of waiver must—
700
Subpart C—Registration Certifi- (i) The name and total number of test
cate, Certificate for Provider- procedures and examinations per-
formed annually (excluding waived
performed Microscopy Proce- tests or tests for quality control, qual-
dures, and Certificate of ity assurance or proficiency testing
Compliance purposes);
(ii) The methodologies for each lab-
SOURCE: 57 FR 7143, Feb. 28, 1992, unless oratory test procedure or examination
otherwise noted. performed, or both;
(iii) The qualifications (educational
§ 493.43 Application for registration background, training, and experience)
certificate, certificate for provider- of the personnel directing and super-
performed microscopy (PPM) proce-
dures, and certificate of compli- vising the laboratory and performing
ance. the examinations and test procedures.
(d) Access and reporting requirements.
(a) Filing of application. Except as All laboratories must make records
specified in paragraph (b) of this sec- available and submit reports to HHS as
tion, all laboratories performing non- HHS may reasonably require to deter-
waived testing must file a separate ap- mine compliance with this section.
plication for each laboratory location.
(b) Exceptions. (1) Laboratories that [57 FR 7143, Feb. 28, 1992, as amended at 58
FR 5222, Jan. 19, 1993; 58 FR 39155, July 22,
are not at a fixed location, that is, lab-
1993; 60 FR 20045, Apr. 24, 1995; 68 FR 3702,
oratories that move from testing site Jan. 24, 2003]
to testing site, such as mobile units
providing laboratory testing, health § 493.45 Requirements for a registra-
screening fairs, or other temporary tion certificate.
testing locations may be covered under Laboratories performing only waived
the certificate of the designated pri- tests, PPM procedures, or any com-
mary site or home base, using its ad- bination of these tests, are not re-
dress. quired to obtain a registration certifi-
(2) Not-for-profit or Federal, State, cate.
or local government laboratories that (a) A registration certificate is re-
engage in limited (not more than a quired—(1) Initially for all laboratories
combination of 15 moderately complex performing test procedures of moderate
or waived tests per certificate) public complexity (other than the sub-
health testing may file a single appli- category of PPM procedures) or high
cation. complexity, or both; and
(3) Laboratories within a hospital (2) For all laboratories that have
that are located at contiguous build- been issued a certificate of waiver or
ings on the same campus and under certificate for PPM procedures that in-
common direction may file a single ap- tend to perform tests of moderate or
plication or multiple applications for high complexity, or both, in addition
the laboratory sites within the same to those tests listed in § 493.15(c) or
physical location or street address. specified as PPM procedures.
(c) Application format and contents. (b) HHS will issue a registration cer-
The application must—(1) Be made to tificate if the laboratory—
HHS or its designee on a form or forms (1) Complies with the requirements of
prescribed by HHS; § 493.43;
(2) Be signed by an owner, or by an (2) Agrees to notify HHS or its des-
authorized representative of the lab- ignee within 30 days of any changes in
oratory who attests that the labora- ownership, name, location, director or
tory will be operated in accordance technical supervisor (laboratories per-
with the requirements established by forming high complexity testing only);
the Secretary under section 353 of the (3) Agrees to treat proficiency testing
Public Health Service Act; and samples in the same manner as it
(3) Describe the characteristics of the treats patient specimens; and
laboratory operation and the examina- (4) Remits the fee for the registration
tions and other test procedures per- certificate, as specified in subpart F of
formed by the laboratory including— this part.
701
§ 493.47 42 CFR Ch. IV (10–1–24 Edition)
(c) Prior to the expiration of the reg- nial of the certificate application even
istration certificate, a laboratory if there has been no appeals decision
must— issued.
(1) Remit the certificate fee specified
in subpart F of this part; FR 5223, Jan. 19, 1993; 60 FR 20045, Apr. 24,
(2) Be inspected by HHS as specified 1995; 68 FR 3702, Jan. 24, 2003]
in subpart Q of this part; and
(3) Demonstrate compliance with the § 493.47 Requirements for a certificate
applicable requirements of this subpart for provider-performed microscopy
and subparts H, J, K, M, and Q of this (PPM) procedures.
part. (a) A certificate for PPM procedures
(d) In accordance with subpart R of is required—
this part, HHS will initiate suspension (1) Initially for all laboratories per-
or revocation of a laboratory’s reg- forming test procedures specified as
istration certificate and will deny the PPM procedures; and
laboratory’s application for a certifi- (2) For all certificate of waiver lab-
cate of compliance for failure to com- oratories that intend to perform only
ply with the requirements set forth in test procedures specified as PPM proce-
this subpart. HHS may also impose cer- dures in addition to those tests listed
tain alternative sanctions. In addition, in § 493.15(c).
failure to meet the requirements of (b) HHS will issue a certificate for
this subpart will result in suspension of PPM procedures if the laboratory—
payments under Medicare and Medicaid (1) Complies with the requirements of
as specified in subpart R of this part. § 493.43; and
(e) A registration certificate is—
(2) Remits the fee for the certificate,
(1) Valid for a period of no more than
as specified in subpart F of this part.
two years or until such time as an in-
(c) Laboratories issued a certificate
spection to determine program compli-
for PPM procedures are subject to—
ance can be conducted, whichever is
(1) The notification requirements of
shorter; and
§ 493.53;
(2) Not renewable; however, the reg-
istration certificate may be reissued if (2) The applicable requirements of
compliance has not been determined by this subpart and subparts H, J, K, and
HHS prior to the expiration date of the M of this part; and
registration certificate. (3) Inspection only under the cir-
(f) In the event of a noncompliance cumstances specified under §§ 493.1773
determination resulting in an HHS de- and 493.1775, but are not routinely in-
nial of a laboratory’s certificate of spected to determine compliance with
compliance application, HHS will pro- the requirements specified in para-
vide the laboratory with a statement of graphs (c) (1) and (2) of this section.
grounds on which the noncompliance (d) In accordance with subpart R of
determination is based and offer an op- this part, HHS will initiate suspension,
portunity for appeal as provided in sub- limitation, or revocation of a labora-
part R. tory’s certificate for PPM procedures
(g) If the laboratory requests a hear- for failure to comply with the applica-
ing within the time specified by HHS, ble requirements set forth in this sub-
it retains its registration certificate or part. HHS may also impose certain al-
reissued registration certificate until a ternative sanctions. In addition, failure
decision is made by an administrative to meet the requirements of this sub-
law judge as provided in subpart R of part may result in suspension of all or
this part, except when HHS finds that part of payments under Medicare and
conditions at the laboratory pose an Medicaid, as specified in subpart R of
imminent and serious risk to human this part.
health. (e) A certificate for PPM procedures
(h) For laboratories receiving pay- is valid for a period of no more than 2
ment from the Medicare or Medicaid years.
program, such payments will be sus- [58 FR 5223, Jan. 19, 1993, as amended at 60
pended on the effective date specified FR 20045, Apr. 24, 1995; 68 FR 3702, Jan. 24,
in the notice to the laboratory of de- 2003; 68 FR 50723, Aug. 22, 2003]
702
§ 493.49 Requirements for a certificate (1) Provide the laboratory with a

of compliance. statement of grounds on which the de-
A certificate of compliance may in- termination of noncompliance is based;
clude any combination of tests cat- and
egorized as high complexity or mod- (2) Offer an opportunity for appeal as
erate complexity or listed in § 493.15(c) provided in subpart R of this part. If
as waived tests. Moderate complexity the laboratory requests a hearing with-
tests may include those specified as in 60 days of the notice of sanction, it
PPM procedures. retains its certificate of compliance or
(a) HHS will issue a certificate of reissued certificate of compliance until
compliance to a laboratory only if the a decision is made by an administra-
laboratory— tive law judge (ALJ) as provided in
(1) Meets the requirements of §§ 493.43 subpart R of this part, except when
and 493.45; HHS finds that conditions at the lab-
(2) Remits the certificate fee speci- oratory pose an imminent and serious
fied in subpart F of this part; and risk to human health or when the cri-
(3) Meets the applicable requirements teria at § 493.1840(a) (4) and (5) are met.
of this subpart and subparts H, J, K, M, (f) For laboratories receiving pay-
and Q of this part. ment from the Medicare or Medicaid
(b) Laboratories issued a certificate program, such payments will be sus-
of compliance— pended on the effective date specified
(1) Are subject to the notification rein the notice to the laboratory of a
quirements of § 493.51; and noncompliance determination even if
(2) Must permit announced or unan- there has been no appeals decision
nounced inspections by HHS in accord-
issued.
ance with subpart Q of this part—
(g) A laboratory seeking to renew its
(i) To determine compliance with the
applicable requirements of this part; certificate of compliance must—
(ii) To evaluate complaints; (1) Complete and return the renewal
(iii) When HHS has substantive rea- application to HHS 9 to 12 months
son to believe that tests are being per- prior to the expiration of the certifi-
formed, or the laboratory is being oper- cate of compliance; and
ated in a manner that constitutes an (2) Meet the requirements of § 493.43
imminent and serious risk to human and paragraphs (a)(2) and (b)(2) of this
health; and section.
(iv) To collect information regarding (h) If HHS determines that the appli-
the appropriateness of tests listed in cation for the renewal of a certificate
§ 493.15 or tests categorized as moderate of compliance must be denied or lim-
complexity (including the subcategory) ited, HHS will notify the laboratory in
or high complexity. writing of the—
(c) Failure to comply with the re- (1) Basis for denial of the application;
quirements of this subpart will result and
in— (2) Opportunity for appeal as pro-
(1) Suspension, revocation or limita- vided in subpart R of this part.
tion of a laboratory’s certificate of (i) If the laboratory requests a hear-
compliance in accordance with subpart
ing within the time period specified by
R of this part; and
HHS, the laboratory retains its certifi-
(2) Suspension or denial of payments
cate of compliance or reissued certifi-
under Medicare and Medicaid in ac-
cate of compliance until a decision is
cordance with subpart R of this part.
(d) A certificate of compliance issued made by an ALJ as provided in subpart
under this subpart is valid for no more R, except when HHS finds that condi-
than 2 years. tions at the laboratory pose an immi-
(e) In the event of a noncompliance nent and serious risk to human health.
determination resulting in an HHS ac- (j) For laboratories receiving pay-
tion to revoke, suspend or limit the ment from the Medicare or Medicaid
laboratory’s certificate of compliance, program, such payments will be sus-
HHS will— pended on the effective date specified
703
§ 493.51 42 CFR Ch. IV (10–1–24 Edition)
in the notice to the laboratory of non- (4) Director.

renewal of the certificate of compli-
ance even if there has been no appeals
FR 20046, Apr. 24, 1995]
decision issued.
[60 FR 20045, Apr. 24, 1995, as amended at 68 Subpart D—Certificate of
FR 3702, Jan. 24, 2003]
Accreditation
§ 493.51 Notification requirements for
laboratories issued a certificate of SOURCE: 57 FR 7144, Feb. 28, 1992, unless
compliance. otherwise noted.
Laboratories issued a certificate of
compliance must meet the following § 493.55 Application for registration
conditions: certificate and certificate of accred-
itation.
(a) Notify HHS or its designee within
30 days of any change in— (a) Filing of application. A laboratory
(1) Ownership; may be issued a certificate of accredi-
(2) Name; tation in lieu of the applicable certifi-
(3) Location; cate specified in subpart B or subpart C
(4) Director; or of this part provided the laboratory—
(5) Technical supervisor (laboratories (1) Meets the standards of a private
performing high complexity only). non-profit accreditation program ap-
(b) Notify HHS no later than 6 proved by HHS in accordance with sub-
months after performing any test or part E; and
examination within a specialty or sub- (2) Files a separate application for
specialty area that is not included on each location, except as specified in
the laboratory’s certificate of compli- paragraph (b) of this section.
ance, so that compliance with require- (b) Exceptions. (1) Laboratories that
ments can be determined. are not at fixed locations, that is, lab-
(c) Notify HHS no later than 6 oratories that move from testing site
months after any deletions or changes to testing site, such as mobile units
in test methodologies for any test or providing laboratory testing, health
examination included in a specialty or screening fairs, or other temporary
subspecialty, or both, for which the testing locations may be covered under
laboratory has been issued a certificate
the certificate of the designated pri-
of compliance.
mary site or home base, using its ad-
[57 FR 7143, Feb. 28, 1992, as amended at 60 dress.
FR 20046, Apr. 24, 1995] (2) Not-for-profit or Federal, State,
or local government laboratories that
§ 493.53 Notification requirements for
laboratories issued a certificate for engage in limited (not more than a
provider-performed microscopy combination of 15 moderately complex
(PPM) procedures. or waived tests per certificate) public
Laboratories issued a certificate for health testing may file a single appli-
PPM procedures must notify HHS or cation.
its designee— (3) Laboratories within a hospital
(a) Before performing and reporting that are located at contiguous build-
results for any test of moderate or high ings on the same campus and under
complexity, or both, in addition to common direction may file a single ap-
tests specified as PPM procedures or plication or multiple applications for
any test or examination that is not the laboratory sites within the same
specified under § 493.15(c), for which it physical location or street address.
does not have a registration certificate (c) Application format and contents.
as required in subpart C or subpart D, The application must—(1) Be made to
as applicable, of this part; and HHS on a form or forms prescribed by
(b) Within 30 days of any change in— HHS;
(1) Ownership; (2) Be signed by an owner or author-
(2) Name; ized representative of the laboratory
(3) Location; or who attests that the laboratory will be
704
operated in accordance with the re- (ii) Prior to the expiration of the cer-
quirements established by the Sec- tificate of compliance.
retary under section 353 of the Public (2) If such proof of accreditation is
Health Service Act; and not supplied within this timeframe, the
(3) Describe the characteristics of the laboratory must meet, or continue to
laboratory operation and the examina- meet, the requirements of § 493.49.
tions and other test procedures per- (c) In accordance with subpart R of
formed by the laboratory including— this part, HHS will initiate suspension,
(i) The name and total number of revocation, or limitation of a labora-
tests and examinations performed an- tory’s registration certificate and will
nually (excluding waived tests and deny the laboratory’s application for a
tests for quality control, quality assur- certificate of accreditation for failure
ance or proficiency testing purposes); to comply with the requirements set
(ii) The methodologies for each lab- forth in this subpart. In addition, fail-
oratory test procedure or examination ure to meet the requirements of this
performed, or both; and subpart will result in suspension or de-
(iii) The qualifications (educational nial of payments under Medicare and
background, training, and experience) Medicaid as specified in subpart R of
of the personnel directing and super- this part.
vising the laboratory and performing (d) A registration certificate is valid
the laboratory examinations and test for a period of no more than 2 years.
procedures. However, it may be reissued if the lab-
oratory is subject to subpart C of this
(d) Access and reporting requirements.
part, as specified in § 493.57(b)(2) and
All laboratories must make records
compliance has not been determined by
available and submit reports to HHS as
HHS before the expiration date of the
HHS may reasonably require to deter-
registration certificate.
mine compliance with this section.
(e) In the event that the laboratory
[57 FR 7144, Feb. 28, 1992, as amended at 58 does not meet the requirements of this
FR 5224, Jan. 19, 1993; 58 FR 39155, July 22, subpart, HHS will—
1993; 60 FR 20046, Apr. 24, 1995] (1) Deny a laboratory’s request for
certificate of accreditation;
§ 493.57 Requirements for a registra- (2) Notify the laboratory if it must
tion certificate.
meet the requirements for a certificate
A registration certificate is required as defined in subpart C of this part;
for all laboratories seeking a certifi- (3) Provide the laboratory with a
cate of accreditation, unless the lab- statement of grounds on which the ap-
oratory holds a valid certificate of plication denial is based;
compliance issued by HHS. (4) Offer an opportunity for appeal on
(a) HHS will issue a registration cer- the application denial as provided in
tificate if the laboratory— subpart R of this part. If the laboratory
(1) Complies with the requirements of requests a hearing within the time
§ 493.55; specified by HHS, the laboratory will
(2) Agrees to notify HHS within 30 retain its registration certificate or re-
days of any changes in ownership, issued registration certificate until a
name, location, director, or supervisor decision is made by an administrative
(laboratories performing high com- law judge as provided in subpart R, un-
plexity testing only); less HHS finds that conditions at the
(3) Agrees to treat proficiency testing laboratory pose an imminent and seri-
samples in the same manner as it ous risk to human health; and
treats patient specimens; and (5) For those laboratories receiving
(4) Remits the fee for the registration payment from the Medicare or Med-
certificate specified in subpart F of icaid program, such payments will be
this part. suspended on the effective date speci-
(b)(1) The laboratory must provide fied in the notice to the laboratory of
HHS with proof of accreditation by an denial of the request even if there has
approved accreditation program— been no appeals decision issued.
(i) Within 11 months of issuance of [57 FR 7144, Feb. 28, 1992, as amended at 60
the registration certificate; or FR 20046, Apr. 24, 1995]
705
§ 493.61 42 CFR Ch. IV (10–1–24 Edition)
§ 493.61 Requirements for a certificate limit the certificate of accreditation.

of accreditation. HHS will—
(a) HHS will issue a certificate of ac- (1) Provide the laboratory with a
creditation to a laboratory if the lab- statement of grounds on which the de-
oratory— termination of noncompliance is based;
(1) Meets the requirements of § 493.57 (2) Notify the laboratory if it is eligi-
or, if applicable, § 493.49 of subpart C of ble to apply for a certificate as defined
this part; and in subpart C of this part; and
(2) Remits the certificate of accredi- (3) Offer an opportunity for appeal as
tation fee specified in subpart F of this provided in subpart R of this part.
part. (f) If the laboratory requests a hear-
(b) Laboratories issued a certificate ing within the time frame specified by
of accreditation must— HHS—
(1) Treat proficiency testing samples (1) It retains its certificate of accred-
in the same manner as patient samples; itation or reissued certificate of ac-
(2) Meet the requirements of § 493.63; creditation until a decision is made by
(3) Comply with the requirements of an administrative law judge as pro-
the approved accreditation program; vided in subpart R of this part, unless
(4) Permit random sample validation HHS finds that conditions at the lab-
and complaint inspections as required oratory pose an imminent and serious
in subpart Q of this part; risk to human health; and
(5) Permit HHS to monitor the cor- (2) For those laboratories receiving
rection of any deficiencies found payments from the Medicare or Med-
through the inspections specified in icaid program, such payments will be
paragraph (b)(4) of this section; suspended on the effective date speci-
(6) Authorize the accreditation pro- fied in the notice to the laboratory
gram to release to HHS the labora- even if there has been no appeals deci-
tory’s inspection findings whenever sion issued.
HHS conducts random sample or com- (g) In the event the accreditation or-
plaint inspections; and ganization’s approval is removed by
(7) Authorize its accreditation pro- HHS, the laboratory will be subject to
gram to submit to HHS the results of the applicable requirements of subpart
the laboratory’s proficiency testing. C of this part or § 493.57.
(c) A laboratory failing to meet the
(h) A laboratory seeking to renew its
requirements of this section—
certificate of accreditation must—
(1) Will no longer meet the require-
(1) Complete and return the renewal
ments of this part by virtue of its ac-
application to HHS 9 to 12 months
creditation in an approved accredita-
prior to the expiration of the certifi-
tion program;
cate of accreditation;
(2) Will be subject to full determina-
tion of compliance by HHS; (2) Meet the requirements of this sub-
(3) May be subject to suspension, rev- part; and
ocation or limitation of the labora- (3) Submit the certificate of accredi-
tory’s certificate of accreditation or tation fee specified in subpart F of this
certain alternative sanctions; and part.
(4) May be subject to suspension of (i) If HHS determines that the re-
payments under Medicare and Medicaid newal application for a certificate of
as specified in subpart R. accreditation is to be denied or lim-
(d) A certificate of accreditation ited, HHS will notify the laboratory in
issued under this subpart is valid for no writing of—
more than 2 years. In the event of a (1) The basis for denial of the applica-
non-compliance determination as a re- tion;
sult of a random sample validation or (2) Whether the laboratory is eligible
complaint inspection, a laboratory will for a certificate as defined in subpart C
be subject to a full review by HHS in of this part;
accordance with § 488.11 of this chapter. (3) The opportunity for appeal on
(e) Failure to meet the applicable re- HHS’s action to deny the renewal ap-
quirements of part 493, will result in an plication for certificate of accredita-
action by HHS to suspend, revoke or tion as provided in subpart R of this
706
part. If the laboratory requests a hear- § 493.551 General requirements for

ing within the time frame specified by laboratories.
HHS, it retains its certificate of ac- (a) Applicability. CMS may deem a
creditation or reissued certificate of laboratory to meet all applicable CLIA
accreditation until a decision is made program requirements through accredi-
by an administrative law judge as pro- tation by a private nonprofit accredita-
vided in subpart R of this part, unless tion program (that is, grant deemed
HHS finds that conditions at the lab- status), or may exempt from CLIA pro-
oratory pose an imminent and serious gram requirements all State licensed
risk to human health; and or approved laboratories in a State
(4) Suspension of payments under that has a State licensure program es-
Medicare or Medicaid for those labora- tablished by law, if the following condi-
tories receiving payments under the tions are met:
Medicare or Medicaid programs. (1) The requirements of the accredi-
[57 FR 7144, Feb. 28, 1992, as amended at 58 tation organization or State licensure
FR 5224, Jan. 19, 1993] program are equal to, or more strin-
gent than, the CLIA condition-level re-
§ 493.63 Notification requirements for quirements specified in this part, and
laboratories issued a certificate of the laboratory would meet the condi-
accreditation.
tion-level requirements if it were in-
Laboratories issued a certificate of spected against these requirements.
accreditation must: (2) The accreditation program or the
(a) Notify HHS and the approved ac- State licensure program meets the re-
creditation program within 30 days of quirements of this subpart and is ap-
any changes in— proved by CMS.
(1) Ownership; (3) The laboratory authorizes the ap-
(2) Name; proved accreditation organization or
(3) Location; or State licensure program to release to
(4) Director. CMS all records and information re-
(b) Notify the approved accreditation quired and permits inspections as out-
program no later than 6 months after lined in this part.
performing any test or examination (b) Meeting CLIA requirements by ac-
within a specialty or subspecialty area creditation. A laboratory seeking to
that is not included in the laboratory’s meet CLIA requirements through ac-
accreditation, so that the accreditation creditation by an approved accredita-
organization can determine compliance tion organization must do the fol-
and a new certificate of accreditation lowing:
can be issued. (1) Obtain a certificate of accredita-
(c) Notify the accreditation program tion as required in subpart D of this
no later than 6 months after of any depart.
letions or changes in test methodolo- (2) Pay the applicable fees as re-
gies for any test or examination in- quired in subpart F of this part.
cluded in a specialty or subspecialty, (3) Meet the proficiency testing (PT)
or both, for which the laboratory has requirements in subpart H of this part.
been issued a certificate of accredita- (4) Authorize its PT organization to
tion. furnish to its accreditation organiza-
tion the results of the laboratory’s par-
Subpart E—Accreditation by a Pri- ticipation in an approved PT program
vate, Nonprofit Accreditation for the purpose of monitoring the lab-
oratory’s PT and for making the an-
Organization or Exemption nual PT results, along with explana-
Under an Approved State tory information required to interpret
Laboratory Program the PT results, available on a reason-
able basis, upon request of any person.
SOURCE: 63 FR 26732, May 14, 1998, unless A laboratory that refuses to authorize
otherwise noted. release of its PT results is no longer
707
§ 493.553 42 CFR Ch. IV (10–1–24 Edition)
deemed to meet the condition-level re- (2) A detailed description of the in-
quirements and is subject to a full re- spection process, including the fol-
view by CMS, in accordance with sub- lowing:
part Q of this part, and may be subject (i) Frequency of inspections.
to the suspension or revocation of its (ii) Copies of inspection forms.
certificate of accreditation under (iii) Instructions and guidelines.
§ 493.1840. (iv) A description of the review and
(5) Authorize its accreditation orga- decision-making process of inspections.
nization to release to CMS or a CMS (v) A statement concerning whether
agent the laboratory’s PT results that inspections are announced or unan-
constitute unsuccessful participation nounced.
in an approved PT program, in accord- (vi) A description of the steps taken
ance with the definition of ‘‘unsuccess- to monitor the correction of defi-
ful participation in an approved PT ciencies.
program,’’ as specified in § 493.2 of this (3) A description of the process for
part, when the laboratory has failed to monitoring PT performance, including
achieve successful participation in an action to be taken in response to un-
approved PT program. successful participation in a CMS-ap-
(6) Authorize its accreditation orga- proved PT program.
nization to release to CMS a notifica- (4) Procedures for responding to and
tion of the actions taken by the organi- for the investigation of complaints
zation as a result of the unsuccessful against its laboratories.
participation in a PT program within (5) A list of all its current labora-
30 days of the initiation of the action. tories and the expiration date of their
Based on this notification, CMS may accreditation or licensure, as applica-
take an adverse action against a lab- ble.
oratory that fails to participate suc- (6) Procedures for making PT infor-
cessfully in an approved PT program. mation available (under State con-
(c) Withdrawal of laboratory accredita- fidentiality and disclosure require-
tion. After an accreditation organiza- ments, if applicable) including explana-
tion has withdrawn or revoked its ac- tory information required to interpret
creditation of a laboratory, the labora- PT results, on a reasonable basis, upon
tory retains its certificate of accredita- request of any person.
tion for 45 days after the laboratory re- (b) CMS action on an application or re-
ceives notice of the withdrawal or rev- application. If CMS receives an applica-
ocation of the accreditation, or the ef- tion or reapplication from an accredi-
fective date of any action taken by tation organization, or State licensure
CMS, whichever is earlier. program, CMS takes the following ac-
tions:
§ 493.553 Approval process (applica- (1) CMS determines if additional in-
tion and reapplication) for accredi- formation is necessary to make a de-
tation organizations and State li-
censure programs. termination for approval or denial of
the application and notifies the accred-
(a) Information required. An accredita- itation organization or State to afford
tion organization that applies or re- it an opportunity to provide the addi-
applies to CMS for deeming authority, tional information.
or a State licensure program that ap- (2) CMS may visit the accreditation
plies or reapplies to CMS for exemption organization or State licensure pro-
from CLIA program requirements of li- gram offices to review and verify the
censed or approved laboratories within policies and procedures represented in
the State, must provide the following its application and other information,
information: including, but not limited to, review
(1) A detailed comparison of the indi- and examination of documents and
vidual accreditation, or licensure or interviews with staff.
approval requirements with the com- (3) CMS notifies the accreditation or-
parable condition-level requirements; ganization or State licensure program
that is, a crosswalk. indicating whether CMS approves or
708
denies the request for deeming author- (i) Accredited laboratories (or labora-
ity or exemption, respectively, and the tories whose areas of specialty/sub-
rationale for any denial. specialty testing have changed); or
(c) Duration of approval. CMS ap- (ii) Licensed laboratories, including
proval may not exceed 6 years. the specialty/subspecialty areas of test-
(d) Withdrawal of application. The ac- ing.
creditation organization or State licen- (4) Notify each accredited or licensed
sure program may withdraw its appli- laboratory within 10 days of CMS’s
cation at any time before official noti- withdrawal of the organization’s deem-
fication, specified at § 493.553(b)(3). ing authority or State’s exemption.
(e) Change of ownership. An accred- (5) Provide CMS with inspection
iting organization that wishes to un-
schedules, as requested, for validation
dergo a change of ownership is subject
purposes.
to the requirements set out at § 488.5(f)
of this chapter. (6) Notify CMS within 10 days of any
conditional level deficiency under
[63 FR 26732, May 14, 1998, as amended at 87 §§ 493.41 or 493.1100(a).
FR 25429, Apr. 29, 2022]
§ 493.555 Federal review of laboratory FR 54873, Sept. 2, 2020]
requirements.
CMS’s review of an accreditation or- § 493.557 Additional submission re-
quirements.
ganization or State licensure program
includes, but is not limited to, an eval- (a) Specific requirements for accredita-
uation of the following: tion organizations. In addition to the in-
(a) Whether the organization’s or formation specified in §§ 493.553 and
State’s requirements for laboratories 493.555, as part of the approval and re-
are equal to, or more stringent than, view process, an accreditation organi-
the condition-level requirements for zation applying or reapplying for deem-
laboratories. ing authority must also provide the
(b) The organization’s or State’s in- following:
spection process to determine the com- (1) The specialty or subspecialty
parability of the full inspection and areas for which the organization is re-
complaint inspection procedures and questing deeming authority and its
requirements to those of CMS, includ- mechanism for monitoring compliance
ing, but not limited to, inspection fre- with all requirements equivalent to
quency and the ability to investigate condition-level requirements within
and respond to complaints against its the scope of the specialty or sub-
laboratories. specialty areas.
(c) The organization’s or State’s (2) A description of the organization’s
agreement with CMS that requires it
data management and analysis system
to do the following:
with respect to its inspection and ac-
(1) Notify CMS within 30 days of the
creditation decisions, including the
action taken, of any laboratory that
kinds of routine reports and tables gen-
has—
erated by the systems.
(i) Had its accreditation or licensure
suspended, withdrawn, revoked, or lim- (3) Detailed information concerning
ited; the inspection process, including, but
(ii) In any way been sanctioned; or not limited to the following:
(iii) Had any adverse action taken (i) The size and composition of indi-
against it. vidual accreditation inspection teams.
(2) Notify CMS within 10 days of any (ii) Qualifications, education, and ex-
deficiency identified in an accredited perience requirements that inspectors
or CLIA-exempt laboratory if the defi- must meet.
ciency poses an immediate jeopardy to (iii) The content and frequency of
the laboratory’s patients or a hazard to training provided to inspection per-
the general public. sonnel, including the ability of the or-
(3) Notify CMS, within 30 days, of all ganization to provide continuing edu-
newly— cation and training to inspectors.
709
§ 493.557 42 CFR Ch. IV (10–1–24 Edition)
(4) Procedures for removal or with- (14) An agreement to disclose any

drawal of accreditation status for lab- laboratory’s PT results upon reason-
oratories that fail to meet the organi- able request by any person.
zation’s standards. (b) Specific requirements for a State li-
(5) A proposed agreement between censure program. In addition to require-
CMS and the accreditation organiza- ments in §§ 493.553 and 493.555, as part of
tion with respect to the notification re- the approval and review process, when
quirements specified in § 493.555(c). a State licensure program applies or
(6) Procedures for monitoring labora- reapplies for exemption from the CLIA
tories found to be out of compliance program, the State must do the fol-
with its requirements. (These moni- lowing:
toring procedures must be used only (1) Demonstrate to CMS that it has
when the accreditation organization enforcement authority and administra-
identifies noncompliance. If non- tive structures and resources adequate
compliance is identified through vali- to enforce its laboratory requirements.
dation inspections, CMS or a CMS (2) Permit CMS or a CMS agent to in-
agent monitors corrections, as author- spect laboratories in the State.
ized at § 493.565(d)). (3) Require laboratories in the State
(7) A demonstration of its ability to to submit to inspections by CMS or a
provide CMS with electronic data and CMS agent as a condition of licensure
reports in compatible code, including or approval.
the crosswalk specified in § 493.553(a)(1), (4) Agree to pay the cost of the vali-
that are necessary for effective valida- dation program administered in that
tion and assessment of the organiza- State as specified in §§ 493.649(a) and
tion’s inspection process. 493.655(b).
(8) A demonstration of its ability to (5) Take appropriate enforcement ac-
provide CMS with electronic data, in tion against laboratories found by CMS
compatible code, related to the adverse not to be in compliance with require-
actions resulting from PT results con- ments equivalent to CLIA require-
stituting unsuccessful participation in ments.
PT programs as well as data related to (6) Submit for Medicare and Medicaid
the PT failures, within 30 days of the payment purposes, a list of the special-
initiation of adverse action. ties and subspecialties of tests per-
(9) A demonstration of its ability to formed by each laboratory.
provide CMS with electronic data, in (7) Submit a written presentation
compatible code, for all accredited lab- that demonstrates the agency’s ability
oratories, including the area of spe- to furnish CMS with electronic data in
cialty or subspecialty. compatible code, including the cross-
(10) Information defining the ade- walk specified in § 493.553(a)(1).
quacy of numbers of staff and other re- (8) Submit a statement acknowl-
sources. edging that the State will notify CMS
(11) Information defining the organi- through electronic transmission of the
zation’s ability to provide adequate following:
funding for performing required inspec- (i) Any laboratory that has had its li-
tions. censure or approval revoked or with-
(12) Any facility-specific data, upon drawn or has been in any way sanc-
request by CMS, which includes, but is tioned by the State within 30 days of
not limited to, the following: taking the action.
(i) PT results that constitute unsuc- (ii) Changes in licensure or inspec-
cessful participation in a CMS-ap- tion requirements.
proved PT program. (iii) Changes in specialties or sub-
(ii) Notification of the adverse ac- specialties under which any licensed
tions or corrective actions imposed by laboratory in the State performs test-
the accreditation organization as a re- ing.
sult of unsuccessful PT participation. (9) Provide information for the re-
(13) An agreement to provide written view of the State’s enforcement proce-
notification to CMS at least 30 days in dures for laboratories found to be out
advance of the effective date of any of compliance with the State’s require-
proposed change in its requirements. ments.
710
(10) Submit information that dem- been inspected against condition-level

onstrates the ability of the State to requirements.
provide CMS with the following: (3) For a State licensure program, a
(i) Electronic data and reports in description of how the laboratory re-
compatible code with the adverse or quirements of the State are equal to,
corrective actions resulting from PT or more stringent than, those specified
results that constitute unsuccessful in this part.
participation in PT programs. (4) The basis for granting deeming
(ii) Other data that CMS determines authority or exemption.
are necessary for validation and assess-
(5) The term of approval, not to ex-
ment of the State’s inspection process
requirements. ceed 6 years.
(11) Agree to provide CMS with writ- § 493.561 Denial of application or re-
ten notification of any changes in its application.
licensure/approval and inspection re-
quirements. (a) Reconsideration of denial. (1) If
(12) Agree to disclose any labora- CMS denies a request for approval, an
tory’s PT results in accordance with a accreditation organization or State li-
State’s confidentiality requirements. censure program may request, within
(13) Agree to take the appropriate en- 60 days of the notification of denial,
forcement action against laboratories that CMS reconsider its original appli-
found by CMS not to be in compliance cation or application for renewal, in
with requirements comparable to con- accordance with part 488, subpart D.
dition-level requirements and report (2) If the accreditation organization
these enforcement actions to CMS. or State licensure program requests a
(14) If approved, reapply to CMS reconsideration of CMS’s determina-
every 2 years to renew its exempt station to deny its request for approval or
tus and to renew its agreement to pay reapproval, it may not submit a new
the cost of the CMS-administered vali- application until CMS issues a final re-
dation program in that State. consideration determination.
[63 FR 26732, May 14, 1998, as amended at 88 (b) Resubmittal of a request for ap-
FR 90035, Dec. 28, 2023] proval—accreditation organization. An
accreditation organization may resub-
§ 493.559 Publication of approval of
deeming authority or CLIA exemp- mit a request for approval if a final re-
tion. consideration determination is not
pending and the accreditation program
(a) Notice of deeming authority or ex-
meets the following conditions:
emption. CMS publishes a notice in the
FEDERAL REGISTER when it grants (1) It has revised its accreditation
deeming authority to an accreditation program to address the rationale for
organization or exemption to a State denial of its previous request.
licensure program. (2) It demonstrates that it can pro-
(b) Contents of notice. The notice in- vide reasonable assurance that its ac-
cludes the following: credited facilities meet condition-level
(1) The name of the accreditation or- requirements.
ganization or State licensure program. (3) It resubmits the application in its
(2) For an accreditation organization: entirety.
(i) The specific specialty or sub- (c) Resubmittal of request for ap-
specialty areas for which it is granted proval—State licensure program. The
deeming authority. State licensure program may resubmit
(ii) A description of how the accredi- a request for approval if a final recon-
tation organization provides reason- sideration determination is not pend-
able assurance to CMS that a labora- ing and it has taken the necessary ac-
tory accredited by the organization tion to address the rationale for any
meets CLIA requirements equivalent to
previous denial.
those in this part and would meet CLIA
requirements if the laboratory had not
been granted deemed status, but had
711
§ 493.563 42 CFR Ch. IV (10–1–24 Edition)
§ 493.563 Validation inspections—Basis (1) The accreditation organization’s

and focus. representations and to assess the ac-
(a) Basis for validation inspection—(1) creditation organization’s compliance
Laboratory with a certificate of accredita- with its own policies and procedures.
tion. (i) CMS or a CMS agent may con- (2) The State’s representations and to
duct an inspection of an accredited lab- assess the State’s compliance with its
oratory that has been issued a certifi- own policies and procedures, including
cate of accreditation on a representa- verification of State enforcement ac-
tive sample basis or in response to a tions taken on the basis of validation
substantial allegation of noncompli- inspections performed by CMS or a
ance. CMS agent.
(ii) CMS uses the results of these in- (e) Onsite inspection of an accreditation
spections to validate the accreditation organization. An onsite inspection of an
organization’s accreditation process. accreditation organization may in-
(2) Laboratory in a State with an ap- clude, but is not limited to, the fol-
proved State licensure program. (i) CMS lowing:
or a CMS agent may conduct an inspec- (1) A review of documents.
tion of any laboratory in a State with (2) An audit of meetings concerning
an approved State licensure program the accreditation process.
on a representative sample basis or in (3) Evaluation of accreditation in-
response to a substantial allegation of spection results and the accreditation
noncompliance. decision-making process.
(ii) The results of these inspections (4) Interviews with the accreditation
are used to validate the appropriate- organization’s staff.
ness of the exemption of that State’s (f) Onsite inspection of a State licensure
licensed or approved laboratories from program. An onsite inspection of a
CLIA program requirements. State licensure program office may in-
(b) Validation inspection conducted on clude, but is not limited to, the fol-
a representative sample basis. (1) If CMS lowing:
or a CMS agent conducts a validation
(1) A review of documents.
inspection on a representative sample
basis, the inspection is comprehensive, (2) An audit of meetings concerning
addressing all condition-level require- the licensure or approval process.
ments, or it may be focused on a spe- (3) Evaluation of State inspection re-
cific condition-level requirement. sults and the licensure or approval de-
(2) The number of laboratories sam- cision-making process.
pled is sufficient to allow a reasonable (4) Interviews with State employees.
estimate of the performance of the ac-
§ 493.565 Selection for validation in-
creditation organization or State. spection—laboratory responsibil-
(c) Validation inspection conducted in ities.
response to a substantial allegation of
noncompliance. (1) If CMS or a CMS A laboratory selected for a validation
agent conducts a validation inspection inspection must do the following:
in response to a substantial allegation (a) Authorize its accreditation orga-
of noncompliance, the inspection fo- nization or State licensure program, as
cuses on any condition-level require- applicable, to release to CMS or a CMS
ment that CMS determines to be reagent, on a confidential basis, a copy of
lated to the allegation. the laboratory’s most recent full, and
(2) If CMS or a CMS agent substan- any subsequent partial inspection.
tiates a deficiency and determines that (b) Authorize CMS or a CMS agent to
the laboratory is out of compliance conduct a validation inspection.
with any condition-level requirement, (c) Provide CMS or a CMS agent with
CMS or a CMS agent conducts a full access to all facilities, equipment, ma-
CLIA inspection. terials, records, and information that
(d) Inspection of operations and offices. CMS or a CMS agent determines have a
As part of the validation review proc- bearing on whether the laboratory is
ess, CMS may conduct an onsite in- being operated in accordance with the
spection of the operations and offices requirements of this part, and permit
to verify the following: CMS or a CMS agent to copy material
712
or require the laboratory to submit and that are found out of compliance
material. following an inspection under this part;
(d) If the laboratory possesses a valid and
certificate of accreditation, authorize (2) Full review by CMS, in accordance
CMS or a CMS agent to monitor the with this part; that is, the laboratory
correction of any deficiencies found is subject to the principal and alter-
through the validation inspection. native sanctions in § 493.1806.
(b) CLIA-exempt laboratory. If a vali-
§ 493.567 Refusal to cooperate with dation inspection results in a finding
validation inspection. that a CLIA-exempt laboratory is out
(a) Laboratory with a certificate of ac- of compliance with one or more condi-
creditation. (1) A laboratory with a cer- tion-level requirements, CMS directs
tificate of accreditation that refuses to the State to take appropriate enforce-
cooperate with a validation inspection ment action.
by failing to comply with the require-
ments in § 493.565— § 493.571 Disclosure of accreditation,
(i) Is subject to full review by CMS or State and CMS validation inspec-
a CMS agent, in accordance with this tion results.
part; and (a) Accreditation organization inspec-
(ii) May be subject to suspension, tion results. CMS may disclose accredi-
revocation, or limitation of its certifi- tation organization inspection results
cate of accreditation under this part. to the public only if the results are re-
(2) A laboratory with a certificate of lated to an enforcement action taken
accreditation is again deemed to meet by the Secretary.
the condition-level requirements by (b) State inspection results. Disclosure
virtue of its accreditation when the fol- of State inspection results is the re-
lowing conditions exist: sponsibility of the approved State li-
(i) The laboratory withdraws any censure program, in accordance with
prior refusal to authorize its accredita- State law.
tion organization to release a copy of (c) CMS validation inspection results.
the laboratory’s current accreditation CMS may disclose the results of all
inspection, PT results, or notification validation inspections conducted by
of any adverse actions resulting from CMS or its agent.
PT failure.
(ii) The laboratory withdraws any § 493.573 Continuing Federal oversight
prior refusal to allow a validation in- of private nonprofit accreditation
spection. organizations and approved State
licensure programs.
(iii) CMS finds that the laboratory
meets all the condition-level require- (a) Comparability review. In addition
ments. to the initial review for determining
(b) CLIA-exempt laboratory. If a CLIA- equivalency of specified organization
exempt laboratory fails to comply with or State requirements to the com-
the requirements specified in § 493.565, parable condition-level requirements,
CMS notifies the State of the labora- CMS reviews the equivalency of re-
tory’s failure to meet the require- quirements in the following cases:
ments. (1) When CMS promulgates new con-
dition-level requirements.
§ 493.569 Consequences of a finding of (2) When CMS identifies an accredita-
noncompliance as a result of a vali- tion organization or a State licensure
dation inspection. program whose requirements are no
(a) Laboratory with a certificate of ac- longer equal to, or more stringent
creditation. If a validation inspection than, condition-level requirements.
results in a finding that the accredited (3) When an accreditation organiza-
laboratory is out of compliance with tion or State licensure program adopts
one or more condition-level require- new requirements.
ments, the laboratory is subject to— (4) When an accreditation organiza-
(1) The same requirements and sur- tion or State licensure program adopts
vey and enforcement processes applied changes to its inspection process, as re-
to laboratories that are not accredited quired by § 493.575(b)(1), as applicable.
713
§ 493.575 42 CFR Ch. IV (10–1–24 Edition)
(5) Every 6 years, or sooner if CMS (iii) A description of the procedures

determines an earlier review is re- available if the accreditation organiza-
quired. tion or State licensure program, as ap-
(b) Validation review. Following the plicable, desires an opportunity to ex-
end of a validation review period, CMS plain or justify the findings made dur-
evaluates the validation inspection re- ing the comparability or validation re-
sults for each approved accreditation view.
organization and State licensure pro- (iv) The reapplication materials that
gram. the accreditation organization or State
(c) Reapplication procedures. (1) Every licensure program must submit and the
6 years, or sooner, as determined by deadline for that submission.
CMS, an approved accreditation orga-
nization must reapply for continued § 493.575 Removal of deeming author-
approval of deeming authority and a ity or CLIA exemption and final de-
State licensure program must reapply termination review.
for continued approval of a CLIA ex- (a) CMS review. CMS conducts a re-
emption. CMS provides notice of the view of the following:
materials that must be submitted as (1) A deeming authority review of an
part of the reapplication procedure. accreditation organization’s program if
(2) An accreditation organization or the comparability or validation review
State licensure program that does not produces findings, as described at
meet the requirements of this subpart, § 493.573. CMS reviews, as appropriate,
as determined through a comparability the criteria described in §§ 493.555 and
or validation review, must furnish 493.557(a) to reevaluate whether the ac-
CMS, upon request, with the reapplica- creditation organization continues to
tion materials CMS requests. CMS es-
meet all these criteria.
tablishes a deadline by which the mate-
(2) An exemption review of a State’s
rials must be submitted.
licensure program if the comparability
(d) Notice. (1) CMS provides written
or validation review produces findings,
notice, as appropriate, to the following:
as described at § 493.573. CMS reviews,
(i) An accreditation organization in-
as appropriate, the criteria described in
dicating that its approval may be in
§§ 493.555 and 493.557(b) to reevaluate
jeopardy if a comparability or valida-
tion review reveals that it is not meet- whether the licensure program con-
ing the requirements of this subpart tinues to meet all these criteria.
and CMS is initiating a review of the (3) A review of an accreditation orga-
accreditation organization’s deeming nization or State licensure program, at
authority. CMS’s discretion, if validation review
(ii) A State licensure program indi- findings, irrespective of the rate of dis-
cating that its CLIA exemption may be parity, indicate widespread or system-
in jeopardy if a comparability or vali- atic problems in the organization’s ac-
dation review reveals that it is not creditation or State’s licensure process
meeting the requirements of this sub- that provide evidence that the require-
part and that a review is being initi- ments, taken as a whole, are no longer
ated of the CLIA exemption of the equivalent to CLIA requirements,
State’s laboratories. taken as a whole.
(2) The notice contains the following (4) A review of the accreditation or-
information: ganization or State licensure program
(i) A statement of the discrepancies whenever validation inspection results
that were found as well as other re- indicate a rate of disparity of 20 per-
lated documentation. cent or more between the findings of
(ii) An explanation of CMS’s review the organization or State and those of
process on which the final determina- CMS or a CMS agent for the following
tion is based and a description of the periods:
possible actions, as specified in (i) One year for accreditation organi-
§ 493.575, that CMS may impose based zations.
on the findings from the comparability (ii) Two years for State licensure pro-
or validation review. grams.
714
(b) CMS action after review. Following (e) Continuation of validation inspec-
the review, CMS may take the fol- tions. The existence of any validation
lowing action: review, probationary status, or any
(1) If CMS determines that the ac- other action, such as a deeming au-
creditation organization or State has thority review, by CMS does not affect
failed to adopt requirements equal to, or limit the conduct of any validation
or more stringent than, CLIA require- inspection.
ments, CMS may give a conditional ap- (f) Federal Register notice. CMS pub-
proval for a probationary period of its lishes a notice in the FEDERAL REG-
deeming authority to an organization ISTER containing a justification for re-
30 days following the date of CMS’s de- moving the deeming authority from an
termination, or exempt status to a accreditation organization, or the
State within 30 days of CMS’s deter- CLIA-exempt status of a State licen-
mination, both not to exceed 1 year, to sure program.
afford the organization or State an op- (g) Withdrawal of approval-effect on
portunity to adopt equal or more strin- laboratory status—(1) Accredited labora-
gent requirements. tory. After CMS withdraws approval of
(2) If CMS determines that there are an accreditation organization’s deem-
widespread or systematic problems in ing authority, the certificate of accred-
the organization’s or State’s inspection itation of each affected laboratory con-
process, CMS may give conditional ap- tinues in effect for 60 days after it re-
proval during a probationary period, ceives notification of the withdrawal of
not to exceed 1 year, effective 30 days approval.
following the date of the determina- (2) CLIA-exempt laboratory. After CMS
tion. withdraws approval of a State licen-
sure program, the exempt status of
(c) Final determination. CMS makes a
each licensed or approved laboratory in
final determination as to whether the
the State continues in effect for 60
organization or State continues to
days after a laboratory receives notifi-
meet the criteria described in this sub-
cation from the State of the with-
part and issues a notice that includes
drawal of CMS’s approval of the pro-
the reasons for the determination to
gram.
the organization or State within 60
(3) Extension. After CMS withdraws
days after the end of any probationary
approval of an accreditation organiza-
period. This determination is based on
tion or State licensure program, CMS
an evaluation of any of the following:
may extend the period for an addi-
(1) The most recent validation in- tional 60 days for a laboratory if it de-
spection and review findings. To con- termines that the laboratory sub-
tinue to be approved, the organization mitted an application for accreditation
or State must meet the criteria of this to an approved accreditation organiza-
subpart. tion or an application for the appro-
(2) Facility-specific data, as well as priate certificate to CMS or a CMS
other related information. agent before the initial 60-day period
(3) The organization’s or State’s in- ends.
spection procedures, surveyors’ quali- (h) Immediate jeopardy to patients. (1)
fications, ongoing education, training, If at any time CMS determines that
and composition of inspection teams. the continued approval of deeming au-
(4) The organization’s accreditation thority of any accreditation organiza-
requirements, or the State’s licensure tion poses immediate jeopardy to the
or approval requirements. patients of the laboratories accredited
(d) Date of withdrawal of approval. by the organization, or continued ap-
CMS may withdraw its approval of the proval otherwise constitutes a signifi-
accreditation organization or State li- cant hazard to the public health, CMS
censure program, effective 30 days from may immediately withdraw the ap-
the date of written notice to the orga- proval of deeming authority for that
nization or State of this proposed ac- accreditation organization.
tion, if improvements acceptable to (2) If at any time CMS determines
CMS have not been made during the that the continued approval of a State
probationary period. licensure program poses immediate
715
§ 493.602 42 CFR Ch. IV (10–1–24 Edition)
jeopardy to the patients of the labora- § 493.606 Applicability of subpart.

tories in that State, or continued ap- The rules of this subpart are applica-
proval otherwise constitutes a signifi- ble to those laboratories specified in
cant hazard to the public health, CMS § 493.3.
may immediately withdraw the ap-
proval of that State licensure program. [58 FR 5212, Jan. 19, 1993]
(i) Failure to pay fees. CMS withdraws § 493.638 Certificate fees.
the approval of a State licensure pro-
gram if the State fails to pay the appli- (a) Basic rule. Laboratories must pay
a fee that covers the costs incurred for
cable fees, as specified in §§ 493.649(a)
the issuance, renewal, change in cer-
and 493.655(b).
tificate type, or reinstatement of a ter-
(j) State refusal to take enforcement ac- minated certificate with a gap in serv-
tion. (1) CMS may withdraw approval of ice, and other direct administrative
a State licensure program if the State costs, as applicable. The total of fees
refuses to take enforcement action collected by HHS under the laboratory
against a laboratory in that State program must be sufficient to cover
when CMS determines it to be nec- the general costs of administering the
essary. laboratory certification program under
(2) A laboratory that is in a State in section 353 of the PHS Act.
which CMS has withdrawn program ap- (1) For registration certificates, the
proval is subject to the same require- fee is a flat fee that includes the costs
ments and survey and enforcement for issuing the certificates, collecting
processes that are applied to a labora- the fees, and evaluating whether the
tory that is not exempt from CLIA re- procedures, tests, or examinations list-
quirements. ed on the application fall within the
(k) Request for reconsideration. Any testing allowed for the requested cer-
accreditation organization or State tificate.
that is dissatisfied with a determina- (2) For a certificate of waiver, the fee
tion to withdraw approval of its deem- includes the costs for issuing the cer-
tificate; collecting the fees; evaluating
ing authority or remove approval of its
whether the procedures, tests, or ex-
State licensure program, as applicable,
aminations listed on the application
may request that CMS reconsider the fall within the testing appropriate for
determination, in accordance with sub- the requested certificate; and deter-
part D of part 488. mining whether a laboratory test
[63 FR 26732, May 14, 1998, as amended at 88 meets the criteria for a waived test.
FR 90035, Dec. 28, 2023] (3) For a certificate for PPM proce-
dures, the fee includes the costs for
Subpart F—General Administration issuing the certificate, collecting the
fees; and evaluating whether the proce-
dures, tests, or examinations listed on
SOURCE: 57 FR 7138, 7213, Feb. 28, 1992, un- the application meet the criteria for
less otherwise noted. inclusion in the subcategory of PPM
procedures.
§ 493.602 Scope of subpart.
(4) For a certificate of accreditation,
This subpart sets forth the method- the fee includes the costs for issuing
ology for determining the amount of the certificate, collecting the fees,
the fees for issuing the appropriate cer- evaluating the programs of accrediting
tificate, and for determining compli- bodies, and evaluating whether the pro-
ance with the applicable standards of cedures, tests, or examinations listed
the Public Health Service Act (the PHS on the application fall within the test-
Act) and the Federal validation of ac- ing appropriate for the requested cer-
credited laboratories and of CLIA-ex- tificate.
empt laboratories. (5) For a certificate of compliance,
the fee includes the costs for issuing
[60 FR 20047, Apr. 24, 1995] the certificates, collecting the fees,
evaluating and monitoring proficiency
testing programs, and evaluating
716
whether the procedures, tests or exami- tests is counted as 18 separate proce-

nations listed on the application fall dures or tests.
within the testing appropriate for the (2) For purposes of determining a lab-
requested certificate. oratory’s classification under this sec-
(b) Fee amount. (1) The certificate fee tion, the specialties and subspecialties
amount is set biennially by HHS. CMS of service for inclusion are:
will publish a notice in the FEDERAL (i) The specialty of Microbiology,
REGISTER biennially with any adjust- which includes one or more of the fol-
ments to the fee amounts, including lowing subspecialties:
any adjustments due to inflation, in (A) Bacteriology.
accordance with § 493.680. For certifi- (B) Mycobacteriology.
cates of waiver and certificates of (C) Mycology.
PPM, the certificate fee amount is (D) Parasitology.
based on the category of test com- (E) Virology.
plexity performed by the laboratory. (ii) The specialty of Serology, which
For all other certificate types, the fee includes one or more of the following
amount is based on the category of test subspecialties:
complexity performed by the labora- (A) Syphilis Serology.
tory and schedules or ranges of annual (B) General immunology.
laboratory test volume (excluding (iii) The specialty of Chemistry,
waived tests and tests performed for which includes one or more of the fol-
quality control, quality assurance, or lowing subspecialties:
proficiency testing purposes) and spe- (A) Routine chemistry.
cialties tested, with the amounts of the (B) Endocrinology.
fees in each schedule being a function
(C) Toxicology.
of the costs for all aspects of general
(D) Urinalysis.
administration of CLIA as set forth in
(iv) The specialty of Hematology.
paragraph (c) of this section.
(2) Certificate fees are assessed and (v) The specialty of
payable at least biennially. Immunohematology, which includes
(3) The amount of the fee payable by one or more of the following sub-
the laboratory is the amount listed in specialties:
the most recent notice published in the (A) ABO grouping and Rh typing.
FEDERAL REGISTER at the time the ap- (B) Unexpected antibody detection.
plication, renewal, change in certifi- (C) Compatibility testing.
cate type, or reinstatement is proc- (D) Unexpected antibody identifica-
essed by HHS or its designee. tion.
(4) After processing an application (vi) The specialty of Pathology,
for an issuance, renewal, change in cer- which includes the following sub-
tificate type, or reinstatement of a ter- specialties:
minated certificate with a gap in serv- (A) Cytology.
ice, HHS or its designee notifies the (B) Histopathology.
laboratory of the applicable fee (C) Oral pathology.
amount. (vii) The specialty of Radiobioassay.
(c) Classification of laboratories for (viii) The specialty of
purposes of determining the fee amount Histocompatibility.
for certificate types other than certificates (ix) The specialty of Clinical Cyto-
of waiver or certificates of PPM. (1) For genetics.
purposes of determining a laboratory’s (3) There are 11 schedules of labora-
classification under this section, a test tories for the purpose of determining
is a procedure or examination for a sin- the fee amount a laboratory is as-
gle analyte. (Tests performed for qual- sessed. Each laboratory is placed into
ity control, quality assessment, and one of the 11 schedules in paragraphs
proficiency testing are excluded from (c)(3)(i) through (xi) of this section
the laboratory’s total annual volume.) based on the laboratory’s scope and
Each profile (that is, group of tests) is volume of testing:
counted as the number of separate pro- (i) Schedule V. The laboratory per-
cedures or examinations; for example, forms not more than 2,000 laboratory
a chemistry profile consisting of 18 tests annually.
717
§ 493.639 42 CFR Ch. IV (10–1–24 Edition)
(ii) Schedule A. The laboratory per- certificate, the laboratory must pay a
forms tests in no more than three spe- fee to cover the cost of issuing a re-
cialties of service with a total annual placement certificate. The fee for a re-
volume of more than 2,000 but not more placement certificate is based on the
than 10,000 laboratory tests. cost of issuing the replacement certifi-
(iii) Schedule B. The laboratory per- cate to the laboratory. The fee must be
forms tests in at least four specialties paid in full before issuing the replace-
of service with a total annual volume ment certificate.
of not more than 10,000 laboratory [88 FR 90036, Dec. 28, 2023]
tests.
(iv) Schedule C. The laboratory per- § 493.643 Additional fees applicable to
forms tests in no more three specialties laboratories issued a certificate of
of service with a total annual volume compliance.
of more than 10,000 but not more than (a) Fee requirement. In addition to the
25,000 laboratory tests. fee required under § 493.638, a labora-
(v) Schedule D. The laboratory per- tory subject to routine inspections
forms tests in at least four specialties must pay a fee to cover the cost of de-
with a total annual volume of more termining program compliance. Lab-
than 10,000 but not more than 25,000 oratories issued a certificate for PPM
laboratory tests. procedures, certificate of waiver, or a
(vi) Schedule E. The laboratory per- certificate of accreditation are not sub-
forms more than 25,000 but not more ject to this fee for routine inspections.
than 50,000 laboratory tests annually. (b) Costs included in the fee. Included
(vii) Schedule F. The laboratory per- in the fee for determining program
forms more than 50,000 but not more compliance are costs for evaluating
than 75,000 laboratory tests annually. qualifications of laboratory personnel;
(viii) Schedule G. The laboratory per- monitoring laboratory proficiency
forms more than 75,000 but not more testing; and conducting onsite inspec-
than 100,000 laboratory tests annually. tions of laboratories including: docu-
(ix) Schedule H. The laboratory per- menting deficiencies, evaluating lab-
forms more than 100,000 but not more oratories’ plans to correct deficiencies,
than 500,000 laboratory tests annually. creating training programs, training
(x) Schedule I. The laboratory per- surveyors, and necessary administra-
forms more than 500,000 but not more tive costs.
than 1,000,000 laboratory tests annu- (c) Fee amount. The amount of the fee
ally. for determining program compliance is
(xi) Schedule J. The laboratory per- set biennially by HHS.
forms more than 1,000,000 laboratory (1) The fee is based on the category of
tests annually. test complexity and schedules or
[88 FR 90035, Dec. 28, 2023] ranges of annual laboratory test vol-
ume and specialties tested, with the
§ 493.639 Fees for revised and replace- amounts of the fees in each schedule
ment certificates. being a function of the costs for all as-
(a) If, after a laboratory is issued a pects of determining program compli-
certificate, it requests a revised certifi- ance as set forth in § 493.638(c).
cate, the laboratory must pay a fee to (2) The fee is assessed and payable bi-
cover the cost of issuing a revised cer- ennially.
tificate. The fee for a revised certifi- (3) The amount of the program com-
cate is based on the cost to issue the pliance fee is the amount applicable to
revised certificate to the laboratory. the laboratory listed in the most re-
The fee must be paid in full before the cent notice published in the FEDERAL
revised certificate will be issued. REGISTER at the time that the fee is
(1) If laboratory services are added to generated.
a certificate of compliance, the labora- (d) Additional fees. (1) If a laboratory
tory must pay an additional fee if reissued a certificate of compliance has
quired under § 493.643(d)(2). been inspected and follow-up visits are
(2) [Reserved] necessary because of identified defi-
(b) If, after a laboratory is issued a ciencies, HHS assesses the laboratory a
certificate, it requests a replacement fee to cover the cost of these visits.
718
The fee is based on the actual resources § 493.645 Additional fees applicable to
and time necessary to perform the fol- laboratories issued a certificate of
low-up visits. HHS revokes the labora- accreditation, certificate of waiver,
tory’s certificate of compliance for or certificate for PPM procedures.
failure to pay the assessed fee. (a) Accredited laboratories. (1) A lab-
(2) If, after a certificate of compli- oratory that is issued a certificate of
ance is issued, a laboratory adds serv- accreditation is assessed an additional
ices and requests that its certificate be fee to cover the cost of performing val-
upgraded, the laboratory must pay an idation inspections described at
additional fee if, to determine compli- § 493.563. All accredited laboratories
ance with additional requirements, it share in the cost of these inspections.
is necessary to conduct an inspection, These costs are 5 percent of the same
evaluate personnel, or monitor pro- costs as those that are incurred when
ficiency testing performance. The addi- inspecting nonaccredited laboratories
tional fee is based on the actual re- of the same schedule (or range) and are
sources and time necessary to perform paid biennially by each accredited lab-
the activities. HHS revokes the labora- oratory whether the accredited labora-
tory’s certificate for failure to pay the tory has a validation inspection or not.
compliance determination fee. HHS revokes the laboratory’s certifi-
(3) If it is necessary to conduct a cate of accreditation for failure to pay
complaint investigation, impose sanc- the fee.
tions, or conduct a hearing, HHS as- (2) If a laboratory issued a certificate
sesses the laboratory holding a certifi- of accreditation has been inspected and
cate of compliance a fee to cover the follow-up visits are necessary because
cost of these activities. If a complaint of identified deficiencies, HHS assesses
investigation results in a complaint the laboratory an additional fee to
being unsubstantiated, or if an HHS ad- cover the cost of these visits. The fee is
verse action is overturned at the con- based on the actual resources and time
clusion of the administrative appeals necessary to perform the follow-up vis-
its. HHS revokes the laboratory’s cer-
process, the Government’s costs of
tificate of accreditation for failure to
these activities are not imposed upon
pay the fee.
the laboratory. Costs for these activi-
(b) Complaint surveys. If, in the case
ties are based on the actual resources
of a laboratory that has been issued a
and time necessary to perform the ac-
certificate of accreditation, certificate
tivities and are not assessed until after
of waiver, or certificate for PPM proce-
the laboratory concedes the existence
dures, it is necessary to conduct a com-
of deficiencies or an ALJ rules in favor
plaint investigation, impose sanctions,
of HHS. HHS revokes the laboratory’s
or conduct a hearing, HHS assesses
certificate of compliance for failure to that laboratory a fee to cover the cost
pay the assessed costs. of these activities. Costs are based on
(4) Laboratories with a certificate of the actual resources and time nec-
compliance must pay a fee if the lab- essary to perform the activities and are
oratory fails to perform successfully in not assessed until after the laboratory
proficiency testing for one or more spe- concedes the existence of deficiencies
cialties, subspecialties, analytes, or or an ALJ rules in favor of HHS. HHS
tests specified in subpart I of this part, revokes the laboratory’s certificate for
and it is necessary to conduct a desk failure to pay the assessed costs. If a
review of the unsuccessful perform- complaint investigation results in a
ance. The additional fee is based on the complaint being unsubstantiated, or if
actual resources and time necessary to an HHS adverse action is overturned at
perform the desk review. HHS revokes the conclusion of the administrative
the laboratory’s certificate of compli- appeals process, the costs of these ac-
ance for failure to pay the assessed tivities are not imposed upon the lab-
costs. oratory.
[88 FR 90036, Dec. 28, 2023] [60 FR 20047, Apr. 24, 1995, as amended at 88
FR 90037, Dec. 28, 2023]
719
§ 493.649 42 CFR Ch. IV (10–1–24 Edition)
§ 493.649 Additional fees applicable to biennial increase based on a two-part

approved State laboratory pro- calculation of the Consumer Price
grams. Index—Urban (CPI–U) inflation adjust-
(a) Approved State laboratory programs. ment and, if applicable, an additional
State laboratory programs approved by increase as follows:
HHS are assessed a fee for the fol- (1) CMS calculates the inflation rate
lowing: using the compounded CPI–U over 2
(1) Costs of Federal inspections of years and, provided that the calculated
laboratories in that State (that is, rate is greater than zero, applies an in-
CLIA-exempt laboratories) to verify crease to all fee amounts equal to the
that standards are being enforced in an calculated rate.
appropriate manner. (2) If the total fee amounts, including
(2) Costs incurred for investigations any increase applied under paragraph
of complaints against the State’s (a)(1) of this section, do not match or
CLIA-exempt laboratories if the com- exceed actual program obligations
plaint is substantiated. based on a review of the previous 2
(3) The State’s pro rata share of gen- years’ obligations, CMS applies an ad-
eral overhead to administer the labora- ditional across the board increase to
tory certification program under sec- each laboratory’s fees by calculating
tion 353 of the PHS Act. the difference between the total fee
(b) [Reserved] amounts and actual program obliga-
tions.
[88 FR 90037, Dec. 28, 2023] (b) Baseline. Any increase applied
under paragraph (a) of this section is
§ 493.655 Payment of fees.
incorporated into the baseline fee
(a) Except for laboratories covered by amounts for any subsequent biennial
approved State laboratory programs, increase.
all laboratories are notified in writing (c) Publication. Any increase applied
by HHS or its designee of the appro- under paragraph (a) of this section, in-
priate fee(s) and instructions for sub- cluding the calculation thereof, will be
mitting the fee(s), including the due published as a notice in the FEDERAL
date for payment and where to make REGISTER.
payment. The appropriate certificate is
not issued until the applicable fees [88 FR 90037, Dec. 28, 2023]
have been paid.
(b) For approved State laboratory Subpart G [Reserved]
programs, HHS estimates the cost of
conducting validation inspections as Subpart H—Participation in Pro-
described at § 493.563 within the State ficiency Testing for Labora-
on at least a biennial period. HHS or tories Performing Nonwaived
its designee notifies the State by mail Testing
of the appropriate fees, including the
due date for payment and the address
of the United States Department of
otherwise noted.
Treasury designated commercial bank
to which payment must be made. In ad- § 493.801 Condition: Enrollment and
dition, if complaint investigations are testing of samples.
conducted in laboratories within these Each laboratory must enroll in a pro-
States and are substantiated, HHS bills ficiency testing (PT) program that
the State(s) the costs of the complaint meets the criteria in subpart I of this
investigations. part and is approved by HHS. The lab-
[88 FR 90037, Dec. 28, 2023] oratory must enroll in an approved
program or programs for each of the
§ 493.680 Methodology for determining specialties and subspecialties for which
the biennial fee increase. it seeks certification. The laboratory
(a) General rule. Except for fees as- must test the samples in the same
sessed to State laboratory programs manner as patients’ specimens. For
approved by HHS, the fee amounts de- laboratories subject to 42 CFR part 493
scribed in this subpart are subject to a published on March 14, 1990 (55 FR 9538)
720
prior to September 1, 1992, the rules of tient workload by personnel who rou-
this subpart are effective on September tinely perform the testing in the lab-
1, 1992. For all other laboratories, the oratory, using the laboratory’s routine
rules of this subpart are effective Janu- methods. The individual testing or ex-
ary 1, 1994. amining the samples and the labora-
(a) Standard; Enrollment. The laboratory director must attest to the rou-
tory must— tine integration of the samples into the
(1) Notify HHS of the approved pro- patient workload using the labora-
gram or programs in which it chooses tory’s routine methods.
to participate to meet proficiency test- (2) The laboratory must test samples
ing requirements of this subpart. the same number of times that it rou-
(2)(i) Designate the program(s) to be tinely tests patient samples.
used for each specialty, subspecialty,
(3) The laboratory must report PT re-
and analyte or test to determine com-
sults for microbiology organism identi-
pliance with this subpart if the labora-
tory participates in more than one pro- fication to the highest level that it re-
ficiency testing program approved by ports results on patient specimens.
CMS; and (4) Laboratories that perform tests
(ii) For those tests performed by the on proficiency testing samples must
laboratory that are not included in not engage in any inter-laboratory
subpart I of this part, a laboratory communications pertaining to the re-
must establish and maintain the accu- sults of proficiency testing sample(s)
racy of its testing procedures, in ac- until after the date by which the lab-
cordance with § 493.1236(c)(1). oratory must report proficiency testing
(3) For each specialty, subspecialty results to the program for the testing
and analyte or test, participate in one event in which the samples were sent.
approved proficiency testing program Laboratories with multiple testing
or programs, for one year before desig- sites or separate locations must not
nating a different program and must participate in any communications or
notify CMS before any change in des- discussions across sites/locations con-
ignation; and cerning proficiency testing sample re-
(4) Authorize the proficiency testing sults until after the date by which the
program to release to HHS all data re- laboratory must report proficiency
quired to— testing results to the program.
(i) Determine the laboratory’s com- (5) The laboratory must not send pro-
pliance with this subpart; and ficiency testing samples or portions of
(ii) Make PT results available to the proficiency testing samples to another
public as required in section 353(f)(3)(F) laboratory for any analysis for which it
of the Public Health Service Act.
is certified to perform in its own lab-
(b) Standard: Testing of proficiency
oratory. Any laboratory that CMS de-
testing samples. The laboratory must ex-
termines intentionally referred a pro-
amine or test, as applicable, the pro-
ficiency testing samples it receives ficiency testing sample to another lab-
from the proficiency testing program oratory for analysis may have its cer-
in the same manner as it tests patient tification revoked for at least 1 year. If
specimens. This testing must be con- CMS determines that a proficiency
ducted in conformance with paragraph testing sample was referred to another
(b)(4) of this section. If the laboratory’s laboratory for analysis, but the re-
patient specimen testing procedures quested testing was limited to reflex,
would normally require reflex, dis- distributive, or confirmatory testing
tributive, or confirmatory testing at that, if the sample were a patient spec-
another laboratory, the laboratory imen, would have been in full conform-
should test the proficiency testing ance with written, legally accurate and
sample as it would a patient specimen adequate standard operating proce-
up until the point it would refer a pa- dures for the laboratory’s testing of pa-
tient specimen to a second laboratory tient specimens, and if the proficiency
for any form of further testing. testing referral is not a repeat pro-
(1) The samples must be examined or ficiency testing referral, CMS will con-
tested with the laboratory’s regular pa- sider the referral to be improper and
721
§ 493.803 42 CFR Ch. IV (10–1–24 Edition)
subject to alternative sanctions in ac- tial unsuccessful performance, CMS

cordance with § 493.1804(c), but not in- may direct the laboratory to undertake
tentional. Any laboratory that receives training of its personnel or to obtain
a proficiency testing sample from an- technical assistance, or both, rather
other laboratory for testing must no- than imposing alternative or principle
tify CMS of the receipt of that sample sanctions except when one or more of
regardless of whether the referral was the following conditions exists:
made for reflex or confirmatory test- (1) There is immediate jeopardy to
ing, or any other reason. patient health and safety.
(6) The laboratory must document
(2) The laboratory fails to provide
the handling, preparation, processing,
CMS or a CMS agent with satisfactory
examination, and each step in the test-
ing and reporting of results for all pro- evidence that it has taken steps to cor-
ficiency testing samples. The labora- rect the problem identified by the un-
tory must maintain a copy of all successful proficiency testing perform-
records, including a copy of the pro- ance.
ficiency testing program report forms (3) The laboratory has a poor compli-
used by the laboratory to record pro- ance history.
ficiency testing results including the [57 FR 7146, Feb. 28, 1992, as amended at 60
attestation statement provided by the FR 20048, Apr. 24, 1995; 63 FR 26737, May 14,
PT program, signed by the analyst and 1998; 68 FR 3702, Jan. 24, 2003]
the laboratory director, documenting
that proficiency testing samples were § 493.807 Condition: Reinstatement of
tested in the same manner as patient laboratories performing nonwaived
specimens, for a minimum of two years testing.
from the date of the proficiency testing (a) If a laboratory’s certificate is sus-
event.
pended or limited or its Medicare or
(7) PT is required for only the test
Medicaid approval is cancelled or its
system, assay, or examination used as
the primary method for patient testing Medicare or Medicaid payments are
during the PT event. suspended because it fails to partici-
pate successfully in proficiency testing
[57 FR 7146, Feb. 28, 1992, as amended at 58 for one or more specialties, subspecial-
FR 5228, Jan. 19, 1993; 68 FR 3702, Jan. 24,
ties, analyte or test, or voluntarily
2003; 79 FR 27157, May 12, 2014; 87 FR 41232,
July 11, 2022] withdraws its certification under CLIA
for the failed specialty, subspecialty,
§ 493.803 Condition: Successful partici- or analyte, the laboratory must then
pation. demonstrate sustained satisfactory
(a) Each laboratory performing non- performance on two consecutive pro-
waived testing must successfully par- ficiency testing events, one of which
ticipate in a proficiency testing pro- may be on site, before CMS will con-
gram approved by CMS, if applicable, sider it for reinstatement for certifi-
as described in subpart I of this part cation and Medicare or Medicaid ap-
for each specialty, subspecialty, and proval in that specialty, subspecialty,
analyte or test in which the laboratory analyte or test.
is certified under CLIA. (b) The cancellation period for Medi-
(b) Except as specified in paragraph care and Medicaid approval or period
(c) of this section, if a laboratory fails for suspension of Medicare or Medicaid
to participate successfully in pro- payments or suspension or limitation
ficiency testing for a given specialty,
of certification under CLIA for the
subspecialty, analyte or test, as de-
failed specialty, subspecialty, or
fined in this section, or fails to take re-
analyte or test is for a period of not
medial action when an individual fails
gynecologic cytology, CMS imposes less than six months from the date of
sanctions, as specified in subpart R of cancellation, limitation or suspension
this part. of the CLIA certificate.
(c) If a laboratory fails to perform [58 FR 5228, Jan. 19, 1993, as amended at 60
successfully in a CMS-approved pro- FR 20048, Apr. 24, 1995]
ficiency testing program, for the ini-
722
PROFICIENCY TESTING BY SPECIALTY AND (e) Failure to achieve an overall test-

SUBSPECIALTY FOR LABORATORIES ing event score of satisfactory perform-
PERFORMING TESTS OF MODERATE ance for two consecutive testing events
COMPLEXITY (INCLUDING THE SUB- or two out of three consecutive testing
CATEGORY), HIGH COMPLEXITY, OR ANY events is unsuccessful performance.
COMBINATION OF THESE TESTS
§ 493.825 Standard; Mycobacteriology.
§ 493.821 Condition: Microbiology.
(a) Failure to attain an overall test-
The specialty of microbiology ining event score of at least 80 percent is
cludes, for purposes of proficiency test- unsatisfactory performance.
ing, the subspecialties of bacteriology, (b) Failure to participate in a testing
mycobacteriology, mycology, event is unsatisfactory performance
parasitology and virology.
and results in a score of 0 for the test-
§ 493.823 Standard; Bacteriology. ing event. Consideration may be given
to those laboratories failing to partici-
(a) Failure to attain an overall test- pate in a testing event only if—
ing event score of at least 80 percent is (1) Patient testing was suspended
unsatisfactory performance.
during the time frame allotted for test-
(b) Failure to participate in a testing
ing and reporting proficiency testing
event is unsatisfactory performance
results;
ing event. Consideration may be given (2) The laboratory notifies the in-
to those laboratories failing to partici- specting agency and the proficiency
pate in a testing event only if— testing program within the time frame
(1) Patient testing was suspended for submitting proficiency testing re-
during the time frame allotted for test- sults of the suspension of patient test-
ing and reporting proficiency testing ing and the circumstances associated
results; with failure to perform tests on pro-
(2) The laboratory notifies the in- ficiency testing samples; and
specting agency and the proficiency (3) The laboratory participated in the
testing program within the time frame previous two proficiency testing
for submitting proficiency testing re- events.
sults of the suspension of patient test- (c) Failure to return proficiency test-
ing and the circumstances associated ing results to the proficiency testing
with failure to perform tests on pro- program within the time frame speci-
ficiency testing samples; and fied by the program is unsatisfactory
(3) The laboratory participated in the performance and results in a score of 0
previous two proficiency testing for the testing event.
events. (d)(1) For any unsatisfactory testing
(c) Failure to return proficiency test- event for reasons other than a failure
ing results to the proficiency testing to participate, the laboratory must un-
program within the time frame speci- dertake appropriate training and em-
fied by the program is unsatisfactory ploy the technical assistance necessary
performance and results in a score of 0 to correct problems associated with a
for the testing event.
proficiency testing failure.
(d)(1) For any unsatisfactory testing
(2) Remedial action must be taken
event for reasons other than a failure
and documented, and the documenta-
to participate, the laboratory must un-
dertake appropriate training and em- tion must be maintained by the labora-
ploy the technical assistance necessary tory for two years from the date of par-
to correct problems associated with a ticipation in the proficiency testing
proficiency testing failure. event.
(2) Remedial action must be taken (e) Failure to achieve an overall test-
and documented, and the documenta- ing event score of satisfactory perform-
tion must be maintained by the labora- ance for two consecutive testing events
tory for two years from the date of par- or two out of three consecutive testing
ticipation in the proficiency testing events is unsuccessful performance.
event.
723
§ 493.827 42 CFR Ch. IV (10–1–24 Edition)
§ 493.827 Standard; Mycology. to those laboratories failing to partici-

pate in a testing event only if—
(1) Patient testing was suspended
ing event score of at least 80 percent is
during the time frame allotted for test-
ing and reporting proficiency testing
results;
(2) The laboratory notifies the in-
specting agency and the proficiency
ing event. Consideration may be given
testing program within the time frame
for submitting proficiency testing re-
pate in a testing event only if—
sults of the suspension of patient test-
(1) Patient testing was suspended ing and the circumstances associated
during the time frame allotted for test- with failure to perform tests on pro-
ing and reporting proficiency testing ficiency testing samples; and
results; (3) The laboratory participated in the
(2) The laboratory notifies the in- previous two proficiency testing
specting agency and the proficiency events.
testing program within the time frame (c) Failure to return proficiency test-
for submitting proficiency testing re- ing results to the proficiency testing
sults of the suspension of patient test- program within the time frame speci-
ing and the circumstances associated fied by the program is unsatisfactory
with failure to perform tests on pro- performance and results in a score of 0
ficiency testing samples; and for the testing event.
(3) The laboratory participated in the (d)(1) For any unsatisfactory testing
previous two proficiency testing event for reasons other than a failure
events. to participate, the laboratory must un-
(c) Failure to return proficiency test- dertake appropriate training and em-
ing results to the proficiency testing ploy the technical assistance necessary
program within the time frame speci- to correct problems associated with a
fied by the program is unsatisfactory proficiency testing failure.
performance and results in a score of 0 (2) Remedial action must be taken
for the testing event. and documented, and the documenta-
(d)(1) For any unsatisfactory testing tion must be maintained by the labora-
event for reasons other than a failure tory for two years from the date of par-
to participate, the laboratory must un- ticipation in the proficiency testing
dertake appropriate training and em- event.
ploy the technical assistance necessary (e) Failure to achieve an overall test-
to correct problems associated with a ing event score of satisfactory perform-
proficiency testing failure. ance for two consecutive testing events
(2) Remedial action must be taken or two out of three consecutive testing
and documented, and the documenta- events is unsuccessful performance.
tion must be maintained by the labora-
tory for two years from the date of par- § 493.831 Standard; Virology.
ticipation in the proficiency testing (a) Failure to attain an overall test-
event. ing event score of at least 80 percent is
(e) Failure to achieve an overall test- unsatisfactory performance.
ing event score of satisfactory perform- (b) Failure to participate in a testing
ance for two consecutive testing events event is unsatisfactory performance
or two out of three consecutive testing and results in a score of 0 for the test-
events is unsuccessful performance. ing event. Consideration may be given
§ 493.829 Standard; Parasitology. pate in a testing event only if—
(a) Failure to attain an overall test- (1) Patient testing was suspended
ing event score of at least 80 percent is during the time frame allotted for test-
unsatisfactory performance. ing and reporting proficiency testing
(b) Failure to participate in a testing results;
event is unsatisfactory performance (2) The laboratory notifies the in-
and results in a score of 0 for the test- specting agency and the proficiency
ing event. Consideration may be given testing program within the time frame
724
for submitting proficiency testing re- for submitting proficiency testing re-
sults of the suspension of patient test- sults of the suspension of patient test-
ing and the circumstances associated ing and the circumstances associated
with failure to perform tests on pro- with failure to perform tests on pro-
ficiency testing samples; and ficiency testing samples; and
(3) The laboratory participated in the (3) The laboratory participated in the
previous two proficiency testing previous two proficiency testing
events. events.
(c) Failure to return proficiency test- (c) Failure to return proficiency test-
ing results to the proficiency testing ing results to the proficiency testing
program within the time frame speci- program within the time frame speci-
fied by the program is unsatisfactory fied by the program is unsatisfactory
performance and results in a score of 0
performance and results in a score of 0
(d)(1) For any unsatisfactory testing
event for reasons other than a failure (d)(1) For any unsatisfactory testing
to participate, the laboratory must un- event for reasons other than a failure
dertake appropriate training and em- to participate, the laboratory must un-
ploy the technical assistance necessary dertake appropriate training and em-
to correct problems associated with a ploy the technical assistance necessary
proficiency testing failure. to correct problems associated with a
(2) For any unsatisfactory testing proficiency testing failure.
events, remedial action must be taken (2) For any unacceptable testing
and documented, and the documenta- event score, remedial action must be
tion must be maintained by the labora- taken and documented, and the docu-
tory for two years from the date of par- mentation must be maintained by the
ticipation in the proficiency testing laboratory for two years from the date
event. of participation in the proficiency test-
(e) Failure to achieve an overall testing event.
ing event score of satisfactory perform- (e) Failure to achieve an overall test-
ance for two consecutive testing events ing event score of satisfactory perform-
or two out of three consecutive testing ance for two consecutive testing events
events is unsuccessful performance. or two out of three consecutive testing
events is unsuccessful performance.
§ 493.833 Condition: Diagnostic immu-
nology. § 493.837 Standard; General immu-
The specialty of diagnostic immunology.
nology includes for purposes of pro- (a) Failure to attain a score of at
ficiency testing the subspecialties of least 80 percent of acceptable responses
syphilis serology and general immu- for each analyte in each testing event
nology. is unsatisfactory analyte performance
§ 493.835 Standard; Syphilis serology. for the testing event.
(b) Failure to attain an overall test-
(b) Failure to participate in a testing (c) Failure to participate in a testing
event is unsatisfactory performance event is unsatisfactory performance
and results in a score of 0 for the test- and results in a score of 0 for the test-
ing event. Consideration may be given ing event. Consideration may be given
to those laboratories failing to partici- to those laboratories failing to partici-
pate in a testing event only if— pate in a testing event only if—
(1) Patient testing was suspended (1) Patient testing was suspended
during the time frame allotted for test- during the time frame allotted for test-
ing and reporting proficiency testing ing and reporting proficiency testing
results; results;
(2) The laboratory notifies the in- (2) The laboratory notifies the in-
specting agency and the proficiency specting agency and the proficiency
testing program within the time frame testing program within the time frame
725
§ 493.839 42 CFR Ch. IV (10–1–24 Edition)
for submitting proficiency testing re- to those laboratories failing to partici-

sults of the suspension of patient test- pate in a testing event only if—
ing and the circumstances associated (1) Patient testing was suspended
with failure to perform tests on pro- during the time frame allotted for test-
ficiency testing samples; and ing and reporting proficiency testing
(3) The laboratory participated in the results;
previous two proficiency testing (2) The laboratory notifies the in-
events. specting agency and the proficiency
(d) Failure to return proficiency test- testing program within the time frame
ing results to the proficiency testing for submitting proficiency testing re-
program within the time frame speci- sults of the suspension of patient test-
fied by the program is unsatisfactory ing and the circumstances associated
performance and results in a score of 0 with failure to perform tests on pro-
for the testing event. ficiency testing samples; and
(e)(1) For any unsatisfactory analyte (3) The laboratory participated in the
or test performance or testing event previous two proficiency testing
for reasons other than a failure to par- events.
ticipate, the laboratory must under- (d) Failure to return proficiency test-
take appropriate training and employ ing results to the proficiency testing
the technical assistance necessary to program within the time frame speci-
correct problems associated with a pro- fied by the program is unsatisfactory
ficiency testing failure. performance and results in a score of 0
(2) For any unacceptable analyte or for the testing event.
testing event score, remedial action
(e)(1) For any unsatisfactory analyte
must be taken and documented, and
or test performance or testing event
the documentation must be maintained
for reasons other than a failure to par-
by the laboratory for two years from
ticipate, the laboratory must under-
the date of participation in the pro-
take appropriate training and employ
ficiency testing event.
the technical assistance necessary to
(f) Failure to achieve satisfactory
correct problems associated with a pro-
performance for the same analyte or
ficiency testing failure.
test in two consecutive testing events
or two out of three consecutive testing (2) For any unacceptable analyte or
events is unsuccessful performance. testing event score, remedial action
(g) Failure to achieve an overall test- must be taken and documented, and
ing event score of satisfactory perform- the documentation must be maintained
ance for two consecutive testing events by the laboratory for two years from
or two out of three consecutive testing the date of participation in the pro-
events is unsuccessful performance. ficiency testing event.
(f) Failure to achieve satisfactory
§ 493.839 Condition: Chemistry. performance for the same analyte or
The specialty of chemistry includes test in two consecutive testing events
for the purposes of proficiency testing or two out of three consecutive testing
the subspecialties of routine chem- events is unsuccessful performance.
istry, endocrinology, and toxicology. (g) Failure to achieve an overall test-
ing event score of satisfactory perform-
§ 493.841 Standard; Routine chemistry. ance for two consecutive testing events
(a) Failure to attain a score of at or two out of three consecutive testing
least 80 percent of acceptable responses events is unsuccessful performance.
for each analyte in each testing event
§ 493.843 Standard; Endocrinology.
is unsatisfactory analyte performance
for the testing event. (a) Failure to attain a score of at
(b) Failure to attain an overall test- least 80 percent of acceptable responses
ing event score of at least 80 percent is for each analyte in each testing event
unsatisfactory performance. is unsatisfactory analyte performance
(c) Failure to participate in a testing for the testing event.
event is unsatisfactory performance (b) Failure to attain an overall test-
and results in a score of 0 for the testing event score of at least 80 percent is
ing event. Consideration may be given unsatisfactory performance.
726
(c) Failure to participate in a testing (b) Failure to attain an overall test-

event is unsatisfactory performance ing event score of at least 80 percent is
and results in a score of 0 for the test- unsatisfactory performance.
ing event. Consideration may be given (c) Failure to participate in a testing
to those laboratories failing to partici- event is unsatisfactory performance
pate in a testing event only if— and results in a score of 0 for the test-
(1) Patient testing was suspended ing event. Consideration may be given
during the time frame allotted for test- to those laboratories failing to partici-
ing and reporting proficiency testing pate in a testing event only if—
results; (1) Patient testing was suspended
(2) The laboratory notifies the in- during the time frame allotted for test-
specting agency and the proficiency ing and reporting proficiency testing
testing program within the time frame results;
for submitting proficiency testing re- (2) The laboratory notifies the in-
sults of the suspension of patient test- specting agency and the proficiency
ing and the circumstances associated testing program within the time frame
with failure to perform tests on pro- for submitting proficiency testing re-
ficiency testing samples; and sults of the suspension of patient test-
(3) The laboratory participated in the ing and the circumstances associated
previous two proficiency testing with failure to perform tests on pro-
events. ficiency testing samples; and
(d) Failure to return proficiency test- (3) The laboratory participated in the
ing results to the proficiency testing previous two proficiency testing
program within the time frame speci- events.
fied by the program is unsatisfactory (d) Failure to return proficiency test-
performance and results in a score of 0 ing results to the proficiency testing
for the testing event. program within the time frame speci-
(e)(1) For any unsatisfactory analyte fied by the program is unsatisfactory
or test performance or testing event performance and results in a score of 0
for reasons other than a failure to par- for the testing event.
ticipate, the laboratory must under- (e)(1) For any unsatisfactory analyte
take appropriate training and employ or test performance or testing event
the technical assistance necessary to for reasons other than a failure to par-
correct problems associated with a pro- ticipate, the laboratory must under-
ficiency testing failure. take appropriate training and employ
(2) For any unacceptable analyte or the technical assistance necessary to
testing event score, remedial action correct problems associated with a pro-
must be taken and documented, and ficiency testing failure.
the documentation must be maintained (2) For any unacceptable analyte or
by the laboratory for two years from testing event score, remedial action
the date of participation in the pro- must be taken and documented, and
ficiency testing event. the documentation must be maintained
(f) Failure to achieve satisfactory by the laboratory for two years from
performance for the same analyte or the date of participation in the pro-
test in two consecutive testing events ficiency testing event.
or two out of three consecutive testing (f) Failure to achieve satisfactory
events is unsuccessful performance. performance for the same analyte or
(g) Failure to achieve an overall test- test in two consecutive testing events
ing event score of satisfactory perform- or two out of three consecutive testing
ance for two consecutive testing events events is unsuccessful performance.
or two out of three consecutive testing (g) Failure to achieve an overall test-
events is unsuccessful performance. ing event score of satisfactory perform-
ance for two consecutive testing events
§ 493.845 Standard; Toxicology. or two out of three consecutive testing
(a) Failure to attain a score of at events is unsuccessful performance.
least 80 percent of acceptable responses
for each analyte in each testing event § 493.849 Condition: Hematology.
is unsatisfactory analyte performance The specialty of hematology, for the
for the testing event. purpose of proficiency testing, is not
727
§ 493.851 42 CFR Ch. IV (10–1–24 Edition)
subdivided into subspecialties of test- (g) Failure to achieve an overall test-

ing. ing event score of satisfactory perform-
ance for two consecutive testing events
§ 493.851 Standard; Hematology. or two out of three consecutive testing
(a) Failure to attain a score of at events is unsuccessful performance.
least 80 percent of acceptable responses
for each analyte in each testing event § 493.853 Condition: Pathology.
is unsatisfactory analyte performance The specialty of pathology includes,
for the testing event. for purposes of proficiency testing, the
(b) Failure to attain an overall test- subspecialty of cytology limited to
ing event score of at least 80 percent is gynecologic examinations.
(c) Failure to participate in a testing § 493.855 Standard; Cytology:
event is unsatisfactory performance gynecologic examinations.
and results in a score of 0 for the test- To participate successfully in a cy-
ing event. Consideration may be given tology proficiency testing program for
to those laboratories failing to partici- gynecologic examinations (Pap
pate in a testing event only if— smears), the laboratory must meet the
(1) Patient testing was suspended requirements of paragraphs (a) through
during the time frame allotted for test- (c) of this section.
ing and reporting proficiency testing (a) The laboratory must ensure that
results; each individual engaged in the exam-
(2) The laboratory notifies the in- ination of gynecologic preparations is
specting agency and the proficiency enrolled in a proficiency testing pro-
testing program within the time frame gram approved by CMS by January 1,
for submitting proficiency testing re- 1995, if available in the State in which
sults of the suspension of patient test- he or she is employed. The laboratory
ing and the circumstances associated must ensure that each individual is
with failure to perform tests on pro- tested at least once per year and ob-
ficiency testing samples; and tains a passing score. To ensure this
(3) The laboratory participated in the annual testing of individuals, an an-
previous two proficiency testing nounced or unannounced testing event
events. will be conducted on-site in each lab-
(d) Failure to return proficiency test- oratory at least once each year. Lab-
ing results to the proficiency testing oratories will be notified of the time of
program within the time frame speci- each announced on-site testing event
fied by the program is unsatisfactory at least 30 days prior to each event. Ad-
performance and results in a score of 0 ditional testing events will be con-
for the testing event. ducted as necessary in each State or
(e)(1) For any unsatisfactory analyte region for the purpose of testing indi-
or test performance or testing event viduals who miss the on-site testing
for reasons other than a failure to par- event and for retesting individuals as
ticipate, the laboratory must under- described in paragraph (b) of this sec-
take appropriate training and employ tion.
the technical assistance necessary to (b) The laboratory must ensure that
correct problems associated with a pro- each individual participates in an an-
ficiency testing failure. nual testing event that involves the ex-
(2) For any unacceptable analyte or amination of a 10-slide test set as de-
testing event score, remedial action scribed in § 493.945. Individuals who fail
must be taken and documented, and this testing event are retested with an-
the documentation must be maintained other 10-slide test set as described in
by the laboratory for two years from paragraphs (b)(1) and (b)(2) of this sec-
the date of participation in the pro- tion. Individuals who fail this second
ficiency testing event. test are subsequently retested with a
(f) Failure to achieve satisfactory 20-slide test set as described in para-
performance for the same analyte in graphs (b)(2) and (b)(3) of this section.
two consecutive events or two out of Individuals are given not more than 2
three consecutive testing events is un- hours to complete a 10-slide test and
successful performance. not more than 4 hours to complete a 20-
728
slide test. Unexcused failure to appear testing in accordance with subpart R of

by an individual for a retest will result this part.
in test failure with resulting remedi- [57 FR 7146, Feb. 28, 1992, as amended at 58
ation and limitations on slide examina- FR 5228, Jan. 19, 1993; 59 FR 62609, Dec. 6,
tions as specified in (b)(1), (b)(2), and 1994]
(b)(3) of this section.
(1) An individual is determined to § 493.857 Condition:
have failed the annual testing event if Immunohematology.
he or she scores less than 90 percent on The specialty of immunohematology
a 10-slide test set. For an individual includes four subspecialties for the pur-
who fails an annual proficiency testing poses of proficiency testing: ABO group
event, the laboratory must schedule a and D (Rho) typing; unexpected anti-
retesting event which must take place body detection; compatibility testing;
not more than 45 days after receipt of and antibody identification.
the notification of failure.
(2) An individual is determined to § 493.859 Standard; ABO group and D
have failed the second testing event if (Rho) typing.
he or she scores less than 90 percent on (a) Failure to attain a score of at
a 10-slide test set. For an individual least 100 percent of acceptable re-
who fails a second testing event, the sponses for each analyte or test in each
laboratory must provide him or her testing event is unsatisfactory analyte
with documented, remedial training performance for the testing event.
and education in the area of failure, (b) Failure to attain an overall test-
and must assure that all gynecologic ing event score of at least 100 percent
slides evaluated subsequent to the no- is unsatisfactory performance.
tice of failure are reexamined until the (c) Failure to participate in a testing
individual is again retested with a 20- event is unsatisfactory performance
slide test set and scores at least 90 per- and results in a score of 0 for the test-
cent. Reexamination of slides must be ing event. Consideration may be given
documented. to those laboratories failing to partici-
(3) An individual is determined to pate in a testing event only if—
have failed the third testing event if he (1) Patient testing was suspended
or she scores less than 90 percent on a during the time frame allotted for test-
20-slide test set. An individual who ing and reporting proficiency testing
fails the third testing event must cease results;
examining gynecologic slide prepara- (2) The laboratory notifies the in-
tions immediately upon notification of specting agency and the proficiency
test failure and may not resume exam- testing program within the time frame
ining gynecologic slides until the lab- for submitting proficiency testing re-
oratory assures that the individual ob- sults of the suspension of patient test-
tains at least 35 hours of documented, ing and the circumstances associated
formally structured, continuing edu- with failure to perform tests on pro-
cation in diagnostic cytopathology ficiency testing samples; and
that focuses on the examination of (3) The laboratory participated in the
gynecologic preparations, and until he previous two proficiency testing
or she is retested with a 20-slide test events.
set and scores at least 90 percent. (d) Failure to return proficiency test-
(c) If a laboratory fails to ensure that ing results to the proficiency testing
individuals are tested or those who fail program within the time frame speci-
a testing event are retested, or fails to fied by the program is unsatisfactory
take required remedial actions as de- performance and results in a score of 0
scribed in paragraphs (b)(1), (b)(2) or for the testing event.
(b)(3) of this section, CMS will initiate (e)(1) For any unsatisfactory testing
intermediate sanctions or limit the event for reasons other than a failure
laboratory’s certificate to exclude to participate, the laboratory must un-
gynecologic cytology testing under dertake appropriate training and em-
CLIA, and, if applicable, suspend the ploy the technical assistance necessary
laboratory’s Medicare and Medicaid to correct problems associated with a
payments for gynecologic cytology proficiency testing failure.
729
§ 493.861 42 CFR Ch. IV (10–1–24 Edition)
(2) For any unacceptable analyte or taken and documented, and the docu-
unsatisfactory testing event score, re- mentation must be maintained by the
medial action must be taken and docu- laboratory for two years from the date
mented, and the documentation must of participation in the proficiency test-
be maintained by the laboratory for ing event.
two years from the date of participa- (e) Failure to achieve an overall test-
tion in the proficiency testing event. ing event score of satisfactory for two
(f) Failure to achieve satisfactory consecutive testing events or two out
performance for the same analyte in of three consecutive testing events is
two consecutive testing events or two unsuccessful performance.
out of three consecutive testing events [57 FR 7146, Feb. 28, 1992, as amended at 87
is unsuccessful performance. FR 41232, July 11, 2022]
(g) Failure to achieve an overall test-
ing event score of satisfactory for two § 493.863 Standard; Compatibility test-
consecutive testing events or two out ing.
of three consecutive testing events is (a) Failure to attain an overall test-
unsuccessful performance. ing event score of at least 100 percent
is unsatisfactory performance.
§ 493.861 Standard; Unexpected anti- (b) Failure to participate in a testing
body detection.
(a) Failure to attain an overall test- and results in a score of 0 for the test-
ing event score of at least 100 percent ing event. Consideration may be given
is unsatisfactory performance. to those laboratories failing to partici-
(b) Failure to participate in a testing pate in a testing event only if—
event is unsatisfactory performance (1) Patient testing was suspended
and results in a score of 0 for the test- during the time frame allotted for test-
ing event. Consideration may be given ing and reporting proficiency testing
to those laboratories failing to partici- results;
pate in a testing event only if— (2) The laboratory notifies the in-
(1) Patient testing was suspended specting agency and the proficiency
during the time frame allotted for test- testing program within the time frame
ing and reporting proficiency testing for submitting proficiency testing re-
results; sults of the suspension of patient test-
(2) The laboratory notifies the ining and the circumstances associated
specting agency and the proficiency with failure to perform tests on pro-
testing program within the time frame ficiency testing samples; and
for submitting proficiency testing re- (3) The laboratory participated in the
sults of the suspension of patient test- previous two proficiency testing
ing and the circumstances associated events.
with failure to perform tests on pro- (c) Failure to return proficiency test-
ficiency testing samples; and ing results to the proficiency testing
(3) The laboratory participated in the program within the time frame speci-
previous two proficiency testing fied by the program is unsatisfactory
events. performance and results in a score of 0
(c) Failure to return proficiency test- for the testing event.
ing results to the proficiency testing (d)(1) For any unsatisfactory testing
program within the time frame speci- event for reasons other than a failure
fied by the program is unsatisfactory to participate, the laboratory must un-
performance and results in a score of 0 dertake appropriate training and em-
for the testing event. ploy the technical assistance necessary
(d)(1) For any unsatisfactory testing to correct problems associated with a
event for reasons other than a failure proficiency testing failure.
to participate, the laboratory must un- (2) For any unsatisfactory testing
dertake appropriate training and em- event score, remedial action must be
ploy the technical assistance necessary taken and documented, and the docu-
to correct problems associated with a mentation must be maintained by the
proficiency testing failure. laboratory for two years from the date
(2) For any unsatisfactory testing of participation in the proficiency test-
event score, remedial action must be ing event.
730
(e) Failure to achieve an overall test- of three consecutive testing events is

ing event score of satisfactory for two unsuccessful performance.
consecutive testing events or two out
of three consecutive testing events is Subpart I—Proficiency Testing
unsuccessful performance. Programs for Nonwaived Testing
§ 493.865 Standard; Antibody identi-
fication. SOURCE: 57 FR 7151, Feb. 28, 1992, unless
otherwise noted.
ing event score of at least 80 percent is § 493.901 Approval of proficiency test-
unsatisfactory performance. ing programs.
event is unsatisfactory performance In order for a proficiency testing pro-
and results in a score of 0 for the test- gram to receive HHS approval, the pro-
ing event. Consideration may be given gram must be offered by a private non-
to those laboratories failing to partici- profit organization or a Federal or
pate in a testing event only if— State agency, or entity acting as a des-
(1) Patient testing was suspended ignated agent for the State. An organi-
during the time frame allotted for test- zation, Federal, or State program seek-
ing and reporting proficiency testing ing approval or reapproval for its pro-
results; gram for the next calendar year must
(2) The laboratory notifies the in- submit an application providing the re-
specting agency and the proficiency quired information by July 1 of the
testing program within the time frame current year. The organization, Fed-
for submitting proficiency testing re- eral, or State program must provide
sults of the suspension of patient test- technical assistance to laboratories
ing and the circumstances associated seeking to qualify under the program,
with failure to perform tests on pro- and must, for each specialty, sub-
ficiency testing samples; and specialty, and analyte or test for which
(3) The laboratory participated in the it provides testing—
previous two proficiency testing (a) Require a minimum of 10 labora-
events. tory participants for each specialty,
(c) Failure to return proficiency test- subspecialty, and analyte or test for
ing results to the proficiency testing which the proficiency testing program
program within the time frame speci- is seeking reapproval;
fied by the program is unsatisfactory (b) Assure the quality of test sam-
performance and results in a score of 0 ples, appropriately evaluate and score
for the testing event. the testing results, and identify per-
(d)(1) For any unsatisfactory testing formance problems in a timely manner;
event for reasons other than a failure (c) Demonstrate to HHS that it has—
to participate, the laboratory must un- (1) The technical ability required to—
dertake appropriate training and em- (i) Prepare or purchase samples from
ploy the technical assistance necessary manufacturers who prepare the sam-
to correct problems associated with a ples in conformance with the appro-
proficiency testing failure. priate good manufacturing practices
(2) For any unsatisfactory testing required in 21 CFR parts 606, 640, and
event score, remedial action must be 820; and
taken and documented, and the docu- (ii) Distribute the samples, using rig-
mentation must be maintained by the orous quality control to assure that
laboratory for two years from the date samples mimic actual patient speci-
of participation in the proficiency test- mens when possible and that samples
ing event. are homogeneous, except for specific
(e) Failure to identify the same anti- subspecialties such as cytology, and
body in two consecutive or two out of will be stable within the time frame for
three consecutive testing events is un- analysis by proficiency testing partici-
successful performance. pants;
(f) Failure to achieve an overall test- (2) A scientifically defensible process
ing event score of satisfactory for two for determining the correct result for
consecutive testing events or two out each challenge offered by the program;
731
§ 493.903 42 CFR Ch. IV (10–1–24 Edition)
(3) A program of sufficient annual test contained in §§ 493.901 through

challenge and with the frequency speci- 493.959 for initial approval and there-
fied in §§ 493.909 through 493.959 to es- after provide HHS, on an annual basis,
tablish that a laboratory has met min- with the information necessary to as-
imum performance requirements; sure that the proficiency testing pro-
(4) The resources needed to provide gram meets the criteria required for
Statewide or nationwide reports to reg- approval; and
ulatory agencies on individual’s per- (e) HHS may require on-site visits for
formance for gynecologic cytology and all initial proficiency testing program
on individual laboratory performance applications for CMS approval and pe-
on testing events, cumulative reports riodically or when problems are en-
and scores for each laboratory or indi- countered for previously HHS-approved
vidual, and reports of specific labora- proficiency testing programs either
tory failures using grading criteria ac- during the reapproval process or as
ceptable to HHS. These reports must be necessary to review and verify the poli-
provided to HHS on a timely basis cies and procedures represented in its
when requested; application and other information, in-
(5) Provisions to include on each pro- cluding, but not limited to, review and
ficiency testing program report form examination of documents and inter-
used by the laboratory to record test- views of staff.
ing event results, an attestation state- (f) HHS may require a proficiency
ment that proficiency testing samples testing program to reapply for ap-
were tested in the same manner as pa- proval using the process for initial ap-
tient specimens with a signature block plications if significant problems are
to be completed by the individual per- encountered during the reapproval
forming the test as well as by the lab- process.
oratory director; [57 FR 7151, Feb. 28, 1992, as amended at 58
(6) A mechanism for notifying par- FR 5228, Jan. 19, 1993; 87 FR 41232, July 11,
ticipants of the PT shipping schedule 2022]
and for participants to notify the pro-
ficiency testing program within three § 493.903 Administrative responsibil-
days of the expected date of receipt of ities.
the shipment that samples have not ar- The proficiency testing program
rived or are unacceptable for testing. must—
The program must have provisions for (a)(1) Provide HHS or its designees
replacement of samples that are lost in and participating laboratories with an
transit or are received in a condition electronic or a hard copy, or both, of
that is unacceptable for testing; and reports of proficiency testing results
(7) A process to resolve technical, ad- and all scores for each laboratory’s per-
ministrative, and scientific problems formance in a format as required by
about program operations; and and approved by CMS for each CLIA-
(8) A contractor performing technical certified specialty, subspecialty, and
and scientific responsibilities as de- analyte or test within 60 days after the
scribed in this section and § 493.903 (in- date by which the laboratory must re-
cluding, but not limited to, processes port proficiency testing results to the
for selecting appropriate target values proficiency testing program;
to be included in challenges as part of (2) Provide HHS with reports of PT
the annual PT program or grading PT results and scores of individual per-
results, determining target values, re- formance in cytology and provide cop-
porting scores to CMS, and deter- ies of reports to participating individ-
mining organisms included in microbi- uals, and to all laboratories that em-
ology PT samples) must be a private ploy the individuals, within 15 working
nonprofit organization or a Federal or days of the testing event; and
State agency, or an entity acting as a (3) Not change submitted laboratory
designated agent for the Federal or data and results for any proficiency
State agency. testing event;
(d) Meet the specific criteria for pro- (b) Furnish to HHS cumulative re-
ficiency testing programs listed by spe- ports on an individual laboratory’s per-
cialty, subspecialty, and analyte or formance and aggregate data on CLIA-
732
certified laboratories for the purpose of CMS reconsider the determination, in

establishing a system to make the pro- accordance with subpart D of part 488.
ficiency testing program’s results
[87 FR 41233, July 11, 2022]
available, on a reasonable basis, upon
request of any person, and include such
PROFICIENCY TESTING PROGRAMS BY
explanatory information as may be ap-
SPECIALTY AND SUBSPECIALTY
propriate to assist in the interpreta-
tion of the proficiency testing pro- § 493.909 Microbiology.
gram’s results;
(c) Provide HHS with additional in- The subspecialties under the spe-
formation and data upon request and cialty of microbiology for which a pro-
submit such information necessary for gram may offer proficiency testing are
HHS to conduct an annual evaluation bacteriology, mycobacteriology, my-
to determine whether the proficiency cology, parasitology and virology. Spe-
testing program continues to meet the cific criteria for these subspecialties
requirements of §§ 493.901 through are found at §§ 493.911 through 493.919.
493.959;
(d) Maintain records of laboratories’ § 493.911 Bacteriology.
performance for a period of five years (a) Program content and frequency of
or such time as may be necessary for challenge. To be approved for pro-
any legal proceedings; and ficiency testing for bacteriology, the
(e) Provide HHS with an annual re- annual program must provide a min-
port and, if needed, an interim report imum of five samples per testing event.
which identifies any previously unrec- There must be at least three testing
ognized sources of variability in kits, events provided to the laboratory at
instruments, methods, or PT samples, approximately equal intervals per year.
which adversely affect the programs’ The samples may be provided to the
ability to evaluate laboratory perform- laboratory through mailed shipments.
ance. The specific organisms included in the
[57 FR 7151, Feb. 28, 1992, as amended at 58 samples may vary from year to year.
FR 5228, Jan. 19, 1993; 87 FR 41233, July 11, (1) The annual program must include,
2022] as applicable, samples for:
§ 493.905 Nonapproved proficiency (i) Gram stain including bacterial
testing programs. morphology;
(ii) Direct bacterial antigen detec-
(a) Effect on approval status. If a pro-
tion;
ficiency testing program is determined
(iii) Bacterial toxin detection; and,
by HHS to fail to meet any criteria
contained in §§ 493.901 through 493.959 (iv) Detection and identification of
for approval of the proficiency testing bacteria which includes one of the fol-
program, CMS will notify the program lowing:
of its withdrawal of approval. Approval (A) Detection of the presence or ab-
of the PT program remains in effect for sence of bacteria without identifica-
60 days from the date of notification. tion; or
The proficiency testing program must (B) Identification of bacteria; and
notify all of its participating labora- (v) Antimicrobial susceptibility test-
tories of the withdrawal of approval ing of select bacteria.
within 30 days from the date of notifi- (2) An approved program must fur-
cation. CMS may disapprove any pro- nish HHS and its agents with a descrip-
ficiency testing program that provides tion of samples that it plans to include
false or misleading information with in its annual program no later than 6
respect to any information that is nec- months before each calendar year. The
essary to meet any criteria contained program must include bacteria com-
in §§ 493.901 through 493.959 for approval monly occurring in patient specimens
of the proficiency testing program. and other important emerging patho-
(b) Request for reconsideration. Any gens. The program determines the re-
proficiency testing program that is dis- portable isolates and correct responses
satisfied with a determination to dis- for antimicrobial susceptibility testing
approve the program may request that for any designated isolate. At least 25
733
§ 493.911 42 CFR Ch. IV (10–1–24 Edition)
percent of the samples must be mix- (1) The program determines the re-
tures of the principal organism and ap- portable bacterial staining and mor-
propriate normal flora. Mixed cultures phological characteristics to be inter-
are samples that require reporting of preted by Gram stain. The program de-
one or more principal pathogens. Mixed termines the bacteria to be reported by
cultures are not ‘‘negative’’ samples direct bacterial antigen detection, bac-
such as when two commensal orga- terial toxin detection, detection of the
nisms are provided in a PT sample with presence or absence of bacteria without
the intended response of ‘‘negative’’ or identification, identification of bac-
‘‘no pathogen present.’’ The program teria, and antimicrobial susceptibility
must include the following two types of testing. To determine the accuracy of
samples to meet the 25 percent mixed each of the laboratory’s responses, the
culture criterion: program must compare each response
(i) Samples that require laboratories with the response which reflects agree-
to report only organisms that the test- ment of either 80 percent or more of 10
ing laboratory considers to be a prin- or more referee laboratories or 80 per-
cipal pathogen that is clearly respon- cent or more of all participating lab-
sible for a described illness (excluding oratories. Both methods must be at-
immuno-compromised patients). The tempted before the program can choose
program determines the reportable iso- to not grade a PT sample.
lates, including antimicrobial suscepti- (2) A laboratory must identify the or-
bility for any designated isolate; and ganisms to highest level that the lab-
(ii) Samples that require laboratories oratory reports results on patient
to report all organisms present. Sam- specimens.
ples must contain multiple organisms (3) A laboratory’s performance will
frequently found in specimens where be evaluated on the basis of the aver-
multiple isolates are clearly signifi- age of its scores for paragraph (b)(4)
cant or where specimens are derived through (8) of this section as deter-
from immuno-compromised patients. mined in paragraph (b)(9) of this sec-
The program determines the reportable tion.
isolates. (4) The performance criteria for
(3) The content of an approved pro- Gram stain including bacterial mor-
gram must vary over time, as appro- phology is staining reaction, that is,
priate. The types of bacteria included Gram positive or Gram negative and
annually must be representative of the morphological description for each
following major groups of medically sample. The score is the number of cor-
important aerobic and anaerobic bac- rect responses for Gram stain reaction
teria, if appropriate for the sample plus the number of correct responses
sources: for morphological description divided
(i) Gram-negative bacilli. by 2 then divided by the number of
(ii) Gram-positive bacilli. samples to be tested, multiplied by 100.
(iii) Gram-negative cocci. (5) The performance criterion for di-
(iv) Gram-positive cocci. rect bacterial antigen detection is the
(4) For antimicrobial susceptibility presence or absence of the bacterial
testing, the program must provide at antigen. The score is the number of
least two samples per testing event. correct responses divided by the num-
The program must annually provide ber of samples to be tested, multiplied
samples that include Gram-positive or- by 100.
ganisms and samples that include (6) The performance criterion for bac-
Gram-negative organisms that have a terial toxin detection is the presence or
predetermined pattern of susceptibility absence of the bacterial toxin. The
or resistance to the common anti- score is the number of correct re-
microbial agents. sponses divided by the number of sam-
(b) Evaluation of a laboratory’s per- ples to be tested multiplied by 100.
formance. HHS approves only those pro- (7) The performance criterion for the
grams that assess the accuracy of a detection and identification of bacteria
laboratory’s responses in accordance includes one of the following:
with paragraphs (b)(1) through (9) of (i) The performance criterion for the
this section. detection of the presence or absence of
734
bacteria without identification is the on the type of service offered by the

correct detection of the presence or ab- laboratory.
sence of bacteria without identifica- [87 FR 41233, July 11, 2022]
tion. The score is the number of cor-
rect responses divided by the number of § 493.913 Mycobacteriology.
samples to be tested multiplied by 100.
(a) Program content and frequency of
(ii) The performance criterion for the challenge. To be approved for pro-
identification of bacteria is the total ficiency testing for mycobacteriology,
number of correct responses for bac- the annual program must provide a
terial identification submitted by the minimum of five samples per testing
laboratory divided by the number of or- event. There must be at least two test-
ganisms present plus the number of ining events provided to the laboratory
correct organisms reported by the lab- at approximately equal intervals per
oratory multiplied by 100 to establish a year. The samples may be provided
score for each sample in each testing through mailed shipments. The specific
event. Since laboratories may incor- organisms included in the samples may
rectly report the presence of organisms vary from year to year.
in addition to the correctly identified (1) The annual program must include,
principal organism(s), the scoring sys- as applicable, samples for:
tem must provide a means of deducting (i) Acid-fast stain; and
credit for additional erroneous orga- (ii) Detection and identification of
nisms that are reported. For example, mycobacteria which includes one of the
if a sample contained one principal or- following:
ganism and the laboratory reported it (A) Detection of the presence or ab-
correctly but reported the presence of sence of mycobacteria without identi-
an additional organism, which was not fication; or
considered reportable, the sample (B) Identification of mycobacteria.
grade would be 1/(1+1) × 100 = 50 per- (2) An approved program must fur-
cent. nish HHS and its agents with a descrip-
(8) For antimicrobial susceptibility tion of the samples it plans to include
testing, a laboratory must indicate in its annual program no later than 6
which drugs are routinely included in months before each calendar year. At
its test panel when testing patient least 25 percent of the samples must be
samples. A laboratory’s performance mixtures of the principal mycobacteria
will be evaluated for only those and appropriate normal flora. The pro-
antimicrobials for which susceptibility gram must include mycobacteria com-
monly occurring in patient specimens
testing is routinely performed on pa-
and other important emerging
tient specimens. A correct response for
mycobacteria. The program determines
each antimicrobial will be determined
the reportable isolates and correct re-
as described in paragraph (b)(1) of this
sponses.
section. Scoring for each sample is
(3) The content of an approved pro-
based on the number of correct suscep- gram may vary over time, as appro-
tibility responses reported by the lab- priate. The mycobacteria included an-
oratory divided by the actual number nually must contain species represent-
of correct susceptibility responses de- ative of the following major groups of
termined by the program, multiplied medically important mycobacteria, if
by 100. For example, if a laboratory of- appropriate for the sample sources:
fers susceptibility testing using three (i) Mycobacterium tuberculosis com-
antimicrobial agents, and the labora- plex; and
tory reports correct responses for two (ii) Mycobacterium other than tuber-
of the three antimicrobial agents, the culosis (MOTT).
laboratory’s grade would be 2⁄3 × 100 = 67 (4) The program must provide at
percent. least five samples per testing event
(9) The score for a testing event in that include challenges that contain
bacteriology is the average of the acid-fast organisms and challenges
scores determined under paragraphs that do not contain acid-fast orga-
(b)(4) through (8) of this section based nisms.
735
§ 493.915 42 CFR Ch. IV (10–1–24 Edition)
(b) Evaluation of a laboratory’s per- ber of incorrect organisms reported by

formance. HHS approves only those pro- the laboratory multiplied by 100 to es-
grams that assess the accuracy of a tablish a score for each sample in each
laboratory’s response in accordance testing event. Since laboratories may
with paragraphs (b)(1) through (6) of incorrectly report the presence of
this section. mycobacteria in addition to the cor-
(1) The program determines the re- rectly identified principal organism(s),
portable mycobacteria to be detected the scoring system must provide a
by acid-fast stain. The program deter- means of deducting credit for addi-
mines the mycobacteria to be reported tional erroneous organisms reported.
by detection of the presence or absence For example, if a sample contained one
of mycobacteria without identifica- principal organism and the laboratory
tion, and identification of reported it correctly but reported the
mycobacteria. To determine the accu- presence of an additional organism,
racy of each of the laboratory’s re- which was not considered reportable,
sponses, the program must compare the sample grade would be 1/(1+1) × 100
each response with the response that = 50 percent.
reflects agreement of either 80 percent (6) The score for a testing event in
or more of 10 or more referee labora- mycobacteriology is the average of the
tories or 80 percent or more of all par- scores determined under paragraphs
ticipating laboratories. Both methods (b)(4) through (5) of this section based
must be attempted before the program on the type of service offered by the
can choose to not grade a PT sample. laboratory.
(2) A laboratory must detect and [87 FR 41234, July 11, 2022]
identify the organisms to the highest
level that the laboratory reports re- § 493.915 Mycology.
sults on patient specimens. (a) Program content and frequency of
(3) A laboratory’s performance will challenge. To be approved for pro-
be evaluated on the basis of the aver- ficiency testing for mycology, the an-
age of its scores for paragraph (b)(4) nual program must provide a minimum
through (5) of this section as deter- of five samples per testing event. There
mined in paragraph (b)(6) of this sec- must be at least three testing events
tion. provided to the laboratory at approxi-
(4) The performance criterion for mately equal intervals per year. The
acid-fast stains is positive or negative samples may be provided through
or the presence or absence of acid-fast mailed shipments. The specific orga-
organisms. The score is the number of nisms included in the samples may
correct responses divided by the num- vary from year to year.
ber of samples to be tested, multiplied (1) The annual program must include,
by 100. as applicable, samples for:
(5) The performance criterion for the (i) Direct fungal antigen detection;
detection and identification of and
mycobacteria includes one of the fol- (ii) Detection and identification of
lowing: fungi and aerobic actinomycetes which
(i) The performance criterion for the includes one of the following:
detection of the presence or absence of (A) Detection of the presence or ab-
mycobacteria without identification is sence of fungi and aerobic
the correct detection of the presence or actinomycetes without identification;
absence of mycobacteria without iden- or
tification. The score is the number of (B) Identification of fungi and aer-
correct responses divided by the num- obic actinomycetes.
ber of samples to be tested multiplied (2) An approved program must fur-
by 100. nish HHS and its agents with a descrip-
(ii) The performance criterion for the tion of the samples it plans to include
identification of mycobacteria is the in its annual program no later than 6
total number of correct responses for months before each calendar year. At
mycobacterial identification submitted least 25 percent of the samples must be
by the laboratory divided by the num- mixtures of the principal organism and
ber of organisms present plus the num- appropriate normal background flora.
736
The program must include fungi and (5) The performance criterion for the
aerobic actinomycetes commonly oc- detection and identification of fungi
curring in patient specimens and other and aerobic actinomycetes includes
important emerging fungi. The pro- one of the following:
gram determines the reportable iso- (i) The performance criterion for the
lates and correct responses. detection of the presence or absence of
(3) The content of an approved pro- fungi and aerobic actinomycetes with-
gram must vary over time, as appro- out identification is the correct detec-
priate. The fungi included annually tion of the presence or absence of fungi
must contain species representative of and aerobic actinomycetes without
the following major groups of medi- identification. The score is the number
cally important fungi and aerobic of correct responses divided by the
actinomycetes, if appropriate for the number of samples to be tested multi-
sample sources: plied by 100.
(i) Yeast or yeast-like organisms; (ii) The performance criterion for the
(ii) Molds that include; identification of fungi and aerobic
(A) Dematiaceous fungi; actinomycetes is the total number of
(B) Dermatophytes; correct responses for fungal and aer-
(C) Hyaline hyphomycetes; obic actinomycetes identification sub-
(D) Mucormycetes; and mitted by the laboratory divided by
(iii) Aerobic actinomycetes. the number of organisms present plus
(b) Evaluation of a laboratory’s per- the number of incorrect organisms re-
formance. HHS approves only those pro- ported by the laboratory multiplied by
grams that assess the accuracy of a 100 to establish a score for each sample
laboratory’s response, in accordance in each testing event. Since labora-
with paragraphs (b)(1) through (6) of tories may incorrectly report the pres-
this section. ence of fungi and aerobic
(1) The program determines the re- actinomycetes in addition to the cor-
portable fungi to be reported by direct rectly identified principal organism(s),
fungal antigen detection, detection of the scoring system must provide a
the presence or absence of fungi and means of deducting credit for addi-
aerobic actinomycetes without identi- tional erroneous organisms that are re-
fication, and identification of fungi and ported. For example, if a sample con-
aerobic actinomycetes. To determine tained one principal organism and the
the accuracy of a laboratory’s re- laboratory reported it correctly but re-
sponses, the program must compare ported the presence of an additional or-
each response with the response re- ganism, which was not considered re-
flects agreement of either 80 percent or portable, the sample grade would be 1/
more of 10 or more referee laboratories (1+1) × 100 = 50 percent.
or 80 percent or more of all partici- (6) The score for a testing event is
pating laboratories. Both methods the average of the sample scores as de-
must be attempted before the program termined under paragraphs (b)(4)
can choose to not grade a PT sample. through (5) of this section.
(2) A laboratory must detect and
identify the organisms to highest level [87 FR 41235, July 11, 2022]
that the laboratory reports results on
patient specimens. § 493.917 Parasitology.
(3) A laboratory’s performance will (a) Program content and frequency of
be evaluated on the basis of the aver- challenge. To be approved for pro-
age of its scores for paragraphs (b)(4) ficiency testing for parasitology, the
through (5) of this section as deter- annual program must provide a min-
mined in paragraph (b)(6) of this sec- imum of five samples per testing event.
tion. There must be at least three testing
(4) The performance criterion for di- events provided to the laboratory at
rect fungal antigen detection is the approximately equal intervals per year.
presence or absence of the fungal anti- The samples may be provided through
gen. The score is the number of correct mailed shipments. The specific orga-
responses divided by the number of nisms included in the samples may
samples to be tested, multiplied by 100. vary from year to year.
737
§ 493.917 42 CFR Ch. IV (10–1–24 Edition)
(1) The annual program must include, must compare each response with the
as applicable, samples for: response which reflects agreement of
(i) Direct parasite antigen detection; either 80 percent or more of 10 or more
and referee laboratories or 80 percent or
(ii) Detection and identification of more of all participating laboratories.
parasites which includes one of the fol- Both methods must be attempted be-
lowing: fore the program can choose to not
(A) Detection of the presence or ab- grade a PT sample.
sence of parasites without identifica- (2) A laboratory must detect and
tion; or identify or concentrate and identify
(B) Identification of parasites. the parasites to the highest level that
(2) An approved program must fur- the laboratory reports results on pa-
nish HHS and its agents with a descrip- tient specimens.
tion of the samples it plans to include (3) A laboratory’s performance will
in its annual program no later than 6 be evaluated on the basis of the aver-
months before each calendar year. age of its scores for paragraphs (b)(4)
Samples must include both through (5) of this section as deter-
formalinized specimens and PVA (poly- mined in paragraph (b)(6) of this sec-
vinyl alcohol) fixed specimens as well tion.
as blood smears, as appropriate for a (4) The performance criterion for di-
particular parasite and stage of the rect parasite antigen detection is the
parasite. The majority of samples must presence or absence of the parasite
contain protozoa or helminths or a antigen. The score is the number of
combination of parasites. Some sam- correct responses divided by the num-
ples must be devoid of parasites. ber of samples to be tested, multiplied
(3) The content of an approved pro- by 100.
gram must vary over time, as appro- (5) The performance criterion for the
priate. The types of parasites included detection and identification of
annually must be representative of the parasites includes one of the following:
following major groups of medically (i) The performance criterion for the
important parasites, if appropriate for detection of the presence or absence of
the sample sources: parasites without identification is the
(i) Intestinal parasites; and correct detection of the presence or ab-
(ii) Blood and tissue parasites. sence of parasites without identifica-
(4) The program must provide at tion. The score is the number of cor-
least five samples per testing event rect responses divided by the number of
that include challenges that contain samples to be tested, multiplied by 100.
parasites and challenges that are de- (ii) The performance criterion for the
void of parasites. identification of parasites is the total
(b) Evaluation of a laboratory’s per- number of correct responses for para-
formance. HHS approves only those pro- site identification submitted by the
grams that assess the accuracy of a laboratory divided by the number of
laboratory’s responses in accordance parasites present plus the number of
with paragraphs (b)(1) through (6) of incorrect parasites reported by the lab-
this section. oratory multiplied by 100 to establish a
(1) The program determines the re- score for each sample in each testing
portable parasites to be detected by di- event. Since laboratories may incor-
rect parasite antigen detection, detec- rectly report the presence of parasites
tion of the presence or absence of in addition to the correctly identified
parasites without identification, and principal organism(s), the scoring sys-
identification of parasites. It may elect tem must provide a means of deducting
to establish a minimum number of credit for additional erroneous orga-
parasites to be identified in samples nisms that are reported and not found
before they are reported. Parasites in rare numbers by the program’s ref-
found in rare numbers by referee lab- erencing process. For example, if a
oratories are not considered in a lab- sample contained one principal orga-
oratory’s performance; such findings nism and the laboratory reported it
are neutral. To determine the accuracy correctly but reported the presence of
of a laboratory’s response, the program an additional organism, which was not
738
considered reportable, the sample or more of 10 or more referee labora-

grade would be 1/(1+1) × 100 = 50 per- tories or 80 percent or more of all par-
cent. ticipating laboratories. Both methods
(6) The score for a testing event is must be attempted before the program
the average of the sample scores as de- can choose to not grade a PT sample.
termined under paragraphs (b)(4) (2) A laboratory must detect and
through (5) of this section. identify the viruses to the highest level
[87 FR 41235, July 11, 2022] that the laboratory reports results on
patient specimens.
§ 493.919 Virology. (3) A laboratory’s performance will
(a) Program content and frequency of be evaluated on the basis of the aver-
challenge. To be approved for pro- age of its scores for paragraphs (b)(4)
ficiency testing for virology, a program through (5) of this section as deter-
must provide a minimum of five sam- mined in paragraph (b)(6) of this sec-
ples per testing event. There must be tion.
at least three testing events at ap- (4) The performance criterion viral
proximately equal intervals per year. antigen detection is the presence or ab-
The samples may be provided to the sence of the viral antigen. The score is
laboratory through mailed shipments. the number of correct responses di-
The specific organisms included in the vided by the number of samples to be
samples may vary from year to year. tested, multiplied by 100.
(1) The annual program must include, (5) The performance criterion for the
as applicable, samples for: detection and identification of viruses
(i) Viral antigen detection; and is the total number of correct re-
(ii) Detection and identification of sponses for viral detection and identi-
viruses. fication submitted by the laboratory
(2) An approved program must fur- divided by the number of viruses
nish HHS and its agents with a descrip- present plus the number of incorrect
tion of the samples it plans to include virus reported by the laboratory multi-
in its annual program no later than 6 plied by 100 to establish a score for
months before each calendar year. The each sample in each testing event.
program must include other important Since laboratories may incorrectly re-
emerging viruses and viruses com- port the presence of viruses in addition
monly occurring in patient specimens. to the correctly identified principal or-
(3) The content of an approved pro- ganism(s), the scoring system must
gram must vary over time, as appro- provide a means of deducting credit for
priate. If appropriate for the sample additional erroneous organisms that
sources, the types of viruses included are reported. For example, if a sample
annually must be representative of the contained one principal organism and
following major groups of medically the laboratory reported it correctly
important viruses: but reported the presence of an addi-
(i) Respiratory viruses; tional organism, which was not consid-
(ii) Herpes viruses; ered reportable, the sample grade
(iii) Enterovirus; and would be 1/(1+1) × 100 = 50 percent.
(iv) Intestinal viruses. (6) The score for a testing event is
(b) Evaluation of laboratory’s perform- the average of the sample scores as de-
ance. HHS approves only those pro- termined under paragraphs (b)(4) and
grams that assess the accuracy of a (5) of this section.
laboratory’s response in accordance
with paragraphs (b)(1) through (6) of [87 FR 41236, July 11, 2022]
this section.
(1) The program determines the vi- § 493.921 Diagnostic immunology.
ruses to be reported by direct viral The subspecialties under the spe-
antigen detection, and detection and cialty of immunology for which a pro-
identification of viruses. To determine gram may offer proficiency testing are
the accuracy of a laboratory’s re- syphilis serology and general immu-
sponse, the program must compare nology. Specific criteria for these sub-
each response with the response which specialties are found at §§ 493.923 and
reflects agreement of either 80 percent 493.927.
739
§ 493.923 42 CFR Ch. IV (10–1–24 Edition)
§ 493.923 Syphilis serology. reflects agreement of either 80 percent

(a) Program content and frequency of or more of 10 or more referee labora-
challenge. To be approved for pro- tories or 80 percent or more of all par-
ficiency testing for syphilis serology, a ticipating laboratories. Both methods
program must provide a minimum of must be attempted before the program
five samples per testing event. There can choose to not grade a PT sample.
must be at least three testing events at (2) For quantitative syphilis tests,
approximately equal intervals per year. the program must determine the cor-
The samples may be provided through rect response for each method by the
mailed shipments. An annual program distance of the response from the tar-
must include samples that cover the get value. After the target value has
full range of reactivity from highly re- been established for each response, the
active to non-reactive. appropriateness of the response must
(b) Evaluation of test performance. be determined by using fixed criteria.
HHS approves only those programs The criterion for acceptable perform-
that assess the accuracy of a labora- ance for quantitative syphilis serology
tory’s responses in accordance with tests is the target value ±1 dilution.
paragraphs (b)(1) through (4) of this (3) The criterion for acceptable per-
section. formance for qualitative syphilis serol-
(1) To determine the accuracy of a ogy tests is reactive or nonreactive.
laboratory’s response for qualitative (4) To determine the overall testing
and quantitative syphilis tests, the event score, the number of correct re-
program must compare the labora- sponses must be averaged using the fol-
tory’s response with the response that lowing formula:
Number of acceptable responses for all challenges

× 100 = Testing event score
Total numbber of all challenges
[57 FR 7151, Feb. 28, 1992, as amended at 58 TABLE 1 TO PARAGRAPH (b)—ANALYTE OR TEST
FR 5229, Jan. 19, 1993; 68 FR 3702, Jan. 24, PROCEDURE
2003; 87 FR 41236, July 11, 2022]
§ 493.927 General immunology. Alpha-l antitrypsin.

Alpha-fetoprotein (tumor marker).
(a) Program content and frequency of Antinuclear antibody.
challenge. To be approved for pro- Antistreptolysin O (ASO).
ficiency testing for immunology, the Anti-human immunodeficiency virus (HIV).
annual program must provide a min- Complement C3.
imum of five samples per testing event. Complement C4.
There must be at least three testing C-reactive protein (high sensitivity).
events at approximately equal inter- HBsAg.
vals per year. The annual program Anti-HBc.
must provide samples that cover the HBeAg.
full range of reactivity from highly re- Anti-HBs.
active to nonreactive. The samples Anti-HCV.
may be provided through mailed ship- IgA.
ments. IgG.
(b) Challenges per testing event. The IgE.
minimum number of challenges per IgM.
testing event the program must pro- Infectious mononucleosis.
vide for each analyte or test procedure Rheumatoid factor.
is five. Analytes or tests for which lab- Rubella.
oratory performance is to be evaluated
include: (c) Evaluation of a laboratory’s analyte
or test performance. HHS approves only
740
those programs that assess the accu- as indicating a positive response. Both
racy of a laboratory’s responses in ac- methods must be attempted before the
cordance with paragraphs (c)(1) program can choose to not grade a PT
through (5) of this section. sample.
(1) To determine the accuracy of a (2) For quantitative immunology
laboratory’s response for quantitative analytes or tests, the program must de-
and qualitative immunology tests or termine the correct response for each
analytes, the program must compare analyte by the distance of the response
the laboratory’s response for each
from the target value. After the target
analyte with the response that reflects
value has been established for each re-
agreement of either 80 percent or more
of 10 or more referee laboratories or 80 sponse, the appropriateness of the re-
percent or more of all participating sponse must be determined by using ei-
laboratories. The proficiency testing ther fixed criteria or the number of
program must indicate the minimum standard deviations (SDs) the response
concentration that will be considered differs from the target value.
TABLE 2 TO PARAGRAPH (c)(2)—CRITERIA FOR ACCEPTABLE PERFORMANCE

The criteria for acceptable performance are— Criteria for acceptable performance
Analyte or test
Alpha-1 antitrypsin .................................................. Target value ± 20%.

Alpha-fetoprotein (tumor marker) ............................ Target value ± 20%.
Antinuclear antibody (ANA) ..................................... Target value ±2 dilutions or positive or negative.
Antistreptolysin O .................................................... Target value ±2 dilutions or positive or negative.
Anti-Human Immunodeficiency virus (HIV) ............. Reactive (positive) or nonreactive (negative).
Complement C3 ...................................................... Target value ±15%.
Complement C4 ...................................................... Target value ±20% or ±5 mg/dL (greater).
C-reactive protein (HS) ........................................... Target value ±30% or ±1 mg/L (greater).
HBsAg ..................................................................... Reactive (positive) or nonreactive (negative).
Anti-HBc .................................................................. Reactive (positive) or nonreactive (negative).
HBeAg ..................................................................... Reactive (positive) or nonreactive (negative).
Anti-HBs .................................................................. Reactive (positive) or nonreactive (negative).
Anti-HCV ................................................................. Reactive (positive) or nonreactive (negative).
IgA ........................................................................... Target value ±20%.
IgE ........................................................................... Target value ±20%.
IgG ........................................................................... Target value ±20%.
IgM .......................................................................... Target value ±20%.
Infectious mononucleosis ........................................ Target value ±2 dilutions or positive or negative.
Rheumatoid factor ................................................... Target value ±2 dilutions or positive or negative.
Rubella .................................................................... Target value ±2 dilutions or positive or negative or immune or nonimmune.
(3) The criterion for acceptable per- (4) To determine the analyte testing
formance for qualitative general im- event score, the number of acceptable
munology tests is positive or negative. analyte responses must be averaged
using the following formula:
Number of acceptable responses for the analyte

× 100 = Analyte score for
Total number of challenges for the analyte the testing event
(5) To determine the overall testing sponses for all analytes must be aver-
event score, the number of correct re- aged using the following formula:

741
§ 493.929 42 CFR Ch. IV (10–1–24 Edition)
FR 5229, Jan. 19, 1993; 68 FR 3702, Jan. 24, PROCEDURE—Continued
2003; 87 FR 41237, July 11, 2022]
Glucose (Excluding measurements on de-
§ 493.929 Chemistry. vices cleared by FDA for home use).
The subspecialties under the spe- Hemoglobin A1c.
cialty of chemistry for which a pro- Iron, total.
ficiency testing program may offer pro- Lactate dehydrogenase (LDH).
ficiency testing are routine chemistry, Magnesium.
endocrinology, and toxicology. Specific Phosphorus.
criteria for these subspecialties are
Potassium.
listed in §§ 493.931 through 493.939.
Prostate specific antigen (PSA), total.
§ 493.931 Routine chemistry. Sodium.
(a) Program content and frequency of Total iron binding capacity (TIBC) (direct
challenge. To be approved for pro- measurement).
ficiency testing for routine chemistry, Total Protein.
a program must provide a minimum of Triglycerides.
five samples per testing event. There Troponin I.
must be at least three testing events at Troponin T.
approximately equal intervals per year. Urea Nitrogen.
The annual program must provide sam- Uric Acid.
ples that cover the clinically relevant
range of values that would be expected (c) Evaluation of a laboratory’s analyte
in patient specimens. The specimens or test performance. HHS approves only
may be provided through mailed ship-
those programs that assess the accu-
ments.
racy of a laboratory’s responses in ac-
(b) Challenges per testing event. The
cordance with paragraphs (c)(1)
minimum number of challenges per
testing event a program must provide through (5) of this section.
for each analyte or test procedure list- (1) To determine the accuracy of a
ed below is five serum, plasma or blood laboratory’s response for qualitative
samples. and quantitative chemistry tests or
analytes, the program must compare
TABLE 1 TO PARAGRAPH (b)—ANALYTE OR TEST the laboratory’s response for each
PROCEDURE analyte with the response that reflects
agreement of either 80 percent or more
Alanine aminotransferase (ALT/SGPT). of 10 or more referee laboratories or 80
Albumin. percent or more of all participating
Alkaline phosphatase. laboratories. Both methods must be at-
Amylase. tempted before the program can choose
Aspartate aminotransferase (AST/SGOT). to not grade a PT sample.
Bilirubin, total. (2) For quantitative chemistry tests
Blood gas (pH, pO2, and pCO2). or analytes, the program must deter-
B-natriuretic peptide (BNP). mine the correct response for each
proBNP. analyte by the distance of the response
Calcium, total. from the target value. After the target
Carbon dioxide. value has been established for each re-
Chloride. sponse, the appropriateness of the re-
Cholesterol, total. sponse must be determined by using ei-
Cholesterol, high density lipoprotein. ther fixed criteria based on the per-
Cholesterol, low density lipoprotein, (direct centage difference from the target
measurement).
value or the number of standard devi-
Creatine kinase (CK).
ations (SD) the response differs from
CK–MB isoenzymes.
the target value.
Creatinine.
Ferritin.
Gamma glutamyl transferase.
742

Analyte or test
Alanine aminotransferase (ALT/SGPT) .................. Target value ±15% or ±6 U/L (greater).

Albumin ................................................................... Target value ±8%.
Alkaline phosphatase .............................................. Target value ±20%.
Amylase ................................................................... Target value ±20%.
Aspartate aminotransferase (AST/SGOT) .............. Target value ±15% or ±6 U/L (greater).
Bilirubin, total ........................................................... Target value ±20% or ±0.4 mg/dL (greater).
Blood gas pCO2 ...................................................... Target value ±8% or ±5 mm Hg (greater).
Blood gas pO2 ........................................................ Target value ±15% or ±15 mmHg (greater).
Blood gas pH .......................................................... Target value ±0.04.
B-natriuretic peptide (BNP) ..................................... Target value ±30%.
Pro B-natriuretic peptide (proBNP) ......................... Target value ±30%.
Calcium, total .......................................................... Target value ±1.0 mg/dL.
Carbon dioxide ........................................................ Target value ±20%.
Chloride ................................................................... Target value ±5%.
Cholesterol, total ..................................................... Target value ±10%.
Cholesterol, high density lipoprotein (HDL) ............ Target value ±20% or ±6 mg/dL (greater).
Cholesterol, low density lipoprotein (LDL), direct Target value ±20%.
measurement.
Creatine kinase (CK) ............................................... Target value ±20%.
CK–MB isoenzymes ................................................ Target value ± 25% or ±3 ng/mL (greater) or MB elevated (presence or ab-
sence).
Creatinine ................................................................ Target value ±10% or ±0.2 mg/dL (greater).
Ferritin ..................................................................... Target value ±20%.
Gamma glutamyl transferase .................................. Target value ±15% or ±5 U/L (greater).
Glucose (excluding measurements devices Target value ±8% or ±6 mg/dL (greater).
cleared by FDA for home use.).
Hemoglobin A1c ...................................................... Target value ±8%.
Iron, total ................................................................. Target value ±15%.
Lactate dehydrogenase (LDH) ................................ Target value ±15%.
Magnesium .............................................................. Target value ±15%.
Phosphorus ............................................................. Target value ± 10% or ±0.3 mg/dL (greater).
Potassium ................................................................ Target value ±0.3 mmol/L.
Prostate Specific Antigen, total ............................... Target value ±20% or ±0.2 ng/mL (greater).
Sodium .................................................................... Target value ±4 mmol/L.
Total Iron Binding Capacity (TIBC). (direct meas- Target value ±20%.
urement).
Total Protein ............................................................ Target value ±8%.
Triglycerides ............................................................ Target value ±15%.
Troponin I ................................................................ Target value ± 30% or ±0.9 ng/mL (greater).
Troponin T ............................................................... Target value ±30% or ±0.2 ng/mL (greater).
Urea nitrogen .......................................................... Target value ±9% or ±2 mg/dL (greater).
Uric acid .................................................................. Target value ±10%.
formance for qualitative routine chem- event score, the number of acceptable
istry tests is positive or negative. analyte responses must be averaged


743
§ 493.933 42 CFR Ch. IV (10–1–24 Edition)
[57 FR 7151, Feb. 28, 1992, as amended at 68 TABLE 1 TO PARAGRAPH (b)—ANALYTE OR
FR 3702, Jan. 24, 2003; 87 FR 41238, July 11, TEST—Continued
2022]
Testosterone.
§ 493.933 Endocrinology. T3 Uptake.
(a) Program content and frequency of Triiodothyronine.
challenge. To be approved for pro- Thyroid-stimulating hormone.
ficiency testing for endocrinology, a Thyroxine.
program must provide a minimum of Vitamin B12.
five samples per testing event. There
must be at least three testing events at (c) Evaluation of a laboratory’s analyte
approximately equal intervals per year. or test performance. HHS approves only
The annual program must provide sam- those programs that assess the accu-
ples that cover the clinically relevant racy of a laboratory’s responses in ac-
range of values that would be expected cordance with paragraphs (c)(1)
in patient specimens. The samples may through (5) of this section.
be provided through mailed shipments. (1) To determine the accuracy of a
(b) Challenges per testing event. The laboratory’s response for qualitative
minimum number of challenges per and quantitative endocrinology tests
testing event a program must provide or analytes, a program must compare
for each analyte or test procedure is the laboratory’s response for each
five serum, plasma, blood, or urine analyte with the response that reflects
samples. agreement of either 80 percent or more
of 10 or more referee laboratories or 80
TABLE 1 TO PARAGRAPH (b)—ANALYTE OR TEST percent or more of all participating
laboratories. Both methods must be at-
Cancer antigen (CA) 125. tempted before the program can choose
Carcinoembryonic antigen (CEA). to not grade a PT sample.
Cortisol. (2) For quantitative endocrinology
Estradiol. tests or analytes, the program must de-
Folate, serum. termine the correct response for each
Follicle stimulating hormone. analyte by the distance of the response
Free thyroxine. from the target value. After the target
Human chorionic gonadotropin (HCG) (ex- value has been established for each re-
cluding urine pregnancy tests done by vis- sponse, the appropriateness of the re-
ual color comparison categorized as sponse must be determined by using ei-
waived tests). ther fixed criteria based on the per-
Luteinizing hormone. centage difference from the target
Parathyroid hormone. value or the number of standard devi-
Progesterone. ations (SDs) the response differs from
Prolactin. the target value.
TABLE 2 TO PARAGRAPH (c)(2)–CRITERIA FOR ACCEPTABLE PERFORMANCE
Analyte or test
Cancer antigen (CA) 125 ........................................ Target value ±20%.

Carcinoembryonic antigen (CEA) ........................... Target value ±15% or ±1 ng/mL (greater).
Cortisol .................................................................... Target value ±20%.
Estradiol .................................................................. Target value ±30%.
Folate, serum .......................................................... Target value ±30% or ±1 ng/mL (greater).
Follicle stimulating hormone ................................... Target value ±18% or ±2 IU/L (greater).
Free thyroxine ......................................................... Target value or ±15% or ±0.3 ng/dL (greater).
Human chorionic ..................................................... Target value ±18% or ±3
gonadotropin (excluding urine pregnancy tests mIU/mL (greater) or positive or negative.
done by visual color comparison categorized as
waived tests).
Luteinizing hormone ................................................ Target value ±20%.
Parathyroid hormone ............................................... Target value ±30%.
Progesterone ........................................................... Target value ±25%.
Prolactin .................................................................. Target value ±20%.
Testosterone ........................................................... Target value ±30% or ±20 ng/dL (greater).
T3 uptake ................................................................ Target value ±18%.
744
TABLE 2 TO PARAGRAPH (c)(2)–CRITERIA FOR ACCEPTABLE PERFORMANCE—Continued

Analyte or test
Triiodothyronine ....................................................... Target value ±30%.

Thyroid-stimulating hormone ................................... Target value ±20% or ±0.2 mIU/L (greater).
Thyroxine ................................................................. Target value ±20% or ±1.0 mcg/dL (greater).
Vitamin B12 ............................................................. Target value ±25% or ±30 pg/mL (greater).
formance for qualitative endocrinology event score, the number of acceptable
tests is positive or negative. analyte responses must be averaged


FR 5229, Jan. 19, 1993; 68 FR 3702, Jan. 24, PROCEDURE
2003; 87 FR 41239, July 11, 2022; 87 FR 68912,
Nov. 17, 2022]
Acetaminophen, serum.
§ 493.937 Toxicology. Alcohol (blood).
Blood lead.
(a) Program content and frequency of
Carbamazepine, total.
challenge. To be approved for pro-
ficiency testing for toxicology, the an- Digoxin, total.
nual program must provide a minimum Gentamicin.
of five samples per testing event. There Lithium.
must be at least three testing events at Phenobarbital.
approximately equal intervals per year. Phenytoin, total.
The annual program must provide sam- Salicylate.
ples that cover the full range of values Theophylline.
that could occur in patient specimens Tobramycin.
and that cover the level of clinical sig- Valproic Acid, total.
nificance for the particular drug. The Vancomycin.
samples may be provided through
mailed shipments. (c) Evaluation of a laboratory’s analyte
(b) Challenges per testing event. The or test performance. HHS approves only
minimum number of challenges per those programs that assess the accu-
testing event a program must provide racy of a laboratory’s responses in ac-
for each analyte or test procedure is cordance with paragraphs (c)(1)
five serum, plasma, or blood samples. through (4) of this section.
(1) To determine the accuracy of a
laboratory’s responses for quantitative
745
§ 493.941 42 CFR Ch. IV (10–1–24 Edition)
toxicology tests or analytes, the pro- (2) For quantitative toxicology tests
gram must compare the laboratory’s or analytes, the program must deter-
response for each analyte with the re- mine the correct response for each
sponse that reflects agreement of ei- analyte by the distance of the response
ther 80 percent or more of 10 or more from the target value. After the target
referee laboratories or 80 percent or value has been established for each re-
more of all participating laboratories. sponse, the appropriateness of the re-
Both methods must be attempted be- sponse must be determined by using
fore the program can choose to not fixed criteria based on the percentage
grade a PT sample. difference from the target value.
Analyte or test
Acetaminophen ....................................................... Target value ±15% or ±3 mcg/mL (greater).

Alcohol, blood .......................................................... Target Value ±20%.
Blood lead ............................................................... Target Value ±10% or ±2 mcg/dL (greater).
Carbamazepine, total .............................................. Target Value ±20% or ±1.0 mcg/mL (greater).
Digoxin, total ........................................................... Target Value ±15% or ± 0.2 ng/mL (greater).
Gentamicin .............................................................. Target Value ±25%.
Lithium ..................................................................... Target Value ±15% or ±0.3 mmol/L (greater).
Phenobarbital .......................................................... Target Value ±15% or ±2 mcg/mL (greater).
Phenytoin total ........................................................ Target Value ±15% or ± 2 mcg/mL (greater).
Salicylate ................................................................. Target Value ±15% or ±2 mcg/mL (greater).
Theophylline ............................................................ Target Value ±20%.
Tobramycin .............................................................. Target Value ±20%.
Valproic Acid, total .................................................. Target Value ±20%.
Vancomycin ............................................................. Target Value ±15% or ±2 mcg/mL (greater).
(3) To determine the analyte testing analyte responses must be averaged

event score, the number of acceptable using the following formula:


[57 FR 7151, Feb. 28, 1992, as amended at 58 be at least three testing events at ap-
FR 5229, Jan. 19, 1993; 68 FR 3702, Jan. 24, proximately equal intervals per year.
2003; 87 FR 41240, July 11, 2022] The annual program must provide sam-
ples that cover the full range of values
§ 493.941 Hematology (including rou-
tine hematology and coagulation). that would be expected in patient
specimens. The samples may be pro-
(a) Program content and frequency of vided through mailed shipments.
challenge. To be approved for pro- (b) Challenges per testing event. The
ficiency testing for hematology, a pro- minimum number of challenges per
gram must provide a minimum of five testing event a program must provide
samples per testing event. There must
746
for each analyte or test procedure is (1) To determine the accuracy of a

five. laboratory’s responses for qualitative
and quantitative hematology tests or
TABLE 1 TO PARAGRAPH (b)—ANALYTE OR TEST analytes, the program must compare
PROCEDURE the laboratory’s response for each
analyte with the response that reflects
Cell identification. agreement of either 80 percent or more
White blood cell differential. of 10 or more referee laboratories or 80
Erythrocyte count. percent or more of all participating
Hematocrit (excluding spun microhematocrit). laboratories. Both methods must be at-
tempted before the program can choose
Hemoglobin.
to not grade a PT sample.
Leukocyte count.
(2) For quantitative hematology tests
Platelet count. or analytes, the program must deter-
Fibrinogen. mine the correct response for each
Partial thromboplastin time. analyte by the distance of the response
Prothrombin time (seconds or INR). from the target value. After the target
value has been established for each re-
(c) Evaluation of a laboratory’s analyte sponse, the appropriateness of the re-
or test performance. HHS approves only sponse is determined using either fixed
those programs that assess the accu- criteria based on the percentage dif-
racy of a laboratory’s responses in ac- ference from the target value or the
cordance with paragraphs (c) (1) number of standard deviations (SD) the
through (5) of this section. response differs from the target value.
The criteria for acceptable performance are: Criteria for acceptable performance
Analyte or test
Cell identification ..................................................... 80% or greater consensus on identification.

White blood cell differential ..................................... Target ±3SD based on the percentage of different types of white blood cells
in the samples.
Erythrocyte count .................................................... Target ±4%.
Hematocrit (Excluding spun hematocrit) ................. Target ±4%.
Hemoglobin ............................................................. Target ±4%.
Leukocyte count ...................................................... Target ±10%.
Platelet count .......................................................... Target ±25%.
Fibrinogen ............................................................... Target ±20%.
Partial thromboplastin time ..................................... Target ±15%.
If a laboratory reports a prothrombin time in both INR and seconds, the INR should be reported to the PT provider program.
Prothrombin time (seconds or INR) ........................ Target ±15%.
formance for the qualitative hema- event score, the number of acceptable
tology test is correct cell identifica- analyte responses must be averaged
tion. using the following formula:

747
§ 493.945 42 CFR Ch. IV (10–1–24 Edition)

[57 FR 7151, Feb. 28, 1992, as amended at 58 challenge (slide), the program must
FR 5229, Jan. 19, 1993; 68 FR 3702, Jan. 24, compare the individual’s response for
2003; 87 FR 41241, July 11, 2022] each slide preparation with the re-
sponse that reflects the predetermined
§ 493.945 Cytology; gynecologic exami-
nations. consensus agreement or confirmation
on the diagnostic category, as de-
(a) Program content and frequency of scribed in the table in paragraph
challenge. (1) To be approved for pro- (b)(3)(ii)(A) of this section. For all slide
ficiency testing for gynecologic exami- preparations, a 100% consensus agree-
nations (Pap smears) in cytology, a ment among a minimum of three phy-
program must provide test sets com- sicians certified in anatomic pathology
posed of 10- and 20-glass slides. Pro- is required. In addition, for
ficiency testing programs may obtain premalignant and malignant slide
slides for test sets from cytology lab- preparations, confirmation by tissue
oratories, provided the slides have been biopsy is required either by comparison
retained by the laboratory for the re- of the reported biopsy results or re-
quired period specified in evaluation of biopsy slide material by
§§ 493.1105(a)(7)(i)(A) and 493.1274(f)(2). If a physician certified in anatomic pa-
slide preparations are still subject to thology.
retention by the laboratory, they may (2) An individual qualified as a tech-
be loaned to a proficiency testing pro- nical supervisor under § 493.1449 (b) or
gram if the program provides the lab- (k) who routinely interprets
oratory with documentation of the gynecologic slide preparations only
loan of the slides and ensures that after they have been examined by a
slides loaned to it are retrievable upon cytotechnologist can either be tested
request. Each test set must include at using a test set that has been screened
least one slide representing each of the by a cytotechnologist in the same lab-
response categories described in para- oratory or using a test set that has not
graph (b)(3)(ii)(A) of this section, and been screened. A technical supervisor
test sets should be comparable so that who screens and interprets slide prep-
equitable testing is achieved within arations that have not been previously
and between proficiency testing pro- examined must be tested using a test
viders. set that has not been previously
(2) To be approved for proficiency screened.
testing in gynecologic cytology, a pro- (3) The criteria for acceptable per-
gram must provide announced and un- formance are determined by using the
announced on-site testing for each in- scoring system in paragraphs (b)(3) (i)
dividual at least once per year and and (ii) of this section.
must provide an initial retesting event (i) Each slide set must contain 10 or
for each individual within 45 days after 20 slides with point values established
notification of test failure and subse- for each slide preparation based on the
quent retesting events within 45 days significance of the relationship of the
after completion of remedial action de- interpretation of the slide to a clinical
scribed in § 493.855. condition and whether the participant
(b) Evaluation of an individual’s per- in the testing event is a
formance. HHS approves only those pro- cytotechnologist qualified under
grams that assess the accuracy of each § 493.1469 or § 493.1483 or functioning as a
individual’s responses on both 10- and technical supervisor in cytology quali-
20-slide test sets in which the slides fied under § 493.1449 (b) or (k) of this
have been referenced as specified in part.
paragraph (b)(1) of this section. (ii) The scoring system rewards or pe-
(1) To determine the accuracy of an nalizes the participants in proportion
individual’s response on a particular to the distance of their answers from
748
the correct response or target diag- the point value achieved for each slide
nosis and the penalty or reward is preparation, dividing by the total
weighted in proportion to the severity points for the testing event and multi-
of the lesion. plying by 100.
(A) The four response categories for (C) Criteria for scoring system for a
reporting proficiency testing results 10-slide test set. (See table at
and their descriptions are as follows: (b)(3)(ii)(A) of this section for a de-
scription of the response categories.)
Category Description For technical supervisors qualified
under § 493.1449(b) or (k):
A ............... Unsatisfactory for diagnosis due to:
(1) Scant cellularity. Examinee’s response: A B C D
(2) Air drying.
(3) Obscuring material (blood, inflam- Correct response category:
matory cells, or lubricant). A ................................................. 10 0 0 0
B ............... Normal or Benign Changes—includes: B ................................................. 5 10 0 0
(1) Normal, negative or within normal C ................................................. 5 0 10 5
limits. D ................................................. 0 ¥5 5 10
(2) Infection other than Human
Papillomavirus (HPV) (e.g., (D) Criteria for scoring system for a
Trichomonas vaginalis, changes or 10-slide test set. (See table at para-
morphology consistent with Candida graph (b)(3)(ii)(A) of this section for a
spp., Actinomyces spp. or Herpes description of the response categories.)
simplex virus). For cytotechnologists qualified under
(3) Reactive and reparative changes
(e.g., inflammation, effects of chem-
§ 493.1469 or § 493.1483:
otherapy or radiation). Examinee’s response: A B C D
C ............... Low Grade Squamous Intraepithelial
Lesion—includes: Correct response category:
(1) Cellular changes associated with A ................................................. 10 0 5 5
HPV. B ................................................. 5 10 5 5
(2) Mild dysplasia/CIN–1. C ................................................. 5 0 10 10
D ............... High Grade Lesion and Carcinoma— D ................................................. 0 ¥5 10 10
includes:
(1) High grade squamous (E) In accordance with the criteria
intraepithelial lesions which include for the scoring system, the charts in
moderate dysplasia/CIN–2 and se- paragraphs (b)(3)(ii)(F) and (G) of this
vere dysplasia/carcinoma in-situ/ section, for technical supervisors and
CIN–3. cytotechnologists, respectively, pro-
(2) Squamous cell carcinoma.
(3) Adenocarcinoma and other malig-
vide maximums of 5 points for a cor-
nant neoplasms. rect response and minus ten (¥10)
points for an incorrect response on a
(B) In accordance with the criteria 20-slide test set.
for the scoring system, the charts in (F) Criteria for scoring system for a
paragraphs (b)(3)(ii)(C) and (D) of this 20-slide test set. (See table at para-
section, for technical supervisors and graph (b)(3)(ii)(A) of this section for a
cytotechnologists, respectively, pro- description of the response categories.)
vide a maximum of 10 points for a cor- For technical supervisors qualified
rect response and a maximum of minus under § 493.1449(b) or (k):
five (¥5) points for an incorrect re- Examinee’s response: A B C D
sponse on a 10-slide test set. For exam-
ple, if the correct response on a slide is Correct response category:
A ........................................... 5 0 0 0
‘‘high grade squamous intraepithelial B ........................................... 2.5 5 0 0
lesion’’ (category ‘‘D’’ on the scoring C .......................................... 2.5 0 5 2.5
system chart) and an examinee calls it D .......................................... 0 ¥10 2.5 5
‘‘normal or negative’’ (category ‘‘B’’ on
the scoring system chart), then the (G) Criteria for scoring system for a
examinee’s point value on that slide is 20-slide test set. (See table at
calculated as minus five (¥5). Each (b)(3)(ii)(A) of this section for a de-
slide is scored individually in the same scription of the response categories.)
manner. The individual’s score for the For cytotechnologists qualified under
testing event is determined by adding § 493.1469 or § 493.1483:
749
Examinee’s response: A B C D § 493.959 Immunohematology.

Correct response category: (a) Types of services offered by labora-
A ......................................... 5 0 2.5 2.5 tories. In immunohematology, there are
B ......................................... 2.5 5 2.5 2.5 four types of laboratories for pro-
C ......................................... 2.5 0 5 5
D ......................................... 0 ¥10 5 5
ficiency testing purposes—
(1) Those that perform ABO group
and/or D (Rho) typing;
[57 FR 7151, Feb. 28, 1992, as amended at 58 (2) Those that perform ABO group
FR 5229, Jan. 19, 1993; 68 FR 3702, Jan. 24, and/or D (Rho) typing, and unexpected
2003]
antibody detection;
EFFECTIVE DATE NOTE: At 88 FR 90038, Dec. (3) Those that in addition to para-
28, 2023, § 493.945 was amended by revising graph (a)(2) of this section perform
paragraphs (b)(2), (b)(3)(i), (b)(3)(ii)(C) intro- compatibility testing; and
ductory text, and (b)(3)(ii)(F) introductory (4) Those that perform in addition to
text, effective Dec. 28, 2024. For the conven-
paragraph (a)(3) of this section anti-
ience of the user, the revised text is set forth
as follows:
body identification.
(b) Program content and frequency of
§ 493.945 Cytology; gynecologic examina- challenge. To be approved for pro-
tions. ficiency testing for
immunohematology, a program must
* * * * * provide a minimum of five samples per
testing event. There must be at least
(b) * * *
(2) An individual qualified as a technical
three testing events at approximately
supervisor under § 493.1449(b) or (e) who rou- equal intervals per year. The annual
tinely interprets gynecologic slide prepara- program must provide samples that
tions only after they have been examined by cover the full range of interpretation
a cytotechnologist can either be tested using that would be expected in patient
a test set that has been screened by a specimens. The samples may be pro-
cytotechnologist in the same laboratory or vided through mailed shipments.
using a test set that has not been screened. (c) Challenges per testing event. The
A technical supervisor who screens and in- minimum number of challenges per
terprets slide preparations that have not
been previously examined must be tested
testing event a program must provide
using a test set that has not been previously for each analyte or test procedure is
screened. five.
(3) * * *
Analyte or Test Procedure
(i) Each slide set must contain 10 or 20
slides with point values established for each ABO group (excluding subgroups)
slide preparation based on the significance of D (Rho) typing
the relationship of the interpretation of the Unexpected antibody detection
slide to a clinical condition and whether the Compatibility testing
participant in the testing event is a Antibody identification
cytotechnologist qualified under § 493.1469 or
§ 493.1483 or functioning as a technical super- (d) Evaluation of a laboratory’s analyte
visor in cytology qualified under § 493.1449(b) or test performance. HHS approves only
or (e) of this part. those programs that assess the accu-
(ii) * * * racy of a laboratory’s response in ac-
(C) Criteria for scoring system for a 10- cordance with paragraphs (d)(1)
slide test set. (See table at paragraph through (5) of this section.
(b)(3)(ii)(A) of this section for a description (1) To determine the accuracy of a
of the response categories.) For technical su- laboratory’s response, a program must
pervisors qualified under § 493.1449(b) or (e):
compare the laboratory’s response for
each analyte with the response that re-
* * * * * flects agreement of either 100 percent
(F) Criteria for scoring system for a 20- of 10 or more referee laboratories or 95
slide test set. (See table at paragraph percent or more of all participating
(b)(3)(ii)(A) of this section for a description laboratories except for antibody identi-
of the response categories.) For technical su- fication. To determine the accuracy of
pervisors qualified under § 493.1449(b) or (e): a laboratory’s response for antibody
identification, a program must com-
* * * * * pare the laboratory’s response for each
750
analyte with the response that reflects tempted before the program can choose
agreement of either 95 percent or more to not grade a PT sample.
of 10 or more referee laboratories or 95 (2) Criteria for acceptable performance.
percent or more of all participating The criteria for acceptable perform-
laboratories. Both methods must be at- ance are—
TABLE 2 TO PARAGRAPH (d)(2)—CRITERIA FOR ACCEPTABLE PERFORMANCE
Analyte or test Criteria for acceptable performance
ABO group .............................................................. 100% accuracy.

D (Rho) typing ......................................................... 100% accuracy.
Unexpected antibody detection ............................... 100% accuracy.
Compatibility testing ................................................ 100% accuracy.
Antibody identification ............................................. 80%+ accuracy.
formance for qualitative event score, the number of acceptable
immunohematology tests is positive or analyte responses must be averaged
negative. using the following formula:


[57 FR 7151, Feb. 28, 1992, as amended at 87 chapter, each laboratory that performs
FR 41242, July 11, 2022] a test that is intended to detect SARS–
CoV–2 or to diagnose a possible case of
Subpart J—Facility Administration COVID–19 (hereinafter referred to as a
for Nonwaived Testing ‘‘SARS–CoV–2 test’’) must report
SARS–CoV–2 test results to the Sec-
SOURCE: 68 FR 3703, Jan. 24, 2003, unless retary in such form and manner, and at
otherwise noted. such timing and frequency, as the Sec-
retary may prescribe.
§ 493.1100 Condition: Facility adminis-
tration. (b) [Reserved]
Each laboratory that performs non- [68 FR 3703, Jan. 24, 2003, as amended at 85
waived testing must meet the applica- FR 54873, Sept. 2, 2020]
ble requirements under §§ 493.1101
through 493.1105, unless HHS approves a § 493.1101 Standard: Facilities.
procedure that provides equivalent (a) The laboratory must be con-
quality testing as specified in Appendix structed, arranged, and maintained to
C of the State Operations Manual (CMS ensure the following:
Pub. 7). (1) The space, ventilation, and utili-
(a) Reporting of SARS–CoV–2 test re- ties necessary for conducting all phases
sults. During the Public Health Emer- of the testing process.
gency, as defined in § 400.200 of this
751
§ 493.1103 42 CFR Ch. IV (10–1–24 Edition)
(2) Contamination of patient speci- (2) The facility must establish and
mens, equipment, instruments, re- follow policies to ensure positive iden-
agents, materials, and supplies is mini- tification of a blood or blood product
mized. beneficiary.
(3) Molecular amplification proce- (d) Investigation of transfusion reac-
dures that are not contained in closed tions. The facility must have proce-
systems have a uni-directional dures for preventing transfusion reac-
workflow. This must include separate tions and when necessary, promptly
areas for specimen preparation, ampli- identify, investigate, and report blood
fication and product detection, and, as and blood product transfusion reac-
applicable, reagent preparation. tions to the laboratory and, as appro-
(b) The laboratory must have appropriate, to Federal and State authori-
priate and sufficient equipment, instru- ties.
ments, reagents, materials, and sup-
plies for the type and volume of testing § 493.1105 Standard: Retention re-
it performs. quirements.
(c) The laboratory must be in compli- (a) The laboratory must retain its
ance with applicable Federal, State, records and, as applicable, slides,
and local laboratory requirements. blocks, and tissues as follows:
(d) Safety procedures must be estab- (1) Test requisitions and authorizations.
lished, accessible, and observed to en- Retain records of test requisitions and
sure protection from physical, chem- test authorizations, including the pa-
ical, biochemical, and electrical haz- tient’s chart or medical record if used
ards, and biohazardous materials. as the test requisition or authoriza-
(e) Records and, as applicable, slides, tion, for at least 2 years.
blocks, and tissues must be maintained
(2) Test procedures. Retain a copy of
and stored under conditions that en-
each test procedure for at least 2 years
sure proper preservation.
after a procedure has been discon-
§ 493.1103 Standard: Requirements for tinued. Each test procedure must in-
transfusion services. clude the dates of initial use and dis-
continuance.
A facility that provides transfusion
services must meet all of the require- (3) Analytic systems records. Retain
ments of this section and document all quality control and patient test
transfusion-related activities. records (including instrument print-
(a) Arrangement for services. The facil- outs, if applicable) and records docu-
ity must have a transfusion service menting all analytic systems activities
specified in §§ 493.1252 through 493.1289
agreement reviewed and approved by
for at least 2 years. In addition, retain
the responsible party(ies) that govern
the following:
the procurement, transfer, and avail-
ability of blood and blood products. (i) Records of test system perform-
(b) Provision of testing. The facility ance specifications that the laboratory
must provide prompt ABO grouping, establishes or verifies under § 493.1253
D(Rho) typing, unexpected antibody for the period of time the laboratory
detection, compatibility testing, and uses the test system but no less than 2
laboratory investigation of transfusion years.
reactions on a continuous basis (ii) Immunohematology records,
through a CLIA-certified laboratory or blood and blood product records, and
a laboratory meeting equivalent re- transfusion records as specified in 21
quirements as determined by CMS. CFR 606.160(b)(3)(ii), (b)(3)(iv), (b)(3)(v)
(c) Blood and blood products storage and (d).
and distribution. (1) If a facility stores (4) Proficiency testing records. Retain
or maintains blood or blood products all proficiency testing records for at
for transfusion outside of a monitored least 2 years.
refrigerator, the facility must ensure (5) Quality system assessment records.
the storage conditions, including tem- Retain all laboratory quality systems
perature, are appropriate to prevent assessment records for at least 2 years.
deterioration of the blood or blood (6) Test reports. Retain or be able to
product. retrieve a copy of the original report
752
(including final, preliminary, and cor- must be appropriate for the specialties
rected reports) at least 2 years after and subspecialties of testing the lab-
the date of reporting. In addition, re- oratory performs, services it offers, and
tain the following: clients it serves.
(i) Immunohematology reports as
specified in 21 CFR 606.160(d). [68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22,
2003]
(ii) Pathology test reports for at
least 10 years after the date of report- § 493.1201 Condition: Bacteriology.
ing.
(7) Slide, block, and tissue retention—(i) If the laboratory provides services in
Slides. (A) Retain cytology slide prep- the subspecialty of Bacteriology, the
arations for at least 5 years from the laboratory must meet the require-
date of examination (see § 493.1274(f) for ments specified in §§ 493.1230 through
proficiency testing exception). 493.1256, § 493.1261, and §§ 493.1281
(B) Retain histopathology slides for through 493.1299.
at least 10 years from the date of exam-
ination. § 493.1202 Condition:
(ii) Blocks. Retain pathology speci- Mycobacteriology.
men blocks for at least 2 years from If the laboratory provides services in
the date of examination. the subspecialty of Mycobacteriology,
(iii) Tissue. Preserve remnants of tis- the laboratory must meet the require-
sue for pathology examination until a ments specified in §§ 493.1230 through
diagnosis is made on the specimen.
493.1256, § 493.1262, and §§ 493.1281
(b) If the laboratory ceases operation,
through 493.1299.
the laboratory must make provisions
to ensure that all records and, as appli- § 493.1203 Condition: Mycology.
cable, slides, blocks, and tissue are re-
tained and available for the time If the laboratory provides services in
frames specified in this section. the subspecialty of Mycology, the lab-
oratory must meet the requirements
[68 FR 3703, Jan. 24, 2003; 68 FR 50723, Aug. 22,
specified in §§ 493.1230 through 493.1256,
2003]
§ 493.1263, and §§ 493.1281 through
493.1299.
Subpart K—Quality System for
Nonwaived Testing § 493.1204 Condition: Parasitology.
If the laboratory provides services in
SOURCE: 68 FR 3703, Jan. 24, 2003, unless
the subspecialty of Parasitology, the
otherwise noted.
laboratory must meet the require-
§ 493.1200 Introduction. ments specified in §§ 493.1230 through
493.1256, § 493.1264, and §§ 493.1281
(a) Each laboratory that performs
nonwaived testing must establish and through 493.1299.
maintain written policies and proce- § 493.1205 Condition: Virology.
dures that implement and monitor a
quality system for all phases of the If the laboratory provides services in
total testing process (that is, the subspecialty of Virology, the lab-
preanalytic, analytic, and oratory must meet the requirements
postanalytic) as well as general labora- specified in §§ 493.1230 through 493.1256,
tory systems. § 493.1265, and §§ 493.1281 through
(b) The laboratory’s quality systems 493.1299.
must include a quality assessment
component that ensures continuous § 493.1207 Condition: Syphilis serology.
improvement of the laboratory’s per- If the laboratory provides services in
formance and services through ongoing the subspecialty of Syphilis serology,
monitoring that identifies, evaluates
the laboratory must meet the require-
and resolves problems.
ments specified in §§ 493.1230 through
(c) The various components of the
493.1256, and §§ 493.1281 through 493.1299.
laboratory’s quality system are used to
meet the requirements in this part and
753
§ 493.1208 42 CFR Ch. IV (10–1–24 Edition)
§ 493.1208 Condition: General immu- the laboratory must meet the require-
nology. ments specified in §§ 493.1230 through
If the laboratory provides services in 493.1256, § 493.1271, and §§ 493.1281
the subspecialty of General immu- through 493.1299.
nology, the laboratory must meet the
requirements specified in §§ 493.1230 § 493.1219 Condition: Histopathology.
through 493.1256, and §§ 493.1281 through If the laboratory provides services in
493.1299. the subspecialty of Histopathology, the
[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22, laboratory must meet the require-
2003] ments specified in §§ 493.1230 through
493.1256, § 493.1273, and §§ 493.1281
§ 493.1210 Condition: Routine chem- through 493.1299.
istry.
If the laboratory provides services in § 493.1220 Condition: Oral pathology.
the subspecialty of Routine chemistry, If the laboratory provides services in
the laboratory must meet the require- the subspecialty of Oral pathology, the
ments specified in §§ 493.1230 through laboratory must meet the require-
493.1256, § 493.1267, and §§ 493.1281 ments specified in §§ 493.1230 through
through 493.1299. 493.1256, and §§ 493.1281 through 493.1299.
§ 493.1211 Condition: Urinalysis. § 493.1221 Condition: Cytology.
If the laboratory provides services in If the laboratory provides services in
the subspecialty of Urinalysis, the lab- the subspecialty of Cytology, the lab-
oratory must meet the requirements oratory must meet the requirements
specified in §§ 493.1230 through 493.1256, specified in §§ 493.1230 through 493.1256,
and §§ 493.1281 through 493.1299. § 493.1274, and §§ 493.1281 through
§ 493.1212 Condition: Endocrinology. 493.1299.
If the laboratory provides services in § 493.1225 Condition: Clinical cyto-
the subspecialty of Endocrinology, the genetics.
laboratory must meet the require-
ments specified in §§ 493.1230 through
the specialty of Clinical cytogenetics,
493.1256, and §§ 493.1281 through 493.1299.
the laboratory must meet the require-
§ 493.1213 Condition: Toxicology. ments specified in §§ 493.1230 through
493.1256, § 493.1276, and §§ 493.1281
through 493.1299.
the subspecialty of Toxicology, the lab-
oratory must meet the requirements § 493.1226 Condition: Radiobioassay.
specified in §§ 493.1230 through 493.1256,
and §§ 493.1281 through 493.1299. If the laboratory provides services in
the specialty of Radiobioassay, the lab-
§ 493.1215 Condition: Hematology. oratory must meet the requirements
If the laboratory provides services in specified in §§ 493.1230 through 493.1256,
the specialty of Hematology, the lab- and §§ 493.1281 through 493.1299.
oratory must meet the requirements
specified in §§ 493.1230 through 493.1256, § 493.1227 Condition:
Histocompatibility.
§ 493.1269, and §§ 493.1281 through
493.1299. If the laboratory provides services in
the specialty of Histocompatibility,
§ 493.1217 Condition: the laboratory must meet the require-
Immunohematology. ments specified in §§ 493.1230 through
If the laboratory provides services in 493.1256, § 493.1278, and §§ 493.1281
the specialty of Immunohematology, through 493.1299.
754
GENERAL LABORATORY SYSTEMS § 493.1235 Standard: Personnel com-

petency assessment policies.
§ 493.1230 Condition: General labora- As specified in the personnel require-
tory systems.
ments in subpart M, the laboratory
Each laboratory that performs non- must establish and follow written poli-
waived testing must meet the applica- cies and procedures to assess employee
ble general laboratory systems require- and, if applicable, consultant com-
ments in §§ 493.1231 through 493.1236, un- petency.
less HHS approves a procedure, speci-
fied in Appendix C of the State Oper- § 493.1236 Standard: Evaluation of pro-
ficiency testing performance.
ations Manual (CMS Pub. 7), that pro-
vides equivalent quality testing. The (a) The laboratory must review and
laboratory must monitor and evaluate evaluate the results obtained on pro-
the overall quality of the general lab- ficiency testing performed as specified
in subpart H of this part.
oratory systems and correct identified
(b) The laboratory must verify the
problems as specified in § 493.1239 for
accuracy of the following:
each specialty and subspecialty of test- (1) Any analyte or subspecialty with-
ing performed. out analytes listed in subpart I of this
part that is not evaluated or scored by
§ 493.1231 Standard: Confidentiality of
patient information. a CMS-approved proficiency testing
program.
The laboratory must ensure confiden- (2) Any analyte, specialty or sub-
tiality of patient information through- specialty assigned a proficiency testing
out all phases of the total testing proc- score that does not reflect laboratory
ess that are under the laboratory’s contest performance (that is, when the
trol. proficiency testing program does not
obtain the agreement required for scor-
§ 493.1232 Standard: Specimen identi- ing as specified in subpart I of this
fication and integrity. part, or the laboratory receives a zero
The laboratory must establish and score for nonparticipation, or late re-
follow written policies and procedures turn of results).
that ensure positive identification and (c) At least twice annually, the lab-
optimum integrity of a patient’s speci- oratory must verify the accuracy of
the following:
men from the time of collection or re-
(1) Any test or procedure it performs
ceipt of the specimen through comple-
that is not included in subpart I of this
tion of testing and reporting of results. part.
(2) Any test or procedure listed in
§ 493.1233 Standard: Complaint inves-
tigations. subpart I of this part for which com-
patible proficiency testing samples are
The laboratory must have a system not offered by a CMS-approved pro-
in place to ensure that it documents all ficiency testing program.
complaints and problems reported to (d) All proficiency testing evaluation
the laboratory. The laboratory must and verification activities must be doc-
conduct investigations of complaints, umented.
when appropriate.
§ 493.1239 Standard: General labora-
§ 493.1234 Standard: Communications. tory systems quality assessment.
The laboratory must have a system (a) The laboratory must establish
in place to identify and document prob- and follow written policies and proce-
dures for an ongoing mechanism to
lems that occur as a result of a break-
monitor, assess, and, when indicated,
down in communication between the
correct problems identified in the gen-
laboratory and an authorized person eral laboratory systems requirements
who orders or receives test results. specified at §§ 493.1231 through 493.1236.
[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22, (b) The general laboratory systems
2003] quality assessment must include a re-
view of the effectiveness of corrective
755
§ 493.1240 42 CFR Ch. IV (10–1–24 Edition)
actions taken to resolve problems, re- (4) The test(s) to be performed.

vision of policies and procedures nec- (5) The source of the specimen, when
essary to prevent recurrence of prob- appropriate.
lems, and discussion of general labora- (6) The date and, if appropriate, time
tory systems quality assessment re- of specimen collection.
views with appropriate staff. (7) For Pap smears, the patient’s last
(c) The laboratory must document all menstrual period, and indication of
general laboratory systems quality as- whether the patient had a previous ab-
sessment activities. normal report, treatment, or biopsy.
[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22,
(8) Any additional information rel-
2003] evant and necessary for a specific test
to ensure accurate and timely testing
PREANALYTIC SYSTEMS and reporting of results, including in-
terpretation, if applicable.
§ 493.1240 Condition: Preanalytic sys- (d) The patient’s chart or medical
tems. record may be used as the test requisi-
Each laboratory that performs non- tion or authorization but must be
waived testing must meet the applica- available to the laboratory at the time
ble preanalytic system(s) requirements of testing and available to CMS or a
in §§ 493.1241 and 493.1242, unless HHS CMS agent upon request.
approves a procedure, specified in Ap- (e) If the laboratory transcribes or
pendix C of the State Operations Man- enters test requisition or authorization
ual (CMS Pub. 7), that provides equiva- information into a record system or a
lent quality testing. The laboratory laboratory information system, the
must monitor and evaluate the overall laboratory must ensure the informa-
quality of the preanalytic systems and tion is transcribed or entered accu-
correct identified problems as specified rately.
in § 493.1249 for each specialty and sub-
specialty of testing performed. § 493.1242 Standard: Specimen submis-
sion, handling, and referral.
§ 493.1241 Standard: Test request. (a) The laboratory must establish
(a) The laboratory must have a writ- and follow written policies and proce-
ten or electronic request for patient dures for each of the following, if appli-
testing from an authorized person. cable:
(b) The laboratory may accept oral (1) Patient preparation.
requests for laboratory tests if it solic- (2) Specimen collection.
its a written or electronic authoriza- (3) Specimen labeling, including pa-
tion within 30 days of the oral request tient name or unique patient identifier
and maintains the authorization or and, when appropriate, specimen
documentation of its efforts to obtain source.
the authorization. (4) Specimen storage and preserva-
(c) The laboratory must ensure the tion.
test requisition solicits the following (5) Conditions for specimen transpor-
information: tation.
(1) The name and address or other (6) Specimen processing.
suitable identifiers of the authorized (7) Specimen acceptability and rejec-
person requesting the test and, if ap- tion.
propriate, the individual responsible (8) Specimen referral.
for using the test results, or the name (b) The laboratory must document
and address of the laboratory submit- the date and time it receives a speci-
ting the specimen, including, as appli- men.
cable, a contact person to enable the (c) The laboratory must refer a speci-
reporting of imminently life threat- men for testing only to a CLIA-cer-
ening laboratory results or panic or tified laboratory or a laboratory meet-
alert values. ing equivalent requirements as deter-
(2) The patient’s name or unique pa- mined by CMS.
tient identifier. (d) If the laboratory accepts a refer-
(3) The sex and age or date of birth of ral specimen, written instructions
the patient. must be available to the laboratory’s
756
clients and must include, as appro- (1) Requirements for patient prepara-
priate, the information specified in tion; specimen collection, labeling,
paragraphs (a)(1) through (a)(7) of this storage, preservation, transportation,
section. processing, and referral; and criteria
for specimen acceptability and rejec-
§ 493.1249 Standard: Preanalytic sys-
tems quality assessment. tion as described in § 493.1242.
(2) Microscopic examination, includ-
(a) The laboratory must establish ing the detection of inadequately pre-
and follow written policies and proce-
pared slides.
dures for an ongoing mechanism to
(3) Step-by-step performance of the
monitor, assess, and when indicated,
correct problems identified in the procedure, including test calculations
preanalytic systems specified at and interpretation of results.
§§ 493.1241 through 493.1242. (4) Preparation of slides, solutions,
(b) The preanalytic systems quality calibrators, controls, reagents, stains,
assessment must include a review of and other materials used in testing.
the effectiveness of corrective actions (5) Calibration and calibration
taken to resolve problems, revision of verification procedures.
policies and procedures necessary to (6) The reportable range for test re-
prevent recurrence of problems, and sults for the test system as established
discussion of preanalytic systems qual- or verified in § 493.1253.
ity assessment reviews with appro- (7) Control procedures.
priate staff. (8) Corrective action to take when
(c) The laboratory must document all calibration or control results fail to
preanalytic systems quality assess- meet the laboratory’s criteria for ac-
ment activities.
ceptability.
[68 FR 3703, Jan. 24, 2003; 68 FR 3703, Aug. 22, (9) Limitations in the test method-
2003] ology, including interfering substances.
ANALYTIC SYSTEMS (10) Reference intervals (normal val-
ues).
§ 493.1250 Condition: Analytic systems. (11) Imminently life-threatening test
Each laboratory that performs non- results, or panic or alert values.
waived testing must meet the applica- (12) Pertinent literature references.
ble analytic systems requirements in (13) The laboratory’s system for en-
§§ 493.1251 through 493.1283, unless HHS tering results in the patient record and
approves a procedure, specified in Ap- reporting patient results including,
pendix C of the State Operations Man- when appropriate, the protocol for re-
ual (CMS Pub. 7), that provides equiva- porting imminently life-threatening
lent quality testing. The laboratory results, or panic, or alert values.
must monitor and evaluate the overall (14) Description of the course of ac-
quality of the analytic systems and tion to take if a test system becomes
correct identified problems as specified inoperable.
in § 493.1289 for each specialty and sub- (c) Manufacturer’s test system in-
specialty of testing performed. structions or operator manuals may be
§ 493.1251 Standard: Procedure man- used, when applicable, to meet the re-
ual. quirements of paragraphs (b)(1)
through (b)(12) of this section. Any of
(a) A written procedure manual for
all tests, assays, and examinations per- the items under paragraphs (b)(1)
formed by the laboratory must be through (b)(12) of this section not pro-
available to, and followed by, labora- vided by the manufacturer must be
tory personnel. Textbooks may supple- provided by the laboratory.
ment but not replace the laboratory’s (d) Procedures and changes in proce-
written procedures for testing or exam- dures must be approved, signed, and
ining specimens. dated by the current laboratory direc-
(b) The procedure manual must in- tor before use.
clude the following when applicable to (e) The laboratory must maintain a
the test procedure: copy of each procedure with the dates
757
§ 493.1252 42 CFR Ch. IV (10–1–24 Edition)
of initial use and discontinuance as de- § 493.1253 Standard: Establishment

scribed in § 493.1105(a)(2). and verification of performance
specifications.
[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22,
2003] (a) Applicability. Laboratories are not
required to verify or establish perform-
§ 493.1252 Standard: Test systems, ance specifications for any test system
equipment, instruments, reagents, used by the laboratory before April 24,
materials, and supplies. 2003.
(a) Test systems must be selected by (b)(1) Verification of performance speci-
the laboratory. The testing must be fications. Each laboratory that intro-
performed following the manufactur- duces an unmodified, FDA-cleared or
approved test system must do the fol-
er’s instructions and in a manner that
lowing before reporting patient test re-
provides test results within the labora-
sults:
tory’s stated performance specifica-
(i) Demonstrate that it can obtain
tions for each test system as deter-
performance specifications comparable
mined under § 493.1253. to those established by the manufac-
(b) The laboratory must define cri- turer for the following performance
teria for those conditions that are es- characteristics:
sential for proper storage of reagents (A) Accuracy.
and specimens, accurate and reliable (B) Precision.
test system operation, and test result (C) Reportable range of test results
reporting. The criteria must be con- for the test system.
sistent with the manufacturer’s in- (ii) Verify that the manufacturer’s
structions, if provided. These condi- reference intervals (normal values) are
tions must be monitored and docu- appropriate for the laboratory’s pa-
mented and, if applicable, include the tient population.
following: (2) Establishment of performance speci-
(1) Water quality. fications. Each laboratory that modifies
(2) Temperature. an FDA-cleared or approved test sys-
(3) Humidity. tem, or introduces a test system not
(4) Protection of equipment and in- subject to FDA clearance or approval
struments from fluctuations and inter- (including methods developed in-house
ruptions in electrical current that ad- and standardized methods such as text
versely affect patient test results and book procedures), or uses a test system
test reports. in which performance specifications
(c) Reagents, solutions, culture are not provided by the manufacturer
media, control materials, calibration must, before reporting patient test re-
materials, and other supplies, as appro- sults, establish for each test system
the performance specifications for the
priate, must be labeled to indicate the
following performance characteristics,
following:
as applicable:
(1) Identity and when significant,
(i) Accuracy.
titer, strength or concentration.
(ii) Precision.
(2) Storage requirements. (iii) Analytical sensitivity.
(3) Preparation and expiration dates. (iv) Analytical specificity to include
(4) Other pertinent information re- interfering substances.
quired for proper use. (v) Reportable range of test results
(d) Reagents, solutions, culture for the test system.
media, control materials, calibration (vi) Reference intervals (normal val-
materials, and other supplies must not ues).
be used when they have exceeded their (vii) Any other performance char-
expiration date, have deteriorated, or acteristic required for test perform-
are of substandard quality. ance.
(e) Components of reagent kits of dif- (3) Determination of calibration and
ferent lot numbers must not be inter- control procedures. The laboratory must
changed unless otherwise specified by determine the test system’s calibration
the manufacturer. procedures and control procedures
758
based upon the performance specifica- substantiate the continued accuracy of

tions verified or established under the test system throughout the labora-
paragraph (b)(1) or (b)(2) of this sec- tory’s reportable range of test results
tion. for the test system. Unless otherwise
(c) Documentation. The laboratory specified in this subpart, for each ap-
must document all activities specified plicable test system the laboratory
in this section. must do the following:
[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22, (a) Perform and document calibra-
2003] tion procedures—
(1) Following the manufacturer’s test
§ 493.1254 Standard: Maintenance and system instructions, using calibration
function checks. materials provided or specified, and
(a) Unmodified manufacturer’s equip- with at least the frequency rec-
ment, instruments, or test systems. The ommended by the manufacturer;
laboratory must perform and document (2) Using the criteria verified or es-
the following: tablished by the laboratory as specified
(1) Maintenance as defined by the in § 493.1253(b)(3)—
manufacturer and with at least the fre- (i) Using calibration materials appro-
quency specified by the manufacturer. priate for the test system and, if pos-
(2) Function checks as defined by the sible, traceable to a reference method
manufacturer and with at least the fre- or reference material of known value;
quency specified by the manufacturer. and
Function checks must be within the (ii) Including the number, type, and
manufacturer’s established limits be- concentration of calibration materials,
fore patient testing is conducted. as well as acceptable limits for and the
(b) Equipment, instruments, or test sys- frequency of calibration; and
tems developed in-house, commercially (3) Whenever calibration verification
available and modified by the laboratory, fails to meet the laboratory’s accept-
or maintenance and function check proto- able limits for calibration verification.
cols are not provided by the manufac- (b) Perform and document calibra-
turer. The laboratory must do the fol- tion verification procedures—
lowing:
(1) Following the manufacturer’s
(1)(i) Establish a maintenance pro-
calibration verification instructions;
tocol that ensures equipment, instru-
(2) Using the criteria verified or es-
ment, and test system performance
tablished by the laboratory under
that is necessary for accurate and reli-
§ 493.1253(b)(3)—
able test results and test result report-
ing. (i) Including the number, type, and
(ii) Perform and document the main- concentration of the materials, as well
tenance activities specified in para- as acceptable limits for calibration
graph (b)(1)(i) of this section. verification; and
(2)(i) Define a function check pro- (ii) Including at least a minimal (or
tocol that ensures equipment, instru- zero) value, a mid-point value, and a
ment, and test system performance maximum value near the upper limit of
that is necessary for accurate and reli- the range to verify the laboratory’s re-
able test results and test result report- portable range of test results for the
ing. test system; and
(ii) Perform and document the func- (3) At least once every 6 months and
tion checks, including background or whenever any of the following occur:
baseline checks, specified in paragraph (i) A complete change of reagents for
(b)(2)(i) of this section. Function a procedure is introduced, unless the
checks must be within the laboratory’s laboratory can demonstrate that
established limits before patient test- changing reagent lot numbers does not
ing is conducted. affect the range used to report patient
test results, and control values are not
§ 493.1255 Standard: Calibration and adversely affected by reagent lot num-
calibration verification procedures. ber changes.
Calibration and calibration (ii) There is major preventive main-
verification procedures are required to tenance or replacement of critical
759
§ 493.1256 42 CFR Ch. IV (10–1–24 Edition)
parts that may influence test perform- (i) Each quantitative procedure, in-
ance. clude two control materials of different
(iii) Control materials reflect an un- concentrations;
usual trend or shift, or are outside of (ii) Each qualitative procedure, in-
the laboratory’s acceptable limits, and clude a negative and positive control
other means of assessing and cor- material;
recting unacceptable control values (iii) Test procedures producing grad-
fail to identify and correct the prob- ed or titered results, include a negative
lem. control material and a control mate-
(iv) The laboratory’s established rial with graded or titered reactivity,
schedule for verifying the reportable respectively;
range for patient test results requires (iv) Each test system that has an ex-
more frequent calibration verification. traction phase, include two control ma-
terials, including one that is capable of
§ 493.1256 Standard: Control proce- detecting errors in the extraction proc-
dures. ess; and
(a) For each test system, the labora- (v) Each molecular amplification pro-
tory is responsible for having control cedure, include two control materials
procedures that monitor the accuracy and, if reaction inhibition is a signifi-
and precision of the complete analytic cant source of false negative results, a
process. control material capable of detecting
the inhibition.
(b) The laboratory must establish the
(4) For thin layer chromatography—
number, type, and frequency of testing
(i) Spot each plate or card, as appli-
control materials using, if applicable,
cable, with a calibrator containing all
the performance specifications verified
known substances or drug groups, as
or established by the laboratory as
appropriate, which are identified by
specified in § 493.1253(b)(3).
thin layer chromatography and re-
(c) The control procedures must—
ported by the laboratory; and
(1) Detect immediate errors that (ii) Include at least one control mate-
occur due to test system failure, ad- rial on each plate or card, as applica-
verse environmental conditions, and ble, which must be processed through
operator performance. each step of patient testing, including
(2) Monitor over time the accuracy extraction processes.
and precision of test performance that (5) For each electrophoretic proce-
may be influenced by changes in test dure include, concurrent with patient
system performance and environ- specimens, at least one control mate-
mental conditions, and variance in op- rial containing the substances being
erator performance. identified or measured.
(d) Unless CMS approves a procedure, (6) Perform control material testing
specified in Appendix C of the State as specified in this paragraph before re-
Operations Manual (CMS Pub. 7), that suming patient testing when a com-
provides equivalent quality testing, the plete change of reagents is introduced;
laboratory must— major preventive maintenance is per-
(1) Perform control procedures as de- formed; or any critical part that may
fined in this section unless otherwise influence test performance is replaced.
specified in the additional specialty (7) Over time, rotate control material
and subspecialty requirements at testing among all operators who per-
§§ 493.1261 through 493.1278. form the test.
(2) For each test system, perform (8) Test control materials in the
control procedures using the number same manner as patient specimens.
and frequency specified by the manu- (9) When using calibration material
facturer or established by the labora- as a control material, use calibration
tory when they meet or exceed the re- material from a different lot number
quirements in paragraph (d)(3) of this than that used to establish a cut-off
section. value or to calibrate the test system.
(3) At least once each day patient (10) Establish or verify the criteria
specimens are assayed or examined for acceptability of all control mate-
perform the following for— rials.
760
(i) When control materials providing (f) Results of control materials must
quantitative results are used, statis- meet the laboratory’s and, as applica-
tical parameters (for example, mean ble, the manufacturer’s test system
and standard deviation) for each batch criteria for acceptability before report-
and lot number of control materials ing patient test results.
must be defined and available. (g) The laboratory must document all
(ii) The laboratory may use the stat- control procedures performed.
ed value of a commercially assayed (h) If control materials are not avail-
control material provided the stated able, the laboratory must have an al-
value is for the methodology and in- ternative mechanism to detect imme-
strumentation employed by the labora- diate errors and monitor test system
tory and is verified by the laboratory. performance over time. The perform-
(iii) Statistical parameters for ance of alternative control procedures
unassayed control materials must be must be documented.
established over time by the laboratory [68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22,
through concurrent testing of control 2003]
materials having previously deter-
mined statistical parameters. § 493.1261 Standard: Bacteriology.
(e) For reagent, media, and supply (a) The laboratory must check the
checks, the laboratory must do the fol- following for positive and negative re-
lowing: activity using control organisms:
(1) Check each batch (prepared in- (1) Each day of use for beta-
house), lot number (commercially pre- lactamase methods other than
pared) and shipment of reagents, disks, Cefinase TM.
stains, antisera, (except those specifi- (2) Each week of use for Gram stains.
cally referenced in § 493.1261(a)(3)) and (3) When each batch (prepared in-
identification systems (systems using house), lot number (commercially pre-
two or more substrates or two or more pared), and shipment of antisera is pre-
reagents, or a combination) when prepared or opened, and once every 6
pared or opened for positive and nega- months thereafter.
tive reactivity, as well as graded reac- (b) For antimicrobial susceptibility
tivity, if applicable. tests, the laboratory must check each
(2) Each day of use (unless otherwise batch of media and each lot number
specified in this subpart), test staining and shipment of antimicrobial agent(s)
materials for intended reactivity to en- before, or concurrent with, initial use,
sure predictable staining characteris- using approved control organisms.
tics. Control materials for both posi- (1) Each day tests are performed, the
tive and negative reactivity must be laboratory must use the appropriate
included, as appropriate. control organism(s) to check the proce-
(3) Check fluorescent and dure.
immunohistochemical stains for posi- (2) The laboratory’s zone sizes or
tive and negative reactivity each time minimum inhibitory concentration for
of use. control organisms must be within es-
(4) Before, or concurrent with the ini- tablished limits before reporting pa-
tial use— tient results.
(i) Check each batch of media for ste- (c) The laboratory must document all
rility if sterility is required for testing; control procedures performed, as speci-
(ii) Check each batch of media for its fied in this section.
ability to support growth and, as ap-
propriate, select or inhibit specific or- § 493.1262 Standard: Mycobacteriology.
ganisms or produce a biochemical re- (a) Each day of use, the laboratory
sponse; and must check all reagents or test proce-
(iii) Document the physical charac- dures used for mycobacteria identifica-
teristics of the media when com- tion with at least one acid-fast orga-
promised and report any deterioration nism that produces a positive reaction
in the media to the manufacturer. and an acid-fast organism that pro-
(5) Follow the manufacturer’s speci- duces a negative reaction.
fications for using reagents, media, and (b) For antimycobacterial suscepti-
supplies and be responsible for results. bility tests, the laboratory must check
761
§ 493.1263 42 CFR Ch. IV (10–1–24 Edition)
each batch of media and each lot num- (c) Each month of use, the laboratory
ber and shipment of antimycobacterial must check permanent stains using a
agent(s) before, or concurrent with, ini- fecal sample control material that will
tial use, using an appropriate control demonstrate staining characteristics.
organism(s). (d) The laboratory must document all
(1) The laboratory must establish control procedures performed, as speci-
limits for acceptable control results. fied in this section.
(2) Each week tests are performed,
the laboratory must use the appro- § 493.1265 Standard: Virology.
priate control organism(s) to check the (a) When using cell culture to isolate
procedure. or identify viruses, the laboratory
(3) The results for the control orga- must simultaneously incubate a cell
nism(s) must be within established lim- substrate control or uninoculated cells
its before reporting patient results. as a negative control material.
(c) The laboratory must document all (b) The laboratory must document all
control procedures performed, as speci- control procedures performed, as speci-
fied in this section. fied in this section.
§ 493.1263 Standard: Mycology. § 493.1267 Standard: Routine chem-

istry.
(a) The laboratory must check each
batch (prepared in-house), lot number For blood gas analyses, the labora-
(commercially prepared), and shipment tory must perform the following:
of lactophenol cotton blue when pre- (a) Calibrate or verify calibration ac-
pared or opened for intended reactivity cording to the manufacturer’s speci-
with a control organism(s). fications and with at least the fre-
quency recommended by the manufac-
(b) For antifungal susceptibility
turer.
tests, the laboratory must check each
(b) Test one sample of control mate-
batch of media and each lot number
rial each 8 hours of testing using a
and shipment of antifungal agent(s) be-
combination of control materials that
fore, or concurrent with, initial use,
include both low and high values on
using an appropriate control orga-
each day of testing.
nism(s).
(c) Test one sample of control mate-
(1) The laboratory must establish rial each time specimens are tested un-
limits for acceptable control results. less automated instrumentation inter-
(2) Each day tests are performed, the nally verifies calibration at least every
laboratory must use the appropriate 30 minutes.
control organism(s) to check the proce- (d) Document all control procedures
dure. performed, as specified in this section.
(3) The results for the control orga-
nism(s) must be within established lim- § 493.1269 Standard: Hematology.
its before reporting patient results. (a) For manual cell counts performed
(c) The laboratory must document all using a hemocytometer—
control procedures performed, as speci- (1) One control material must be
fied in this section. tested each 8 hours of operation; and
(2) Patient specimens and control
§ 493.1264 Standard: Parasitology.
materials must be tested in duplicate.
(a) The laboratory must have avail- (b) For all nonmanual coagulation
able a reference collection of slides or test systems, the laboratory must in-
photographs and, if available, gross clude two levels of control material
specimens for identification of each 8 hours of operation and each
parasites and use these references in time a reagent is changed.
the laboratory for appropriate com- (c) For manual coagulation tests—
parison with diagnostic specimens. (1) Each individual performing tests
(b) The laboratory must calibrate must test two levels of control mate-
and use the calibrated ocular microm- rials before testing patient samples and
eter for determining the size of ova and each time a reagent is changed; and
parasites, if size is a critical param- (2) Patient specimens and control
eter. materials must be tested in duplicate.
762
(d) The laboratory must document all occurring in facilities for which it has
control procedures performed, as speci- investigational responsibility and
fied in this section. make recommendations to the medical
staff regarding improvements in trans-
§ 493.1271 Standard: fusion procedures.
Immunohematology. (2) The laboratory must document, as
(a) Patient testing. (1) The laboratory applicable, that all necessary remedial
must perform ABO grouping, D(Rho) actions are taken to prevent
typing, unexpected antibody detection, recurrences of transfusion reactions
antibody identification, and compat- and that all policies and procedures are
ibility testing by following the manu- reviewed to assure they are adequate
facturer’s instructions, if provided, and to ensure the safety of individuals
as applicable, 21 CFR 606.151(a) through being transfused.
(e). (f) Documentation. The laboratory
(2) The laboratory must determine must document all control procedures
ABO group by concurrently testing un- performed, as specified in this section.
known red cells with, at a minimum, [68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22,
anti-A and anti-B grouping reagents. 2003]
For confirmation of ABO group, the
unknown serum must be tested with § 493.1273 Standard: Histopathology.
known A1 and B red cells. (a) As specified in § 493.1256(e)(3), fluo-
(3) The laboratory must determine rescent and immunohistochemical
the D(Rho) type by testing unknown stains must be checked for positive and
red cells with anti-D (anti-Rho) blood negative reactivity each time of use.
typing reagent. For all other differential or special
(b) Immunohematological testing and stains, a control slide of known reac-
distribution of blood and blood products. tivity must be stained with each pa-
Blood and blood product testing and tient slide or group of patient slides.
distribution must comply with 21 CFR Reaction(s) of the control slide with
606.100(b)(12); 606.160(b)(3)(ii) and each special stain must be documented.
(b)(3)(v); 610.40; 640.5(a), (b), (c), and (e); (b) The laboratory must retain
and 640.11(b). stained slides, specimen blocks, and
(c) Blood and blood products storage. tissue remnants as specified in
Blood and blood products must be § 493.1105. The remnants of tissue speci-
stored under appropriate conditions mens must be maintained in a manner
that include an adequate temperature that ensures proper preservation of the
alarm system that is regularly in- tissue specimens until the portions
spected. submitted for microscopic examination
(1) An audible alarm system must have been examined and a diagnosis
monitor proper blood and blood prod- made by an individual qualified under
uct storage temperature over a 24-hour § 493.1449(b), (l), or (m).
period. (c) An individual who has success-
(2) Inspections of the alarm system fully completed a training program in
must be documented. neuromuscular pathology approved by
(d) Retention of samples of transfused HHS may examine and provide reports
blood. According to the laboratory’s es- for neuromuscular pathology.
tablished procedures, samples of each (d) Tissue pathology reports must be
unit of transfused blood must be re- signed by an individual qualified as
tained for further testing in the event specified in paragraph (b) or, as appro-
of transfusion reactions. The labora- priate, paragraph (c) of this section. If
tory must promptly dispose of blood a computer report is generated with an
not retained for further testing that electronic signature, it must be au-
has passed its expiration date. thorized by the individual who per-
(e) Investigation of transfusion reac- formed the examination and made the
tions. (1) According to its established diagnosis.
procedures, the laboratory that per- (e) The laboratory must use accept-
forms compatibility testing, or issues able terminology of a recognized sys-
blood or blood products, must promptly tem of disease nomenclature in report-
investigate all transfusion reactions ing results.
763
(f) The laboratory must document all (1) A review of slides from at least 10
control procedures performed, as speci- percent of the gynecologic cases inter-
fied in this section. preted by individuals qualified under
§ 493.1469 or § 493.1483, to be negative for
[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22,
2003] epithelial cell abnormalities and other
malignant neoplasms (as defined in
EFFECTIVE DATE NOTE: At 88 FR 90038, Dec. paragraph (e)(1) of this section).
28, 2023, § 493.1273 was amended by revising (i) The review must be performed by
paragraph (b), effective Dec. 28, 2024. For the
convenience of the user, the revised text is
an individual who meets one of the fol-
set forth as follows: lowing qualifications:
(A) A technical supervisor qualified
§ 493.1273 Standard: Histopathology. under § 493.1449(b) or (k).
(B) A cytology general supervisor
* * * * * qualified under § 493.1469.
(C) A cytotechnologist qualified
(b) The laboratory must retain stained
slides, specimen blocks, and tissue remnants under § 493.1483 who has the experience
as specified in § 493.1105. The remnants of tis- specified in § 493.1469(b)(2).
sue specimens must be maintained in a man- (ii) Cases must be randomly selected
ner that ensures proper preservation of the from the total caseload and include
tissue specimens until the portions sub- negatives and those from patients or
mitted for microscopic examination have groups of patients that are identified
been examined and a diagnosis made by an as having a higher than average prob-
individual qualified under § 493.1449(b), (f), or
ability of developing cervical cancer
(g).
based on available patient information.
(iii) The review of those cases se-
* * * * * lected must be completed before re-
porting patient results.
§ 493.1274 Standard: Cytology.
(2) Laboratory comparison of clinical
(a) Cytology slide examination site. All information, when available, with cy-
cytology slide preparations must be tology reports and comparison of all
evaluated on the premises of a labora- gynecologic cytology reports with a di-
tory certified to conduct testing in the agnosis of high-grade squamous
subspecialty of cytology. intraepithelial lesion (HSIL), adenocar-
(b) Staining. The laboratory must cinoma, or other malignant neoplasms
have available and follow written poli- with the histopathology report, if
cies and procedures for each of the fol- available in the laboratory (either on-
lowing, if applicable: site or in storage), and determination
(1) All gynecologic slide preparations of the causes of any discrepancies.
must be stained using a Papanicolaou (3) For each patient with a current
or modified Papanicolaou staining HSIL, adenocarcinoma, or other malig-
method. nant neoplasm, laboratory review of all
(2) Effective measures to prevent normal or negative gynecologic speci-
cross-contamination between mens received within the previous 5
gynecologic and nongynecologic speci- years, if available in the laboratory (ei-
mens during the staining process must ther on-site or in storage). If signifi-
be used. cant discrepancies are found that will
(3) Nongynecologic specimens that affect current patient care, the labora-
have a high potential for cross-con- tory must notify the patient’s physi-
tamination must be stained separately cian and issue an amended report.
from other nongynecologic specimens, (4) Records of initial examinations
and the stains must be filtered or and all rescreening results must be
changed following staining. documented.
(c) Control procedures. The laboratory (5) An annual statistical laboratory
must establish and follow written poli- evaluation of the number of—
cies and procedures for a program de- (i) Cytology cases examined;
signed to detect errors in the perform- (ii) Specimens processed by specimen
ance of cytologic examinations and the type;
reporting of results. The program must (iii) Patient cases reported by diag-
include the following: nosis (including the number reported
764
as unsatisfactory for diagnostic inter- (ii) For the purposes of establishing

pretation); workload limits for individuals exam-
(iv) Gynecologic cases with a diag- ining slides in less than an 8-hour
nosis of HSIL, adenocarcinoma, or workday (includes full-time employees
other malignant neoplasm for which with duties other than slide examina-
histology results were available for tion and part-time employees), a period
comparison; of 8 hours is used to prorate the num-
(v) Gynecologic cases where cytology ber of slides that may be examined.
and histology are discrepant; and The formula—
(vi) Gynecologic cases where any re-
screen of a normal or negative speci- Number of hours examining slides × 100
men results in reclassification as low- 8
grade squamous intraepithelial lesion
(LSIL), HSIL, adenocarcinoma, or is used to determine maximum slide
other malignant neoplasms. volume to be examined;
(6) An evaluation of the case reviews (iii) Nongynecologic slide prepara-
of each individual examining slides tions made using liquid-based slide pre-
against the laboratory’s overall statis- paratory techniques that result in cell
tical values, documentation of any dis- dispersion over one-half or less of the
crepancies, including reasons for the total available slide may be counted as
deviation and, if appropriate, correc- one-half slide; and
tive actions taken. (iv) Technical supervisors who per-
form primary screening are not re-
(d) Workload limits. The laboratory
quired to include tissue pathology
must establish and follow written poli-
slides and previously examined cytol-
cies and procedures that ensure the fol-
ogy slides (gynecologic and
lowing:
nongynecologic) in the 100 slide work-
(1) The technical supervisor estab- load limit.
lishes a maximum workload limit for (3) The laboratory must maintain
each individual who performs primary records of the total number of slides
screening. examined by each individual during
(i) The workload limit is based on the each 24-hour period and the number of
individual’s performance using evalua- hours spent examining slides in the 24-
tions of the following: hour period irrespective of the site or
(A) Review of 10 percent of the cases laboratory.
interpreted as negative for the condi- (4) Records are available to document
tions defined in paragraph (e)(1) of this the workload limit for each individual.
section. (e) Slide examination and reporting.
(B) Comparison of the individual’s in- The laboratory must establish and fol-
terpretation with the technical super- low written policies and procedures
visor’s confirmation of patient smears that ensure the following:
specified in paragraphs (e)(1) and (e)(3) (1) A technical supervisor confirms
of this section. each gynecologic slide preparation in-
(ii) Each individual’s workload limit terpreted to exhibit reactive or repar-
is reassessed at least every 6 months ative changes or any of the following
and adjusted when necessary. epithelial cell abnormalities:
(2) The maximum number of slides (i) Squamous cell.
examined by an individual in each 24- (A) Atypical squamous cells of unde-
hour period does not exceed 100 slides termined significance (ASC-US) or can-
(one patient specimen per slide; not exclude HSIL (ASC-H).
gynecologic, nongynecologic, or both) (B) LSIL-Human papillomavirus
irrespective of the site or laboratory. (HPV)/mild dysplasia/cervical
This limit represents an absolute max- intraepithelial neoplasia 1 (CIN 1).
imum number of slides and must not be (C) HSIL-moderate and severe dys-
employed as an individual’s perform- plasia, carcinoma in situ (CIS)/CIN 2
ance target. In addition— and CIN 3 or with features suspicious
(i) The maximum number of 100 slides for invasion.
is examined in no less than an 8-hour (D) Squamous cell carcinoma.
workday; (ii) Glandular cell.
765
(A) Atypical cells not otherwise spec- automated screening devices, the lab-
ified (NOS) or specified in comments oratory must follow manufacturer’s in-
(endocervical, endometrial, or glan- structions for preanalytic, analytic,
dular). and postanalytic phases of testing, as
(B) Atypical cells favor neoplastic applicable, and meet the applicable re-
(endocervical or glandular). quirements of this subpart K.
(C) Endocervical adenocarcinoma in (h) Documentation. The laboratory
situ. must document all control procedures
(D) Adenocarcinoma endocervical, performed, as specified in this section.
adenocarcinoma endometrial, adeno- [68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22,
carcinoma extrauterine, and adenocar- 2003]
cinoma NOS.
(iii) Other malignant neoplasms. EFFECTIVE DATE NOTE: At 88 FR 90038, Dec.
28, 2023, § 493.1274 was amended by revising
(2) The report of gynecologic slide paragraph (c)(1)(i)(A), effective Dec. 28, 2024.
preparations with conditions specified For the convenience of the user, the revised
in paragraph (e)(1) of this section must text is set forth as follows:
be signed to reflect the technical su-
pervisory review or, if a computer re- § 493.1274 Standard: Cytology.
port is generated with signature, it
must reflect an electronic signature * * * * *
authorized by the technical supervisor (c) * * *
who performed the review. (1) * * *
(3) All nongynecologic preparations (i) * * *
are reviewed by a technical supervisor. (A) A technical supervisor qualified under
The report must be signed to reflect § 493.1449(b) or (e).
technical supervisory review or, if a
computer report is generated with sig- * * * * *
nature, it must reflect an electronic
signature authorized by the technical § 493.1276 Standard: Clinical cyto-
supervisor who performed the review. genetics.
(4) Unsatisfactory specimens or slide (a) The laboratory must have policies
preparations are identified and re- and procedures for ensuring accurate
ported as unsatisfactory. and reliable patient specimen identi-
(5) The report contains narrative de- fication during the process of
scriptive nomenclature for all results. accessioning, cell preparation,
(6) Corrected reports issued by the photographing or other image repro-
laboratory indicate the basis for cor- duction technique, photographic print-
rection. ing, and reporting and storage of re-
(f) Record and slide retention. (1) The sults, karyotypes, and photographs.
laboratory must retain all records and (b) The laboratory must have records
slide preparations as specified in that document the following:
§ 493.1105. (1) The media used, reactions ob-
(2) Slides may be loaned to pro- served, number of cells counted, num-
ficiency testing programs in lieu of ber of cells karyotyped, number of
maintaining them for the required chromosomes counted for each meta-
time period, provided the laboratory phase spread, and the quality of the
receives written acknowledgment of banding.
the receipt of slides by the proficiency (2) The resolution is appropriate for
testing program and maintains the ac- the type of tissue or specimen and the
knowledgment to document the loan of type of study required based on the
these slides. clinical information provided to the
(3) Documentation of slides loaned or laboratory.
referred for purposes other than pro- (3) An adequate number of
ficiency testing must be maintained. karyotypes are prepared for each pa-
(4) All slides must be retrievable tient.
upon request. (c) Determination of sex must be per-
(g) Automated and semi-automated formed by full chromosome analysis.
screening devices. When performing (d) The laboratory report must in-
evaluations using automated and semi- clude a summary and interpretation of
766
the observations, number of cells designation that cannot be confused

counted and analyzed, and use the with W.H.O. terminology.
International System for Human Cyto- (5) Have available and follow written
genetic Nomenclature. criteria for the following:
(e) The laboratory must document all (i) The preparation of cells or cel-
control procedures performed, as speci- lular extracts (for example, solubilized
fied in this section. antigens and nucleic acids), as applica-
ble to the HLA typing technique(s) per-
[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22,
formed.
2003]
(ii) Selecting typing reagents, wheth-
§ 493.1278 Standard: er prepared in-house or commercially.
Histocompatibility. (iii) Ensuring that reagents used for
typing are adequate to define all HLA-
(a) General. The laboratory must A, B and DR specificities that are offi-
meet the following requirements: cially recognized by the most recent
(1) An audible alarm system must be W.H.O. Committee on Nomenclature
used to monitor the storage tempera- and for which reagents are readily
ture of specimens (donor and bene- available.
ficiary) and reagents. The laboratory (iv) The assignment of HLA antigens.
must have an emergency plan for alter- (v) When antigen redefinition and re-
nate storage. typing are required.
(2) All patient specimens must be (6) Check each HLA typing by test-
easily retrievable. ing, at a minimum the following:
(3) Reagent typing sera inventory (i) A positive control material.
prepared in-house must indicate (ii) A negative control material in
source, bleeding date and identification which, if applicable to the technique
number, reagent specificity, and vol- performed, cell viability at the end of
ume remaining. incubation is sufficient to permit accu-
(4) If the laboratory uses rate interpretation of results. In assays
immunologic reagents (for example, in which cell viability is not required,
antibodies, antibody-coated particles, the negative control result must be
or complement) to facilitate or en- sufficiently different from the positive
hance the isolation of lymphocytes, or control result to permit accurate inter-
lymphocyte subsets, the efficacy of the pretation of results.
methods must be monitored with ap- (iii) Positive control materials for
propriate quality control procedures. specific cell types when applicable
(5) Participate in at least one na- (that is, T cells, B cells, and mono-
tional or regional cell exchange pro- cytes).
gram, if available, or develop an ex- (c) Disease-associated studies. The lab-
change system with another laboratory oratory must check each typing for
in order to validate interlaboratory re- disease-associated HLA antigens using
producibility. control materials to monitor the test
(b) HLA typing. The laboratory must components and each phase of the test
do the following: system to ensure acceptable perform-
(1) Use a technique(s) that is estab- ance.
lished to optimally define, as applica- (d) Antibody Screening. The labora-
ble, HLA Class I and II specificities. tory must do the following:
(2) HLA type all potential transplant (1) Use a technique(s) that detects
beneficiaries at a level appropriate to HLA-specific antibody with a speci-
support clinical transplant protocol ficity equivalent or superior to that of
and donor selection. the basic complement-dependent
(3) HLA type cells from organ donors microlymphocytotoxicity assay.
referred to the laboratory. (2) Use a method that distinguishes
(4) Use HLA antigen terminology antibodies to HLA Class II antigens
that conforms to the latest report of from antibodies to Class I antigens to
the World Health Organization detect antibodies to HLA Class II anti-
(W.H.O.) Committee on Nomenclature. gens.
Potential new antigens not yet ap- (3) Use a panel that contains all the
proved by this committee must have a major HLA specificities and common
767
splits. If the laboratory does not use transplanted. The laboratory’s policies
commercial panels, it must maintain a must include, as applicable—
list of individuals for fresh panel bleed- (i) Testing protocols for cadaver
ing. donor, living, living-related, and com-
(4) Make a reasonable attempt to bined organ and tissue transplants;
have available monthly serum speci- (ii) Testing protocols for patients at
mens for all potential transplant bene- high risk for allograft rejection; and
ficiaries for periodic antibody screen- (iii) The level of testing required to
ing and crossmatch. support clinical transplant protocols
(5) Have available and follow a writ- (for example, antigen or allele level).
ten policy consistent with clinical (2) For renal allotransplantation and
transplant protocols for the frequency combined organ and tissue transplants
of screening potential transplant bene- in which a kidney is to be trans-
ficiary sera for preformed HLA-specific planted, have available results of final
antibodies. crossmatches before the kidney is
(6) Check each antibody screening by transplanted.
testing, at a minimum the following: (3) For nonrenal transplantation, if
(i) A positive control material con- HLA testing and final crossmatches
taining antibodies of the appropriate were not performed prospectively be-
isotype for the assay. cause of an emergency situation, the
laboratory must document the cir-
(ii) A negative control material.
cumstances, if known, under which the
(7) As applicable, have available and emergency transplant was performed,
follow written criteria and procedures and records of the transplant must re-
for antibody identification to the level flect any information provided to the
appropriate to support clinical trans- laboratory by the patient’s physician.
plant protocol. (g) Documentation. The laboratory
(e) Crossmatching. The laboratory must document all control procedures
must do the following: performed, as specified in this section.
(1) Use a technique(s) documented to
have increased sensitivity in compari- [68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22,
2003]
son with the basic complement-depend-
ent microlymphocytotoxicity assay. EFFECTIVE DATE NOTE: At 88 FR 90038, Dec.
(2) Have available and follow written 28, 2023, § 493.1278 was revised, effective Dec.
28, 2024. For the convenience of the user, the
criteria for the following:
revised text is set forth as follows:
(i) Selecting appropriate patient
serum samples for crossmatching. § 493.1278 Standard: Histocompatibility.
(ii) The preparation of donor cells or (a) General. The laboratory must meet the
cellular extracts (for example, solu- following requirements:
bilized antigens and nucleic acids), as (1) Use a continuous monitoring system
and alert system to monitor the storage
applicable to the crossmatch tech-
temperature of specimens (donor and recipi-
nique(s) performed. ent) and reagents and notify laboratory per-
(3) Check each crossmatch and com- sonnel when temperature limits are exceed-
patibility test for HLA Class II anti- ed.
genic differences using control mate- (2) Establish and follow written policies
rials to monitor the test components and procedures for the storage and retention
and each phase of the test system to of specimens based on the specific type of
ensure acceptable performance. specimen. All specimens must be easily re-
trievable. The laboratory must have an
(f) Transplantation. Laboratories per- emergency plan for alternate storage.
forming histocompatibility testing for (3) If the laboratory uses immunologic re-
transfusion and transplantation pur- agents to facilitate or enhance the isolation
poses must do the following: or identification of lymphocytes or lym-
(1) Have available and follow written phocyte subsets, the efficacy of the methods
policies and protocols specifying the must be monitored with appropriate quality
control procedures.
histocompatibility testing (that is,
(4) Participate in at least one national or
HLA typing, antibody screening, com- regional cell exchange program, if available,
patibility testing and crossmatching) or develop an exchange system with another
to be performed for each type of cell, laboratory in order to validate interlabora-
tissue or organ to be transfused or tory reproducibility.
768
(b) Human leukocyte antigen (HLA) typing. transplantation. If the laboratory is unable
The laboratory must do the following: to obtain a recipient specimen on the day of
(1) Use HLA antigen terminology that con- the transplant, the laboratory must have a
forms to the World Health Organization process to document its efforts to obtain the
(WHO) Nomenclature Committee for Factors specimen.
of the HLA System. (f) Documentation. The laboratory must
(2) Have available and follow written cri- document all control procedures performed,
teria for determining when antigen and as specified in this section.
allele typing are required.
(c) Antibody screening and identification. § 493.1281 Standard: Comparison of
The laboratory must make a reasonable ef- test results.
fort to have available monthly serum speci-
mens for all potential transplant recipients (a) If a laboratory performs the same
for periodic antibody screening, identifica- test using different methodologies or
tion, and crossmatch. instruments, or performs the same test
(d) Crossmatching. For each type of cross- at multiple testing sites, the labora-
match that a laboratory performs, the lab- tory must have a system that twice a
oratory must do the following, as applicable: year evaluates and defines the relation-
(1) Establish and follow written policies ship between test results using the dif-
and procedures for performing a crossmatch.
(2) Have available and follow written cri-
ferent methodologies, instruments, or
teria for the following: testing sites.
(i) Defining donor and recipient HLA anti- (b) The laboratory must have a sys-
gens, alleles, and antibodies to be tested; tem to identify and assess patient test
(ii) Defining the criteria necessary to as- results that appear inconsistent with
sess a recipient’s alloantibody status; the following relevant criteria, when
(iii) Assessing recipient antibody presence available:
or absence on an ongoing basis;
(iv) Typing the donor, to include those
(1) Patient age.
HLA antigens to which antibodies have been (2) Sex.
identified in the potential recipient, as appli- (3) Diagnosis or pertinent clinical
cable; data.
(v) Describing the circumstances in which (4) Distribution of patient test re-
pre- and post-transplant confirmation test- sults.
ing of donor and recipient specimens is re- (5) Relationship with other test pa-
quired; rameters.
(vi) Making available all applicable donor
(c) The laboratory must document all
and recipient test results to the transplant
team; test result comparison activities.
(vii) Ensuring immunologic assessments
are based on test results obtained from a test § 493.1282 Standard: Corrective ac-
report from a CLIA-certified laboratory; and tions.
(viii) Defining time limits between recipi- (a) Corrective action policies and
ent testing and the performance of a cross- procedures must be available and fol-
match. lowed as necessary to maintain the lab-
(3) The test report must specify the type of
crossmatch performed. oratory’s operation for testing patient
(e) Transplantation. Laboratories per- specimens in a manner that ensures ac-
forming histocompatibility testing for infu- curate and reliable patient test results
sion and transplantation purposes must es- and reports.
tablish and follow written policies and proce- (b) The laboratory must document all
dures specifying the histocompatibility test- corrective actions taken, including ac-
ing (that is, HLA typing, antibody screening tions taken when any of the following
and identification, and crossmatching) to be
occur:
performed for each type of cell, tissue, or
organ to be infused or transplanted. The lab- (1) Test systems do not meet the lab-
oratory’s policies and procedures must in- oratory’s verified or established per-
clude, as applicable— formance specifications, as determined
(1) Testing protocols that address: in § 493.1253(b), which include but are
(i) Transplant type (organ, tissue, cell); not limited to—
(ii) Donor (living, deceased, or paired): and (i) Equipment or methodologies that
(iii) Recipient (high risk vs. unsensitized);
perform outside of established oper-
(2) Type and frequency of testing required
to support clinical transplant protocols; and ating parameters or performance speci-
(3) Process to obtain a recipient specimen, fications;
if possible, for crossmatch that is collected (ii) Patient test values that are out-
on the day of the transplant and prior to side of the laboratory’s reportable
769
§ 493.1283 42 CFR Ch. IV (10–1–24 Edition)
range of test results for the test sys- assessment reviews with appropriate
tem; and staff.
(iii) When the laboratory determines (c) The laboratory must document all
that the reference intervals (normal analytic systems quality assessment
values) for a test procedure are inap- activities.
propriate for the laboratory’s patient [68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22,
population. 2003]
(2) Results of control or calibration
materials, or both, fail to meet the lab- POSTANALYTIC SYSTEMS
oratory’s established criteria for ac-
ceptability. All patient test results ob- § 493.1290 Condition: Postanalytic sys-
tained in the unacceptable test run and tems.
since the last acceptable test run must Each laboratory that performs non-
be evaluated to determine if patient waived testing must meet the applica-
test results have been adversely af- ble postanalytic systems requirements
fected. The laboratory must take the in § 493.1291 unless HHS approves a pro-
corrective action necessary to ensure cedure, specified in Appendix C of the
the reporting of accurate and reliable State Operations Manual (CMS Pub. 7)
patient test results. that provides equivalent quality test-
(3) The criteria for proper storage of ing. The laboratory must monitor and
reagents and specimens, as specified evaluate the overall quality of the
under § 493.1252(b), are not met. postanalytic systems and correct iden-
tified problems as specified in § 493.1299
§ 493.1283 Standard: Test records. for each specialty and subspecialty of
(a) The laboratory must maintain an testing performed.
information or record system that in-
cludes the following: § 493.1291 Standard: Test report.
(1) The positive identification of the (a) The laboratory must have an ade-
specimen. quate manual or electronic system(s)
(2) The date and time of specimen rein place to ensure test results and
ceipt into the laboratory. other patient-specific data are accu-
(3) The condition and disposition of rately and reliably sent from the point
specimens that do not meet the labora- of data entry (whether interfaced or
tory’s criteria for specimen accept- entered manually) to final report des-
ability. tination, in a timely manner. This in-
(4) The records and dates of all speci- cludes the following:
men testing, including the identity of (1) Results reported from calculated
the personnel who performed the data.
test(s). (2) Results and patient-specific data
(b) Records of patient testing includ- electronically reported to network or
ing, if applicable, instrument print- interfaced systems.
outs, must be retained. (3) Manually transcribed or electroni-
cally transmitted results and patient-
§ 493.1289 Standard: Analytic systems specific information reported directly
quality assessment. or upon receipt from outside referral
(a) The laboratory must establish laboratories, satellite or point-of-care
and follow written policies and proce- testing locations.
dures for an ongoing mechanism to (b) Test report information main-
monitor, assess, and when indicated, tained as part of the patient’s chart or
correct problems identified in the ana- medical record must be readily avail-
lytic systems specified in §§ 493.1251 able to the laboratory and to CMS or a
through 493.1283. CMS agent upon request.
(b) The analytic systems quality as- (c) The test report must indicate the
sessment must include a review of the following:
effectiveness of corrective actions (1) For positive patient identifica-
taken to resolve problems, revision of tion, either the patient’s name and
policies and procedures necessary to identification number, or a unique pa-
prevent recurrence of problems, and tient identifier and identification num-
discussion of analytic systems quality ber.
770
(2) The name and address of the lab- related to the interpretation of results
oratory location where the test was provided by the testing laboratory;
performed. (2) The referring laboratory may per-
(3) The test report date. mit each testing laboratory to send the
(4) The test performed. test result directly to the authorized
(5) Specimen source, when appro- person who initially requested the test.
priate. The referring laboratory must retain
(6) The test result and, if applicable, or be able to produce an exact dupli-
the units of measurement or interpre- cate of each testing laboratory’s re-
tation, or both. port; and
(7) Any information regarding the (3) The authorized person who orders
condition and disposition of specimens a test must be notified by the referring
that do not meet the laboratory’s cri- laboratory of the name and address of
teria for acceptability. each laboratory location where the test
(d) Pertinent ‘‘reference intervals’’ or was performed.
‘‘normal’’ values, as determined by the (j) All test reports or records of the
laboratory performing the tests, must information on the test reports must
be available to the authorized person be maintained by the laboratory in a
who ordered the tests and, if applica- manner that permits ready identifica-
ble, the individual responsible for using tion and timely accessibility.
the test results. (k) When errors in the reported pa-
(e) The laboratory must, upon re- tient test results are detected, the lab-
quest, make available to clients a list oratory must do the following:
of test methods employed by the lab- (1) Promptly notify the authorized
oratory and, as applicable, the per- person ordering the test and, if applica-
formance specifications established or ble, the individual using the test re-
verified as specified in § 493.1253. In ad- sults of reporting errors.
dition, information that may affect the (2) Issue corrected reports promptly
interpretation of test results, for exam- to the authorized person ordering the
ple test interferences, must be provided test and, if applicable, the individual
upon request. Pertinent updates on using the test results.
testing information must be provided (3) Maintain duplicates of the origi-
to clients whenever changes occur that nal report, as well as the corrected re-
affect the test results or interpretation port.
of test results. (l) Upon request by a patient (or the
(f) Except as provided in § 493.1291(l), patient’s personal representative), the
test results must be released only to laboratory may provide patients, their
authorized persons and, if applicable, personal representatives, and those
the persons responsible for using the persons specified under 45 CFR
test results and the laboratory that 164.524(c)(3)(ii), as applicable, with ac-
initially requested the test. cess to completed test reports that,
(g) The laboratory must immediately using the laboratory’s authentication
alert the individual or entity request- process, can be identified as belonging
ing the test and, if applicable, the indi- to that patient.
vidual responsible for using the test re- [68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22,
sults when any test result indicates an 2003, as amended at 79 FR 7316, Feb. 6, 2014]
imminently life-threatening condition,
or panic or alert values. § 493.1299 Standard: Postanalytic sys-
(h) When the laboratory cannot re- tems quality assessment.
port patient test results within its es- (a) The laboratory must establish
tablished time frames, the laboratory and follow written policies and proce-
must determine, based on the urgency dures for an ongoing mechanism to
of the patient test(s) requested, the monitor, assess and, when indicated,
need to notify the appropriate indi- correct problems identified in the
vidual(s) of the delayed testing. postanalytic systems specified in
(i) If a laboratory refers patient § 493.1291.
specimens for testing— (b) The postanalytic systems quality
(1) The referring laboratory must not assessment must include a review of
revise results or information directly the effectiveness of corrective actions
771
§ 493.1351 42 CFR Ch. IV (10–1–24 Edition)
taken to resolve problems, revision of § 493.1357 Standard; laboratory direc-

policies and procedures necessary to tor qualifications.
prevent recurrence of problems, and The laboratory director must be
discussion of postanalytic systems qualified to manage and direct the lab-
quality assessment reviews with appro- oratory personnel and the performance
priate staff. of PPM procedures as specified in
(c) The laboratory must document all § 493.19(c) and must be eligible to be an
postanalytic systems quality assess- operator of a laboratory within the re-
ment activities. quirements of subpart R of this part.
(a) The laboratory director must pos-
[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22,
2003]
sess a current license as a laboratory
director issued by the State in which
the laboratory is located, if the licens-
Subpart L [Reserved] ing is required.
(b) The laboratory director must
Subpart M—Personnel for meet one of the following require-
Nonwaived Testing ments:
(1) Be a physician, as defined in
§ 493.2.
otherwise noted. (2) Be a midlevel practitioner, as de-
fined in § 493.2, authorized by a State to
§ 493.1351 General. practice independently in the State in
which the laboratory is located.
This subpart consists of the per-
(3) Be a dentist, as defined in § 493.2.
sonnel requirements that must be met
by laboratories performing moderate § 493.1359 Standard; PPM laboratory
complexity testing, PPM procedures, director responsibilities.
high complexity testing, or any com- The laboratory director is respon-
bination of these tests. sible for the overall operation and ad-
[60 FR 20049, Apr. 24, 1995] ministration of the laboratory, includ-
ing the prompt, accurate, and pro-
LABORATORIES PERFORMING PROVIDER- ficient reporting of test results. The
PERFORMED MICROSCOPY (PPM) PRO- laboratory director must—
CEDURES (a) Direct no more than five labora-
tories; and
SOURCE: 60 FR 20049, Apr. 24, 1995, unless (b) Ensure that any procedure listed
otherwise noted. under § 493.19(c)—
(1) Is personally performed by an in-
§ 493.1353 Scope. dividual who meets the qualification
In accordance with § 493.19(b), the requirements in § 493.1363; and
moderate complexity procedures speci- (2) Is performed in accordance with
fied as PPM procedures are considered applicable requirements in subparts H,
such only when personally performed J, K, and M of this part.
by a health care provider during a pa- [57 FR 7172, Feb. 28, 1992, as amended at 68
tient visit in the context of a physical FR 3713, Jan. 24, 2003; 68 FR 50724, Aug. 22,
examination. PPM procedures are sub- 2003]
ject to the personnel requirements in EFFECTIVE DATE NOTE: At 88 FR 90039, Dec.
§§ 493.1355 through 493.1365. 28, 2023, § 493.1359 was amended by revising
paragraph (b)(2) and adding paragraphs (c)
§ 493.1355 Condition: Laboratories per- and (d), effective Dec. 28, 2024. For the con-
forming PPM procedures; labora- venience of the user, the added and revised
tory director. text is set forth as follows:
The laboratory must have a director § 493.1359 Standard; PPM laboratory direc-
tor responsibilities.
who meets the qualification require-
ments of § 493.1357 and provides overall
management and direction in accord- * * * * *
ance with § 493.1359. (b) * * *
772
(2) Is performed in accordance with appliance, and for reporting test results.
cable requirements in this subpart and sub- Any PPM procedure must be—
parts H, J, and K of this part; (a) Personally performed by one of
(c) Evaluate the competency of all testing the following practitioners:
personnel and ensure that the staff main-
(1) A physician during the patient’s
tains their competency to perform test pro-
cedures and report test results promptly, ac- visit on a specimen obtained from his
curately, and proficiently. The procedures or her own patient or from a patient of
for evaluation of the competency of the staff a group medical practice of which the
must include, but are not limited to— physician is a member or employee.
(1) Direct observations of routine patient (2) A midlevel practitioner, under the
test performance, including, if applicable, supervision of a physician or in inde-
specimen handling, processing, and testing; pendent practice if authorized by the
(2) Monitoring the recording and reporting State in which the laboratory is lo-
of test results; cated, during the patient’s visit on a
(3) Review of test results or worksheets; specimen obtained from his or her own
(4) Assessment of test performance through patient or from the patient of a clinic,
testing internal blind testing samples or ex-
ternal proficiency testing samples; and
group medical practice, or other health
(5) Assessment of problem solving skills;
care provider, in which the midlevel
and practitioner is a member or an em-
(d) Evaluate and document the perform- ployee.
ance of individuals responsible for PPM test- (3) A dentist during the patient’s
ing at least semiannually during the first visit on a specimen obtained from his
year the individual tests patient specimens. or her own patient or from a patient of
Thereafter, evaluations and documentation a group dental practice of which the
must be performed at least annually. dentist is a member or an employee;
and
§ 493.1361 Condition: Laboratories per- (b) Performed using a microscope
forming PPM procedures; testing
personnel. limited to a brightfield or a phase/con-
trast microscope.
The laboratory must have a suffi-
cient number of individuals who meet LABORATORIES PERFORMING MODERATE
the qualification requirements of COMPLEXITY TESTING
§ 493.1363 to perform the functions spec-
ified in § 493.1365 for the volume and § 493.1403 Condition: Laboratories per-
forming moderate complexity test-
complexity of testing performed. ing; laboratory director.
§ 493.1363 Standard: PPM testing per- The laboratory must have a director
sonnel qualifications. who meets the qualification require-
Each individual performing PPM pro- ments of § 493.1405 of this subpart and
cedures must— provides overall management and di-
rection in accordance with § 493.1407 of
(a) Possess a current license issued
this subpart.
by the State in which the laboratory is
located if the licensing is required; and § 493.1405 Standard; Laboratory direc-
(b) Meet one of the following require- tor qualifications.
ments: The laboratory director must be
(1) Be a physician, as defined in qualified to manage and direct the lab-
§ 493.2. oratory personnel and the performance
(2) Be a midlevel practitioner, as de- of moderate complexity tests and must
fined in § 493.2, under the supervision of be eligible to be an operator of a lab-
a physician or in independent practice oratory within the requirements of
if authorized by the State in which the subpart R of this part.
laboratory is located. (a) The laboratory director must pos-
(3) Be a dentist as defined in § 493.2 of sess a current license as a laboratory
this part. director issued by the State in which
the laboratory is located, if such li-
§ 493.1365 Standard; PPM testing per- censing is required; and
sonnel responsibilities. (b) The laboratory director must—
The testing personnel are responsible (1) (i) Be a doctor of medicine or doc-
for specimen processing, test perform- tor of osteopathy licensed to practice
773
medicine or osteopathy in the State in (ii) Have at least 2 years of labora-

which the laboratory is located; and tory training or experience, or both in
(ii) Be certified in anatomic or clin- non-waived testing; and
ical pathology, or both, by the Amer- (iii) In addition, have at least 2 years
ican Board of Pathology or the Amer- of supervisory laboratory experience in
ican Osteopathic Board of Pathology or non-waived testing;
possess qualifications that are equiva- (6) Be serving as a laboratory direc-
lent to those required for such certifi- tor and must have previously qualified
cation; or or could have qualified as a laboratory
(2)(i) Be a doctor of medicine, doctor director under § 493.1406; or
of osteopathy, or doctor of podiatric
(7) On or before February 28, 1992,
medicine licensed to practice medicine,
qualified under State law to direct a
osteopathy, or podiatry in the State in
laboratory in the State in which the
which the laboratory is located; and
(ii) Have had laboratory training or laboratory is located.
experience consisting of: [57 FR 7172, Feb. 28, 1992, as amended at 58
(A) At least one year directing or su- FR 5233, Jan. 19, 1993]
pervising non-waived laboratory test- EFFECTIVE DATE NOTE: At 88 FR 90039, Dec.
ing; or 28, 2023, § 493.1405 was amended by revising
(B) Beginning September 1, 1993, have paragraph (b), effective Dec. 28, 2024. For the
at least 20 continuing medical edu- convenience of the user, the revised text is
cation credit hours in laboratory prac- set forth as follows:
tice commensurate with the director
responsibilities defined in § 493.1407; or § 493.1405 Standard; Laboratory director
qualifications.
(C) Laboratory training equivalent to
paragraph (b)(2)(ii)(B) of this section
obtained during medical residency. * * * * *
(For example, physicians certified ei- (b) The laboratory director must—
ther in hematology or hematology and (1)(i) Be a doctor of medicine or doctor of
medical oncology by the American osteopathy licensed to practice medicine or
Board of Internal Medicine); or osteopathy in the State in which the labora-
(3) Hold an earned doctoral degree in tory is located; and
a chemical, physical, biological, or (ii) Be certified in anatomic or clinical pa-
clinical laboratory science from an ac- thology, or both, by the American Board of
credited institution; and Pathology or the American Osteopathic
(i) Be certified by the American Board of Pathology; or
Board of Medical Microbiology, the (2)(i) Be a doctor of medicine, doctor of os-
teopathy, or doctor of podiatric medicine li-
American Board of Clinical Chemistry,
censed to practice medicine, osteopathy, or
the American Board of Bioanalysis, or podiatry in the State in which the labora-
the American Board of Medical Labora- tory is located; and
tory Immunology; or (ii) Have had laboratory training or experi-
(ii) Have had at least one year experience consisting of:
ence directing or supervising non- (A) At least 1 year directing or supervising
waived laboratory testing; nonwaived laboratory testing; and
(4)(i) Have earned a master’s degree (B) Have at least 20 CE credit hours in lab-
in a chemical, physical, biological or oratory practice that cover the laboratory
clinical laboratory science or medical director responsibilities defined in § 493.1407;
technology from an accredited institu- or
tion; (3)(i)(A) Hold an earned doctoral degree in
(ii) Have at least one year of labora- a chemical, biological, clinical or medical
laboratory science or medical technology
tory training or experience, or both in
from an accredited institution; or
non-waived testing; and
(B) Hold an earned doctoral degree; and
(iii) In addition, have at least one
(1) Have at least 16 semester hours of doc-
year of supervisory laboratory experi- toral level coursework in biology, chemistry,
ence in non-waived testing; or medical technology (MT), clinical laboratory
(5)(i) Have earned a bachelor’s degree science (CLS), or medical laboratory science
in a chemical, physical, or biological (MLS); or
science or medical technology from an (2) An approved thesis or research project
accredited institution; in biology/chemistry/MT/CLS/MLS related to
774
laboratory testing for the diagnosis, preven- (iii) Have at least 2 years of supervisory
tion, or treatment of any disease or impair- laboratory experience in nonwaived testing;
ment of, or the assessment of the health of, and
human beings; and (iv) Have at least 20 CE credit hours in lab-
(ii) Have at least 20 CE credit hours in laboratory practice that cover the director re-
oratory practice that cover the laboratory sponsibilities defined in § 493.1407.
director responsibilities defined in § 493.1407;
(6) Notwithstanding any other provision of
and
(A) Be certified and continue to be cer- this section, an individual is considered
tified by a board approved by HHS; and qualified as a laboratory director of mod-
(B) Have had at least 1 year of experience erate complexity testing under this section
directing or supervising nonwaived labora- if they were qualified and serving as a lab-
tory testing; or oratory director of moderate complexity
(4)(i)(A) Have earned a master’s degree in a testing in a CLIA-certified laboratory as of
chemical, biological, clinical or medical lab- December 28, 2024, and have done so continu-
oratory science or medical technology from ously since December 28, 2024.
an accredited institution; or
(B)(1) Meet bachelor’s degree equivalency; § 493.1406 Standard; Laboratory direc-
and tor qualifications on or before Feb-
(2) Have at least 16 semester hours of addi- ruary 28, 1992.
tional graduate level coursework in biology,
chemistry, medical technology, clinical or The laboratory director must be
medical laboratory science; or qualified to manage and direct the lab-
(C)(1) Meet bachelor’s degree equivalency; oratory personnel and test perform-
and
ance.
(2) Have at least 16 semester hours in a
combination of graduate level coursework in (a) The laboratory director must pos-
biology, chemistry, medical technology, sess a current license as a laboratory
clinical or medical laboratory science and an director issued by the State, if such li-
approved thesis or research project related censing exists; and
to laboratory testing for the diagnosis, pre-
(b) The laboratory director must:
vention, or treatment of any disease or im-
pairment of, or the assessment of the health (1) Be a physician certified in ana-
of, human beings; and tomical or clinical pathology (or both)
(ii) Have at least 1 year of laboratory by the American Board of Pathology or
training or experience, or both, in nonwaived the American Osteopathic Board of Pa-
testing; and thology or possess qualifications that
(iii) Have at least 1 year of supervisory lab-
oratory experience in nonwaived testing; and are equivalent to those required for
(iv) Have at least 20 CE credit hours in lab- such certification;
oratory practice that cover the director re- (2) Be a physician who:
sponsibilities defined in § 493.1407; or (i) Is certified by the American Board
(5)(i)(A) Have earned a bachelor’s degree in
of Pathology or the American Osteo-
a chemical, biological, clinical or medical
laboratory science or medical technology pathic Board of Pathology in at least
from an accredited institution; or one of the laboratory specialties; or
(B) At least 120 semester hours, or equiva- (ii) Is certified by the American
lent, from an accredited institution that, at Board of Medical Microbiology, the
a minimum, includes either— American Board of Clinical Chemistry,
(1) Forty-eight (48) semester hours of med-
ical laboratory science or medical laboratory the American Board of Bioanalysis, or
technology courses; or other national accrediting board in one
(2) Forty-eight (48) semester hours of of the laboratory specialties; or
science courses that include— (iii) Is certified by the American So-
(i) Twelve (12) semester hours of chemistry, ciety of Cytology to practice
which must include general chemistry and
biochemistry or organic chemistry; cytopathology or possesses qualifica-
(ii) Twelve (12) semester hours of biology, tions that are equivalent to those re-
which must include general biology and mo- quired for such certification; or
lecular biology, cell biology or genetics; and (iv) Subsequent to graduation, has
(iii) Twenty-four (24) semester hours of had 4 or more years of full-time general
chemistry, biology, or medical laboratory
science or medical laboratory technology in
laboratory training and experience of
any combination; and which at least 2 years were spent ac-
(ii) Have at least 2 years of laboratory quiring proficiency in one of the lab-
training or experience, or both, in nonwaived oratory specialties;
testing; and
775
§ 493.1407 42 CFR Ch. IV (10–1–24 Edition)
(3) For the subspecialty of oral pa- ary 1, 1958 required by State law for a labora-
thology only, be certified by the Amer- tory director license. An exception to the
ican Board of Oral Pathology, Amer- July 1, 1971 qualifying date in paragraph
(b)(5) of this section was made provided that
ican Board of Pathology or the Amer-
the individual requested qualification ap-
ican Osteopathic Board of Pathology or proval by October 21, 1975 and had been em-
possesses qualifications that are equiv- ployed in a laboratory for at least 3 years of
alent to those required for certifi- the 5 years preceding the date of submission
cation; of his qualifications.
(4) Hold an earned doctoral degree [58 FR 5233, Jan. 19, 1993]
from an accredited institution with a
chemical, physical, or biological EFFECTIVE DATE NOTE: At 88 FR 90039, Dec.
science as a major subject and 28, 2023, § 493.1406 was removed, effective Dec.
28, 2024.
(i) Is certified by the American Board
of Medical Microbiology, the American § 493.1407 Standard; Laboratory direc-
Board of Clinical Chemistry, the Amer- tor responsibilities.
ican Board of Bioanalysis, or other na-
tional accrediting board acceptable to The laboratory director is respon-
HHS in one of the laboratory special- sible for the overall operation and ad-
ties; or ministration of the laboratory, includ-
(ii) Subsequent to graduation, has ing the employment of personnel who
had 4 or more years of full-time general are competent to perform test proce-
laboratory training and experience of dures, and record and report test re-
which at least 2 years were spent ac- sults promptly, accurate, and pro-
quiring proficiency in one of the lab- ficiently and for assuring compliance
oratory specialties; with the applicable regulations.
(5) With respect to individuals first (a) The laboratory director, if quali-
qualifying before July 1, 1971, have fied, may perform the duties of the
been responsible for the direction of a technical consultant, clinical consult-
laboratory for 12 months between July ant, and testing personnel, or delegate
1, 1961, and January 1, 1968, and, in ad- these responsibilities to personnel
dition, either: meeting the qualifications of §§ 493.1409,
(i) Was a physician and subsequent to 493.1415, and 493.1421, respectively.
graduation had at least 4 years of per- (b) If the laboratory director reappor-
tinent full-time laboratory experience; tions performance of his or her respon-
(ii) Held a master’s degree from an sibilities, he or she remains responsible
accredited institution with a chemical, for ensuring that all duties are prop-
physical, or biological science as a erly performed.
major subject and subsequent to grad- (c) The laboratory director must be
uation had at least 4 years of pertinent accessible to the laboratory to provide
full-time laboratory experience; onsite, telephone or electronic con-
(iii) Held a bachelor’s degree from an sultation as needed.
accredited institution with a chemical, (d) Each individual may direct no
physical, or biological science as a more than five laboratories.
major subject and subsequent to grad- (e) The laboratory director must—
uation had at least 6 years of pertinent (1) Ensure that testing systems de-
full-time laboratory experience; or veloped and used for each of the tests
(iv) Achieved a satisfactory grade performed in the laboratory provide
through an examination conducted by quality laboratory services for all as-
or under the sponsorship of the U.S. pects of test performance, which in-
Public Health Service on or before July cludes the preanalytic, analytic, and
1, 1970; or postanalytic phases of testing;
(6) Qualify under State law to direct (2) Ensure that the physical plant
the laboratory in the State in which and environmental conditions of the
the laboratory is located. laboratory are appropriate for the test-
ing performed and provide a safe envi-
NOTE: The January 1, 1968 date for meeting
the 12 months’ laboratory direction require- ronment in which employees are pro-
ment in paragraph (b)(5) of this section may tected from physical, chemical, and bi-
be extended 1 year for each year of full-time ological hazards;
laboratory experience obtained before Janu- (3) Ensure that—
776
(i) The test methodologies selected (10) Employ a sufficient number of

have the capability of providing the laboratory personnel with the appro-
quality of results required for patient priate education and either experience
care; or training to provide appropriate con-
(ii) Verification procedures used are sultation, properly supervise and accu-
adequate to determine the accuracy, rately perform tests and report test re-
precision, and other pertinent perform- sults in accordance with the personnel
ance characteristics of the method; and responsibilities described in this sub-
(iii) Laboratory personnel are per- part;
forming the test methods as required (11) Ensure that prior to testing pa-
for accurate and reliable results; tients’ specimens, all personnel have
(4) Ensure that the laboratory is en- the appropriate education and experi-
rolled in an HHS approved proficiency ence, receive the appropriate training
testing program for the testing per- for the type and complexity of the
formed and that— services offered, and have dem-
(i) The proficiency testing samples onstrated that they can perform all
are tested as required under subpart H testing operations reliably to provide
of this part; and report accurate results;
(ii) The results are returned within (12) Ensure that policies and proce-
the timeframes established by the pro- dures are established for monitoring
ficiency testing program; individuals who conduct preanalytical,
analytical, and postanalytical phases
(iii) All proficiency testing reports
of testing to assure that they are com-
received are reviewed by the appro-
petent and maintain their competency
priate staff to evaluate the labora-
to process specimens, perform test pro-
tory’s performance and to identify any
cedures and report test results prompt-
problems that require corrective ac-
ly and proficiently, and whenever nec-
tion; and
essary, identify needs for remedial
(iv) An approved corrective action
training or continuing education to im-
plan is followed when any proficiency
prove skills;
testing results are found to be unac-
(13) Ensure that an approved proce-
ceptable or unsatisfactory;
dure manual is available to all per-
(5) Ensure that the quality control sonnel responsible for any aspect of the
and quality assessment programs are testing process; and
established and maintained to assure
(14) Specify, in writing, the respon-
the quality of laboratory services pro-
sibilities and duties of each consultant
vided and to identify failures in quality
and each person, engaged in the per-
as they occur; formance of the preanalytic, analytic,
(6) Ensure the establishment and and postanalytic phases of testing,
maintenance of acceptable levels of an- that identifies which examinations and
alytical performance for each test sys- procedures each individual is author-
tem; ized to perform, whether supervision is
(7) Ensure that all necessary reme- required for specimen processing, test
dial actions are taken and documented performance or results reporting, and
whenever significant deviations from whether consultant or director review
the laboratory’s established perform- is required prior to reporting patient
ance specifications are identified, and test results.
that patient test results are reported
only when the system is functioning [57 FR 7172, Feb. 28, 1992, as amended at 68
properly; FR 3713, Jan. 24, 2003]
(8) Ensure that reports of test results EFFECTIVE DATE NOTE: At 88 FR 90039, Dec.
include pertinent information required 28, 2023, § 493.1407 was amended by revising
for interpretation; paragraph (c), effective Dec. 28, 2024. For the
(9) Ensure that consultation is avail- set forth as follows:
able to the laboratory’s clients on mat-
ters relating to the quality of the test § 493.1407 Standard; Laboratory director re-
results reported and their interpreta- sponsibilities.
tion concerning specific patient condi-
tions; * * * * *
777
§ 493.1409 42 CFR Ch. IV (10–1–24 Edition)
(c) The laboratory director must: osteopathy, or podiatry in the State in
(1) Be onsite at least once every 6 months, which the laboratory is located; and
with at least 4 months between the min- (ii) Have at least one year of labora-
imum two on-site visits. Laboratory direc- tory training or experience, or both in
tors may elect to be on-site more frequently non-waived testing, in the designated
and must continue to be accessible to the
laboratory to provide telephone or electronic
specialty or subspecialty areas of serv-
consultation as needed; and ice for which the technical consultant
(2) Provide documentation of these visits, is responsible (for example, physicians
including evidence of performing activities certified either in hematology or he-
that are part of the laboratory director re- matology and medical oncology by the
sponsibilities. American Board of Internal Medicine
are qualified to serve as the technical
* * * * * consultant in hematology); or
(3)(i) Hold an earned doctoral or mas-
§ 493.1409 Condition: Laboratories per- ter’s degree in a chemical, physical, bi-
forming moderate complexity test- ological or clinical laboratory science
ing; technical consultant. or medical technology from an accred-
ited institution; and
The laboratory must have a technical (ii) Have at least one year of labora-
consultant who meets the qualification tory training or experience, or both in
requirements of § 493.1411 of this sub- non-waived testing, in the designated
part and provides technical oversight specialty or subspecialty areas of serv-
in accordance with § 493.1413 of this ice for which the technical consultant
subpart. is responsible; or
(4)(i) Have earned a bachelor’s degree
§ 493.1411 Standard; Technical con- in a chemical, physical or biological
sultant qualifications.
science or medical technology from an
The laboratory must employ one or accredited institution; and
more individuals who are qualified by (ii) Have at least 2 years of labora-
education and either training or expe- tory training or experience, or both in
rience to provide technical consulta- non-waived testing, in the designated
tion for each of the specialties and subspecialty or subspecialty areas of serv-
specialties of service in which the lab- ice for which the technical consultant
oratory performs moderate complexity is responsible.
tests or procedures. The director of a NOTE: The technical consultant require-
laboratory performing moderate comments for ‘‘laboratory training or experi-
plexity testing may function as the ence, or both’’ in each specialty or sub-
technical consultant provided he or she specialty may be acquired concurrently in
meets the qualifications specified in more than one of the specialties or sub-
this section. specialties of service, excluding waived tests.
(a) The technical consultant must For example, an individual who has a bach-
elor’s degree in biology and additionally has
possess a current license issued by the
documentation of 2 years of work experience
State in which the laboratory is lo- performing tests of moderate complexity in
cated, if such licensing is required. all specialties and subspecialties of service,
(b) The technical consultant must— would be qualified as a technical consultant
(1) (i) Be a doctor of medicine or doc- in a laboratory performing moderate com-
tor of osteopathy licensed to practice plexity testing in all specialties and sub-
specialties of service.
medicine or osteopathy in the State in
which the laboratory is located; and [57 FR 7172, Feb. 28, 1992, as amended at 58
(ii) Be certified in anatomic or clin- FR 5234, Jan. 19, 1993]
ical pathology, or both, by the Amer- EFFECTIVE DATE NOTE: At 88 FR 90040, Dec.
ican Board of Pathology or the Amer- 28, 2023, § 493.1411 was amended by revising
ican Osteopathic Board of Pathology or paragraph (b), effective Dec. 28, 2024. For the
possess qualifications that are equiva- convenience of the user, the revised text is
set forth as follows:
lent to those required for such certifi-
cation; or § 493.1411 Standard; Technical consultant
(2)(i) Be a doctor of medicine, doctor qualifications.
medicine licensed to practice medicine, * * * * *
778
(b) The technical consultant must— qualified as a technical consultant under
(1)(i) Be a doctor of medicine or doctor of this section if they were qualified and serv-
osteopathy licensed to practice medicine or ing as a technical consultant for moderate
osteopathy in the State in which the labora- complexity testing in a CLIA-certified lab-
tory is located; and oratory as of December 28, 2024, and have
(ii) Be certified in anatomic or clinical pa- done so continuously since December 28,
thology, or both, by the American Board of 2024.
Pathology or the American Osteopathic NOTE 1 TO PARAGRAPH (b): The technical
Board of Pathology; or consultant requirements for ‘‘laboratory
(2)(i) Be a doctor of medicine, doctor of os-
training or experience, or both’’ in each spe-
cialty or subspecialty may be acquired con-
currently in more than one of the specialties
podiatry in the State in which the labora-
or subspecialties of service, excluding waived
tory is located; and
(ii) Have at least 1 year of laboratory tests. For example, an individual who has a
training or experience, or both, in nonwaived bachelor’s degree in biology and additionally
testing, in the designated specialty or sub- has documentation of 2 years of work experi-
specialty areas of service for which the tech- ence performing tests of moderate com-
nical consultant is responsible (for example, plexity in all specialties and subspecialties
physicians certified either in hematology or of service, would be qualified as a technical
hematology and medical oncology by the consultant in a laboratory performing mod-
American Board of Internal Medicine are erate complexity testing in all specialties
qualified to serve as the technical consultant and subspecialties of service.
in hematology); or
(3)(i)(A) Hold an earned doctoral or mas- § 493.1413 Standard; Technical con-
ter’s degree in a chemical, biological, clin- sultant responsibilities.
ical or medical laboratory science, or med-
The technical consultant is respon-
ical technology from an accredited institu-
tion; or sible for the technical and scientific
(B) Meet either requirements in oversight of the laboratory. The tech-
§ 493.1405(b)(3)(i)(B) or (b)(4)(i)(B) or (C); and nical consultant is not required to be
(ii) Have at least 1 year of laboratory onsite at all times testing is per-
training or experience, or both, in nonwaived formed; however, he or she must be
testing, in the designated specialty or sub- available to the laboratory on an as
specialty areas of service for which the tech-
nical consultant is responsible; or
needed basis to provide consultation,
(4)(i)(A) Have earned a bachelor’s degree in as specified in paragraph (a) of this sec-
a chemical, biological, clinical or medical tion.
laboratory science, or medical technology (a) The technical consultant must be
from an accredited institution; or accessible to the laboratory to provide
(B) Meet § 493.1405(b)(5)(i)(B); and on-site, telephone, or electronic con-
(ii) Have at least 2 years of laboratory
sultation; and
training or experience, or both, in nonwaived
testing, in the designated specialty or sub- (b) The technical consultant is re-
specialty areas of service for which the tech- sponsible for—
nical consultant is responsible; or (1) Selection of test methodology ap-
(5)(i) Have earned an associate degree in propriate for the clinical use of the test
medical laboratory technology, medical lab- results;
oratory science, or clinical laboratory
science; and (2) Verification of the test procedures
(ii) Have at least 4 years of laboratory performed and the establishment of the
training or experience, or both, in nonwaived laboratory’s test performance charac-
testing, in the designated specialty or sub- teristics, including the precision and
specialty areas of service for which the tech- accuracy of each test and test system;
nical consultant is responsible. (3) Enrollment and participation in
(6) For blood gas analysis, the individual
must— an HHS approved proficiency testing
(i) Be qualified under paragraph (b)(1), (2), program commensurate with the serv-
(3), or (4) of this section; or ices offered;
(ii)(A) Have earned a bachelor’s degree in (4) Establishing a quality control
respiratory therapy or cardiovascular tech- program appropriate for the testing
nology from an accredited institution; and performed and establishing the param-
(B) Have at least 2 years of laboratory
training or experience, or both, in blood gas
eters for acceptable levels of analytic
analysis; or performance and ensuring that these
(7) Notwithstanding any other provision of levels are maintained throughout the
this section, an individual is considered entire testing process from the initial
779
§ 493.1415 42 CFR Ch. IV (10–1–24 Edition)
receipt of the specimen, through sam- § 493.1415 Condition: Laboratories per-

ple analysis and reporting of test re- forming moderate complexity test-
sults; ing; clinical consultant.
(5) Resolving technical problems and The laboratory must have a clinical
ensuring that remedial actions are consultant who meets the qualification
taken whenever test systems deviate requirements of § 493.1417 of this part
from the laboratory’s established per- and provides clinical consultation in
formance specifications; accordance with § 493.1419 of this part.
(6) Ensuring that patient test results
are not reported until all corrective ac- § 493.1417 Standard; Clinical consult-
tions have been taken and the test sys- ant qualifications.
tem is functioning properly;
(7) Identifying training needs and as- The clinical consultant must be
suring that each individual performing qualified to consult with and render
tests receives regular in-service train- opinions to the laboratory’s clients
ing and education appropriate for the concerning the diagnosis, treatment
type and complexity of the laboratory and management of patient care. The
services performed; clinical consultant must—
(8) Evaluating the competency of all (a) Be qualified as a laboratory direc-
testing personnel and assuring that the tor under § 493.1405(b) (1), (2), or (3)(i);
staff maintain their competency to or
perform test procedures and report test (b) Be a doctor of medicine, doctor of
results promptly, accurately and pro- osteopathy or doctor of podiatric medi-
ficiently. The procedures for evalua- cine and possess a license to practice
tion of the competency of the staff medicine, osteopathy or podiatry in
must include, but are not limited to— the State in which the laboratory is lo-
(i) Direct observations of routine pa- cated.
tient test performance, including pa- [57 FR 7172, Feb. 28, 1992, as amended at 58
tient preparation, if applicable, speci- FR 5234, Jan. 19, 1993]
men handling, processing and testing;
(ii) Monitoring the recording and re- EFFECTIVE DATE NOTE: At 88 FR 90040, Dec.
porting of test results; 28, 2023, § 493.1417 was amended by revising
paragraph (a), effective Dec. 28, 2024. For the
(iii) Review of intermediate test re- convenience of the user, the revised text is
sults or worksheets, quality control set forth as follows:
records, proficiency testing results,
and preventive maintenance records; § 493.1417 Standard; Clinical consultant
(iv) Direct observation of perform- qualifications.
ance of instrument maintenance and
function checks; * * * * *
(v) Assessment of test performance (a) Be qualified as a laboratory director
through testing previously analyzed under § 493.1405(b)(1), (2), or (3); or
specimens, internal blind testing sam-
ples or external proficiency testing
samples; and * * * * *
(vi) Assessment of problem solving
§ 493.1419 Standard; Clinical consult-
skills; and ant responsibilities.
(9) Evaluating and documenting the
performance of individuals responsible The clinical consultant provides con-
for moderate complexity testing at sultation regarding the appropriate-
least semiannually during the first ness of the testing ordered and inter-
year the individual tests patient speci- pretation of test results. The clinical
mens. Thereafter, evaluations must be consultant must—
performed at least annually unless test (a) Be available to provide clinical
methodology or instrumentation consultation to the laboratory’s cli-
changes, in which case, prior to report- ents;
ing patient test results, the individ- (b) Be available to assist the labora-
ual’s performance must be reevaluated tory’s clients in ensuring that appro-
to include the use of the new test priate tests are ordered to meet the
methodology or instrumentation. clinical expectations;
780
(c) Ensure that reports of test results (A) The skills required for proper
include pertinent information required specimen collection, including patient
for specific patient interpretation; and preparation, if applicable, labeling,
(d) Ensure that consultation is avail- handling, preservation or fixation,
able and communicated to the labora- processing or preparation, transpor-
tory’s clients on matters related to the tation and storage of specimens;
quality of the test results reported and (B) The skills required for imple-
their interpretation concerning spe- menting all standard laboratory proce-
cific patient conditions. dures;
(C) The skills required for performing
§ 493.1421 Condition: Laboratories per- each test method and for proper instru-
forming moderate complexity test- ment use;
ing; testing personnel. (D) The skills required for per-
The laboratory must have a suffi- forming preventive maintenance, trou-
cient number of individuals who meet bleshooting and calibration procedures
the qualification requirements of related to each test performed;
§ 493.1423, to perform the functions (E) A working knowledge of reagent
specified in § 493.1425 for the volume stability and storage;
and complexity of tests performed. (F) The skills required to implement
the quality control policies and proce-
§ 493.1423 Standard; Testing personnel dures of the laboratory;
qualifications. (G) An awareness of the factors that
Each individual performing moderate influence test results; and
complexity testing must— (H) The skills required to assess and
(a) Possess a current license issued verify the validity of patient test re-
by the State in which the laboratory is sults through the evaluation of quality
located, if such licensing is required; control sample values prior to report-
and ing patient test results.
(b) Meet one of the following require- [57 FR 7172, Feb. 28, 1992, as amended at 58
ments: FR 5234, Jan. 19, 1993]
(1) Be a doctor of medicine or doctor EFFECTIVE DATE NOTE: At 88 FR 90040, Dec.
of osteopathy licensed to practice med- 28, 2023, and corrected at 89 FR 6431, Feb. 1,
icine or osteopathy in the State in 2024, § 493.1423 was amended by revising para-
which the laboratory is located or have graph (b), effective Dec. 28, 2024. For the con-
earned a doctoral, master’s, or bach- venience of the user, the revised text with
elor’s degree in a chemical, physical, correction is set forth as follows:
biological or clinical laboratory § 493.1423 Standard; Testing personnel
science, or medical technology from an qualifications.
accredited institution; or
(2) Have earned an associate degree * * * * *
in a chemical, physical or biological (b) Meet one of the following requirements:
science or medical laboratory tech- (1) Be a doctor of medicine or doctor of os-
nology from an accredited institution; teopathy licensed to practice medicine or os-
or teopathy in the State in which the labora-
(3) Be a high school graduate or tory is located; or
equivalent and have successfully com- (2) Have earned a doctoral, master’s, or
pleted an official military medical lab- bachelor’s degree in a chemical, biological,
clinical or medical laboratory science, or
oratory procedures course of at least 50 medical technology, or nursing from an ac-
weeks duration and have held the mili- credited institution; or
tary enlisted occupational specialty of (3) Meet the requirements in
Medical Laboratory Specialist (Labora- § 493.1405(b)(3)(i)(B), (b)(4)(i)(B) or (C), or
tory Technician); or (b)(5)(i)(B); or
(4)(i) Have earned a high school di- (4) Have earned an associate degree in a
ploma or equivalent; and chemical, biological, clinical or medical lab-
oratory science, or medical laboratory tech-
(ii) Have documentation of training
nology or nursing from an accredited institu-
appropriate for the testing performed tion; or
prior to analyzing patient specimens. (5) Be a high school graduate or equivalent
Such training must ensure that the in- and have successfully completed an official
dividual has— military medical laboratory procedures
781
§ 493.1425 42 CFR Ch. IV (10–1–24 Edition)
course of at least a duration of 50 weeks and are authorized by the laboratory direc-
have held the military enlisted occupational tor and require a degree of skill com-
specialty of Medical Laboratory Specialist mensurate with the individual’s edu-
(Laboratory Technician); or
(6)(i) Have earned a high school diploma or
cation, training or experience, and
equivalent; and technical abilities.
(ii) Have documentation of laboratory (b) Each individual performing mod-
training appropriate for the testing per- erate complexity testing must—
formed prior to analyzing patient specimens. (1) Follow the laboratory’s proce-
Such training must ensure that the indi- dures for specimen handling and proc-
vidual has—
essing, test analyses, reporting and
(A) The skills required for proper specimen
collection, including patient preparation, if maintaining records of patient test re-
applicable, labeling, handling, preservation sults;
or fixation, processing or preparation, trans- (2) Maintain records that dem-
portation, and storage of specimens; onstrate that proficiency testing sam-
(B) The skills required for implementing ples are tested in the same manner as
all standard laboratory procedures; patient samples;
(C) The skills required for performing each
test method and for proper instrument use;
(3) Adhere to the laboratory’s quality
(D) The skills required for performing pre- control policies, document all quality
ventive maintenance, troubleshooting, and control activities, instrument and pro-
calibration procedures related to each test cedural calibrations and maintenance
performed; performed;
(E) A working knowledge of reagent sta- (4) Follow the laboratory’s estab-
bility and storage; lished corrective action policies and
(F) The skills required to implement the
quality control policies and procedures of
procedures whenever test systems are
the laboratory; not within the laboratory’s established
(G) An awareness of the factors that influ- acceptable levels of performance;
ence test results; and (5) Be capable of identifying problems
(H) The skills required to assess and verify that may adversely affect test perform-
the validity of patient test results through ance or reporting of test results and ei-
the evaluation of quality control sample val- ther must correct the problems or im-
ues prior to reporting patient test results.
(7) For blood gas analysis, the individual
mediately notify the technical consult-
must—(i) Be qualified under paragraph (b)(1), ant, clinical consultant or director;
(2), (3), (4), (5), or (6) of this section; or and
(ii)(A) Have earned a bachelor’s degree in (6) Document all corrective actions
respiratory therapy or cardiovascular tech- taken when test systems deviate from
nology from an accredited institution; and the laboratory’s established perform-
(B) Have at least 1 year of laboratory ance specifications.
training or experience, or both, in blood gas
analysis; or LABORATORIES PERFORMING HIGH
(iii)(A) Have earned an associate degree re-
lated to pulmonary function from an accred-
COMPLEXITY TESTING
(B) Have at least 2 years of laboratory § 493.1441 Condition: Laboratories per-
training or experience, or both, in blood gas forming high complexity testing;
analysis. laboratory director.
(8) Notwithstanding any other provision of The laboratory must have a director
this section, an individual is considered who meets the qualification require-
qualified as a testing personnel under this ments of § 493.1443 of this subpart and
section if they were qualified and serving as
provides overall management and di-
a testing personnel for moderate complexity
testing in a CLIA-certified laboratory as of rection in accordance with § 493.1445 of
December 28, 2024, and have done so continu- this subpart.
ously since December 28, 2024.
§ 493.1443 Standard; Laboratory direc-
§ 493.1425 Standard; Testing personnel tor qualifications.
responsibilities. The laboratory director must be
The testing personnel are responsible qualified to manage and direct the lab-
for specimen processing, test perform- oratory personnel and performance of
ance, and for reporting test results. high complexity tests and must be eli-
(a) Each individual performs only gible to be an operator of a laboratory
those moderate complexity tests that within the requirements of subpart R.
782
(a) The laboratory director must pos- (6) For the subspecialty of oral pa-
sess a current license as a laboratory thology, be certified by the American
director issued by the State in which Board of Oral Pathology, American
the laboratory is located, if such li- Board of Pathology, the American Os-
censing is required; and teopathic Board of Pathology, or pos-
(b) The laboratory director must— sess qualifications that are equivalent
(1)(i) Be a doctor of medicine or doc- to those required for certification.
tor of osteopathy licensed to practice
medicine or osteopathy in the State in FR 5234, Jan. 19, 1993; 59 FR 62609, Dec. 6,
which the laboratory is located; and 1994; 62 FR 25858, May 12, 1997; 63 FR 55034,
(ii) Be certified in anatomic or clin- Oct. 14, 1998; 65 FR 82944, Dec. 29, 2000; 68 FR
ical pathology, or both, by the Amer- 3713, Jan. 24, 2003]
ican Board of Pathology or the Amer- EFFECTIVE DATE NOTE: At 88 FR 90041, Dec.
ican Osteopathic Board of Pathology or 28, 2023, § 493.1443 was amended by revising
possess qualifications that are equiva- paragraph (b), effective Dec. 28, 2024. For the
lent to those required for such certifi- convenience of the user, the revised text is
cation; or set forth as follows:
(2) Be a doctor of medicine, a doctor
§ 493.1443 Standard: Laboratory director
of osteopathy or doctor of podiatric qualifications.
medicine licensed to practice medicine,
osteopathy or podiatry in the State in
which the laboratory is located; and * * * * *
(i) Have at least one year of labora- (b) The laboratory director must—
tory training during medical residency (1)(i) Be a doctor of medicine or doctor of
(for example, physicians certified ei- osteopathy licensed to practice medicine or
ther in hematology or hematology and osteopathy in the State in which the labora-
medical oncology by the American
(ii) Be certified in anatomic or clinical pa-
Board of Internal Medicine); or thology, or both, by the American Board of
(ii) Have at least 2 years of experi- Pathology or the American Osteopathic
ence directing or supervising high com- Board of Pathology; or
plexity testing; or (2)(i) Be a doctor of medicine, a doctor of
(3) Hold an earned doctoral degree in osteopathy, or doctor of podiatric medicine
a chemical, physical, biological, or licensed to practice medicine, osteopathy, or
clinical laboratory science from an ac- podiatry in the State in which the labora-
credited institution and— tory is located; and
(i) Be certified and continue to be (ii) Have at least 2 years of experience di-
recting or supervising high complexity test-
certified by a board approved by HHS; ing; and
or (iii) Have at least 20 CE credit hours in lab-
(ii) Before February 24, 2003, must oratory practice that cover the director re-
have served or be serving as a director sponsibilities defined in § 493.1445; or
of a laboratory performing high com- (3)(i)(A) Hold an earned doctoral degree in
plexity testing and must have at a chemical, biological, clinical or medical
least— laboratory science or medical technology
(A) Two years of laboratory training from an accredited institution; or
or experience, or both; and (B) Hold an earned doctoral degree; and
(1) Have at least 16 semester hours of doc-
(B) Two years of laboratory experi- toral level coursework in biology, chemistry,
ence directing or supervising high com- medical technology (MT), clinical laboratory
plexity testing. science (CLS), or medical laboratory science
(4) Be serving as a laboratory direc- (MLS); or
tor and must have previously qualified (2) An approved thesis or research project
or could have qualified as a laboratory in biology/chemistry/MT/CLS/MLS related to
director under regulations at 42 CFR laboratory testing for the diagnosis, preven-
493.1415, published March 14, 1990 at 55 tion, or treatment of any disease or impair-
ment of, or the assessment of the health of,
FR 9538, on or before February 28, 1992;
human beings; and
or (ii) Be certified and continue to be cer-
(5) On or before February 28, 1992, be tified by a board approved by HHS; and
qualified under State law to direct a (iii) Have at least 2 years of:
laboratory in the State in which the (A) Laboratory training or experience, or
laboratory is located; or both: and
783
§ 493.1445 42 CFR Ch. IV (10–1–24 Edition)
(B) Laboratory experience directing or su- ing performed and provide a safe envi-
pervising high complexity testing; and ronment in which employees are pro-
(iv) Have at least 20 CE credit hours in lab- tected from physical, chemical, and bi-
oratory practice that cover the director re-
sponsibilities defined in § 493.1445; or
ological hazards;
(4) Notwithstanding any other provision of (3) Ensure that—
this section, an individual is considered (i) The test methodologies selected
qualified as a laboratory director of high have the capability of providing the
complexity testing under this section if they quality of results required for patient
were qualified and serving as a laboratory di-
care;
rector of high complexity testing in a CLIA-
certified laboratory as of December 28, 2024, (ii) Verification procedures used are
and have done so continuously since Decem- adequate to determine the accuracy,
ber 28, 2024. precision, and other pertinent perform-
(5) For the subspecialty of oral pathology, ance characteristics of the method; and
be certified by the American Board of Oral (iii) Laboratory personnel are per-
Pathology, American Board of Pathology, or
forming the test methods as required
the American Osteopathic Board of Pathol-
ogy. for accurate and reliable results;
(4) Ensure that the laboratory is en-
§ 493.1445 Standard; Laboratory direc- rolled in an HHS-approved proficiency
tor responsibilities. testing program for the testing per-
The laboratory director is respon- formed and that—
sible for the overall operation and ad- (i) The proficiency testing samples
ministration of the laboratory, includ- are tested as required under subpart H
ing the employment of personnel who of this part;
are competent to perform test proce- (ii) The results are returned within
dures, record and report test results the timeframes established by the pro-
promptly, accurately and proficiently, ficiency testing program;
and for assuring compliance with the (iii) All proficiency testing reports
applicable regulations. received are reviewed by the appro-
(a) The laboratory director, if quali- priate staff to evaluate the labora-
fied, may perform the duties of the tory’s performance and to identify any
technical supervisor, clinical consult- problems that require corrective ac-
ant, general supervisor, and testing tion; and
personnel, or delegate these respon- (iv) An approved corrective action
sibilities to personnel meeting the plan is followed when any proficiency
qualifications under §§ 493.1447, 493.1453, testing result is found to be unaccept-
493.1459, and 493.1487, respectively. able or unsatisfactory;
(b) If the laboratory director reappor-
(5) Ensure that the quality control
tions performance of his or her respon-
and quality assessment programs are
sibilities, he or she remains responsible
established and maintained to assure
for ensuring that all duties are prop-
erly performed. the quality of laboratory services pro-
(c) The laboratory director must be vided and to identify failures in quality
accessible to the laboratory to provide as they occur;
onsite, telephone or electronic con- (6) Ensure the establishment and
sultation as needed. maintenance of acceptable levels of an-
(d) Each individual may direct no alytical performance for each test sys-
more than five laboratories. tem;
(e) The laboratory director must— (7) Ensure that all necessary reme-
(1) Ensure that testing systems de- dial actions are taken and documented
veloped and used for each of the tests whenever significant deviations from
performed in the laboratory provide the laboratory’s established perform-
quality laboratory services for all as- ance characteristics are identified, and
pects of test performance, which in- that patient test results are reported
cludes the preanalytic, analytic, and only when the system is functioning
postanalytic phases of testing; properly;
(2) Ensure that the physical plant (8) Ensure that reports of test results
and environmental conditions of the include pertinent information required
laboratory are appropriate for the test- for interpretation;
784
(9) Ensure that consultation is avail- is required prior to reporting patient

able to the laboratory’s clients on mat- test results.
ters relating to the quality of the test [57 FR 7172, Feb. 28, 1992, as amended at 68
results reported and their interpreta- FR 3714, Jan. 24, 2003]
tion concerning specific patient condi-
tions; 28, 2023, § 493.1445 was amended by revising
(10) Ensure that a general supervisor paragraphs (c) and (e)(10), effective Dec. 28,
provides on-site supervision of high 2024. For the convenience of the user, the re-
complexity test performance by testing vised text is set forth as follows:
personnel qualified under § 493.1445 Standard; Laboratory director re-
§ 493.1489(b)(4); sponsibilities.
(11) Employ a sufficient number of
laboratory personnel with the appro- * * * * *
priate education and either experience
(c) The laboratory director must:
or training to provide appropriate con- (1) Be onsite at least once every 6 months,
sultation, properly supervise and accu- with at least 4 months between the min-
rately perform tests and report test re- imum two on-site visits. Laboratory direc-
sults in accordance with the personnel tors may elect to be on-site more frequently
responsibilities described in this sub- and must continue to be accessible to the
part; laboratory to provide telephone or electronic
consultation as needed; and
(12) Ensure that prior to testing pa- (2) Provide documentation of these visits,
tients’ specimens, all personnel have including evidence of performing activities
the appropriate education and experi- that are part of the laboratory director re-
ence, receive the appropriate training sponsibilities.
for the type and complexity of the
services offered, and have dem- * * * * *
onstrated that they can perform all (e) * * *
testing operations reliably to provide (10) Ensure that a general supervisor pro-
and report accurate results; vides on-site supervision of high complexity
(13) Ensure that policies and proce- test performance by testing personnel quali-
dures are established for monitoring fied under § 493.1489(b)(5);
individuals who conduct preanalytical,
analytical, and postanalytical phases * * * * *
of testing to assure that they are com-
§ 493.1447 Condition: Laboratories per-
petent and maintain their competency forming high complexity testing;
to process specimens, perform test pro- technical supervisor.
cedures and report test results prompt-
The laboratory must have a technical
ly and proficiently, and whenever nec-
supervisor who meets the qualification
essary, identify needs for remedial
requirements of § 493.1449 of this sub-
training or continuing education to im-
part and provides technical supervision
prove skills;
in accordance with § 493.1451 of this
(14) Ensure that an approved proce- subpart.
dure manual is available to all per-
sonnel responsible for any aspect of the § 493.1449 Standard; Technical super-
testing process; and visor qualifications.
(15) Specify, in writing, the respon- The laboratory must employ one or
sibilities and duties of each consultant more individuals who are qualified by
and each supervisor, as well as each education and either training or expe-
person engaged in the performance of rience to provide technical supervision
the preanalytic, analytic, and for each of the specialties and sub-
postanalytic phases of testing, that specialties of service in which the lab-
identifies which examinations and pro- oratory performs high complexity tests
cedures each individual is authorized or procedures. The director of a labora-
to perform, whether supervision is re- tory performing high complexity test-
quired for specimen processing, test ing may function as the technical su-
performance or result reporting and pervisor provided he or she meets the
whether supervisory or director review qualifications specified in this section.
785
§ 493.1449 42 CFR Ch. IV (10–1–24 Edition)
(a) The technical supervisor must of 6 months experience in high com-

possess a current license issued by the plexity testing within the subspecialty
State in which the laboratory is lo- of bacteriology; or
cated, if such licensing is required; and (4)(i) Have earned a master’s degree
(b) The laboratory may perform ana- in a chemical, physical, biological or
tomic and clinical laboratory proce- clinical laboratory science or medical
dures and tests in all specialties and technology from an accredited institu-
subspecialties of services except tion; and
histocompatibility and clinical cyto- (ii) Have at least 2 years of labora-
genetics services provided the indi- tory training or experience, or both, in
vidual functioning as the technical su- high complexity testing within the spe-
pervisor— cialty of microbiology with a minimum
(1) Is a doctor of medicine or doctor of 6 months experience in high com-
of osteopathy licensed to practice med- plexity testing within the subspecialty
icine or osteopathy in the State in of bacteriology; or
which the laboratory is located; and (5)(i) Have earned a bachelor’s degree
(2) Is certified in both anatomic and in a chemical, physical, or biological
clinical pathology by the American science or medical technology from an
Board of Pathology or the American accredited institution; and
Osteopathic Board of Pathology or Pos-
(ii) Have at least 4 years of labora-
sesses qualifications that are equiva-
tory training or experience, or both, in
lent to those required for such certifi-
high complexity testing within the spe-
cation.
cialty of microbiology with a minimum
(c) If the requirements of paragraph
of 6 months experience in high com-
(b) of this section are not met and the
plexity testing within the subspecialty
laboratory performs tests in the sub-
of bacteriology.
specialty of bacteriology, the indi-
(d) If the requirements of paragraph
vidual functioning as the technical su-
(b) of this section are not met and the
pervisor must—
laboratory performs tests in the sub-
(1)(i) Be a doctor of medicine or doc-
specialty of mycobacteriology, the in-
tor of osteopathy licensed to practice
dividual functioning as the technical
medicine or osteopathy in the State in
supervisor must—
which the laboratory is located; and
(ii) Be certified in clinical pathology (1)(i) Be a doctor of medicine or doc-
by the American Board of Pathology or tor of osteopathy licensed to practice
the American Osteopathic Board of Pa- medicine or osteopathy in the State in
thology or possess qualifications that which the laboratory is located; and
are equivalent to those required for (ii) Be certified in clinical pathology
such certification; or by the American Board of Pathology or
(2)(i) Be a doctor of medicine, doctor the American Osteopathic Board of Pa-
of osteopathy, or doctor of podiatric thology or possess qualifications that
medicine licensed to practice medicine, are equivalent to those required for
osteopathy, or podiatry in the State in such certification; or
which the laboratory is located; and (2)(i) Be a doctor of medicine, doctor
(ii) Have at least one year of labora- of osteopathy, or doctor or podiatric
tory training or experience, or both, in medicine licensed to practice medicine,
high complexity testing within the spe- osteopathy, or podiatry in the State in
cialty of microbiology with a minimum which the laboratory is located; and
of 6 months experience in high com- (ii) Have at least 1 year of laboratory
plexity testing within the subspecialty training or experience, or both, in high
of bacteriology; or complexity testing within the spe-
(3)(i) Have an earned doctoral degree cialty of microbiology with a minimum
in a chemical, physical, biological or of 6 months experience in high com-
clinical laboratory science from an ac- plexity testing within the subspecialty
credited institution; and of mycobacteriology; or
(ii) Have at least 1 year of laboratory (3)(i) Have an earned doctoral degree
training or experience, or both, in high in a chemical, physical, biological or
complexity testing within the spe- clinical laboratory science from an ac-
cialty of microbiology with a minimum credited institution; and
786
plexity testing within the subspecialty training or experience, or both in high
of mycobacteriology; or complexity testing within the spe-
(4)(i) Have earned a master’s degree ciality of microbiology with a min-
in a chemical, physical, biological or imum of 6 months experience in high
clinical laboratory science or medical complexity testing within the sub-
technology from an accredited institu- specialty of mycology; or
tion; and (4)(i) Have earned a master’s degree
(ii) Have at least 2 years of labora- in a chemical, physical, biological or
tory training or experience, or both, in clinical laboratory science or medical
high complexity testing within the spe- technology from an accredited institu-
cialty of microbiology with a minimum tion; and
of 6 months experience in high com- (ii) Have at least 2 years of labora-
plexity testing within the subspecialty tory training or experience, or both, in
of mycobacteriology; or high complexity testing within the spe-
(5)(i) Have earned a bachelor’s degree cialty of microbiology with a minimum
in a chemical, physical or biological of 6 months experience in high com-
science or medical technology from an plexity testing within the subspecialty
accredited institution; and of mycology; or
(ii) Have at least 4 years of labora- (5)(i) Have earned a bachelor’s degree
tory training or experience, or both, in in a chemical, physical or biological
high complexity testing within the spe- science or medical technology from an
cialty of microbiology with a minimum accredited institution; and
of mycobacteriology. high complexity testing within the spe-
(e) If the requirements of paragraph cialty of microbiology with a minimum
(b) of this section are not met and the of 6 months experience in high com-
laboratory performs tests in the sub- plexity testing within the subspecialty
specialty of mycology, the individual of mycology.
functioning as the technical supervisor (f) If the requirements of paragraph
must— (b) of this section are not met and the
(1)(i) Be a doctor of medicine or doc- laboratory performs tests in the sub-
tor of osteopathy licensed to practice specialty of parasitology, the indi-
medicine or osteopathy in the State in vidual functioning as the technical su-
which the laboratory is located; and pervisor must—
(ii) Be certified in clinical pathology (1)(i) Be a doctor of medicine or a
by the American Board of Pathology or doctor of osteopathy licensed to prac-
the American osteopathic Board of Pa- tice medicine or osteopathy in the
thology or possess qualifications that State in which the laboratory is lo-
are equivalent to those required for cated; and
such certification; or (ii) Be certified in clinical pathology
(2)(i) Be a doctor of medicine, doctor by the American Board of Pathology or
of osteopathy, or doctor of podiatric the American Osteopathic Board of Pa-
medicine licensed to practice medicine, thology or possess qualifications that
osteopathy, or podiatry in the State in are equivalent to those required for
which the laboratory is located; and such certification; or
(ii) Have at least 1 year of laboratory (2)(i) Be a doctor of medicine, doctor
training or experience, or both, in high of osteopathy, or doctor of podiatric
complexity testing within the spe- medicine licensed to practice medicine,
cialty of microbiology with a minimum osteopathy, or podiatry in the State in
of 6 months experience in high com- which the laboratory is located; and
plexity testing within the subspecialty (ii) Have at least one year of labora-
of mycology; or tory training or experience, or both, in
787
§ 493.1449 42 CFR Ch. IV (10–1–24 Edition)
high complexity testing within the spe- osteopathy, or podiatry in the State in
cialty of microbiology with a minimum which the laboratory is located; and
of parasitology; complexity testing within the spe-
(3)(i) Have an earned doctoral degree cialty of microbiology with a minimum
clinical laboratory science from an ac- plexity testing within the subspecialty
credited institution; and of virology; or
of parasitology; or complexity testing within the spe-
(4)(i) Have earned a master’s degree cialty of microbiology with a minimum
clinical laboratory science or medical plexity testing within the subspecialty
technology from an accredited institu- of virology; or
tion; and (4)(i) Have earned a master’s degree
(ii) Have at least 2 years of labora- in a chemical, physical, biological or
tory training or experience, or both, in clinical laboratory science or medical
high complexity testing within the spe- technology from an accredited institu-
cialty of microbiology with a minimum tion; and
of parasitology; or high complexity testing within the spe-
(5)(i) Have earned a bachelor’s degree cialty of microbiology with a minimum
in a chemical, physical or biological of 6 months experience in high com-
science or medical technology from an plexity testing within the subspecialty
accredited institution; and of virology; or
(ii) Have at least 4 years of labora- (5)(i) Have earned a bachelor’s degree
tory training or experience, or both, in in a chemical, physical or biological
high complexity testing within the spe- science or medical technology from an
cialty of microbiology with a minimum accredited institution; and
of parasitology. high complexity testing within the spe-
(g) If the requirements of paragraph cialty of microbiology with a minimum
(b) of this section are not met and the of 6 months experience in high com-
laboratory performs tests in the sub- plexity testing within the subspecialty
specialty of virology, the individual of virology.
functioning as the technical supervisor (h) If the requirements of paragraph
must— (b) of this section are not met and the
(1)(i) Be a doctor of medicine or doc- laboratory performs tests in the spe-
tor of osteopathy licensed to practice cialty of diagnostic immunology, the
medicine or osteopathy in the State in individual functioning as the technical
which the laboratory is located; and supervisor must—
(ii) Be certified in clinical pathology (1)(i) Be a doctor of medicine or a
by the American Board of Pathology or doctor of osteopathy licensed to prac-
the American Osteopathic Board of Pa- tice medicine or osteopathy in the
thology or possess qualifications that State in which the laboratory is lo-
are equivalent to those required for cated; and
such certification; or (ii) Be certified in clinical pathology
(2)(i) Be a doctor of medicine, doctor by the American Board of Pathology or
of osteopathy, or doctor of podiatric the American Osteopathic Board of Pa-
medicine licensed to practice medicine, thology or possess qualifications that
788
are equivalent to those required for complexity testing for the specialty of
such certification; or chemistry; or
(2)(i) Be a doctor of medicine, doctor (3)(i) Have an earned doctoral degree
of osteopathy, or doctor of podiatric in a chemical, physical, biological or
medicine licensed to practice medicine, clinical laboratory science from an ac-
osteopathy, or podiatry in the State in credited institution; and
which the laboratory is located; and (ii) Have at least 1 year of laboratory
(ii) Have at least 1 year of laboratory training or experience, or both, in high
training or experience, or both, in high complexity testing within the spe-
complexity testing for the specialty of cialty of chemistry; or
diagnostic immunology; or (4)(i) Have earned a master’s degree
(3)(i) Have an earned doctoral degree in a chemical, physical, biological or
in a chemical, physical, biological or clinical laboratory science or medical
clinical laboratory science from an ac- technology from an accredited institu-
credited institution; and tion; and
(ii) Have at least 1 year of laboratory (ii) Have at least 2 years of labora-
training or experience, or both, in high tory training or experience, or both, in
complexity testing within the spe- high complexity testing for the spe-
cialty of diagnostic immunology; or cialty of chemistry; or
(4)(i) Have earned a master’s degree (5)(i) Have earned a bachelor’s degree
in a chemical, physical, biological or in a chemical, physical or biological
clinical laboratory science or medical science or medical technology from an
technology from an accredited institu- accredited institution; and
tion; and (ii) Have at least 4 years of labora-
(ii) Have at least 2 years of laboratory training or experience, or both, in
tory training or experience, or both, in high complexity testing for the spe-
high complexity testing for the specialty of chemistry.
cialty of diagnostic immunology; or (j) If the requirements of paragraph
(5) (i) Have earned a bachelor’s de- (b) of this section are not met and the
gree in a chemical, physical or biologi- laboratory performs tests in the spe-
cal science or medical technology from cialty of hematology, the individual
an accredited institution; and functioning as the technical supervisor
(ii) Have at least 4 years of labora- must—
tory training or experience, or both, in (1)(i) Be a doctor of medicine or a
high complexity testing for the spe- doctor of osteopathy licensed to prac-
cialty of diagnostic immunology. tice medicine or osteopathy in the
(i) If the requirements of paragraph State in which the laboratory is lo-
(b) of this section are not met and the cated; and
laboratory performs tests in the spe- (ii) Be certified in clinical pathology
cialty of chemistry, the individual by the American Board of Pathology or
functioning as the technical supervisor the American Osteopathic Board of Pa-
must— thology or possess qualifications that
(1)(i) Be a doctor of medicine or doc- are equivalent to those required for
tor of osteopathy licensed to practice such certification; or
medicine or osteopathy in the State in (2)(i) Be a doctor of medicine, doctor
which the laboratory is located; and of osteopathy, or doctor of podiatric
(ii) Be certified in clinical pathology medicine licensed to practice medicine,
by the American Board of Pathology or osteopathy, or podiatry in the State in
the American Osteopathic Board of Pa- which the laboratory is located; and
thology or possess qualifications that (ii) Have at least one year of labora-
are equivalent to those required for tory training or experience, or both, in
such certification; or high complexity testing for the spe-
(2)(i) Be a doctor of medicine, doctor cialty of hematology (for example,
of osteopathy, or doctor of podiatric physicians certified either in hema-
medicine licensed to practice medicine, tology or hematology and medical on-
osteopathy, or podiatry in the State in cology by the American Board of Inter-
which the laboratory is located; and nal Medicine); or
789
§ 493.1449 42 CFR Ch. IV (10–1–24 Edition)
clinical laboratory science from an ac- sponsibilities of the cytology technical

credited institution; and supervisor are met.
(ii) Have at least 1 year of laboratory (l) If the requirements of paragraph
training or experience, or both, in high (b) of this section are not met and the
complexity testing within the spe- laboratory performs tests in the sub-
cialty of hematology; or specialty of histopathology, the indi-
(4)(i) Have earned a master’s degree vidual functioning as the technical su-
in a chemical, physical, biological or pervisor must—
clinical laboratory science or medical (1) Meet one of the following require-
technology from an accredited institu- ments:
tion; and (i) (A) Be a doctor of medicine or a
(ii) Have at least 2 years of labora- doctor of osteopathy licensed to prac-
tory training or experience, or both, in tice medicine or osteopathy in the
high complexity testing for the spe- State in which the laboratory is lo-
cialty of hematology; or cated; and
(5)(i) Have earned a bachelor’s degree (B) Be certified in anatomic pathol-
in a chemical, physical or biological ogy by the American Board of Pathol-
science or medical technology from an ogy or the American Osteopathic Board
accredited institution; and of Pathology or possess qualifications
that are equivalent to those required
for such certification;
tory training or experience, or both, in
(ii) An individual qualified under
high complexity testing for the spe-
§ 493.1449(b) or paragraph (l)(1) of this
cialty of hematology.
section may delegate to an individual
(k)(1) If the requirements of para- who is a resident in a training program
graph (b) of this section are not met leading to certification specified in
and the laboratory performs tests in paragraph (b) or (l)(1)(i)(B) of this sec-
the subspecialty of cytology, the indi- tion, the responsibility for examina-
vidual functioning as the technical su- tion and interpretation of
pervisor must— histopathology specimens.
(i) Be a doctor of medicine or a doc- (2) For tests in dermatopathology,
tor of osteopathy licensed to practice meet one of the following require-
medicine or osteopathy in the State in ments:
which the laboratory is located; and (i) (A) Be a doctor of medicine or doc-
(ii) Meet one of the following require- tor of osteopathy licensed to practice
ments— medicine or osteopathy in the State in
(A) Be certified in anatomic pathol- which the laboratory is located and—
ogy by the American Board of Pathol- (B) Meet one of the following require-
ogy or the American Osteopathic Board ments:
of Pathology or possess qualifications (1) Be certified in anatomic pathol-
that are equivalent to those required ogy by the American Board of Pathol-
for such certification; or ogy or the American Osteopathic Board
(B) Be certified by the American So- of Pathology or possess qualifications
ciety of Cytology to practice that are equivalent to those required
cytopathology or possess qualifications for such certification; or
that are equivalent to those required (2) Be certified in dermatopathology
for such certification; by the American Board of Dermatology
(2) An individual qualified under and the American Board of Pathology
§ 493.1449(b) or paragraph (k)(1) of this or possess qualifications that are
section may delegate some of the cy- equivalent to those required for such
tology technical supervisor responsibil- certification; or
ities to an individual who is in the (3) Be certified in dermatology by the
final year of full-time training leading American Board of Dermatology or
to certification specified in paragraphs possess qualifications that are equiva-
(b) or (k)(1)(ii)(A) of this section pro- lent to those required for such certifi-
vided the technical supervisor qualified cation; or
under § 493.1449(b) or paragraph (k)(1) of (ii) An individual qualified under
this section remains ultimately respon- § 493.1449(b) or paragraph (l)(2)(i) of this
sible for ensuring that all of the re- section may delegate to an individual
790
who is a resident in a training program or possess qualifications for such cer-

leading to certification specified in tification; or
paragraphs (b) or (l)(2)(i)(B) of this sec- (3) An individual qualified under
tion, the responsibility for examina- § 493.1449(b) or paragraph (m) (1) or (2)
tion and interpretation of of this section may delegate to an indi-
dermatopathology specimens. vidual who is a resident in a training
(3) For tests in ophthalmic pathol- program leading to certification speci-
ogy, meet one of the following require- fied in paragraphs (b) or (m) (1) or (2) of
ments: this section, the responsibility for ex-
(i)(A) Be a doctor of medicine or doc- amination and interpretation of oral
tor of osteopathy licensed to practice pathology specimens.
medicine or osteopathy in the State in (n) If the requirements of paragraph
which the laboratory is located and— (b) of this section are not met and the
(B) Must meet one of the following laboratory performs tests in the spe-
requirements: cialty of radiobioassay, the individual
(1) Be certified in anatomic pathol- functioning as the technical supervisor
ogy by the American Board of Pathol- must—
ogy or the American Osteopathic Board (1)(i) Be a doctor of medicine or a
of Pathology or possess qualifications doctor of osteopathy licensed to prac-
that are equivalent to those required tice medicine or osteopathy in the
for such certification; or State in which the laboratory is lo-
(2) Be certified by the American cated; and
Board of Ophthalmology or possess (ii) Be certified in clinical pathology
qualifications that are equivalent to by the American Board of Pathology or
those required for such certitication the American Osteopathic Board of Pa-
and have successfully completed at thology or possess qualifications that
least 1 year of formal post-residency are equivalent to those required for
fellowship training in ophthalmic pa- such certification; or
thology; or (2)(i) Be a doctor of medicine, doctor
(ii) An individual qualified under of osteopathy, or doctor of podiatric
§ 493.1449(b) or paragraph (1)(3)(i) of this medicine licensed to practice medicine,
section may delegate to an individual osteopathy, or podiatry in the State in
who is a resident in a training program which the laboratory is located; and
leading to certification specified in (ii) Have at least 1 year of laboratory
paragraphs (b) or (1)(3)(i)(B) of this sec- training or experience, or both, in high
tion, the responsibility for examina- complexity testing for the specialty of
tion and interpretation of ophthalmic radiobioassay; or
specimens; or (3)(i) Have an earned doctoral degree
(m) If the requirements of paragraph in a chemical, physical, biological or
(b) of this section are not met and the clinical laboratory science from an ac-
laboratory performs tests in the sub- credited institution; and
specialty of oral pathology, the indi- (ii) Have at least 1 year of laboratory
vidual functioning as the technical su- training or experience, or both, in high
pervisor must meet one of the fol- complexity testing within the spe-
lowing requirements: cialty of radiobioassay; or
(1)(i) Be a doctor of medicine or a (4)(i) Have earned a master’s degree
doctor of osteopathy licensed to prac- in a chemical, physical, biological or
tice medicine or osteopathy in the clinical laboratory science or medical
State in which the laboratory is lo- technology from an accredited institu-
cated and— tion; and
(ii) Be certified in anatomic pathol- (ii) Have at least 2 years of labora-
ogy by the American Board of Pathol- tory training or experience, or both, in
ogy or the American Osteopathic Board high complexity testing for the spe-
of Pathology or possess qualifications cialty of radiobioassay; or
that are equivalent to those required (5)(i) Have earned a bachelor’s degree
for such certification; or in a chemical, physical or biological
(2) Be certified in oral pathology by science or medical technology from an
the American Board of Oral Pathology accredited institution; and
791
(ii) Have at least 4 years of labora- (ii) Have 4 years of training or experi-
tory training or experience, or both, in ence, or both, in genetics, 2 of which
high complexity testing for the spe- have been in clinical cytogenetics.
cialty of radiobioassay. (q) If the requirements of paragraph
(o) If the laboratory performs tests in (b) of this section are not met and the
the specialty of histocompatibility, the laboratory performs tests in the spe-
individual functioning as the technical cialty of immunohematology, the indi-
supervisor must either— vidual functioning as the technical su-
(1)(i) Be a doctor of medicine, doctor pervisor must—
of osteopathy, or doctor of podiatric (1)(i) Be a doctor of medicine or a
medicine licensed to practice medicine, doctor of osteopathy licensed to prac-
osteopathy, or podiatry in the State in tice medicine or osteopathy in the
which the laboratory is located; and State in which the laboratory is lo-
(ii) Have training or experience that cated; and
meets one of the following require- (ii) Be certified in clinical pathology
ments: by the American Board of Pathology or
the American Osteopathic Board of Pa-
(A) Have 4 years of laboratory train-
thology or possess qualifications that
ing or experience, or both, within the
are equivalent to those required for
specialty of histocompatibility; or
such certification; or
(B)(1) Have 2 years of laboratory (2)(i) Be a doctor of medicine, doctor
training or experience, or both, in the of osteopathy, or doctor of podiatric
specialty of general immunology; and medicine licensed to practice medicine,
(2) Have 2 years of laboratory train- osteopathy, or podiatry in the State in
ing or experience, or both, in the spe- which the laboratory is located; and
cialty of histocompatibility; or (ii) Have at least one year of labora-
(2)(i) Have an earned doctoral degree tory training or experience, or both, in
in a biological or clinical laboratory high complexity testing for the spe-
science from an accredited institution; cialty of immunohematology.
and
NOTE: The technical supervisor require-
(ii) Have training or experience that ments for ‘‘laboratory training or experi-
meets one of the following require- ence, or both’’ in each specialty or sub-
ments: specialty may be acquired concurrently in
(A) Have 4 years of laboratory train- more than one of the specialties or sub-
ing or experience, or both, within the specialties of service. For example, an indi-
specialty of histocompatibility; or vidual, who has a doctoral degree in chem-
istry and additionally has documentation of
(B)(1) Have 2 years of laboratory 1 year of laboratory experience working con-
training or experience, or both, in the currently in high complexity testing in the
specialty of general immunology; and specialties of microbiology and chemistry
(2) Have 2 years of laboratory train- and 6 months of that work experience in-
ing or experience, or both, in the spe- cluded high complexity testing in bacteri-
cialty of histocompatibility. ology, mycology, and mycobacteriology,
would qualify as the technical supervisor for
(p) If the laboratory performs tests in the specialty of chemistry and the sub-
the specialty of clinical cytogenetics, specialties of bacteriology, mycology, and
the individual functioning as the tech- mycobacteriology.
nical supervisor must—
(1)(i) Be a doctor of medicine, doctor FR 5234, Jan. 19, 1993]
medicine licensed to practice medicine, EFFECTIVE DATE NOTE: At 88 FR 90041, Dec.
28, 2023, § 493.1449 was revised, effective Dec.
osteopathy, or podiatry in the State in 28, 2024. For the convenience of the user, the
which the laboratory is located; and revised text is set forth as follows:
(ii) Have 4 years of training or experi-
ence, or both, in genetics, 2 of which § 493.1449 Standard; Technical supervisor
qualifications.
have been in clinical cytogenetics; or
The laboratory must employ one or more
(2)(i) Hold an earned doctoral degree
individuals who are qualified by education
in a biological science, including bio- and either training or experience to provide
chemistry, or clinical laboratory technical supervision for each of the special-
science from an accredited institution; ties and subspecialties of service in which
and the laboratory performs high complexity
792
tests or procedures. The director of a labora- (B)(1) Meet bachelor’s degree equivalency;
tory performing high complexity testing and
may function as the technical supervisor (2) Have at least 16 semester hours of addi-
provided he or she meets the qualifications tional graduate level coursework in chem-
specified in this section. ical, biological, clinical or medical labora-
(a) The technical supervisor must possess a tory science, or medical technology; or
current license issued by the State in which (C)(1) Meet bachelor’s degree equivalency;
the laboratory is located, if such licensing is and
required; and (2) Have at least 16 semester hours in a
(b) The laboratory may perform anatomic combination of graduate level coursework in
and clinical laboratory procedures and tests biology, chemistry, medical technology, or
in all specialties and subspecialties of serv- clinical or medical laboratory science and an
ices except histocompatibility and clinical approved thesis or research project related
cytogenetics services provided the individual to laboratory testing for the diagnosis, pre-
functioning as the technical supervisor— vention, or treatment of any disease or im-
(1) Is a doctor of medicine or doctor of os- pairment of, or the assessment of the health
teopathy licensed to practice medicine or os- of, human beings; and
teopathy in the State in which the labora- (ii) Have at least 2 years of laboratory
tory is located; and training or experience, or both, in high com-
(2) Is certified in both anatomic and clin- plexity testing within the specialty of micro-
biology with a minimum of 6 months of expe-
ical pathology by the American Board of Pa-
rience in high complexity testing within the
thology or the American Osteopathic Board
applicable subspecialty; or
of Pathology.
(5)(i)(A) Have earned a bachelor’s degree in
(c) Bacteriology, Mycobacteriology, My-
a chemical, biological, clinical or medical
cology, Parasitology or Virology—If the re-
laboratory science, or medical technology
quirements of paragraph (b) of this section
from an accredited institution; or
are not met and the laboratory performs (B) Have at least 120 semester hours, or
tests in the subspecialty of bacteriology, equivalent, from an accredited institution
mycobacteriology, mycology, parasitology, that, at a minimum, includes either—
or virology, the individual functioning as the (1) Forty-eight (48) semester hours of med-
technical supervisor must— ical laboratory technology courses; or
(1)(i) Be a doctor of medicine or doctor of (2) Forty-eight (48) semester hours of
osteopathy licensed to practice medicine or science courses that include—
osteopathy in the State in which the labora- (i) Twelve (12) semester hours of chemistry,
tory is located; and which must include general chemistry and
(ii) Be certified in clinical pathology by biochemistry or organic chemistry;
the American Board of Pathology or the (ii) Twelve (12) semester hours of biology,
American Osteopathic Board of Pathology; which must include general biology and mo-
or lecular biology, cell biology or genetics; and
(2)(i) Be a doctor of medicine, doctor of os- (iii) Twenty-four (24) semester hours of
teopathy, or doctor of podiatric medicine li- chemistry, biology, or medical laboratory
censed to practice medicine, osteopathy, or science or technology in any combination;
podiatry in the State in which the labora- and
tory is located; and (ii) Have at least 4 years of laboratory
(ii) Have at least 1 year of laboratory training or experience, or both, in high com-
training or experience, or both, in high complexity testing within the specialty of micro-
plexity testing within the specialty of microbiology with a minimum of 6 months of expe-
biology with a minimum of 6 months of experience in high complexity testing within the
rience in high complexity testing within the applicable subspecialty.
applicable microbiology subspecialty; or (d) Diagnostic Immunology, Chemistry,
(3)(i)(A) Have an earned doctoral degree in Hematology, Radiobioassay, or
a chemical, biological, clinical or medical Immunohematology—If the requirements of
laboratory science, or medical technology paragraph (b) of this section are not met and
from an accredited institution; or the laboratory performs tests in the spe-
(B) Meet the requirements in cialty of diagnostic immunology, chemistry,
§ 493.1443(b)(3)(i)(B); and hematology, radiobioassay, or
(ii) Have at least 1 year of laboratory immunohematology, the individual func-
training or experience, or both, in high com- tioning as the technical supervisor must—
plexity testing within the specialty of micro- (1)(i) Be a doctor of medicine or a doctor of
biology with a minimum of 6 months of expe- osteopathy licensed to practice medicine or
rience in high complexity testing within the osteopathy in the State in which the labora-
applicable subspecialty; or tory is located; and
(4)(i)(A) Have earned a master’s degree in a (ii) Be certified in clinical pathology by
chemical, biological, clinical or medical lab- the American Board of Pathology or the
oratory science, or medical technology from American Osteopathic Board of Pathology;
an accredited institution; or or
793
(2)(i) Be a doctor of medicine, doctor of os- specialty of histopathology, the individual
teopathy, or doctor of podiatric medicine li- functioning as the technical supervisor
censed to practice medicine, osteopathy, or must—
podiatry in the State in which the labora- (1) Meet one of the following requirements:
tory is located; and (i)(A) Be a doctor of medicine or a doctor
(ii) Have at least 1 year of laboratory of osteopathy licensed to practice medicine
training or experience, or both, in high com- or osteopathy in the State in which the lab-
plexity testing for the applicable specialty; oratory is located; and
or (B) Be certified in anatomic pathology by
(3)(i)(A) Have an earned doctoral degree in the American Board of Pathology or the
a chemical, biological, clinical or medical American Osteopathic Board of Pathology;
laboratory science, or medical technology or
from an accredited institution; or (ii) An individual qualified under para-
(B) Meet the education requirement at graph (b) of this section or this paragraph
§ 493.1443(b)(3)(i)(B); and (f)(1) may delegate to an individual who is a
(ii) Have at least 1 year of laboratory resident in a training program leading to
training or experience, or both, in high com- certification specified in paragraph (b) or
plexity testing within the applicable spe- (f)(1)(i)(B) of this section, the responsibility
cialty; or for examination and interpretation of
(4)(i)(A) Have earned a master’s degree in a histopathology specimens.
chemical, biological, clinical or medical lab- (2) For tests in dermatopathology, meet
oratory science, or medical technology from one of the following requirements:
an accredited institution; or (i)(A) Be a doctor of medicine or doctor of
(B) Meet the education requirement at osteopathy licensed to practice medicine or
paragraph (c)(4)(i)(B) or (C) of this section; osteopathy in the State in which the labora-
and tory is located; and
(ii) Have at least 2 years of laboratory (B) Meet one of the following require-
training or experience, or both, in high comments:
plexity testing for the applicable specialty; (1) Be certified in anatomic pathology by
or the American Board of Pathology or the
(5)(i)(A) Have earned a bachelor’s degree in American Osteopathic Board of Pathology;
a chemical, biological, clinical or medical or
laboratory science, or medical technology (2) Be certified in dermatopathology by the
from an accredited institution; or American Board of Dermatology and the
(B) Meet the education requirement at American Board of Pathology; or
paragraph (c)(5)(i)(B) of this section; and (3) Be certified in dermatology by the
(ii) Have at least 4 years of laboratory American Board of Dermatology; or
training or experience, or both, in high com- (ii) An individual qualified under para-
plexity testing for the applicable specialty. graph (b) or (f)(2)(i) of this section may dele-
(e) Cytology—If the requirements of para- gate to an individual who is a resident in a
graph (b) of this section are not met and the training program leading to certification
laboratory performs tests in the subspecialty specified in paragraph (b) or (f)(2)(i)(B) of
of cytology, the individual functioning as this section, the responsibility for examina-
the technical supervisor must— tion and interpretation of dermatopathology
(1)(i) Be a doctor of medicine or a doctor of specimens.
osteopathy licensed to practice medicine or (3) For tests in ophthalmic pathology,
osteopathy in the State in which the labora- meet one of the following requirements:
tory is located; and (i)(A) Be a doctor of medicine or doctor of
(ii) Be certified in anatomic pathology by osteopathy licensed to practice medicine or
the American Board of Pathology or the osteopathy in the State in which the labora-
American Osteopathic Board of Pathology; tory is located; and
or (B) Must meet one of the following require-
(2) An individual qualified under paragraph ments:
(b) or (e)(1) of this section may delegate (1) Be certified in anatomic pathology by
some of the cytology technical supervisor re- the American Board of Pathology or the
sponsibilities to an individual who is in the American Osteopathic Board of Pathology;
final year of full-time training leading to or
certification specified in paragraph (b) or (2) Be certified by the American Board of
(e)(1)(ii) of this section provided the tech- Ophthalmology and have successfully com-
nical supervisor qualified under paragraph pleted at least 1 year of formal post-resi-
(b) or (e)(1) of this section remains ulti- dency fellowship training in ophthalmic pa-
mately responsible for ensuring that all of thology; or
the responsibilities of the cytology technical (ii) An individual qualified under para-
supervisor are met. graph (b) or (f)(3)(i) of this section may dele-
(f) Histopathology—If the requirements of gate to an individual who is a resident in a
paragraph (b) of this section are not met and training program leading to certification
the laboratory performs tests in the sub- specified in paragraph (b) or (f)(3)(i)(B) of
794
this section, the responsibility for examina- togenetics, the individual functioning as the
tion and interpretation of ophthalmic speci- technical supervisor must—
mens; or (1)(i) Be a doctor of medicine, doctor of os-
(g) Oral Pathology—If the requirements of teopathy, or doctor of podiatric medicine li-
paragraph (b) of this section are not met and censed to practice medicine, osteopathy, or
the laboratory performs tests in the sub- podiatry in the State in which the labora-
specialty of oral pathology, the individual tory is located; and
functioning as the technical supervisor must (ii) Have 4 years of laboratory training or
meet one of the following requirements: experience, or both, in genetics, 2 of which
(1)(i) Be a doctor of medicine or a doctor of have been in clinical cytogenetics; or
osteopathy licensed to practice medicine or (2)(i) Hold an earned doctoral degree in a
osteopathy in the State in which the labora- biological science, including biochemistry,
tory is located; and clinical or medical laboratory science, or
(ii) Be certified in anatomic pathology by medical technology from an accredited insti-
the American Board of Pathology or the tution; or meet the education requirement at
American Osteopathic Board of Pathology; § 493.1443(b)(3)(i)(B); and
or
(ii) Have 4 years of laboratory training or
(2) Be certified in oral pathology by the experience, or both, in genetics, 2 of which
American Board of Oral Pathology; or have been in clinical cytogenetics.
(3) An individual qualified under paragraph
(j) Notwithstanding any other provision of
(b) or (g)(1) or (2) of this section may dele-
this section, an individual is considered
gate to an individual who is a resident in a
qualified as a technical supervisor under this
training program leading to certification
specified in paragraph (b) or (g)(1) or (2) of
a technical supervisor for high complexity
this section, the responsibility for examina-
testing in a CLIA-certified laboratory as of
tion and interpretation of oral pathology
December 28, 2024, and have done so continu-
specimens.
ously since December 28, 2024.
(h) Histocompatibility—If the laboratory
performs tests in the specialty of NOTE 1 TO PARAGRAPHS (b) THROUGH (i): The
histocompatibility, the individual func- technical supervisor requirements for ‘‘lab-
tioning as the technical supervisor must ei- oratory training or experience, or both’’ in
ther— each specialty or subspecialty may be ac-
quired concurrently in more than one of the
specialties or subspecialties of service. For
example, an individual, who has a doctoral
degree in chemistry and additionally has
podiatry in the State in which the labora-
documentation of 1 year of laboratory expe-
rience working concurrently in high com-
(ii) Have training or experience that meets
plexity testing in the specialties of microbi-
one of the following requirements:
ology and chemistry and 6 months of that
(A) Have 4 years of laboratory training or
work experience included high complexity
experience, or both, within the specialty of
testing in bacteriology, mycology, and
histocompatibility; or
mycobacteriology, would qualify as the tech-
(B)(1) Have 2 years of laboratory training
nical supervisor for the specialty of chem-
or experience, or both, in the specialty of
istry and the subspecialties of bacteriology,
general immunology; and
mycology, and mycobacteriology.
(2) Have 2 years of laboratory training or
experience, or both, in the specialty of
histocompatibility; or
§ 493.1451 Standard: Technical super-
(2)(i) Have an earned doctoral degree in a
visor responsibilities.
biological, clinical or medical laboratory The technical supervisor is respon-
science, or medical technology from an ac- sible for the technical and scientific
credited institution; or meet the education oversight of the laboratory. The tech-
requirement at § 493.1443(b)(3)(i)(B); and
nical supervisor is not required to be
(ii) Have training or experience that meets
one of the following requirements: on site at all times testing is per-
(A) Have 4 years of laboratory training or formed; however, he or she must be
experience, or both, within the specialty of available to the laboratory on an as
histocompatibility; or needed basis to provide supervision as
(B)(1) Have 2 years of laboratory training specified in (a) of this section.
or experience, or both, in the specialty of (a) The technical supervisor must be
general immunology; and accessible to the laboratory to provide
(2) Have 2 years of laboratory training or
experience, or both, in the specialty of
on-site, telephone, or electronic con-
histocompatibility. sultation; and
(i) Clinical cytogenetics—If the laboratory (b) The technical supervisor is re-
performs tests in the specialty of clinical cy- sponsible for—
795
(1) Selection of the test methodology (v) Assessment of test performance

that is appropriate for the clinical use through testing previously analyzed
of the test results; specimens, internal blind testing sam-
(2) Verification of the test procedures ples or external proficiency testing
performed and establishment of the samples; and
laboratory’s test performance charac- (vi) Assessment of problem solving
teristics, including the precision and skills; and
accuracy of each test and test system; (9) Evaluating and documenting the
(3) Enrollment and participation in performance of individuals responsible
an HHS approved proficiency testing for high complexity testing at least
program commensurate with the serv- semiannually during the first year the
ices offered; individual tests patient specimens.
(4) Establishing a quality control Thereafter, evaluations must be per-
program appropriate for the testing formed at least annually unless test
performed and establishing the param- methodology or instrumentation
eters for acceptable levels of analytic
changes, in which case, prior to report-
performance and ensuring that these
ing patient test results, the individ-
levels are maintained throughout the
entire testing process from the initial ual’s performance must be reevaluated
receipt of the specimen, through sam- to include the use of the new test
ple analysis and reporting of test re- methodology or instrumentation.
sults; (c) In cytology, the technical super-
(5) Resolving technical problems and visor or the individual qualified under
ensuring that remedial actions are § 493.1449(k)(2)—
taken whenever test systems deviate (1) May perform the duties of the cy-
from the laboratory’s established per- tology general supervisor and the
formance specifications; cytotechnologist, as specified in
(6) Ensuring that patient test results §§ 493.1471 and 493.1485, respectively;
are not reported until all corrective ac- (2) Must establish the workload limit
tions have been taken and the test sys- for each individual examining slides;
tem is functioning properly; (3) Must reassess the workload limit
(7) Identifying training needs and as- for each individual examining slides at
suring that each individual performing least every 6 months and adjust as nec-
tests receives regular in-service train- essary;
ing and education appropriate for the (4) Must perform the functions speci-
type and complexity of the laboratory fied in § 493.1274(d) and (e);
services performed; (5) Must ensure that each individual
(8) Evaluating the competency of all examining gynecologic preparations
testing personnel and assuring that the participates in an HHS approved cytol-
staff maintain their competency to ogy proficiency testing program, as
perform test procedures and report test specified in § 493.945 and achieves a
results promptly, accurately and pro-
passing score, as specified in § 493.855;
ficiently. The procedures for evalua-
and
tion of the competency of the staff
must include, but are not limited to— (6) If responsible for screening cytol-
(i) Direct observations of routine pa- ogy slide preparations, must document
tient test performance, including pa- the number of cytology slides screened
tient preparation, if applicable, speci- in 24 hours and the number of hours de-
men handling, processing and testing; voted during each 24-hour period to
(ii) Monitoring the recording and rescreening cytology slides.
porting of test results; [57 FR 7172, Feb. 28, 1992, as amended at 58
(iii) Review of intermediate test re- FR 5235, Jan. 19, 1993; 68 FR 3714, Jan. 24,
sults or worksheets, quality control 2003]
records, proficiency testing results, EFFECTIVE DATE NOTE: At 88 FR 90043, Dec.
and preventive maintenance records; 28, 2023, § 493.1451 was amended by revising
(iv) Direct observation of perform- paragraph (c), effective Dec. 28, 2024. For the
ance of instrument maintenance and convenience of the user, the revised text is
function checks; set forth as follows:
796
§ 493.1451 Standard: Technical supervisor ness of the testing ordered and inter-
responsibilities. pretation of test results. The clinical
consultant must—
* * * * * (a) Be available to provide consulta-
(c) In cytology, the technical supervisor or tion to the laboratory’s clients;
the individual qualified under (b) Be available to assist the labora-
§ 493.1449(e)(2)— tory’s clients in ensuring that appro-
priate tests are ordered to meet the
* * * * * clinical expectations;
(c) Ensure that reports of test results
§ 493.1453 Condition: Laboratories per- include pertinent information required
forming high complexity testing; for specific patient interpretation; and
clinical consultant. (d) Ensure that consultation is avail-
The laboratory must have a clinical able and communicated to the labora-
consultant who meets the require- tory’s clients on matters related to the
ments of § 493.1455 of this subpart and quality of the test results reported and
provides clinical consultation in ac- their interpretation concerning spe-
cordance with § 493.1457 of this subpart. cific patient conditions.
§ 493.1455 Standard; Clinical consult- § 493.1459 Condition: Laboratories per-
ant qualifications. forming high complexity testing;
The clinical consultant must be general supervisor.
qualified to consult with and render The laboratory must have one or
opinions to the laboratory’s clients more general supervisors who are
concerning the diagnosis, treatment qualified under § 493.1461 of this subpart
and management of patient care. The to provide general supervision in ac-
clinical consultant must— cordance with § 493.1463 of this subpart.
(a) Be qualified as a laboratory direc-
tor under § 493.1443(b)(1), (2), or (3)(i) or, § 493.1461 Standard: General super-
for the subspecialty of oral pathology, visor qualifications.
§ 493.1443(b)(6); or The laboratory must have one or
(b) Be a doctor of medicine, doctor of more general supervisors who, under
osteopathy, doctor of podiatric medi- the direction of the laboratory director
cine licensed to practice medicine, os- and supervision of the technical super-
teopathy, or podiatry in the State in visor, provides day-to-day supervision
which the laboratory is located. of testing personnel and reporting of
test results. In the absence of the di-
FR 5235, Jan. 19, 1993] rector and technical supervisor, the
general supervisor must be responsible
EFFECTIVE DATE NOTE: At 88 FR 90043, Dec. for the proper performance of all lab-
oratory procedures and reporting of
convenience of the user, the revised text is test results.
set forth as follows: (a) The general supervisor must pos-
sess a current license issued by the
§ 493.1455 Standard: Clinical consultant State in which the laboratory is lo-
qualifications.
cated, if such licensing is required; and
(b) The general supervisor must be
* * * * * qualified as a—
(a) Be qualified as a laboratory director (1) Laboratory director under
under § 493.1443(b)(1), (2), or (3) or, for the § 493.1443; or
subspecialty of oral pathology, (2) Technical supervisor under
§ 493.1443(b)(5); § 493.1449.
(c) If the requirements of paragraph
* * * * * (b)(1) or paragraph (b)(2) of this section
are not met, the individual functioning
§ 493.1457 Standard; Clinical consult- as the general supervisor must—
ant responsibilities. (1)(i) Be a doctor of medicine, doctor
The clinical consultant provides con- of osteopathy, or doctor of podiatric
sultation regarding the appropriate- medicine licensed to practice medicine,
797
osteopathy, or podiatry in the State in in high complexity testing, including

which the laboratory is located or have at least 6 years of supervisory experi-
earned a doctoral, master’s, or bach- ence between September 1, 1982 and
elor’s degree in a chemical, physical, September 1, 1992.
biological or clinical laboratory (d) For blood gas analysis, the indi-
science, or medical technology from an vidual providing general supervision
accredited institution; and must—
(ii) Have at least 1 year of laboratory (1) Be qualified under § 493.1461(b) (1)
training or experience, or both, in high or (2), or § 493.1461(c); or
complexity testing; or
(2)(i) Have earned a bachelor’s degree
(2)(i) Qualify as testing personnel
in respiratory therapy or cardio-
under § 493.1489(b)(2); and
vascular technology from an accredited
tory training or experience, or both, in institution; and
high complexity testing; or (ii) Have at least one year of labora-
(3)(i) Except as specified in paragraph tory training or experience, or both, in
(3)(ii) of this section, have previously blood gas analysis; or
qualified as a general supervisor under (3)(i) Have earned an associate degree
§ 493.1462 on or before February 28, 1992. related to pulmonary function from an
(ii) Exception. An individual who accredited institution; and
achieved a satisfactory grade in a pro- (ii) Have at least two years of train-
ficiency examination for technologist ing or experience, or both in blood gas
given by HHS between March 1, 1986 analysis.
and December 31, 1987, qualifies as a (e) The general supervisor require-
general supervisor if he or she meets ment is met in histopathology, oral pa-
the requirements of § 493.1462 on or be- thology, dermatopathology, and oph-
fore January 1, 1994.’’ thalmic pathology because all tests
(4) On or before September 1, 1992, and examinations, must be performed:
have served as a general supervisor of (1) In histopathology, by an indi-
high complexity testing and as of April vidual who is qualified as a technical
24, 1995— supervisor under § 493.1449(b) or
(i) Meet one of the following require-
§ 493.1449(l)(1);
ments:
(2) In dermatopathology, by an indi-
(A) Have graduated from a medical
laboratory or clinical laboratory train- vidual who is qualified as a technical
ing program approved or accredited by supervisor under § 493.1449(b) or
the Accrediting Bureau of Health Edu- § 493.1449(l) or (2);
cation Schools (ABHES), the Commis- (3) In ophthalmic pathology, by an
sion on Allied Health Education Ac- individual who is qualified as a tech-
creditation (CAHEA), or other organi- nical supervisor under § 493.1449(b) or
zation approved by HHS. § 493.1449(1)(3); and
(B) Be a high school graduate or (4) In oral pathology, by an indi-
equivalent and have successfully com- vidual who is qualified as a technical
pleted an official U.S. military medical supervisor under § 493.1449(b) or
laboratory procedures course of at § 493.1449(m).
least 50 weeks duration and have held [57 FR 7172, Feb. 28, 1992, as amended at 58
the military enlisted occupational spe- FR 5235, Jan. 19, 1993; 58 FR 39155, July 22,
cialty of Medical Laboratory Specialist 1993; 60 FR 20049, Apr. 24, 1995]
(Laboratory Technician).
(ii) Have at least 2 years of clinical EFFECTIVE DATE NOTE: At 88 FR 90043, Dec.
28, 2023, and corrected at 89 FR 6431, Feb. 1,
laboratory training, or experience, or
2024, § 493.1461 was amended by revising para-
both, in high complexity testing; or graphs (c), (d)(3)(i), and (e)(1) through (4).
(5) On or before September 1, 1992, For the convenience of the user, the revised
have served as a general supervisor of text is set forth as follows:
high complexity testing and—
(i) Be a high school graduate or § 493.1461 Standard: General supervisor
equivalent; and qualifications.
(ii) Have had at least 10 years of lab-
oratory training or experience, or both, * * * * *
798
(c) If the requirements of paragraph (b)(1) (1) Who qualifies as a laboratory di-
or (2) of this section are not met, the indi- rector under § 493.1406(b)(1), (2), (4), or
vidual functioning as the general supervisor (5) is also qualified as a general super-
must—
visor; therefore, depending upon the
teopathy, or doctor of podiatric medicine li- size and functions of the laboratory,
censed to practice medicine, osteopathy, or the laboratory director may also serve
podiatry in the State in which the labora- as the laboratory supervisor; or
tory is located or have earned a doctoral, (2)(i) Is a physician or has earned a
master’s, or bachelor’s degree in a chemical, doctoral degree from an accredited in-
biological, clinical or medical laboratory stitution with a major in one of the
science, or medical technology from an ac- chemical, physical, or biological
credited institution; and sciences; and
(ii) Have at least 1 year of laboratory
(ii) Subsequent to graduation, has
training or experience, or both, in high com-
plexity testing; or had at least 2 years of experience in
(2)(i) Qualify as testing personnel under one of the laboratory specialties in a
§ 493.1489(b)(3); and laboratory; or
(ii) Have at least 2 years of laboratory (3)(i) Holds a master’s degree from an
training or experience, or both, in high com- accredited institution with a major in
plexity testing; or one of the chemical, physical, or bio-
(3) Meet the requirements at § 493.1443(b)(3) logical sciences; and
or § 493.1449(c)(4) or (5); or (ii) Subsequent to graduation has had
(4) Notwithstanding any other provision of
this section, an individual is considered
at least 4 years of pertinent full-time
qualified as a general supervisor under this laboratory experience of which not less
section if they were qualified and serving as than 2 years have been spent working
a general supervisor in a CLIA-certified lab- in the designated specialty in a labora-
oratory as of December 28, 2024, and have tory; or
done so continuously since December 28, (4)(i) Is qualified as a laboratory
2024. technologist under § 493.1491; and
(d) * * * (ii) After qualifying as a laboratory
(3)(i) Have earned an associate degree re- technologist, has had at least 6 years of
lated to pulmonary function from an accred-
pertinent full-time laboratory experi-
ence of which not less than 2 years
have been spent working in the des-
* * * * * ignated laboratory specialty in a lab-
(e) * * * oratory; or
(1) In histopathology, by an individual who (5) With respect to individuals first
is qualified as a technical supervisor under qualifying before July 1, 1971, has had
§ 493.1449(b) or (f)(1); at least 15 years of pertinent full-time
(2) In dermatopathology, by an individual
who is qualified as a technical supervisor
laboratory experience before January
under § 493.1449(b) or (f)(2); 1, 1968; this required experience may be
(3) In ophthalmic pathology, by an indi- met by the substitution of education
vidual who is qualified as a technical super- for experience.
visor under § 493.1449(b) or (f)(3); and
[58 FR 39155, July 22, 1993]
(4) In oral pathology, by an individual who
is qualified as a technical supervisor under EFFECTIVE DATE NOTE: At 88 FR 90044, Dec.
§ 493.1449(b) or (g). 28, 2023, § 493.1462 was removed, effective Dec.
28, 2024.
§ 493.1462 General supervisor quali-
fications on or before February 28, § 493.1463 Standard: General super-
1992. visor responsibilities.
To qualify as a general supervisor The general supervisor is responsible
under § 493.1461(c)(3), an individual for day-to-day supervision or oversight
must have met or could have met the of the laboratory operation and per-
following qualifications as they were in sonnel performing testing and report-
effect on or before February 28, 1992. ing test results.
(a) Each supervisor possesses a cur- (a) The general supervisor—(1) Must
rent license as a laboratory supervisor be accessible to testing personnel at all
issued by the State, if such licensing times testing is performed to provide
exists; and on-site, telephone or electronic con-
(b) The laboratory supervisor— sultation to resolve technical problems
799
in accordance with policies and proce- (4) Evaluating and documenting the com-
dures established either by the labora- petency of all testing personnel.
tory director or technical supervisor;
(2) Is responsible for providing day- * * * * *
to-day supervision of high complexity
test performance by a testing per- § 493.1467 Condition: Laboratories per-
sonnel qualified under § 493.1489; forming high complexity testing; cy-
tology general supervisor.
(3) Except as specified in paragraph
(c) of this section, must be onsite to For the subspecialty of cytology, the
provide direct supervision when high laboratory must have a general super-
complexity testing is performed by any visor who meets the qualification re-
individuals qualified under quirements of § 493.1469 of this subpart,
§ 493.1489(b)(5); and and provides supervision in accordance
(4) Is responsible for monitoring test with § 493.1471 of this subpart.
analyses and specimen examinations to
§ 493.1469 Standard: Cytology general
ensure that acceptable levels of ana- supervisor qualifications.
lytic performance are maintained.
(b) The director or technical super- The cytology general supervisor
visor may delegate to the general su- must be qualified to supervise cytology
pervisor the responsibility for— services. The general supervisor in cy-
(1) Assuring that all remedial actions tology must possess a current license
are taken whenever test systems devi- issued by the State in which the lab-
ate from the laboratory’s established oratory is located, if such licensing is
performance specifications; required, and must—
(a) Be qualified as a technical super-
(2) Ensuring that patient test results
visor under § 493.1449 (b) or (k); or
are not reported until all corrective ac-
(b)(1) Be qualified as a
tions have been taken and the test sys-
cytotechnologist under § 493.1483; and
tem is properly functioning;
(2) Have at least 3 years of full-time
(3) Providing orientation to all test-
(2,080 hours per year) experience as a
ing personnel; and
cytotechnologist within the preceding
(4) Annually evaluating and docu- 10 years.
menting the performance of all testing
personnel. EFFECTIVE DATE NOTE: At 88 FR 90044, Dec.
(c) Exception. For individuals quali-
fied under § 493.1489(b)(5), who were per- convenience of the user, the revised text is
forming high complexity testing on or set forth as follows:
before January 19, 1993, the require-
ments of paragraph (a)(3) of this sec- § 493.1469 Standard: Cytology general su-
pervisor qualifications.
tion are not effective, provided that all
high complexity testing performed by
the individual in the absence of a gen- * * * * *
eral supervisor is reviewed within 24 (a) Be qualified as a technical supervisor
hours by a general supervisor qualified under § 493.1449(b) or (e); or
under § 493.1461.
[57 FR 7172, Feb. 28, 1992, as amended at 58 * * * * *
FR 5235, Jan. 19, 1993; 60 FR 20050, Apr. 24,
1995] § 493.1471 Standard: Cytology general
supervisor responsibilities.
28, 2023, § 493.1463 was amended by revising The technical supervisor of cytology
paragraph (b)(4), effective Dec. 28, 2024. For may perform the duties of the cytology
the convenience of the user, the revised text general supervisor or delegate the re-
is set forth as follows: sponsibilities to an individual qualified
under § 493.1469.
§ 493.1463 Standard: General supervisor re-
sponsibilities. (a) The cytology general supervisor is
responsible for the day-to-day super-
vision or oversight of the laboratory
* * * * * operation and personnel performing
(b) * * * testing and reporting test results.
800
(b) The cytology general supervisor (A) Have had 12 months of training in
must— a school of cytotechnology accredited
(1) Be accessible to provide on-site, by an accrediting agency approved by
telephone, or electronic consultation HHS; or
to resolve technical problems in ac- (B) Have received 6 months of formal
cordance with policies and procedures training in a school of cytotechnology
established by the technical supervisor accredited by an accrediting agency
of cytology; approved by HHS and 6 months of full-
(2) Document the slide interpretation time experience in cytotechnology in a
results of each gynecologic and laboratory acceptable to the patholo-
nongynecologic cytology case he or she gist who directed the formal 6 months
examined or reviewed (as specified of training; or
under § 493.1274(c)); (ii) Have achieved a satisfactory
(3) For each 24-hour period, document grade to qualify as a cytotechnologist
the total number of slides he or she ex- in a proficiency examination approved
amined or reviewed in the laboratory by HHS and designed to qualify persons
as well as the total number of slides ex- as cytotechnologists; or
amined or reviewed in any other lab- (4) Before September 1, 1994, have
oratory or for any other employer; and full-time experience of at least 2 years
(4) Document the number of hours or equivalent within the preceding 5
spent examining slides in each 24-hour years examining slide preparations
period. under the supervision of a physician
[57 FR 7172, Feb. 28, 1992, as amended at 68 qualified under § 493.1449(b) or (k)(1),
FR 3714, Jan. 24, 2003] and before January 1, 1969, must have—
(i) Graduated from high school;
§ 493.1481 Condition: Laboratories per- (ii) Completed 6 months of training
forming high complexity testing; in cytotechnology in a laboratory di-
cytotechnologist. rected by a pathologist or other physi-
For the subspecialty of cytology, the cian providing cytology services; and
laboratory must have a sufficient num- (iii) Completed 2 years of full-time
ber of cytotechnologists who meet the supervised experience in
qualifications specified in § 493.1483 to cytotechnology; or
perform the functions specified in (5)(i) On or before September 1, 1994,
§ 493.1485. have full-time experience of at least 2
years or equivalent examining cytol-
§ 493.1483 Standard: Cytotechnologist ogy slide preparations within the pre-
qualifications.
ceding 5 years in the United States
Each person examining cytology under the supervision of a physician
slide preparations must meet the quali- qualified under § 493.1449(b) or (k)(1);
fications of § 493.1449 (b) or (k), or— and
(a) Possess a current license as a (ii) On or before September 1, 1995,
cytotechnologist issued by the State in have met the requirements in either
which the laboratory is located, if such paragraph (b)(1) or (2) of this section.
licensing is required; and
(b) Meet one of the following require- [57 FR 7172, Feb. 28, 1992, as amended at 59
FR 685, Jan. 6, 1994]
ments:
(1) Have graduated from a school of EFFECTIVE DATE NOTE: At 88 FR 90044, Dec.
cytotechnology accredited by the Com- 28, 2023, and corrected at 89 FR 6431, Feb. 1,
mittee on Allied Health Education and 2024, § 493.1483 was amended by revising the
Accreditation or other organization ap- introductory text and paragraph (b), effec-
tive Dec. 28, 2024. For the convenience of the
proved by HHS; or user, the revised text is set forth as follows:
(2) Be certified in cytotechnology by
a certifying agency approved by HHS; § 493.1483 Standard: Cytotechnologist quali-
or fications.
(3) Before September 1, 1992— Each person examining cytology slide
(i) Have successfully completed 2 preparations must meet the qualifications of
years in an accredited institution with § 493.1449 (b) or (e), or—
at least 12 semester hours in science, 8
hours of which are in biology; and * * * * *
801
§ 493.1485 42 CFR Ch. IV (10–1–24 Edition)
(b) Meet one of the following requirements: earned a doctoral, master’s or bach-
(1) Have graduated from a school of elor’s degree in a chemical, physical,
cytotechnology accredited by the Commis- biological or clinical laboratory
sion on Accreditation of Allied Health Edu-
cation Programs (CAAHEP); or
science, or medical technology from an
(2) Be certified in cytotechnology by a cer- accredited institution;
tifying agency approved by HHS; or (2)(i) Have earned an associate degree
(3) Notwithstanding any other provision of in a laboratory science, or medical lab-
this section, an individual is considered oratory technology from an accredited
qualified as a cytotechnologist under this institution or—
a cytotechnologist in a CLIA-certified lab- (ii) Have education and training
oratory as of December 28, 2024, and have equivalent to that specified in para-
done so continuously since December 28, graph (b)(2)(i) of this section that in-
2024. cludes—
(A) At least 60 semester hours, or
§ 493.1485 Standard; Cytotechnologist equivalent, from an accredited institu-
responsibilities. tion that, at a minimum, include ei-
The cytotechnologist is responsible ther—
for documenting— (1) 24 semester hours of medical lab-
(a) The slide interpretation results of oratory technology courses; or
each gynecologic and nongynecologic (2) 24 semester hours of science
cytology case he or she examined or re- courses that include—
viewed (as specified in § 493.1274(c)); (i) Six semester hours of chemistry;
(b) For each 24-hour period, the total
(ii) Six semester hours of biology; and
number of slides examined or reviewed
(iii) Twelve semester hours of chem-
in the laboratory as well as the total
istry, biology, or medical laboratory
number of slides examined or reviewed
technology in any combination; and
in any other laboratory or for any
other employer; and (B) Have laboratory training that in-
(c) The number of hours spent exam- cludes either of the following:
ining slides in each 24-hour period. (1) Completion of a clinical labora-
tory training program approved or ac-
[57 FR 7172, Feb. 28, 1992, as amended at 68 credited by the ABHES, the CAHEA, or
FR 3714, Jan. 24, 2003]
other organization approved by HHS.
§ 493.1487 Condition: Laboratories per- (This training may be included in the
forming high complexity testing; 60 semester hours listed in paragraph
testing personnel. (b)(2)(ii)(A) of this section.)
The laboratory has a sufficient num- (2) At least 3 months documented
ber of individuals who meet the quali- laboratory training in each specialty in
fication requirements of § 493.1489 of which the individual performs high
this subpart to perform the functions complexity testing.
specified in § 493.1495 of this subpart for (3) Have previously qualified or could
the volume and complexity of testing have qualified as a technologist under
performed. § 493.1491 on or before February 28, 1992;
(4) On or before April 24, 1995 be a
§ 493.1489 Standard; Testing personnel high school graduate or equivalent and
qualifications. have either—
Each individual performing high (i) Graduated from a medical labora-
complexity testing must— tory or clinical laboratory training
(a) Possess a current license issued program approved or accredited by
by the State in which the laboratory is ABHES, CAHEA, or other organization
located, if such licensing is required; approved by HHS; or
and (ii) Successfully completed an official
(b) Meet one of the following require- U.S. military medical laboratory pro-
ments: cedures training course of at least 50
(1) Be a doctor of medicine, doctor of weeks duration and have held the mili-
osteopathy, or doctor of podiatric med- tary enlisted occupational specialty of
icine licensed to practice medicine, os- Medical Laboratory Specialist (Labora-
teopathy, or podiatry in the State in tory Technician);
which the laboratory is located or have (5)(i) Until September 1, 1997—
802
(A) Have earned a high school di- EFFECTIVE DATE NOTE: At 88 FR 90044, Dec.
ploma or equivalent; and 28, 2023, § 493.1489 was amended by revising
(B) Have documentation of training paragraph (b), effective Dec. 28, 2024. For the
appropriate for the testing performed set forth as follows:
before analyzing patient specimens.
Such training must ensure that the in- § 493.1489 Standard; Testing personnel
dividual has— qualifications.
(1) The skills required for proper
specimen collection, including patient * * * * *
preparation, if applicable, labeling, (b) Meet one of the following requirements:
handling, preservation or fixation, (1) Be a doctor of medicine, doctor of oste-
processing or preparation, transpor- opathy, or doctor of podiatric medicine li-
tation and storage of specimens; censed to practice medicine, osteopathy, or
(2) The skills required for imple- podiatry in the State in which the labora-
menting all standard laboratory proce- tory is located; or
dures; (2)(i) Have earned a doctoral, master’s, or
bachelor’s degree in a chemical, biological,
(3) The skills required for performing clinical or medical laboratory science, or
each test method and for proper instru- medical technology from an accredited insti-
ment use; tution;
(4) The skills required for performing (ii) Be qualified under the requirements of
preventive maintenance, trouble- § 493.1443(b)(3) or § 493.1449(c)(4) or (5); or
shooting, and calibration procedures (3)(i) Have earned an associate degree in a
related to each test performed; laboratory science or medical laboratory
technology from an accredited institution
(5) A working knowledge of reagent
or—
stability and storage; (ii) Have education and training equivalent
(6) The skills required to implement to that specified in paragraph (b)(2)(i) of this
the quality control policies and proce- section that includes—
dures of the laboratory; (A) At least 60 semester hours, or equiva-
(7) An awareness of the factors that lent, from an accredited institution that, at
influence test results; and a minimum, includes either—
(8) The skills required to assess and (1) Twenty-four (24) semester hours of med-
ical laboratory technology courses; or
verify the validity of patient test re-
(2) Twenty-four (24) semester hours of
sults through the evaluation of quality science courses that include—
control values before reporting patient (i) Six (6) semester hours of chemistry;
test results; and (ii) Six (6) semester hours of biology; and
(ii) As of September 1, 1997, be quali- (iii) Twelve (12) semester hours of chem-
fied under § 493.1489(b)(1), (b)(2), or istry, biology, or medical laboratory tech-
(b)(4), except for those individuals nology in any combination; and
qualified under paragraph (b)(5)(i) of (B) Have laboratory training that includes:
this section who were performing high (1) Completion of a clinical laboratory
complexity testing on or before April training program approved or accredited by
the ABHES or the CAAHEP (this training
24, 1995; may be included in the 60 semester hours
(6) For blood gas analysis— listed in paragraph (b)(3)(ii)(A) of this sec-
(i) Be qualified under § 493.1489(b)(1), tion); or
(b)(2), (b)(3), (b)(4), or (b)(5); (2) At least 3 months documented labora-
(ii) Have earned a bachelor’s degree tory training in each specialty in which the
in respiratory therapy or cardio- individual performs high complexity testing;
vascular technology from an accredited or
(4) Successful completion of an official
institution; or U.S. military medical laboratory procedures
(iii) Have earned an associate degree training course of at least 50 weeks duration
related to pulmonary function from an and having held the military enlisted occu-
accredited institution; or pational specialty of Medical Laboratory
(7) For histopathology, meet the Specialist (Laboratory Technician); or
qualifications of § 493.1449 (b) or (l) to (5) Notwithstanding any other provision of
perform tissue examinations. this section, an individual is considered
qualified as a high complexity testing per-
[57 FR 7172, Feb. 28, 1992, as amended at 58 sonnel under this section if they were quali-
FR 5236, Jan. 19, 1993; 58 FR 39155, July 22, fied and serving as a high complexity testing
1993; 60 FR 20050, Apr. 24, 1995] personnel in a CLIA-certified laboratory as
803
§ 493.1491 42 CFR Ch. IV (10–1–24 Edition)
of December 28, 2024, and have done so con- mester hours were in other chemistry
tinuously since December 28, 2024. courses; and
(6) For blood gas analysis— (2) At least 12 semester hours in biol-
(i) Be qualified under paragraph (b)(1), (2), ogy courses pertinent to the medical
(3), (4), or (5) of this section; or
sciences; or
(ii) Have earned a bachelor’s degree in res-
piratory therapy or cardiovascular tech-
(B) For those whose training was com-
nology from an accredited institution; or pleted after September 14, 1963. (1) 16 se-
(iii) Have earned an associate degree re- mester hours in chemistry courses that
lated to pulmonary function from an accred- included at least 6 semester hours in
ited institution. inorganic chemistry and that are ac-
(7) For histopathology, meet the qualifica- ceptable toward a major in chemistry;
tions of § 493.1449(b) or (f) to perform tissue (2) 16 semester hours in biology
examinations. courses that are pertinent to the med-
ical sciences and are acceptable toward
§ 493.1491 Technologist qualifications a major in the biological sciences; and
on or before February 28, 1992. (3) 3 semester hours of mathematics;
In order to qualify as high com- and
plexity testing personnel under (ii) Has experience, training, or both,
§ 493.1489(b)(3), the individual must covering several fields of medical lab-
have met or could have met the fol- oratory work of at least 1 year and of
lowing qualifications for technologist such quality as to provide him or her
as they were in effect on or before Feb- with education and training in medical
ruary 28, 1992. Each technologist technology equivalent to that de-
must— scribed in paragraphs (b)(1) and (2) of
(a) Possess a current license as a lab- this section; or
oratory technologist issued by the (5) With respect to individuals first
State, if such licensing exists; and qualifying before July 1, 1971, the tech-
(b)(1) Have earned a bachelor’s degree nologist—
in medical technology from an accred- (i) Was performing the duties of a
ited university; or laboratory technologist at any time be-
(2) Have successfully completed 3 tween July 1, 1961, and January 1, 1968,
years of academic study (a minimum of and
90 semester hours or equivalent) in an (ii) Has had at least 10 years of perti-
accredited college or university, which nent laboratory experience prior to
met the specific requirements for en- January 1, 1968. (This required experi-
trance into a school of medical tech- ence may be met by the substitution of
nology accredited by an accrediting education for experience); or
agency approved by the Secretary, and (6) Achieves a satisfactory grade in a
has successfully completed a course of proficiency examination approved by
training of at least 12 months in such a HHS.
school; or [58 FR 39155, July 22, 1993]
(3) Have earned a bachelor’s degree in EFFECTIVE DATE NOTE: At 88 FR 90044, Dec.
one of the chemical, physical, or bio- 28, 2023, § 493.1491 was removed, effective Dec.
logical sciences and, in addition, has at 28, 2024.
least 1 year of pertinent full-time lab-
oratory experience or training, or both, § 493.1495 Standard; Testing personnel
in the specialty or subspecialty in responsibilities.
which the individual performs tests; or The testing personnel are responsible
(4)(i) Have successfully completed 3 for specimen processing, test perform-
years (90 semester hours or equivalent) ance and for reporting test results.
in an accredited college or university (a) Each individual performs only
with the following distribution of those high complexity tests that are
courses— authorized by the laboratory director
(A) For those whose training was com- and require a degree of skill commen-
pleted before September 15, 1963. At least surate with the individual’s education,
24 semester hours in chemistry and bi- training or experience, and technical
ology courses of which— abilities.
(1) At least 6 semester hours were in (b) Each individual performing high
inorganic chemistry and at least 3 se- complexity testing must—
804
(1) Follow the laboratory’s proce- § 493.1771 Condition: Inspection re-

dures for specimen handling and proc- quirements applicable to all CLIA-
essing, test analyses, reporting and certified and CLIA-exempt labora-
maintaining records of patient test re- tories.
sults; (a) Each laboratory issued a CLIA
(2) Maintain records that dem- certificate must meet the requirements
onstrate that proficiency testing sam- in § 493.1773 and the specific require-
ples are tested in the same manner as ments for its certificate type, as speci-
patient specimens; fied in §§ 493.1775 through 493.1780.
(3) Adhere to the laboratory’s quality (b) All CLIA-exempt laboratories
control policies, document all quality must comply with the inspection re-
control activities, instrument and pro- quirements in §§ 493.1773 and 493.1780,
cedural calibrations and maintenance when applicable.
performed; [63 FR 26737, May 14, 1998]
(4) Follow the laboratory’s estab-
lished policies and procedures when- § 493.1773 Standard: Basic inspection
ever test systems are not within the requirements for all laboratories
laboratory’s established acceptable lev- issued a CLIA certificate and CLIA-
els of performance; exempt laboratories.
(5) Be capable of identifying problems (a) A laboratory issued a certificate
that may adversely affect test perform- must permit CMS or a CMS agent to
ance or reporting of test results and ei- conduct an inspection to assess the lab-
ther must correct the problems or im- oratory’s compliance with the require-
mediately notify the general super- ments of this part. A CLIA-exempt lab-
visor, technical supervisor, clinical oratory and a laboratory that requests,
consultant, or director; or is issued a certificate of accredita-
(6) Document all corrective actions tion, must permit CMS or a CMS agent
taken when test systems deviate from to conduct validation and complaint
the laboratory’s established perform- inspections.
ance specifications; and (b) General requirements. As part of
(7) Except as specified in paragraph the inspection process, CMS or a CMS
(c) of this section, if qualified under agent may require the laboratory to do
§ 493.1489(b)(5), perform high complexity the following:
testing only under the onsite, direct (1) Test samples, including pro-
supervision of a general supervisor ficiency testing samples, or perform
qualified under § 493.1461. procedures.
(c) Exception. For individuals quali- (2) Permit interviews of all personnel
fied under § 493.1489(b)(5), who were per- concerning the laboratory’s compli-
forming high complexity testing on or ance with the applicable requirements
before January 19, 1993, the require- of this part.
ments of paragraph (b)(7) of this sec- (3) Permit laboratory personnel to be
tion are not effective, provided that all observed performing all phases of the
high complexity testing performed by total testing process (preanalytic, ana-
the individual in the absence of a gen- lytic, and postanalytic).
eral supervisor is reviewed within 24 (4) Permit CMS or a CMS agent ac-
hours by a general supervisor qualified cess to all areas encompassed under the
under § 493.1461. certificate including, but not limited
to, the following:
(i) Specimen procurement and proc-
FR 5236, Jan. 19, 1993; 60 FR 20050, Apr. 24,
1995] essing areas.
(ii) Storage facilities for specimens,
reagents, supplies, records, and reports.
Subparts N–P [Reserved] (iii) Testing and reporting areas.
(5) Provide CMS or a CMS agent with
Subpart Q—Inspection copies or exact duplicates of all records
and data it requires.
SOURCE: 57 FR 7184, Feb. 28, 1992, unless (c) Accessible records and data. A lab-
otherwise noted. oratory must have all records and data
805
§ 493.1775 42 CFR Ch. IV (10–1–24 Edition)
accessible and retrievable within a rea- (4) Collect information regarding the
sonable time frame during the course appropriateness of tests specified as
of the inspection. waived tests or provider-performed mi-
(d) Requirement to provide information croscopy procedures.
and data. A laboratory must provide, (c) The laboratory must comply with
upon request, all information and data the basic inspection requirements of
needed by CMS or a CMS agent to § 493.1773.
make a determination of the labora-
[63 FR 26737, May 14, 1998]
tory’s compliance with the applicable
requirements of this part. § 493.1777 Standard: Inspection of lab-
(e) Reinspection. CMS or a CMS agent oratories that have requested or
may reinspect a laboratory at any time have been issued a certificate of
to evaluate the ability of the labora- compliance.
tory to provide accurate and reliable (a) Initial inspection. (1) A laboratory
test results. issued a registration certificate must
(f) Complaint inspection. CMS or a permit an initial inspection to assess
CMS agent may conduct an inspection the laboratory’s compliance with the
when there are complaints alleging requirements of this part before CMS
noncompliance with any of the require- issues a certificate of compliance.
ments of this part.
(2) The inspection may occur at any
(g) Failure to permit an inspection or
time during the laboratory’s hours of
reinspection. Failure to permit CMS or
operation.
a CMS agent to conduct an inspection
(b) Subsequent inspections. (1) CMS or
or reinspection results in the suspen-
a CMS agent may conduct subsequent
sion or cancellation of the laboratory’s
inspections on a biennial basis or with
participation in Medicare and Medicaid
such other frequency as CMS deter-
for payment, and suspension or limita-
mines to be necessary to ensure com-
tion of, or action to revoke the labora-
pliance with the requirements of this
tory’s CLIA certificate, in accordance
part.
with subpart R of this part.
(2) CMS bases the nature of subse-
[63 FR 26737, May 14, 1998; 63 FR 32699, June quent inspections on the laboratory’s
15, 1998] compliance history.
(c) Provider-performed microscopy pro-
§ 493.1775 Standard: Inspection of lab-
oratories issued a certificate of cedures. The inspection sample for re-
waiver or a certificate for provider- view may include testing in the sub-
performed microscopy procedures. category of provider-performed micros-
copy procedures.
(a) A laboratory that has been issued
a certificate of waiver or a certificate (d) Compliance with basic inspection re-
for provider-performed microscopy pro- quirements. The laboratory must com-
cedures is not subject to biennial in- ply with the basic inspection require-
spections. ments of § 493.1773.
(b) If necessary, CMS or a CMS agent [63 FR 26738, May 14, 1998]
may conduct an inspection of a labora-
tory issued a certificate of waiver or a § 493.1780 Standard: Inspection of
certificate for provider-performed mi- CLIA-exempt laboratories or lab-
croscopy procedures at any time during oratories requesting or issued a cer-
the laboratory’s hours of operation to tificate of accreditation.
do the following: (a) Validation inspection. CMS or a
(1) Determine if the laboratory is op- CMS agent may conduct a validation
erated and testing is performed in a inspection of any accredited or CLIA-
manner that does not constitute an im- exempt laboratory at any time during
minent and serious risk to public its hours of operation.
health. (b) Complaint inspection. CMS or a
(2) Evaluate a complaint from the CMS agent may conduct a complaint
public. inspection of a CLIA-exempt labora-
(3) Determine whether the laboratory tory or a laboratory requesting or
is performing tests beyond the scope of issued a certificate of accreditation at
the certificate held by the laboratory. any time during its hours of operation
806
upon receiving a complaint applicable (iii) Grants the Secretary broad en-
to the requirements of this part. forcement authority, including—
(c) Noncompliance determination. If a (A) Use of intermediate sanctions;
validation or complaint inspection re- (B) Suspension, limitation, or revoca-
sults in a finding that the laboratory is tion of the certificate of a laboratory
not in compliance with one or more that is out of compliance with one or
condition-level requirements, the fol- more requirements for a certificate;
lowing actions occur: and
(1) A laboratory issued a certificate (C) Civil suit to enjoin any labora-
of accreditation is subject to a full re- tory activity that constitutes a signifi-
view by CMS, in accordance with sub- cant hazard to the public health.
part E of this part and § 488.11 of this (3) Section 353 also—
chapter.
(i) Provides for imprisonment or fine
(2) A CLIA-exempt laboratory is sub-
for any person convicted of intentional
ject to appropriate enforcement ac-
violation of CLIA requirements;
tions under the approved State licen-
(ii) Specifies the administrative hear-
sure program.
ing and judicial review rights of a lab-
(d) Compliance with basic inspection re-
oratory that is sanctioned under CLIA;
quirements. CLIA-exempt laboratories
and
and laboratories requesting or issued a
certificate of accreditation must com- (iii) Requires the Secretary to pub-
ply with the basic inspection require- lish annually a list of all laboratories
ments in § 493.1773. that have been sanctioned during the
preceding year.
[63 FR 26738, May 14, 1998] (b) Scope and applicability. This sub-
part sets forth—
Subpart R—Enforcement (1) The policies and procedures that
Procedures CMS follows to enforce the require-
ments applicable to laboratories under
SOURCE: 57 FR 7237, Feb. 28, 1992, unless CLIA and under section 1846 of the Act;
otherwise noted. and
(2) The appeal rights of laboratories
§ 493.1800 Basis and scope. on which CMS imposes sanctions.
(a) Statutory basis. (1) Section 1846 of [57 FR 7237, Feb. 28, 1992, as amended at 79
the Act— FR 25480, May 2, 2014]
(i) Provides for intermediate sanc-
tions that may be imposed on labora- § 493.1804 General considerations.
tories that perform clinical diagnostic
tests on human specimens when those (a) Purpose. The enforcement mecha-
laboratories are found to be out of nisms set forth in this subpart have the
compliance with one or more of the following purposes:
conditions for Medicare coverage of (1) To protect all individuals served
their services; and by laboratories against substandard
(ii) Requires the Secretary to develop testing of specimens.
and implement a range of such sanc- (2) To safeguard the general public
tions, including four that are specified against health and safety hazards that
in the statute. might result from laboratory activi-
(2) The Clinical Laboratory Improve- ties.
ment Act of 1967 (section 353 of the (3) To motivate laboratories to com-
Public Health Service Act) as amended ply with CLIA requirements so that
by CLIA 1988, as amended by section 2 they can provide accurate and reliable
of the Taking Essential Steps for Test- test results.
ing Act of 2012— (b) Basis for decision to impose sanc-
(i) Establishes requirements for all tions. (1) CMS’s decision to impose
laboratories that perform clinical diag- sanctions is based on one or more of
nostic tests on human specimens; the following:
(ii) Requires a Federal certification (i) Deficiencies found by CMS or its
scheme to be applied to all such labora- agents in the conduct of inspections to
tories; and certify or validate compliance with
807
§ 493.1806 42 CFR Ch. IV (10–1–24 Edition)
Federal requirements, or through re- (e) Number of alternative sanctions.

view of materials submitted by the lab- CMS may impose a separate sanction
oratory (e.g., personnel qualifications). for each condition level deficiency or a
(ii) Unsuccessful participation in pro- single sanction for all condition level
ficiency testing. deficiencies that are interrelated and
(2) CMS imposes one or more of the subject to correction by a single course
alternative or principal sanctions spec- of action.
ified in §§ 493.1806 and 493.1807 when (f) Appeal rights. The appeal rights of
CMS or CMS’s agent finds that a lab- laboratories dissatisfied with the impo-
oratory has condition-level defi- sition of a sanction are set forth in
ciencies. § 493.1844.
(c) Imposition of alternative sanctions.
[57 FR 7237, Feb. 28, 1992; 57 FR 35761, Aug. 11,
(1) CMS may impose alternative sanc- 1992, as amended at 60 FR 20051, Apr. 24, 1995;
tions in lieu of, or in addition to, prin- 85 FR 54874, Sept. 2, 2020; 88 FR 90044, Dec. 28,
cipal sanctions. 2023]
(2) CMS may impose alternative
sanctions other than a civil money § 493.1806 Available sanctions: All lab-
penalty after the laboratory has had an oratories.
opportunity to respond, but before the (a) Applicability. CMS may impose
hearing specified in § 493.1844. one or more of the sanctions specified
(d) Choice of sanction: Factors consid- in this section on a laboratory that is
ered. CMS bases its choice of sanction out of compliance with one or more
or sanctions on consideration of one or CLIA conditions.
more factors that include, but are not (b) Principal sanction. CMS may im-
limited to, the following, as assessed pose any of the three principal CLIA
by the State or by CMS, or its agents: sanctions, which are suspension, limi-
(1) Whether the deficiencies pose im- tation, or revocation of any type of
mediate jeopardy. CLIA certificate.
(2) The nature, incidence, severity, (c) Alternative sanctions. CMS may
and duration of the deficiencies or non- impose one or more of the following al-
compliance. ternative sanctions in lieu of or in ad-
(3) Whether the same condition level dition to imposing a principal sanction,
deficiencies have been identified re- except on a laboratory that has a cer-
peatedly. tificate of waiver.
(4) The accuracy and extent of lab- (1) Directed plan of correction, as set
oratory records (e.g., of remedial ac- forth at § 493.1832.
tion) in regard to the noncompliance,
(2) State onsite monitoring as set
and their availability to the State, to
forth at § 493.1836.
other CMS agents, and to CMS.
(3) Civil money penalty, as set forth
(5) The relationship of one deficiency
at § 493.1834.
or group of deficiencies to other defi-
ciencies. (d) Civil suit. CMS may bring suit in
the appropriate U.S. District Court to
(6) The overall compliance history of
enjoin continuation of any activity of
the laboratory including but not lim-
ited to any period of noncompliance any laboratory (including a CLIA-ex-
that occurred between certifications of empt laboratory that has been found
compliance. with deficiencies during a validation
survey), if CMS has reason to believe
(7) The corrective and long-term
that continuation of the activity would
compliance outcomes that CMS hopes
constitute a significant hazard to the
to achieve through application of the
sanction. public health.
(8) Whether the laboratory has made (e) Criminal sanctions. Under section
any progress toward improvement fol- 353(1) of the PHS Act, an individual
lowing a reasonable opportunity to cor- who is convicted of intentionally vio-
rect deficiencies. lating any CLIA requirement may be
(9) Any recommendation by the State imprisoned or fined.
agency as to which sanction would be [57 FR 7237, Feb. 28, 1992, as amended at 58
appropriate. FR 5237, Jan. 19, 1993]
808
§ 493.1807 Additional sanctions: Lab- agent gives the laboratory written no-
oratories that participate in Medi- tice of the following:
care. (1) The condition level noncompli-
The following additional sanctions ance that it has identified.
are available for laboratories that are (2) The sanction or sanctions that
out of compliance with one or more CMS or its agent proposes to impose
CLIA conditions and that have ap- against the laboratory.
proval to receive Medicare payment for (3) The rationale for the proposed
their services. sanction or sanctions.
(a) Principal sanction. Cancellation of (4) The projected effective date and
the laboratory’s approval to receive duration of the proposed sanction or
Medicare payment for its services. sanctions.
(b) Alternative sanctions. (1) Suspen- (5) The authority for the proposed
sion of payment for tests in one or sanction or sanctions.
more specific specialties or subspecial- (6) The time allowed (at least 10 days)
ties, performed on or after the effective for the laboratory to respond to the no-
date of sanction. tice.
(2) Suspension of payment for all (b) Opportunity to respond. During the
tests in all specialties and subspecial- period specified in paragraph (a)(6) of
ties performed on or after the effective this section, the laboratory may sub-
date of sanction. mit to CMS or its agent written evi-
§ 493.1808 Adverse action on any type dence or other information against the
of CLIA certificate: Effect on Medi- imposition of the proposed sanction or
care approval. sanctions.
(c) Notice of imposition of sanction—(1)
(a) Suspension or revocation of any
type of CLIA certificate. When CMS sus- Content. CMS gives the laboratory
pends or revokes any type of CLIA cer- written notice that acknowledges any
tificate, CMS concurrently cancels the evidence or information received from
laboratory’s approval to receive Medi- the laboratory and specifies the fol-
care payment for its services. lowing:
(b) Limitation of any type of CLIA cer- (i) The sanction or sanctions to be
tificate. When CMS limits any type of imposed against the laboratory.
CLIA certificate, CMS concurrently (ii) The authority and rationale for
limits Medicare approval to only those the imposing sanction or sanctions.
specialties or subspecialties that are (iii) The effective date and duration
authorized by the laboratory’s limited of sanction.
certificate. (2) Timing. (i) If CMS or its agent de-
termines that the deficiencies pose im-
§ 493.1809 Limitation on Medicaid pay- mediate jeopardy, CMS provides notice
ment. at least 5 days before the effective date
As provided in section 1902(a)(9)(C) of of sanction.
the Act, payment for laboratory serv- (ii) If CMS or its agent determines
ices may be made under the State plan that the deficiencies do not pose imme-
only if those services are furnished by diate jeopardy, CMS provides notice at
a laboratory that has a CLIA certifi- least 15 days before the effective date
cate or is licensed by a State whose li- of the sanction.
censure program has been approved by (d) Duration of alternative sanctions.
the Secretary under this part. An alternative sanction continues
[57 FR 7237, Feb. 28, 1992; 57 FR 35761, Aug. 11, until the earlier of the following oc-
1992] curs:
(1) The laboratory corrects all condi-
§ 493.1810 Imposition and lifting of al- tion level deficiencies.
ternative sanctions. (2) CMS’s suspension, limitation, or
(a) Notice of noncompliance and of pro- revocation of the laboratory’s CLIA
posed sanction: Content. If CMS or its certificate becomes effective.
agency identifies condition level non- (e) Lifting of alternative sanctions—(1)
compliance in a laboratory, CMS or its General rule. Alternative sanctions are
809
§ 493.1812 42 CFR Ch. IV (10–1–24 Edition)
not lifted until a laboratory’s compli- (a) Initial action. (1) CMS may cancel
ance with all condition level require- the laboratory’s approval to receive
ments is verified. Medicare payment for its services.
(2) Credible allegation of compliance. (2) CMS may suspend, limit, or re-
When a sanctioned laboratory submits voke the laboratory’s CLIA certificate.
a credible allegation of compliance, (3) If CMS does not impose a prin-
CMS’s agent determines whether— cipal sanction under paragraph (a)(1) or
(i) It can certify compliance on the (a)(2) of this section, it imposes one or
basis of the evidence presented by the more alternative sanctions. In the case
laboratory in its allegation; or of unsuccessful participation in pro-
(ii) It must revisit to verify whether ficiency testing, CMS may impose the
the laboratory has, in fact, achieved training and technical assistance re-
compliance. quirement set forth at § 493.1838 in lieu
(3) Compliance achieved before the date of, or in addition to, one or more alter-
of revisit. If during a revisit, the labora- native sanctions.
tory presents credible evidence (as de- (b) Failure to correct condition level de-
termined by CMS or its agent) that it ficiencies. If CMS imposes alternative
achieved compliance before the date of sanctions for condition level defi-
revisit, sanctions are lifted as of that ciencies that do not pose immediate
earlier date. jeopardy, and the laboratory does not
correct the condition level deficiencies
§ 493.1812 Action when deficiencies within 12 months after the last day of
pose immediate jeopardy. inspection, CMS—
If a laboratory’s deficiencies pose im- (1) Cancels the laboratory’s approval
mediate jeopardy, the following rules to receive Medicare payment for its
apply: services, and discontinues the Medicare
(a) CMS requires the laboratory to payment sanctions as of the day can-
take immediate action to remove the cellation is effective.
jeopardy and may impose one or more (2) Following a revisit which indi-
alternative sanctions to help bring the cates that the laboratory has not cor-
laboratory into compliance. rected its condition level deficiencies,
(b) If the findings of a revisit indicate notifies the laboratory that it proposes
that a laboratory has not eliminated to suspend, limit, or revoke the certifi-
the jeopardy, CMS suspends or limits cate, as specified in § 493.1816(b), and
the laboratory’s CLIA certificate no the laboratory’s right to hearing; and
earlier than 5 days after the date of no- (3) May impose (or continue, if al-
tice of suspension or limitation. CMS ready imposed) any alternative sanc-
may later revoke the certificate. tions that do not pertain to Medicare
(c) In addition, if CMS has reason to payments. (Sanctions imposed under
believe that the continuation of any the authority of section 353 of the PHS
activity by any laboratory (either the Act may continue for more than 12
entire laboratory operation or any spe- months from the last date of inspec-
cialty or subspecialty of testing) would tion, while a hearing on the proposed
constitute a significant hazard to the suspension, limitation, or revocation of
public health, CMS may bring suit and the certificate of compliance, registra-
seek a temporary injunction or re-
tion certificate, certificate of accredi-
straining order against continuation of
tation, or certificate for PPM proce-
that activity by the laboratory, regard-
dures is pending.)
less of the type of CLIA certificate the
laboratory has and of whether it is (c) Action after hearing. If a hearing
State-exempt. decision upholds a proposed suspension,
limitation, or revocation of a labora-
§ 493.1814 Action when deficiencies tory’s CLIA certificate, CMS discon-
are at the condition level but do not tinues any alternative sanctions as of
pose immediate jeopardy. the day it makes the suspension, limi-
If a laboratory has condition level de- tation, or revocation effective.
ficiencies that do not pose immediate [57 FR 7237, Feb. 28, 1992, as amended at 60
jeopardy, the following rules apply: FR 20051, Apr. 24, 1995]
810
§ 493.1816 Action when deficiencies § 493.1826 Suspension of part of Medi-

are not at the condition level. care payments.
If a laboratory has deficiencies, that (a) Application. (1) CMS may impose
are not at the condition level, the fol- this sanction if a laboratory—
lowing rules apply: (i) Is found to have condition level
(a) Initial action. The laboratory must deficiencies with respect to one or
submit a plan of correction that is ac- more specialties or subspecialties of
ceptable to CMS in content and time tests; and
frames. (ii) Agrees (in return for not having
(b) Failure to correct deficiencies. If, on its Medicare approval cancelled imme-
revisit, it is found that the laboratory diately) not to charge Medicare bene-
has not corrected the deficiencies with- ficiaries or their private insurance car-
in 12 months after the last day of in- riers for the services for which Medi-
spection, the following rules apply: care payment is suspended.
(1) CMS cancels the laboratory’s ap- (2) CMS suspends Medicare payment
proval to receive Medicare payment for for those specialities or subspecialties
its services. of tests for which the laboratory is out
(2) CMS notifies the laboratory of its of compliance with Federal require-
intent to suspend, limit, or revoke the ments.
laboratory’s CLIA certificate and of (b) Procedures. Before imposing this
the laboratory’s right to a hearing. sanction, CMS provides notice of sanc-
tion and opportunity to respond in ac-
§ 493.1820 Ensuring timely correction cordance with § 493.1810.
of deficiencies. (c) Duration and effect of sanction.
(a) Timing of visits. CMS, the State This sanction continues until the lab-
survey agency or other CMS agent may oratory corrects the condition level de-
visit the laboratory at any time to ficiencies or CMS cancels the labora-
evaluate progress, and at the end of the tory’s approval to receive Medicare
period to determine whether all correc- payment for its services, but in no
tions have been made. event longer than 12 months.
(b) Deficiencies corrected before a visit. (1) If the laboratory corrects all con-
If during a visit, a laboratory produces dition level deficiencies, CMS resumes
credible evidence that it achieved com- Medicare payment effective for all
pliance before the visit, the sanctions services furnished on or after the date
are lifted as of that earlier date. the deficiencies are corrected.
(c) Failure to correct deficiencies. If (2) [Reserved]
during a visit it is found that the lab- [57 FR 7237, Feb. 28, 1992; 57 FR 35761, Aug. 11,
oratory has not corrected its defi- 1992]
ciencies, CMS may propose to suspend,
limit, or revoke the laboratory’s CLIA § 493.1828 Suspension of all Medicare
certificate. payments.
(d) Additional time for correcting lower (a) Application. (1) CMS may suspend
level deficiencies not at the condition payment for all Medicare-approved lab-
level. If at the end of the plan of cor- oratory services when the laboratory
rection period all condition level defi- has condition level deficiencies.
ciencies have been corrected, and there (2) CMS suspends payment for all
are deficiencies, that are not at the Medicare covered laboratory services
condition level, CMS may request a re- when the following conditions are met:
vised plan of correction. The revised (i) Either—
plan may not extend beyond 12 months (A) The laboratory has not corrected
from the last day of the inspection that its condition level deficiencies included
originally identified the cited defi- in the plan of correction within 3
ciencies. months from the last date of inspec-
(e) Persistence of deficiencies. If at the tion; or
end of the period covered by the plan of (B) The laboratory has been found to
correction, the laboratory still has de- have the same condition level defi-
ficiencies, the rules of §§ 493.1814 and ciencies during three consecutive in-
493.1816 apply. spections; and
811
§ 493.1832 42 CFR Ch. IV (10–1–24 Edition)
(ii) The laboratory has chosen (in re- of a sanctioned laboratory, because of
turn for not having its Medicare ap- the seriousness of the noncompliance
proval immediately cancelled), to not (e.g., the existence of immediate jeop-
charge Medicare beneficiaries or their ardy) or for other reasons. When impos-
private insurance carriers for services ing this sanction, CMS takes the fol-
for which Medicare payment is sus- lowing steps—
pended. (i) Directs the laboratory to submit
(3) CMS suspends payment for serv- to CMS, the State survey agency, or
ices furnished on and after the effec- other CMS agent, within 10 calendar
tive date of sanction. days after the notice of the alternative
(b) Procedures. Before imposing this sanction, a list of names and addresses
sanction, CMS provides notice of sanc- of all physicians, providers, suppliers,
tion and opportunity to respond in ac- and other clients who have used some
cordance with § 493.1810. or all of the services of the laboratory
(c) Duration and effect of sanction. (1) since the last certification inspection
Suspension of payment continues until or within any other timeframe speci-
all condition level deficiencies are cor- fied by CMS.
rected, but never beyond twelve (ii) Within 30 calendar days of receipt
months. of the information, may send to each
(2) If all the deficiencies are not cor- laboratory client, via the State survey
rected by the end of the 12 month pe- agency, a notice containing the name
riod, CMS cancels the laboratory’s ap- and address of the laboratory, the na-
proval to receive Medicare payment for ture of the laboratory’s noncompli-
its services. ance, and the kind and effective date of
the alternative sanction.
§ 493.1832 Directed plan of correction (iii) Sends to each laboratory client,
and directed portion of a plan of via the State survey agency, notice of
correction. the recission of an adverse action with-
(a) Application. CMS may impose a di- in 30 days of the rescission.
rected plan of correction as an alter- (3) Notice of imposition of a principal
native sanction for any laboratory that sanction following the imposition of an al-
has condition level deficiencies. If CMS ternative sanction. If CMS imposes a
does not impose a directed plan of cor- principal sanction following the impo-
rection as an alternative sanction for a sition of an alternative sanction, and
laboratory that has condition level de- for which CMS has already obtained a
ficiencies, it at least imposes a di- list of laboratory clients, CMS may use
rected portion of a plan of correction that list to notify the clients of the im-
when it imposes any of the following position of the principal sanction.
alternative sanctions: (c) Duration of a directed plan of cor-
(1) State onsite monitoring. rection. If CMS imposes a directed plan
(2) Civil money penalty. of correction, and on revisit it is found
(3) Suspension of all or part of Medi- that the laboratory has not corrected
care payments. the deficiencies within 12 months from
(b) Procedures—(1) Directed plan of cor- the last day of inspection, the fol-
rection. When imposing this sanction, lowing rules apply:
CMS— (1) CMS cancels the laboratory’s ap-
(i) Gives the laboratory prior notice proval for Medicare payment of its
of the sanction and opportunity to re- services, and notifies the laboratory of
spond in accordance with § 493.1810; CMS’s intent to suspend, limit, or re-
(ii) Directs the laboratory to take voke the laboratory’s CLIA certificate.
specific corrective action within spe- (2) The directed plan of correction
cific time frames in order to achieve continues in effect until the day sus-
compliance; and pension, limitation, or revocation of
(iii) May direct the laboratory to the laboratory’s CLIA certificate.
submit the names of laboratory clients
for notification purposes, as specified § 493.1834 Civil money penalty.
in paragraph (b)(3) of this section. (a) Statutory basis. Sections 1846 of
(2) Directed portion of a plan of correc- the Act and 353(h)(2)(B) of the PHS Act
tion. CMS may decide to notify clients authorize the Secretary to impose civil
812
money penalties on laboratories. Sec- the deficiency continues, CMS shifts

tion 1846(b)(3) of the Act specifically the penalty amount to the lower range.
provides that incrementally more se- (4) Increased penalty amounts. CMS
vere fines may be imposed for repeated may, before the hearing, propose to in-
or uncorrected deficiencies. crease the penalty amount for a labora-
(b) Scope. This section sets forth the tory that has deficiencies which, after
procedures that CMS follows to impose imposition of a lower level penalty
a civil money penalty in lieu of, or in amount, become sufficiently serious to
addition to, suspending, limiting, or re- pose immediate jeopardy.
voking the certificate of compliance, (e) Procedures for imposition of civil
registration certificate, certificate of money penalty—(1) Notice of intent. (i)
accreditation, or certificate for PPM CMS sends the laboratory written no-
procedures of a laboratory that is tice, of CMS’s intent to impose a civil
found to have condition level defi- money penalty.
ciencies. (ii) The notice includes the following
(c) Basis for imposing a civil money information:
penalty. CMS may impose a civil (A) The statutory basis for the pen-
money penalty against any laboratory alty.
determined to have condition level de- (B) The proposed daily or per viola-
ficiencies regardless of whether those tion amount of the penalty.
deficiencies pose immediate jeopardy. (C) The factors (as described in para-
(d) Amount of penalty—(1) Factors con- graph (d)(1) of this section) that CMS
sidered. In determining the amount of considered.
the penalty, CMS takes into account (D) The opportunity for responding
the following factors: to the notice in accordance with
(i) The nature, scope, severity, and § 493.1810(c).
duration of the noncompliance.
(E) A specific statement regarding
(ii) Whether the same condition level
the laboratory’s appeal rights.
deficiencies have been identified during
(2) Appeal rights. (i) The laboratory
three consecutive inspections.
has 60 days from the date of receipt of
(iii) The laboratory’s overall compli-
the notice of intent to impose a civil
ance history including but not limited
money penalty to request a hearing in
to any period of noncompliance that
accordance with § 493.1844(g).
occurred between certifications of com-
pliance. (ii) If the laboratory requests a hear-
(iv) The laboratory’s intent or reason ing, all other pertinent provisions of
for noncompliance. § 493.1844 apply.
(v) The accuracy and extent of lab- (iii) If the laboratory does not re-
oratory records and their availability quest a hearing, CMS may reduce the
to CMS, the State survey agency, or proposed penalty amount by 35 percent.
other CMS agent. (f) Accrual and duration of penalty—(1)
(2) Range of penalty amount. (i) For a Accrual of penalty. The civil money pen-
condition level deficiency that poses alty begins accruing as follows:
immediate jeopardy, the range is (i) 5 days after notice of intent if
$3,050–$10,000 as adjusted annually there is immediate jeopardy.
under 45 CFR part 102 per day of non- (ii) 15 days after notice of intent if
compliance or per violation. there is not immediate jeopardy.
(ii) For a condition level deficiency (2) Duration of penalty. The civil
that does not pose immediate jeopardy, money penalty continues to accrue
the range is $50–$3,000 as adjusted annu- until the earliest of the following oc-
ally under 45 CFR part 102 per day of curs:
noncompliance or per violation. (i) The laboratory’s compliance with
(iii) For a condition level deficiency condition level requirements is verified
under §§ 493.41 or 493.1100(a), the penalty on the basis of the evidence presented
amount is $1,000 for the first day of by the laboratory in its credible allega-
noncompliance and $500 for each addition of compliance or at the time or re-
tional day of noncompliance. visit.
(3) Decreased penalty amounts. If the (ii) Based on credible evidence pre-
immediate jeopardy is removed, but sented by the laboratory at the time of
813
§ 493.1836 42 CFR Ch. IV (10–1–24 Edition)
revisit, CMS determines that compli- (2) Settlement. CMS has authority to
ance was achieved before the revisit. settle any case at any time before the
(In this situation, the money penalty ALJ issues a hearing decision.
stops accruing as of the date of compli- [57 FR 7237, Feb. 28, 1992, as amended at 60
ance.) FR 20051, Apr. 24, 1995; 61 FR 63749, Dec. 2,
(iii) CMS suspends, limits, or revokes 1996; 81 FR 61564, Sept. 6, 2016; 85 FR 54874,
the laboratory’s certificate of compli- Sept. 2, 2020]
ance, registration certificate, certifi-
§ 493.1836 State onsite monitoring.
cate of accreditation, or certificate for
PPM procedures. (a) Application. (1) CMS may require
(g) Computation and notice of total continuous or intermittent monitoring
penalty amount—(1) Computation. CMS of a plan of correction by the State
survey agency to ensure that the lab-
computes the total penalty amount
oratory makes the improvements nec-
after the laboratory’s compliance is
essary to bring it into compliance with
verified or CMS suspends, limits, or re- the condition level requirements. (The
vokes the laboratory’s CLIA certificate State monitor does not have manage-
but in no event before— ment authority, that is, cannot hire or
(i) The 60 day period for requesting a fire staff, obligate funds, or otherwise
hearing has expired without a request dictate how the laboratory operates.
or the laboratory has explicitly waived The monitor’s responsibility is to over-
its right to a hearing; or see whether corrections are made.)
(ii) Following a hearing requested by (2) The laboratory must pay the costs
the laboratory, the ALJ issues a deci- of onsite monitoring by the State sur-
sion that upholds imposition of the vey agency.
penalty. (i) The costs are computed by multi-
(2) Notice of penalty amount and due plying the number of hours of onsite
date of penalty. The notice includes the monitoring in the laboratory by the
following information: hourly rate negotiated by CMS and the
(i) Daily or per violation penalty State.
(ii) The hourly rate includes salary,
amount.
fringe benefits, travel, and other direct
(ii) Number of days or violations for and indirect costs approved by CMS.
which the penalty is imposed. (b) Procedures. Before imposing this
(iii) Total penalty amount. sanction, CMS provides notice of sanc-
(iv) Due date for payment of the pen- tion and opportunity to respond in ac-
alty. cordance with § 493.1810.
(h) Due date for payment of penalty. (1) (c) Duration of sanction. (1) If CMS
Payment of a civil money penalty is imposes onsite monitoring, the sanc-
due 15 days from the date of the notice tion continues until CMS determines
specified in paragraph (g)(2) of this sec- that the laboratory has the capability
tion. to ensure compliance with all condi-
(2) CMS may approve a plan for a lab- tion level requirements.
oratory to pay a civil money penalty, (2) If the laboratory does not correct
plus interest, over a period of up to one all deficiencies within 12 months, and a
year from the original due date. revisit indicates that deficiencies re-
main, CMS cancels the laboratory’s ap-
(i) Collection and settlement—(1) Collec-
proval for Medicare payment for its
tion of penalty amounts. (i) The deter-
services and notifies the laboratory of
mined penalty amount may be de-
its intent to suspend, limit, or revoke
ducted from any sums then or later the laboratory’s certificate of compli-
owing by the United States to the lab- ance, registration certificate, certifi-
oratory subject to the penalty. cate of accreditation, or certificate for
(ii) Interest accrues on the unpaid PPM procedures.
balance of the penalty, beginning on (3) If the laboratory still does not
the due date. Interest is computed at correct its deficiencies, the Medicare
the rate specified in § 405.378(d) of this sanction continues until the suspen-
chapter. sion, limitation, or revocation of the
laboratory’s certificate of compliance,
814
registration certificate, certificate of (7) Failed to comply with an alter-

accreditation, or certificate for PPM native sanction imposed under this
procedures is effective. subpart; or
(8) Within the preceding two-year pe-
FR 20051, Apr. 24, 1995] riod, owned or operated a laboratory
that had its CLIA certificate revoked.
§ 493.1838 Training and technical as- (This provision applies only to the
sistance for unsuccessful participa- owner or operator, not to all of the lab-
tion in proficiency testing. oratory’s employees.)
If a laboratory’s participation in pro- (b) Adverse action based on improper re-
ficiency testing is unsuccessful, CMS ferrals in proficiency testing. If CMS de-
may require the laboratory to under- termines that a laboratory has inten-
take training of its personnel, or to ob- tionally referred its proficiency testing
tain necessary technical assistance, or samples to another laboratory for anal-
both, in order to meet the require- ysis, CMS does one of the following:
ments of the proficiency testing pro- (1)(i) Revokes the laboratory’s CLIA
gram. This requirement is separate certificate for at least 1 year, prohibits
from the principal and alternative the owner and operator from owning or
sanctions set forth in §§ 493.1806 and operating a CLIA-certified laboratory
493.1807. for at least 1 year, and may impose a
civil money penalty in accordance with
§ 493.1840 Suspension, limitation, or § 493.1834(d), if CMS determines that—
revocation of any type of CLIA cer- (A) A proficiency testing referral is a
tificate. repeat proficiency testing referral as
(a) Adverse action based on actions of defined at § 493.2; or
the laboratory’s owner, operator or em- (B) On or before the proficiency test-
ployees. CMS may initiate adverse ac- ing event close date, a laboratory re-
tion to suspend, limit or revoke any ported proficiency testing results ob-
CLIA certificate if CMS finds that a tained from another laboratory to the
laboratory’s owner or operator or one proficiency testing program.
of its employees has— (ii) Following the revocation of a
(1) Been guilty of misrepresentation CLIA certificate in accordance with
in obtaining a CLIA certificate; paragraph (b)(1)(i) of this section, CMS
(2) Performed, or represented the lab- may exempt a laboratory owner from
oratory as entitled to perform, a lab- the generally applicable prohibition on
oratory examination or other proce- owning or operating a CLIA-certified
dure that is not within a category of laboratory under paragraph (a)(8) of
laboratory examinations or other pro- this section on a laboratory-by-labora-
cedures authorized by its CLIA certifi- tory basis if CMS finds, after review of
cate; the relevant facts and circumstances,
(3) Failed to comply with the certifi- that there is no evidence that—
cate requirements and performance (A) Patients would be put at risk as
standards; a result of the owner being exempted
(4) Failed to comply with reasonable from the ban on a laboratory-by-lab-
requests by CMS for any information oratory basis;
or work on materials that CMS con- (B) The laboratory for which the
cludes is necessary to determine the owner is to be exempted from the gen-
laboratory’s continued eligibility for eral ownership ban participated in or
its CLIA certificate or continued com- was otherwise complicit in the PT re-
pliance with performance standards set ferral of the laboratory that resulted in
by CMS; the revocation; and
(5) Refused a reasonable request by (C) The laboratory for which the
CMS or its agent for permission to in- owner is to be exempted from the gen-
spect the laboratory and its operation eral ownership ban received a PT sam-
and pertinent records during the hours ple from another laboratory in the
that the laboratory is in operation; prior two survey cycles, and failed to
(6) Violated or aided and abetted in immediately report such receipt to
the violation of any provisions of CLIA CMS or to the appropriate CMS-ap-
and its implementing regulations; proved accrediting organization.
815
§ 493.1842 42 CFR Ch. IV (10–1–24 Edition)
(2) Suspends or limits the CLIA cer- (e) Procedures for revocation. (1) CMS
tificate for less than 1 year based on does not revoke any type of CLIA cer-
the criteria in § 493.1804(d) and imposes tificate until after an ALJ hearing that
alternative sanctions as appropriate, in upholds revocation.
accordance with §§ 493.1804(c) and (d), (2) CMS may revoke a CLIA certifi-
493.1806(c), 493.1807(b), 493.1809 and, in cate after the hearing decision even if
the case of civil money penalties, it had not previously suspended or lim-
§ 493.1834(d), when CMS determines that ited that certificate.
paragraph (b)(1)(i)(A) or (B) of this sec- (f) Notice to the OIG. CMS notifies the
tion does not apply but that the lab- OIG of any violations under paragraphs
oratory obtained test results for the (a)(1), (a)(2), (a)(6), and (b) of this sec-
proficiency testing samples from an- tion within 30 days of the determina-
other laboratory on or before the pro- tion of the violation.
ficiency testing event close date. [57 FR 7237, Feb. 28, 1992, as amended at 79
Among other possibilities, alternative FR 25480, May 2, 2014]
sanctions will always include a civil
money penalty and a directed plan of § 493.1842 Cancellation of Medicare
correction that includes required train- approval.
ing of staff. (a) Basis for cancellation. (1) CMS al-
(3) Imposes alternative sanctions in ways cancels a laboratory’s approval to
accordance with §§ 493.1804(c) and (d), receive Medicare payment for its serv-
493.1806(c), 493.1807(b), 493.1809 and, in ices if CMS suspends or revokes the
the case of civil money penalties, laboratory’s CLIA certificate.
§ 493.1834(d), when CMS determines that (2) CMS may cancel the laboratory’s
paragraph (b)(1)(i) or (2) of this section approval under any of the following
do not apply, and a PT referral has oc- circumstances:
curred, but no test results are received (i) The laboratory is out of compli-
prior to the event close date by the re- ance with a condition level require-
ferring laboratory from the laboratory ment.
that received the referral. Among other (ii) The laboratory fails to submit a
possibilities, alternative sanctions will plan of correction satisfactory to CMS.
always include a civil money penalty (iii) The laboratory fails to correct
and a directed plan of correction that all its deficiencies within the time
includes required training of staff. frames specified in the plan of correc-
(c) Adverse action based on exclusion tion.
from Medicare. If the OIG excludes a (b) Notice and opportunity to respond.
laboratory from participation in Medi- Before canceling a laboratory’s ap-
care, CMS suspends the laboratory’s proval to receive Medicare payment for
CLIA certificate for the period during its services, CMS gives the labora-
which the laboratory is excluded. tory—
(d) Procedures for suspension or limita- (1) Written notice of the rationale
tion—(1) Basic rule. Except as provided for, effective date, and effect of, can-
in paragraph (d)(2) of this section, CMS cellation;
does not suspend or limit a CLIA cer- (2) Opportunity to submit written
tificate until after an ALJ hearing de- evidence or other information against
cision (as provided in § 493.1844) that cancellation of the laboratory’s ap-
upholds suspension or limitation. proval.
(2) Exceptions. CMS may suspend or This sanction may be imposed before
limit a CLIA certificate before the ALJ the hearing that may be requested by a
hearing in any of the following cir- laboratory, in accordance with the ap-
cumstances: peals procedures set forth in § 493.1844.
(i) The laboratory’s deficiencies pose (c) Effect of cancellation. Cancellation
immediate jeopardy. of Medicare approval terminates any
(ii) The laboratory has refused a rea- Medicare payment sanctions regardless
sonable request for information or of the time frames originally specified.
work on materials.
(iii) The laboratory has refused per- § 493.1844 Appeals procedures.
mission for CMS or a CMS agent to in- (a) General rules. (1) The provisions of
spect the laboratory or its operation. this section apply to all laboratories
816
and prospective laboratories that are (2) The finding that a laboratory de-
dissatisfied with any initial determina- termined to be in compliance with con-
tion under paragraph (b) of this sec- dition-level requirements but has defi-
tion. ciencies that are not at the condition
(2) Hearings are conducted in accord- level.
ance with procedures set forth in sub- (3) The determination not to rein-
part D of part 498 of this chapter, ex- state a suspended CLIA certificate be-
cept that the authority to conduct cause the reason for the suspension has
hearings and issue decisions may be ex- not been removed or there is insuffi-
ercised by ALJs assigned to, or de- cient assurance that the reason will
tailed to, the Departmental Appeals not recur.
Board. (4) The determination as to which al-
(3) Any party dissatisfied with a ternative sanction or sanctions to im-
hearing decision is entitled to request pose, including the amount of a civil
review of the decision as specified in money penalty to impose per day or
subpart E of part 498 of this chapter, per violation.
except that the authority to review the (5) The denial of approval for Medi-
decision may be exercised by the De- care payment for the services of a lab-
partmental Appeals Board. oratory that does not have in effect a
(4) When more than one of the ac- valid CLIA certificate.
tions specified in paragraph (b) of this (6) The determination that a labora-
section are carried out concurrently, tory’s deficiencies pose immediate
the laboratory has a right to only one jeopardy.
hearing on all matters at issue. (7) The amount of the civil money
(b) Actions that are initial determina- penalty assessed per day or for each
tions. The following actions are initial violation of Federal requirements.
determinations and therefore are sub- (d) Effect of pending appeals—(1) Alter-
ject to appeal in accordance with this native sanctions. The effective date of
section: an alternative sanction (other than a
(1) The suspension, limitation, or rev- civil money penalty) is not delayed be-
ocation of the laboratory’s CLIA cer- cause the laboratory has appealed and
tificate by CMS because of noncompli- the hearing or the hearing decision is
ance with CLIA requirements. pending.
(2) The denial of a CLIA certificate. (2) Suspension, limitation, or revocation
(3) The imposition of alternative of a laboratory’s CLIA certificate—(i)
sanctions under this subpart (but not General rule. Except as provided in
the determination as to which alter- paragraph (d)(2)(ii) of this section, sus-
native sanction or sanctions to im- pension, limitation, or revocation of a
pose). CLIA certificate is not effective until
(4) The denial or cancellation of the after a hearing decision by an ALJ is
laboratory’s approval to receive Medi- issued.
care payment for its services. (ii) Exceptions. (A) If CMS determines
(c) Actions that are not initial deter- that conditions at a laboratory pose
minations. Actions that are not listed immediate jeopardy, the effective date
in paragraph (b) of this section are not of the suspension or limitation of a
initial determinations and therefore CLIA certificate is not delayed because
are not subject to appeal under this the laboratory has appealed and the
section. They include, but are not nec- hearing or the hearing decision is pend-
essarily limited to, the following: ing.
(1) The finding that a laboratory ac- (B) CMS may suspend or limit a lab-
credited by a CMS-approved accredita- oratory’s CLIA certificate before an
tion organization is no longer deemed ALJ hearing or hearing decision if the
to meet the conditions set forth in sub- laboratory has refused a reasonable re-
parts H, J, K, M, and Q of this part. quest for information (including but
However, the suspension, limitation or not limited to billing information), or
revocation of a certificate of accredita- for work on materials, or has refused
tion is an initial determination and is permission for CMS or a CMS agent to
appealable. inspect the laboratory or its operation.
817
§ 493.1844 42 CFR Ch. IV (10–1–24 Edition)
(3) Cancellation of Medicare approval. tion and has 60 days from the notice of
The effective date of the cancellation sanction to request a hearing.
of a laboratory’s approval to receive (2) Review of ALJ hearing decisions.
Medicare payment for its services is Any laboratory that is dissatisfied
not delayed because the laboratory has with an ALJ’s hearing decision or dis-
appealed and the hearing or hearing de- missal of a request for hearing may file
cision is pending. a written request for review by the De-
(4) Effect of ALJ decision. (i) An ALJ partmental Appeals Board, as provided
decision is final unless, as provided in in paragraph (a)(3) of this section.
paragraph (a)(3) of this section, one of
(3) Judicial review. Any laboratory
the parties requests review by the De-
dissatisfied with the decision to impose
partmental Appeals Board within 60
days, and the Board reviews the case a civil money penalty or to suspend,
and issues a revised decision. limit, or revoke its CLIA certificate
(ii) If an ALJ decision upholds a sus- may, within 60 days after the decision
pension imposed because of immediate becomes final, file with the U.S. Court
jeopardy, that suspension becomes a of Appeals of the circuit in which the
revocation. laboratory has its principal place of
(e) Appeal rights for prospective labora- business, a petition for judicial review.
tories—(1) Reconsideration. Any prospec- (g) Notice of adverse action. (1) If CMS
tive laboratory dissatisfied with a de- suspends, limits, or revokes a labora-
nial of a CLIA certificate, or of ap- tory’s CLIA certificate or cancels the
proval for Medicare payment for its approval to receive Medicare payment
services, may initiate the appeals proc- for its services, CMS gives notice to
ess by requesting reconsideration in ac- the laboratory, and may give notice to
cordance with §§ 498.22 through 498.25 of physicians, providers, suppliers, and
this chapter. other laboratory clients, according to
(2) Notice of reopening. If CMS reopens the procedures set forth at § 493.1832. In
an initial or reconsidered determina- addition, CMS notifies the general pub-
tion, CMS gives the prospective labora- lic each time one of these principal
tory notice of the revised determina- sanctions is imposed.
tion in accordance with § 498.32 of this
(2) The notice to the laboratory—
chapter.
(3) ALJ hearing. Any prospective lab- (i) Sets forth the reasons for the ad-
oratory dissatisfied with a reconsidered verse action, the effective date and ef-
determination under paragraph (e)(1) of fect of that action, and the appeal
this section or a revised reconsidered rights if any; and
determination under § 498.30 of this (ii) When the certificate is limited,
chapter is entitled to a hearing before specifies the specialties or subspecial-
an ALJ, as specified in paragraph (a)(2) ties of tests that the laboratory is no
of this section. longer authorized to perform, and that
(4) Review of ALJ hearing decisions. are no longer covered under Medicare.
Any prospective laboratory that is dis- (3) The notice to other entities in-
satisfied with an ALJ’s hearing deci- cludes the same information except the
sion or dismissal of a request for hear- information about the laboratory’s ap-
ing may file a written request for re- peal rights.
view by the Departmental Appeals (h) Effective date of adverse action. (1)
Board as provided in paragraph (a)(3) of When the laboratory’s deficiencies pose
this section. immediate jeopardy, the effective date
(f) Appeal rights of laboratories—(1) of the adverse action is at least 5 days
ALJ hearing. Any laboratory dissatis- after the date of the notice.
fied with the suspension, limitation, or (2) When CMS determines that the
revocation of its CLIA certificate, with
laboratory’s deficiencies do not pose
the imposition of an alternative sanc-
immediate jeopardy, the effective date
tion under this subpart, or with can-
of the adverse action is at least 15 days
cellation of the approval to receive
after the date of the notice.
Medicare payment for its services, is
entitled to a hearing before an ALJ as [57 FR 7237, Feb. 28, 1992; 57 FR 35761, Aug. 11,
specified in paragraph (a)(2) of this sec- 1992, as amended at 68 FR 3714, Jan. 24, 2003]
818
§ 493.1846 Civil action. (8) A list of laboratories that have

been excluded from participation in
If CMS has reason to believe that
Medicare or Medicaid and the reasons
continuation of the activities of any
for the exclusion.
laboratory, including a State-exempt
laboratory, would constitute a signifi- (b) The laboratory registry is com-
cant hazard to the public health, CMS piled for the calendar year preceding
may bring suit in a U.S. District Court the date the information is made avail-
to enjoin continuation of the specific able and includes appropriate explana-
activity that is causing the hazard or tory information to aid in the interpre-
to enjoin the continued operation of tation of the data. It also contains cor-
the laboratory if CMS deems it nec- rections of any erroneous statements
essary. Upon proper showing, the court or information that appeared in the
shall issue a temporary injunction or previous registry.
restraining order without bond against
continuation of the activity. Subpart S [Reserved]
§ 493.1850 Laboratory registry. Subpart T—Consultations
(a) Once a year CMS makes available
to physicians and to the general public SOURCE: 57 FR 7185, Feb. 28, 1992, unless
specific information (including infor- otherwise noted.
mation provided to CMS by the OIG)
that is useful in evaluating the per- § 493.2001 Establishment and function
formance of laboratories, including the of the Clinical Laboratory Improve-
following: ment Advisory Committee.
(1) A list of laboratories that have (a) HHS will establish a Clinical Lab-
been convicted, under Federal or State oratory Improvement Advisory Com-
laws relating to fraud and abuse, false mittee to advise and make rec-
billing, or kickbacks. ommendations on technical and sci-
(2) A list of laboratories that have entific aspects of the provisions of this
had their CLIA certificates suspended, part 493.
limited, or revoked, and the reason for (b) The Clinical Laboratory Improve-
the adverse actions. ment Advisory Committee will be com-
(3) A list of persons who have been prised of individuals involved in the
convicted of violating CLIA require- provision of laboratory services, utili-
ments, as specified in section 353(1) of zation of laboratory services, develop-
the PHS Act, together with the cir- ment of laboratory testing or method-
cumstances of each case and the pen- ology, and others as approved by HHS.
alties imposed. (c) HHS will designate specialized
(4) A list of laboratories on which al- subcommittees as necessary.
ternative sanctions have been imposed, (d) The Clinical Laboratory Improve-
showing— ment Advisory Committee or any des-
(i) The effective date of the sanc- ignated subcommittees will meet as
tions; needed, but not less than once each
(ii) The reasons for imposing them; year.
(iii) Any corrective action taken by (e) The Clinical Laboratory Improve-
the laboratory; and ment Advisory Committee or sub-
(iv) If the laboratory has achieved committee, at the request of HHS, will
compliance, the verified date of com- review and make recommendations
pliance. concerning:
(5) A list of laboratories whose ac- (1) Criteria for categorizing non-
creditation has been withdrawn or re- waived testing;
voked and the reasons for the with- (2) Determination of waived tests;
drawal or revocation. (3) Personnel standards;
(6) All appeals and hearing decisions. (4) Facility administration and qual-
(7) A list of laboratories against ity systems standards.
which CMS has brought suit under (5) Proficiency testing standards;
§ 493.1846 and the reasons for those ac- (6) Applicability to the standards of
tions. new technology; and
819
(7) Other issues relevant to part 493, (1) Section 299I of the Social Security
if requested by HHS. Amendments of 1972 (Pub. L. 92–603),
(f) HHS will be responsible for pro- which extended Medicare coverage to
viding the data and information, as insured individuals, their spouses, and
necessary, to the members of the Clin- their dependent children with ESRD
ical Laboratory Improvement Advisory who require dialysis or transplan-
Committee. tation.
(2) Section 1861(e)(9) of the Act,
FR 5237, Jan. 19, 1993; 60 FR 20051, Apr. 24, which requires hospitals to meet such
1995; 68 FR 3714, Jan. 24, 2003] other requirements as the Secretary
finds necessary in the interest of
PART 494—CONDITIONS FOR COV- health and safety of individuals who
are furnished services in the institu-
ERAGE FOR END-STAGE RENAL tion.
DISEASE FACILITIES (3) Section 1861(s)(2)(F) of the Act,
which describes ‘‘medical and other
Subpart A—General Provisions health services’’ covered under Medi-
Sec. care to include home dialysis supplies
494.1 Basis and scope. and equipment, self-care home dialysis
494.10 Definitions. support services, and institutional di-
494.20 Condition: Compliance with Federal, alysis services and supplies, for items
State, and local laws and regulations. and services furnished on or after Jan-
Subpart B—Patient Safety uary 1, 2011, renal dialysis services (as
defined in section 1881(b)(14)(B)), in-
494.30 Condition: Infection control. cluding such renal dialysis services fur-
494.40 Condition: Water and dialysate qual- nished on or after January 1, 2017, by a
ity. renal dialysis facility or provider of
494.50 Condition: Reuse of hemodialyzers
services paid under section 1881(b)(14)
and bloodlines.
494.60 Condition: Physical environment. to an individual with acute kidney in-
494.62 Condition of participation: Emer- jury (as defined in section 1834(r)(2)).
gency preparedness. (4) Section 1862(a) of the Act, which
specifies exclusions from coverage.
Subpart C—Patient Care (5) Section 1881 of the Act, which au-
494.70 Condition: Patients’ rights.
thorizes Medicare coverage and pay-
494.80 Condition: Patient assessment. ment for the treatment of ESRD in ap-
494.90 Condition: Patient plan of care. proved facilities, including institu-
494.100 Condition: Care at home. tional dialysis services, transplan-
494.110 Condition: Quality assessment and tation services, self-care home dialysis
performance improvement. services, and the administration of
494.120 Condition: Special purpose renal di- erythropoiesis-stimulating agent(s).
alysis facilities.
(6) Section 12(d) of the National
494.130 Condition: Laboratory services.
Technology Transfer and Advancement
Subpart D—Administration Act of 1995 (Pub. L. 104–113), which re-
quires Federal agencies to use tech-
494.140 Condition: Personnel qualifications. nical standards that are developed or
494.150 Condition: Responsibilities of the adopted by voluntary consensus stand-
medical director.
494.160 [Reserved]
ards bodies, unless their use would be
494.170 Condition: Medical records. inconsistent with applicable law or
494.180 Condition: Governance. otherwise impractical.
(7) Section 1861(s)(2)(F) of the Act,
AUTHORITY: 42 U.S.C. l302 and l395hh.
which authorizes coverage for renal di-
SOURCE: 73 FR 20475, Apr. 15, 2008, unless alysis services furnished on or after
otherwise noted. January 1, 2017 by a renal dialysis fa-
cility or provider of services currently
Subpart A—General Provisions paid under section 1881(b)(14) of the Act
to an individual with AKI.
§ 494.1 Basis and scope. (b) Scope. The provisions of this part
(a) Statutory basis. This part is based establish the conditions for coverage of
on the following provisions: services under Medicare and are the
820
basis for survey activities for the pur- Subpart B—Patient Safety
pose of determining whether an ESRD
facility’s services may be covered. § 494.30 Condition: Infection control.
[73 FR 20475, Apr. 15, 2008, as amended at 81 The dialysis facility must provide
FR 77969, Nov. 4, 2016] and monitor a sanitary environment to
minimize the transmission of infec-
§ 494.10 Definitions. tious agents within and between the
unit and any adjacent hospital or other
As used in this part— public areas.
Dialysis facility means an entity that (a) Standard: Procedures for infection
provides outpatient maintenance dialy- control. The facility must demonstrate
sis services, or home dialysis training that it follows standard infection con-
and support services, or both. A dialy- trol precautions by implementing—
sis facility may be an independent or (1)(i) The recommendations (with the
hospital-based unit (as described in exception of screening for hepatitis C),
§ 413.174(b) and (c) of this chapter) that found in ‘‘Recommendations for Pre-
includes a self-care dialysis unit that venting Transmission of Infections
furnishes only self-dialysis services. Among Chronic Hemodialysis Pa-
Discharge means the termination of tients,’’ developed by the Centers for
patient care services by a dialysis fa- Disease Control and Prevention, Mor-
cility or the patient voluntarily termi- bidity and Mortality Weekly Report,
nating dialysis when he or she no volume 50, number RR05, April 27, 2001,
pages 18 to 28. The Director of the Fed-
longer wants to be dialyzed by that fa-
eral Register approves this incorpora-
cility. tion by reference in accordance with 5
Furnishes directly means the ESRD fa- U.S.C. 552(a) and 1 CFR part 51. This
cility provides the service through its publication is available for inspection
own staff and employees or through in- at the CMS Information Resource Cen-
dividuals who are under direct contract ter, 7500 Security Boulevard, Central
to furnish these services personally for Building, Baltimore, MD or at the Na-
the facility. tional Archives and Records Adminis-
Home dialysis means dialysis per- tration (NARA). Copies may be ob-
formed at home by an ESRD patient or tained at the CMS Information Re-
caregiver who has completed an appro- source Center. For information on the
priate course of training as described availability of this material at NARA,
in § 494.100(a) of this part. call 202–741–6030, or go to: http://
Self-dialysis means dialysis performed www.archives.gov/federal_register/
with little or no professional assistance code_of_federal_regulations/
by an ESRD patient or caregiver who ibr_locations.html. The recommendation
has completed an appropriate course of found under section header ‘‘HBV-In-
training as specified in § 494.100(a) of fected Patients’’, found on pages 27 and
this part. 28 of RR05 (‘‘Recommendations for Pre-
venting Transmission of Infections
Transfer means a temporary or per-
Among Chronic Hemodialysis Pa-
manent move of a patient from one di-
tients’’), concerning isolation rooms,
alysis facility to another that requires must be complied with by February 9,
a transmission of the patient’s medical 2009.
record to the facility receiving the pa- (ii) When dialysis isolation rooms as
tient. required by (a)(1)(i) are available lo-
cally that sufficiently serve the needs
§ 494.20 Condition: Compliance with
of patients in the geographic area, a
Federal, State, and local laws and
regulations. new dialysis facility may request a
waiver of such requirement. Isolation
The facility and its staff must oper- room waivers may be granted at the
ate and furnish services in compliance discretion of, and subject to, additional
with applicable Federal, State, and qualifications as may be deemed nec-
local laws and regulations pertaining essary by the Secretary.
to licensure and any other relevant (2) The ‘‘Guidelines for the Preven-
health and safety requirements. tion of Intravascular Catheter-Related
821
§ 494.40 42 CFR Ch. IV (10–1–24 Edition)
Infections’’ entitled ‘‘Recommenda- nicable diseases as required by Federal,

tions for Placement of Intravascular State, and local regulations.
Catheters in Adults and Children’’
parts I–IV; and ‘‘Central Venous Cath- FR 61626, Nov. 5, 2021; 88 FR 36510, June 5,
eters, Including PICCs, Hemodialysis, 2023]
and Pulmonary Artery Catheters, in
Adult and Pediatric Patients,’’ Mor- § 494.40 Condition: Water and
bidity and Mortality Weekly Report, dialysate quality.
volume 51 number RR–10, pages 16 The facility must be able to dem-
through 18, August 9, 2002. The Director onstrate the following:
of the Federal Register approves this (a) Standard: Water purity. Water and
incorporation by reference in accord- equipment used for dialysis meets the
ance with 5 U.S.C. 552(a) and 1 CFR water and dialysate quality standards
part 51. This publication is available and equipment requirements found in
for inspection at the CMS Information the Association for the Advancement
Resource Center, 7500 Security Boule- of Medical Instrumentation (AAMI)
vard, Central Building, Baltimore, MD publication, ‘‘Dialysate for hemo-
or at the National Archives and dialysis,’’ ANSI/AAMI RD52: 2004. The
Records Administration (NARA). Cop- Director of the Federal Register ap-
ies may be obtained at the CMS Infor- proves this incorporation by reference
mation Resource Center. For informa- in accordance with 5 U.S.C. 552(a) and 1
tion on the availability of this mate- CFR part 51. This publication is avail-
rial at NARA, call 202–741–6030, or go able for inspection at the CMS Infor-
to: http://www.archives.gov/fed- mation Resource Center, 7500 Security
eral_register/code_of_federal_regulations/ Boulevard, Central Building, Balti-
ibr_locations.html. more, MD or at the National Archives
and Records Administration (NARA).
(3) Patient isolation procedures to
For information on the availability of
minimize the spread of infectious
this material at NARA, call 202–741–
agents and communicable diseases; and 6030, or go to: http://www.archives.gov/
(4) Maintaining procedures, in ac- federal_register/
cordance with applicable State and code_of_federal_regulations/
local laws and accepted public health ibr_locations.html. Copies may be pur-
procedures, for the— chased from the Association for the
(i) Handling, storage, and disposal of Advancement of Medical Instrumenta-
potentially infectious waste; and tion, 3300 Washington Boulevard, Suite
(ii) Cleaning and disinfection of con- 400, Arlington, VA 22201–4598.
taminated surfaces, medical devices, (b) Standard: Chlorine/chloramines. (1)
and equipment. The water treatment system must in-
(b) Standard: Oversight. The facility clude a component or carbon tank
must— which removes chlorine/chloramine
(1) Monitor and implement biohazard along with a backup component or sec-
and infection control policies and ac- ond carbon tank in series for chlorine/
tivities within the dialysis unit; chloramine removal;
(2) Ensure that clinical staff dem- (2)(i) If the test results from the port
onstrate compliance with current asep- of the initial component or carbon
tic techniques when dispensing and ad- tank referred to in section 6.2.5 of
ministering intravenous medications AAMI RD52:2004 are greater than 0.5
mg/L for free chlorine or 0.1 mg/L for
from vials and ampules; and
chloramines, or equal to or greater
(3) Require all clinical staff to report than 0.1 mg/L of total chlorine, then
infection control issues to the dialysis the second component or carbon tank
facility’s medical director (see § 494.150 which removes chlorine/chloramine
of this part) and the quality improve- must be tested;
ment committee. (ii) If the test results from the last
(c) Standard: Reporting. The facility component or carbon tank are greater
must report incidences of commu- than the parameters for chlorine or
chloramine specified in paragraph
822
(b)(2)(i) of this section the facility the water and dialysate are within
must— AAMI limits.
(A) Immediately take corrective ac-
tion to bring chlorine or chloramine § 494.50 Condition: Reuse of
levels into compliance with paragraph hemodialyzers and bloodlines.
(b)(2)(i) of this section and confirm (a) Standard: General requirements for
through testing that the corrective ac- the reuse of hemodialyzers and bloodlines.
tion has been effective, or terminate Certain hemodialyzers and bloodlines—
dialysis treatment to protect patients (1) May be reused for certain patients
from exposure to chlorine/chloramine;
with the exception of Hepatitis B posi-
(B) Only allow use of purified water
tive patients;
in a holding tank, if appropriate, and if
testing shows water chlorine or chlor- (2) Must be reused only for the same
amine levels that are in compliance patient; and
with paragraph (b)(2)(i) of this section; (3) Must be labeled for multiple reuse
and in accordance with the premarket noti-
(C) Immediately notify the medical fication provisions of section 510(k) of
director; and the Food, Drug, and Cosmetics Act and
(D) Take corrective action to ensure 21 CFR 876.5860.
ongoing compliance with acceptable (b) Standard: Reprocessing requirements
chlorine and chloramine levels as de- for the reuse of hemodialyzers and blood-
scribed in paragraph (b)(2)(i) of this lines. A dialysis facility that reuses
section. hemodialyzers and bloodlines must ad-
(c) Standard: Corrective action plan. here to the following reprocessing
Water testing results including, but guidelines:
not limited to, chemical, microbial, (1) Meet the requirements of AAMI
and endotoxin levels which meet AAMI published in ‘‘Reuse of Hemodialyzers,’’
action levels or deviate from the AAMI third edition, ANSI/AAMI RD47:2002
standards must be addressed with a
and RD47:2002/A1:2003. The Director of
corrective action plan that ensures pa-
the Federal Register approves this in-
tient safety.
(d) Standard: Adverse events. A dialy- corporation by reference in accordance
sis facility must maintain active sur- with 5 U.S.C. 552(a) and 1 CFR part 51.
veillance of patient reactions during This publication is available for inspec-
and following dialysis. When clinically tion at the CMS Information Resource
indicated (for example, after adverse Center, 7500 Security Boulevard, Cen-
patient reactions) the facility must— tral Building, Baltimore, MD or at the
(1) Obtain blood and dialysate cul- National Archives and Records Admin-
tures and endotoxin levels; istration (NARA). For information on
(2) Evaluate the water purification the availability of this material at
system; and NARA, call 202–741–6030, or go to: http://
(3) Take corrective action. www.archives.gov/federal_register/
(e) Standard: In-center use of code_of_federal_regulations/
preconfigured hemodialysis systems. ibr_locations.html. Copies may be pur-
When using a preconfigured, FDA-ap- chased from the Association for the
proved hemodialysis system designed, Advancement of Medical Instrumenta-
tested and validated to yield AAMI tion, 3300 Washington Boulevard, Suite
quality (which includes standards for 400, Arlington, VA 22201–4598.
chemical and chlorine/chloramine test- (2) Reprocess hemodialyzers and
ing) water and dialysate, the system’s bloodlines—
FDA-approved labeling must be ad-
(i) By following the manufacturer’s
hered to for machine use and moni-
recommendations; or
toring of the water and dialysate qual-
ity. The facility must meet all AAMI (ii) Using an alternate method and
RD52:2004 requirements for water and maintaining documented evidence that
dialysate. Moreover, the facility must the method is safe and effective.
perform bacteriological and endotoxin (3) Not expose hemodialyzers to more
testing on a quarterly, or more fre- than one chemical germicide, other
quent basis, as needed, to ensure that than bleach (used as a cleaner in this
823
§ 494.60 42 CFR Ch. IV (10–1–24 Edition)
application), during the life of the dia- tamination, and to accommodate med-
lyzer. All hemodialyzers must be dis- ical emergency equipment and staff.
carded before a different chemical ger- (2) The dialysis facility must:
micide is used in the facility. (i) Maintain a comfortable tempera-
(c) Standard: Monitoring, evaluation, ture within the facility; and
and reporting requirements for the reuse (ii) Make reasonable accommoda-
of hemodialyzers and bloodlines. In additions for the patients who are not com-
tion to the requirements for fortable at this temperature.
hemodialyzer and bloodline reuse spec- (3) The dialysis facility must make
ified in paragraphs (a) and (b) of this accommodations to provide for patient
section, the dialysis facility must ad- privacy when patients are examined or
here to the following: treated and body exposure is required.
(1) Monitor patient reactions during
(4) Patients must be in view of staff
and following dialysis.
during hemodialysis treatment to en-
(2) When clinically indicated (for ex-
sure patient safety (video surveillance
ample, after adverse patient reactions),
will not meet this requirement).
the facility must—
(i) Obtain blood and dialysate cul- (d) Standard: Fire safety. (1) Except as
tures and endotoxin levels; and provided in paragraph (d)(2) of this sec-
(ii) Undertake evaluation of its dia- tion, dialysis facilities that do not pro-
lyzer reprocessing and water purifi- vide one or more exits to the outside at
cation system. When this evaluation grade level from the patient treatment
suggests a cluster of adverse patient area level must comply with provisions
reactions is associated with of the Life Safety Code (NFPA 101 and
hemodialyzer reuse, the facility must its Tentative Interim Amendments TIA
suspend reuse of hemodialyzers until it 12–1, TIA 12–2, TIA 12–3, and TIA 12–4)
is satisfied the problem has been cor- applicable to Ambulatory Health Care
rected. Occupancies, regardless of the number
(iii) Report the adverse outcomes to of patients served.
the FDA and other Federal, State or (2) Notwithstanding paragraph (d)(1)
local government agencies as required of this section, dialysis facilities par-
by law. ticipating in Medicare as of October 14,
2008 that require sprinkler systems are
§ 494.60 Condition: Physical environ- those housed in multi-story buildings
ment. construction Types II(000), III(200), or
The dialysis facility must be de- V(000), as defined in the Life Safety
signed, constructed, equipped, and Code, section 21.1.6.1, which were con-
maintained to provide dialysis pa- structed after January 1, 2008, and
tients, staff, and the public a safe, those housed in high rise buildings over
functional, and comfortable treatment 75 feet in height, which were con-
environment. structed after January 1, 2008.
(a) Standard: Building. The building (3) If CMS finds that a fire and safety
in which dialysis services are furnished code imposed by the facility’s State
must be constructed and maintained to law adequately protects a dialysis fa-
ensure the safety of the patients, the cility’s patients, CMS may allow the
staff, and the public. State survey agency to apply the
(b) Standard: Equipment maintenance. State’s fire and safety code instead of
The dialysis facility must implement the Life Safety Code.
and maintain a program to ensure that (4) In consideration of a rec-
all equipment (including emergency ommendation by the State survey
equipment, dialysis machines and agency or at the discretion of the Sec-
equipment, and the water treatment retary, the Secretary may waive, for
system) are maintained and operated periods deemed appropriate, specific
in accordance with the manufacturer’s provisions of the Life Safety Code,
recommendations. which would result in unreasonable
(c) Standard: Patient care environment. hardship upon an ESRD facility, but
(1) The space for treating each patient only if the waiver will not adversely af-
must be sufficient to provide needed fect the health and safety of the pa-
care and services, prevent cross-con- tients.
824
(5) No dialysis facility may operate (iv) TIA 12–4 to NFPA 99, issued
in a building that is adjacent to an in- March 7, 2013.
dustrial high hazard area, as described (v) TIA 12–5 to NFPA 99, issued Au-
in sections 20.1.3.7 and 21.1.3.7 of the gust 1, 2013.
Health Care Facilities Code (NFPA 99 (vi) TIA 12–6 to NFPA 99, issued
and its Tentative Interim Amendments March 3, 2014.
TIA 12–2, TIA 12–3, TIA 12–4, TIA 12–5, (vii) NFPA 101, Life Safety Code, 2012
and TIA 12–6). edition, issued August 11, 2011.
(e) Standard: Building safety. (1) Di- (viii) TIA 12–1 to NFPA 101, issued
alysis facilities that do not provide one August 11, 2011.
or more exits to the outside at grade (ix) TIA 12–2 to NFPA 101, issued Oc-
level from the patient treatment area tober 30, 2012.
level must meet the applicable provi- (x) TIA 12–3 to NFPA 101, issued Oc-
sions of the Health Care Facilities tober 22, 2013.
Code, regardless of the number of pa- (xi) TIA 12–4 to NFPA 101, issued Oc-
tients served. tober 22, 2013.
(2) Chapters 7, 8, 12, and 13 of the (2) [Reserved]
Health Care Facilities Code do not
apply to a dialysis facility.
FR 29031, May 16, 2012; 81 FR 64042, Sept. 16,
(3) If application of the Health Care 2016; 84 FR 51832, Sept. 30, 2019]
Facilities Code would result in unrea-
sonable hardship for the dialysis facil- § 494.62 Condition of participation:
ity, CMS may waive specific provisions Emergency preparedness.
of the Health Care Facilities Code for The dialysis facility must comply
such facility, but only if the waiver with all applicable Federal, State, and
does not adversely affect the health local emergency preparedness require-
and safety of patients. ments. These emergencies include, but
(f) Incorporation by reference. The are not limited to, fire, equipment or
standards incorporated by reference in power failures, care-related emer-
this section are approved for incorpora- gencies, water supply interruption, and
tion by reference by the Director of the natural disasters likely to occur in the
Office of the Federal Register in ac- facility’s geographic area. The dialysis
cordance with 5 U.S.C. 552(a) and 1 CFR facility must establish and maintain
part 51. You may obtain the material an emergency preparedness program
from the sources listed below. You may that meets the requirements of this
inspect a copy at the CMS Information section. The emergency preparedness
Resource Center, 7500 Security Boule- program must include, but not be lim-
vard, Baltimore, MD or at the National ited to, the following elements:
Archives and Records Administration (a) Emergency plan. The dialysis facil-
(NARA). For information on the avail- ity must develop and maintain an
ability of this material at NARA, email emergency preparedness plan that
fedreg.legal@nara.gov, or go to: must be evaluated and updated at least
www.archives.gov/federal_register/cfr/ibr- every 2 years. The plan must do all of
locations.html. If any changes in the the following:
editions of the Codes are incorporated (1) Be based on and include a docu-
by reference, CMS will publish a documented, facility-based and community-
ment in the FEDERAL REGISTER to an- based risk assessment, utilizing an all-
nounce the changes. hazards approach.
(1) National Fire Protection Associa- (2) Include strategies for addressing
tion, 1 Batterymarch Park, Quincy, emergency events identified by the
MA 02169, www.nfpa.org, 1–617–770–3000. risk assessment.
(i) NFPA 99, Health Care Facilities (3) Address patient population, in-
Code, 2012 edition, issued August 11 cluding, but not limited to, the type of
2011. services the dialysis facility has the
(ii) TIA 12–2 to NFPA 99, issued Au- ability to provide in an emergency; and
gust 11, 2011. continuity of operations, including del-
(iii) TIA 12–3 to NFPA 99, issued Au- egations of authority and succession
gust 9, 2012. plans.
825
§ 494.62 42 CFR Ch. IV (10–1–24 Edition)
(4) Include a process for cooperation providers to receive patients in the

and collaboration with local, tribal, re- event of limitations or cessation of op-
gional, State, and Federal emergency erations to maintain the continuity of
preparedness officials’ efforts to main- services to dialysis facility patients.
tain an integrated response during a (7) The role of the dialysis facility
disaster or emergency situation. The under a waiver declared by the Sec-
dialysis facility must contact the local retary, in accordance with section 1135
emergency preparedness agency at of the Act, in the provision of care and
least annually to confirm that the treatment at an alternate care site
agency is aware of the dialysis facili- identified by emergency management
ty’s needs in the event of an emer- officials.
gency. (8) How emergency medical system
(b) Policies and procedures. The dialy- assistance can be obtained when need-
sis facility must develop and imple- ed.
ment emergency preparedness policies (9) A process by which the staff can
and procedures, based on the emer- confirm that emergency equipment, in-
gency plan set forth in paragraph (a) of cluding, but not limited to, oxygen,
this section, risk assessment at para- airways, suction, defibrillator or auto-
graph (a)(1) of this section, and the mated external defibrillator, artificial
communication plan at paragraph (c) resuscitator, and emergency drugs, are
of this section. The policies and proce- on the premises at all times and imme-
dures must be reviewed and updated at diately available.
least every 2 years. These emergencies (c) Communication plan. The dialysis
include, but are not limited to, fire, facility must develop and maintain an
equipment or power failures, care-re- emergency preparedness communica-
lated emergencies, water supply inter- tion plan that complies with Federal,
ruption, and natural disasters likely to State, and local laws and must be re-
occur in the facility’s geographic area. viewed and updated at least every 2
At a minimum, the policies and proce- years. The communication plan must
dures must address the following: include all of the following:
(1) A system to track the location of (1) Names and contact information
on-duty staff and sheltered patients in for the following:
the dialysis facility’s care during and (i) Staff.
after an emergency. If on-duty staff (ii) Entities providing services under
and sheltered patients are relocated arrangement.
during the emergency, the dialysis fa- (iii) Patients’ physicians.
cility must document the specific
(iv) Other dialysis facilities.
name and location of the receiving fa-
(v) Volunteers.
cility or other location.
(2) Safe evacuation from the dialysis (2) Contact information for the fol-
facility, which includes staff respon- lowing:
sibilities, and needs of the patients. (i) Federal, State, tribal, regional or
(3) A means to shelter in place for pa- local emergency preparedness staff.
tients, staff, and volunteers who re- (ii) Other sources of assistance.
main in the facility. (3) Primary and alternate means for
(4) A system of medical documenta- communicating with the following:
tion that preserves patient informa- (i) Dialysis facility’s staff.
tion, protects confidentiality of patient (ii) Federal, State, tribal, regional,
information, and secures and main- or local emergency management agen-
tains the availability of records. cies.
(5) The use of volunteers in an emer- (4) A method for sharing information
gency or other emergency staffing and medical documentation for pa-
strategies, including the process and tients under the dialysis facility’s care,
role for integration of State or Feder- as necessary, with other health care
ally designated health care profes- providers to maintain the continuity of
sionals to address surge needs during care.
an emergency. (5) A means, in the event of an evacu-
(6) The development of arrangements ation, to release patient information as
with other dialysis facilities or other permitted under 45 CFR 164.510(b)(1)(ii).
826
(6) A means of providing information (v) Properly train its nursing staff in
about the general condition and loca- the use of emergency equipment and
tion of patients under the facility’s emergency drugs.
care as permitted under 45 CFR (vi) Maintain documentation of the
164.510(b)(4). training.
(7) A means of providing information (vii) If the emergency preparedness
about the dialysis facility’s needs, and policies and procedures are signifi-
its ability to provide assistance, to the cantly updated, the dialysis facility
authority having jurisdiction or the In- must conduct training on the updated
cident Command Center, or designee. policies and procedures.
(d) Training, testing, and orientation. (2) Testing. The dialysis facility must
The dialysis facility must develop and conduct exercises to test the emer-
maintain an emergency preparedness gency plan at least annually. The di-
training, testing and patient orienta- alysis facility must do all of the fol-
tion program that is based on the lowing:
emergency plan set forth in paragraph (i) Participate in a full-scale exercise
(a) of this section, risk assessment at that is community-based every 2 years;
paragraph (a)(1) of this section, policies or
and procedures at paragraph (b) of this (A) When a community-based exer-
section, and the communication plan cise is not accessible, an individual,
at paragraph (c) of this section. The and a facility-based functional exercise
training, testing, and patient orienta- every 2 years; or
tion program must be evaluated and (B) If the dialysis facility experiences
updated at least every 2 years. an actual natural or man-made emer-
(1) Training program. The dialysis fa- gency that requires activation of the
cility must do all of the following: emergency plan, the dialysis facility is
(i) Provide initial training in emer- exempt from engaging in its next re-
gency preparedness policies and proce- quired full-scale community-based or
dures to all new and existing staff, in- individual, facility-based functional ex-
dividuals providing services under ar- ercise following the onset of the emer-
rangement, and volunteers, consistent gency event.
with their expected roles. (ii) Conduct an additional exercise
(ii) Provide emergency preparedness every 2 years, opposite the year the
training at least every 2 years. full-scale or functional exercise under
(iii) Demonstrate staff knowledge of paragraph (d)(2)(i) of this section is
emergency procedures, including in- conducted, that may include, but is not
forming patients of— limited to the following:
(A) What to do; (A) A second full-scale exercise that
(B) Where to go, including instruc- is community-based or an individual,
tions for occasions when the geo- facility-based functional exercise; or
graphic area of the dialysis facility (B) A mock disaster drill; or
must be evacuated; (C) A tabletop exercise or workshop
(C) Whom to contact if an emergency that is led by a facilitator and includes
occurs while the patient is not in the a group discussion, using a narrated,
dialysis facility. This contact informa- clinically-relevant emergency scenario,
tion must include an alternate emer- and a set of problem statements, di-
gency phone number for the facility for rected messages, or prepared questions
instances when the dialysis facility is designed to challenge an emergency
unable to receive phone calls due to an plan.
emergency situation (unless the facil- (iii) Analyze the dialysis facility’s re-
ity has the ability to forward calls to a sponse to and maintain documentation
working phone number under such of all drills, tabletop exercises, and
emergency conditions); and emergency events, and revise the dialy-
(D) How to disconnect themselves sis facility’s emergency plan, as need-
from the dialysis machine if an emer- ed.
gency occurs. (3) Patient orientation: Emergency pre-
(iv) Demonstrate that, at a min- paredness patient training. The facility
imum, its patient care staff maintains must provide appropriate orientation
current CPR certification; and and training to patients, including the
827
§ 494.70 42 CFR Ch. IV (10–1–24 Edition)
areas specified in paragraph (d)(1) of Subpart C—Patient Care

this section.
(e) Integrated healthcare systems. If a § 494.70 Condition: Patients’ rights.
dialysis facility is part of a healthcare The dialysis facility must inform pa-
system consisting of multiple sepa- tients (or their representatives) of
rately certified healthcare facilities their rights (including their privacy
that elects to have a unified and inte- rights) and responsibilities when they
grated emergency preparedness pro- begin their treatment and must protect
gram, the dialysis facility may choose and provide for the exercise of those
to participate in the healthcare sys- rights.
tem’s coordinated emergency prepared- (a) Standard: Patients’ rights. The pa-
ness program. If elected, the unified tient has the right to—
and integrated emergency preparedness (1) Respect, dignity, and recognition
program must do all of the following: of his or her individuality and personal
needs, and sensitivity to his or her psy-
(1) Demonstrate that each separately
chological needs and ability to cope
certified facility within the system ac- with ESRD;
tively participated in the development (2) Receive all information in a way
of the unified and integrated emer- that he or she can understand;
gency preparedness program. (3) Privacy and confidentiality in all
(2) Be developed and maintained in a aspects of treatment;
manner that takes into account each (4) Privacy and confidentiality in
separately certified facility’s unique personal medical records;
circumstances, patient populations, (5) Be informed about and partici-
and services offered. pate, if desired, in all aspects of his or
(3) Demonstrate that each separately her care, and be informed of the right
certified facility is capable of actively to refuse treatment, to discontinue
using the unified and integrated emer- treatment, and to refuse to participate
gency preparedness program and is in in experimental research;
compliance with the program. (6) Be informed about his or her right
(4) Include a unified and integrated to execute advance directives, and the
facility’s policy regarding advance di-
emergency plan that meets the require-
rectives;
ments of paragraphs (a)(2), (3), and (4)
(7) Be informed about all treatment
of this section. The unified and inte- modalities and settings, including but
grated emergency plan must also be not limited to, transplantation, home
based on and include all of the fol- dialysis modalities (home hemo-
lowing: dialysis, intermittent peritoneal dialy-
(i) A documented community–based sis, continuous ambulatory peritoneal
risk assessment, utilizing an all-haz- dialysis, continuous cycling peritoneal
ards approach. dialysis),and in-facility hemodialysis.
(ii) A documented individual facility- The patient has the right to receive re-
based risk assessment for each sepa- source information for dialysis modali-
rately certified facility within the ties not offered by the facility, includ-
health system, utilizing an all-hazards ing information about alternative
approach. scheduling options for working pa-
(5) Include integrated policies and tients;
procedures that meet the requirements (8) Be informed of facility policies re-
set forth in paragraph (b) of this sec- garding patient care, including, but not
tion, a coordinated communication limited to, isolation of patients;
(9) Be informed of facility policies re-
plan and training and testing programs
garding the reuse of dialysis supplies,
that meet the requirements of para-
including hemodialyzers;
graphs (c) and (d) of this section, re- (10) Be informed by the physician,
spectively. nurse practitioner, clinical nurse spe-
[81 FR 64042, Sept. 16, 2016, as amended by 84 cialist, or physician’s assistant treat-
FR 51833, Sept. 30, 2019] ing the patient for ESRD of his or her
own medical status as documented in
the patient’s medical record, unless the
828
medical record contains a documented (i) How plans in the individual mar-
contraindication; ket will affect the patient’s access to,
(11) Be informed of services available and costs for the providers and sup-
in the facility and charges for services pliers, services, and prescription drugs
not covered under Medicare; that are currently within the individ-
(12) Receive the necessary services ual’s ESRD plan of care as well as
outlined in the patient plan of care de- those likely to result from other docu-
scribed in § 494.90; mented health care needs. This must
(13) Be informed of the rules and ex- include an overview of the health-re-
pectations of the facility regarding pa- lated and financial risks and benefits
tient conduct and responsibilities; of the individual market plans avail-
(14) Be informed of the facility’s in-
able to the patient (including plans of-
ternal grievance process;
fered through and outside the Ex-
(15) Be informed of external griev-
ance mechanisms and processes, in- change).
cluding how to contact the ESRD Net- (ii) Medicare and Medicaid/Children’s
work and the State survey agency; Health Insurance Coverage (CHIP) cov-
(16) Be informed of his or her right to erage, including Medicare Savings Pro-
file internal grievances or external grams, and how enrollment in those
grievances or both without reprisal or programs will affect the patient’s ac-
denial of services; and cess to and costs for health care pro-
(17) Be informed that he or she may viders, services, and prescription drugs
file internal or external grievances, that are currently within the individ-
personally, anonymously or through a ual’s plan of care.
representative of the patient’s choos- (iii) Each option’s coverage and an-
ing. ticipated costs associated with trans-
(b) Standard: Right to be informed re- plantation, including patient and liv-
garding the facility’s discharge and trans- ing donor costs for pre- and post-trans-
fer policies. The patient has the right plant care.
to— (2) Receive current information from
(1) Be informed of the facility’s poli- the facility about premium assistance
cies for transfer, routine or involun-
for enrollment in an individual market
tary discharge, and discontinuation of
health plan that may be available to
services to patients; and
the patient from the facility, its parent
(2) Receive written notice 30 days in
advance of an involuntary discharge, organization, or third parties, includ-
after the facility follows the involun- ing but not limited to limitations and
tary discharge procedures described in any associated risks of such assistance.
§ 494.180(f)(4). In the case of immediate (3) Receive current information
threats to the health and safety of oth- about the facility’s, or its parent orga-
ers, an abbreviated discharge procedure nization’s, contributions to patients or
may be allowed. third parties that subsidize the individ-
(c) Standard: Right to be informed of ual’s enrollment in individual market
health coverage options. For patients of health plans for individuals on dialysis,
dialysis facilities that make payments including the reimbursements for serv-
of premiums for individual market ices rendered that the facility receives
health plans (in any amount), whether as a result of subsidizing such enroll-
directly, through a parent organization ment.
(such as a dialysis corporation), or (d) Standard: Posting of rights. The di-
through another entity (including by alysis facility must prominently dis-
providing contributions to entities play a copy of the patient’s rights in
that make such payments), the patient the facility, including the current
has the right to— State agency and ESRD network mail-
(1) Be informed annually, on a timely
ing addresses and telephone complaint
basis for each plan year, of all avail-
numbers, where it can be easily seen
able health coverage options, including
and read by patients.
but not limited to Medicare, Medicaid,
CHIP and individual market plans. [73 FR 20475, Apr. 15, 2008, as amended at 81
This must include information on: FR 90227, Dec. 14, 2016]
829
§ 494.80 42 CFR Ch. IV (10–1–24 Edition)
§ 494.80 Condition: Patient assessment. (11) Evaluation of family and other

support systems.
The facility’s interdisciplinary team
(12) Evaluation of current patient
consists of, at a minimum, the patient
physical activity level.
or the patient’s designee (if the patient
(13) Evaluation for referral to voca-
chooses), a registered nurse, a physi-
tional and physical rehabilitation serv-
cian treating the patient for ESRD, a
ices.
social worker, and a dietitian. The
(b) Standard: Frequency of assessment
interdisciplinary team is responsible
for patients admitted to the dialysis facil-
for providing each patient with an indi-
ity. (1) An initial comprehensive assess-
vidualized and comprehensive assess-
ment must be conducted on all new pa-
ment of his or her needs. The com-
tients (that is, all admissions to a di-
prehensive assessment must be used to
alysis facility), within the latter of 30
develop the patient’s treatment plan
calendar days or 13 outpatient hemo-
and expectations for care.
dialysis sessions beginning with the
(a) Standard: Assessment criteria. The first outpatient dialysis session.
patient’s comprehensive assessment (2) A follow up comprehensive reas-
must include, but is not limited to, the sessment must occur within 3 months
following: after the completion of the initial as-
(1) Evaluation of current health sta- sessment to provide information to ad-
tus and medical condition, including just the patient’s plan of care specified
co-morbid conditions. in § 494.90.
(2) Evaluation of the appropriateness (c) Standard: Assessment of treatment
of the dialysis prescription, blood pres- prescription. The adequacy of the pa-
sure, and fluid management needs. tient’s dialysis prescription, as de-
(3) Laboratory profile, immunization scribed in § 494.90(a)(1), must be as-
history, and medication history. sessed on an ongoing basis as follows:
(4) Evaluation of factors associated (1) Hemodialysis patients. At least
with anemia, such as hematocrit, he- monthly by calculating delivered Kt/V
moglobin, iron stores, and potential or an equivalent measure.
treatment plans for anemia, including (2) Peritoneal dialysis patients. At least
administration of erythropoiesis-stim- every 4 months by calculating deliv-
ulating agent(s). ered weekly Kt/V or an equivalent
(5) Evaluation of factors associated measure.
with renal bone disease. (d) Standard: Patient reassessment. In
(6) Evaluation of nutritional status accordance with the standards speci-
by a dietitian. fied in paragraphs (a)(1) through (a)(13)
(7) Evaluation of psychosocial needs of this section, a comprehensive reas-
by a social worker. sessment of each patient and a revision
(8) Evaluation of dialysis access type of the plan of care must be conducted—
and maintenance (for example, (1) At least annually for stable pa-
arteriovenous fistulas, arteriovenous tients; and
grafts, and peritoneal catheters). (2) At least monthly for unstable pa-
(9) Evaluation of the patient’s abili- tients including, but not limited to, pa-
ties, interests, preferences, and goals, tients with the following:
including the desired level of participa- (i) Extended or frequent hospitaliza-
tion in the dialysis care process; the tions;
preferred modality (hemodialysis or (ii) Marked deterioration in health
peritoneal dialysis), and setting, (for status;
example, home dialysis), and the pa- (iii) Significant change in psycho-
tient’s expectations for care outcomes. social needs; or
(10) Evaluation of suitability for a (iv) Concurrent poor nutritional sta-
transplantation referral, based on cri- tus, unmanaged anemia, and inad-
teria developed by the prospective equate dialysis.
transplantation center and its sur-
geon(s). If the patient is not suitable § 494.90 Condition: Patient plan of
for transplantation referral, the basis care.
for nonreferral must be documented in The interdisciplinary team as defined
the patient’s medical record. at § 494.80 must develop and implement
830
a written, individualized comprehen- ulating agent(s), including blood pres-

sive plan of care that specifies the serv- sure levels and utilization of iron
ices necessary to address the patient’s stores, must be monitored on a routine
needs, as identified by the comprehen- basis.
sive assessment and changes in the pa- (5) Vascular access. The interdiscipli-
tient’s condition, and must include nary team must provide vascular ac-
measurable and expected outcomes and cess monitoring and appropriate, time-
estimated timetables to achieve these ly referrals to achieve and sustain vas-
outcomes. The outcomes specified in cular access. The hemodialysis patient
the patient plan of care must be con- must be evaluated for the appropriate
sistent with current evidence-based vascular access type, taking into con-
professionally-accepted clinical prac- sideration co-morbid conditions, other
tice standards. risk factors, and whether the patient is
(a) Standard: Development of patient a potential candidate for arteriovenous
plan of care. The interdisciplinary team fistula placement. The patient’s vas-
must develop a plan of care for each pa- cular access must be monitored to pre-
tient. The plan of care must address, vent access failure, including moni-
but not be limited to, the following: toring of arteriovenous grafts and
(1) Dose of dialysis. The interdiscipli- fistulae for symptoms of stenosis.
nary team must provide the necessary (6) Psychosocial status. The inter-
care and services to manage the pa- disciplinary team must provide the
tient’s volume status; and achieve and necessary monitoring and social work
sustain the prescribed dose of dialysis interventions. These include coun-
to meet a hemodialysis Kt/V of at least seling services and referrals for other
1.2 and a peritoneal dialysis weekly Kt/ social services, to assist the patient in
V of at least 1.7 or meet an alternative achieving and sustaining an appro-
equivalent professionally-accepted priate psychosocial status as measured
clinical practice standard for adequacy
by a standardized mental and physical
of dialysis.
assessment tool chosen by the social
(2) Nutritional status. The inter-
worker, at regular intervals, or more
disciplinary team must provide the
frequently on an as-needed basis.
necessary care and counseling services
(7) Modality—(i) Home dialysis. The
to achieve and sustain an effective nu-
interdisciplinary team must identify a
tritional status. A patient’s albumin
plan for the patient’s home dialysis or
level and body weight must be meas-
explain why the patient is not a can-
ured at least monthly. Additional evi-
didate for home dialysis.
dence-based professionally-accepted
clinical nutrition indicators may be (ii) Transplantation status. When the
monitored, as appropriate. patient is a transplant referral can-
(3) Mineral metabolism. Provide the didate, the interdisciplinary team must
necessary care to manage mineral me- develop plans for pursuing transplan-
tabolism and prevent or treat renal tation. The patient’s plan of care must
bone disease. include documentation of the—
(4) Anemia. The interdisciplinary (A) Plan for transplantation, if the
team must provide the necessary care patient accepts the transplantation re-
and services to achieve and sustain the ferral;
clinically appropriate hemoglobin/hem- (B) Patient’s decision, if the patient
atocrit level. The patient’s hemo- is a transplantation referral candidate
globin/hematocrit must be measured at but declines the transplantation refer-
least monthly. The dialysis facility ral; or
must conduct an evaluation of the pa- (C) Reason(s) for the patient’s non-
tient’s anemia management needs. For referral as a transplantation candidate
a home dialysis patient, the facility as documented in accordance with
must evaluate whether the patient can § 494.80(a)(10).
safely, aseptically, and effectively ad- (8) Rehabilitation status. The inter-
minister erythropoiesis-stimulating disciplinary team must assist the pa-
agents and store this medication under tient in achieving and sustaining an
refrigeration if necessary. The pa- appropriate level of productive activ-
tient’s response to erythropoiesis-stim- ity, as desired by the patient, including
831
§ 494.100 42 CFR Ch. IV (10–1–24 Edition)
the educational needs of pediatric pa- (2) Monitor the status of any facility
tients (patients under the age of 18 patients who are on the transplant
years), and make rehabilitation and vo- wait list; and
cational rehabilitation referrals as ap- (3) Communicate with the transplant
propriate. center regarding patient transplant
(b) Standard: Implementation of the pa- status at least annually, and when
tient plan of care. (1) The patient’s plan there is a change in transplant can-
of care must— didate status.
(i) Be completed by the interdiscipli- (d) Standard: Patient education and
nary team, including the patient if the training. The patient care plan must in-
patient desires; and clude, as applicable, education and
(ii) Be signed by team members, in- training for patients and family mem-
cluding the patient or the patient’s bers or caregivers or both, in aspects of
designee; or, if the patient chooses not the dialysis experience, dialysis man-
to sign the plan of care, this choice agement, infection prevention and per-
must be documented on the plan of sonal care, home dialysis and self-care,
care, along with the reason the signa- quality of life, rehabilitation, trans-
ture was not provided. plantation, and the benefits and risks
(2) Implementation of the initial plan of various vascular access types.
of care must begin within the latter of
30 calendar days after admission to the § 494.100 Condition: Care at home.
dialysis facility or 13 outpatient hemo- A dialysis facility that is certified to
dialysis sessions beginning with the
provide services to home patients must
first outpatient dialysis session. Imple-
ensure through its interdisciplinary
mentation of monthly or annual up-
team, that home dialysis services are
dates of the plan of care must be per-
at least equivalent to those provided to
formed within 15 days of the comple-
in-facility patients and meet all appli-
tion of the additional patient assess-
ments specified in § 494.80(d). cable conditions of this part.
(3) If the expected outcome is not (a) Standard: Training. The inter-
achieved, the interdisciplinary team disciplinary team must oversee train-
must adjust the patient’s plan of care ing of the home dialysis patient, the
to achieve the specified goals. When a designated caregiver, or self-dialysis
patient is unable to achieve the desired patient before the initiation of home
outcomes, the team must— dialysis or self-dialysis (as defined in
(i) Adjust the plan of care to reflect § 494.10) and when the home dialysis
the patient’s current condition; caregiver or home dialysis modality
(ii) Document in the record the rea- changes. The training must—
sons why the patient was unable to (1) Be provided by a dialysis facility
achieve the goals; and that is approved to provide home dialy-
(iii) Implement plan of care changes sis services;
to address the issues identified in para- (2) Be conducted by a registered
graph (b)(3)(ii) of this section. nurse who meets the requirements of
(4) The dialysis facility must ensure § 494.140(b)(2); and
that all dialysis patients are seen by a (3) Be conducted for each home dialy-
physician, nurse practitioner, clinical sis patient and address the specific
nurse specialist, or physician’s assist- needs of the patient, in the following
ant providing ESRD care at least areas:
monthly, as evidenced by a monthly (i) The nature and management of
progress note placed in the medical ESRD.
record, and periodically while the (ii) The full range of techniques asso-
hemodialysis patient is receiving in-fa- ciated with the treatment modality se-
cility dialysis. lected, including effective use of dialy-
(c) Standard: Transplantation referral sis supplies and equipment in achieving
tracking. The interdisciplinary team and delivering the physician’s prescrip-
must— tion of Kt/V or URR, and effective ad-
(1) Track the results of each kidney ministration of erythropoiesis-stimu-
transplant center referral; lating agent(s) (if prescribed) to
832
achieve and maintain a target level he- dialysis patients including conducting
moglobin or hematocrit as written in an onsite evaluation and testing of the
patient’s plan of care. water and dialysate system in accord-
(iii) How to detect, report, and man- ance with—
age potential dialysis complications, (A) The recommendations specified
including water treatment problems. in the manufacturers’ instructions; and
(iv) Availability of support resources (B) The system’s FDA-approved la-
and how to access and use resources. beling for preconfigured systems de-
(v) How to self-monitor health status signed, tested, and validated to meet
and record and report health status in- AAMI quality (which includes stand-
formation. ards for chemical and chlorine/chlor-
(vi) How to handle medical and non- amine testing) water and dialysate.
medical emergencies. The facility must meet testing and
(vii) Infection control precautions. other requirements of AAMI RD52:2004.
(viii) Proper waste storage and dis- In addition, bacteriological and
posal procedures. endotoxin testing must be performed
(b) Standard: Home dialysis monitoring. on a quarterly, or more frequent basis
The dialysis facility must— as needed, to ensure that the water and
(1) Document in the medical record dialysate are within the AAMI limits.
that the patient, the caregiver, or both (C) The dialysis facility must correct
received and demonstrated adequate any water and dialysate quality prob-
comprehension of the training; lem for the home hemodialysis patient,
(2) Retrieve and review complete self- and if necessary, arrange for backup di-
monitoring data and other information alysis until the problem is corrected
from self-care patients or their des- if—
ignated caregiver(s) at least every 2 (1) Analysis of the water and
months; and dialysate quality indicates contamina-
(3) Maintain this information in the tion; or
patient’s medical record. (2) The home hemodialysis patient
(c) Standard: Support services. (1) A demonstrates clinical symptoms asso-
home dialysis facility must furnish (ei- ciated with water and dialysate con-
ther directly, under agreement, or by tamination.
arrangement with another ESRD facil- (vi) Purchasing, leasing, renting, de-
ity) home dialysis support services re- livering, installing, repairing and
gardless of whether dialysis supplies maintaining medically necessary home
are provided by the dialysis facility or dialysis supplies and equipment (in-
a durable medical equipment company. cluding supportive equipment) pre-
Services include, but are not limited scribed by the attending physician.
to, the following: (vii) Identifying a plan and arranging
(i) Periodic monitoring of the pa- for emergency back-up dialysis serv-
tient’s home adaptation, including vis- ices when needed.
its to the patient’s home by facility (2) The dialysis facility must main-
personnel in accordance with the pa- tain a recordkeeping system that en-
tient’s plan of care. sures continuity of care and patient
(ii) Coordination of the home pa- privacy. This includes items and serv-
tient’s care by a member of the dialysis ices furnished by durable medical
facility’s interdisciplinary team. equipment (DME) suppliers referred to
(iii) Development and periodic review in § 414.330(a)(2) of this chapter.
of the patient’s individualized com-
prehensive plan of care that specifies § 494.110 Condition: Quality assess-
the services necessary to address the ment and performance improve-
patient’s needs and meets the measur- ment.
able and expected outcomes as speci- The dialysis facility must develop,
fied in § 494.90 of this part. implement, maintain, and evaluate an
(iv) Patient consultation with mem- effective, data-driven, quality assess-
bers of the interdisciplinary team, as ment and performance improvement
needed. program with participation by the pro-
(v) Monitoring of the quality of water fessional members of the interdiscipli-
and dialysate used by home hemo- nary team. The program must reflect
833
§ 494.120 42 CFR Ch. IV (10–1–24 Edition)
the complexity of the dialysis facility’s improvements, and track performance

organization and services (including to ensure that improvements are sus-
those services provided under arrange- tained over time.
ment), and must focus on indicators re- (c) Standard: Prioritizing improvement
lated to improved health outcomes and activities. The dialysis facility must set
the prevention and reduction of med- priorities for performance improve-
ical errors. The dialysis facility must ment, considering prevalence and se-
maintain and demonstrate evidence of verity of identified problems and giv-
its quality improvement and performing priority to improvement activities
ance improvement program for review that affect clinical outcomes or patient
by CMS. safety. The facility must immediately
(a) Standard: Program scope. (1) The correct any identified problems that
program must include, but not be lim- threaten the health and safety of pa-
ited to, an ongoing program that tients.
achieves measurable improvement in
health outcomes and reduction of med- § 494.120 Condition: Special purpose
ical errors by using indicators or per- renal dialysis facilities.
formance measures associated with im- A special purpose renal dialysis facil-
proved health outcomes and with the ity is approved to furnish dialysis on a
identification and reduction of medical short-term basis at special locations.
errors. Special purpose dialysis facilities are
(2) The dialysis facility must meas- divided into two categories: vacation
ure, analyze, and track quality indica- camps (locations that serve ESRD pa-
tors or other aspects of performance tients while the patients are in a tem-
that the facility adopts or develops porary residence) and facilities estab-
that reflect processes of care and facil- lished to serve ESRD patients under
ity operations. These performance emergency circumstances.
components must influence or relate to (a) Standard: Approval period. The pe-
the desired outcomes or be the out- riod of approval for a special purpose
comes themselves. The program must renal dialysis facility may not exceed 8
include, but not be limited to, the fol- months in any 12-month period.
lowing: (b) Standard: Service limitation. Spe-
(i) Adequacy of dialysis. cial purpose renal dialysis facilities are
(ii) Nutritional status. limited to areas in which there are lim-
(iii) Mineral metabolism and renal ited dialysis resources or access-to-
bone disease. care problems due to an emergency cir-
(iv) Anemia management. cumstance. A special purpose renal di-
(v) Vascular access. alysis facility may provide services
(vi) Medical injuries and medical er- only to those patients who would oth-
rors identification. erwise be unable to obtain treatments
(vii) Hemodialyzer reuse program, if in the geographic locality served by
the facility reuses hemodialyzers. the facility.
(viii) Patient satisfaction and griev- (c) Standard: Scope of requirements—(1)
ances. Scope of requirements for a vacation
(ix) Infection control; with respect to camp. A vacation camp that provides
this component the facility must— dialysis services must be operated
(A) Analyze and document the inci- under the direction of a certified renal
dence of infection to identify trends dialysis facility that assumes full re-
and establish baseline information on sponsibility for the care provided to pa-
infection incidence; tients. A special purpose renal dialysis
(B) Develop recommendations and ac- facility established as a vacation camp
tion plans to minimize infection trans- must comply with the following condi-
mission, promote immunization; and tions for coverage—
(C) Take actions to reduce future in- (i) Infection control at § 494.30;
cidents. (ii) Water and dialysate quality at
(b) Standard: Monitoring performance § 494.40 (except as provided in paragraph
improvement. The dialysis facility must (c)(1)(viii) of this section);
continuously monitor its performance, (iii) Reuse of hemodialyzers at § 494.50
take actions that result in performance (if reuse is performed);
834
(iv) Patients’ rights and posting of § 494.130 Condition: Laboratory serv-

patients’ rights at § 494.70(a) and ices.
§ 494.70(c); The dialysis facility must provide, or
(v) Laboratory services at § 494.130; make available, laboratory services
(vi) Medical director responsibilities (other than tissue pathology and
for staff education and patient care histocompatibility) to meet the needs
policies and procedures at § 494.150(c) of the ESRD patient. Any laboratory
and § 494.150(d); services, including tissue pathology
(vii) Medical records at § 494.170; and and histocompatibility must be fur-
(viii) When portable home water nished by or obtained from, a facility
treatment systems are used in place of that meets the requirements for lab-
a central water treatment system, the oratory services specified in part 493 of
facility may adhere to § 494.100(c)(1)(v) this chapter.
(home monitoring of water quality), in
place of § 494.40 (water quality). Subpart D—Administration
(2) Scope of requirements for an emer-
§ 494.140 Condition: Personnel quali-
gency circumstance facility. A special fications.
purpose renal dialysis facility set up
due to emergency circumstances may All dialysis facility staff must meet
provide services only to those patients the applicable scope of practice board
who would otherwise be unable to ob- and licensure requirements in effect in
tain treatments in the geographic the State in which they are employed.
The dialysis facility’s staff (employee
areas served by the facility. These
or contractor) must meet the personnel
types of special purpose dialysis facili-
qualifications and demonstrated com-
ties must comply with paragraph (c)(1) petencies necessary to serve collec-
of this section and addition to com- tively the comprehensive needs of the
plying with the following conditions: patients. The dialysis facility’s staff
(i) Section 494.20 (compliance with must have the ability to demonstrate
Federal, State, and local laws and reg- and sustain the skills needed to per-
ulations). form the specific duties of their posi-
(ii) Section 494.60 (physical environ- tions.
ment). (a) Standard: Medical director. (1) The
(iii) Section 494.70(a) through section medical director must be a board-cer-
494.70(c) (patient rights). tified physician in internal medicine or
(iv) Section 494.140 (personnel quali- pediatrics by a professional board who
fications). has completed a board-approved train-
(v) Section 494.150 (medical director). ing program in nephrology and has at
(vi) Section 494.180 (governance). least 12-months of experience providing
care to patients receiving dialysis.
(d) Standard: Physician contact. The
(2) If a physician, as specified in para-
facility must contact the patient’s
graph (a)(1) of this section, is not avail-
physician, if possible, prior to initi-
able to direct a certified dialysis facil-
ating dialysis in the special purpose
ity another physician may direct the
renal dialysis facility, to discuss the facility, subject to the approval of the
patient’s current condition to assure Secretary.
care provided in the special purpose (b) Standard: Nursing services—(1)
renal dialysis facility is consistent Nurse manager. The facility must have
with the patient plan of care (described a nurse manager responsible for nurs-
in § 494.90). ing services in the facility who must—
(e) Standard: Documentation. All pa- (i) Be a full time employee of the fa-
tient care provided in the special pur- cility;
pose facility is documented and for- (ii) Be a registered nurse; and
warded to the patient’s usual dialysis (iii) Have at least 12 months of expe-
facility, if possible, within 30 days of rience in clinical nursing, and an addi-
the last scheduled treatment in the tional 6 months of experience in pro-
special purpose renal dialysis facility. viding nursing care to patients on
maintenance dialysis.
835
§ 494.150 42 CFR Ch. IV (10–1–24 Edition)
(2) Self-care and home dialysis training credentialing, competency, standards

nurse. The nurse responsible for self- of practice, certification, and licensure
care and/or home care training must— in the State in which he or she is em-
(i) Be a registered nurse; and ployed as a dialysis technician; and
(ii) Have at least 12 months experi- (2) Have a high school diploma or
ence in providing nursing care and an equivalency;
additional 3 months of experience in (3) Have completed a training pro-
the specific modality for which the gram that is approved by the medical
nurse will provide self-care training. director and governing body, under the
(3) Charge nurse. The charge nurse re- direction of a registered nurse, focused
sponsible for each shift must— on the operation of kidney dialysis
(i) Be a registered nurse, a licensed equipment and machines, providing di-
practical nurse, or vocational nurse rect patient care, and communication
who meets the practice requirements and interpersonal skills, including pa-
in the State in which he or she is em- tient sensitivity training and care of
ployed; difficult patients. The training pro-
(ii) Have at least 12 months experi- gram must include the following sub-
ence in providing nursing care, includ- jects:
ing 3 months of experience in providing (i) Principles of dialysis.
nursing care to patients on mainte- (ii) Care of patients with kidney fail-
nance dialysis; and ure, including interpersonal skills.
(iii) If such nurse is a licensed prac- (iii) Dialysis procedures and docu-
tical nurse or licensed vocational mentation, including initiation, proper
nurse, work under the supervision of a cannulation techniques, monitoring,
registered nurse in accordance with and termination of dialysis.
state nursing practice act provisions. (iv) Possible complications of dialy-
(4) Staff nurse. Each nurse who pro- sis.
vides care and treatment to patients (v) Water treatment and dialysate
must be either a registered nurse or a preparation.
practical nurse who meets the practice (vi) Infection control.
requirements in the State in which he (vii) Safety.
or she is employed. (viii) Dialyzer reprocessing, if appli-
(c) Standard: Dietitian. The facility cable.
must have a dietitian who must— (4) Be certified under a State certifi-
(1) Be a registered dietitian with the cation program or a national commer-
Commission on Dietetic Registration; cially available certification program,
and as follows—
(2) Have a minimum of 1 year profes- (i) For newly employed patient care
sional work experience in clinical nu- technicians, within 18 months of being
trition as a registered dietitian. hired as a dialysis patient care techni-
(d) Standard: Social worker. The facil- cian; or
ity must have a social worker who— (ii) For patient care technicians em-
(1) Holds a master’s degree in social ployed on October 14, 2008, within 18
work with a specialization in clinical months after such date.
practice from a school of social work (f) Standard: Water treatment system
accredited by the Council on Social technicians. Technicians who perform
Work Education; or monitoring and testing of the water
(2) Has served at least 2 years as a so- treatment system must complete a
cial worker, 1 year of which was in a training program that has been ap-
dialysis unit or transplantation pro- proved by the medical director and the
gram prior to September 1, 1976, and governing body.
has established a consultative relation-
ship with a social worker who qualifies § 494.150 Condition: Responsibilities of
under § 494.140(d)(1). the medical director.
(e) Standard: Patient care dialysis tech- The dialysis facility must have a
nicians. Patient care dialysis techni- medical director who meets the quali-
cians must— fications of § 494.140(a) to be responsible
(1) Meet all applicable State require- for the delivery of patient care and
ments for education, training, outcomes in the facility. The medical
836
director is accountable to the gov- (3) Obtaining written authorization

erning body for the quality of medical from the patient or legal representa-
care provided to patients. Medical di- tive before releasing information that
rector responsibilities include, but are is not authorized by law.
not limited to, the following: (b) Standard: Completion of patient
(a) Quality assessment and perform- records and centralization of clinical in-
ance improvement program. formation. (1) Current medical records
(b) Staff education, training, and per- and those of discharged patients must
formance. be completed promptly.
(c) Policies and procedures. The med- (2) All clinical information per-
ical director must— taining to a patient must be central-
(1) Participate in the development, ized in the patient’s record, including
periodic review and approval of a ‘‘pa- whether the patient has executed an
tient care policies and procedures man- advance directive. These records must
ual’’ for the facility; and be maintained in a manner such that
(2) Ensure that— each member of the interdisciplinary
(i) All policies and procedures rel- team has access to current information
ative to patient admissions, patient regarding the patient’s condition and
care, infection control, and safety are prescribed treatment.
adhered to by all individuals who treat (3) The dialysis facility must com-
patients in the facility, including at- plete, maintain, and monitor home
tending physicians and nonphysician care patients’ records, including the
providers; and records of patients who receive supplies
(ii) The interdisciplinary team ad- and equipment from a durable medical
heres to the discharge and transfer equipment supplier.
policies and procedures specified in (c) Standard: Record retention and
§ 494.180(f). preservation. In accordance with 45 CFR
§ 164.530(j)(2), all patient records must
§ 494.160 [Reserved] be retained for 6 years from the date of
the patient’s discharge, transfer, or
§ 494.170 Condition: Medical records. death.
The dialysis facility must maintain (d) Standard: Transfer of patient record
complete, accurate, and accessible information. When a dialysis patient is
records on all patients, including home transferred, the dialysis facility releas-
patients who elect to receive dialysis ing the patient must send all requested
supplies and equipment from a supplier medical record information to the re-
that is not a provider of ESRD services ceiving facility within 1 working day of
and all other home dialysis patients the transfer.
whose care is under the supervision of
the facility. § 494.180 Condition: Governance.
(a) Standard: Protection of the patient’s The ESRD facility is under the con-
record. The dialysis facility must— trol of an identifiable governing body,
(1) Safeguard patient records against or designated person(s) with full legal
loss, destruction, or unauthorized use; authority and responsibility for the
and governance and operation of the facil-
(2) Keep confidential all information ity. The governing body adopts and en-
contained in the patient’s record, ex- forces rules and regulations relative to
cept when release is authorized pursuits own governance and to the health
ant to one of the following: care and safety of patients, to the pro-
(i) The transfer of the patient to an- tection of the patients’ personal and
other facility. property rights, and to the general op-
(ii) Certain exceptions provided for in eration of the facility.
the law. (a) Standard: Designating a chief exec-
(iii) Provisions allowed under third utive officer or administrator. The gov-
party payment contracts. erning body or designated person re-
(iv) Approval by the patient. sponsible must appoint an individual
(v) Inspection by authorized agents of who serves as the dialysis facility’s
the Secretary, as required for the ad- chief executive officer or administrator
ministration of the dialysis program. who exercises responsibility for the
837
§ 494.180 42 CFR Ch. IV (10–1–24 Edition)
management of the facility and the nishes services directly on its main
provision of all dialysis services, in- premises or on other premises that are
cluding, but not limited to— contiguous with the main premises and
(1) Staff appointments; are under the direction of the same
(2) Fiscal operations; professional staff and governing body
(3) The relationship with the ESRD as the main premises (except for serv-
networks; and ices provided under § 494.100).
(4) Allocation of necessary staff and (e) Standard: Internal grievance proc-
other resources for the facility’s qual- ess. The facility’s internal grievance
ity assessment and performance im- process must be implemented so that
provement program as described in the patient may file an oral or written
§ 494.110. grievance with the facility without re-
(b) Standard: Adequate number of prisal or denial of services. The griev-
qualified and trained staff. The gov- ance process must include:
erning body or designated person re- (1) A clearly explained procedure for
sponsible must ensure that— the submission of grievances.
(1) An adequate number of qualified (2) Timeframes for reviewing the
personnel are present whenever pa- grievance.
tients are undergoing dialysis so that (3) A description of how the patient
the patient/staff ratio is appropriate to or the patient’s designated representa-
the level of dialysis care given and tive will be informed of steps taken to
meets the needs of patients; and the resolve the grievance.
registered nurse, social worker and die- (f) Standard: Involuntary discharge and
titian members of the interdisciplinary transfer policies and procedures. The gov-
team are available to meet patient erning body must ensure that all staff
clinical needs; follow the facility’s patient discharge
(2) A registered nurse, who is respon- and transfer policies and procedures.
sible for the nursing care provided, is The medical director ensures that no
present in the facility at all times that patient is discharged or transferred
in-center dialysis patients are being from the facility unless—
treated; (1) The patient or payer no longer re-
(3) All staff, including the medical di- imburses the facility for the ordered
rector, have appropriate orientation to services;
the facility and their work responsibil- (2) The facility ceases to operate;
ities; and (3) The transfer is necessary for the
(4) All employees have an oppor- patient’s welfare because the facility
tunity for continuing education and re- can no longer meet the patient’s docu-
lated development activities. mented medical needs; or
(c) Standard: Medical staff appoint- (4) The facility has reassessed the pa-
ments. The governing body— tient and determined that the patient’s
(1) Is responsible for all medical staff behavior is disruptive and abusive to
appointments and credentialing in ac- the extent that the delivery of care to
cordance with State law, including at- the patient or the ability of the facility
tending physicians, physician assist- to operate effectively is seriously im-
ants, nurse practitioners, and clinical paired, in which case the medical direc-
nurse specialists; and tor ensures that the patient’s inter-
(2) Ensures that all medical staff who disciplinary team—
provide care in the facility are in- (i) Documents the reassessments, on-
formed of all facility policies and pro- going problem(s), and efforts made to
cedures, including the facility’s quality resolve the problem(s), and enters this
assessment and performance improve- documentation into the patient’s med-
ment program specified in § 494.110. ical record;
(3) Communicates expectations to the (ii) Provides the patient and the local
medical staff regarding staff participa- ESRD Network with a 30-day notice of
tion in improving the quality of med- the planned discharge;
ical care provided to facility patients. (iii) Obtains a written physician’s
(d) Standard: Furnishing services. The order that must be signed by both the
governing body is responsible for en- medical director and the patient’s at-
suring that the dialysis facility fur- tending physician concurring with the
838
patient’s discharge or transfer from the (iii) Patient survival information;

facility; and
(iv) Contacts another facility, at- (iv) Existing ESRD clinical perform-
tempts to place the patient there, and ance measures, and any future clinical
documents that effort; and performance standards developed in ac-
(v) Notifies the State survey agency cordance with a voluntary consensus
of the involuntary transfer or dis- standards process identified by the Sec-
charge. retary.
(5) In the case of immediate severe (i) Standard: Relationship with the
threats to the health and safety of oth- ESRD network. The governing body re-
ers, the facility may utilize an abbre- ceives and acts upon recommendations
viated involuntary discharge proce- from the ESRD network. The dialysis
dure. facility must cooperate with the ESRD
(g) Standard: Emergency coverage. (1) network designated for its geographic
The governing body is responsible for area, in fulfilling the terms of the Net-
ensuring that the dialysis facility pro- work’s current statement of work.
vides patients and staff with written Each facility must participate in ESRD
instructions for obtaining emergency network activities and pursue network
medical care. goals.
(2) The dialysis facility must have (j) Standard: Disclosure of ownership.
available at the nursing/monitoring
In accordance with § 420.200 through
station, a roster with the names of
§ 420.206 of this chapter, the governing
physicians to be called for emer-
body must report ownership interests
gencies, when they can be called, and
of 5 percent or more to its State survey
how they can be reached.
agency.
(3) The dialysis facility must have an
agreement with a hospital that can (k) Standard: Disclosure to Insurers of
provide inpatient care, routine and Payments of Premiums. (1) Facilities
emergency dialysis and other hospital that make payments of premiums for
services, and emergency medical care individual market health plans (in any
which is available 24 hours a day, 7 amount), whether directly, through a
days a week. The agreement must: parent organization (such as a dialysis
(i) Ensure that hospital services are corporation), or through another enti-
available promptly to the dialysis fa- ty (including by providing contribu-
cility’s patients when needed. tions to entities that make such pay-
(ii) Include reasonable assurances ments) must—
that patients from the dialysis facility (i) Disclose to the applicable issuer
are accepted and treated in emer- each policy for which a third party
gencies. payment described in this paragraph
(h) Standard: Furnishing data and in- (k) will be made, and
formation for ESRD program administra- (ii) Obtain assurance from the issuer
tion. Effective February 1, 2009, the di- that the issuer will accept such pay-
alysis facility must furnish data and ments for the duration of the plan
information to CMS and at intervals as year. If such assurances are not pro-
specified by the Secretary. This infor- vided, the facility shall not make pay-
mation is used in a national ESRD in- ments of premiums and shall take rea-
formation system and in compilations sonable steps to ensure such payments
relevant to program administration, are not made by the facility or by third
including claims processing and reim- parties to which the facility contrib-
bursement, quality improvement, and utes as described in this paragraph (k).
performance assessment. The data and (2) If a facility is aware that a pa-
information must— tient is not eligible for Medicaid and is
(1) Be submitted at the intervals not eligible to enroll in Medicare Part
specified by the Secretary; A and/or Part B except during the Gen-
(2) Be submitted electronically in the eral Enrollment Period, and the facil-
format specified by the Secretary; ity is aware that the patient intends to
(3) Include, but not be limited to— enroll in Medicare Part A and/or Part
(i) Cost reports; B during that period, the standards
(ii) ESRD administrative forms; under this paragraph (k) will not apply
839
with respect to payments for that pa- Subpart D—Requirements Specific to the
tient until July 1, 2017. Medicaid Program
[73 FR 20475, Apr. 15, 2008, as amended at 81 495.300 Basis and purpose.
FR 90228, Dec. 14, 2016] 495.302 Definitions.
495.304 Medicaid provider scope and eligi-
bility.
PART 495—STANDARDS FOR THE 495.306 Establishing patient volume.
ELECTRONIC HEALTH RECORD 495.308 Net average allowable costs as the
TECHNOLOGY INCENTIVE PRO- basis for determining the incentive pay-
GRAM ment.
495.310 Medicaid provider incentive pay-
ments.
Subpart A—General Provisions 495.312 Process for payments.
Sec. 495.314 Activities required to receive an in-
centive payment.
495.2 Basis and purpose.
495.316 State monitoring and reporting re-
495.4 Definitions.
garding activities required to receive an
495.5 Requirements for EPs seeking to re-
incentive payment.
verse a hospital-based determination
495.318 State responsibilities for receiving
under § 495.4.
FFP.
495.20 Meaningful use objectives and meas- 495.320 FFP for payments to Medicaid pro-
ures for EPs, eligible hospitals, and CAHs viders.
before 2015. 495.322 FFP for reasonable administrative
495.22 Meaningful use objectives and meas- expenses.
ures for EPs, eligible hospitals, and CAHs 495.324 Prior approval conditions.
for 2015 through 2018. 495.326 Disallowance of FFP.
495.24 Stage 3 meaningful use objectives and 495.328 Request for reconsideration of ad-
measures for EPs, eligible hospitals and verse determination.
CAHs for 2019 and subsequent years. 495.330 Termination of FFP for failure to
495.40 Demonstration of meaningful use cri- provide access to information.
teria. 495.332 State Medicaid health information
495.60 Participation requirements for EPs, technology (HIT) plan requirements.
eligible hospitals, and CAHs. 495.334 Reserved.
495.336 Health information technology plan-
Subpart B—Requirements Specific to the ning advance planning document require-
Medicare Program ments (HIT PAPD).
495.338 Health information technology im-
495.100 Definitions. plementation advance planning docu-
495.102 Incentive payments to EPs. ment requirements (HIT IAPD).
495.104 Incentive payments to eligible hos- 495.340 As-needed HIT PAPD update and as-
pitals. needed HIT IAPD update requirements.
495.106 Incentive payments to CAHs. 495.342 Annual HIT IAPD requirements.
495.108 Posting of required information. 495.344 Approval of the State Medicaid HIT
495.110 Preclusion on administrative and ju- plan, the HIT PAPD and update, the HIT
dicial review. IAPD and update, and the annual HIT
IAPD.
Subpart C—Requirements Specific to 495.346 Access to systems and records.
Medicare Advantage (MA) Organizations 495.348 Procurement standards.
495.350 State Medicaid agency attestations.
495.200 Definitions. 495.352 Reporting requirements.
495.202 Identification of qualifying MA orga- 495.354 Rules for charging equipment.
nizations, MA–EPs, and MA-affiliated el- 495.356 Nondiscrimination requirements.
igible hospitals. 495.358 Cost allocation plans.
495.204 Incentive payments to qualifying 495.360 Software and ownership rights.
MA organizations for qualifying MA–EPs 495.362 Retroactive approval of FFP with an
and qualifying MA-affiliated eligible hos- effective date of February 18, 2009.
pitals. 495.364 Review and assessment of adminis-
495.206 Timeframe for payment to quali- trative activities and expenses of Med-
fying MA organizations. icaid provider health information tech-
495.208 Avoiding duplicate payment. nology adoption and operation.
495.210 Meaningful EHR user attestation. 495.366 Financial oversight and monitoring
495.211 Payment adjustments effective for of expenditures.
2015 and subsequent MA payment years 495.368 Combating fraud and abuse.
with respect to MA EPs and MA-affili- 495.370 Appeals process for a Medicaid pro-
ated eligible hospitals. vider receiving electronic health record
495.212 Limitation on review. incentive payments.
840
AUTHORITY: 42 U.S.C. 1302 and 1395hh. are not meaningful users of certified
SOURCE: 75 FR 44565, July 28, 2010, unless EHR technology.
otherwise noted.
Subpart A—General Provisions In this part, unless otherwise indi-
cated—
§ 495.2 Basis and purpose. Ambulatory surgical center-based EP
This part implements the following: means an EP who furnishes 75 percent
(a) Section 1848(o) of the Act by es- or more of his or her covered profes-
tablishing payment incentives under sional services in sites of service iden-
Medicare Part B for eligible profes- tified by the codes used in the HIPAA
sionals who adopt and meaningfully standard transaction as an ASC setting
use certified electronic health record in the calendar year that is 2 years be-
(EHR) technology. fore the payment adjustment year.
(b) Section 1853(1) of the Act to pro- API stands for application program-
vide incentive payments to Medicare ming interface.
Advantage organizations for certain af- Certified electronic health record tech-
filiated professionals who meaningfully nology (CEHRT) means the following:
use certified EHR technology and meet
(1) For any Federal fiscal year or cal-
certain other requirements.
endar year before 2018, EHR technology
(c) Section 1886(n) of the Act by es-
(which could include multiple tech-
tablishing incentives payments for the
nologies) certified under the ONC
meaningful use of certified EHR tech-
Health IT Certification Program that
nology by subsection (d) hospitals, as
meets one of the following:
defined under section 1886(d)(1)(B) of
the Act, participating in the Medicare (i) The 2014 Edition Base EHR defini-
FFS program. tion (as defined at 45 CFR 170.102) and
(d) Section 1814(l) of the Act to pro- has been certified to the certification
vide an incentive payment to critical criteria that are necessary to be a
access hospitals that meaningfully use Meaningful EHR User (as defined in
certified EHR technology based on the this section), including the applicable
hospitals’ reasonable costs. measure calculation certification cri-
(e) Section 1853(m) of the Act to pro- terion at 45 CFR 170.314(g)(1) or (2) for
vide incentive payments to MA organi- all certification criteria that support a
zations for certain affiliated hospitals meaningful use objective with a per-
that meaningfully use certified EHR centage-based measure.
technology. (ii) Certification to—
(f) Sections 1903(a)(3)(F) and 1903(t) of (A) The following certification cri-
the Act to provide 100 percent Federal teria:
financial participation (FFP) to States (1) CPOE at—
for incentive payments to certain eligi- (i) 45 CFR 170.314(a)(1), (18), (19) or
ble providers participating in the Med- (20); or
icaid program to purchase, implement, (ii) 45 CFR 170.315(a)(1), (2) or (3).
and operate (including support services (2)(i) Record demographics at 45 CFR
and training for staff) certified EHR 170.314(a)(3); or
technology and 90 percent FFP for (ii) 45 CFR 170.315(a)(5).
State administrative expenses related (3)(i) Problem list at 45 CFR
to such incentive payments. 170.314(a)(5); or
(g) Sections 1848(a)(7), 1853(l)(4),
(ii) 45 CFR 170.315(a)(6).
1886(b)(3)(B)(ix)(I), and 1853(m)(4) of the
Act, providing for payment reductions (4)(i) Medication list at 45 CFR
for inpatient services furnished on or 170.314(a)(6); or
after October 1, 2014 to Medicare bene- (ii) 45 CFR 170.315(a)(7).
ficiaries by hospitals that are not (5)(i) Medication allergy list 45 CFR
meaningful users of certified EHR 170.314(a)(7); or
technology, and for covered profes- (ii) 45 CFR 170.315(a)(8).
sional services furnished on or after (6)(i) Clinical decision support at 45
January 1, 2015 to Medicare bene- CFR 170.314(a)(8); or
ficiaries by certain professionals who (ii) 45 CFR 170.315(a)(9).
841
§ 495.4 42 CFR Ch. IV (10–1–24 Edition)
(7) Health information exchange at (7) 45 CFR 170.314(d)(7) or 170.315(d)(7);

transitions of care at one of the fol- (8) 45 CFR 170.314(d)(8) or 170.315(d)(8);
lowing: and
(i) 45 CFR 170.314(b)(1) and (2). (D) The certification criteria that are
(ii) 45 CFR 170.314(b)(1), (b)(2), and necessary to be a Meaningful EHR User
(h)(1). (as defined in this section), including
(iii) 45 CFR 170.314(b)(1), (b)(2), and the applicable measure calculation cer-
(b)(8). tification criterion at 45 CFR
(iv) 45 CFR 170.314(b)(1), (b)(2), (b)(8), 170.314(g)(1) or (2) or 45 CFR 170.315(g)(1)
and (h)(1). or (2) for all certification criteria that
(v) 45 CFR 170.314(b)(8) and (h)(1). support a meaningful use objective
(vi) 45 CFR 170.314(b)(1), (b)(2), and with a percentage-based measure.
170.315(h)(2). (iii) The definition for 2019 and subse-
(vii) 45 CFR 170.314(b)(1), (b)(2), (h)(1), quent years specified in paragraph (2)
and 170.315(h)(2). of this definition.
(viii) 45 CFR 170.314(b)(1), (b)(2), (b)(8), (2) For 2019 and subsequent years,
and 170.315(h)(2). EHR technology (which could include
(ix) 45 CFR 170.314(b)(1), (b)(2), (b)(8), multiple technologies) certified under
(h)(1), and 170.315(h)(2). the ONC Health IT Certification Pro-
(x) 45 CFR 170.314(b)(8), (h)(1), and gram that meets the 2015 Edition Base
170.315(h)(2). EHR definition, or subsequent Base
(xi) 45 CFR 170.314(b)(1), (b)(2), and EHR definition (as defined at 45 CFR
170.315(b)(1). 170.102) and has been certified to the
(xii) 45 CFR 170.314(b)(1), (b)(2), (h)(1), ONC health IT certification criteria, as
and 170.315(b)(1). adopted and updated in 45 CFR 170.315–
(xiii) 45 CFR 170.314(b)(1), (b)(2), (b)(8), (i) At 45 CFR 170.315(a)(12) (family
and 170.315(b)(1). health history) and 45 CFR 170.315(e)(3)
(xiv) 45 CFR 170.314(b)(1), (b)(2), (b)(8), (patient health information capture);
(h)(1), and 170.315(b)(1). and
(xv) 45 CFR 170.314(b)(8), (h)(1), and (ii) Necessary to be a Meaningful
170.315(b)(1). EHR User (as defined in this section),
(xvi) 45 CFR 170.314(b)(1), (b)(2), (b)(8), including the following:
(h)(1), 170.315(b)(1), and 170.315(h)(1). (A) The applicable measure calcula-
(xvii) 45 CFR 170.314(b)(1), (b)(2), (b)(8), tion certification criterion at 45 CFR
(h)(1), 170.315(b)(1), and 170.315(h)(2). 170.315(g)(1) or (2) for all certification
(xviii) 45 CFR 170.314(h)(1) and criteria that support a meaningful use
170.315(b)(1). objective with a percentage-based
(xix) 45 CFR 170.315(b)(1) and (h)(1). measure.
(xx) 45 CFR 170.315(b)(1) and (h)(2). (B) Clinical quality measure certifi-
(xxi) 45 CFR 170.315(b)(1), (h)(1), and cation criteria that support the cal-
(h)(2); and culation and reporting of clinical qual-
(B) Clinical quality measures at— ity measures at 45 CFR 170.315(c)(2) and
(1) 45 CFR 170.314(c)(1) or 170.315(c)(1); (c)(3)(i) and (ii), and can be electroni-
(2) 45 CFR 170.314(c)(2) or 170.315(c)(2); cally accepted by CMS.
(3) Clinical quality measure certifi- Critical access hospital (CAH) means a
cation criteria that support the cal- facility that has been certified as a
culation and reporting of clinical qual- critical access hospital under section
ity measures at 45 CFR 170.314(c)(2) and 1820(e) of the Act and for which Medi-
(3); or 45 CFR 170.315(c)(3)(i) and (ii); care payment is made under section
and can be electronically accepted by 1814(l) of the Act for inpatient services
CMS if the provider is submitting elec- and under section 1834(g) of the Act for
tronically. outpatient services.
(C) Privacy and security at— EHR reporting period. Except with re-
(1) 45 CFR 170.314(d)(1) or 170.315(d)(1); spect to payment adjustment years,
(2) 45 CFR 170.314(d)(2) or 170.315(d)(2); EHR reporting period means either of
(3) 45 CFR 170.314(d)(3) or 170.315(d)(3); the following:
(4) 45 CFR 170.314(d)(4) or 170.315(d)(4); (1) For an eligible EP—
(5) 45 CFR 170.314(d)(5) or 170.315(d)(5); (i) The following are applicable be-
(6) 45 CFR 170.314(d)(6) or 170.315(d)(6); fore 2015:
842
(A) For the payment year in which (D) For the CY 2018 payment year
the EP is first demonstrating he or she under the Medicaid EHR Incentive Pro-
is a meaningful EHR user, any contin- gram:
uous 90-day period within the calendar (1) For the EP first demonstrating he
year; or she is a meaningful EHR user, any
(B) Except as specified in paragraphs continuous 90-day period within CY
(1)(iii) and (1)(iv) of this definition, for 2018.
the subsequent payment years fol- (2) For the EP who has successfully
lowing the payment year in which the demonstrated he or she is a meaningful
EP first successfully demonstrates he EHR user in any prior year, any con-
or she is a meaningful EHR user, the tinuous 90-day period within CY 2018.
calendar year. (iii) For the CY 2019 payment year
(C) For an EP seeking to dem- under the Medicaid Promoting Inter-
onstrate he or she is a meaningful EHR operability Program:
user for the Medicare EHR incentive (A) For the EP first demonstrating
program for CY 2014, any of the fol- he or she is a meaningful EHR user,
lowing 3-month periods: any continuous 90-day period within
(1) January 1, 2014 through March 31, CY 2019.
2014. (B) For the EP who has successfully
(2) April 1, 2014 through June 30, 2014. demonstrated he or she is a meaningful
(3) July 1, 2014 through September 30, EHR user in any prior year, any con-
2014. tinuous 90-day period within CY 2019.
(4) October 1, 2014 through December (iv) For the CY 2020 payment year
31, 2014. under the Medicaid Promoting Inter-
operability Program:
(D) For an EP seeking to dem-
(A) For the EP first demonstrating
onstrate he or she is a meaningful EHR
he or she is a meaningful EHR user,
user for the Medicaid EHR incentive
any continuous 90-day period within
program for CY 2014 any continuous 90-
CY 2020.
day period within CY 2014.
(B) For the EP who has successfully
(ii) The following are applicable for
demonstrated he or she is a meaningful
2015, 2016, 2017, and 2018:
EHR user in any prior year, any con-
(A) For the CY 2015 payment year, tinuous 90-day period within CY 2020.
any continuous 90-day period within (v) Under the Medicaid Promoting
CY 2015. Interoperability Program, for the CY
(B) For the CY 2016 payment year: 2021 payment year:
(1) For the EP first demonstrating he (A) For the EP first demonstrating
or she is a meaningful EHR user, any he or she is a meaningful EHR user,
continuous 90-day period within CY any continuous 90-day period within
2016. CY 2021 that ends before October 31,
(2) For the EP who has successfully 2021, or that ends before an earlier date
demonstrated he or she is a meaningful in CY 2021 that is specified by the state
EHR user in any prior year, any con- and approved by CMS in the State Med-
tinuous 90-day period within CY 2016. icaid HIT plan described at § 495.332.
(C) For the CY 2017 payment year (B) For the EP who has successfully
under the Medicaid EHR Incentive Pro- demonstrated he or she is a meaningful
gram: EHR user in any prior year, any con-
(1) For the EP first demonstrating he tinuous 90-day period within CY 2021
or she is a meaningful EHR user, any that ends before October 31, 2021, or
continuous 90-day period within CY that ends before an earlier date in CY
2017. 2021 that is specified by the state and
(2) For the EP who has successfully approved by CMS in the State Medicaid
demonstrated he or she is a meaningful HIT plan described at § 495.332.
EHR user in any prior year, any con- (2) For an eligible hospital or CAH—
tinuous 90-day period within CY 2017. (i) The following are applicable be-
(3) For the EP demonstrating the fore 2015:
Stage 3 objectives and measures at (A) For the payment year in which
§ 495.24, any continuous 90-day period the eligible hospital or CAH is first
within CY 2017. demonstrating it is a meaningful EHR
843
§ 495.4 42 CFR Ch. IV (10–1–24 Edition)
user, any continuous 90-day period (D) For the FY 2018 payment year as
within the Federal fiscal year; follows:
(B) Except as specified in paragraph (1) Under the Medicaid Promoting
(2)(iii) of this definition, for the subse- Interoperability Program:
quent payment years following the (i) For the eligible hospital or CAH
payment year in which the eligible hos- first demonstrating it is a meaningful
pital or CAH first successfully dem- EHR user, any continuous 90-day pe-
onstrates it is a meaningful EHR user, riod within CY 2018.
the Federal fiscal year. (ii) For the eligible hospital or CAH
(C) For an eligible hospital or CAH that has successfully demonstrated it
seeking to demonstrate it is a mean- is a meaningful EHR user in any prior
ingful EHR user for FY 2014, any of the
year, any continuous 90-day period
following 3-month periods:
within CY 2018.
(1) October 1, 2013 through December
31, 2013. (2) Under the Medicare Promoting
Interoperability Program, for a Puerto
(2) January 1, 2014 through March 31,
2014. Rico eligible hospital, any continuous
90-day period within CY 2018.
(3) April 1, 2014 through June 30, 2014.
(4) July 1, 2014 through September 30, (iii) For the FY 2019 payment year as
2014. follows:
(ii) The following are applicable for (A) Under the Medicaid Promoting
2015, 2016, 2017, and 2018: Interoperability Program:
(A) For the FY 2015 payment year, (1) For the eligible hospital or CAH
any continuous 90-day period within first demonstrating it is a meaningful
the period beginning on October 1, 2014 EHR user, any continuous 90-day pe-
and ending on December 31, 2015. riod within CY 2019.
(B) For the FY 2016 payment year as (2) For the eligible hospital or CAH
follows: that has successfully demonstrated it
(1) For the eligible hospital or CAH is a meaningful EHR user in any prior
first demonstrating it is a meaningful year, any continuous 90-day period
EHR user, any continuous 90-day pe- within CY 2019.
riod within CY 2016. (B) Under the Medicare Promoting
(2) For the eligible hospital or CAH Interoperability Program, for a Puerto
that has successfully demonstrated it Rico eligible hospital, any continuous
is a meaningful EHR user in any prior 90-day period within CY 2019.
year, any continuous 90-day period (iv) For the FY 2020 payment year as
within CY 2016. follows:
(C) For the FY 2017 payment year as (A) Under the Medicaid Promoting
follows: Interoperability Program:
(1) Under the Medicaid EHR Incen- (1) For the eligible hospital or CAH
tive Program:
first demonstrating it is a meaningful
(i) For the eligible hospital or CAH
EHR user, any continuous 90-day pe-
first demonstrating it is a meaningful
riod within CY 2020.
EHR user, any continuous 90-day pe-
riod within CY 2017. (2) For the eligible hospital or CAH
(ii) For the eligible hospital or CAH that has successfully demonstrated it
that has successfully demonstrated it is a meaningful EHR user in any prior
is a meaningful EHR user in any prior year, any continuous 90-day period
year, any continuous 90-day period within CY 2020.
within CY 2017. (B) Under the Medicare Promoting
(iii) For the eligible hospital or CAH Interoperability Program, for a Puerto
demonstrating the Stage 3 objectives Rico eligible hospital, any continuous
and measures at § 495.24, any contin- 90-day period within CY 2020.
uous 90-day period within CY 2017. (v) For the FY 2021 payment year as
(2) Under the Medicare EHR Incen- follows: Under the Medicare Promoting
tive Program, for a Puerto Rico eligi- Interoperability Program, for a Puerto
ble hospital, any continuous 14-day pe- Rico eligible hospital, any continuous
riod within CY 2017. 90-day period within CY 2021.
844
EHR reporting period for a payment ad- (1) If an EP has not successfully dem-
justment year. For a payment adjust- onstrated he or she is a meaningful
ment year, the EHR reporting period EHR user in a prior year, the EHR re-
means the following: porting period is any continuous 90-day
(1) For an EP— period within CY 2016 and applies for
(i) The following are applicable be- the CY 2017 and 2018 payment adjust-
fore 2015: ment years. For the CY 2017 payment
(A)(1) Except as provided in para- adjustment year, the EHR reporting
graphs (1)(i)(A)(2), (1)(i)(B), and (1)(i)(C) period must end before and the EP
of this definition, the calendar year must successfully register for and at-
that is 2 years before the payment ad- test to meaningful use no later than
justment year. October 1, 2016.
(2) The special EHR reporting period (2) If in a prior year an eligible hos-
for CY 2014 (specified in paragraph pital has successfully demonstrated it
(1)(i)(C) of this definition, as applica- is a meaningful EHR user, the EHR re-
ble) of the definition of ‘‘EHR Report- porting period is any continuous 90-day
ing Period’’ that occurs within the cal- period within CY 2016 and applies for
endar year that is 2 years before the the FY 2018 payment adjustment year.
payment adjustment year and is only (C) In 2017 as follows:
for EHR reporting periods in CY 2014. (1) If an EP has not successfully dem-
(B) If an EP is demonstrating he or onstrated he or she is a meaningful
she is a meaningful EHR user for the EHR user in a prior year, the EHR re-
first time in the calendar year, that is porting period is any continuous 90-day
2 years before the payment adjustment period within CY 2017 and applies for
year, then any continuous 90-day pe- the CY 2018 payment adjustment year.
riod within such (2 years prior) cal- For the CY 2018 payment adjustment
endar year. year, the EHR reporting period must
(C)(1) If in the calendar year that is 2 end before and the EP must success-
years before the payment adjustment fully register for and attest to mean-
year and in all prior calendar years, ingful use no later than October 1, 2017.
the EP has not successfully dem- (2) [Reserved]
onstrated he or she is a meaningful (2) For an eligible hospital—
EHR user, then any continuous 90-day (i) The following are applicable be-
period that both begins in the calendar fore 2015:
year 1 year before the payment adjust- (A)(1) Except as provided in para-
ment year and ends at least 3 months graphs (2)(i)(A)(2), (2)(i)(B), and (2)(i)(C)
before the end of such prior year. of this definition, the Federal fiscal
(2) Under this exception, the provider year that is 2 years before the payment
must successfully register for and at- adjustment year.
test to meaningful use no later than (2) The special EHR reporting period
the date October 1 of the year before for FY 2014 (defined in paragraph
the payment adjustment year. (2)(i)(C) of the definition ‘‘EHR Report-
(ii) The following are applicable for ing Period’’) that occurs within the fis-
2015, 2016, and 2017: cal year that is 2 years before the pay-
(A) In 2015 as follows: ment adjustment year and is only for
(1) If an EP has not successfully dem- EHR reporting periods in fiscal year
onstrated he or she is a meaningful 2014.
EHR user in a prior year, the EHR re- (B) If an eligible hospital is dem-
porting period is any continuous 90-day onstrating it is a meaningful EHR user
period within CY 2015 and applies for for the first time in the Federal fiscal
the CY 2016 and 2017 payment adjust- year that is 2 years before the payment
ment years. adjustment year, then any continuous
(2) If in a prior year an EP has suc- 90-day period within such (2 years
cessfully demonstrated he or she is a prior) Federal fiscal year.
meaningful EHR user, the EHR report- (C)(1) If in the Federal fiscal year
ing period is any continuous 90-day pe- that is 2 years before the payment ad-
riod within CY 2015 and applies for the justment year and for all prior Federal
CY 2017 payment adjustment year. fiscal years the eligible hospital has
(B) In 2016 as follows: not successfully demonstrated it is a
845
§ 495.4 42 CFR Ch. IV (10–1–24 Edition)
meaningful EHR user, then any contin- ing period must end before and the eli-
uous 90-day period that both begins in gible hospital must successfully reg-
the Federal fiscal year that is 1 year ister for and attest to meaningful use
before the payment adjustment year no later than October 1, 2017.
and ends at least 3 months before the (2) If an eligible hospital is dem-
end of such prior Federal fiscal year. onstrating Stage 3 of meaningful use
(2) Under this exception, the eligible under § 495.24, the EHR reporting period
hospital must successfully register for is any continuous 90-day period within
and attest to meaningful use no later CY 2017 and applies for the FY 2019 pay-
than July 1 of the year before the payment adjustment year.
ment adjustment year. (3) If in a prior year an eligible hos-
(ii) The following are applicable for
pital has successfully demonstrated it
2015, 2016, 2017, and 2018:
is a meaningful EHR user, the EHR re-
(A) In 2015 as follows:
porting period is any continuous 90-day
(1) If an eligible hospital has not suc-
period within CY 2017 and applies for
cessfully demonstrated it is a meaning-
the FY 2019 payment adjustment year.
ful EHR user in a prior year, the EHR
reporting period is any continuous 90- (D) In 2018 as follows:
day period within the period beginning (1) If an eligible hospital has not suc-
on October 1, 2014 and ending on De- cessfully demonstrated it is a meaning-
cember 31, 2015 and applies for the FY ful EHR user in a prior year, the EHR
2016 and 2017 payment adjustment reporting period is any continuous 90-
years. day period within CY 2018 and applies
(2) If in a prior year an eligible hos- for the FY 2019 and 2020 payment ad-
pital has successfully demonstrated it justment years. For the FY 2019 pay-
is a meaningful EHR user, the EHR re- ment adjustment year, the EHR report-
porting period is any continuous 90-day ing period must end before and the eli-
period within the period beginning on gible hospital must successfully reg-
October 1, 2014 and ending on December ister for and attest to meaningful use
31, 2015 and applies for the FY 2017 pay- no later than October 1, 2018.
ment adjustment year. (2) If in a prior year an eligible hos-
(B) In 2016 as follows: pital has successfully demonstrated it
(1) If an eligible hospital has not suc- is a meaningful EHR user, the EHR re-
cessfully demonstrated it is a meaning- porting period is any continuous 90-day
ful EHR user in a prior year, the EHR period within CY 2018 and applies for
reporting period is any continuous 90- the FY 2020 payment adjustment year.
day period within CY 2016 and 2017 ap- (iii) The following are applicable for
plies for the FY 2017 and 2018 payment 2019:
adjustment years. For the FY 2017 pay- (A) If an eligible hospital has not suc-
ment adjustment year, the EHR report- cessfully demonstrated it is a meaning-
ing period must end before and the eli- ful EHR user in a prior year, the EHR
gible hospital must successfully reg- reporting period is any continuous 90-
ister for and attest to meaningful use
day period within CY 2019 and applies
no later than October 1, 2016.
for the FY 2020 and FY 2021 payment
(2) If in a prior year an eligible hos-
adjustment years.
pital has successfully demonstrated it
is a meaningful EHR user, the EHR re- (B) If in a prior year an eligible hos-
porting period is any continuous 90-day pital has successfully demonstrated it
period within CY 2016 and applies for is a meaningful EHR user, the EHR re-
the FY 2018 payment adjustment year. porting period is any continuous 90-day
(C) In 2017 as follows: period within CY 2019 and applies for
(1) If an eligible hospital has not suc- the FY 2021 payment adjustment year.
cessfully demonstrated it is a meaning- (iv) The following are applicable for
ful EHR user in a prior year, the EHR 2020:
reporting period is any continuous 90- (A) If an eligible hospital has not suc-
day period within CY 2017 and applies cessfully demonstrated it is a meaning-
for the FY 2018 and 2019 payment ad- ful EHR user in a prior year, the EHR
justment years. For the FY 2018 pay- reporting period is any continuous 90-
ment adjustment year, the EHR report- day period within CY 2020 and applies
846
for the FY 2021 and 2022 payment ad- day period within CY 2023 and applies
justment years. For the FY 2021 pay- for the FY 2024 and 2025 payment ad-
ment adjustment year, the EHR report- justment years. For the FY 2024 pay-
ing period must end before and the eli- ment adjustment year, the EHR report-
gible hospital must successfully reg- ing period must end before and the eli-
ister for and attest to meaningful use gible hospital must successfully reg-
no later than October 1, 2020. ister for and attest to meaningful use
(B) If in a prior year an eligible hos- no later than October 1, 2023.
pital has successfully demonstrated it (B) If in a prior year an eligible hos-
is a meaningful EHR user, the EHR re- pital has successfully demonstrated it
porting period is any continuous 90-day is a meaningful EHR user, the EHR re-
period within CY 2020 and applies for porting period is any continuous 90-day
the FY 2022 payment adjustment year. period within CY 2023 and applies for
(v) The following are applicable for the FY 2025 payment adjustment year.
2021: (viii) The following are applicable for
(A) If an eligible hospital has not suc- 2024:
cessfully demonstrated it is a meaning- (A) If an eligible hospital has not suc-
ful EHR user in a prior year, the EHR cessfully demonstrated it is a meaning-
reporting period is any continuous 90- ful EHR user in a prior year, the EHR
day period within CY 2021 and applies reporting period is any continuous 180-
for the FY 2022 and 2023 payment ad- day period within CY 2024 and applies
justment years. For the FY 2022 pay- for the FY 2025 and 2026 payment ad-
ment adjustment year, the EHR report- justment years. For the FY 2025 pay-
ing period must end before and the eli- ment adjustment year, the EHR report-
gible hospital must successfully reg- ing period must end before and the eli-
ister for and attest to meaningful use gible hospital must successfully reg-
no later than October 1, 2021. ister for and attest to meaningful use
(B) If in a prior year an eligible hos- no later than October 1, 2024.
pital has successfully demonstrated it (B) If in a prior year an eligible hos-
is a meaningful EHR user, the EHR re- pital has successfully demonstrated it
porting period is any continuous 90-day is a meaningful EHR user, the EHR re-
period within CY 2021 and applies for porting period is any continuous 180-
the FY 2023 payment adjustment year. day period within CY 2024 and applies
(vi) The following are applicable for for the FY 2026 payment adjustment
2022: year.
(A) If an eligible hospital has not suc- (ix) For an eligible hospital in CY
cessfully demonstrated it is a meaning- 2025, the EHR reporting period is any
ful EHR user in a prior year, the EHR continuous 180-day period within CY
reporting period is any continuous 90- 2025 and applies for the FY 2027 pay-
day period within CY 2022 and applies ment adjustment year.
for the FY 2023 and 2024 payment ad- (3) For a CAH—
justment years. For the FY 2023 pay- (i) The following are applicable be-
ment adjustment year, the EHR report- fore 2015:
ing period must end before and the eli- (A) Except as provided in paragraph
gible hospital must successfully reg- (3)(i)(B) of this definition, the Federal
ister for and attest to meaningful use fiscal year that is the payment adjust-
no later than October 1, 2022. ment year.
(B) If in a prior year an eligible hos- (B) If the CAH is demonstrating it is
pital has successfully demonstrated it a meaningful EHR user for the first
is a meaningful EHR user, the EHR re- time in the payment adjustment year,
porting period is any continuous 90-day any continuous 90-day period within
period within CY 2022 and applies for the Federal fiscal year that is the pay-
the FY 2024 payment adjustment year. ment adjustment year.
(vii) The following are applicable for (ii) The following are applicable for
2023: 2015, 2016, 2017, and 2018:
(A) If an eligible hospital has not suc- (A) In 2015 as follows:
cessfully demonstrated it is a meaning- (1) The EHR reporting period is any
ful EHR user in a prior year, the EHR continuous 90-day period within the pe-
reporting period is any continuous 90- riod beginning on October 1, 2014 and
847
§ 495.4 42 CFR Ch. IV (10–1–24 Edition)
ending on December 31, 2015 and applies (B) If in a prior year a CAH has suc-
for the FY 2015 payment adjustment cessfully demonstrated it is a meaning-
year. ful EHR user, the EHR reporting period
(2) [Reserved] is any continuous 90-day period within
(B) In 2016 as follows: CY 2019 and applies for the FY 2019 pay-
(1) If a CAH has not successfully dem- ment adjustment year.
onstrated it is a meaningful EHR user (iv) The following are applicable for
in a prior year, the EHR reporting pe- 2020:
riod is any continuous 90-day period (A) If a CAH has not successfully
within CY 2016 and applies for the FY demonstrated it is a meaningful EHR
2016 payment adjustment year. user in a prior year, the EHR reporting
(2) If in a prior year a CAH has suc- period is any continuous 90-day period
cessfully demonstrated it is a meaning- within CY 2020 and applies for the FY
ful EHR user, the EHR reporting period 2020 payment adjustment year.
is any continuous 90-day period within (B) If in a prior year a CAH has suc-
CY 2016 and applies for the FY 2016 pay- cessfully demonstrated it is a meaning-
ment adjustment year. ful EHR user, the EHR reporting period
(C) In 2017 as follows: is any continuous 90-day period within
CY 2020 and applies for the FY 2020 pay-
(1) If the CAH has not successfully
ment adjustment year.
demonstrated meaningful EHR use in a
(v) The following are applicable for
prior year the EHR reporting period is
2021:
any continuous 90-day period within
(A) If a CAH has not successfully
CY 2017 and applies for the FY 2017 pay-
demonstrated it is a meaningful EHR
user in a prior year, the EHR reporting
(2) If a CAH is demonstrating Stage 3
period is any continuous 90-day period
of meaningful use under § 495.24, the
within CY 2021 and applies for the FY
EHR reporting period is any contin-
2021 payment adjustment year.
uous 90-day period within CY 2017 and
(B) If in a prior year a CAH has suc-
applies for that begins on the first day
cessfully demonstrated it is a meaning-
of second quarter of the FY 2017 pay-
ful EHR user, the EHR reporting period
is any continuous 90-day period within
(3) If in a prior year a CAH has suc- CY 2021 and applies for the FY 2021 pay-
cessfully demonstrated it is a meaning- ment adjustment year.
ful EHR user, the EHR reporting period (vi) The following are applicable for
is any continuous 90-day period within 2022:
CY 2017 and applies for the FY 2017 pay- (A) If a CAH has not successfully
ment adjustment year. demonstrated it is a meaningful EHR
(D) In 2018 as follows: user in a prior year, the EHR reporting
(1) If a CAH has not successfully dem- period is any continuous 90-day period
onstrated it is a meaningful EHR user within CY 2022 and applies for the FY
in a prior year, the EHR reporting pe- 2022 payment adjustment year.
riod is any continuous 90-day period (B) If in a prior year a CAH has suc-
within CY 2018 and applies for the FY cessfully demonstrated it is a meaning-
2018 payment adjustment year. ful EHR user, the EHR reporting period
(2) If in a prior year a CAH has suc- is any continuous 90-day period within
cessfully demonstrated it is a meaning- CY 2022 and applies for the FY 2022 pay-
ful EHR user, the EHR reporting period ment adjustment year.
is any continuous 90-day period within (vii) The following are applicable for
CY 2018 and applies for the FY 2018 pay- 2023:
ment adjustment year. (A) If a CAH has not successfully
(iii) The following are applicable for demonstrated it is a meaningful EHR
2019: user in a prior year, the EHR reporting
(A) If a CAH has not successfully period is any continuous 90-day period
demonstrated it is a meaningful EHR within CY 2023 and applies for the FY
user in a prior year, the EHR reporting 2023 payment adjustment year.
period is any continuous 90-day period (B) If in a prior year a CAH has suc-
within CY 2019 and applies for the FY cessfully demonstrated it is a meaning-
2019 payment adjustment year. ful EHR user, the EHR reporting period
848
is any continuous 90-day period within less of whether the year immediately
CY 2023 and applies for the FY 2023 pay- follows the prior payment year; and
ment adjustment year. (B) With respect to a Medicaid eligi-
(viii) The following are applicable for ble hospital, for years prior to FY 2017,
2024: the second, third, fourth, fifth, or sixth
(A) If a CAH has not successfully Federal FY for which the hospital re-
demonstrated it is a meaningful EHR ceives an incentive payment under sub-
user in a prior year, the EHR reporting part D of this part, regardless of
period is any continuous 180-day period whether the year immediately follows
within CY 2024 and applies for the FY the prior payment year. Beginning
2024 payment adjustment year. with FY 2017, payments to Medicaid el-
(B) If in a prior year a CAH has suc- igible hospitals must be consecutive,
cessfully demonstrated it is a meaning- and the hospital is not eligible for an
ful EHR user, the EHR reporting period incentive payment under subpart D of
is any continuous 180-day period within this part unless it received such incen-
CY 2024 and applies for the FY 2024 pay- tive payment for the prior fiscal year.
ment adjustment year. Hospital-based EP. Unless it meets the
(ix) For a CAH in CY 2025, the EHR requirements of § 495.5, a hospital-based
reporting period is any continuous 180- EP means an EP who furnishes 90 per-
day period within CY 2025 and applies cent or more of his or her covered pro-
for the FY 2025 payment adjustment fessional services in sites of service
year. identified by the codes used in the
HIPAA standard transaction as an in-
Eligible hospital means an eligible
patient hospital or emergency room
hospital as defined under § 495.100 or
setting in the year preceding the pay-
Medicaid eligible hospital under sub-
ment year, or in the case of a payment
part D of this part.
adjustment year, in either of the 2
Eligible professional (EP) means an eli- years before the year preceding such
gible professional as defined under payment adjustment year.
§ 495.100 or a Medicaid eligible profes- (1) For Medicare, this is calculated
sional under subpart D of this part. based on—
First, second, third, fourth, fifth, or (i) The Federal fiscal year preceding
sixth payment years mean as follows: the payment year; and
(1) The first payment year is: with re- (ii) For the payment adjustments,
spect to an EP, the first calendar year based on—
for which the EP receives an incentive (A) The Federal fiscal year 2 years
payment under this part; and with re- before the payment adjustment year;
spect to an eligible hospital or CAH, or
the first FY for which the hospital re- (B) The Federal fiscal year 3 years
ceives an incentive payment under this before the payment adjustment year.
part. (2) For Medicaid, it is at the State’s
(2) The second, third, fourth, fifth, or discretion if the data are gathered on
sixth payment year is: the Federal fiscal year or calendar year
(i) With respect to a Medicare EP, preceding the payment year.
the second, third, fourth or fifth suc- (3) For the CY 2013 payment year
cessive CY immediately following the only, an EP who furnishes services
first payment year; and with respect to billed by a CAH receiving payment
a Medicare eligible hospital or CAH, under Method II (as described in
the second, third, or fourth successive § 413.70(b)(3) of this chapter) is consid-
Federal FY immediately following the ered to be hospital-based if 90 percent
first payment year. (Note: Medicare or more of his or her covered profes-
EPs are not eligible for a sixth pay- sional services are furnished in sites of
ment year and Medicare eligible hos- service identified by the codes used in
pitals are not eligible for a fifth or the HIPAA standard transaction as an
sixth payment year.) inpatient hospital or emergency room
(ii)(A) With respect to a Medicaid EP, setting in each of the Federal fiscal
the second, third, fourth, fifth, or sixth years 2012 and 2013.
CY for which the EP receives an incen- Meaningful EHR user means all of the
tive payment under subpart D, regard- following:
849
§ 495.5 42 CFR Ch. IV (10–1–24 Edition)
(1) Subject to paragraphs (3) and (4) 171.103 during the calendar year of the
of this definition, an eligible profes- EHR reporting period.
sional, eligible hospital or CAH that, Payment adjustment year means the
for an EHR reporting period for a pay- following:
ment year or payment adjustment (1) For an EP, a calendar year begin-
year— ning with CY 2015.
(i) Demonstrates in accordance with (2) For a CAH or an eligible hospital,
§ 495.40 meaningful use of certified EHR a Federal fiscal year beginning with
technology by meeting the applicable FY 2015.
objectives and associated measures (3) For a Puerto Rico eligible hos-
under §§ 495.20, 495.22, 495.24; pital, a Federal fiscal year beginning
(ii) Does not knowingly and willfully with FY 2022.
take action (such as to disable Payment year means the following:
functionality) to limit or restrict the (1) For an EP, a calendar year begin-
compatibility or interoperability of ning with CY 2011.
CEHRT;
(2) For a CAH or an eligible hospital,
(iii) Engages in activities related to a Federal fiscal year beginning with
supporting providers with the perform- FY 2011.
ance of CEHRT; and
(3) For a Puerto Rico eligible hos-
(iv) Successfully reports the clinical pital, a Federal fiscal year beginning
quality measures selected by CMS to with FY 2016.
CMS or the States, as applicable, in the
Qualified EHR has the same defini-
form and manner specified by CMS or
tion as this term is defined at 45 CFR
the States, as applicable.
170.102.
(2)(i) Except as specified in paragraph
(2)(ii) of this definition, a Medicaid EP [75 FR 44565, July 28, 2010]
or Medicaid eligible hospital, that EDITORIAL NOTE: For FEDERAL REGISTER ci-
meets the requirements of paragraph tations affecting § 495.4, see the List of CFR
(1) of this definition and any additional Sections Affected, which appears in the
criteria for meaningful use imposed by Finding Aids section of the printed volume
the State and approved by CMS under and at www.govinfo.gov.
§§ 495.316 and 495.332.
(ii) An eligible hospital or CAH is § 495.5 Requirements for EPs seeking
to reverse a hospital-based deter-
deemed to be a meaningful EHR user mination under § 495.4.
for purposes of receiving an incentive
payment under subpart D of this part, (a) Exception for certain EPs. Begin-
if the hospital participates in both the ning with payment year 2013, an EP
Medicare and Medicaid EHR incentive who meets the definition of hospital-
programs, and the hospital meets the based EP specified in § 495.4 but who
requirements of paragraph (1) of this can demonstrate to CMS that the EP
definition. funds the acquisition, implementation,
(3) To be considered a meaningful and maintenance of Certified EHR
EHR user, at least 50 percent of an EP’s Technology, including supporting hard-
patient encounters during an EHR re- ware and interfaces needed for mean-
porting period for a payment year (or, ingful use without reimbursement from
in the case of a payment adjustment an eligible hospital or CAH, and uses
year, during an applicable EHR report- such Certified EHR Technology in the
ing period for such payment adjust- inpatient or emergency department of
ment year) must occur at a practice/lo- a hospital (instead of the hospital’s
cation or practices/locations equipped Certified EHR Technology), may be de-
with certified EHR technology. termined by CMS to be a nonhospital-
(4) An eligible professional, eligible based EP.
hospital or CAH is not a meaningful (b) Process for determining a nonhos-
EHR user in a payment adjustment pital-based EP. When an EP registers
year if the HHS Inspector General re- for a given payment year they should
fers a determination that the eligible receive a determination of whether
hospital or CAH committed informa- they have been determined ‘‘hospital-
tion blocking as defined at 45 CFR based.’’
850
(1) An EP determined ‘‘hospital- EP meets all of the following require-

based,’’ but who wishes to be deter- ments:
mined nonhospital-based as specified in (A) Must ensure that the objective in
paragraph (a) of section, may use an paragraph (d) or (e) of this section in-
administrative process to provide docu- cludes an option for the EP to attest
mentation and seek a nonhospital- that the objective is not applicable.
based determination. Such administra- (B) Meets the criteria in the applica-
tive process will be available through- ble objective that would permit the at-
out the incentive payment year and in- testation.
cluding the 2 months following the in- (C) Attests.
centive payment year in which the EP (ii) (A) An exclusion will reduce (by
may attest to being a meaningful EHR the number of exclusions applicable)
user. the number of objectives that would
(2) If an EP is determined nonhos- otherwise apply. For example, an EP
pital-based under paragraph (a) of this that has an exclusion from one of the
section, to be considered nonhospital- objectives in paragraph (e) of this sec-
based for subsequent payment years, tion must meet four (and not five) ob-
the EP must attest in such payment jectives of the EP’s choice from such
year (or by the time the EP must at- paragraph to meet the definition of a
test it is a meaningful EHR user for meaningful EHR user.
such year) that the EP continues to (B) Beginning 2014, an exclusion does
meet the criteria of paragraph (a) of not reduce (by the number of exclu-
this section. sions applicable) the number of objec-
(c) Requirements for nonhospital-based tives that would otherwise apply in
EPs. An EP determined nonhospital- paragraph (e) of this section unless five
based must— or more objectives can be excluded. An
(1) Continue to meet all applicable EP must meet five of the objectives
requirements to receive an incentive and associated measures specified in
payment, including meeting all re- paragraph (e) of this section, one of
quirements for meaningful use; and which must be either paragraph (e)(9)
(2) Demonstrate meaningful use or (10) of this section, unless the EP
using all encounters at all locations has an exclusion from five or more ob-
equipped with Certified EHR Tech- jectives specified in paragraph (e) of
nology, including those in the inpa- this section, in which case the EP must
tient and emergency departments of meet all remaining objectives and asso-
the hospital. ciated measures in paragraph (e) of this
section.
[77 FR 54149, Sept. 4, 2012] (3) Exception for Medicaid EPs who
adopt, implement or upgrade in their first
§ 495.20 Meaningful use objectives and payment year. For Medicaid EPs who
measures for EPs, eligible hospitals, adopt, implement, or upgrade certified
and CAHs before 2015.
EHR technology in their first payment
The following criteria are applicable year, the meaningful use objectives and
before 2015: associated measures of the Stage 1 cri-
(a) Stage 1 criteria for EPs—(1) General teria specified in paragraphs (d) and (e)
rule regarding Stage 1 criteria for mean- apply beginning with the second pay-
ingful use for EPs. Except as specified in ment year, and do not apply to the
paragraphs (a)(2) and (a)(3) of this sec- first payment year.
tion, EPs must meet all objectives and (4) Flexible options for using certified
associated measures of the Stage 1 cri- EHR technology in 2014. For an EHR re-
teria specified in paragraph (d) of this porting period in 2014, if an EP could
section and five objectives of the EP’s not fully implement 2014 Edition cer-
choice from paragraph (e) of this sec- tified EHR technology due to delays in
tion to meet the definition of a mean- availability and uses—
ingful EHR user. (i) Only 2011 Edition certified EHR
(2) Exclusion for non-applicable objec- technology, the EP must satisfy the
tives. (i) An EP may exclude a par- objectives and associated measures of
ticular objective contained in para- the Stage 1 criteria that were applica-
graphs (d) or (e) of this section, if the ble for 2013; or
851
§ 495.20 42 CFR Ch. IV (10–1–24 Edition)
(ii) A combination of 2011 Edition (3) Exception for Medicaid eligible hos-
certified EHR technology and 2014 Edi- pitals that adopt, implement or upgrade in
tion certified EHR technology, the EP their first payment year. For Medicaid
may choose to satisfy one of the fol- eligible hospitals that adopt, imple-
lowing sets of objectives and associated ment, or upgrade certified EHR tech-
measures: nology in their first payment year, the
(A) The Stage 1 criteria that were ap- meaningful use objectives and associ-
plicable for 2013. ated measures of the Stage 1 criteria
(B) The Stage 1 criteria that are ap- specified in paragraphs (f) and (g) of
plicable beginning 2014. this section apply beginning with the
(C) If the EP is scheduled to begin second payment year, and do not apply
Stage 2 in 2014, the Stage 2 criteria. to the first payment year.
(b) Stage 1 criteria for eligible hospitals (4) Flexible options for using certified
and CAHs—(1) General rule regarding EHR technology in 2014. For an EHR re-
Stage 1 criteria for meaningful use for eli- porting period in 2014, if an eligible
gible hospitals or CAHs. Except as speci- hospital or CAH could not fully imple-
fied in paragraphs (b)(2) and (b)(3) of ment 2014 Edition certified EHR tech-
this section, eligible hospitals and nology due to delays in availability
CAHs must meet all objectives and as- and uses—
sociated measures of the Stage 1 cri- (i) Only 2011 Edition certified EHR
teria specified in paragraph (f) of this technology, the eligible hospital or
section and five objectives of the eligi- CAH must satisfy the objectives and
ble hospital’s or CAH’s choice from associated measures of the Stage 1 cri-
paragraph (g) of this section to meet teria that were applicable for 2013;
the definition of a meaningful EHR (ii) A combination of 2011 Edition
user. certified EHR technology and 2014 Edi-
(2) Exclusions for nonapplicable objection certified EHR technology, the eli-
tives. (i) An eligible hospital or CAH gible hospital or CAH may choose to
may exclude a particular objective satisfy one of the following sets of ob-
that includes an option for exclusion jectives and associated measures:
contained in paragraphs (f) or (g) of (A) The Stage 1 criteria that were ap-
this section, if the hospital meets all of plicable for 2013.
the following requirements: (B) The Stage 1 criteria that are ap-
(A) The hospital meets the criteria in plicable beginning 2014.
the applicable objective that would (C) If the eligible hospital or CAH is
permit an exclusion. scheduled to begin Stage 2 in 2014, the
(B) The hospital so attests. Stage 2 criteria.
(ii)(A) An exclusion will reduce (by (c) Many of the objective and associ-
the number of exclusions received) the ated measures in paragraphs para-
number of objectives that would other- graphs (d) through (m) of this section
wise apply. For example, an eligible rely on measures that count unique pa-
hospital that is excluded from one of tients or actions.
the objectives in paragraph (g) of this (1) If a measure (or associated objec-
section must meet four (and not five) tive) in paragraphs (d) through (g) of
objectives of the hospital’s choice from this section references paragraph (c) of
such paragraph to meet the definition this section, then the measure may be
of a meaningful EHR user. calculated by reviewing only the ac-
(B) Beginning 2014, an exclusion does tions for patients whose records are
not reduce (by the number of exclu- maintained using certified EHR tech-
sions applicable) the number of objec- nology. A patient’s record is main-
tives that would otherwise apply in tained using certified EHR technology
paragraph (g) of this section. Eligible if sufficient data was entered in the
hospitals or CAHs must meet five of certified EHR technology to allow the
the objectives and associated measures record to be saved, and not rejected due
specified in paragraph (g) of this sec- to incomplete data.
tion, one which must be specified in (2) If the objective and associated
paragraph (g)(8), (9), or (10) of this sec- measure does not reference this para-
tion. graph (c) of this section, then the
852
measure must be calculated by review- who writes fewer than 100 prescriptions
ing all patient records, not just those during the EHR reporting period.
maintained using certified EHR tech- (B) Beginning 2013, any EP who does
nology. not have a pharmacy within their orga-
(d) Stage 1 core criteria for EPs. An EP nization and there are no pharmacies
must satisfy the following objectives that accept electronic prescriptions
and associated measures, except those within 10 miles of the EP’s practice lo-
objectives and associated measures for cation at the start of his/her EHR re-
which an EP qualifies for an exclusion porting period, or the exclusion speci-
under paragraph (a)(2) of this section fied in (d)(4)(iii)(A) of this section.
specified in this paragraph: (5)(i) Objective. Maintain active medi-
(1)(i) Objective. Use computerized pro- cation list.
vider order entry (CPOE) for medica- (ii) Measure. More than 80 percent of
tion orders directly entered by any li- all unique patients seen by the EP have
censed healthcare professional who can at least one entry (or an indication
enter orders into the medical record that the patient is not currently pre-
per state, local and professional guide- scribed any medication) recorded as
lines. structured data.
(ii) Measure. (A) Subject to paragraph (6)(i) Objective. Maintain active medi-
(c) of this section, more than 30 percent cation allergy list.
of all unique patients with at least one (ii) Measure. More than 80 percent of
medication in their medication list all unique patients seen by the EP have
seen by the EP have at least one medi- at least one entry (or an indication
cation order entered using CPOE. that the patient has no known medica-
(B) Subject to paragraph (c) of this tion allergies) recorded as structured
section, more than 30 percent of medi- data.
cation orders created by the EP during (7)(i) Objective. Record all of the fol-
the EHR reporting period are recorded lowing demographics:
using computerized provider order (A) Preferred language.
entry, or the measure specified in para- (B) Gender.
graph (d)(1)(ii)(A) of this section. (C) Race.
(D) Ethnicity.
(iii) Exclusion in accordance with para-
(E) Date of birth.
graph (a)(2) of this section Any EP who
(ii) Measure. More than 50 percent of
writes fewer than 100 prescriptions dur-
all unique patients seen by the EP have
ing the EHR reporting period.
demographics recorded as structured
(2)(i) Objective. Implement drug-drug
data.
and drug-allergy interaction checks.
(8)(i) Objective. Record and chart
(ii) Measure. The EP has enabled this changes in the following vital signs:
functionality for the entire EHR re- (A) Height.
porting period. (B) Weight.
(3)(i) Objective. Maintain an up-to- (C) Blood pressure.
date problem list of current and active (D) Calculate and display body mass
diagnoses. index (BMI).
(ii) Measure. More than 80 percent of (E)(1) Plot and display growth charts
all unique patients seen by the EP have for children 2–20 years, including BMI.
at least one entry or an indication that (2) For 2013, plot and display growth
no problems are known for the patient charts for patients 0–20 years, includ-
recorded as structured data. ing body mass index, or paragraph
(4)(i) Objective. Generate and trans- (d)(8)(i)(E)(1) of this section.
mit permissible prescriptions elec- (3) Beginning 2014, plot and display
tronically (eRx). growth charts for patients 0–20 years,
(ii) Measure. Subject to paragraph (c) including body mass index.
of this section, more than 40 percent of (ii) Measure. (A) Subject to paragraph
all permissible prescriptions written by (c) of this section, more than 50 percent
the EP are transmitted electronically of all unique patients age 2 and over
using certified EHR technology. seen by the EP, height, weight and
(iii) Exclusion in accordance with para- blood pressure are recorded as struc-
graph (a)(2) of this section (A) Any EP tured data.
853
§ 495.20 42 CFR Ch. IV (10–1–24 Edition)
(B) For 2013—(1) Subject to paragraph (B) Beginning 2013, this objective is
(c) of this section, more than 50 percent reflected in the definition of a mean-
of all unique patients seen by the EP ingful EHR user in § 495.4 and is no
during the EHR reporting period have longer listed as an objective in this
blood pressure (for patients age 3 and paragraph (d).
over only) and height/length and (ii) Measure. (A) Subject to paragraph
weight (for all ages) recorded as struc- (c) of this section, successfully report
tured data; or to CMS (or, in the case of Medicaid
(2) The measure specified in para- EPs, the States) ambulatory clinical
graph (d)(8)(ii)(A) of this section. quality measures selected by CMS in
(C) Beginning 2014, only the measure the manner specified by CMS (or in the
specified in paragraph (d)(8)(ii)(B)(1) of case of Medicaid EPs, the States).
this section. (B) Beginning 2013, this measure is
(iii) Exclusion in accordance with para- reflected in the definition of a mean-
graph (a)(2) of this section. (A) Any EP ingful EHR user in § 495.4 and no longer
who either see no patients 2 years or listed as a measure in this paragraph
older, or who believes that all three (d).
vital signs of height, weight, and blood (11)(i) Objective. Implement one clin-
pressure of their patients have no rel- ical decision support rules relevant to
evance to their scope of practice. specialty or high clinical priority
(B) For 2013, either of the following: along with the ability to track compli-
(1) The exclusion specified in para- ance with that rule.
graph (d)(8)(iii)(A) of this section. (ii) Measure. Implement one clinical
(2) The exclusion for an EP who— decision support rule.
(i) Sees no patients 3 years or older is (12)(i) Objective. (A) Provide patients
excluded from recording blood pres- with an electronic copy of their health
sure; information (including diagnostics test
(ii) Believes that all three vital signs results, problem list, medication lists,
of height/length, weight, and blood medication allergies) upon request.
pressure have no relevance to their (B) Beginning 2014, provide patients
scope of practice is excluded from re- the ability to view online, download,
cording them; and transmit their health information
(iii) Believes that height/length and within 4 business days of the informa-
weight are relevant to their scope of tion being available to the EP.
practice, but blood pressure is not, is (ii) Measure. (A) Subject to paragraph
excluded from recording blood pres- (c) of this section, more than 50 percent
sure; or of all patients who request an elec-
(iv) Believes that blood pressure is tronic copy of their health information
relevant to their scope of practice, but are provided it within 3 business days.
height/length and weight are not, is ex- (B) Beginning 2014, subject to para-
cluded from recording height/length graph (c) of this section, more than 50
and weight. percent of all unique patients seen by
(C) Beginning 2014, only the exclusion the EP during the EHR reporting pe-
specified in paragraph (d)(8)(iii)(B)(2) of riod are provided timely (available to
this section. the patient within 4 business days after
(9)(i) Objective. Record smoking sta- the information is available to the EP)
tus for patients 13 years old or older. online access to their health informa-
(ii) Measure. Subject to paragraph (c) tion subject to the EP’s discretion to
of this section, more than 50 percent of withhold certain information.
all unique patients 13 years old or older (iii) Exclusion in accordance with para-
seen by the EP have smoking status re- graph (a)(2) of this section. (A) Any EP
corded as structured data. that has no requests from patients or
(iii) Exclusion in accordance with para- their agents for an electronic copy of
graph (a)(2) of this section. Any EP who patient health information during the
sees no patients 13 years or older. EHR reporting period.
(10)(i) Objective. (A) Report ambula- (B) Beginning 2014, any EP who nei-
tory clinical quality measures to CMS ther orders nor creates any of the in-
or, in the case of Medicaid EPs, the formation listed for inclusion as part of
States. this measure.
854
(13)(i) Objective. Provide clinical sum- (1)(i) Objective. Implement drug-for-

maries for patients for each office mulary checks.
visit. (ii) Measure. The EP has enabled this
(ii) Measure. Subject to paragraph (c) functionality and has access to at least
of this section, clinical summaries pro- one internal or external formulary for
vided to patients for more than 50 per- the entire EHR reporting period.
cent of all office visits within 3 busi- (iii) Exclusion in accordance with para-
ness days. graph (a)(2) of this section. Any EP who
(iii) Exclusion in accordance with para- writes fewer than 100 prescriptions dur-
graph (a)(2) of this section. Any EP who ing the EHR reporting period.
has no office visits during the EHR re- (2)(i) Objective. Incorporate clinical
porting period. lab-test results into EHR as structured
(14)(i) Objective. (A) Capability to ex- data.
change key clinical information (for (ii) Measure. Subject to paragraph (c)
example, problem list, medication list, of this section, more than 40 percent of
medication allergies, and diagnostic all clinical lab tests results ordered by
test results), among providers of care the EP during the EHR reporting pe-
and patient authorized entities elec- riod whose results are either in a posi-
tronically. tive/negative or numerical format are
(B) Beginning 2013, this objective is incorporated in certified EHR tech-
no longer required as part of the core nology as structured data.
set. (iii) Exclusion in accordance with para-
(ii) Measure. (A) Performed at least graph (a)(2) of this section. An EP who
one test of certified EHR technology’s orders no lab tests whose results are ei-
capacity to electronically exchange ther in a positive/negative or numeric
key clinical information. format during the EHR reporting pe-
(B) Beginning 2013, this measure is no riod.
longer required as part of the core set. (3)(i) Objective. Generate lists of pa-
(15)(i) Objective. Protect electronic tients by specific conditions to use for
health information created or main- quality improvement, reduction of dis-
tained by the certified EHR technology parities, research, or outreach.
through the implementation of appro- (ii) Measure. Subject to paragraph (c)
priate technical capabilities. of this section, generate at least one
(ii) Measure. Conduct or review a se- report listing patients of the EP with a
curity risk analysis in accordance with specific condition.
the requirements under 45 CFR (4)(i) Objective. Send reminders to pa-
164.308(a)(1) and implement security up- tients per patient preference for pre-
dates as necessary and correct identi- ventive/follow-up care.
fied security deficiencies as part of its (ii) Measure. Subject to paragraph (c)
risk management process. of this section, more than 20 percent of
(e) Stage 1 menu set criteria for EPs. An all patients 65 years or older or 5 years
EP must meet five of the following ob- old or younger were sent an appro-
jectives and associated measures, one priate reminder during the EHR report-
of which must be either paragraph ing period.
(e)(9) or (e)(10) of this section, except (iii) Exclusion in accordance with para-
that the required number of objectives graph (a)(2) of this section. An EP who
and associated measures is reduced by has no patients 65 years old or older or
an EP’s paragraph (a)(2) of this section 5 years old or younger with records
exclusions specified in this paragraph. maintained using certified EHR tech-
Beginning 2014, an EP must meet five nology.
of the following objectives and associ- (5)(i) Objective. (A) Provide patients
ated measures, one of which must be with timely electronic access to their
either paragraph (e)(9) or (10) of this health information (including lab re-
section unless the EP has an exclusion sults, problem list, medication lists,
from five or more objectives in this and allergies) within 4 business days of
paragraph (e), in which case the EP the information being available to the
must meet all remaining objectives EP.
and associated measures in paragraph (B) Beginning 2014, this objective is
(e) of this section. no longer included in the menu set.
855
§ 495.20 42 CFR Ch. IV (10–1–24 Edition)
(ii) Measure. (A) At least 10 percent of provider during the EHR reporting pe-
all unique patients seen by the EP are riod.
provided timely (available to the pa- (9)(i) Objective. (A) Capability to sub-
tient within four business days of being mit electronic data to immunization
updated in the certified EHR tech- registries or immunization information
nology) electronic access to their systems and actual submission accord-
health information subject to the EP’s ing to applicable law and practice.
discretion to withhold certain informa- (B) Beginning 2013, capability to sub-
tion. mit electronic data to immunization
(B) Beginning 2014, this measure is no registries or immunization information
longer included in the menu set. systems and actual submission except
(iii) Exclusion in accordance with para- where prohibited and according to ap-
graph (a)(2) of this section. Any EP that plicable law and practice.
neither orders nor creates any of the (ii) Measure. Performed at least one
information listed at 45 CFR 170.314(g) test of certified EHR technology’s ca-
during the EHR reporting period. pacity to submit electronic data to im-
(6)(i) Objective. Use certified EHR munization registries and follow up
technology to identify patient-specific submission if the test is successful (un-
education resources and provide those less none of the immunization reg-
resources to the patient if appropriate. istries to which the EP submits such
information has the capacity to receive
(ii) Measure. More than 10 percent of
the information electronically).
all unique patients seen by the EP are
provided patient-specific education re-
graph (a)(2) of this section. An EP who
sources.
administers no immunizations during
(7)(i) Objective. The EP who receives a the EHR reporting period or where no
patient from another setting of care or immunization registry has the capac-
provider of care or believes an encoun- ity to receive the information elec-
ter is relevant should perform medica- tronically.
tion reconciliation. (10)(i) Objective. (A) Capability to sub-
(ii) Measure. Subject to paragraph (c) mit electronic syndromic surveillance
of this section, the EP performs medi- data to public health agencies and ac-
cation reconciliation for more than 50 tual submission according to applica-
percent of transitions of care in which ble law and practice.
the patient is transitioned into the (B) Beginning 2013, capability to sub-
care of the EP. mit electronic syndromic surveillance
(iii) Exclusion in accordance with para- data to public health agencies and ac-
graph (a)(2) of this section. An EP who tual submission except where prohib-
was not the beneficiary of any transi- ited and according to applicable law
tions of care during the EHR reporting and practice.
period. (ii) Measure. Performed at least one
(8)(i) Objective. The EP who transi- test of certified EHR technology’s ca-
tions their patient to another setting pacity to provide electronic syndromic
of care or provider of care or refers surveillance data to public health
their patient to another provider of agencies and follow-up submission if
care should provide summary care the test is successful (unless none of
record for each transition of care or re- the public health agencies to which an
ferral. EP submits such information has the
(ii) Measure. Subject to paragraph (c) capacity to receive the information
of this section, the EP who transitions electronically).
or refers their patient to another set- (iii) Exclusion in accordance with
ting of care or provider of care provides paragraph (a)(2) of this section. An EP
a summary of care record for more who does not collect any reportable
than 50 percent of transitions of care syndromic information on their pa-
and referrals. tients during the EHR reporting period
(iii) Exclusion in accordance with para- or does not submit such information to
graph (a)(2) of this section. An EP who any public health agency that has the
neither transfers a patient to another capacity to receive the information
setting nor refers a patient to another electronically.
856
(f) Stage 1 core criteria for eligible hos- prescribed any medication) recorded as
pitals or CAHs. An eligible hospital or structured data.
CAH must meet the following objec- (5)(i) Objective. Maintain active medi-
tives and associated measures except cation allergy list.
those objectives and associated meas- (ii) Measure. More than 80 percent of
ures for which an eligible hospital or all unique patients admitted to the eli-
CAH qualifies for a paragraph (b)(2) of gible hospital’s or CAH’s inpatient or
this section exclusion specified in this emergency department (POS 21 or 23)
paragraph: have at least one entry (or an indica-
(1)(i) Objective. Use CPOE for medication that the patient has no known
tion orders directly entered by any li- medication allergies) recorded as struc-
censed healthcare professional who can tured data.
enter orders into the medical record (6)(i) Objective. Record all of the fol-
per State, local, and professional lowing demographics;
guidelines. (A) Preferred language.
(ii) Measure. (A) Subject to paragraph (B) Gender.
(c) of this section, more than 30 percent (C) Race.
of all unique patients with at least one (D) Ethnicity.
medication in their medication list ad- (E) Date of birth.
mitted to the eligible hospital’s or (F) Date and preliminary cause of
CAH’s inpatient or emergency depart- death in the event of mortality in the
ment (POS 21 or 23) have at least one eligible hospital or CAH.
medication order entered using CPOE. (ii) Measure. More than 50 percent of
all unique patients admitted to the eli-
(B) Subject to paragraph (c) of this
gible hospital’s or CAH’s inpatient or
section, more than 30 percent of medi-
emergency department (POS 21 or 23)
cation orders created by the authorized
have demographics recorded as struc-
providers of the eligible hospital or
tured data.
CAH for patients admitted to their in-
(7)(i) Objective. Record and chart
patient or emergency departments
changes in the following vital signs:
(POS 21 or 23) during the EHR report-
(A) Height.
ing period are recorded using comput-
(B) Weight.
erized provider order entry, or the
(C) Blood pressure.
measure specified in paragraph
(D) Calculate and display body mass
(f)(1)(ii)(A) of this section.
index (BMI).
(2)(i) Objective. Implement drug-drug
(E)(1) Plot and display growth charts
and drug-allergy interaction checks.
for children 2–20 years, including BMI.
(ii) Measure. The eligible hospital or (2) For 2013, plot and display growth
CAH has enabled this functionality for charts for patients 0–20 years, includ-
the entire EHR reporting period. ing body mass index, or paragraph
(3)(i) Objective. Maintain an up-to- (f)(7)(i)(E)(1) of this section.
date problem list of current and active (3) Beginning 2014, plot and display
diagnoses. growth charts for patients 0–20 years,
(ii) Measure. More than 80 percent of including body mass index.
all unique patients admitted to the eli- (ii) Measure. (A) Subject to paragraph
gible hospital’s or CAH’s inpatient or (c) of this section, for more than 50 per-
emergency department (POS 21 or 23) cent of all unique patients age 2 and
have at least one entry or an indica- over admitted to the eligible hospital’s
tion that no problems are known for or CAH’s inpatient or emergency de-
the patient recorded as structured partment (POS 21 or 23), height,
data. weight, and blood pressure are recorded
(4)(i) Objective. Maintain active medi- as structured data.
cation list. (B) For 2013—
(ii) Measure. More than 80 percent of (1) Subject to paragraph (c) of this
all unique patients admitted to the eli- section, more than 50 percent of all
gible hospital’s or CAH’s inpatient or unique patients admitted to the eligi-
emergency department (POS 21 or 23) ble hospital’s or CAH’s inpatient or
have at least one entry (or an indica- emergency department (POS 21 or 23)
tion that the patient is not currently during the EHR reporting period have
857
§ 495.20 42 CFR Ch. IV (10–1–24 Edition)
blood pressure (for patients age 3 and (B) Beginning 2014, this objective is
over only) and height/length and no longer required as part of the core
weight (for all ages) recorded as struc- set.
tured data; or (ii) Measure. (A) Subject to paragraph
(2) The measure specified in para- (c) of this section, more than 50 percent
graph (f)(7)(ii)(A) of this section. of all patients of the inpatient or emer-
(C) Beginning 2014, only the measure gency departments of the eligible hos-
specified in paragraph (f)(7)(ii)(B)(1) of pital or CAH (POS 21 or 23) who request
this section. an electronic copy of their health in-
(8)(i) Objective. Record smoking for formation are provided it within 3 busi-
patients 13 years old or older. ness days.
(ii) Measure. Subject to paragraph (c) (B) Beginning 2014, this measure is no
of this section, more than 50 percent of longer required as part of the core set.
all unique patients 13 years old or older (iii) Exclusion in accordance with para-
or admitted to the eligible hospital’s graph (b)(2) of this section. Any eligible
inpatient or emergency department hospital or CAH that has no requests
(POS 21 or 23) have smoking status re- from patients or their agents for an
corded as structured data. electronic copy of patient health infor-
(iii) Exclusion in accordance with para- mation during the EHR reporting pe-
graph (b)(2) of this section. Any eligible riod.
hospital or CAH that admits no pa-
(12)(i) Objective. (A) Provide patients
tients 13 years or older to their inpa-
with an electronic copy of their dis-
tient or emergency department (POS 21
charge instructions at time of dis-
or 23).
charge, upon request.
(9)(i) Objective. (A) Report hospital
(B) Beginning 2014, provide patients
clinical quality measures to CMS or, in
the ability to view online, download,
the case of Medicaid eligible hospitals,
and transmit information about a hos-
the States.
pital admission.
(B) Beginning 2013, this objective is
reflected in the definition of a mean- (ii) Measure. (A) Subject to paragraph
ingful EHR user in § 495.4 and no longer (c) of this section, more than 50 percent
listed as an objective in this paragraph of all patients who are discharged from
(f). an eligible hospital or CAH’s inpatient
(ii) Measure. (A) Subject to paragraph or emergency department (POS 21 or
(c) of this section, successfully report 23) and who request an electronic copy
to CMS (or, in the case of Medicaid eli- of their discharge instructions are pro-
gible hospitals or CAHs, the States) vided it.
hospital clinical quality measures se- (B) Beginning 2014, subject to para-
lected by CMS in the manner specified graph (c) of this section, more than 50
by CMS (or, in the case of Medicaid eli- percent of all unique patients who are
gible hospitals or CAHs, the States). discharged from the inpatient or emer-
(B) Beginning 2013, this measure is gency department (POS 21 or 23) of an
reflected in the definition of a mean- eligible hospital or CAH have their in-
ingful EHR user in § 495.4 and no longer formation available online within 36
listed as a measure in this paragraph hours of discharge.
(f). (iii) Exclusion in accordance with para-
(10)(i) Objective. Implement one clin- graph (b)(2) of this section. (A) Any eligi-
ical decision support rule related to a ble hospital or CAH that has no re-
high priority hospital condition along quests from patients or their agents for
with the ability to track compliance an electronic copy of the discharge in-
with that rule. structions during the EHR reporting
(ii) Measure. Implement one clinical period.
decision support rule. (B) Beginning 2014, this exclusion is
(11)(i) Objective. (A) Provide patients no longer available.
with an electronic copy of their health (13)(i) Objective. (A) Capability to ex-
information (including diagnostic test change key clinical information (for
results, problem list, medication lists, example, problem list, medication list,
medication allergies, discharge sum- medication allergies, and diagnostic
mary, procedures), upon request. test results), among providers of care
858
and patient authorized entities elec- tients age 65 years old or older during
tronically. the EHR reporting period.
(B) Beginning 2013, this objective is (3)(i) Objective. Incorporate clinical
no longer required as part of the core lab-test results into EHR as structured
set. data.
(ii) Measure. Performed at least one (ii) Measure. Subject to paragraph (c)
test of certified EHR technology’s ca- of this section, more than 40 percent of
pacity to electronically exchange key all clinical lab test results ordered by
clinical information. an authorized provider of the eligible
(B) Beginning 2013, this measure is no hospital or CAH for patients admitted
longer required as part of the core set. to its inpatient or emergency depart-
(14)(i) Objective. Protect electronic ment (POS 21 and 23) during the EHR
health information created or main- reporting period whose results are ei-
tained by the certified EHR technology ther in a positive/negative or numer-
through the implementation of appro- ical format are incorporated in cer-
priate technical capabilities. tified EHR technology as structured
data.
(ii) Measure. Conduct or review a se-
(4)(i) Objective. Generate lists of pa-
curity risk analysis in accordance with
tients by specific conditions to use for
the requirements under 45 CFR
quality improvement, reduction of dis-
164.308(a)(1) and implement security up-
parities, research, or outreach.
dates as necessary and correct identi-
(ii) Measure. Subject to paragraph (c)
fied security deficiencies as part of its
of this section, generate at least one
risk management process.
report listing patients of the eligible
(g) Stage 1 menu set criteria for eligible hospital or CAH with a specific condi-
hospitals or CAHs. Eligible hospitals or tion.
CAHs must meet five of the following (5)(i) Objective. Use certified EHR
objectives and associated measures, technology to identify patient-specific
one which must be specified in para- education resources and provide those
graph (g)(8), (g)(9), or (g)(10) of this sec- resources to the patient if appropriate.
tion, except that the required number (ii) Measure. More than 10 percent of
of objectives and associated measures all unique patients admitted to the eli-
is reduced by a hospital’s paragraph gible hospital’s or CAH’s inpatient or
(b)(2) of this section exclusions speci- emergency department (POS 21 or 23)
fied in this paragraph. Beginning 2014, are provided patient-specific education
eligible hospitals or CAHs must meet resources.
five of the following objectives and as- (6)(i) Objective. The eligible hospital
sociated measures, one which must be or CAH who receives a patient from an-
specified in paragraph (g)(8), (9), or (10) other setting of care or provider of care
of this section: or believes an encounter is relevant
(1)(i) Objective. Implement drug-for- should perform medication reconcili-
mulary checks. ation.
(ii) Measure. The eligible hospital or (ii) Measure. Subject to paragraph (c)
CAH has enabled this functionality and of this section, the eligible hospital or
has access to at least one internal or CAH performs medication reconcili-
external formulary for the entire EHR ation for more than 50 percent of tran-
reporting period. sitions of care in which the patient is
(2)(i) Objective. Record advance direc- admitted to the eligible hospital’s or
tives for patient 65 years old or older. CAH’s inpatient or emergency depart-
(ii) Measure. Subject to paragraph (c) ment (POS 21 or 23).
of this section, more than 50 percent of (7)(i) Objective. The eligible hospital
all unique patients 65 years old or older or CAH that transitions their patient
admitted to the eligible hospital’s or to another setting of care or provider
CAH’s inpatient (POS 21) have an indi- of care or refers their patient to an-
cation of an advance directive status other provider of care should provide
recorded as structured data. summary care record for each transi-
(iii) Exclusion in accordance with para- tion of care or referral.
graph (b)(2) of this section. An eligible (ii) Measure. Subject to paragraph (c)
hospital or CAH that admits no pa- of this section, the eligible hospital or
859
§ 495.20 42 CFR Ch. IV (10–1–24 Edition)
CAH that transitions or refers their pa- health agency to which the eligible
tient to another setting of care or pro- hospital or CAH submits such informa-
vider of care provides a summary of tion has the capacity to receive the in-
care record for more than 50 percent of formation electronically.
transitions of care and referrals. (10)(i) Objective. (A) Capability to sub-
(8)(i) Objective. (A) Capability to submit electronic syndromic surveillance
mit electronic data to immunization data to public health agencies and ac-
registries or immunization information tual submission according to applica-
systems and actual submission accord- ble law and practice.
ing to applicable law and practice. (B) Beginning 2013, capability to sub-
(B) Beginning 2013, Capability to submit electronic syndromic surveillance
mit electronic data to immunization data to public health agencies and ac-
registries or immunization information tual submission except where prohib-
systems and actual submission except ited and according to applicable law
where prohibited and according to ap- and practice.
plicable law and practice. (ii) Measure. Performed at least one
(ii) Measure. Performed at least one test of certified EHR technology’s ca-
test of certified EHR technology’s capacity to provide electronic syndromic
pacity to submit electronic data to im- surveillance data to public health
munization registries and follow up agencies and follow-up submission if
submission if the test is successful (un- the test is successful (unless none of
less none of the immunization reg- the public health agencies to which an
istries to which the eligible hospital or eligible hospital or CAH submits infor-
CAH submits such information has the mation has the capacity to receive the
capacity to receive the information information electronically).
electronically). (iii) Exclusion in accordance with para-
(iii) Exclusion in accordance with paragraph (a)(2) of this section. No public
graph (b)(2) of this section. An eligible health agency to which the eligible
hospital or CAH that administers no hospital or CAH submits information
immunizations during the EHR report- has the capacity to receive the infor-
ing period or where no immunization mation electronically.
registry has the capacity to receive the (h) Stage 2 criteria for EPs—(1) General
information electronically. rule regarding Stage 2 criteria for mean-
(9)(i) Objective. (A) Capability to sub- ingful use for EPs. Except as specified in
mit electronic data on reportable (as paragraph (h)(2) of this section, EPs
required by State or local law) lab re- must meet all objectives and associ-
sults to public health agencies and ac- ated measures of the Stage 2 criteria
tual submission according to applica- specified in paragraph (j) of this sec-
ble law and practice. tion and 3 objectives of the EP’s choice
(B) Beginning 2013, capability to sub- from paragraph (k) of this section to
mit electronic data on reportable (as meet the definition of a meaningful
required by State or local law) lab re- EHR user.
sults to public health agencies and ac- (2) Exclusion for nonapplicable objec-
tual submission except where prohib- tives. (i) An EP may exclude a par-
ited according to applicable law and ticular objective contained in para-
practice. graph (j) or (k) of this section, if the
(ii) Measure. Performed at least one EP meets all of the following require-
test of certified EHR technology’s ca- ments:
pacity to provide electronic submission (A) Must ensure that the objective in
of reportable lab results to public paragraph (j) or (k) of this section in-
health agencies and follow-up submis- cludes an option for the EP to attest
sion if the test is successful (unless that the objective is not applicable.
none of the public health agencies to (B) Meets the criteria in the applica-
which an eligible hospital or CAH sub- ble objective that would permit the at-
mits such information has the capacity testation.
to receive the information electroni- (C) Attests.
cally). (ii)(A) An exclusion will reduce (by
(iii) Exclusion in accordance with para- the number of exclusions applicable)
graph (b)(2) of this section. No public the number of objectives that would
860
otherwise apply in paragraph (j) of this (A) The hospital meets the criteria in
section. For example, an EP that has the applicable objective that would
an exclusion from one of the objectives permit an exclusion.
in paragraph (j) of this section must (B) The hospital so attests.
meet 16 objectives from such paragraph (ii)(A) An exclusion will reduce (by
to meet the definition of a meaningful the number of exclusions applicable)
EHR user. the number of objectives that would
(B) An exclusion does not reduce (by otherwise apply in paragraph (l) of this
the number of exclusions applicable) section. For example, an eligible hos-
the number of objectives that would pital that has an exclusion from 1 of
otherwise apply in paragraph (k) of the objectives in paragraph (l) of this
this section unless four or more exclu- section must meet 15 objectives from
sions apply. For example, an EP that such paragraph to meet the definition
has an exclusion for one of the objec- of a meaningful EHR user.
tives in paragraph (k) of this section (B) An exclusion does not reduce (by
must meet three of the five non- the number of exclusions applicable)
excluded objectives from such para- the number of objectives that would
graph to meet the definition of a mean- otherwise apply in paragraph (m) of
ingful EHR user. If an EP has an exclu- this section. For example, an eligible
sion for four of the objectives in para- hospital that has an exclusion for one
graph (k) of this section, then he or she of the objectives in paragraph (m) of
must meet the remaining two non- this section must meet three of the five
excluded objectives from such para- nonexcluded objectives from such para-
graph to meet the definition of a mean- graph to meet the definition of a mean-
ingful EHR user. ingful EHR user.
(3) Flexible options for using certified (3) Flexible options for using certified
EHR technology in 2014. For an EHR re- EHR technology in 2014. For an EHR re-
porting period in 2014, if an EP is porting period in 2014, if an eligible
scheduled to begin Stage 2 in 2014, but hospital or CAH is scheduled to begin
is unable to fully implement all the Stage 2 in 2014, but is unable to fully
functions of 2014 Edition certified EHR implement all the functions of 2014
technology required for the objectives Edition certified EHR technology re-
and associated measures of the Stage 2 quired for the objectives and associated
criteria due to delays in availability, measures of the Stage 2 criteria due to
the EP may choose to satisfy the objec- delays in availability, the eligible hos-
tives and associated measures of the pital or CAH may choose to satisfy the
Stage 1 criteria that are applicable be- objectives and associated measures of
ginning 2014 using 2014 Edition certified the Stage 1 criteria that are applicable
EHR technology. beginning 2014 using 2014 Edition cer-
(i) Stage 2 criteria for eligible hospitals tified EHR technology.
and CAHs—(1) General rule regarding (j) Stage 2 core criteria for EPs. An EP
Stage 2 criteria for meaningful use for eli- must satisfy the following objectives
gible hospitals or CAHs. Except as speci- and associated measures, except those
fied in paragraph (i)(2) of this section, objectives and associated measures for
eligible hospitals and CAHs must meet which an EP qualifies for an exclusion
all objectives and associated measures under paragraph (h)(2) of this section
of the Stage 2 criteria specified in specified in this paragraph (j).
paragraph (l) of this section and three (1)(i) Objective. Use computerized pro-
objectives of the eligible hospital’s or vider order entry for medication, lab-
CAH’s choice from paragraph (m) of oratory, and radiology orders directly
this section to meet the definition of a entered by any licensed healthcare pro-
meaningful EHR user. fessional who can enter orders into the
(2) Exclusions for nonapplicable objec- medical record per State, local, and
tives. (i) An eligible hospital or CAH professional guidelines.
may exclude a particular objective (ii) Measures. Subject to paragraph
that includes an option for exclusion (c) of this section—
contained in paragraphs (l) or (m) of (A) More than 60 percent of medica-
this section, if the hospital meets all of tion orders created by the EP during
the following requirements: the EHR reporting period are recorded
861
§ 495.20 42 CFR Ch. IV (10–1–24 Edition)
using computerized provider order mographics recorded as structured

entry; data.
(B) More than 30 percent of labora- (4)(i) Objective. Record and chart
tory orders created by the EP during changes in the following vital signs:
the EHR reporting period are recorded (A) Height/Length.
using computerized provider order (B) Weight.
entry; and (C) Blood pressure (ages 3 and over).
(C) More than 30 percent of radiology (D) Calculate and display body mass
orders created by the EP during the index (BMI).
EHR reporting period are recorded (E) Plot and display growth charts
using computerized provider order for patients 0–20 years, including body
entry. mass index.
(iii) Exclusions in accordance with (ii) Measure. Subject to paragraph (c)
paragraph (h)(2) of this section. (A) For of this section, more than 80 percent of
the measure specified in paragraph all unique patients seen by the EP dur-
(j)(1)(ii)(A) of this section, any EP who ing the EHR reporting period have
writes fewer than 100 medication orders blood pressure (for patients age 3 and
during the EHR reporting period. over only) and height/length and
(B) For the measure specified in weight (for all ages) recorded as struc-
paragraph (j)(1)(ii)(B) of this section, tured data.
any EP who writes fewer than 100 lab- (iii) Exclusion in accordance with para-
oratory orders during the EHR report- graph (h)(2) of this section. Any EP
ing period. who—
(C) For the measure specified in para- (A) Sees no patients 3 years or older
graph (j)(1)(ii)(C), any EP who writes is excluded from recording blood pres-
fewer than 100 radiology orders during sure;
the EHR reporting period. (B) Believes that all three vital signs
(2)(i) Objective. Generate and trans- of height/length, weight, and blood
mit permissible prescriptions elec- pressure have no relevance to their
tronically (eRx). scope of practice is excluded from re-
(ii) Measure. Subject to paragraph (c) cording them;
of this section, more than 50 percent of (C) Believes that height/length and
all permissible prescriptions, or all pre- weight are relevant to their scope of
scriptions, written by the EP are practice, but blood pressure is not, is
queried for a drug formulary and trans- excluded from recording blood pres-
mitted electronically using Certified sure; or
EHR Technology. (D) Believes that blood pressure is
(iii) Exclusion in accordance with para- relevant to their scope of practice, but
graph (h)(2) of this section. Any EP height/length and weight are not, is ex-
who— cluded from recording height/length
(A) Writes fewer than 100 permissible and weight.
prescriptions during the EHR reporting (5)(i) Objective. Record smoking sta-
period; or (B) Does not have a phar- tus for patients 13 years old or older.
macy within their organization and (ii) Measure. Subject to paragraph (c)
there are no pharmacies that accept of this section, more than 80 percent of
electronic prescriptions within 10 miles all unique patients 13 years old or older
of the EP’s practice location at the seen by the EP during the EHR report-
start of his or her EHR reporting pe- ing period have smoking status re-
riod. corded as structured data.
(3)(i) Objective. Record all of the fol- (iii) Exclusion in accordance with para-
lowing demographics: graph (h)(2) of this section. Any EP who
(A) Preferred language. sees no patients 13 years old or older.
(B) Sex. (6)(i) Objective. Use clinical decision
(C) Race. support to improve performance on
(D) Ethnicity. high priority health conditions.
(E) Date of birth. (ii) Measures. (A) Implement five clin-
(ii) Measure. More than 80 percent of ical decision support interventions re-
all unique patients seen by the EP dur- lated to four or more clinical quality
ing the EHR reporting period have de- measures at a relevant point in patient
862
care for the entire EHR reporting pe- (10)(i) Objective. Provide patients the
riod. Absent four clinical quality meas- ability to view online, download, and
ures related to an EP’s scope of prac- transmit their health information
tice or patient population, the clinical within 4 business days of the informa-
decision support interventions must be tion being available to the EP.
related to high-priority health condi- (ii) Measures. (A) More than 50 per-
tions; and cent of all unique patients seen by the
(B) The EP has enabled and imple- EP during the EHR reporting period
mented the functionality for drug-drug are provided timely (available to the
and drug-allergy interaction checks for patient within 4 business days after the
the entire EHR reporting period. information is available to the EP) on-
(iii) Exclusion in accordance with para- line access to their health information
graph (h)(2) of this section for paragraph subject to the EP’s discretion to with-
(j)(6)(ii)(B) of this section. An EP who hold certain information; and
writes fewer than 100 medication orders (B) More than 5 percent of all unique
during the EHR reporting period. patients seen by the EP during the
(7)(i) Objective. Incorporate clinical EHR reporting period (or their author-
lab test results into Certified EHR ized representatives) view, download or
Technology as structured data. transmit to a third party their health
(ii) Measure. Subject to paragraph (c) information.
of this section, more than 55 percent of (iii) Exclusion in accordance with para-
all clinical lab tests results ordered by graph (h)(2) of this section. Any EP
the EP during the EHR reporting pe- who—
riod whose results are either in a posi- (A) Neither orders nor creates any of
tive/negative affirmation or numerical the information listed for inclusion as
format are incorporated in Certified part of the measures in paragraphs
EHR Technology as structured data. (j)(10)(ii)(A) and (B) of this section, ex-
(iii) Exclusion in accordance with para- cept for ‘‘Patient name’’ and ‘‘Pro-
graph (h)(2) of this section. Any EP who vider’s name and office contact infor-
orders no lab tests whose results are ei- mation,’’ is excluded from both para-
ther in a positive/negative affirmation graphs (j)(10)(ii)(A) and (B) of this sec-
or numerical format during the EHR tion; or
reporting period. (B) Conducts 50 percent or more of
(8)(i) Objective. Generate lists of pa- his or her patient encounters in a coun-
tients by specific conditions to use for ty that does not have 50 percent or
quality improvement, reduction of dis- more of its housing units with 3Mbps
parities, research, or outreach. broadband availability according to
(ii) Measure. Generate at least one re- the latest information available from
port listing patients of the EP with a the FCC on the first day of the EHR re-
specific condition. porting period is excluded from para-
(9)(i) Objective. Use clinically rel- graph (j)(10)(ii)(B) of this section.
evant information to identify patients (11)(i) Objective. Provide clinical sum-
who should receive reminders for pre- maries for patients for each office
ventive/follow-up care and send these visit.
patients the reminder, per patient pref- (ii) Measure. Subject to paragraph (c)
erence. of this section, clinical summaries pro-
(ii) Measure. Subject to paragraph (c) vided to patients or patient-authorized
of this section, more than 10 percent of representatives within 1 business day
all unique patients who have had two for more than 50 percent of office vis-
or more office visits with the EP with- its.
in the 24 months before the beginning (iii) Exclusion in accordance with para-
of the EHR reporting period were sent graph (h)(2) of this section. Any EP who
a reminder, per patient preference has no office visits during the EHR re-
when available. porting period.
(iii) Exclusion in accordance with para- (12)(i) Objective. Use clinically rel-
graph (h)(2) of this section. Any EP who evant information from Certified EHR
has had no office visits in the 24 Technology to identify patient-specific
months before the beginning of the education resources and provide those
EHR reporting period. resources to the patient.
863
§ 495.20 42 CFR Ch. IV (10–1–24 Edition)
(ii) Measure. Patient-specific edu- (C) Subject to paragraph (c) of this

cation resources identified by Certified section an EP must satisfy one of the
EHR Technology are provided to pa- following:
tients for more than 10 percent of all (1) Conducts one or more successful
unique patients with office visits seen electronic exchanges of a summary of
by the EP during the EHR reporting care record meeting the measure speci-
period. fied in paragraph (j)(14)(ii)(B) of this
(iii) Exclusion in accordance with para- section with a beneficiary using tech-
graph (h)(2) of this section. Any EP who nology to receive the summary of care
has no office visits during the EHR re- record that was designed by a different
porting period. EHR developer than the sender’s EHR
(13)(i) Objective. The EP who receives technology certified at 45 CFR
a patient from another setting of care 170.314(b)(2); or
or provider of care or believes an en- (2) Conducts one or more successful
counter is relevant should perform tests with the CMS designated test
medication reconciliation. EHR during the EHR reporting period.
(ii) Measure. Subject to paragraph (c) (iii) Exclusion in accordance with para-
of this section, the EP performs medi- graph (h)(2) of this section. Any EP who
cation reconciliation for more than 50 transfers a patient to another setting
or refers a patient to another provider
percent of transitions of care in which
less than 100 times during the EHR re-
the patient is transitioned into the
porting period.
care of the EP.
(15)(i) Objective. Capability to submit
(iii) Exclusion in accordance with para- electronic data to immunization reg-
graph (h)(2) of this section. Any EP who istries or immunization information
was not the beneficiary of any transi- systems except where prohibited, and
tions of care during the EHR reporting in accordance with applicable law and
period. practice.
(14)(i) Objective. The EP who transi- (ii) Measure. Successful ongoing sub-
tions their patient to another setting mission of electronic immunization
of care or provider of care or refers data from Certified EHR Technology to
their patient to another provider of an immunization registry or immuni-
care provides a summary care record zation information system for the en-
for each transition of care or referral. tire EHR reporting period.
(ii) Measures. (A) Subject to para- (iii) Exclusion in accordance with para-
graph (c) of this section, the EP that graph (h)(2) of this section. Any EP that
transitions or refers their patient to meets one or more of the following cri-
another setting of care or provider of teria:
care provides a summary of care record (A) Does not administer any of the
for more than 50 percent of transitions immunizations to any of the popu-
of care and referrals; lations for which data is collected by
(B) Subject to paragraph (c) of this their jurisdiction’s immunization reg-
section, the EP that transitions or re- istry or immunization information sys-
fers their patient to another setting of tem during the EHR reporting period.
care or provider of care provides a sum- (B) Operates in a jurisdiction for
mary of care record for more than 10 which no immunization registry or im-
percent of such transitions and refer- munization information system is ca-
rals either— pable of accepting the specific stand-
(1) Electronically transmitted using ards required for Certified EHR Tech-
Certified EHR Technology to a bene- nology at the start of his or her EHR
ficiary; or reporting period.
(2) Where the beneficiary receives the (C) Operates in a jurisdiction where
summary of care record via exchange no immunization registry or immuni-
facilitated by an organization that is a zation information system provides in-
NwHIN Exchange participant or in a formation timely on capability to re-
manner that is consistent with the ceive immunization data.
governance mechanism ONC estab- (D) Operates in a jurisdiction for
lishes for the nationwide health infor- which no immunization registry or im-
mation network, and munization information system that is
864
capable of accepting the specific stand- (ii) Measure. Subject to paragraph (c)
ards required by Certified EHR Tech- of this section, more than 10 percent of
nology at the start of his or her EHR all tests whose result is one or more
reporting period can enroll additional images ordered by the EP during the
EPs. EHR reporting period are accessible
(16)(i) Objective. Protect electronic through Certified EHR Technology.
health information created or main- (iii) Exclusion in accordance with para-
tained by the Certified EHR Tech- graph (h)(2) of this section. Any EP who
nology through the implementation of meets one or more of the following cri-
appropriate technical capabilities. teria.
(ii) Measure. Conduct or review a se- (A) Orders less than 100 tests whose
curity risk analysis in accordance with result is an image during the EHR re-
the requirements under 45 CFR porting period.
164.308(a)(1), including addressing the (B) Has no access to electronic imag-
encryption/security of data stored in ing results at the start of the EHR re-
Certified EHR Technology in accord- porting period.
ance with requirements under 45 CFR (2)(i) Objective. Record patient family
164.312(a)(2)(iv) and 45 CFR 164.306(d)(3), health history as structured data.
and implement security updates as nec- (ii) Measure. More than 20 percent of
essary and correct identified security all unique patients seen by the EP dur-
deficiencies as part of the EP’s risk ing the EHR reporting period have a
management process. structured data entry for one or more
(17)(i) Objective. Use secure electronic first-degree relatives.
messaging to communicate with pa-
tients on relevant health information.
graph (h)(2) of this section. Any EP who
(ii) Measure. A secure message was
has no office visits during the EHR re-
sent using the electronic messaging
porting period.
function of Certified EHR Technology
(3)(i) Objective. Capability to submit
by more than 5 percent of unique pa-
electronic syndromic surveillance data
tients (or their authorized representa-
to public health agencies, except where
tives) seen by the EP during the EHR
prohibited, and in accordance with ap-
reporting period.
plicable law and practice.
graph (h)(2) of this section. Any EP who (ii) Measure. Successful ongoing sub-
meets one or more of the following cri- mission of electronic syndromic sur-
teria: veillance data from Certified EHR
(A) Has no office visits during the Technology to a public health agency
EHR reporting period. for the entire EHR reporting period.
(B) Who conducts 50 percent or more (iii) Exclusion in accordance with para-
of his or her patient encounters in a graph (h)(2) of this section. Any EP that
county that does not have 50 percent or meets one or more of the following cri-
more of its housing units with 3Mbps teria:
broadband availability according to (A) Is not in a category of providers
the latest information available from who collect ambulatory syndromic sur-
the FCC on the first day of their EHR veillance information on their patients
reporting period. during the EHR reporting period.
(k) Stage 2 menu set criteria for EPs. (B) Operates in a jurisdiction for
An EP must meet 3 of the following ob- which no public health agency is capa-
jectives and associated measures, un- ble of receiving electronic syndromic
less the EP has an exclusion from 4 or surveillance data in the specific stand-
more objectives in this paragraph (k) ards required for Certified EHR Tech-
of this section, in which case the EP nology at the start of their EHR re-
must meet all remaining objectives porting period.
and associated measures. (C) Operates in a jurisdiction where
(1)(i) Objective. Imaging results con- no public health agency provides infor-
sisting of the image itself and any ex- mation timely on capability to receive
planation or other accompanying infor- syndromic surveillance data.
mation are accessible through Certified (D) Operates in a jurisdiction for
EHR Technology. which no public health agency that is
865
§ 495.20 42 CFR Ch. IV (10–1–24 Edition)
capable of accepting the specific stand- EP is eligible, or the public health

ards required by Certified EHR Tech- agencies in their jurisdiction;
nology at the start of their EHR re- (B) Operates in a jurisdiction for
porting period can enroll additional which no specialized registry sponsored
EPs. by a public health agency or by a na-
(4)(i) Objective. Capability to identify tional specialty society for which the
and report cancer cases to a public EP is eligible is capable of receiving
health central cancer registry, except electronic specific case information in
where prohibited, and in accordance the specific standards required by Cer-
with applicable law and practice. tified EHR Technology at the begin-
(ii) Measure. Successful ongoing sub- ning of their EHR reporting period;
mission of cancer case information (C) Operates in a jurisdiction where
from Certified EHR Technology to a no public health agency or national
public health central cancer registry specialty society for which the EP is
for the entire EHR reporting period. eligible provides information timely on
(iii) Exclusion in accordance with para- capability to receive information into
graph (h)(2) of this section. Any EP who their specialized registries; or
meets one or more of the following— (D) Operates in a jurisdiction for
(A) Does not diagnose or directly which no specialized registry sponsored
treat cancer. by a public health agency or by a na-
tional specialty society for which the
(B) Operates in a jurisdiction for
EP is eligible that is capable of receiv-
which no public health agency is capa-
ing electronic specific case information
ble of receiving electronic cancer case
in the specific standards required by
information in the specific standards
Certified EHR Technology at the begin-
required for Certified EHR Technology
ning of his or her EHR reporting period
at the start of their EHR reporting pe-
can enroll additional EPs.
riod.
(6)(i) Objective. Record electronic
(C) Operates in a jurisdiction where notes in patient records.
no public health agency provides infor- (ii) Measure. Enter at least one elec-
mation timely on capability to receive tronic progress note created, edited,
electronic cancer case information. and signed by an EP for more than 30
(D) Operates in a jurisdiction for percent of unique patients with at least
which no public health agency that is one office visit during the EHR report-
capable of receiving electronic cancer ing period. The text of the electronic
case information in the specific stand- note must be text-searchable and may
ards required for Certified EHR Tech- contain drawings and other content.
nology at the beginning of their EHR (l) Stage 2 core criteria for eligible hos-
reporting period can enroll additional pitals or CAHs. An eligible hospital or
EPs. CAH must meet the following objec-
(5)(i) Objective. Capability to identify tives and associated measures except
and report specific cases to a special- those objectives and associated meas-
ized registry (other than a cancer reg- ures for which an eligible hospital or
istry), except where prohibited, and in CAH qualifies for an exclusion under
accordance with applicable law and paragraph (i)(2) of this section.
practice. (1)(i) Objective. Use computerized pro-
(ii) Measure. Successful ongoing sub- vider order entry for medication, lab-
mission of specific case information oratory, and radiology orders directly
from Certified EHR Technology to a entered by any licensed healthcare pro-
specialized registry for the entire EHR fessional who can enter orders into the
reporting period. medical record per State, local, and
(iii) Exclusion in accordance with paraprofessional guidelines.
graph (h)(2) of this section. Any EP who (ii) Measures. Subject to paragraph
meets one or more of the following cri- (c) of this section, more than—
teria: (A) Sixty percent of medication or-
(A) Does not diagnose or directly ders created by authorized providers of
treat any disease associated with a spe- the eligible hospital’s or CAH’s inpa-
cialized registry sponsored by a na- tient or emergency department (POS 21
tional specialty society for which the or 23) during the EHR reporting period
866
are recorded using computerized pro- CAH’s inpatient or emergency depart-

vider order entry, ment (POS 21 or 23) during the EHR re-
(B) Thirty percent of laboratory or- porting period have smoking status re-
ders created by authorized providers of corded as structured data.
the eligible hospital’s or CAH’s inpa- (iii) Exclusion in accordance with para-
tient or emergency department (POS 21 graph (i)(2) of this section. Any eligible
or 23) during the EHR reporting period hospital or CAH that admits no pa-
are recorded using computerized pro- tients 13 years old or older to their in-
vider order entry, and patient or emergency department (POS
(C) Thirty percent of radiology orders 21 or 23) during the EHR reporting pe-
created by authorized providers of the
riod.
eligible hospital’s or CAH’s inpatient
or emergency department (POS 21 or (5)(i) Objective. Use clinical decision
23) during the EHR reporting period are support to improve performance on
recorded using computerized provider high priority health conditions.
order entry. (ii) Measures. (A) Implement five clin-
(2)(i) Objective. Record all of the fol- ical decision support interventions re-
lowing demographics: lated to four or more clinical quality
(A) Preferred language. measures at a relevant point in patient
(B) Sex. care for the entire EHR reporting pe-
(C) Race. riod. Absent four clinical quality meas-
(D) Ethnicity. ures related to an eligible hospital or
(E) Date of birth. CAH’s patient population, the clinical
(F) Date and preliminary cause of decision support interventions must be
death in the event of mortality in the related to high-priority health condi-
eligible hospital or CAH. tions; and
(ii) Measure. More than 80 percent of (B) The eligible hospital or CAH has
all unique patients admitted to the eli- enabled and implemented the
gible hospital’s or CAH’s inpatient or functionality for drug-drug and drug-
emergency department (POS 21 or 23) allergy interaction checks for the en-
during the EHR reporting period have
tire EHR reporting period.
demographics recorded as structured
data. (6)(i) Objective. Incorporate clinical
(3)(i) Objective. Record and chart lab test results into Certified EHR
changes in the following vital signs: Technology as structured data.
(A) Height/Length. (ii) Measure. Subject to paragraph (c)
(B) Weight. of this section, more than 55 percent of
(C) Blood pressure (ages 3 and over). all clinical lab tests results ordered by
(D) Calculate and display body mass authorized providers of the eligible
index (BMI). hospital or CAH for patients admitted
(E) Plot and display growth charts to its inpatient or emergency depart-
for patients 0–20 years, including body ment (POS 21 or 23) during the EHR re-
mass index. porting period whose results are either
(ii) Measure. Subject to paragraph (c) in a positive/negative affirmation or
of this section, more than 80 percent of numerical format are incorporated in
all unique patients admitted to the eli- Certified EHR Technology as struc-
gible hospital’s or CAH’s inpatient or tured data.
emergency department (POS 21 or 23) (7)(i) Objective. Generate lists of pa-
during the EHR reporting period have tients by specific conditions to use for
blood pressure (for patients age 3 and quality improvement, reduction of dis-
over only) and height/length and parities, research or outreach.
weight (for all ages) recorded as struc-
(ii) Measure. Generate at least one re-
tured data.
(4)(i) Objective. Record smoking sta- port listing patients of the eligible hos-
tus for patients 13 years old or older. pital or CAH with a specific condition.
(ii) Measure. Subject to paragraph (c) (8)(i) Objective. Provide patients the
of this section, more than 80 percent of ability to view online, download, and
all unique patients 13 years old or older transmit information about a hospital
admitted to the eligible hospital’s or admission.
867
§ 495.20 42 CFR Ch. IV (10–1–24 Edition)
(ii) Measures. (A) More than 50 per- (ii) Measures. (A) Subject to para-
cent of all unique patients who are dis- graph (c) in this section, the eligible
charged from the inpatient or emer- hospital or CAH that transitions or re-
gency department (POS 21 or 23) of an fers their patient to another setting of
eligible hospital or CAH have their in- care or provider of care provides a sum-
formation available online within 36 mary of care record for more than 50
hours of discharge; and percent of transitions of care and refer-
(B) More than 5 percent of all unique rals,
patients who are discharged from the (B) Subject to paragraph (c) in this
inpatient or emergency department section, the eligible hospital or CAH
(POS 21 or 23) of an eligible hospital or that transitions their patient to an-
CAH (or their authorized representa- other setting of care or provider of care
tive) view, download or transmit to a provides a summary of care record for
third party their information during more than 10 percent of such transi-
the EHR reporting period. tions and referrals either—
(iii) Exclusion in accordance with para- (1) Electronically transmitted using
graph (i)(2) of this section. Any eligible Certified EHR Technology to a bene-
hospital or CAH that is located in a ficiary; or
county that does not have 50 percent or (2) Where the beneficiary receives the
more of its housing units with 3Mbps summary of care record via exchange
broadband availability according to facilitated by an organization that is a
the latest information available from NwHIN Exchange participant or in a
the FCC on the first day of the EHR re- manner that is consistent with the
porting period is excluded from para- governance mechanism ONC estab-
graph (l)(8)(ii)(B) of this section. lishes for the nationwide health infor-
(9)(i) Objective. Use clinically rel- mation network; and
evant information from Certified EHR (C) Subject to paragraph (c) of this
Technology to identify patient-specific section an eligible hospital or CAH
education resources and provide those must satisfy one of the following:
resources to the patient. (1) Conducts one or more successful
(ii) Measure. More than 10 percent of electronic exchanges of a summary of
all unique patients admitted to the eli- care record meeting the measure speci-
gible hospital’s or CAH’s inpatient or fied in paragraph (l)(11)(ii)(B) of this
emergency department (POS 21 or 23) section with a beneficiary using tech-
are provided patient-specific education nology to receive the summary of care
resources identified by Certified EHR record that was designed by a different
Technology. EHR developer than the sender’s EHR
(10)(i) Objective. The eligible hospital technology certified at 45 CFR
or CAH that receives a patient from 170.314(b)(2); or
another setting of care or provider of (2) Conducts one or more successful
care or believes an encounter is rel- tests with the CMS designated test
evant should perform medication rec- EHR during the EHR reporting period.
onciliation. (12)(i) Objective. Capability to submit
(ii) Measure. Subject to paragraph (c) electronic data to immunization reg-
of this section, the eligible hospital or istries or immunization information
CAH performs medication reconcili- systems except where prohibited, and
ation for more than 50 percent of tran- in accordance with applicable law and
sitions of care in which the patient is practice.
admitted to the eligible hospital’s or (ii) Measure. Successful ongoing sub-
CAH’s inpatient or emergency depart- mission of electronic immunization
ment (POS 21 or 23). data from Certified EHR Technology to
(11)(i) Objective. The eligible hospital an immunization registry or immuni-
or CAH that transitions their patient zation information system for the en-
to another setting of care or provider tire EHR reporting period.
of care or refers their patient to an- (iii) Exclusion in accordance with para-
other provider of care provides a sum- graph (i)(2) of this section. Any eligible
mary care record for each transition of hospital or CAH that meets one or
care or referral. more of the following criteria:
868
(A) The eligible hospital or CAH does nology at the start of their EHR re-
not administer any of the immuniza- porting period can enroll additional el-
tions to any of the populations for igible hospitals or CAHs.
which data is collected by their juris- (14)(i) Objective. Capability to submit
diction’s immunization registry or im- electronic syndromic surveillance data
munization information system during to public health agencies, except where
the EHR reporting period. prohibited, and in accordance with ap-
(B) The eligible hospital or CAH op- plicable law and practice.
erates in a jurisdiction for which no (ii) Measure. Successful ongoing sub-
immunization registry or immuniza- mission of electronic syndromic sur-
tion information system is capable of veillance data from Certified EHR
accepting the specific standards re- Technology to a public health agency
quired for Certified EHR Technology at for the entire EHR reporting period.
the start of their EHR reporting pe- (iii) Exclusion in accordance with para-
riod. graph (i)(2) of this section. Any eligible
(C) The eligible hospital or CAH oper- hospital or CAH that meets one or
ates in a jurisdiction where no immuni- more of the following criteria:
zation registry or immunization infor- (A) Does not have an emergency or
mation system provides information urgent care department.
timely on capability to receive immu- (B) Operates in a jurisdiction for
nization data. which no public health agency is capa-
(D) Operates in a jurisdiction for ble of receiving electronic syndromic
which no immunization registry or im- surveillance data in the specific stand-
munization information system that is ards required for Certified EHR Tech-
capable of accepting the specific stand- nology at the start of their EHR re-
ards required by Certified EHR Tech- porting period or can enroll additional
nology at the start of their EHR re- eligible hospitals or CAHs.
porting period can enroll additional el- (C) Operates in a jurisdiction for
igible hospitals or CAHs. which no public health agency provides
(13)(i) Objective. Capability to submit information timely on capability to re-
electronic reportable laboratory receive syndromic surveillance data.
sults to public health agencies, where (D) Operates in a jurisdiction for
except where prohibited, and in accord- which no public health agency that is
ance with applicable law and practice. capable of accepting the specific stand-
(ii) Measure. Successful ongoing sub- ards required by Certified EHR Tech-
mission of electronic reportable labora- nology at the start of their EHR re-
tory results from Certified EHR Tech- porting period can enroll additional el-
nology to a public health agency for igible hospitals or CAHs.
the entire EHR reporting period. (15)(i) Objective. Protect electronic
(iii) Exclusion in accordance with para- health information created or main-
graph (i)(2) of this section. Any eligible tained by the Certified EHR Tech-
hospital or CAH that meets one or nology through the implementation of
more of the following criteria: appropriate technical capabilities.
(A) Operates in a jurisdiction for (ii) Measure. Conduct or review a se-
which no public health agency is capa- curity risk analysis in accordance with
ble of receiving electronic reportable the requirements under 45 CFR
laboratory results in the specific stand- 164.308(a)(1), including addressing the
ards required for Certified EHR Tech- encryption/security of data stored in
nology at the start of their EHR re- Certified EHR Technology in accord-
porting period. ance with requirements under 45 CFR
(B) Operates in a jurisdiction for 164.312(a)(2)(iv) and 45 CFR 164.306(d)(3),
which no public health agency provides and implement security updates as nec-
information timely on capability to re- essary and correct identified security
ceive electronic reportable laboratory deficiencies as part of the eligible hos-
results. pital’s or CAH’s risk management proc-
(C) Operates in a jurisdiction for ess.
which no public health agency that is (16)(i) Objective. Automatically track
capable of accepting the specific stand- medications from order to administra-
ards required by Certified EHR Tech- tion using assistive technologies in
869
§ 495.22 42 CFR Ch. IV (10–1–24 Edition)
conjunction with an electronic medica- (4)(i) Objective. Generate and trans-

tion administration record (eMAR). mit permissible discharge prescriptions
(ii) Measure. Subject to paragraph (c) electronically (eRx).
of this section, more than 10 percent of (ii) Measure. Subject to paragraph (c)
medication orders created by author- of this section, more than 10 percent of
ized providers of the eligible hospital’s hospital discharge medication orders
or CAH’s inpatient or emergency de- for permissible prescriptions (for new,
partment (POS 21 or 23) during the changed and refilled prescriptions) are
EHR reporting period for which all queried for a drug formulary and trans-
doses are tracked using eMAR. mitted electronically using Certified
(iii) Exclusion in accordance with para- EHR Technology.
graph (i)(2) of this section. Any eligible (iii) Exclusion in accordance with para-
hospital or CAH with an average daily graph (i)(2) of this section. Any eligible
inpatient census of fewer than 10 pa- hospital or CAH that does not have an
tients. internal pharmacy that can accept
(m) Stage 2 menu set criteria for eligible electronic prescriptions and there are
hospitals or CAHs. An eligible hospital no pharmacies that accept electronic
or CAH must meet the measure criteria prescriptions within 10 miles at the
for three of the following objectives start of its EHR reporting period.
and associated measures. (5)(i) Objective. Record electronic
(1)(i) Objective. Record whether a pa-
notes in patient records.
tient 65 years old or older has an ad-
(ii) Measure: Enter at least one elec-
vance directive.
tronic progress note created, edited
(ii) Measure. Subject to paragraph (c)
of this section, more than 50 percent of and signed by an authorized provider of
all unique patients 65 years old or older the eligible hospital’s or CAH’s inpa-
admitted to the eligible hospital’s or tient or emergency department (POS 21
CAH’s inpatient department (POS 21) or 23) for more than 30 percent of
during the EHR reporting period have unique patients admitted to the eligi-
an indication of an advance directive ble hospital or CAH’s inpatient or
status recorded as structured data. emergency department during the EHR
(iii) Exclusion in accordance with para- reporting period. The text of the elec-
graph (i)(2) of this section. Any eligible tronic note must be text-searchable
hospital or CAH that admits no pa- and may contain drawings and other
tients age 65 years old or older during content.
the EHR reporting period. (6)(i) Objective. Provide structured
(2)(i) Objective. Imaging results con- electronic lab results to ambulatory
sisting of the image itself and any ex- providers.
planation or other accompanying infor- (ii) Measures. Hospital labs send
mation are accessible through Certified structured electronic clinical lab re-
EHR Technology. sults to the ordering provider for more
(ii) Measure. Subject to paragraph (c) than 20 percent of—
of this section, more than 10 percent of (A) The electronic lab orders re-
all tests whose result is an image or- ceived; or
dered by an authorized provider of the (B) The lab orders received.
eligible hospital or CAH for patients
admitted to its inpatient or emergency FR 81887, Dec. 29, 2010; 77 FR 54149, Sept. 4,
department (POS 21 or 23) during the 2012; 77 FR 64758, Oct. 23, 2012; 77 FR 72991,
EHR reporting period are accessible Dec. 7, 2012; 79 FR 52932, Sept. 4, 2014. Redes-
through Certified EHR Technology. ignated and amended at 80 FR 62943, Oct. 16,
(3)(i) Objective. Record patient family 2015; 85 FR 59026, Sept. 18, 2020]
health history as structured data.
(ii) Measure. More than 20 percent of § 495.22 Meaningful use objectives and
all unique patients admitted to the eli- measures for EPs, eligible hospitals,
gible hospital or CAH’s inpatient or and CAHs for 2015 through 2018.
emergency department (POS 21 or 23) (a) General rules. (1) Subject to the
during the EHR reporting period have a provisions of paragraph (a)(2) of this
structured data entry for one or more section, the criteria specified in this
first-degree relatives. section are applicable for EPs, eligible
870
hospitals, and CAHs for 2015 through icaid EHR Incentive Program must
2018. meet all objectives and associated
(2) For 2017 and 2018, EPs, eligible measures of the meaningful use cri-
hospitals, and CAHs that have success- teria specified under paragraph (e) of
fully demonstrated meaningful use in a this section to meet the definition of a
prior year have the option to use the meaningful EHR user in 2015 through
criteria specified for 2019 in § 495.24 in- 2018.
stead of the criteria specified for 2017 (2) Exclusion for non-applicable objec-
and 2018 under paragraphs (e) and (f) of tives. (i) An eligible hospital or CAH
this section. may exclude a particular objective con-
(b) Criteria for EPs for 2015 through tained in paragraph (e) of this section,
2018—(1) General rule regarding criteria if the eligible hospital or CAH meets
for meaningful use for 2015 through 2018 all of the following requirements:
for EPs. Except as specified in para- (A) Must ensure that the objective in
graph (b)(2) of this section, EPs must paragraph (e) of this section includes
meet all objectives and associated an option for the eligible hospital or
measures of the meaningful use cri- CAH to attest that the objective is not
teria specified under paragraph (e) of applicable.
this section to meet the definition of a (B) Meets the criteria in the applica-
meaningful EHR user. ble objective that would permit the at-
(2) Exclusion for non-applicable objec-
testation to the exclusion.
tives. (i) An EP may exclude a par-
(C) Attests.
ticular objective contained in para-
graph (e) of this section, if the EP (ii) An exclusion will reduce (by the
meets all of the following require- number of exclusions applicable) the
ments: number of objectives that would other-
(A) Must ensure that the objective in wise apply in paragraph (e) of this sec-
paragraph (e) of this section includes tion.
an option for the EP to attest that the (d) Many of the objectives and associ-
objective is not applicable. ated measures in paragraph (e) of this
(B) Meets the criteria in the applica- section rely on measures that count
ble objective that would permit the at- unique patients or actions. (1) If a meas-
testation to the exclusion. ure (or associated objective) in para-
(C) Attests. graph (e) or (f) of this section ref-
(ii) An exclusion will reduce (by the erences this paragraph (d), the measure
number of exclusions applicable) the may be calculated by reviewing only
number of objectives that would other- the actions for patients whose records
wise apply in paragraph (e) of this sec- are maintained using CEHRT. A pa-
tion. tient’s record is maintained using
(c) Criteria for eligible hospitals and CEHRT if sufficient data were entered
CAHs for 2015 through 2018—(1) General in the CEHRT to allow the record to be
rule regarding criteria for meaningful use saved, and not rejected due to incom-
for 2015 through 2018 for eligible hospitals plete data.
and CAHs. Except as specified in para- (2) If the objective and associated
graph (c)(2) of this section, eligible hos- measure does not reference this para-
pitals and CAHs attesting to CMS must graph (d) of this section, then the
meet all objectives and associated measure must be calculated by review-
measures of the meaningful use cri- ing all patient records, not just those
teria specified under paragraph (e) of maintained using CEHRT.
this section to meet the definition of a (e) Meaningful use objectives and meas-
meaningful EHR user in 2015 and 2016 ures for EPs for 2015 through 2018, for eli-
and must meet all objectives and asso- gible hospitals and CAHs attesting to CMS
ciated measures of the meaningful use for 2015 and 2016, and for eligible hos-
criteria specified under paragraph (f) of pitals and CAHs attesting to a State for
this section to meet the definition of a the Medicaid EHR Incentive Program for
meaningful EHR user in 2017 and 2018. 2015 through 2018.—(1) Protect patient
Except as specified in paragraph (c)(2) health information—(i) Objective. Pro-
of this section, eligible hospitals and tect electronic protected health infor-
CAHs attesting to a State for the Med- mation created or maintained by the
871
§ 495.22 42 CFR Ch. IV (10–1–24 Edition)
CEHRT through the implementation of and measure specified in paragraph

appropriate technical capabilities. (e)(2)(ii)(C)(1) and (2) in place of the
(ii) Measures—(A) EP measure. Con- measure outlined under paragraph
duct or review a security risk analysis (e)(2)(ii)(A)(1) of this section for an
in accordance with the requirements in EHR reporting period in 2015 only.
45 CFR 164.308(a)(1), including address- (1) Alternate objective. Implement one
ing the security (to include encryption) clinical decision support rule relevant
of ePHI created or maintained by to specialty or high clinical priority
CEHRT in accordance with require- along with the ability to track compli-
ments under 45 CFR 164.312(a)(2)(iv) and ance with that rule.
45 CFR 164.306(d)(3), and implement se- (2) Alternate measure. Implement one
curity updates as necessary and correct clinical decision support rule.
identified security deficiencies as part (iii) Eligible hospital and CAH meas-
of the EP’s risk management process. ures—(A) Measure. In order for eligible
(B) Eligible hospital or CAH measure. hospitals and CAHs to meet the objec-
Conduct or review a security risk anal- tive they must satisfy both of the fol-
ysis in accordance with the require- lowing measures:
ments under 45 CFR 164.308(a)(1), in-
(1) Implement five clinical decision
cluding Addressing the security (to in-
support interventions related to four or
clude encryption) of ePHI created or
more clinical quality measures at a
maintained in CEHRT in accordance
relevant point in patient care for the
with requirements under 45 CFR
entire EHR reporting period. Absent
164.312(a)(2)(iv) and 45 CFR 164.306(d)(3),
four clinical quality measures related
and implement security updates as nec-
to an eligible hospital or CAH’s scope
essary, and correct identified security
of practice or patient population, the
deficiencies as part of the eligible hos-
clinical decision support interventions
pital’s or CAH’s risk management proc-
must be related to high-priority health
ess.
conditions.
(2) Clinical decision support—(i) Objec-
(2) Enabled and implemented the
tive. Use clinical decision support to
functionality for drug-drug and drug-
improve performance on high-priority
allergy interaction checks for the en-
health conditions.
tire EHR reporting period.
(ii) EP measures—(A) Measure. In
order for EPs to meet the objective (B) Alternate specifications. An eligible
they must satisfy both of the following hospital or CAH previously scheduled
measures: to be in Stage 1 in 2015 may meet an al-
(1) Implement five clinical decision ternate measure described in paragraph
support interventions related to four or (e)(2)(iii)(B)(2) of this section in place
more clinical quality measures at a of the measure described in paragraph
relevant point in patient care for the (e)(2)(iii)(A)(1) of this section for an
entire EHR reporting period. Absent EHR reporting period in 2015.
four clinical quality measures related (1) Alternate objective. Implement one
to an EP’s scope of practice or patient clinical decision support rule relevant
population, the clinical decision sup- to a high priority hospital condition
port interventions must be related to along with the ability to track compli-
high-priority health conditions. ance with that rule.
(2) Enabled and implemented the (2) Alternate measure. Implement one
functionality for drug-drug and drug- clinical decision support rule.
allergy interaction checks for the en- (3) Computerized provider order entry—
tire EHR reporting period. (i) Objective. Use computerized provider
(B) Exclusion in accordance with para- order entry for medication, laboratory,
graph (b)(2) of this section. An EP who and radiology orders directly entered
writes fewer than 100 medication orders by any licensed healthcare professional
during the EHR reporting period may who can enter orders into the medical
be excluded from the measure under record per state, local, and professional
paragraph (e)(2)(i)(A)(2) of this section. guidelines.
(C) Alternate specifications. An EP pre- (ii) EP measures—(A) Measures. An EP
viously scheduled to be in Stage 1 in must meet the following 3 measures,
2015 may meet an alternate objective subject to paragraph (d) of this section:
872
(1) More than 60 percent of medica- (2) Alternate exclusions in 2015. An EP

tion orders created by the EP during scheduled to be in Stage 1 in 2015 may
the EHR reporting period are recorded exclude the measures specified in para-
using computerized provider order graphs (e)(3)(ii)(A)(2) and (e)(3)(ii)(A)(3)
entry. of this section in 2015.
(2) More than 30 percent of labora- (3) Alternate exclusions in 2016. An EP
tory orders created by the EP during scheduled to be in Stage 1 in 2016 may
the EHR reporting period are recorded exclude the measure specified in para-
using computerized provider order graphs (e)(3)(ii)(A)(2) and (e)(3)(ii)(A)(3)
entry. of this section in 2016.
(3) More than 30 percent of radiology (iii) Eligible hospital and CAH meas-
orders created by the EP during the ures. (A) An eligible hospital or CAH
EHR reporting period are recorded must meet the following 3 measures,
using computerized provider order subject to paragraph (d) of this section:
entry. (1) More than 60 percent of medica-
(B) Exclusion in accordance with para- tion orders created by authorized pro-
graph (b)(2) of this section. (1) For the viders of the eligible hospital’s or
measure specified in paragraph CAH’s inpatient or emergency depart-
(e)(3)(ii)(A)(1) of this section, any EP ment (POS 21 or 23) during the EHR re-
who writes fewer than 100 medication porting period are recorded using com-
orders during the EHR reporting pe-
puterized provider order entry.
riod.
(2) More than 30 percent of labora-
(2) For the measure specified in para-
tory orders created by authorized pro-
graph (e)(3)(ii)(A)(2) of this section, any
EP who writes fewer than 100 labora- viders of the eligible hospital’s or
tory orders during the EHR reporting CAH’s inpatient or emergency depart-
period. ment (POS 21 or 23) during the EHR re-
(3) For the measure specified in para- porting period are recorded using com-
graph (e)(3)(ii)(A)(3) of this section, any puterized provider order entry.
EP who writes fewer than 100 radiology (3) More than 30 percent of radiology
orders during the EHR reporting pe- orders created by authorized providers
riod. of the eligible hospital’s or CAH’s inpa-
(C) Alternate exclusions and specifica- tient or emergency department (POS 21
tions. An EP previously scheduled to be or 23) during the EHR reporting period
in Stage 1 in 2015 may meet an alter- are recorded using computerized pro-
nate measure (e)(3)(ii)(C)(1) in place of vider order entry.
the measure outlined under paragraph (B) Alternate exclusions and specifica-
(e)(3)(ii)(A)(1) of this section, and may tions. (1) An eligible hospital or CAH
exclude the measures outlined under previously scheduled to be in Stage 1 in
paragraphs (e)(3)(ii)(A)(2) and (3) of this 2015 may meet an alternate measure
section for an EHR reporting period in specified in paragraph (e)(3)(iii)(B)(2) of
2015. An EP previously scheduled to be this section in place of the measure
in Stage 1 in 2016 may exclude the outlined under paragraph
measures outlined under paragraphs (e)(3)(iii)(A)(1) of this section, and may
(e)(3)(ii)(A)(2) and (3) of this section for exclude the measures outlined under
an EHR reporting period in 2016. paragraphs (e)(3)(iii)(A)(2) and
(1) Alternate measure 1 in 2015. Subject (e)(3)(iii)(A)(3) of this section for an
to paragraph (d) of this section— EHR reporting period in 2015. An eligi-
(i) More than 30 percent of all unique ble hospital or CAH previously sched-
patients with at least one medication uled to be in Stage 1 in 2016 may ex-
in their medication list seen by the EP clude the measures outlined under
during the EHR reporting period have paragraphs (e)(3)(iii)(A)(2) and (3) of
at least one medication order entered this section for an EHR reporting pe-
using CPOE; or riod in 2016.
(ii) More than 30 percent of medica- (2) Alternate measure 1 in 2015. Subject
tion orders created by the EP during to paragraph (d) of this section—
the EHR reporting period are recorded (i) More than 30 percent of all unique
using computerized provider order patients with at least one medication
entry. in their medication list admitted to
873
§ 495.22 42 CFR Ch. IV (10–1–24 Edition)
the eligible hospital’s or CAH’s inpa- the EP are transmitted electronically

tient or emergency department (POS 21 using CEHRT.
or 23) have at least one medication (iii) Eligible hospital and CAH meas-
order entered using CPOE; or ure—(A) Measure. Subject to paragraph
(ii) More than 30 percent of medica- (d) of this section, more than 10 per-
tion orders created by the authorized cent of hospital discharge medication
providers of the eligible hospital or orders for permissible prescriptions are
CAH for patients admitted to their in- queried for a drug formulary and trans-
patient or emergency departments mitted electronically using CEHRT.
(POS 21 or 23) during the EHR report- (B) Exclusion in accordance with para-
ing period are recorded using comput- graph (c)(2) of this section. Any eligible
erized provider order entry. hospital or CAH that does not have an
(3) Alternate exclusions in 2015 and internal pharmacy that can accept
2016. An eligible hospital or CAH sched- electronic prescriptions and is not lo-
uled to be in Stage 1 in 2015 may ex- cated within 10 miles of any pharmacy
clude the following measures in 2015 that accepts electronic prescriptions at
and eligible hospital or CAH scheduled the start of their EHR reporting pe-
to be in Stage 1 in 2016 may exclude the riod.
following measures in 2016: (C) Alternate exclusions. (1) An eligible
(i) The measure specified in para- hospital or CAH previously scheduled
graph (e)(3)(iii)(A)(2) of this section. to be in—
(ii) The measure specified in para- (i) Stage 1 in 2015 may exclude the
graph (e)(3)(iii)(A)(3) of this section. measure specified in paragraph
(4) Electronic prescribing—(i) Objective. (e)(4)(iii)(A) of this section for an EHR
For EPs, generate and transmit per- reporting period in 2015; or
missible prescriptions electronically (ii) Stage 2 in 2015 may exclude the
(eRx); and, for eligible hospitals and measure specified in paragraph
CAHs, generate, and transmit permis- (e)(4)(iii)(A) of this section for an EHR
sible discharge prescriptions electroni- reporting period in 2015.
cally (eRx). (2) An eligible hospital or CAH pre-
(ii) EP measure—(A) Measure. Subject viously scheduled to be in—
to paragraph (d) of this section, more (i) Stage 1 in 2016, may exclude the
than 50 percent of all permissible pre- measure specified in paragraph
scriptions written by the EP are (e)(4)(iii)(A) of this section for an EHR
queried for a drug formulary and trans- reporting period in 2016; or
mitted electronically using CEHRT. (ii) Stage 2 in 2016, may exclude the
(B) Exclusion in accordance with para- measure specified in paragraph
graph (b)(2) of this section. Any EP (e)(4)(iii)(A) of this section for an EHR
who— reporting period in 2016.
(1) Writes fewer than 100 permissible (5) Health Information Exchange—(i)
prescriptions during the EHR reporting Objective. The EP, eligible hospital or
period; or CAH who transitions a patient to an-
(2) Does not have a pharmacy within other setting of care or provider of care
his or her organization and there are or refers a patient to another provider
no pharmacies that accept electronic of care provides a summary care record
prescriptions within 10 miles of the for each transition of care or referral.
EP’s practice location at the start of (ii) EP measure—(A) Measure. Subject
his or her EHR reporting period. to paragraph (d) of this section, the EP
(C) Alternate specification. In 2015 an who transitions or refers his or her pa-
EP— tient to another setting of care or pro-
(1) Previously scheduled to be in vider of care must do the following:
Stage 1 in 2015 may meet an alternate (1) Use CEHRT to create a summary
measure under paragraph (e)(4)(ii)(C)(2) of care record.
of this section in place of the measure (2) Electronically transmit such sum-
outlined under paragraph(e)(4)(ii)(A) of mary to a receiving provider for more
this section; and than 10 percent of transitions of care
(2) Subject to paragraph (d) of this and referrals.
section, more than 40 percent of all (B) Exclusion in accordance with para-
permissible prescriptions written by graph (b)(2) of this section. Any EP who
874
transfers a patient to another setting (e)(6)(iii)(A) of this section for an EHR

or refers a patient to another provider reporting period in 2015.
less than 100 times during the EHR re- (7) Medication reconciliation—(i) Objec-
porting period. tive. The EP, eligible hospital or CAH
(C) Alternate exclusion. An EP pre- that receives a patient from another
viously scheduled to be in Stage 1 in setting of care or provider of care or
2015 may exclude the measure specified believes an encounter is relevant per-
in paragraph (e)(5)(ii)(A) of this section forms medication reconciliation.
for an EHR reporting period in 2015. (ii) EP measure—(A) Measure. Subject
(iii) Eligible hospital and CAH meas- to paragraph (d) of this section, the EP
ure—(A) Measure. Subject to paragraph performs medication reconciliation for
(d) of this section, the eligible hospital more than 50 percent of transitions of
or CAH that transitions or refers its care in which the patient is
patient to another setting of care or transitioned into the care of the EP.
provider of care must do the following: (B) Exclusion in accordance with para-
(1) Use CEHRT to create a summary graph (b)(2) of this section. Any EP who
of care record. was not the recipient of any transi-
(2) Electronically transmit such sum- tions of care during the EHR reporting
mary to a receiving provider for more period.
than 10 percent of transitions of care (C) Alternate exclusion. An EP pre-
and referrals. viously scheduled to be in Stage 1 in
(B) Alternate exclusion. An eligible 2015 may exclude the measure specified
hospital or CAH previously scheduled in paragraph (e)(7)(ii)(A) of this section
to be in Stage 1 in 2015 may exclude the for an EHR reporting period in 2015.
measure specified in paragraph (iii) Eligible hospital or CAH measure.
(e)(5)(iii)(A) of this section for an EHR An eligible hospital or CAH must meet
reporting period in 2015. the following measure, subject to para-
(6) Patient specific education—(i) Ob- graph (d) of this section:
jective. Use clinically relevant informa- (A) Measure. Subject to paragraph (d)
tion from CEHRT to identify patient- of this section, the eligible hospital or
specific education resources and pro- CAH performs medication reconcili-
vide those resources to the patient. ation for more than 50 percent of tran-
(ii) EP measure—(A) Measure. Patient- sitions of care in which the patient is
specific education resources identified admitted to the eligible hospital’s or
by CEHRT are provided to patients for CAH’s inpatient or emergency depart-
more than 10 percent of all unique pa- ment (POS 21 or 23).
tients with office visits seen by the EP (B) Alternate exclusion. An eligible
during the EHR reporting period. hospital or CAH previously scheduled
(B) Exclusion in accordance with para- to be in Stage 1 in 2015 may exclude the
graph (b)(2) of this section. Any EP who measure specified in paragraph
has no office visits during the EHR re- (e)(7)(iii)(A) of this section for an EHR
porting period. reporting period in 2015.
(C) Alternate exclusion. An EP pre- (8) Patient electronic access—(i) EP ob-
viously scheduled to be in Stage 1 in jective. Provide patients the ability to
2015 may exclude the measure specified view online, download, and transmit
in paragraph (e)(6)(ii)(A) of this section their health information within 4 busi-
for an EHR reporting period in 2015. ness days of the information being
(iii) Eligible hospital and CAH meas- available to the EP.
ure—(A) Measure. More than 10 percent (A) EP measures. An EP must meet
of all unique patients admitted to the the following 2 measures:
eligible hospital’s or CAH’s inpatient (1) Measure 1: More than 50 percent of
or emergency department (POS 21 or all unique patients seen by the EP dur-
23) are provided patient-specific edu- ing the EHR reporting period are pro-
cation resources identified by CEHRT. vided timely access to view online,
(B) Alternate exclusion. An eligible download and transmit to a third party
hospital or CAH previously scheduled their health information subject to the
to be in Stage 1 in 2015 may exclude the EP’s discretion to withhold certain in-
measure specified in paragraph formation.
875
§ 495.22 42 CFR Ch. IV (10–1–24 Edition)
(2) Measure 2: For an EHR reporting (2) Measure 2. For an EHR reporting
period— period—
(i) In 2015 and 2016, at least 1 patient (i) In 2015 or 2016, at least 1 patient
seen by the EP during the EHR report- (or patient-authorized representative)
ing period (or patient-authorized rep- who is discharged from the inpatient or
resentative) views, downloads or trans- emergency department (POS 21 or 23)
mits his or her health information to a of an eligible hospital or CAH during
third party during the EHR reporting the EHR reporting period views,
period. downloads or transmits to a third
(ii) In 2017 and 2018, more than 5 per- party his or her information during the
cent of unique patients seen by the EP EHR reporting period; and
during the EHR reporting period (or (ii) In 2017 and 2018, more than 5 per-
their authorized representatives) cent of unique patients (or patient-au-
views, downloads or transmits their thorized representatives) discharged
health information to a third party from the inpatient or emergency de-
during the EHR reporting period. partment (POS 21 or POS 23) of an eli-
(B) Exclusion in accordance with para- gible hospital or CAH during the EHR
graph (b)(2) of this section—(1) Any EP reporting period view, download or
who neither orders nor creates any of transmit to a third party their health
information during the EHR reporting
the information listed for inclusion as
period.
part of the measure in paragraph
(B) Exclusion applicable under para-
(e)(8)(ii)(A)(1) or (2) of this section, ex-
graph (c)(2) of this section. Any eligible
cept for ‘‘Patient name’’ and ‘‘Pro-
hospital or CAH that is located in a
vider’s name and office contact infor-
county that does not have 50 percent or
mation,’’ is excluded from paragraphs
more of its housing units with 4Mbps
(e)(8)(ii)(A)(1) and (2) of this section.
broadband availability according to
(2) Any EP who conducts 50 percent the latest information available from
or more of his or her patient encoun- the FCC on the first day of the EHR re-
ters in a county that does not have 50 porting period is excluded from para-
percent or more of its housing units graph (e)(8)(iii)(A)(2) of this section.
with 4Mbps broadband availability ac- (C) Alternate exclusion. An eligible
cording to the latest information avail- hospital or CAH previously scheduled
able from the Federal Communications to be in Stage 1 in 2015 may exclude the
Commission on the first day of the measure specified in paragraph
EHR reporting period is excluded from (e)(8)(iii)(A)(2) of this section for an
paragraph (e)(8)(ii)(A)(2) of this sec- EHR reporting period in 2015.
tion. (9) Secure messaging—(i) EP objective.
(C) Alternate exclusion. An EP pre- Use secure electronic messaging to
viously scheduled to be in Stage 1 in communicate with patients on relevant
2015 may exclude the measure specified health information.
in paragraph (e)(8)(ii)(A)(2) of this sec- (ii) EP measure—(A) Measure. For an
tion for an EHR reporting period in EHR reporting period—
2015. (1) In 2015, the capability for patients
(ii) Eligible hospital and CAH objective. to send and receive a secure electronic
Provide patients the ability to view on- message with the EP was fully enabled
line, download, and transmit informa- during the EHR reporting period;
tion within 36 hours of hospital dis- (2) In 2016, for at least 1 patient seen
charge. by the EP during the EHR reporting
(A) Eligible hospital and CAH measures. period, a secure message was sent using
An eligible hospital or CAH must meet the electronic messaging function of
the following 2 measures: CEHRT to the patient (or the patient-
(1) Measure 1. More than 50 percent of authorized representative), or in re-
all unique patients who are discharged sponse to a secure message sent by the
from the inpatient or emergency de- patient (or the patient-authorized rep-
partment (POS 21 or 23) of an eligible resentative) during the EHR reporting
hospital or CAH have timely access to period; and
view online, download and transmit to (3) In 2017 and 2018, for more than 5
a third party their health information. percent of unique patients seen by the
876
EP during the EHR reporting period, a (C) Exclusions in accordance with para-
secure message was sent using the elec- graph (b)(2) of this section. (1) Any EP
tronic messaging function of CEHRT to meeting one or more of the following
the patient (or the patient-authorized criteria may be excluded from the im-
representative), or in response to a se- munization registry reporting measure
cure message sent by the patient (or in paragraph (e)(10)(i)(B)(1) of this sec-
the patient-authorized representative) tion if the EP:
during the EHR reporting period. (i) Does not administer any immuni-
(B) Exclusion in accordance with para- zations to any of the populations for
graph (b)(2) of this section. An EP may which data is collected by his or her ju-
exclude from the measure if he or she— risdiction’s immunization registry or
(1) Has no office visits during the immunization information system dur-
EHR reporting period; or ing the EHR reporting period.
(2) Conducts 50 percent or more of his (ii) Operates in a jurisdiction for
or her patient encounters in a county which no immunization registry or im-
that does not have 50 percent or more munization information system is ca-
of its housing units with 4Mbps pable of accepting the specific stand-
broadband availability according to ards required to meet the CEHRT defi-
the latest information available from nition at the start of his or her EHR re-
the Federal Communications Commis- porting period.
(iii) Operates in a jurisdiction in
sion on the first day of the EP’s EHR
which no immunization registry or im-
reporting period.
munization information system has de-
(C) Alternate specification. An EP pre-
clared readiness to receive immuniza-
viously scheduled to be in Stage 1 in
tion data from the EP at the start of
2015 may exclude the measure specified
the EHR reporting period.
in paragraph (e)(9)(ii)(A) of this section
(2) Any EP meeting one or more of
for an EHR reporting period in 2015.
the following criteria may be excluded
(10) Public Health Reporting—(i) EP from the syndromic surveillance re-
Public Health Reporting—(A) Objective. porting measure described in paragraph
The EP is in active engagement with a (e)(10)(i)(B)(2) of the section if the EP:
public health agency to submit elec- (i) Is not in a category of providers
tronic public health data from CEHRT, from which ambulatory syndromic sur-
except where prohibited, and in accord- veillance data is collected by their ju-
ance with applicable law and practice. risdiction’s syndromic surveillance
(B) Measures. In order to meet the ob- system;
jective under paragraph (e)(10)(i)(A) of (ii) Operates in a jurisdiction for
this section, an EP must choose from which no public health agency is capa-
measures 1 through 3 (as specified in ble of receiving electronic syndromic
paragraphs (e)(10)(i)(B)(1) through (3) of surveillance data from EPs in the spe-
this section) and must successfully at- cific standards required to meet the
test to any combination of two meas- CEHRT definition at the start of the
ures. The EP may attest to measure 3 EHR reporting period.
(as specified in paragraph (iii) Operates in a jurisdiction where
(e)(10)(i)(B)(3) of this section more than no public health agency has declared
one time. These measures may be met readiness to receive syndromic surveil-
by any combination in accordance with lance data from EPs at the start of the
applicable law and practice. EHR reporting period.
(1) Immunization registry reporting. (3) Any EP who meets one or more of
The EP is in active engagement with a the following criteria may be excluded
public health agency to submit immu- from the specialized registry reporting
nization data. measure described in paragraph
(2) Syndromic surveillance reporting. (e)(10)(i)(B)(3) of this section if the EP:
The EP is in active engagement with a (i) Does not diagnose or treat any dis-
public health agency to submit ease or condition associated with or
syndromic surveillance data. collect relevant data that is required
(3) Specialized registry reporting. The by a specialized registry in their juris-
EP is in active engagement to submit diction during the EHR reporting pe-
data to specialized registry. riod;
877
§ 495.22 42 CFR Ch. IV (10–1–24 Edition)
(ii) Operates in a jurisdiction for (4) Electronic reportable laboratory re-

which no specialized registry is capable sult reporting. The eligible hospital or
of accepting electronic registry trans- CAH is in active engagement with a
actions in the specific standards re- public health agency to submit elec-
quired to meet the CEHRT definition tronic reportable laboratory results.
at the start of the EHR reporting pe- (C) Exclusions in accordance with para-
riod; or graph (c)(2) of this section. (1) Any eligi-
(iii) Operates in a jurisdiction where ble hospital or CAH meeting one or
no specialized registry for which the more of the following criteria may be
EP is eligible has declared readiness to excluded from the immunization reg-
receive electronic registry transactions istry reporting measure specified in
at the beginning of the EHR reporting paragraph (e)(10)(ii)(B)(1) of this sec-
period. tion if the eligible hospital or CAH:
(D) Alternate specifications. An EP (i) Does not administer any immuni-
previously scheduled to be in Stage 1 in zations to any of the populations for
2015 may choose from measures 1 which data is collected by its jurisdic-
through 3 (as specified in paragraphs tion’s immunization registry or immu-
(e)(10)(i)(B)(1) through (3) of this sec- nization information system during the
tion) and must successfully attest to EHR reporting period.
any one measure in accordance with (ii) Operates in a jurisdiction for
applicable law and practice for an EHR which no immunization registry or im-
reporting period in 2015. munization information system is ca-
(ii) Eligible hospital and CAH Public pable of accepting the specific stand-
Health and Clinical Data Registry report- ards required to meet the CEHRT defi-
ing objective—(A) Objective. The eligible nition at the start of the EHR report-
hospital or CAH is in active engage- ing period.
ment with a public health agency to
(iii) Operates in a jurisdiction where
submit electronic public health data
no immunization registry or immuni-
from CEHRT, except where prohibited,
zation information system has declared
and in accordance with applicable law
readiness to receive immunization data
and practice.
from the eligible hospital or CAH at
(B) Measures. In order to meet the ob-
the start of the EHR reporting period.
jective under paragraph (e)(10)(ii)(A) of
(2) Any eligible hospital or CAH
this section, an eligible hospital or
meeting one or more of the following
CAH must choose from measures 1
criteria may be excluded from the
through 4 (as described in paragraphs
syndromic surveillance reporting
(e)(10)(ii)(B)(1) through (4) of this sec-
tion) and must successfully attest to measure specified in paragraph
any combination of three measures. (e)(10)(ii)(B)(2) of this section if the eli-
These measures may be met by any gible hospital or CAH:
combination, including meeting the (i) Does not have an emergency or ur-
measure specified in paragraph gent care department.
(e)(10)(ii)(B)(3) of this section multiple (ii) Operates in a jurisdiction for
times, in accordance with applicable which no public health agency is capa-
law and practice: ble of receiving electronic syndromic
(1) Immunization registry reporting. surveillance data from eligible hos-
The eligible hospital or CAH is in ac- pitals or CAHs in the specific standards
tive engagement with a public health required to meet the CEHRT definition
agency to submit immunization. at the start of the EHR reporting pe-
(2) Syndromic surveillance reporting. riod.
The eligible hospital or CAH is in ac- (iii) Operates in a jurisdiction where
tive engagement with a public health no public health agency has declared
agency to submit syndromic surveil- readiness to receive syndromic surveil-
lance data lance data from eligible hospitals or
(3) Specialized registry reporting. The CAHs at the start of the EHR reporting
eligible hospital or CAH is in active en- period.
gagement to submit data to a special- (3) Any eligible hospital or CAH
ized registry. meeting one or more of the following
878
criteria may be excluded from the spe- (f) Meaningful use objectives and meas-
cialized registry reporting measure de- ures for eligible hospitals and CAHs at-
scribed in paragraph (e)(10)(i)(B)(3) of testing to CMS for 2017 and 2018—(1) Pro-
this section if the eligible hospital or tect patient health information—(i) Objec-
CAH: tive. Protect electronic protected
(i) Does not diagnose or directly treat health information created or main-
any disease associated with or collect tained by the CEHRT through the im-
relevant data is required by a special- plementation of appropriate technical
ized registry for which the eligible hos- capabilities.
pital or CAH is eligible in their juris- (ii) Security risk analysis measure. Con-
diction. duct or review a security risk analysis
(ii) Operates in a jurisdiction for in accordance with the requirements
which no specialized registry is capable under 45 CFR 164.308(a)(1), including ad-
of accepting electronic registry trans- dressing the security (to include
actions in the specific standards re- encryption) of ePHI created or main-
quired to meet the CEHRT definition tained in CEHRT in accordance with
at the start of the EHR reporting pe- requirements under 45 CFR
riod; or 164.312(a)(2)(iv) and 45 CFR 164.306(d)(3),
(iii) Operates in a jurisdiction where and implement security updates as nec-
no specialized registry for which the el- essary, and correct identified security
igible hospital or CAH is eligible has deficiencies as part of the eligible hos-
declared readiness to receive electronic pital’s or CAH’s risk management proc-
registry transactions at the beginning ess.
of the EHR reporting period. (2)–(3) [Reserved]
(4) Any eligible hospital or CAH (4) Electronic Prescribing—(i) Objective.
meeting one or more of the following Generate and transmit permissible dis-
criteria may be excluded from the elec- charge prescriptions electronically
tronic reportable laboratory result re- (eRx).
porting measure specified in paragraph (ii) e-Prescribing measure. Subject to
(d)(10)(ii)(B)(4) of this section if the eli- the provisions of paragraph (d) of this
gible hospital or CAH: section, more than 10 percent of hos-
(i) Does not perform or order labora- pital discharge medication orders for
tory tests that are reportable in the el- permissible prescriptions are queried
igible hospital’s or CAH’s jurisdiction for a drug formulary and transmitted
during the EHR reporting period electronically using CEHRT.
(ii) Operates in a jurisdiction for (iii) Exclusion for nonapplicable objec-
which no public health agency that is tives. Subject to the provisions of para-
capable of accepting the specific ELR graph (c)(2) of this section, any eligible
standards required to meet the CEHRT hospital or CAH that does not have an
definition at the start of the EHR re- internal pharmacy that can accept
porting period. electronic prescriptions and is not lo-
(iii) Operates in a jurisdiction where cated within 10 miles of any pharmacy
no public health agency has declared that accepts electronic prescriptions at
readiness to receive electronic report- the start of their EHR reporting pe-
able laboratory results from eligible riod.
hospitals or CAHs at the start of the (5) Health Information Exchange—(i)
EHR reporting period. Objective. The eligible hospital or CAH
(D) Alternate specification. An eligible who transitions a patient to another
hospital or CAH previously scheduled setting of care or provider of care or re-
to be in Stage 1 in 2015 may choose fers a patient to another provider of
from measures 1 through 4 (as specified care provides a summary care record
in paragraphs (e)(10)(ii)(B)(1) through for each transition of care or referral.
(4) of this section) and must success- (ii) Health information exchange meas-
fully attest to any 2 measures. These ure. Subject to the provisions of para-
measures may be met by any combina- graph (d) of this section, the eligible
tion, including meeting the measures hospital or CAH that transitions or re-
specified in paragraph (e)(10)(ii)(B)(3) of fers their patient to another setting of
this section multiple times, in accord- care or provider of care must do the
ance with applicable law and practice. following:
879
§ 495.22 42 CFR Ch. IV (10–1–24 Edition)
(A) Use CEHRT to create a summary (iii) Exclusion for nonapplicable objec-
of care record; and tives. Subject to the provisions of para-
(B) Electronically transmit such graph (c)(2) of this section, any eligible
summary to a receiving provider for hospital or CAH that is located in a
more than 10 percent of transitions of county that does not have 50 percent or
care and referrals. more of its housing units with 4Mbps
(6) Patient specific education—(i) Ob- broadband availability according to
jective. Use clinically relevant informa- the latest information available from
tion from CEHRT to identify patient- the FCC on the first day of the EHR re-
specific education resources and pro- porting period is excluded from para-
vide those resources to the patient. graph (f)(8)(ii)(B) of this section.
(ii) Patient-specific education measure. (9) Public health reporting—(i) Objec-
More than 10 percent of all unique pa- tive. The eligible hospital or CAH is in
tients admitted to the eligible hos- active engagement with a public health
pital’s or CAH’s inpatient or emer- agency to submit electronic public
gency department (POS 21 or 23) are health data from CEHRT, except where
provided patient specific education re- prohibited, and in accordance with ap-
sources identified by CEHRT. plicable law and practice.
(7) Medication reconciliation—(i) Objec- (ii) Measures. In order to meet the ob-
tive. The eligible hospital or CAH that jective under paragraph (f)(9)(i) of this
receives a patient from another setting section, an eligible hospital or CAH
of care or provider of care or believes must choose from measures 1 through 4
an encounter is relevant performs (as described in paragraphs (f)(9)(ii)(A)
medication reconciliation. through (D) of this section).
(ii) Medication reconciliation measure. (A) Immunization registry reporting
Subject to the provisions of paragraph measure. The eligible hospital or CAH is
(d) of this section, the eligible hospital in active engagement with a public
or CAH performs medication reconcili- health agency to submit immunization
ation for more than 50 percent of tran- data.
sitions of care in which the patient is (B) Syndromic surveillance reporting
admitted to the eligible hospital’s or measure. The eligible hospital or CAH is
CAH’s inpatient or emergency depart- in active engagement with a public
ment (POS 21 or 23). health agency to submit syndromic
(8) Patient electronic access—(i) Objec- surveillance data.
tive. Provide patients the ability to (C) Specialized registry reporting meas-
view online, download, and transmit ure. The eligible hospital or CAH is in
information within 36 hours of hospital active engagement to submit data to a
discharge. specialized registry.
(ii) Measures. An eligible hospital or (D) Electronic reportable laboratory re-
CAH must meet the following two sult reporting measure. The eligible hos-
measures: pital or CAH is in active engagement
(A) Provide patient access measure. with a public health agency to submit
More than 50 percent of all unique pa- electronic reportable laboratory re-
tients who are discharged from the in- sults.
patient or emergency department (POS (iii) Exclusions for non-applicable ob-
21 or 23) of an eligible hospital or CAH jectives. Subject to the provisions of
have timely access to view online, paragraph (c)(2) of this section—
download, and transmit to a third (A) Any eligible hospital or CAH
party their health information. meeting one or more of the following
(B) View, download or transmit (VDT) criteria may be excluded from the im-
measure. At least 1 patient (or patient- munization measure specified in para-
authorized representative) who is dis- graph (f)(9)(ii)(A) of this section if the
charged from the inpatient or emer- eligible hospital or CAH—
gency department (POS 21 or 23) of an (1) Does not administer any immuni-
eligible hospital or CAH during the zations to any of the populations for
EHR reporting period views, which data is collected by its jurisdic-
downloads, or transmits to a third tion’s immunization registry or immu-
party his or her information during the nization information system during the
EHR reporting period. EHR reporting period.
880
(2) Operates in a jurisdiction for registry transactions at the beginning

which no immunization registry or im- of the EHR reporting period.
munization information system is ca- (D) Any eligible hospital or CAH
pable of accepting the specific stand- meeting one or more of the following
ards required to meet the CEHRT defi- criteria may be excluded from the elec-
nition at the start of the EHR report- tronic reportable laboratory result re-
ing period. porting measure specified in paragraph
(3) Operates in a jurisdiction where (f)(9)(ii)(D) of this section if the eligi-
no immunization registry or immuni- ble hospital or CAH—
zation information system has declared (1) Does not perform or order labora-
readiness to receive immunization data tory tests that are reportable in the el-
from the eligible hospital or CAH at igible hospital’s or CAH’s jurisdiction
the start of the EHR reporting period. during the EHR reporting period.
(B) Any eligible hospital or CAH (2) Operates in a jurisdiction for
meeting one or more of the following which no public health agency that is
criteria may be excluded from the capable of accepting the specific ELR
syndromic surveillance measure speci- standards required to meet the CEHRT
fied in paragraph (f)(9)(ii)(B) of this definition at the start of the EHR re-
section if the eligible hospital or porting period.
CAH— (3) Operates in a jurisdiction where
(1) Does not have an emergency or no public health agency has declared
urgent care department. readiness to receive electronic report-
(2) Operates in a jurisdiction for able laboratory results from eligible
which no public health agency is capa- hospitals or CAHs at the start of the
ble of receiving electronic syndromic EHR reporting period.
surveillance data from eligible hos- [80 FR 62943, Oct. 16, 2015, as amended at 81
pitals or CAHs in the specific standards FR 11449, Mar. 4, 2016; 81 FR 79882, Nov. 14,
required to meet the CEHRT definition 2016; 82 FR 38517, Aug. 14, 2017]
at the start of the EHR reporting pe-
riod. § 495.24 Stage 3 meaningful use objec-
(3) Operates in a jurisdiction where tives and measures for EPs, eligible
no public health agency has declared hospitals and CAHs for 2019 and
readiness to receive syndromic surveil- subsequent years.
lance data from eligible hospitals or The criteria specified in paragraphs
CAHs at the start of the EHR reporting (c) and (d) of this section are optional
period. for 2017 and 2018 for EPs, eligible hos-
(C) Any eligible hospital or CAH pitals, and CAHs that have successfully
meeting one or more of the following demonstrated meaningful use in a prior
criteria may be excluded from the spe- year. The criteria specified in para-
cialized registry measure specified in graph (d) of this section are applicable
paragraph (f)(9)(ii)(C) of this section if for all EPs for 2019 and subsequent
the eligible hospital or CAH— years, and for eligible hospitals and
(1) Does not diagnose or directly CAHs attesting to a State for the Med-
treat any disease associated with or icaid Promoting Interoperability Pro-
collect relevant data is required by a gram for 2019 and subsequent years.
specialized registry for which the eligi- The criteria specified in paragraph (e)
ble hospital or CAH is eligible in their of this section are applicable for eligi-
jurisdiction. ble hospitals and CAHs attesting to
(2) Operates in a jurisdiction for CMS for 2019 through 2022. The criteria
which no specialized registry is capable specified in paragraph (f) of this sec-
of accepting electronic registry trans- tion are applicable for eligible hos-
actions in the specific standards re- pitals and CAHs attesting to CMS for
quired to meet the CEHRT definition 2023 and subsequent years.
at the start of the EHR reporting pe- (a) Stage 3 criteria for EPs—(1) General
riod; or rule regarding Stage 3 criteria for mean-
(3) Operates in a jurisdiction where ingful use for EPs. Except as specified in
no specialized registry for which the el- paragraphs (a)(2) and (3) of this section,
igible hospital or CAH is eligible has EPs must meet all objectives and asso-
declared readiness to receive electronic ciated measures of the Stage 3 criteria
881
§ 495.24 42 CFR Ch. IV (10–1–24 Edition)
specified in paragraph (d) of this sec- objective) in paragraph (d) of this sec-
tion to meet the definition of a mean- tion references paragraph (a)(5) of this
ingful EHR user. section, the measure may be calculated
(2) Selection of measures for specified by reviewing only the actions for pa-
objectives in paragraph (d) of this section. tients whose records are maintained
An EP may meet the criteria for 2 out using CEHRT. A patient’s record is
of the 3 measures associated with an maintained using CEHRT if sufficient
objective, rather than meeting the cri- data were entered in the CEHRT to
teria for all 3 of the measures, if the allow the record to be saved, and not
EP meets all of the following require- rejected due to incomplete data.
ments: (ii) If the objective and associated
(i) Must ensure that the objective in measure does not reference paragraph
paragraph (d) of this section includes (a)(5) of this section, the measure must
an option to meet 2 out of the 3 associ- be calculated by reviewing all patient
ated measures. records, not just those maintained
(ii) Meets the threshold for 2 out of using CEHRT.
the 3 measures for that objective. (b) Stage 3 criteria for meaningful use
(iii) Attests to all 3 of the measures for eligible hospitals and CAHs—(1) Gen-
for that objective. eral rule. Except as specified in para-
(3) Exclusion for non-applicable objec- graphs (b)(2) and (3) of this section, eli-
tives and measures. (i) An EP may ex- gible hospitals and CAHs must meet all
clude a particular objective that in- objectives and associated measures of
cludes an option for exclusion con- the Stage 3 criteria specified in para-
tained in paragraph (d) of this section, graphs (c) and (d) of this section, as ap-
if the EP meets all of the following re- plicable, to meet the definition of a
quirements: meaningful EHR user.
(A) Meets the criteria in the applica- (2) Selection of measures for specified
ble objective that would permit the ex- objectives in paragraphs (c) and (d) of
clusion. this section. An eligible hospital or CAH
(B) Attests to the exclusion. may meet the criteria for 2 out of the
(ii) An EP may exclude a measure 3 measures associated with an objec-
within an objective which allows for a tive, rather than meeting the criteria
provider to meet the threshold for 2 of for all 3 of the measures, if the eligible
the 3 measures, as outlined in para- hospital or CAH meets all of the fol-
graph (a)(2) of this section, in the following requirements:
lowing manner: (i) Must ensure that the objective in
(A)(1) Meets the criteria in the appli- paragraph (c) or (d) of this section, as
cable measure or measures that would applicable, includes an option to meet
permit the exclusion; and 2 out of the 3 associated measures.
(2) Attests to the exclusion or exclu- (ii) Meets the threshold for 2 out of
sions. the 3 measures for that objective.
(B)(1) Meets the threshold; and (iii) Attests to all 3 of the measures
(2) Attests to any remaining measure for that objective.
or measures. (3) Exclusion for nonapplicable objec-
(4) Exception for Medicaid EPs who tives and measures. (i) An eligible hos-
adopt, implement or upgrade in their first pital or CAH may exclude a particular
payment year. For Medicaid EPs who objective that includes an option for
adopt, implement, or upgrade its exclusion contained in paragraph (c) or
CEHRT in their first payment year, the (d) of this section, as applicable, if the
meaningful use objectives and associ- eligible hospital or CAH meets all of
ated measures of the Stage 3 criteria the following requirements:
specified in paragraph (d) of this sec- (A) Meets the criteria in the applica-
tion apply beginning with the second ble objective that would permit the ex-
payment year, and do not apply to the clusion.
first payment year. (B) Attests to the exclusion.
(5) Objectives and associated measures (ii) An eligible hospital or CAH may
in paragraph (d) of this section that rely exclude a measure within an objective
on measures that count unique patients or which allows for a provider to meet the
actions. (i) If a measure (or associated threshold for 2 of the 3 measures, as
882
outlined in paragraph (b)(2) of this sec- requirements under 45 CFR

tion, in the following manner: 164.312(a)(2)(iv) and 45 CFR 164.306(d)(3),
(A)(1) Meets the criteria in the appli- implement security updates as nec-
cable measure or measures that would essary, and correct identified security
permit the exclusion; and deficiencies as part of the provider’s
(2) Attests to the exclusion or exclu- risk management process.
sions. (2) Electronic prescribing—(i) Objective.
(B)(1) Meets the threshold; and Generate and transmit permissible dis-
(2) Attests to any remaining measure charge prescriptions electronically
or measures. (eRx).
(4) Exception for Medicaid eligible hos- (ii) e-Prescribing measure. Subject to
pitals or CAHs that adopt, implement or paragraph (b)(5) of this section, more
upgrade in their first payment year. For than 25 percent of hospital discharge
Medicaid eligible hospitals or CAHs medication orders for permissible pre-
that adopt, implement or upgrade scriptions (for new and changed pre-
CEHRT in their first payment year, the scriptions) are queried for a drug for-
meaningful use objectives and associ- mulary and transmitted electronically
ated measures of the Stage 3 criteria using CEHRT.
specified in paragraph (c) or (d) of this (iii) Exclusions in accordance with
section apply beginning with the sec- paragraph (b)(3) of this section. Any eli-
ond payment year, and do not apply to gible hospital or CAH that does not
the first payment year. have an internal pharmacy that can ac-
(5) Objectives and associated measures cept electronic prescriptions and there
in paragraph (c) or (d) of this section that are no pharmacies that accept elec-
rely on measures that count unique pa- tronic prescriptions within 10 miles at
tients or actions. (i) If a measure (or as- the start of the eligible hospital or
sociated objective) in paragraph (c) or CAH’s EHR reporting period.
(d) of this section, as applicable, ref- (3)–(4) [Reserved]
erences paragraph (b)(5) of this section, (5) Patient electronic access to health
the measure may be calculated by re- information—(i) Objective. The eligible
viewing only the actions for patients hospital or CAH provides patients (or
whose records are maintained using patient-authorized representative) with
CEHRT. A patient’s record is main- timely electronic access to their health
tained using CEHRT if sufficient data information and patient-specific edu-
were entered in the CEHRT to allow cation.
the record to be saved, and not rejected (ii) Measures. Eligible hospitals and
due to incomplete data. CAHs must meet the following two
(ii) If the objective and associated measures:
measure does not reference this para- (A) Provide patient access measure. For
graph (b)(5) of this section, the meas- more than 50 percent of all unique pa-
ure must be calculated by reviewing all tients discharged from the eligible hos-
patient records, not just those main- pital or CAH inpatient or emergency
tained using CEHRT. department (POS 21 or 23):
(c) Stage 3 objectives and measures for (1) The patient (or patient-authorized
eligible hospitals and CAHs attesting to representative) is provided timely ac-
CMS—(1) Protect patient health informa- cess to view online, download, and
tion—(i) Objective. Protect electronic transmit his or her health information;
protected health information (ePHI) and
created or maintained by the CEHRT (2) The provider ensures the patient’s
through the implementation of appro- health information is available for the
priate technical, administrative, and patient (or patient-authorized rep-
physical safeguards. resentative) to access using any appli-
(ii) Security risk analysis measure. Con- cation of their choice that is config-
duct or review a security risk analysis ured to meet the technical specifica-
in accordance with the requirements tions of the API in the provider’s
under 45 CFR 164.308(a)(1), including ad- CEHRT.
dressing the security (including (B) Patient-specific education measure.
encryption) of data created or main- The eligible hospital or CAH must use
tained by CEHRT in accordance with clinically relevant information from
883
§ 495.24 42 CFR Ch. IV (10–1–24 Edition)
CEHRT to identify patient-specific sent using the electronic messaging

educational resources and provide elec- function of CEHRT to the patient (or
tronic access to those materials to the patient authorized representative),
more than 10 percent of unique pa- or in response to a secure message sent
tients discharged from the eligible hos- by the patient (or the patient author-
pital or CAH inpatient or emergency ized representative).
department (POS 21 or 23) during the (C) Patient generated health data. Pa-
EHR reporting period. tient generated health data or data
(iii) Exclusion in accordance with para- from a non-clinical setting is incor-
graph (b)(3) of this section. Any eligible porated into the CEHRT for more than
hospital or CAH that is located in a 5 percent of unique patients discharged
county that does not have 50 percent or from the eligible hospital or CAH inpa-
more of its housing units with 4Mbps tient or emergency department (POS 21
broadband availability according to or 23) during the EHR reporting period.
the latest information available from (iii) Exclusions under paragraph (b)(3)
the FCC on the first day of the EHR re- of this section. Any eligible hospital or
porting period is excluded from the CAH operating in a location that does
measures specified in paragraphs not have 50 percent or more of its hous-
(c)(5)(ii)(A) and (B) of this section. ing units with 4Mbps broadband avail-
(6) Coordination of care through patient ability according to the latest informa-
engagement—(i) Objective. Use CEHRT tion available from the FCC on the
to engage with patients or their au- first day of the EHR reporting period
thorized representatives about the pa- may exclude from the measures speci-
tient’s care. fied in paragraphs (c)(6)(ii)(A) through
(ii) Measures. In accordance with (C) of this section.
paragraph (b)(2) of this section, an eli-
(7) Health information exchange—(i)
gible hospital or CAH must satisfy 2 of
Objective. The eligible hospital or CAH
the 3 following measures in paragraphs
provides a summary of care record
(c)(6)(ii)(A), (B), and (C) of this section,
when transitioning or referring their
except those measures for which an eli-
patient to another setting of care, re-
gible hospital or CAH qualifies for an
ceives or retrieves a summary of care
exclusion under paragraph (b)(3) of this
record upon the receipt of a transition
section.
or referral or upon the first patient en-
(A) View, download or transmit (VDT)
counter with a new patient, and incor-
measure. During the EHR reporting pe-
porates summary of care information
riod, at least one unique patient (or
from other providers into their EHR
their authorized representatives) dis-
using the functions of CEHRT.
charged from the eligible hospital or
CAH inpatient or emergency depart- (ii) Measures. In accordance with
ment (POS 21 or 23) actively engage paragraph (b)(2) of this section, a eligi-
with the electronic health record made ble hospital or CAH must attest to all
accessible by the provider and one of 3 measures, but must meet the thresh-
the following: old for 2 of the 3 measures in para-
(1) View, download or transmit to a graphs (e)(7)(ii)(A) through (C) of this
third party their health information. section. Subject to paragraph (b)(5) of
(2) Access their health information this section—
through the use of an API that can be (A) Send a summary of care measure.
used by applications chosen by the pa- For more than 10 percent of transitions
tient and configured to the API in the of care and referrals, the eligible hos-
provider’s CEHRT; or pital or CAH that transitions or refers
(3) A combination of paragraphs its patient to another setting of care or
(c)(6)(ii)(A)(1) and (2) of this section. provider of care—
(B) Secure messaging measure. During (1) Creates a summary of care record
the EHR reporting period, more than 5 using CEHRT; and
percent of all unique patients dis- (2) Electronically exchanges the sum-
charged from the eligible hospital or mary of care record.
CAH inpatient or emergency depart- (B) Request/accept summary of care
ment (POS 21 or 23) during the EHR re- measure. For more than 10 percent of
porting period, a secure message was transitions or referrals received and
884
patient encounters in which the pro- successfully attest to any combination

vider has never before encountered the of three measures. These measures may
patient, the eligible hospital or CAH be met by any combination, including
incorporates into the patient’s EHR an meeting the measure specified in para-
electronic summary of care document. graphs (c)(8)(ii)(D) and (E) of this sec-
(C) Clinical information reconciliation tion multiple times, in accordance
measure. For more than 50 percent of with applicable law and practice:
transitions or referrals received and (A) Immunization registry reporting
patient encounters in which the pro- measure. The eligible hospital or CAH is
vider has never before encountered the in active engagement with a public
patient, the eligible hospital or CAH
health agency to submit immunization
performs a clinical information rec-
data and receive immunization fore-
onciliation. The provider must imple-
ment clinical information reconcili- casts and histories from the public
ation for the following three clinical health immunization registry/immuni-
information sets: zation information system (IIS).
(1) Medication. Review of the pa- (B) Syndromic surveillance reporting
tient’s medication, including the name, measure. The eligible hospital or CAH is
dosage, frequency, and route of each in active engagement with a public
medication. health agency to submit syndromic
(2) Medication allergy. Review of the surveillance data from an urgent care
patient’s known allergic medications. setting.
(3) Current problem list. Review of the (C) Electronic case reporting measure.
patient’s current and active diagnoses. The eligible hospital or CAH is in ac-
(iii) Exclusions in accordance with tive engagement with a public health
paragraph (b)(3) of this section. (A) Any agency to submit case reporting of re-
eligible hospital or CAH for whom the portable conditions.
total of transitions or referrals re- (D) Public health registry reporting
ceived and patient encounters in which measure. The eligible hospital or CAH is
the provider has never before encoun- in active engagement with a public
tered the patient, is fewer than 100 dur-
health agency to submit data to public
ing the EHR reporting period may be
health registries.
excluded from paragraphs (c)(7)(ii)(B)
and (C) of this section. (E) Clinical data registry reporting
(B) Any eligible hospital or CAH op- measure. The eligible hospital or CAH is
erating in a location that does not in active engagement to submit data to
have 50 percent or more of its housing a clinical data registry.
units with 4Mbps broadband avail- (F) Electronic reportable laboratory re-
ability according to the latest informa- sult reporting measure. The eligible hos-
tion available from the FCC on the pital or CAH is in active engagement
first day of the EHR reporting period with a public health agency to submit
may be excluded from the measures electronic reportable laboratory re-
specified in paragraphs (e)(7)(ii)(A) and sults.
(B) of this section. (iii) Exclusions in accordance with
(8) Public health and clinical data reg- paragraph (b)(3) of this section. (A) Any
istry reporting—(i) Objective. The eligi- eligible hospital or CAH meeting one
ble hospital or CAH is in active engage- or more of the following criteria may
ment with a public health agency be excluded from the immunization
(PHA) or clinical data registry (CDR) registry reporting measure specified in
to submit electronic public health data paragraph (c)(8)(ii)(A) of this section if
in a meaningful way using CEHRT, ex- the eligible hospital or CAH—
cept where prohibited, and in accord-
(1) Does not administer any immuni-
ance with applicable law and practice.
(ii) Measures. In order to meet the ob- zations to any of the populations for
jective under paragraph (c)(8)(i) of this which data is collected by its jurisdic-
section, an eligible hospital or CAH tion’s immunization registry or immu-
must choose from measures 1 through 6 nization information system during the
(as described in paragraphs (c)(8)(ii)(A) EHR reporting period.
through (F) of this section) and must
885
§ 495.24 42 CFR Ch. IV (10–1–24 Edition)
(2) Operates in a jurisdiction for (D) Any eligible hospital or CAH

which no immunization registry or im- meeting at least one of the following
munization information system is ca- criteria may be excluded from the pub-
pable of accepting the specific stand- lic health registry reporting measure
ards required to meet the CEHRT defi- specified in paragraph (c)(8)(ii)(D) of
nition at the start of the EHR report- this section if the eligible hospital or
ing period. CAH—
(3) Operates in a jurisdiction where (1) Does not diagnose or directly
no immunization registry or immuni- treat any disease or condition associ-
zation information system has declared ated with a public health registry in its
readiness to receive immunization data jurisdiction during the EHR reporting
as of 6 months prior to the start of the period.
EHR reporting period. (2) Operates in a jurisdiction for
(B) Any eligible hospital or CAH which no public health agency is capa-
meeting one or more of the following ble of accepting electronic registry
criteria may be excluded from the transactions in the specific standards
syndromic surveillance reporting required to meet the CEHRT definition
measure specified in paragraph at the start of the EHR reporting pe-
(c)(8)(ii)(B) of this section if the eligi- riod.
ble hospital or CAH— (3) Operates in a jurisdiction where
no public health registry for which the
(1) Does not have an emergency or
eligible hospital or CAH is eligible has
urgent care department.
declared readiness to receive electronic
(2) Operates in a jurisdiction for registry transactions as of 6 months
which no public health agency is capa- prior to the start of the EHR reporting
ble of receiving electronic syndromic period.
surveillance data in the specific stand- (E) Any eligible hospital or CAH
ards required to meet the CEHRT defi- meeting at least one of the following
nition at the start of the EHR report- criteria may be excluded from the clin-
ing period. ical data registry reporting measure
(3) Operates in a jurisdiction where specified in paragraph (c)(8)(ii)(E) of
no public health agency has declared this section if the eligible hospital or
readiness to receive syndromic surveil- CAH—
lance data from eligible hospitals or (1) Does not diagnose or directly
CAHs as of 6 months prior to the start treat any disease or condition associ-
of the EHR reporting period. ated with a clinical data registry in
(C) Any eligible hospital or CAH their jurisdiction during the EHR re-
meeting one or more of the following porting period.
criteria may be excluded from the case (2) Operates in a jurisdiction for
reporting measure specified in para- which no clinical data registry is capa-
graph (e)(8)(ii)(C) of this section if the ble of accepting electronic registry
eligible hospital or CAH— transactions in the specific standards
(1) Does not treat or diagnose any re- required to meet the CEHRT definition
portable diseases for which data is col- at the start of the EHR reporting pe-
lected by their jurisdiction’s reportable riod.
disease system during the EHR report- (3) Operates in a jurisdiction where
ing period. no clinical data registry for which the
(2) Operates in a jurisdiction for eligible hospital or CAH is eligible has
which no public health agency is capa- declared readiness to receive electronic
ble of receiving electronic case report- registry transactions as of 6 months
ing data in the specific standards re- prior to the start of the EHR reporting
quired to meet the CEHRT definition period.
at the start of their EHR reporting pe- (F) Any eligible hospital or CAH
riod. meeting one or more of the following
(3) Operates in a jurisdiction where criteria may be excluded from the elec-
no public health agency has declared tronic reportable laboratory result re-
readiness to receive electronic case reporting measure specified in paragraph
porting data as of 6 months prior to the (c)(8)(ii)(F) of this section if the eligi-
start of the EHR reporting period. ble hospital or CAH—
886
(1) Does not perform or order labora- fied security deficiencies as part of the
tory tests that are reportable in its ju- provider’s risk management process.
risdiction during the EHR reporting pe- (2) Electronic Prescribing—(i) EP Elec-
riod. tronic Prescribing—(A) Objective. Gen-
(2) Operates in a jurisdiction for erate and transmit permissible pre-
which no public health agency that is scriptions electronically (eRx).
capable of accepting the specific ELR (B) Measure. Subject to paragraph
standards required to meet the CEHRT (a)(5) of this section, more than 60 per-
definition at the start of the EHR recent of all permissible prescriptions
porting period. written by the EP are queried for a
(3) Operates in a jurisdiction where drug formulary and transmitted elec-
no public health agency has declared tronically using CEHRT.
readiness to receive electronic report- (C) Exclusions in accordance with para-
able laboratory results from an eligible graph (a)(3) of this section. (1) Any EP
hospital or CAH as of 6 months prior to who writes fewer than 100 permissible
the start of the EHR reporting period. prescriptions during the EHR reporting
(d) Stage 3 objectives and measures for period; or
all EPs for 2019 and subsequent years,
(2) Any EP who does not have a phar-
and for eligible hospitals and CAHs attest-
macy within its organization and there
ing to a State for the Medicaid Promoting
are no pharmacies that accept elec-
Interoperability Program for 2019 and sub-
tronic prescriptions within 10 miles of
sequent years—(1) Protect patient health
the EP’s practice location at the start
information—(i) EP protect patient health
of his/her EHR reporting period.
information—(A) Objective. Protect elec-
tronic protected health information (ii) Eligible hospital/CAH electronic pre-
(ePHI) created or maintained by the scribing—(A) Objective. Generate and
CEHRT through the implementation of transmit permissible discharge pre-
appropriate technical, administrative, scriptions electronically (eRx).
and physical safeguards. (B) Measure. Subject to paragraph
(B) Measure. Conduct or review a se- (b)(5) of this section, more than 25 per-
curity risk analysis in accordance with cent of hospital discharge medication
the requirements under 45 CFR orders for permissible prescriptions
164.308(a)(1), including addressing the (for new and changed prescriptions) are
security (including encryption) of data queried for a drug formulary and trans-
created or maintained by CEHRT in ac- mitted electronically using CEHRT.
cordance with requirements under 45 (C) Exclusions in accordance with para-
CFR 164.312(a)(2)(iv) and 45 CFR graph (b)(3) of this section. Any eligible
164.306(d)(3), implement security up- hospital or CAH that does not have an
dates as necessary, and correct identi- internal pharmacy that can accept
fied security deficiencies as part of the electronic prescriptions and there are
provider’s risk management process. no pharmacies that accept electronic
(ii) Eligible hospital/CAH protect pa- prescriptions within 10 miles at the
tient health information—(A) Objective. start of the eligible hospital or CAH’s
Protect electronic protected health in- EHR reporting period.
formation (ePHI) created or main- (3) Clinical decision support—(i) EP
tained by the CEHRT through the im- clinical decision support—(A) Objective.
plementation of appropriate technical, Implement clinical decision support
administrative, and physical safe- (CDS) interventions focused on improv-
guards. ing performance on high-priority
(B) Measure. Conduct or review a se- health conditions.
curity risk analysis in accordance with (B) Measures. (1) Implement five clin-
the requirements under 45 CFR ical decision support interventions re-
164.308(a)(1), including addressing the lated to four or more clinical quality
security (including encryption) of data measures at a relevant point in patient
created or maintained by CEHRT in ac- care for the entire EHR reporting pe-
cordance with requirements under 45 riod. Absent four clinical quality meas-
CFR 164.312(a)(2)(iv) and 45 CFR ures related to an EP’s scope of prac-
164.306(d)(3), implement security up- tice or patient population, the clinical
dates as necessary, and correct identi- decision support interventions must be
887
§ 495.24 42 CFR Ch. IV (10–1–24 Edition)
related to high-priority health condi- (3) More than 60 percent of diagnostic

tions; and imaging orders created by the EP dur-
(2) The EP has enabled and imple- ing the EHR reporting period are re-
mented the functionality for drug-drug corded using computerized provider
and drug-allergy interaction checks for order entry.
the entire EHR reporting period. (C) Exclusions in accordance with para-
(C) Exclusion in accordance with paragraph (a)(3) of this section. (1) For the
graph (a)(3) of this section for paragraph measure specified in paragraph
(d)(3)(i)(B)(2) of this section. An EP who (d)(4)(i)(B)(1) of this section, any EP
writes fewer than 100 medication orders who writes fewer than 100 medication
during the EHR reporting period. orders during the EHR reporting pe-
(ii) Eligible hospital/CAH clinical deci- riod.
sion support—(A) Objective. Implement (2) For the measure specified in para-
clinical decision support (CDS) inter- graph (d)(4)(i)(B)(2) of this section, any
ventions focused on improving per- EP who writes fewer than 100 labora-
formance on high-priority health con- tory orders during the EHR reporting
ditions. period.
(B) Measures. (1) Implement five clin- (3) For the measure specified in para-
ical decision support interventions re- graph (d)(4)(i)(B)(3) of this section, any
lated to four or more clinical quality EP who writes fewer than 100 diag-
measures at a relevant point in patient nostic imaging orders during the EHR
care for the entire EHR reporting pe- reporting period.
riod. Absent four clinical quality meas- (ii) Eligible hospital and CAH CPOE—
ures related to an eligible hospital or (A) Objective. Use computerized pro-
CAH’s patient population, the clinical vider order entry (CPOE) for medica-
decision support interventions must be tion, laboratory, and diagnostic imag-
related to high-priority health condi- ing orders directly entered by any li-
tions; and censed healthcare professional,
(2) The eligible hospital or CAH has credentialed medical assistant, or a
enabled and implemented the medical staff member credentialed to
functionality for drug-drug and drug- and performing the equivalent duties of
allergy interaction checks for the en- a credentialed medical assistant; who
tire EHR reporting period. can enter orders into the medical
(4) Computerized provider order entry record per State, local, and profes-
(CPOE)—(i) EP CPOE—(A) Objective. sional guidelines.
Use computerized provider order entry (B) Measures. Subject to paragraph
(CPOE) for medication, laboratory, and (b)(5) of this section—
diagnostic imaging orders directly en- (1) More than 60 percent of medica-
tered by any licensed healthcare pro- tion orders created by authorized pro-
fessional, credentialed medical assist- viders of the eligible hospital’s or
ant, or a medical staff member CAH’s inpatient or emergency depart-
credentialed to and performing the ment (POS 21 or 23) during the EHR re-
equivalent duties of a credentialed porting period are recorded using com-
medical assistant, who can enter orders puterized provider order entry;
into the medical record per state, (2) More than 60 percent of labora-
local, and professional guidelines. tory orders created by authorized pro-
(B) Measures. Subject to paragraph viders of the eligible hospital’s or
(a)(5) of this section— CAH’s inpatient or emergency depart-
(1) More than 60 percent of medica- ment (POS 21 or 23) during the EHR re-
tion orders created by the EP during porting period are recorded using com-
the EHR reporting period are recorded puterized provider order entry; and
using computerized provider order (3) More than 60 percent of diagnostic
entry; imaging orders created by authorized
(2) More than 60 percent of labora- providers of the eligible hospital’s or
tory orders created by the EP during CAH’s inpatient or emergency depart-
the EHR reporting period are recorded ment (POS 21 or 23) during the EHR re-
using computerized provider order porting period are recorded using com-
entry; and puterized provider order entry.
888
(5) Patient electronic access to health (1) For more than 80 percent of all
information—(i) EP patient electronic ac- unique patients discharged from the el-
cess to health information—(A) Objective. igible hospital or CAH inpatient or
The EP provides patients (or patient- emergency department (POS 21 or 23):
authorized representative) with timely (i) The patient (or patient-authorized
electronic access to their health infor- representative) is provided timely ac-
mation and patient-specific education. cess to view online, download, and
(B) Measures. EPs must meet the fol- transmit his or her health information;
lowing two measures: and
(1) For more than 80 percent of all (ii) The provider ensures the patient’s
unique patients seen by the EP— health information is available for the
(i) The patient (or the patient-au- patient (or patient-authorized rep-
thorized representative) is provided resentative) to access using any appli-
timely access to view online, download, cation of their choice that is config-
and transmit his or her health informa- ured to meet the technical specifica-
tion; and tions of the API in the provider’s
CEHRT.
(ii) The provider ensures the patient’s
(2) The eligible hospital or CAH must
health information is available for the
use clinically relevant information
patient (or patient-authorized rep-
from CEHRT to identify patient-spe-
resentative) to access using any appli-
cific educational resources and provide
cation of their choice that is config-
electronic access to those materials to
ured to meet the technical specifica-
more than 35 percent of unique pa-
tions of the API in the provider’s
tients discharged from the eligible hos-
CEHRT.
pital or CAH inpatient or emergency
(2) The EP must use clinically rel- department (POS 21 or 23) during the
evant information from CEHRT to EHR reporting period.
identify patient-specific educational (C) Exclusion in accordance with para-
resources and provide electronic access graph (b)(3) of this section. Any eligible
to those materials to more than 35 per- hospital or CAH that is located in a
cent of unique patients seen by the EP county that does not have 50 percent or
during the EHR reporting period. more of its housing units with 4Mbps
(C) Exclusions in accordance with para- broadband availability according to
graph (a)(3) of this section. (1) Any EP the latest information available from
who has no office visits during the re- the FCC on the first day of the EHR re-
porting period may exclude from the porting period is excluded from the
measures specified in paragraphs measures specified in paragraphs
(d)(5)(i)(B)(1) and (2) of this section. (d)(5)(ii)(B)(1) and (2) of this section.
(2) Any EP that conducts 50 percent (6) Coordination of care through patient
or more of his or her patient encoun- engagement—(i) EP coordination of care
ters in a county that does not have 50 through patient engagement—(A) Objec-
percent or more of its housing units tive. Use CEHRT to engage with pa-
with 4Mbps broadband availability ac- tients or their authorized representa-
cording to the latest information avail- tives about the patient’s care.
able from the FCC on the first day of (B) Measures. In accordance with
the EHR reporting period may exclude paragraph (a)(2) of this section, an EP
from the measures specified in para- must satisfy 2 out of the 3 following
graphs (d)(5)(i)(B)(1) and (2) of this sec- measures in paragraphs (d)(6)(i)(B)(1)
tion. through (3) of this section except those
(ii) Eligible hospital and CAH patient measures for which an EP qualifies for
electronic access to health information— an exclusion under paragraph (a)(3) of
(A) Objective. The eligible hospital or this section.
CAH provides patients (or patient-au- (1) During the EHR reporting period,
thorized representative) with timely more than 5 percent of all unique pa-
electronic access to their health infor- tients (or their authorized representa-
mation and patient-specific education. tives) seen by the EP actively engage
(B) Measures. Eligible hospitals and with the electronic health record made
CAHs must meet the following two accessible by the provider and do either
measures: of the following:
889
§ 495.24 42 CFR Ch. IV (10–1–24 Edition)
(i) View, download or transmit to a pital or CAH inpatient or emergency

third party their health information; department (POS 21 or 23) actively en-
(ii) Access their health information gage with the electronic health record
through the use of an API that can be made accessible by the provider and
used by applications chosen by the pa- one of the following:
tient and configured to the API in the (i) View, download or transmit to a
provider’s CEHRT; or third party their health information.
(iii) A combination of paragraphs (ii) Access their health information
(d)(6)(i)(B)(1)(i) and (ii) of this section. through the use of an API that can be
(2) A secure message was sent using used by applications chosen by the pa-
the electronic messaging function of tient and configured to the API in the
CEHRT to the patient (or their author- provider’s CEHRT.
ized representatives), or in response to (iii) A combination of paragraphs
a secure message sent by the patient, (d)(6)(ii)(B)(1)(i) and (ii) of this section.
for more than 5 percent of all unique
(iv) For an EHR reporting period in
patients seen by the EP during the
2017 and 2018, an eligible hospital or
EHR reporting period.
CAH may meet a threshold of 5 percent
(3) Patient generated health data or
instead of 10 percent for the measure at
data from a nonclinical setting is in-
paragraph (d)(6)(ii)(B)(1) of this sec-
corporated into the CEHRT for more
tion.
than 5 percent of all unique patients
seen by the EP during the EHR report- (2) During the EHR reporting pe-
ing period. riod—
(C) Exclusions in accordance with para- (i) For an EHR reporting period in
graph (a)(3) of this section. (1) Any EP 2017 and 2018, for more than 5 percent of
who has no office visits during the re- all unique patients discharged from the
porting period may exclude from the eligible hospital or CAH inpatient or
measures specified in paragraphs emergency department (POS 21 or 23)
(d)(6)(i)(B)(1) through (3) of this sec- during the EHR reporting period, a se-
tion. cure message was sent using the elec-
(2) Any EP that conducts 50 percent tronic messaging function of CEHRT to
or more of his or her patient encoun- the patient (or their authorized rep-
ters in a county that does not have 50 resentatives), or in response to a secure
percent or more of its housing units message sent by the patient (or their
with 4Mbps broadband availability ac- authorized representatives).
cording to the latest information avail- (ii) For an EHR reporting period
able from the FCC on the first day of other than 2017 and 2018, for more than
the EHR reporting period may exclude 25 percent of all unique patients dis-
from the measures specified in para- charged from the eligible hospital or
graphs (d)(6)(i)(B)(1) through (3) of this CAH inpatient or emergency depart-
section. ment (POS 21 or 23) during the EHR re-
(ii) Eligible hospital and CAH coordina- porting period, a secure message was
tion of care through patient engagement— sent using the electronic messaging
(A) Objective. Use CEHRT to engage function of CEHRT to the patient (or
with patients or their authorized rep- their authorized representatives), or in
resentatives about the patient’s care. response to a secure message sent by
(B) Measures. In accordance with the patient (or their authorized rep-
paragraph (b)(2) of this section, an eli- resentatives).
gible hospital or CAH must satisfy 2 of (3) Patient generated health data or
the 3 following measures in paragraphs data from a non-clinical setting is in-
(d)(6)(ii)(B)(1) through (3) of this sec- corporated into the CEHRT for more
tion, except those measures for which than 5 percent of unique patients dis-
an eligible hospital or CAH qualifies charged from the eligible hospital or
for an exclusion under paragraph (b)(3) CAH inpatient or emergency depart-
of this section. ment (POS 21 or 23) during the EHR re-
(1) During the EHR reporting period, porting period.
more than 10 percent of all unique pa- (C) Exclusions under paragraph (b)(3)
tients (or their authorized representa- of this section. Any eligible hospital or
tives) discharged from the eligible hos- CAH operating in a location that does
890
not have 50 percent or more of its hous- (ii) Medication allergy. Review of the
ing units with 4Mbps broadband avail- patient’s known allergic medications.
ability according to the latest informa- (iii) Current problem list. Review of the
tion available from the FCC on the patient’s current and active diagnoses.
first day of the EHR reporting period (C) Exclusions in accordance with para-
may exclude from the measures speci- graph (a)(3) of this section. An EP must
fied in paragraphs (d)(6)(ii)(B)(1) be excluded when any of the following
through (3) of this section. occur:
(7) Health information exchange—(i) EP (1) Any EP who transfers a patient to
health information exchange—(A) Objec- another setting or refers a patient to
tive. The EP provides a summary of another provider less than 100 times
care record when transitioning or re- during the EHR reporting period must
ferring their patient to another setting be excluded from paragraph
of care, receives or retrieves a sum- (d)(7)(i)(B)(1) of this section.
mary of care record upon the receipt of
(2) Any EP for whom the total of
a transition or referral or upon the
transitions or referrals received and
first patient encounter with a new pa-
patient encounters in which the pro-
tient, and incorporates summary of
vider has never before encountered the
care information from other providers
patient, is fewer than 100 during the
into their EHR using the functions of
CEHRT. EHR reporting period may be excluded
from paragraphs (d)(7)(i)(B)(2) and (3) of
(B) Measures. In accordance with
this section.
paragraph (a)(2) of this section, an EP
must attest to all 3 measures, but must (3) Any EP that conducts 50 percent
meet the threshold for 2 of the 3 meas- or more of his or her patient encoun-
ures in paragraphs (d)(7)(i)(B)(1) ters in a county that does not have 50
through (3) of this section, in order to percent or more of its housing units
meet the objective. Subject to para- with 4Mbps broadband availability ac-
graph (c) of this section— cording to the latest information avail-
(1) Measure 1. For more than 50 per- able from the FCC on the first day of
cent of transitions of care and refer- the EHR reporting period may exclude
rals, the EP that transitions or refers from the measures specified in para-
their patient to another setting of care graphs (d)(7)(i)(B)(1) and (2) of this sec-
or provider of care— tion.
(i) Creates a summary of care record (ii) Eligible hospitals and CAHs health
using CEHRT; and information exchange—(A) Objective. The
(ii) Electronically exchanges the eligible hospital or CAH provides a
summary of care record. summary of care record when
(2) Measure 2. For more than 40 per- transitioning or referring their patient
cent of transitions or referrals received to another setting of care, receives or
and patient encounters in which the retrieves a summary of care record
provider has never before encountered upon the receipt of a transition or re-
the patient, the EP incorporates into ferral or upon the first patient encoun-
the patient’s EHR an electronic sum- ter with a new patient, and incor-
mary of care document. porates summary of care information
(3) Measure 3. For more than 80 per- from other providers into their EHR
cent of transitions or referrals received using the functions of CEHRT.
and patient encounters in which the (B) Measures. In accordance with
provider has never before encountered paragraph (b)(2) of this section, an eli-
the patient, the EP performs clinical gible hospital or CAH must attest to
information reconciliation. The EP all three measures, but must meet the
must implement clinical information threshold for 2 of the 3 measures in
reconciliation for the following three paragraphs (d)(7)(ii)(B)(1) through (3) of
clinical information sets: this section. Subject to paragraph
(i) Medication. Review of the patient’s (b)(5) of this section—
medication, including the name, dos- (1) Measure 1. For more than 50 per-
age, frequency, and route of each medi- cent of transitions of care and refer-
cation. rals, the eligible hospital or CAH that
891
§ 495.24 42 CFR Ch. IV (10–1–24 Edition)
transitions or refers its patient to an- agency or clinical data registry to sub-
other setting of care or provider of mit electronic public health data in a
care— meaningful way using CEHRT, except
(i) Creates a summary of care record where prohibited, and in accordance
using CEHRT; and with applicable law and practice.
(ii) Electronically exchanges the (B) Measures. In order to meet the ob-
summary of care record. jective under paragraph (d)(8)(i)(A) of
(2) Measure 2. For more than 40 per- this section, an EP must choose from
cent of transitions or referrals received measures 1 through 5 (paragraphs
and patient encounters in which the (d)(8)(i)(B)(1) through (5) of this sec-
provider has never before encountered tion) and must successfully attest to
the patient, the eligible hospital or any combination of two measures.
CAH incorporates into the patient’s These measures may be met by any
EHR an electronic summary of care combination, including meeting meas-
document from a source other than the ure specified in paragraph (d)(8)(i)(B)(4)
provider’s EHR system. or (5) of this section multiple times, in
(3) Measure 3. For more than 80 per- accordance with applicable law and
cent of transitions or referrals received practice:
and patient encounters in which the (1) Immunization registry reporting.
provider has never before encountered The EP is in active engagement with a
the patient, the eligible hospital or public health agency to submit immu-
CAH performs a clinical information nization data and receive immuniza-
reconciliation. The provider must im- tion forecasts and histories from the
plement clinical information reconcili- public health immunization registry/
ation for the following three clinical immunization information system
information sets: (IIS).
(i) Medication. Review of the patient’s (2) Syndromic surveillance reporting.
medication, including the name, dos- The EP is in active engagement with a
age, frequency, and route of each medi- public health agency to submit
cation. syndromic surveillance data from an
(ii) Medication allergy. Review of the urgent care setting, or from any other
patient’s known allergic medications. setting from which ambulatory
(iii) Current problem list. Review of the syndromic surveillance data are col-
patient’s current and active diagnoses. lected by the state or a local public
(C) Exclusions in accordance with para- health agency.
graph (b)(3) of this section. (1) Any eligi- (3) Electronic case reporting. The EP is
ble hospital or CAH for whom the total in active engagement with a public
of transitions or referrals received and health agency to submit case reporting
patient encounters in which the proof reportable conditions.
vider has never before encountered the (4) Public health registry reporting. The
patient, is fewer than 100 during the EP is in active engagement with a pub-
EHR reporting period may be excluded lic health agency to submit data to
from paragraphs (d)(7)(i)(B)(2) and (3) of public health registries.
this section. (5) Clinical data registry reporting. The
(2) Any eligible hospital or CAH oper- EP is in active engagement to submit
ating in a location that does not have data to a clinical data registry.
50 percent or more of its housing units (C) Exclusions in accordance with para-
with 4Mbps broadband availability ac- graph (a)(3) of this section. (1) Any EP
cording to the latest information avail- meeting one or more of the following
able from the FCC on the first day of criteria may be excluded from the im-
the EHR reporting period may exclude munization registry reporting measure
from the measures specified in para- in paragraph (d)(8)(i)(B)(1) of this sec-
graphs (d)(7)(ii)(B)(1) and (2) of this section if the EP—
tion. (i) Does not administer any immuni-
(8) Public Health and Clinical Data zations to any of the populations for
Registry Reporting—(i) EP Public Health which data is collected by their juris-
and Clinical Data Registry: Reporting ob- diction’s immunization registry or im-
jective—(A) Objective. The EP is in ac- munization information system during
tive engagement with a public health the EHR reporting period.
892
(ii) Operates in a jurisdiction for (4) Any EP meeting at least one of

which no immunization registry or im- the following criteria may be excluded
munization information system is ca- from the public health registry report-
pable of accepting the specific standing measure specified in paragraph
ards required to meet the CEHRT defi- (d)(8)(i)(B)(4) of this section if the EP—
nition at the start of its EHR reporting (i) Does not diagnose or directly treat
period. any disease or condition associated
(iii) Operates in a jurisdiction where with a public health registry in the
no immunization registry or immuni- EP’s jurisdiction during the EHR re-
zation information system has declared porting period.
readiness to receive immunization data (ii) Operates in a jurisdiction for
as of 6 months prior to the start of the which no public health agency is capa-
EHR reporting period. ble of accepting electronic registry
(2) Any EP meeting one or more of transactions in the specific standards
the following criteria may be excluded required to meet the CEHRT definition
from the syndromic surveillance re- at the start of the EHR reporting pe-
porting measure described in paragraph riod.
(d)(8)(i)(B)(2) of the section if the EP— (iii) Operates in a jurisdiction where
(i) Is not in a category of providers no public health registry for which the
from which ambulatory syndromic sur- EP, eligible hospital, or CAH is eligible
veillance data is collected by their ju- has declared readiness to receive elec-
risdiction’s syndromic surveillance tronic registry transactions as of 6
system. months prior to the start of the EHR
(ii) Operates in a jurisdiction for reporting period.
which no public health agency is capa- (5) Any EP meeting at least one of
ble of receiving electronic syndromic the following criteria may be excluded
surveillance data in the specific stand- from the clinical data registry report-
ards required to meet the CEHRT defi- ing measure specified in paragraph
nition at the start of the EHR report- (d)(8)(i)(B)(5) of this section if the EP—
ing period. (i) Does not diagnose or directly treat
(iii) Operates in a jurisdiction where any disease or condition associated
no public health agency has declared with a clinical data registry in their
readiness to receive syndromic surveil- jurisdiction during the EHR reporting
lance data from EPs as of 6 months period.
prior to the start of the EHR reporting (ii) Operates in a jurisdiction for
period. which no clinical data registry is capa-
(3) Any EP meeting one or more of ble of accepting electronic registry
the following criteria may be excluded transactions in the specific standards
from the case reporting measure at required to meet the CEHRT definition
paragraph (d)(8)(i)(B)(3) of this section at the start of the EHR reporting pe-
if the EP: riod.
(i) Does not treat or diagnose any re- (iii) Operates in a jurisdiction where
portable diseases for which data is col- no clinical data registry for which the
lected by their jurisdiction’s reportable EP, eligible hospital, or CAH is eligible
disease system during the EHR report- has declared readiness to receive elec-
ing period. tronic registry transactions as of 6
(ii) Operates in a jurisdiction for months prior to the start of the EHR
which no public health agency is capa- reporting period.
ble of receiving electronic case report- (ii) Eligible hospital and CAH Public
ing data in the specific standards re- Health and Clinical Data Registry: Re-
quired to meet the CEHRT definition porting objective—(A) Objective. The eli-
at the start of the EHR reporting pe- gible hospital or CAH is in active en-
riod. gagement with a public health agency
(iii) Operates in a jurisdiction where (PHA) or clinical data registry (CDR)
no public health agency has declared to submit electronic public health data
readiness to receive electronic case rein a meaningful way using CEHRT, ex-
porting data as of 6 months prior to the cept where prohibited, and in accord-
start of the EHR reporting period. ance with applicable law and practice.
893
§ 495.24 42 CFR Ch. IV (10–1–24 Edition)
(B) Measures. In order to meet the ob- (ii) Operates in a jurisdiction for
jective under paragraph (d)(8)(ii)(A) of which no immunization registry or im-
this section, an eligible hospital or munization information system is ca-
CAH must choose from measures 1 pable of accepting the specific stand-
through 6 (as described in paragraphs ards required to meet the CEHRT defi-
(d)(8)(ii)(B)(1) through (6) of this sec- nition at the start of the EHR report-
tion) and must successfully attest to ing period.
any combination of four measures. (iii) Operates in a jurisdiction where
These measures may be met by any no immunization registry or immuni-
combination, including meeting the zation information system has declared
measure specified in paragraph readiness to receive immunization data
(d)(8)(ii)(B)(4) or (5) of this section mul- as of 6 months prior to the start of the
tiple times, in accordance with applica- EHR reporting period.
ble law and practice: (2) Any eligible hospital or CAH
(1) Immunization registry reporting. meeting one or more of the following
The eligible hospital or CAH is in ac- criteria may be excluded from the
tive engagement with a public health syndromic surveillance reporting
agency to submit immunization data measure specified in paragraph
and receive immunization forecasts (d)(8)(ii)(B)(2) of this section if the eli-
and histories from the public health gible hospital or CAH—
immunization registry/immunization
(i) Does not have an emergency or ur-
information system (IIS).
gent care department.
(2) Syndromic surveillance reporting.
(ii) Operates in a jurisdiction for
The eligible hospital or CAH is in ac-
which no public health agency is capa-
tive engagement with a public health
ble of receiving electronic syndromic
agency to submit syndromic surveil-
surveillance data in the specific stand-
lance data from an urgent care setting.
ards required to meet the CEHRT defi-
(3) Case reporting. The eligible hos-
nition at the start of the EHR report-
pital or CAH is in active engagement
ing period.
with a public health agency to submit
case reporting of reportable conditions. (iii) Operates in a jurisdiction where
(4) Public health registry reporting. The no public health agency has declared
eligible hospital or CAH is in active en- readiness to receive syndromic surveil-
gagement with a public health agency lance data from eligible hospitals or
to submit data to public health reg- CAHs as of 6 months prior to the start
istries. of the EHR reporting period.
(5) Clinical data registry reporting. The (3) Any eligible hospital or CAH
eligible hospital or CAH is in active en- meeting one or more of the following
gagement to submit data to a clinical criteria may be excluded from the case
data registry. reporting measure specified in para-
(6) Electronic reportable laboratory re- graph (d)(8)(ii)(B)(3) of this section if
sult reporting. The eligible hospital or the eligible hospital or CAH—
CAH is in active engagement with a (i) Does not treat or diagnose any re-
public health agency to submit elec- portable diseases for which data is col-
tronic reportable laboratory results. lected by their jurisdiction’s reportable
(C) Exclusions in accordance with para- disease system during the EHR report-
graph (b)(3) of this section. (1) Any eligi- ing period.
ble hospital or CAH meeting one or (ii) Operates in a jurisdiction for
more of the following criteria may be which no public health agency is capa-
excluded from to the immunization ble of receiving electronic case report-
registry reporting measure specified in ing data in the specific standards re-
paragraph (d)(8)(ii)(B)(1) of this section quired to meet the CEHRT definition
if the eligible hospital or CAH— at the start of their EHR reporting pe-
(i) Does not administer any immuni- riod.
zations to any of the populations for (iii) Operates in a jurisdiction where
which data is collected by its jurisdic- no public health agency has declared
tion’s immunization registry or immu- readiness to receive electronic case re-
nization information system during the porting data as of 6 months prior to the
EHR reporting period. start of the EHR reporting period.
894
(4) Any eligible hospital or CAH (i) Does not perform or order labora-
meeting at least one of the following tory tests that are reportable in its ju-
criteria may be excluded from the pub- risdiction during the EHR reporting pe-
lic health registry reporting measure riod.
specified in paragraph (d)(8)(ii)(B)(4) of (ii) Operates in a jurisdiction for
this section if the eligible hospital or which no public health agency that is
CAH— capable of accepting the specific ELR
(i) Does not diagnose or directly treat standards required to meet the CEHRT
any disease or condition associated definition at the start of the EHR re-
with a public health registry in its ju- porting period.
risdiction during the EHR reporting pe-
(iii) Operates in a jurisdiction where
riod.
(ii) Operates in a jurisdiction for no public health agency has declared
which no public health agency is capa- readiness to receive electronic report-
ble of accepting electronic registry able laboratory results from an eligible
transactions in the specific standards hospital or CAH as of 6 months prior to
required to meet the CEHRT definition the start of the EHR reporting period.
at the start of the EHR reporting pe- (e) Stage 3 objectives and measures for
riod. eligible hospitals and CAHs attesting to
(iii) Operates in a jurisdiction where CMS for 2019 through 2022—(1) General
no public health registry for which the rule. (i) Except as specified in para-
eligible hospital or CAH is eligible has graph (e)(2) of this section, eligible hos-
declared readiness to receive electronic pitals and CAHs must do all of the fol-
registry transactions as of 6 months lowing as part of meeting the defini-
prior to the start of the EHR reporting tion of a meaningful EHR user under
period. § 495.4:
(5) Any eligible hospital or CAH (A) Meet all objectives and associ-
meeting at least one of the following ated measures of the Stage 3 criteria
criteria may be excluded from the clin- specified in this paragraph (e).
ical data registry reporting measure
(B) In 2019, 2020, and 2021, earn a total
specified in paragraph (d)(8)(ii)(B)(5) of
score of at least 50 points.
this section if the eligible hospital or
CAH— (C) In 2022, earn a total score of at
(i) Does not diagnose or directly treat least 60 points.
any disease or condition associated (ii) Beginning in CY 2020, the numer-
with a clinical data registry in their ator and denominator of measures in-
jurisdiction during the EHR reporting crement based on actions occurring
period. during the EHR reporting period se-
(ii) Operates in a jurisdiction for lected by the eligible hospital or CAH,
which no clinical data registry is capa- unless otherwise indicated.
ble of accepting electronic registry (2) Exclusion for nonapplicable meas-
transactions in the specific standards ures. (i) An eligible hospital or CAH
required to meet the CEHRT definition may exclude a particular measure that
at the start of the EHR reporting pe- includes an option for exclusion con-
riod. tained in this paragraph (e) if the eligi-
(iii) Operates in a jurisdiction where ble hospital or CAH meets the fol-
no clinical data registry for which the lowing requirements:
eligible hospital or CAH is eligible has (A) Meets the criteria in the applica-
declared readiness to receive electronic ble measure that would permit the ex-
registry transactions as of 6 months
clusion.
prior to the start of the EHR reporting
period. (B) Attests to the exclusion.
(6) Any eligible hospital or CAH (ii) Distribution of points for non-
meeting one or more of the following applicable measures. For eligible hos-
criteria may be excluded from the elec- pitals or CAHs that claim such exclu-
tronic reportable laboratory result re- sion, the points assigned to the ex-
porting measure specified in paragraph cluded measure will be distributed to
(d)(8)(ii)(B)(6) of this section if the eli- other measures as outlined in this
gible hospital or CAH— paragraph (e).
895
§ 495.24 42 CFR Ch. IV (10–1–24 Edition)
(3) Objectives and associated measures (5) Electronic prescribing—(i) Objective.

in this paragraph (e) that rely on meas- Generate and transmit permissible dis-
ures that count unique patients or ac- charge prescriptions electronically
tions. (i) If a measure (or associated ob- (eRx).
jective) in this paragraph (e) references (ii) Measures scoring. (A) In 2019, eligi-
paragraph (e)(3) of this section, the ble hospitals and CAHs must meet the
measure may be calculated by review- e-Prescribing measure in paragraph
ing only the actions for patients whose (e)(5)(iii)(A) of this section and have
records are maintained using CEHRT. the option to report on the query of
A patient’s record is maintained using PDMP measure and verify opioid treat-
CEHRT if sufficient data were entered ment agreement measure in paragraphs
in the CEHRT to allow the record to be (e)(5)(iii)(B) and (C) of this section. The
saved, and not rejected due to incom- electronic prescribing objective in
plete data. paragraph (e)(5)(i) of this section is
(ii) If the objective and associated worth up to 20 points.
measure does not reference this para- (B) In 2020 through 2022, eligible hos-
graph (e)(3), the measure must be cal- pitals and CAHs must meet the e-Pre-
culated by reviewing all patient scribing measure in paragraph
records, not just those maintained (e)(5)(iii)(A) of this section, and have
using CEHRT. the option to report on the query of
(4) Protect patient health information— PDMP measure in paragraph
(i) Objective. Protect electronic pro- (e)(5)(iii)(B) of this section.
tected health information (ePHI) cre- (1) In 2020 and 2021, the electronic
ated or maintained by the CEHRT prescribing objective in paragraph
through the implementation of appro- (e)(5)(i) of this section is worth up to 15
priate technical, administrative, and points.
physical safeguards. (2) In 2022, the electronic prescribing
(ii) Measure scoring. Eligible hospitals objective in paragraph (e)(5)(i) of this
and CAHs are required to report on the section is worth up to 20 points.
security risk analysis measure in para- (iii) Measures—(A) e-Prescribing meas-
graph (e)(4)(iii) of this section, but no ure. Subject to paragraph (e)(3) of this
points are available for this measure. section, at least one hospital discharge
In 2022, eligible hospitals and CAHs are medication order for permissible pre-
required to report on the SAFER scriptions (for new and changed pre-
Guides measure in paragraph (e)(4)(iv) scriptions) is queried for a drug for-
of this section, but no points are avail- mulary and transmitted electronically
able for this measure. using CEHRT. This measure is worth
(iii) Security risk analysis measure. up to 10 points in CY 2019 through CY
Conduct or review a security risk anal- 2022.
ysis in accordance with the require- (B) Query of prescription drug moni-
ments under 45 CFR 164.308(a)(1), in- toring program (PDMP) measure. Subject
cluding addressing the security (in- to paragraph (e)(3) of this section, for
cluding encryption) of data created or at least one Schedule II opioid elec-
maintained by CEHRT in accordance tronically prescribed using CEHRT
with requirements under 45 CFR during the EHR reporting period, the
164.312(a)(2)(iv) and 45 CFR 164.306(d)(3), eligible hospital or CAH uses data from
implement security updates as nec- CEHRT to conduct a query of a Pre-
essary, and correct identified security scription Drug Monitoring Program
deficiencies as part of the provider’s (PDMP) for prescription drug history,
risk management process. Actions in- except where prohibited and in accord-
cluded in the security risk analysis ance with applicable law. This measure
measure may occur any time during is worth—
the calendar year in which the EHR re- (1) 5 bonus points in CYs 2019, 2020,
porting period occurs. and 2021; and
(iv) SAFER Guides measure. Conduct (2) 10 bonus points in CY 2022.
an annual self- assessment using all (C) Verify opioid treatment agreement
nine SAFER Guides at any point dur- measure. Subject to paragraph (e)(3) of
ing the calendar year in which the EHR this section, for at least one unique pa-
reporting period occurs. tient for whom a Schedule II opioid
896
was electronically prescribed by the el- (e)(6)(ii)(C) of this section (worth 40

igible hospital or CAH using CEHRT points).
during the EHR reporting period, if the (A) Support electronic referral loops by
total duration of the patient’s Sched- sending health information measure: Sub-
ule II opioid prescriptions is at least 30 ject to paragraph (e)(3) of this section,
cumulative days within a 6-month for at least one transition of care or re-
look-back period, the eligible hospital ferral, the eligible hospital or CAH
or CAH seeks to identify the existence that transitions or refers its patient to
of a signed opioid treatment agreement another setting of care or provider of
and incorporates it into the patient’s care—
electronic health record using CEHRT. (1) Creates a summary of care record
This measure is worth 5 bonus points in using CEHRT; and
CY 2019. (2) Electronically exchanges the sum-
(iv) Exclusions in accordance with mary of care record.
paragraph (e)(2) of this section and redis- (B) Support electronic referral loops by
tribution of points. An exclusion claimed receiving and reconciling health informa-
under paragraph (e)(5)(v) of this section tion measure. Subject to paragraph
will redistribute 10 points in CY 2019 (e)(3) of this section, for at least one
and CY 2020 equally among the meas- electronic summary of care record re-
ures associated with the health infor- ceived using CEHRT for patient en-
mation exchange objective under para- counters during the EHR reporting pe-
graph (e)(6) of this section. riod for which an eligible hospital or
(v) Exclusion in accordance with para- CAH was the receiving party of a tran-
graph (e)(2) of this section. For the EHR sition of care or referral, or for patient
reporting periods in CY 2019 through encounters during the EHR reporting
CY 2022, any eligible hospital or CAH period in which the eligible hospital or
that does not have an internal phar- CAH has never before encountered the
macy that can accept electronic pre- patient, the eligible hospital or CAH
scriptions and there are no pharmacies conducts clinical information rec-
that accept electronic prescriptions onciliation for medication, medication
within 10 miles at the start of the eligi- allergy, and current problem list using
ble hospital or CAH’s EHR reporting CEHRT.
period may be excluded from the meas- (C) Health information exchange (HIE)
ure specified in paragraph (e)(5)(iii)(A) bi-directional exchange measure. Subject
of this section. to paragraph (e)(3) of this section, the
(6) Health information exchange—(i) eligible hospital or CAH must attest to
Objective. The eligible hospital or CAH the following:
provides a summary of care record (1) Participating in an HIE in order
when transitioning or referring their to enable secure, bi-directional ex-
patient to another setting of care, re- change of information to occur for all
ceives or retrieves a summary of care unique patients discharged from the el-
record upon the receipt of a transition igible hospital or CAH inpatient or
or referral or upon the first patient en- emergency department (POS 21 or 23),
counter with a new patient, and incor- and all unique patient records stored or
porates summary of care information maintained in the EHR for these de-
from other providers into their EHR partments, during the EHR reporting
using the functions of CEHRT. period in accordance with applicable
(ii) Measures. For CYs 2019, 2020, and law and policy.
2021, eligible hospitals and CAHs must (2) Participating in an HIE that is ca-
meet both of the measures specified in pable of exchanging information across
paragraphs (e)(6)(ii)(A) and (B) of this a broad network of unaffiliated ex-
section (each worth up to 20 points). change partners including those using
For CY 2022, eligible hospitals and disparate EHRs, and not engaging in
CAHs either must meet both of the exclusionary behavior when deter-
measures specified in paragraphs mining exchange partners.
(e)(6)(ii)(A) and (B) of this section (each (3) Using the functions of CEHRT to
worth up to 20 points) or must meet the support bi-directional exchange with
measure specified in paragraph an HIE.
897
§ 495.24 42 CFR Ch. IV (10–1–24 Edition)
(iii) Exclusions in accordance with paragraphs (e)(8)(ii)(A) through (F) of

paragraph (e)(2) of this section. Any eli- this section. For CY 2022, eligible hos-
gible hospital or CAH that is unable to pitals and CAHs could receive a total of
implement the support electronic re- 15 points for the objective under para-
ferral loops by receiving and incor- graph (e)(8)(i) of this section. In order
porating health information measure to meet the objective under paragraph
under paragraph (e)(6)(ii)(B) of this sec- (e)(8)(i) of this section and receive 10
tion for an EHR reporting period in points, an eligible hospital or CAH
2019 may be excluded from that meas- must meet each of the four measures
ure. Claiming the exclusion will redis- specified in paragraphs (e)(8)(ii)(A), (B),
tribute 20 points to the support elec- (C), and (F) of this section. An eligible
tronic referral loops by sending health hospital or CAH receives a bonus of 5
information measure under paragraph points for this objective if they meet
(e)(6)(ii)(A) of this section. one of the measures specified in para-
(7) Provider to patient exchange—(i) graph (e)(8)(ii)(D) or (E).
Objective. The eligible hospital or CAH (A) Syndromic surveillance reporting
provides patients (or patient-author- measure. For CYs 2019, 2020, and 2021,
ized representative) with timely elec- the eligible hospital or CAH is in active
tronic access to their health informa- engagement with a public health agen-
tion. cy to submit syndromic surveillance
(ii) Provide patients electronic access to data from an urgent care setting. For
their health information measure. Eligi- CY 2022, the eligible hospital or CAH is
ble hospitals and CAHs must meet the in active engagement with a public
following measure, and could receive health agency to submit syndromic
up to 40 points for this objective for CY surveillance data from an emergency
2019 through CY 2022. For at least one department setting (POS 23).
unique patient discharged from the eli- (B) Immunization registry reporting
gible hospital or CAH inpatient or measure. The eligible hospital or CAH is
emergency department (POS 21 or 23) in active engagement with a public
all of the following: health agency to submit immunization
(A) The patient (or patient-author- data and receive immunization fore-
ized representative) is provided timely casts and histories from the public
access to view online, download, and health immunization registry/immuni-
transmit his or her health information. zation information system (IIS).
(B) The eligible hospital or CAH en- (C) Electronic case reporting measure.
sures the patient’s health information The eligible hospital or CAH is in ac-
is available for the patient (or patient- tive engagement with a public health
authorized representative) to access agency to submit case reporting of re-
using any application of their choice portable conditions.
that is configured to meet the tech- (D) Public health registry reporting
nical specifications of the API in the measure. The eligible hospital or CAH is
eligible hospital or CAH’s CEHRT. in active engagement with a public
(8) Public health and clinical data ex- health agency to submit data to public
change.—(i) Objective. The eligible hos- health registries.
pital or CAH is in active engagement (E) Clinical data registry reporting
with a public health agency (PHA) or measure. The eligible hospital or CAH is
clinical data registry (CDR) to submit in active engagement to submit data to
electronic public health data in a a clinical data registry.
meaningful way using CEHRT, except (F) Electronic reportable laboratory re-
where prohibited, and in accordance sult reporting measure. The eligible hos-
with applicable law and practice. pital or CAH is in active engagement
(ii) Measures. For CYs 2019, 2020, and with a public health agency to submit
2021, eligible hospitals and CAHs could electronic reportable laboratory re-
receive a total of 10 points for the ob- sults.
jective under paragraph (e)(8)(i) of this (iii) Exclusions in accordance with
section. In order to meet the objective paragraph (e)(2) of this section. For CYs
under paragraph (e)(8)(i) of this sec- 2019, 2020, and 2021, if an exclusion is
tion, an eligible hospital or CAH must claimed under paragraphs (e)(8)(iii)(A)
meet any two measures specified in through (F) of this section for each of
898
the two measures selected for report- as of 6 months prior to the start of the
ing, the 10 points for the objective EHR reporting period.
specified in paragraph (e)(8)(i) of this (C) Any eligible hospital or CAH
section will be redistributed to the pro- meeting one or more of the following
vide patients electronic access to their criteria may be excluded from the elec-
health information measure under tronic case reporting measure specified
paragraph (e)(7)(ii) of this section. For in paragraph (e)(8)(ii)(C) of this section
CY 2022, if an exclusion is claimed if the eligible hospital or CAH—
under paragraphs (e)(8)(iii)(A) through (1) Does not treat or diagnose any re-
(F) of this section for each of the four portable diseases for which data is col-
measures required for reporting, the 10 lected by their jurisdiction’s reportable
points for the objective specified in disease system during the EHR report-
paragraph (e)(8)(i) of this section will ing period.
be redistributed to the provide patients (2) Operates in a jurisdiction for
electronic access to their health infor- which no public health agency is capa-
mation measure under paragraph ble of receiving electronic case report-
(e)(7)(ii) of this section. ing data in the specific standards re-
(A) Any eligible hospital or CAH quired to meet the CEHRT definition
meeting one or more of the following at the start of their EHR reporting pe-
criteria may be excluded from the riod.
syndromic surveillance reporting (3) Operates in a jurisdiction where
measure specified in paragraph no public health agency has declared
(e)(8)(ii)(A) of this section if the eligi- readiness to receive electronic case re-
ble hospital or CAH— porting data as of 6 months prior to the
(1) For CYs 2019, 2020 and 2021, does start of the EHR reporting period.
not have an emergency or urgent care (D)(1) For CYs 2019, 2020, and 2021,
department. any eligible hospital or CAH meeting
(2) For CY 2022, does not have an at least one of the following criteria
emergency department. may be excluded from the public health
(3) Operates in a jurisdiction where registry reporting measure specified in
no public health agency has declared paragraph (e)(8)(ii)(D) of this section if
readiness to receive syndromic surveil- the eligible hospital or CAH:
lance data from eligible hospitals or (i) Does not diagnose or directly treat
CAHs as of 6 months prior to the start any disease or condition associated
of the EHR reporting period. with a public health registry in its ju-
(B) Any eligible hospital or CAH risdiction during the EHR reporting pe-
meeting one or more of the following riod.
criteria may be excluded from to the (ii) Operates in a jurisdiction for
immunization registry reporting meas- which no public health agency is capa-
ure specified in paragraph (e)(8)(ii)(B) ble of accepting electronic registry
of this section if the eligible hospital transactions in the specific standards
or CAH— required to meet the CEHRT definition
(1) Does not administer any immuni- at the start of the EHR reporting pe-
zations to any of the populations for riod.
which data is collected by its jurisdic- (iii) Operates in a jurisdiction where
tion’s immunization registry or immuno public health registry for which the
nization information system during the eligible hospital or CAH is eligible has
EHR reporting period. declared readiness to receive electronic
(2) Operates in a jurisdiction for registry transactions as of 6 months
which no immunization registry or im- prior to the start of the EHR reporting
munization information system is ca- period.
pable of accepting the specific stand- (2) For CY 2022, the exclusions speci-
ards required to meet the CEHRT defi- fied in paragraph (D)(1) of this para-
nition at the start of the EHR report- graph are no longer available.
ing period. (E)(1) For CYs 2019, 2020, and 2021, any
(3) Operates in a jurisdiction where eligible hospital or CAH meeting at
no immunization registry or immuni- least one of the following criteria may
zation information system has declared be excluded from the clinical data reg-
readiness to receive immunization data istry reporting measure specified in
899
§ 495.40 42 CFR Ch. IV (10–1–24 Edition)
paragraph (e)(8)(ii)(E) of this section if section 1886(n)(3) of the Act for an EHR
the eligible hospital or CAH: reporting period.
(i) Does not diagnose or directly treat (B) In 2023 and 2024, earn a total score
any disease or condition associated of at least 60 points.
with a clinical data registry in their (C) In 2025 earn a total score of at
jurisdiction during the EHR reporting least 70 points.
period. (D) In 2026 and subsequent years, earn
(ii) Operates in a jurisdiction for a total score of at least 80 points.
which no clinical data registry is capa- (ii) The numerator and denominator
ble of accepting electronic registry of the measures increment based on ac-
transactions in the specific standards tions occurring during the EHR report-
required to meet the CEHRT definition ing period selected by the eligible hos-
at the start of the EHR reporting pe- pital or CAH, unless otherwise indi-
riod. cated.
(iii) Operates in a jurisdiction where (2) Exclusion for nonapplicable meas-
no clinical data registry for which the ures. (i) Exclusion of a particular meas-
eligible hospital or CAH is eligible has ure. An eligible hospital or CAH may
declared readiness to receive electronic exclude a particular measure that in-
registry transactions as of 6 months cludes an option for exclusion if the el-
prior to the start of the EHR reporting igible hospital or CAH meets the fol-
period. lowing requirements:
(2) For CY 2022, the exclusions speci- (A) Meets the criteria in the applica-
fied in paragraph (E)(1) of this parable measure that would permit the ex-
graph are no longer available. clusion.
(F) Any eligible hospital or CAH (B) Attests to the exclusion.
meeting one or more of the following (ii) Distribution of points for non-
criteria may be excluded from the elec- applicable measures. For eligible hos-
tronic reportable laboratory result re- pitals or CAHs that claim such exclu-
porting measure specified in paragraph sion, the points assigned to the ex-
(e)(8)(ii)(F) of this section if the eligi- cluded measure are distributed to other
ble hospital or CAH— measures as specified by CMS for an
EHR reporting period.
(1) Does not perform or order labora-
tory tests that are reportable in its ju- [81 FR 79884, Nov. 14, 2016, as amended at 82
risdiction during the EHR reporting pe- FR 38517, August 14, 2017; 82 FR 46143, Oct. 4,
riod. 2017; 83 FR 41707, Aug. 17, 2018; 83 FR 60096,
Nov. 23, 2018; 84 FR 42616, Aug. 16, 2019; 85 FR
(2) Operates in a jurisdiction for
59026, Sept. 18, 2020; 86 FR 45522, Aug. 13, 2021;
which no public health agency that is 87 FR 49410, Aug. 10, 2022; 89 FR 69914, Aug.
capable of accepting the specific ELR 28, 2024; 89 FR 80131, Oct. 2, 2024]
standards required to meet the CEHRT
definition at the start of the EHR re- § 495.40 Demonstration of meaningful
porting period. use criteria.
(3) Operates in a jurisdiction where (a) Demonstration by EPs. An EP must
no public health agency has declared demonstrate that he or she satisfies
readiness to receive electronic report- each of the applicable objectives and
able laboratory results from an eligible associated measures under § 495.20,
hospital or CAH as of 6 months prior to § 495.22 or § 495.24, supports information
the start of the EHR reporting period. exchange and the prevention of health
(f) Stage 3 objectives and measures for information blocking, and engages in
eligible hospitals and CAHs attesting to activities related to supporting pro-
CMS for 2023 and subsequent years—(1) viders with the performance of CEHRT:
General rule. (i) Except as specified in (1) For CY 2011—(i) Attestation. At-
paragraph (f)(2) of this section, eligible test, through a secure mechanism, in a
hospitals and CAHs must do all of the manner specified by CMS (or for a Med-
following as part of meeting the defini- icaid EP, in a manner specified by the
tion of a meaningful EHR user under State), that during the EHR reporting
§ 495.4: period, the EP—
(A) Meet all objectives and associ- (A) Used certified EHR technology,
ated measures selected by CMS under and specify the technology used;
900
(B) Satisfied the required objectives (F) For CY 2017 and CY 2018: An EP
and associated measures under § 495.20 that has successfully demonstrated it
or § 495.24; is a meaningful EHR user in any prior
(C) Must specify the EHR reporting year may satisfy either the objectives
period and provide the result of each and measures specified in § 495.22(e) for
applicable measure for all patients meaningful use or the objectives and
seen during the EHR reporting period measures specified in § 495.24(d) for
for which a selected measure is appli- meaningful use; an EP that has never
cable; successfully demonstrated it is a mean-
(ii) Additional requirements for Med- ingful EHR user in any prior year must
icaid EPs. For Medicaid EPs, if, in ac- satisfy the objectives and measures
cordance with §§ 495.316 and 495.332, specified in § 495.22(e) for meaningful
CMS has approved a State’s revised use.
definition for meaningful use, in addi- (G) For CY 2019 and subsequent years,
tion to meeting paragraphs (a)(1)(i) satisfied the required objectives and
through (ii) of this section, the EP associated measures under § 495.24(d)
must also demonstrate meeting the for meaningful use.
State revised definition using the (H) Supporting providers with the
method approved by CMS; and performance of CEHRT (SPPC). To en-
(iii) Exception for Medicaid EPs. If a gage in activities related to supporting
Medicaid EP has adopted, implemented providers with the performance of
or upgraded certified EHR technology CEHRT, the EP—
in the first payment year, the EP need (1) Must attest that he or she:
not demonstrate meaningful use until (i) Acknowledges the requirement to
the second payment year, as described cooperate in good faith with ONC di-
in § 495.20 or §§ 495.24 and 495.40. rect review of his or her health infor-
mation technology certified under the
(2) For CY 2012 and subsequent
ONC Health IT Certification Program
years—
if a request to assist in ONC direct re-
(i) Attestation. Attest, through a se- view is received; and
cure mechanism, in a manner specified (ii) If requested, cooperated in good
by CMS (or for a Medicaid EP, in a faith with ONC direct review of his or
manner specified by the State) that her health information technology cer-
during the EHR reporting period, the tified under the ONC Health IT Certifi-
EP— cation Program as authorized by 45
(A) Used certified EHR technology CFR part 170, subpart E, to the extent
and specify the technology used. that such technology meets (or can be
(B) For calendar years before 2015, used to meet) the definition of CEHRT,
satisfied the required objectives and including by permitting timely access
associated measures under § 495.20 for to such technology and demonstrating
the EP’s stage of meaningful use. its capabilities as implemented and
(C) Must specify the EHR reporting used by the EP in the field.
period and provide the result of each (2) Optionally, may also attest that
applicable measure for all patients he or she:
seen during the EHR reporting period (i) Acknowledges the option to co-
for which a selected measure is appli- operate in good faith with ONC–ACB
cable. surveillance of his or her health infor-
(D) For 2014 only, if the EP uses one mation technology certified under the
of the options specified in § 495.20(a)(4) ONC Health IT Certification Program
or (h)(3), the EP must attest that he or if a request to assist in ONC–ACB sur-
she is unable to fully implement 2014 veillance is received; and
Edition certified EHR technology for (ii) If requested, cooperated in good
an EHR reporting period in 2014 due to faith with ONC–ACB surveillance of his
delays in 2014 Edition certified EHR or her health information technology
technology availability. certified under the ONC Health IT Cer-
(E) For CYs 2015 through 2016, satis- tification Program as authorized by 45
fied the required objectives and associ- CFR part 170, subpart E, to the extent
ated measures under § 495.22(e) for that such technology meets (or can be
meaningful use. used to meet) the definition of CEHRT,
901
§ 495.40 42 CFR Ch. IV (10–1–24 Edition)
including by permitting timely access CMS has approved a State’s additional

to such technology and demonstrating criteria for meaningful use, in addition
capabilities as implemented and used to meeting paragraphs (a)(2)(i) through
by the EP in the field. (iii), the EP must also demonstrate
(I) Support for health information ex- meeting such additional criteria using
change and the prevention of informa- the method approved by CMS.
tion blocking. For an EHR reporting (iv) Exception for Medicaid EPs. If a
period in CY 2017 and subsequent years, Medicaid EP has adopted, imple-
the EP must attest that he or she— mented, or upgrade certified EHR tech-
(1) Did not knowingly and willfully nology in the first payment year, the
take action (such as to disable EP need not demonstrate that it is a
functionality) to limit or restrict the meaningful EHR user until the second
compatibility or interoperability of payment year, as described in § 495.20 or
certified EHR technology. §§ 495.24 and 495.40.
(2) Implemented technologies, stand- (v) Exception for Medicare EPs for 2012
ards, policies, practices, and agree- and 2013—Participation in the Physician
ments reasonably calculated to ensure, Quality Reporting System-Medicare EHR
to the greatest extent practicable and Incentive Pilot. To satisfy the clinical
permitted by law, that the certified quality measure reporting require-
EHR technology was, at all relevant ments of meaningful use, aside from at-
times— testation, an EP participating in the
(i) Connected in accordance with ap- Physician Quality Reporting System
plicable law; may also participate in the Physician
(ii) Compliant with all standards ap- Quality Reporting System-Medicare
plicable to the exchange of informa- EHR Incentive Pilot through one of the
tion, including the standards, imple- following methods:
mentation specifications, and certifi- (A) Submission of data extracted
cation criteria adopted at 45 CFR part from the EP’s certified EHR tech-
170; nology through a Physician Quality
(iii) Implemented in a manner that Reporting System qualified EHR data
allowed for timely access by patients submission vendor; or
to their electronic health information; (B) Submission of data extracted
and from the EP’s certified EHR tech-
(iv) Implemented in a manner that nology, which must also be through a
allowed for the timely, secure, and Physician Quality Reporting System
trusted bi-directional exchange of qualified EHR.
structured electronic health informa- (3) For all CYs, an EP who practices
tion with other health care providers in multiple physical locations, not all
(as defined by 42 U.S.C. 300jj(3)), includ- of which have certified EHR tech-
ing unaffiliated providers, and with dis- nology available, will demonstrate
parate certified EHR technology and meaningful use using only the loca-
vendors. tions where the EP has certified EHR
(3) Responded in good faith and in a technology available. (See also § 495.4
timely manner to requests to retrieve regarding the definition of meaningful
or exchange electronic health informa- EHR user).
tion, including from patients, health (b) Demonstration by eligible hospitals
care providers (as defined by 42 U.S.C. and CAHs. An eligible hospital or CAH
300jj(3)), and other persons, regardless must demonstrate that it satisfies each
of the requestor’s affiliation or tech- of the applicable objectives and associ-
nology vendor. ated measures under § 495.20, § 495.22, or
(ii) Reporting clinical quality informa- § 495.24; supports health information ex-
tion. Successfully report the clinical change and the prevention of health in-
quality measures selected by CMS to formation blocking or does not take
CMS or the States, as applicable, in the actions to limit or restrict the compat-
form and manner specified by CMS or ibility or interoperability of CEHRT,
the States, as applicable. as applicable for the EHR reporting pe-
(iii) Additional requirements for Med- riod; and engages in activities related
icaid EPs. For Medicaid EPs, if, in ac- to supporting providers with the per-
cordance with §§ 495.316 and 495.332, formance of CEHRT.
902
(1) For FY 2011— pital during the EHR reporting period

(i) Attestation. Attest, through a se- for which a selected measure is appli-
cure mechanism, in a manner specified cable.
by CMS (or for a Medicaid eligible hos- (D) For 2014 only, if the eligible hos-
pital, in a manner specified by the pital or CAH uses one of the options
State), that during the EHR reporting specified in § 495.20(b)(4) or (h)(3), it
period, the eligible hospital or CAH— must attest that it is unable to fully
(A) Used certified EHR and specify implement 2014 Edition certified EHR
the technology used. technology for an EHR reporting pe-
(B) Satisfied the required objectives riod in 2014 due to delays in 2014 Edi-
and associated measures under § 495.20 tion certified EHR technology avail-
or § 495.24. ability.
(C) Must specify the EHR reporting (E) For CYs 2015 through 2016, satis-
period and provide the result of each fied the required objectives and associ-
applicable measure for all patients ad- ated measures under § 495.22(e) for
mitted to the inpatient or emergency meaningful use.
department (POS 21 or 23) of the hos- (F) For CY 2017 and CY 2018:
pital during the EHR reporting period
(1) For an eligible hospital or CAH
for which a selected measure is appli-
attesting to CMS: An eligible hospital
cable.
or CAH that has successfully dem-
(ii) Additional requirements for Med-
onstrated it is a meaningful EHR user
icaid eligible hospitals. For Medicaid eli-
in any prior year may satisfy either
gible hospitals, if, in accordance with
the objectives and measures specified
§§ 495.316 and 495.332, CMS has approved
a State’s revised definition for mean- in § 495.22(f) for meaningful use or the
ingful use, in addition to meeting para- objectives and measures specified in
graphs (b)(1)(i) through (ii) of this sec- § 495.24(c) for meaningful use; an eligi-
tion, the eligible hospital must also ble hospital or CAH that has never suc-
demonstrate meeting the State’s re- cessfully demonstrated it is a meaning-
vised definition using the method ap- ful EHR user in any prior year must
proved by CMS. satisfy the objectives and measures
(iii) Exception for Medicaid eligible hos- specified in § 495.22(f) for meaningful
pitals. If a Medicaid eligible hospital use.
has adopted, implemented or upgraded (2) For an eligible hospital or CAH
certified EHR technology in the first attesting to a State for the Medicaid
payment year, the eligible hospital EHR Incentive Program: An eligible
need not demonstrate meaningful use hospital or CAH that has successfully
until the second payment year, as de- demonstrated it is a meaningful EHR
scribed in § 495.20 or §§ 495.24 and 495.40. user in any prior year may satisfy ei-
(2) For FY 2012 and subsequent ther the objectives and measures speci-
years— fied in § 495.22(e) for meaningful use or
(i) Attestation. Attest, through a se- the objectives and measures specified
cure mechanism, in a manner specified in § 495.24(d) for meaningful use; an eli-
by CMS (or for a Medicaid eligible hos- gible hospital or CAH that has never
pital, in a manner specified by the successfully demonstrated it is a mean-
State), that during the EHR reporting ingful EHR user in any prior year must
period, the eligible hospital or CAH— satisfy the objectives and measures
(A) Used certified EHR and specify specified in § 495.22(e) for meaningful
the technology used; use.
(B) For fiscal years before 2015, satis- (G) For CY 2019:
fied the required objectives and associ- (1) For an eligible hospital or CAH
ated measures under § 495.20 for the eli- attesting to CMS, satisfied the re-
gible hospital or CAH’s stage of mean- quired objectives and associated meas-
ingful use. ures under § 495.24(c) for meaningful
(C) Must specify the EHR reporting use.
period and provide the result of each (2) For an eligible hospital or CAH
applicable measure for all patients ad- attesting to a State for the Medicaid
mitted to the inpatient or emergency EHR Incentive Program, satisfied the
department (POS 21 or 23) of the hos- required objectives and associated
903
§ 495.40 42 CFR Ch. IV (10–1–24 Edition)
measures under § 495.24(d) for meaning- gible hospital or CAH must attest that
ful use. it—
(H) For CY 2024 and subsequent years, (1) Did not knowingly and willfully
for an eligible hospital or CAH attest- take action (such as to disable
ing to CMS, satisfied the required ob- functionality) to limit or restrict the
jectives and associated measures for compatibility or interoperability of
meaningful use as defined by CMS. certified EHR technology.
(I) Supporting providers with the per- (2) Implemented technologies, stand-
formance of CEHRT (SPPC). To engage ards, policies, practices, and agree-
in activities related to supporting pro- ments reasonably calculated to ensure,
viders with the performance of CEHRT, to the greatest extent practicable and
the eligible hospital or CAH— permitted by law, that the certified
(1) Must attest that it: EHR technology was, at all relevant
times—
(i) Acknowledges the requirement to
(i) Connected in accordance with ap-
cooperate in good faith with ONC di-
plicable law;
rect review of his or her health infor-
(ii) Compliant with all standards ap-
mation technology certified under the
plicable to the exchange of informa-
ONC Health IT Certification Program
tion, including the standards, imple-
if a request to assist in ONC direct re-
mentation specifications, and certifi-
view is received; and
cation criteria adopted at 45 CFR part
(ii) If requested, cooperated in good 170;
faith with ONC direct review of its (iii) Implemented in a manner that
health information technology cer- allowed for timely access by patients
tified under the ONC Health IT Certifi- to their electronic health information;
cation Program as authorized by 45 and
CFR part 170, subpart E, to the extent (iv) Implemented in a manner that
that such technology meets (or can be allowed for the timely, secure, and
used to meet) the definition of CEHRT, trusted bi-directional exchange of
including by permitting timely access structured electronic health informa-
to such technology and demonstrating tion with other health care providers
its capabilities as implemented and (as defined by 42 U.S.C. 300jj(3)), includ-
used by the eligible hospital or CAH in ing unaffiliated providers, and with dis-
the field. parate certified EHR technology and
(2) Optionally, may attest that it: vendors.
(i) Acknowledges the option to co- (3) Responded in good faith and in a
operate in good faith with ONC–ACB timely manner to requests to retrieve
surveillance of his or her health infor- or exchange electronic health informa-
mation technology certified under the tion, including from patients, health
ONC Health IT Certification Program care providers (as defined by 42 U.S.C.
if a request to assist in ONC–ACB sur- 300jj(3)), and other persons, regardless
veillance is received; and of the requestor’s affiliation or tech-
(ii) If requested, cooperated in good nology vendor.
faith with ONC–ACB surveillance of his (K) Actions to limit or restrict the
or her health information technology compatibility or interoperability of
certified under the ONC Health IT Cer- CEHRT. For an EHR reporting period
tification Program as authorized by 45 in CY 2022 and subsequent years, the el-
CFR part 170, subpart E, to the extent igible hospital or CAH must attest that
that such technology meets (or can be it did not knowingly and willfully take
used to meet) the definition of CEHRT, action (such as to disable
including by permitting timely access functionality) to limit or restrict the
to such technology and demonstrating compatibility or interoperability of
its capabilities as implemented and certified EHR technology.
used by the eligible hospital or CAH in (ii) Reporting clinical quality informa-
the field. tion. Successfully report the clinical
(J) Support for health information quality measures selected by CMS to
exchange and the prevention of infor- CMS or the States, as applicable, in the
mation blocking. For an EHR reporting form and manner specified by CMS or
period in CYs 2017 through 2021, the eli- the States, as applicable.
904
(iii) [Reserved] reporting information to CMS, not to

(iv) Additional requirements for Med- their respective state Medicaid agency.
icaid eligible hospitals. For Medicaid eli- (B) Dual-eligible eligible hospitals
gible hospitals if, in accordance with and CAHs that demonstrate meaning-
§§ 495.316 and 495.332, CMS has approved ful use to their state Medicaid agency
a State’s revised definition for mean- may only qualify for an incentive pay-
ingful use, in addition to meeting para- ment under Medicaid and will not qual-
graphs (b)(2)(i) through (iii) of this sec- ify for an incentive payment under
tion, the eligible hospital must also Medicare and/or avoid the Medicare
demonstrate meeting the State’s repayment reduction.
vised definition using the method ap- (c) Review of meaningful use. (1) CMS
proved by CMS. (and in the case of Medicaid EPs and
(v) Exception for Medicare EPs for 2012 eligible hospitals, States) may review
and 2013—Participation in the Physician an EP, eligible hospital or CAH’s dem-
Quality Reporting System-Medicare EHR onstration of meaningful use.
Incentive Pilot. To satisfy the clinical (2) All EPs, eligible hospitals, and
quality measure reporting require- CAHs must keep documentation sup-
ments of meaningful use, aside from at- porting their demonstration of mean-
testation, an EP participating in the ingful use for 6 years.
Physician Quality Reporting System [75 FR 44565, July 28, 2010. Redesignated at 80
may also participate in the Physician FR 62943, Oct. 16, 2015]
Quality Reporting System-Medicare
EHR Incentive Pilot through one of the EDITORIAL NOTE: For FEDERAL REGISTER ci-
tations affecting § 495.40, see the List of CFR
following methods: Sections Affected, which appears in the
(A) Submission of data extracted Finding Aids section of the printed volume
from the EP’s certified EHR tech- and at www.govinfo.gov.
nology through a Physician Quality
Reporting System qualified EHR data § 495.60 Participation requirements
submission vendor; or for EPs, eligible hospitals, and
(B) Submission of data extracted CAHs.
from the EP’s certified EHR tech- (a) An eligible hospital, CAH or EP
nology, which must also be through a must submit in a manner specified by
Physician Quality Reporting System CMS the following information in the
qualified EHR. first payment year:
(vi) Exception for Medicare eligible hos- (1) Name of the EP, eligible hospital
pitals and CAHs for FY 2012 and 2013— or CAH.
Participation in the Medicare EHR Incen- (2) National Provider Identifier
tive Program Electronic Reporting Pilot. (NPI).
In order to satisfy the clinical quality (3) Business address, business email
measure reporting requirements of address, and phone number.
meaningful use, aside from attestation, (4) Such other information as speci-
a Medicare eligible hospital or CAH fied by CMS.
may participate in the Medicare EHR (b) In addition to the information
Incentive Program Electronic Report- submitted under paragraph (a) of this
ing Pilot. section, an eligible hospital or CAH,
(vii) Exception for dual-eligible eligible must, in the first payment year, sub-
hospitals and CAHs beginning in CY 2019. mit in a manner specified by CMS its
(A) Beginning with the EHR reporting CMS Certification Number (CCN) and
period in CY 2019, dual-eligible eligible its Taxpayer Identification Number
hospitals and CAHs (those that are eli- (TIN).
gible for an incentive payment under (c) Subject to paragraph (f) of this
Medicare for meaningful use of CEHRT section, in addition to the information
and/or subject to the Medicare pay- submitted under paragraph (a) of this
ment reduction for failing to dem- section, an EP must submit in a man-
onstrate meaningful use, and are also ner specified by CMS, the Taxpayer
eligible to earn a Medicaid incentive Identification Number (TIN) which
payment for meaningful use) must sat- may be the EP’s Social Security Num-
isfy the requirements under paragraph ber (SSN) to which the EP’s incentive
(b)(2) of this section by attestation and payment should be made.
905
§ 495.100 42 CFR Ch. IV (10–1–24 Edition)
(d) In the event the information spec- (3) Each EP may reassign the entire
ified in paragraphs (a) through (c) of amount of the incentive payment to
this section as previously submitted to only one employer or entity.
CMS is no longer accurate, the EP, eli- [75 FR 44565, July 28, 2010, as amended at 77
gible hospital or CAH must provide up- FR 54157, Sept. 4, 2012. Redesignated at 80 FR
dated information to CMS or the State 62943, Oct. 16, 2015]
on a timely basis in the manner speci-
fied by CMS or the State. Subpart B—Requirements Specific
(e) An EP that qualifies as both a to the Medicare Program
Medicaid EP and Medicare EP—
(1) Must notify CMS in the manner § 495.100 Definitions.
specified by CMS as to whether he or In this subpart unless otherwise indi-
she elects to participate in the Medi- cated—
care or the Medicaid EHR incentive Covered professional services means (as
program; specified in section 1848(k)(3) of the
(2) After receiving at least one EHR Act) services furnished by an EP for
incentive payment, may switch be- which payment is made under, or is
tween the two EHR incentive programs based on, the Medicare physician fee
only one time, and only for a payment schedule.
year before 2015; Eligible hospital means a hospital sub-
ject to the prospective payment system
(3) Must, for each payment year,
specified in § 412.1(a)(1) of this chapter,
meet all of the applicable require-
excluding those hospitals specified in
ments, including applicable patient
§ 412.23 of this chapter, excluding those
volume requirements, for the program hospital units specified in § 412.25 of
in which he or she chooses to partici- this chapter, and including Puerto Rico
pate (Medicare or Medicaid); eligible hospitals unless otherwise indi-
(4) Is limited to receiving, in total, cated.
the maximum payments the EP would Eligible professional (EP) means a phy-
receive under the Medicaid EHR pro- sician as defined in section 1861(r) of
gram, as described in subpart D of this the Act, which includes, with certain
part; and limitations, all of the following types
(5) Is placed in the payment year the of professionals:
EP would have been in had the EP (1) A doctor of medicine or osteop-
begun in and remained in the program athy.
to which he or she has switched. For (2) A doctor of dental surgery or med-
example, an EP that begins receiving icine.
Medicaid incentive payments in 2011, (3) A doctor of podiatric medicine.
and then switches to the Medicare pro- (4) A doctor of optometry.
gram for 2012, is in his or her second (5) A chiropractor.
payment year in 2012. Geographic health professional shortage
(f) Limitations on incentive payment re- area (HPSA) means a geographic area
that is designated by the Secretary
assignments. (1) EPs are permitted to
under section 332(a)(1)(A) of the PHS
reassign their incentive payments to
Act as of December 31 of the year prior
their employer or to an entity with
to the payment year as having a short-
which they have a contractual arrange-
age of health professionals.
ment allowing the employer or entity Puerto Rico eligible hospital means a
to bill and receive payment for the subsection (d) Puerto Rico hospital as
EP’s covered professional services. defined in section 1886(d)(9)(A) of the
(2)(i) Assignments in Medicare must Social Security Act.
be consistent with Section 1842(b)(6)(A) Qualifying CAH means a CAH that is
of the Act and 42 CFR part 424 subpart a meaningful EHR user for the EHR re-
F. porting period applicable to a payment
(ii) Medicaid EPs may also assign year or payment adjustment year in
their incentive payments to a TIN for which a cost reporting period begins.
an entity promoting the adoption of Qualifying eligible professional (quali-
EHR technology, consistent with sub- fying EP) means an EP who is a mean-
part D of this part. ingful EHR user for the EHR reporting
906
period applicable to a payment or pay- (2)(i) If the first payment year for a
ment adjustment year and who is not a qualifying EP is 2014, then the payment
hospital-based EP, as determined for limit for a payment year for the quali-
that payment or payment adjustment fying EP is the same as the amount
year. specified in paragraph (b)(1) of this sec-
Qualifying hospital means an eligible tion for such payment year for a quali-
hospital that is a meaningful EHR user fying EP whose first payment year is
for the EHR reporting period applicable 2013.
to a payment or payment adjustment (ii) If the first payment year for a
year. qualifying EP is after 2014, then the
[75 FR 44565, July 28, 2010, as amended at 77 payment limit specified in this para-
FR 54157, Sept. 4, 2012; 83 FR 41710, Aug. 17, graph for such EP for such year and
2018] any subsequent year is $0.
(c) Increase in incentive payment limit
§ 495.102 Incentive payments to EPs. for EPs who predominantly furnish serv-
(a) General rules. (1) Subject to para- ices in a geographic HPSA. In the case of
graph (b) of this section, in addition to a qualifying EP who furnishes more
the amount otherwise paid under sec- than 50 percent of his or her covered
tion 1848 of the Act, there must be paid professional services during the pay-
to a qualifying EP (or to an employer ment year in a geographic HPSA that
or entity in the cases described in sec- is designated as of December 31 of the
tion 1842(b)(6)(A) of the Act) for a pay- prior year, the incentive payment limit
ment year an amount equal to 75 per- determined under paragraph (b) of this
cent of the estimated allowed charges section is to be increased by 10 percent.
for covered professional services fur- (d) Payment adjustment effective in CY
nished by the EP during the payment 2015 and subsequent years for nonquali-
year. fying EPs. (1) Subject to paragraphs
(2) For purposes of this paragraph (a) (d)(3) and (4) of this section, for CY 2015
of this section, the estimated allowed through the end of CY 2018, for covered
charges for the qualifying EP’s covered professional services furnished by an
professional services during the pay- EP who is not hospital-based, and who
ment year are determined based on is not a qualifying EP by virtue of not
claims submitted no later than 2 being a meaningful EHR user (for the
months after the end of the payment EHR reporting period applicable to the
year, and, in the case of a qualifying payment adjustment year), the pay-
EP who furnishes covered professional ment amount for such services is equal
services in more than one practice, are to the product of the applicable percent
determined based on claims submitted specified in paragraph (d)(2) of this sec-
for the EP’s covered professional serv- tion and the Medicare physician fee
ices across all such practices. schedule amount for such services.
(b) Limitations on amounts of incentive (2) Applicable percent. Applicable per-
payments. (1) Except as otherwise pro- cent is as follows:
vided in paragraphs (b)(2) and (c) of (i) For 2015, 99 percent if the EP is
this section, the amount of the incen- not subject to the payment adjustment
tive payment under paragraph (a) of for an EP who is not a successful elec-
this section for each payment year is tronic prescriber under section
limited to the following amounts: 1848(a)(5) of the Act, or 98 percent if the
(i) For the first payment year, $15,000 EP is subject to the payment adjust-
(or, if the first payment year for such ment for an EP who is not a successful
qualifying EP is 2011 or 2012, $18,000). electronic prescriber under section
(ii) For the second payment year, 1848(a)(5) of the Act).
$12,000. (ii) For 2016, 98 percent.
(iii) For the third payment year, (iii) For 2017, 97 percent.
$8,000. (iv) For 2018, 97 percent, except as
(iv) For the fourth payment year, provided in paragraph (d)(3) of this sec-
$4,000. tion.
(v) For the fifth payment year, $2,000. (3) Decrease in applicable percent in
(vi) For any succeeding payment year certain circumstances. In CY 2018, if the
for such professional, $0. Secretary finds that the proportion of
907
§ 495.102 42 CFR Ch. IV (10–1–24 Edition)
EPs who are meaningful EHR users is treme and uncontrollable cir-
less than 75 percent, the applicable per- cumstances that prevent it from be-
cent must be decreased by 1 percentage coming a meaningful EHR user. Appli-
point for EPs from the applicable per- cations requesting this exception must
cent in the preceding year. be submitted by July 1 of the year be-
(4) Exceptions. The Secretary may, on fore the applicable payment adjust-
a case-by-case basis, exempt an EP ment year, or a later date specified by
from the application of the payment CMS.
adjustment under paragraph (d)(1) of (iv) An EP may request an exception
this section if the Secretary deter- through an application submitted by
mines that compliance with the re-
July 1 of the year before the applicable
quirement for being a meaningful EHR
payment adjustment year, or a later
user would result in a significant hard-
ship for the EP. To be considered for an date specified by CMS due to difficulty
exception, an EP must submit, in the in meeting meaningful use based on
manner specified by CMS, an applica- any one of the following during the pe-
tion demonstrating that it meets one riod that begins 2 calendar years before
or more of the criteria in this para- the payment adjustment year through
graph (d)(4) unless otherwise specified the application deadline:
in the criteria. The Secretary’s deter- (A) The EP practices at multiple lo-
mination to grant an EP an exemption cations and can demonstrate inability
may be renewed on an annual basis, to control the availability of Certified
provided that in no case may an EP be EHR Technology at one such practice
granted an exemption for more than 5 location or a combination of practice
years. locations, and where the location or lo-
(i) During any 90-day period from the cations constitute more than 50 per-
beginning of the year that is 2 years cent of their patient encounters.
before the payment adjustment year to (B) The EP can demonstrate dif-
July 1 of the year preceding the pay- ficulty in meeting meaningful use on
ment adjustment year, or a later date the basis of lack of face-to-face or tele-
specified by CMS, the EP was located medicine interaction with patients and
in an area without sufficient Internet
lack of need for follow up with pa-
access to comply with the meaningful
tients.
use objectives requiring internet
connectivity, and faced insurmount- (C) The EP has a primary specialty
able barriers to obtaining such internet listed in PECOS as anesthesiology, ra-
connectivity. Applications requesting diology or pathology 6 months prior to
this exception must be submitted no the first day of the payment adjust-
later than July 1 of the year before the ments that would otherwise apply.
applicable payment adjustment year, Such an EP may be deemed to qualify
or a later date specified by CMS. for this exception, subject to the 5-year
(ii) The EP has been practicing for limit that applies to all exceptions
less than 2 years. under this paragraph.
(iii)(A) During the calendar year that (v) For the 2018 payment adjustment
is 2 calendar years before the payment only, an EP who has not successfully
adjustment year, the EP that has pre- demonstrated meaningful use in a prior
viously demonstrated meaningful use year, intends to attest to meaningful
faces extreme and uncontrollable cir- use for an EHR reporting period in 2017
cumstances that prevent it from be- by October 1, 2017 to avoid the 2018 pay-
coming a meaningful EHR user. Appli- ment adjustment, and intends to tran-
cations requesting this exception must sition to the Merit-Based Incentive
be submitted no later than July 1 of Payment System (MIPS) and report on
the year before the applicable payment measures specified for the advancing
adjustment year, or a later date speci-
care information performance category
fied by CMS.
under the MIPS in 2017. The EP must
(B) During the calendar year pre-
ceding the payment adjustment year, explain in the application why dem-
the EP that has not previously demonstrating meaningful use for an EHR
onstrated meaningful use faces ex- reporting period in 2017 would result in
908
a significant hardship. Applications re- scribed in paragraph (c) of this section

questing this exception must be sub- for the period specified in paragraph (b)
mitted no later than October 1, 2017, or of this section.
a later date specified by CMS. (b) Transition periods. Subject to para-
(5) Exception for decertified EHR tech- graph (d) of this section and the pay-
nology. The Secretary shall exempt an ment formula specified in paragraph (c)
EP from the application of the pay- of this section, qualifying hospitals
ment adjustment for CY 2018 under may receive incentive payments during
paragraph (d)(1) of this section if the transition periods which comprise the
Secretary determines that compliance following fiscal years:
with the requirement for being a mean- (1) Hospitals whose first payment
ingful EHR user is not possible because year is FY 2011 may receive such pay-
the certified EHR technology used by ments for FYs 2011 through 2014.
the EP has been decertified under (2) Hospitals whose first payment
ONC’s Health IT Certification Pro- year is FY 2012 may receive such pay-
gram. To be considered for an excep- ments for FYs 2012 through 2015.
tion, an EP must submit, in the man- (3) Hospitals whose first payment
ner specified by CMS, an application year is FY 2013 may receive such pay-
demonstrating that the certified EHR ments for FYs 2013 through 2016.
technology was decertified during the (4) Hospitals whose first payment
12-month period preceding the applica- year is FY 2014 may receive such pay-
ble EHR reporting period for the CY ments for FY 2014 through 2016.
2018 payment adjustment year, or dur- (5) Hospitals whose first payment
ing the applicable EHR reporting pe- year is FY 2015 may receive such pay-
riod for the CY 2018 payment adjustments for FY 2015 through 2016.
ment year, and that the EP made a (6) Puerto Rico eligible hospitals
good faith effort to obtain another cer- whose first payment year is FY 2016
tified EHR technology for that EHR re- may receive such payments for FYs
porting period. Applications requesting 2016 through 2019.
this exception must be submitted no (7) Puerto Rico eligible hospitals
later than October 1, 2017, or a later whose first payment year is FY 2017
date specified by CMS. may receive such payments for FYs
(6) Payment adjustments not applicable 2017 through 2020.
to hospital-based EPs. No payment ad- (8) Puerto Rico eligible hospitals
justment under paragraphs (d)(1) whose first payment year is FY 2018
through (3) of this section may be made may receive such payments for FYs
in the case of a hospital-based eligible 2018 through 2021.
professional, as defined in § 495.4. (9) Puerto Rico eligible hospitals
(7) Payment adjustments not applicable whose first payment year is FY 2019
to ambulatory surgical center-based EPs. may receive such payments for FYs
For the CY 2017 and CY 2018 payment 2019 through 2021.
adjustment years, no payment adjust- (10) Puerto Rico eligible hospitals
ment under paragraphs (d)(1) through whose first payment year is FY 2020
(3) of this section may be made in the may receive such payments for FYs
case of an ambulatory surgical center- 2020 through 2021.
based eligible professional, as defined (c) Payment methodology. (1) The in-
in § 495.4. centive payment for each payment
year is calculated as the product of the
FR 54157, Sept. 4, 2012; 77 FR 54157, Sept. 4, following:
2012; 79 FR 68009, Nov. 13, 2014; 81 FR 77557, (i) The initial amount determined
Nov. 4, 2016; 81 FR 79892, Nov. 14, 2016; 82 FR under paragraph (c)(3) of this section.
38518, Aug. 14, 2017] (ii) The Medicare share fraction de-
termined under paragraph (c)(4) of this
§ 495.104 Incentive payments to eligi- section.
ble hospitals. (iii) The transition factor determined
(a) General rule. A qualifying hospital under paragraph (c)(5) of this section.
(as defined in this subpart) must re- (2) Interim and final payments. CMS
ceive the special incentive payment as uses data on hospital acute care inpa-
determined under the formulas de- tient discharges, Medicare Part A
909
§ 495.104 42 CFR Ch. IV (10–1–24 Edition)
acute care inpatient bed-days, Medi- vantage organization (as defined in

care Part C acute care inpatient bed- § 422.2 of this chapter).
days, and total acute care inpatient (B) A denominator which is the prod-
bed-days from the latest submitted 12- uct of—
month hospital cost report as the basis (1) The total number of acute care in-
for making preliminary incentive pay- patient-bed-days; and
ments. Final payments are determined (2) The total amount of the eligible
at the time of settling the first 12- hospital’s charges, not including any
month hospital cost report for the hos- charges that are attributable to char-
pital fiscal year that begins on or after ity care, divided by the estimated total
the first day of the payment year, and amount of the hospitals charges.
settled on the basis of data from that (5) Transition factor. For purposes of
cost reporting period. In cases where the payment formula, the transition
there is no 12-month hospital cost re- factor is as follows:
port period beginning on or after the (i) For hospitals whose first payment
first day of the payment year, final year is FY 2011—
payments may be determined and set- (A) 1 for FY 2011;
tled on the basis of data from the most (B) 3⁄4 for FY 2012;
recently submitted 12-month hospital (C) 1⁄2 for FY 2013; and
cost report. (D) 1⁄4 for FY 2014.
(3) Initial amount. The initial amount (ii) For hospitals whose first pay-
is equal to one of the following: ment year is FY 2012—
(i) For each hospital with 1,149 acute (A) 1 for FY 2012;
care inpatient discharges or fewer, (B) 3⁄4 for FY 2013;
$2,000,000. (C) 1⁄2 for FY 2014; and
(ii) For each hospital with at least (D) 1⁄4 for FY 2015;
1,150 but no more than 23,000 acute care (iii) For hospitals whose first pay-
inpatient discharges, $2,000,000 + [$200 × ment year is FY 2013—
(n ¥ 1,149)], where n is the number of (A) 1 for FY 2013;
discharges for the hospital. (B) 3⁄4 for FY 2014;
(C) 1⁄2 for FY 2015; and
(iii) For each hospital with more
(D) 1⁄4 for FY 2016.
than 23,000 acute care inpatient dis-
(iv) For hospitals whose first pay-
charges, $6,370,200.
ment year is FY 2014—
(4) Medicare share fraction—(i) Gen- (A) 3⁄4 for FY 2014;
eral. (A) CMS determines the Medicare (B) 1⁄2 for FY 2015; and
share fraction for an eligible hospital (C) 1⁄4 for FY 2016.
by using the number of Medicare Part (v) For hospitals whose first payment
A, Medicare Part C, and total acute year is FY 2015—
care inpatient-bed-days using data (A) 1⁄2 for FY 2015; and
from the Medicare cost report as speci- (B) 1⁄4 for FY 2016.
fied by CMS. (vi) For Puerto Rico eligible hos-
(B) CMS computes the denominator pitals whose first payment year is FY
of the Medicare share fraction using 2016—
the charity care charges reported on (A) 1 for FY 2016;
the hospital’s Medicare cost report. (B) 3⁄4 for FY 2017;
(ii) The Medicare share fraction is (C) 1⁄2 for FY 2018; and
the ratio of— (D) 1⁄4 for FY 2019.
(A) A numerator which is the sum (vii) For Puerto Rico eligible hos-
of— pitals whose first payment year is FY
(1) The number of inpatient-bed-days 2017—
which are attributable to individuals (A) 1 for FY 2017;
with respect to whom payment may be (B) 3⁄4 for FY 2018;
made under Part A, including individ- (C) 1⁄2 for FY 2019; and
uals enrolled in section 1876 Medicare (D) 1⁄4 for FY 2020;
cost plans; and (viii) For Puerto Rico eligible hos-
(2) The number of inpatient-bed-days pitals whose first payment year is FY
which are attributable to individuals 2018—
who are enrolled with a Medicare Ad- (A) 1 for FY 2018;
910
(B) 3⁄4 for FY 2019; for the purchase of certified EHR tech-
(C) 1⁄2 for FY 2020; and nology and the Medicare share percent-
(D) 1⁄4 for FY 2021. age.
(ix) For Puerto Rico eligible hos- (2) Calculation of reasonable costs.
pitals whose first payment year is FY CMS or its Medicare contractor com-
2019— putes a qualifying CAH’s reasonable
(A) 3⁄4 for FY 2019; costs incurred for the purchase of cer-
(B) 1⁄2 for FY 2020; and
tified EHR technology, as defined in
(C) 1⁄4 for FY 2021.
(x) For Puerto Rico eligible hospitals paragraph (a) of this section, as the
whose first payment year is FY 2020— sum of—
(A) 1⁄2 for FY 2020; and (i) The reasonable costs incurred for
(B) 1⁄4 for FY 2021. the purchase of certified EHR tech-
(d) No incentive payment for non- nology during the cost reporting period
qualifying hospitals. After the first that begins in a payment year; and
payment year, an eligible hospital will (ii) Any reasonable costs incurred for
not receive an incentive payment for the purchase of certified EHR tech-
any payment year during which it is nology in cost reporting periods begin-
not a qualifying hospital. ning in years prior to the payment
[75 FR 44565, July 28, 2010, as amended at 78 year which have not been fully depre-
FR 75200, Dec. 10, 2013; 83 FR 41710, Aug. 17, ciated as of the cost reporting period
2018; 85 FR 59027, Sept. 18, 2020] beginning in the payment year.
(3) Medicare share percentage. Not-
§ 495.106 Incentive payments to CAHs. withstanding the percentage applicable
(a) Definitions. In this section, unless under § 413.70(a)(1) of this chapter, the
otherwise indicated— Medicare share percentage equals the
Payment year means a Federal fiscal lesser of—
year beginning after FY 2010 but before (i) 100 percent; or
FY 2016. (ii) The sum of the Medicare share
Qualifying CAH means a CAH that
fraction for the CAH as calculated
would meet the definition of a mean-
under § 495.104(c)(4) of this subpart and
ingful EHR user at § 495.4, if it were an
eligible hospital. 20 percentage points.
Reasonable costs incurred for the pur- (d) Incentive payments made to CAHs.
chase of certified EHR technology for a (1) The amount of the incentive pay-
qualifying CAH means the reasonable ment made to a qualifying CAH under
acquisition costs incurred for the pur- this section represents the expensing
chase of depreciable assets as described and payment of the reasonable costs
in part 413 subpart G of this chapter, computed in paragraph (c) of this sec-
such as computers and associated hard- tion in a single payment year and, as
ware and software, necessary to admin- specified in § 413.70(a)(5) of this chapter,
ister certified EHR technology as de- such payment is made in lieu of pay-
fined in § 495.4, excluding any deprecia- ment that would have been made under
tion and interest expenses associated § 413.70(a)(1) of this chapter for the rea-
with the acquisition. sonable costs of the purchase of cer-
(b) General rule. A qualifying CAH re- tified EHR technology including depre-
ceives an incentive payment for its ciation and interest expenses associ-
reasonable costs incurred for the pur- ated with the acquisition.
chase of certified EHR technology, as (2) The amount of the incentive pay-
defined in paragraph (a) of this section, ment made to a qualifying CAH under
in the manner described in paragraph
this section is paid through a prompt
(c) of this section for a cost reporting
interim payment for the applicable
period beginning during a payment
year as defined in paragraph (a) of this payment year after—
section. (i) The CAH submits the necessary
(c) Payment methodology—(1) Payment documentation, as specified by CMS or
amount. A qualifying CAH receives an its Medicare contractors, to support
incentive payment amount equal to the the computation of the incentive pay-
product of its reasonable costs incurred ment amount under this section; and
911
§ 495.108 42 CFR Ch. IV (10–1–24 Edition)
(ii) CMS or its Medicare contractor amount made under paragraph (d) of
reviews such documentation and deter- this section.
mines the interim amount of the incen-
tive payment. FR 54158, Sept. 4, 2012]
(3) The interim incentive payment
made under this paragraph is subject § 495.108 Posting of required informa-
to a reconciliation process as specified tion.
by CMS and the final incentive pay-
ment as determined by CMS or its (a) CMS posts, on its Internet Web
Medicare contractor is considered pay- site, the following information regard-
ment in full for the reasonable costs ining EPs, eligible hospitals, and CAHs
curred for the purchase of certified receiving an incentive payment under
EHR technology in a single payment subparts B and C of this part:
year. (1) Name.
(4) In no case may an incentive pay- (2) Business addressee.
ment be made with respect to a cost re- (3) Business phone number.
porting period beginning during a pay- (4) Such other information as speci-
ment year before FY 2011 or after FY fied by CMS.
2015 and in no case may a CAH receive (b) CMS posts, on its Internet Web
an incentive payment under this sec- site, the following information for
tion with respect to more than 4 con- qualifying MA organizations that re-
secutive payment years. ceive an incentive payment under sub-
(e) Reductions in payment to CAHs. part C of this part—
For cost reporting periods beginning in (1) The information specified in para-
FY 2015, if a CAH is not a qualifying graph (a) of this section for each of the
CAH for a payment adjustment year, qualifying MA organization’s MA plan
then the payment for inpatient serv- information; and
ices furnished by a CAH under (2) The information specified in para-
§ 413.70(a) of this chapter is adjusted by graph (a) of this section for each of the
the applicable percentage described in qualifying MA organization’s MA EPs
§ 413.70(a)(6) of this chapter unless oth- and MA-affiliated eligible hospitals.
erwise exempt from such adjustment.
(f) Administrative or judicial review. § 495.110 Preclusion on administrative
There is no administrative or judicial and judicial review.
review under sections 1869 or 1878 of the There is no administrative or judicial
Act, or otherwise, of the— review under sections 1869 or 1878 of the
(1) Methodology and standards for de- Act, or otherwise, of the following:
termining the amount of payment, the
(a) For EPs—
reasonable cost, and adjustments de-
(1) The methodology and standards
scribed in this section including selec-
for determining EP incentive payment
tion of periods for determining, and
amounts;
making estimates or using proxies of,
inpatient-bed-days, hospital charges, (2) The methodology and standards
charity charges, and the Medicare for determining the payment adjust-
share percentage as described in this ments that apply to EPs beginning
section; with 2015;
(2) Methodology and standards for de- (3) The methodology and standards
termining if a CAH is a qualifying CAH for determining whether an EP is a
under this section; meaningful EHR user, including—
(3) Specification of EHR reporting pe- (i) The selection of clinical quality
riods, cost reporting periods, payment measures; and
years, and fiscal years used to compute (ii) The means of demonstrating
the CAH incentive payment as speci- meaningful EHR use.
fied in this section; and (4) The methodology and standards
(4) Identification of the reasonable for determining the hardship exception
costs used to compute the CAH incen- to the payment adjustments;
tive payment under paragraph (c) of (5) The methodology and standards
this section including any reconcili- for determining whether an EP is hos-
ation of the CAH incentive payment pital-based; and
912
(6) The specification of the EHR re- manner as that term is defined and
porting period, as well as whether pay- used for purposes of implementing sec-
ment will be made only once, in a sin- tion 4201(a) of the American Recovery
gle consolidated payment, or in peri- and Reinvestment Act of 2009 with re-
odic installments. spect to the Medicare FFS hospital
(b) For eligible hospitals— EHR incentive program in § 495.104 of
(1) The methodology and standards this part.
for determining the incentive payment MA payment adjustment year means—
amounts made to eligible hospitals, in- (1) Except as provided in paragraph
cluding— (2) of this definition, for qualifying MA
(i) The estimates or proxies for deter- organizations that receive an MA EHR
mining discharges, inpatient-bed-days, incentive payment for at least 1 pay-
hospital charges, charity charges, and ment year, calendar years beginning
Medicare share; and with CY 2015.
(ii) The period used to determine
(2) For qualifying MA organizations
such estimate or proxy;
that receive an MA EHR incentive pay-
(2) The methodology and standards
ment for a qualifying MA-affiliated eli-
for determining the payment adjust-
gible hospital in Puerto Rico for at
ments that apply to eligible hospitals
least 1 payment year, and that have
beginning with FY 2015;
(3) The methodology and standards not previously received an MA EHR in-
for determining whether an eligible centive payment for a qualifying MA-
hospital is a meaningful EHR user, in- affiliated eligible hospital not in Puer-
cluding— to Rico, calendar years beginning with
(i) The selection of clinical quality CY 2022.
measures; and (3) For MA-affiliated eligible hos-
(ii) The means of demonstrating pitals, the applicable EHR reporting
meaningful EHR use. period for purposes of determining
(4) The methodology and standards whether the MA organization is subject
for determining the hardship exception to a payment adjustment is the Fed-
to the payment adjustments; and eral fiscal year ending in the MA pay-
(5) The specification of the EHR re- ment adjustment year.
porting period, as well as whether pay- (4) For MA EPs, the applicable EHR
ment will be made only once, in a sin- reporting period for purposes of deter-
gle consolidated payment, or in peri- mining whether the MA organization is
odic installments. subject to a payment adjustment is the
calendar year concurrent with the pay-
Subpart C—Requirements Specific ment adjustment year.
to Medicare Advantage (MA) Patient care services means health
care services for which payment would
Organizations be made under, or for which payment
§ 495.200 Definitions. would be based on, the fee schedule es-
tablished under Medicare Part B if
As used in this subpart:
they were furnished by an EP to a
First payment year means with respect
Medicare beneficiary.
to—
(1) Covered professional services fur- Payment year means—
nished by a qualifying MA EP, the first (1) For a qualifying MA EP, a cal-
calendar year for which an incentive endar year beginning with CY 2011 and
payment is made for such services ending with CY 2016; and
under this subsection to a qualifying (2) For an eligible hospital, a Federal
MA organization. fiscal year beginning with FY 2011 and
(2) Qualifying MA-affiliated eligible ending with FY 2016; and
hospitals, the first fiscal year for which (3) For an eligible hospital in Puerto
an incentive payment is made for Rico, a Federal fiscal year beginning
qualifying MA-affiliated eligible hos- with FY 2016 and ending with FY 2021.
pitals under this section to a quali- Potentially qualifying MA EPs and po-
fying MA organization. tentially qualifying MA-affiliated eligible
Inpatient-bed-days is defined in the hospitals are defined for purposes of
same manner and is used in the same this subpart in § 495.202(a)(4).
913
§ 495.202 42 CFR Ch. IV (10–1–24 Edition)
Qualifying MA-affiliated eligible hos- HMO, an organization recognized as an

pital means an eligible hospital under HMO under State law, or a similar or-
section 1886(n)(6) of the Act that is ganization regulated for solvency
under common corporate governance under State law in the same manner
with a qualifying MA organization, for and to the same extent as an HMO.
which at least two thirds of the Medi- Second, third, fourth, and fifth pay-
care hospital discharges (or bed-days) ment year means with respect to incen-
are of (or for) Medicare individuals en- tive payments for qualifying—
rolled under MA plans, and that is a (1) MA EPs to a qualifying MA orga-
meaningful user of certified EHR tech- nization, each successive calendar year
nology as defined by § 495.4 of this part. immediately following the first pay-
In the case of a hospital for which at ment year for the qualifying MA orga-
least one-third of whose Medicare bed- nization. The first payment year and
days for the year are covered under each successive year immediately fol-
Part A rather than Part C, payment for lowing the first payment year, for the
that payment year must only be made qualifying MA organizations, through
under section 1886(n) of the Act and not 2016, is the same for all qualifying MA
under this section. EPs with respect to any specific quali-
Qualifying MA EP means all of the fying MA organization.
following: (2) MA-affiliated eligible hospitals to
(1) A physician (as described in sec- a qualifying MA organization, each
tion 1861(r) of the Act), including a doc- successive fiscal year immediately fol-
tor of medicine or osteopathy who is lowing the first payment year for the
either of the following: qualifying MA organization.
(i) Employed by a qualifying MA or- Under common corporate governance
ganization. means that a qualifying MA organiza-
(ii) Employed by, or is a partner of, tion and a qualifying MA-affiliated eli-
an entity that through a contract with gible hospital have a common parent
a qualifying MA organization furnishes corporation, that one is a subsidiary of
at least 80 percent of the entity’s Medi- the other, or that the organization and
care patient care services to enrollees the hospital have a common board of
of such organization. directors.
(2) Furnishes at least 80 percent of [75 FR 44565, July 28, 2010, as amended at 77
his or her professional services covered FR 54158, Sept. 4, 2012; 83 FR 41711, Aug. 17,
under Title XVIII to enrollees of the 2018]
qualifying MA organization.
(3) Furnishes, on average, at least 20 § 495.202 Identification of qualifying
hours per week of patient care services MA organizations, MA–EPs and MA-
to enrollees of the qualifying MA orga- affiliated eligible hospitals.
nization during the EHR reporting pe- (a) Identification of qualifying MA or-
riod. ganizations. (1) Beginning with bids due
(4) Is a meaningful user of certified in June 2011 (for plan year 2012), MA or-
EHR technology in accordance with ganizations seeking reimbursement for
§ 495.4 of this part. qualifying MA EPs and qualifying MA-
(5) Is not a ‘‘hospital-based EP’’ (as affiliated eligible hospitals under the
defined in § 495.4 of this part) and in de- MA EHR incentive program are re-
termining whether 90 percent or more quired to identify themselves to CMS
of his or her covered professional serv- in a form and manner specified by
ices were furnished in a hospital set- CMS, as part of submissions of initial
ting, only covered professional services bids under section 1854(a)(1)(A) of the
furnished to MA plan enrollees of the Act.
qualifying MA organization, in lieu of (2) Qualifying MA organizations of-
FFS patients, will be considered. fering MA HMO plans, absent evidence
Qualifying MA organization means a to the contrary, are deemed to meet
MA organization that is organized as a the definition of HMO in 42 U.S.C.
health maintenance organization 300gg–91(b)(3)—section 2791(b)(3) of the
(HMO) as defined in section 2791(b)(3) of PHS Act.
the Public Health Service (PHS) Act (3) Qualifying MA organizations of-
which includes a Federally qualified fering MA plan types other than HMOs,
914
must attest to the fact that they meet nished in a designated geographic
the definition of HMO in 42 U.S.C. HPSA (as defined in § 495.100 of this
300gg–91(b)(3)—section 2791(b)(3) of the part).
PHS Act. (4) Final identification of qualifying
(4) Beginning with bids due in June and potentially qualifying, as applica-
2014 (for plan year 2015), all MA organi- ble, MA EPs and MA-affiliated eligible
zations with potentially qualifying MA hospitals must be made within 2
EPs or potentially qualifying MA-af- months of the close of the payment
filiated eligible hospitals under the MA year or the EHR reporting period that
EHR incentive program must identify applies to the payment adjustment
themselves to CMS in a form and man- year as defined in § 495.200.
ner specified by CMS, as part of sub- (5) Beginning plan year 2015 and for
missions of initial bids under section subsequent plan years, all qualifying
1854(a)(1)(A) of the Act. ‘‘Potentially MA organizations, as part of their ini-
qualifying MA EPs’’ and ‘‘potentially tial bids in June for the following plan
qualifying MA-affiliated eligible hos- year must—
pitals’’ are those EPs and hospitals (i) Identify all MA EPs and MA-affili-
that meet the respective definitions of ated eligible hospitals of the MA orga-
‘‘qualifying MA EP’’ and ‘‘qualifying nization that the MA organization be-
MA-affiliated eligible hospital’’ in lieves will be either qualifying or po-
§ 495.200 but who (or which) are not tentially qualifying;
meaningful users of certified EHR (ii) Include information specified in
technology. paragraph (b)(2)(i) through (iii) of this
(b) Identification of qualifying MA EPs section for each professional or hos-
and qualifying MA-affiliated eligible hospital; and
pitals. (1) A qualifying MA organiza- (iii) Include an attestation that each
tion, as part of its initial bid starting professional and hospital either meets
with plan year 2012, must make a pre- or does not meet the EHR incentive
liminary identification of MA EPs and payment eligibility criteria.
MA-affiliated eligible hospitals that
the MA organization believes will be [75 FR 44565, July 28, 2010, as amended at 77
qualifying MA EPs and MA-affiliated FR 54158, Sept. 4, 2012]
eligible hospitals for which the organi-
zation is seeking incentive payments § 495.204 Incentive payments to quali-
fying MA organizations for quali-
for the current plan year. fying MA–EPs and qualifying MA-af-
(2) A qualifying MA organization filiated eligible hospitals.
must provide CMS with the following
for each MA EP or eligible hospital (a) General rule. A qualifying MA or-
when reporting under either paragraph ganization receives an incentive pay-
(b)(1) or (4) of this section: ment for its qualifying MA–EPs and its
(i) The MA EP’s or MA-affiliated eli- qualifying MA-eligible hospitals. The
gible hospital’s name. incentive payment amount paid to a
(ii) The address of the MA EP’s prac- qualifying MA organization for a—
tice or MA-affiliated eligible hospital’s (1) Qualifying MA–EP is the amount
location. determined under paragraph (b) of this
(iii) NPI or CCN. section; and
(iv) An attestation by MA organiza- (2) Qualifying MA-eligible hospital is
tion specifying that the MA EP or MA- the amount determined under para-
affiliated eligible hospital meets the graph (c) of this section.
eligibility criteria. (b) Amount payable to qualifying MA
(3) When reporting under either para- organization for qualifying MA EPs. (1)
graph (b)(1) or (4) of this section for CMS substitutes an amount deter-
purposes of receiving an incentive pay- mined to be equivalent to the amount
ment, a qualifying MA organization computed under § 495.102 of this part.
must also indicate whether more than (2) The qualifying MA organization
50 percent of the covered Medicare pro- must report to CMS within 2 months of
fessional services being furnished by a the close of the calendar year, the ag-
qualifying MA EP to MA plan enrollees gregate annual amount of revenue at-
of the MA organization are being fur- tributable to providing services that
915
§ 495.204 42 CFR Ch. IV (10–1–24 Edition)
would otherwise be covered as profes- amount of EHR incentive payment due

sional services under Part B received the MA organization.
by each qualifying MA EP for enrollees (c) Amount payable to qualifying MA
in MA plans of the MA organization in organization for qualifying MA-affiliated
the payment year. eligible hospitals. (1)(i) CMS substitutes
(3) CMS calculates the incentive an amount determined to be equivalent
amount for the MA organization for to the amount computed under
each qualifying MA EP as an amount § 495.104, to the extent data are not
equal to 75 percent of the reported an- available to compute payments for
nual revenue specified in paragraph qualifying MA-affiliated eligible hos-
(b)(2) of this section, up to the max- pitals under the Medicare FFS EHR
imum amounts specified under section hospital incentive program.
1848(o)(1)(B) of the Act. (ii) CMS uses the same methodology
(4) CMS requires the qualifying MA and defines ‘‘inpatient-bed-days’’and
organization to develop a methodo- other terms as used under the Medicare
logical proposal for estimating the por- FFS EHR hospital incentive program
tion of each qualifying MA EP’s salary in § 495.104 of this part in computing
or revenue attributable to providing amounts due qualifying MA organiza-
services that would otherwise be cov- tions for MA-affiliated eligible hos-
ered as professional services under Part pitals.
B to MA plan enrollees of the MA orga-
(2) To the extent data are available,
nization in the payment year. The
qualifying MA organizations must re-
methodological proposal—
ceive hospital incentive payments
(i) Must be approved by CMS; and
through their affiliated hospitals under
(ii) May include an additional
the Medicare FFS EHR hospital incen-
amount related to overhead, where ap-
tive program, rather than through the
propriate, estimated to account for the
MA EHR hospital incentive program.
MA-enrollee related Part B practice
costs of the qualifying MA EP. (d) Payment to qualifying MA organiza-
(iii) Methodological proposals must tions. CMS makes payment to quali-
be submitted to CMS by June of the fying MA organizations for qualifying
payment year and must be auditable by MA EPs only under the MA EHR incen-
an independent third-party. CMS will tive program and not under the Medi-
review and approve or disapprove such care FFS EHR incentive program to
proposals in a timely manner. the extent an EP has earned less than
(5) For qualifying MA EPs who are the maximum incentive payment for
not salaried, qualifying MA organiza- the same period under the Medicare
tions may obtain attestations from FFS EHR incentive program.
such qualifying MA EPs (or from enti- (e) Potential increase in incentive pay-
ties that the MA EPs are employed by ment for furnishing services in a geo-
or with which they have a partnership graphic HPSA. In the case of a quali-
interest) as to the amount of com- fying MA EP who furnishes more than
pensation received by such EPs for MA 50 percent of his or her covered profes-
plan enrollees of the MA organization. sional services to MA plan enrollees of
The organizations may submit to CMS the qualifying MA organization during
compensation information for each a payment year in a geographic HPSA,
such MA EP based on such attesta- the maximum amounts referred to in
tions. paragraph (b)(3) of this section are in-
(6) For qualifying MA EPs who are creased by 10 percent.
not salaried, qualified MA organiza- (f) Payment review under MA. To en-
tions may have qualifying MA EPs (or sure the accuracy of the incentive pay-
from entities that the MA EPs are em- ments, CMS conducts selected compli-
ployed by or with which they have a ance reviews of qualifying MA organi-
partnership interest) send MA organizations to ensure that EPs and eligible
zation compensation information di- hospitals for which such qualifying or-
rectly to CMS. CMS will use the infor- ganizations received incentive pay-
mation provided in this subparagraph ments were meaningful EHR users in
or paragraph (b)(5) of this section for accordance with § 422.504 of this chap-
no other purpose than to compute the ter.
916
(1) The reviews include validation of ment, or otherwise recoups the applica-
the status of the organization as a ble amounts.
qualifying MA organization, [75 FR 44565, July 28, 2010, as amended at 77
verification of meaningful use and re- FR 54158, Sept. 4, 2012]
view of data used to calculate incen-
tive payments. § 495.206 Timeframe for payment to
(2) MA organizations are required to qualifying MA organizations.
maintain evidence of their qualifica- (a) CMS makes payment to quali-
tion to receive incentive payments and fying MA organizations for qualifying
the data necessary to accurately cal- MA EPs under the MA EHR incentive
culate incentive payments. program after computing incentive
(3) Documents and records must be payments due under the Medicare FFS
maintained for 6 years from the date EHR incentive program according to
such payments are made with respect § 495.102.
to a given payment year. (b) Payments to qualifying MA orga-
(4) Payments that result from incor- nizations for qualifying MA-affiliated
rect or fraudulent attestations, cost eligible hospitals under common cor-
data, or any other submission required porate governance are made under the
to establish eligibility or to qualify for Medicare FFS EHR incentive program,
such payment, will be recouped by CMS following the timeline in specified in
from the MA organization. § 495.104 of this part. To the extent suf-
ficient data do not exist to pay quali-
(5) If an MA EP, or entity that em-
fying MA-affiliated eligible hospitals
ploys an MA EP, or in which an MA EP
under common corporate governance
has a partnership interest, MA-affili-
under the Medicare FFS EHR incentive
ated eligible hospital, or other party
program, payment is made under the
contracting with the MA organization, MA EHR incentive program, following
fails to comply with an audit request the same timeline in § 495.104 of this
to produce applicable documents or part.
data, CMS recoups all or a portion of
the incentive payment, based on the § 495.208 Avoiding duplicate payment.
lack of applicable documents or data. (a) CMS requires a qualifying MA or-
(g) Coordination of payment with FFS ganization that registers MA EPs for
or Medicaid EHR incentive programs. (1) the purpose of participating in the MA
If, after payment is made to an MA or- EHR Incentive Program to notify each
ganization for an MA EP, it is deter- of the MA EPs for which it is claiming
mined that the MA EP is eligible for an incentive payment that the MA or-
the full incentive payment under the ganization intends to claim, or has
Medicare FFS EHR Incentive Program claimed, the MA EP for the current
or has received a payment under the plan year under the MA EHR Incentive
Medicaid EHR Incentive Program, CMS Program.
recoups amounts applicable to the (b) The notice must make clear that
given MA EP from the MA organiza- the MA EP may still directly receive
tion’s monthly MA payment, or other- an EHR incentive payment if the MA
wise recoups the applicable amounts. EP is entitled to a full incentive pay-
(2) If, after payment is made to an ment under the FFS portion of the
MA organization for an MA-affiliated EHR Incentive Program, or if the MA
eligible hospital, it is determined that EP registered to participate under the
the hospital is ineligible for the incen- Medicaid portion of the EHR Incentive
tive payment under the MA EHR In- Program and is entitled to payment
centive Program, or has received a pay- under that program—in both of which
ment under the Medicare FFS EHR In- cases no payment would be made for
centive Program, or if it is determined the EP under the MA EHR incentive
that all or part of the payment should program.
not have been made on behalf of the (c) An attestation by the qualifying
MA-affiliated eligible hospital, CMS re- MA organization that the qualifying
coups amounts applicable to the given MA organization provided notice to its
MA-affiliated eligible hospital from the MA EPs in accordance with this sec-
MA organization’s monthly MA pay- tion must be required at the time that
917
§ 495.210 42 CFR Ch. IV (10–1–24 Edition)
meaningful use attestations are due § 495.211 Payment adjustments effec-

with respect to MA EPs for the pay- tive for 2015 and subsequent MA
ment year. payment years with respect to MA
(d) Unless a qualifying MA EP is en- EPs and MA-affiliated eligible hos-
pitals.
titled to a maximum payment for a
year under the Medicare FFS EHR in- (a) In general. Beginning for MA pay-
centive program, payment for such an ment adjustment year 2015, payment
individual is only made under the MA adjustments set forth in this section
EHR incentive program to a qualifying are made to prospective payments
MA organization. (issued under section 1853(a)(1)(A) of
(e) Payment to qualifying MA organi- the Act) of qualifying MA organiza-
zations for a qualifying MA-affiliated tions that previously received incen-
eligible hospital under common gov- tive payments under the MA EHR In-
centive Program, if all or a portion of
ernance only occurs under the MA EHR
the MA–EPs and MA-affiliated eligible
incentive program to the extent that
hospitals that would meet the defini-
sufficient data does not exist to pay
tion of qualifying MA–EPs or quali-
such hospital under the Medicare FFS
fying MA-affiliated eligible hospitals
hospital incentive program under (but for their demonstration of mean-
§ 495.104 of this part. In no event are ingful use) are not meaningful EHR
EHR incentive payments made for a users.
hospital for a payment year under this (b) Adjustment based on payment ad-
section to the extent they have been justment year. The payment adjustment
made for the same hospital for the is calculated based on the payment ad-
same payment year under § 495.104 of justment year.
this part. (c) Separate application of adjustments
(f) Each qualifying MA organization for MA EPs and MA-affiliated eligible
must ensure that all potentially quali- hospitals. The payment adjustments
fying MA EPs are enumerated through identified in paragraphs (d) and (e) of
the NPI system and that other identi- this section are applied separately.
fying information required under Paragraph (d) of this section applies
§ 495.202(b) is provided to CMS. only to qualifying MA organizations
that received payment for any MA pay-
FR 54159, Sept. 4, 2012] ment year for qualifying MA EPs under
§ 495.204. Paragraph (e) of this section
§ 495.210 Meaningful EHR user attesta- applies only to qualifying MA organiza-
tion. tions that received payment for any
MA payment year for qualifying MA-
(a) Qualifying MA organizations are
affiliated eligible hospitals under
required to attest, in a form and man-
§ 495.204.
ner specified by CMS, that each quali-
(d) Payment adjustments effective for
fying MA EP and qualifying MA-affili-
2015 and subsequent years with respect to
ated eligible hospitals is a meaningful
MA EPs. (1) For payment adjustment
EHR user. year 2015, and subsequent payment ad-
(b) Qualifying MA organizations are justment years, if a qualifying MA EP
required to attest within 2 months is not a meaningful EHR user during
after the close of a calendar year the payment adjustment year, CMS—
whether each qualifying MA EP is a (i) Determines a payment adjustment
meaningful EHR user. based on data from the payment ad-
(c) Qualifying MA organizations are justment year; and
required to attest within 2 months (ii) Collects the payment adjustment
after close of the FY whether each owed by adjusting a subsequent year’s
qualifying MA-affiliated eligible hos- prospective payment or payments
pital is a meaningful EHR user. (issued under section 1853(a)(1)(A) of
the Act), or by otherwise collecting the
FR 54159, Sept. 4, 2012] payment adjustment, if, in the year of
collection, the MA organization does
not have an MA contract with CMS.
918
(2) Beginning for payment adjust- ceived an incentive payment (or a po-
ment year 2015, a qualifying MA orga- tentially qualifying MA-affiliated eli-
nization that previously received in- gible hospital on behalf of its quali-
centive payments must, for each pay- fying MA organization) attests that a
ment adjustment year, report to CMS qualifying MA-affiliated eligible hos-
the following: pital is not a meaningful EHR user for
[the total number of potentially quali- a payment adjustment year.
fying MA EPs]/[(the total number (ii) The payment adjustment is cal-
of potentially qualifying MA EPs) + culated by multiplying the qualifying
(the total number of qualifying MA MA organization’s monthly prospective
EPs)]. payment for the payment adjustment
(3) The monthly prospective payment year under section 1853(a)(1)(A) of the
amount paid under section 1853(a)(1)(A) Act by the percent set forth in para-
of the Act for the payment adjustment graph (e)(2) of this section.
year is adjusted by the product of— (2) The percent set forth in this para-
(i) The percent calculated in accord- graph (e) is the product of—
ance with paragraph (d)(2) of this sec- (i) The percentage point reduction to
tion; the applicable percentage increase in
(ii) The Medicare Physician Expendi- the market basket index for the rel-
ture Proportion percent, which is evant Federal fiscal year as a result of
CMS’s estimate of proportion of ex- § 412.64(d)(3) of this chapter;
penditures under Parts A and B that (ii) The Medicare Hospital Expendi-
are not attributable to Part C that are ture Proportion percent specified in
attributable to expenditures for physi- paragraph (e)(3) of this section; and
cians’ services, adjusted for the propor- (iii) The percent of qualifying and po-
tion of expenditures that are provided tentially qualifying MA-affiliated eli-
by EPs that are neither qualifying nor gible hospitals that are not meaningful
potentially qualifying MA EPs with re- EHR users. Qualifying MA organiza-
spect to a qualifying MA organization; tions are required to report to CMS
and [the number of potentially qualifying
(iii) The applicable percent identified MA-affiliated eligible hospitals] /
in paragraph (d)(4) of this section. [(the total number of potentially
(4) Applicable percent. The applicable qualifying MA-affiliated eligible
percent is as follows: hospitals) + (the total number of
(i) For 2015, 1 percent; qualifying MA-affiliated eligible
(ii) For 2016, 2 percent; hospitals)].
(iii) For 2017, 3 percent.
(3) The Medicare Hospital Expendi-
(iv) For 2018, 3 percent, except, in the
ture Proportion for a year is the Sec-
case described in paragraph (d)(4)(vi) of
retary’s estimate of expenditures under
this section, 4 percent.
(v) For 2019 and each subsequent Parts A and B that are not attributable
year, 3 percent, except, in the case de- to Part C, that are attributable to ex-
scribed in paragraph (d)(4)(vi) of this penditures for inpatient hospital serv-
section, the percent from the prior ices, adjusted for the proportion of ex-
year plus 1 percent. In no case will the penditures that are provided by hos-
applicable percent be higher than 5 per- pitals that are neither qualifying nor
cent. potentially qualifying MA-affiliated el-
(vi) Beginning with payment adjust- igible hospitals with respect to a quali-
ment year 2018, if the percentage in fying MA organization.
paragraph (d)(2) of this section is more (4) For MA payment adjustment
than 25 percent, the applicable percent years prior to 2022, subsection (d) Puer-
is increased in accordance with para- to Rico hospitals are neither poten-
graphs (d)(4)(iv) and (v) of this section. tially qualifying MA-affiliated eligible
(e) Payment adjustments effective for hospitals nor qualifying MA-affiliated
2015 and subsequent years with respect to eligible hospitals for purposes of apply-
MA-affiliated eligible hospitals. (1)(i) The ing the payment adjustments under
payment adjustment set forth in this paragraph (e) of this section.
paragraph (e) applies if a qualifying [77 FR 54159, Sept. 4, 2012, as amended at 83
MA organization that previously re- FR 41711, Aug. 17, 2018]
919
§ 495.212 42 CFR Ch. IV (10–1–24 Edition)
§ 495.212 Limitation on review. Acceptance documents mean written

evidence of satisfactory completion of
(a) There is no administrative or ju-
an approved phase of work or contract
dicial review under section 1869 or 1878
and acceptance thereof by the State
of the Act, or otherwise of the method-
agency.
ology and standards for determining
payment amounts and payment adjust- Acquisition means to acquire health
ments under the MA EHR EP incentive information technology (HIT) equip-
program. This includes provisions re- ment or services for the purpose of im-
lated to duplication of payment avoid- plementation and administration under
ance and rules developed related to the this part from commercial sources or
fixed schedule for application of limita- from State or local government re-
tion on incentive payments for all sources.
qualifying MA EPs related to a specific Acute care hospital means a health
qualifying MA organization. It also in- care facility—
cludes the methodology and standards (1) Where the average length of pa-
developed for determining qualifying tient stay is 25 days or fewer; and
MA EPs and the methodology and (2) With a CMS certification number
standards for determining a meaning- (previously known as the Medicare pro-
ful EHR user, including the means of vider number) that has the last four
demonstrating meaningful use and the digits in the series 0001–0879 or 1300–1399
selection of measures. Adopt, implement or upgrade means—
(b) There is no administrative or ju- (1) Acquire, purchase, or secure ac-
dicial review under sections 1869 or 1878 cess to certified EHR technology capa-
of the Act, or otherwise, of the method- ble of meeting meaningful use require-
ology and standards for determining ments;
payment amounts and payment adjust- (2) Install or commence utilization of
ments under the MA EHR hospital in- certified EHR technology capable of
centive program. This includes provi- meeting meaningful use requirements;
sions related to duplication of payment or
avoidance. It also includes the method- (3) Expand the available
ology and standards developed for de- functionality of certified EHR tech-
termining qualifying MA-affiliated eli- nology capable of meeting meaningful
gible hospitals and the methodology use requirements at the practice site,
and standards for determining a mean- including staffing, maintenance, and
ingful EHR user, including the means training, or upgrade from existing EHR
of demonstrating meaningful use and technology to certified EHR tech-
the selection of measures. nology per the ONC EHR certification
criteria.
Subpart D—Requirements Specific (4) For payment year 2014, the ref-
to the Medicaid Program erences to ‘‘certified EHR technology’’
in paragraphs (1) through (3) of this
§ 495.300 Basis and purpose. definition are deemed to be references
This subpart implements section 4201 to paragraph (2) of the definition of
of the American Reinvestment and Re- ‘‘Certified EHR Technology’’ under 45
covery Act of 2009 and sections CFR 170.102 (that is, the definition of
1903(a)(3)(F) and 1903(t) of the Act, ‘‘Certified EHR Technology’’ for FY
which authorize States, at their op- and CY 2015 and subsequent years).
tion, to provide for incentive payments Children’s hospital means a separately
to Medicaid providers for adopting, im- certified children’s hospital, either
plementing, or upgrading certified EHR freestanding or hospital-within-hos-
technology or for meaningful use of pital that—
such technology. This subpart also pro- (1) Has a CMS certification number
vides enhanced Federal financial par- (CCN), (previously known as the Medi-
ticipation (FFP) to States to admin- care provider number), that has the
ister these incentive payments. last 4 digits in the series 3300–3399; or
(2) Does not have a CCN but has been
§ 495.302 Definitions. provided an alternative number by
As used in this subpart— CMS for purposes of enrollment in the
920
Medicaid EHR Incentive Program as a agement Information Systems

children’s hospital and; (MMIS)—that meets specified require-
(3) Predominantly treats individuals ments and that the Department has
under 21 years of age. found (among other things) is compat-
Entities promoting the adoption of cer- ible with the claims processing and in-
tified electronic health record technology formation retrieval systems used in the
means the State-designated entities administration of the Medicare pro-
that are promoting the adoption of cer- gram. The objectives of the MMIS are
tified EHR technology by enabling to include claims processing and re-
oversight of the business, operational trieval of utilization and management
and legal issues involved in the adop- information necessary for program ad-
tion and implementation of certified ministration and audit and must co-
EHR technology or by enabling the ex- ordinate with other mechanized sys-
change and use of electronic clinical tems and subsystems that perform
and administrative data between par- other functions, such as eligibility de-
ticipating providers, in a secure man- termination.
ner, including maintaining the phys- Needy individuals mean individuals
ical and organizational relationship in- that meet one of following:
tegral to the adoption of certified EHR (1) Received medical assistance from
technology by eligible providers. Medicaid or the Children’s Health In-
Health information technology planning surance Program. (or a Medicaid or
advance planning document (HIT PAPD) CHIP demonstration project approved
means a plan of action that requests under section 1115 of the Act).
FFP and approval to accomplish the (2) Were furnished uncompensated
planning necessary for a State agency care by the provider.
to determine the need for and plan the (3) Were furnished services at either
acquisition of HIT equipment or serv- no cost or reduced cost based on a slid-
ices or both and to acquire information ing scale determined by the individ-
necessary to prepare a HIT implemen- uals’ ability to pay.
tation advanced planning document or Patient volume means the minimum
request for proposal to implement the participation threshold (as described at
State Medicaid HIT plan. § 495.304(c) through (e)) that is esti-
HIT implementation advance planning mated through a numerator and de-
document (HIT IAPD) means a plan of nominator, consistent with the SMHP,
action that requests FFP and approval and that meets the requirements of
to acquire and implement the proposed § 495.306.
State Medicaid HIT plan services or Practices predominantly means an EP
equipment or both. for whom the clinical location for over
Medicaid information technology archi- 50 percent of his or her total patient
tecture (MITA) is both an initiative and encounters over a period of 6 months
a framework. It is a national frame- (within the most recent calendar year
work to support improved systems de- or, as an optional State alternative be-
velopment and health care manage- ginning for payment year 2013, within
ment for the Medicaid enterprise. It is the 12-month period preceding attesta-
an initiative to establish national tion)occurs at a federally qualified
guidelines for technologies and proc- health center or rural health clinic.
esses that enable improved program ad- Service oriented architecture or service
ministration for the Medicaid enter- component based architecture means or-
prise. The MITA initiative includes an ganizing and developing information
architecture framework, models, proc- technology capabilities as collabo-
esses, and planning guidelines for ena- rating services that interact with each
bling State Medicaid enterprises to other based on open standards.
meet common objectives with the State Medicaid health information tech-
framework while supporting unique nology plan (SMHP) means a document
local needs. that describes the State’s current and
Medicaid management information sys- future HIT activities.
tem (MMIS) means a mechanized claims State self-assessment means a process
processing and information retrieval that a State uses to review its stra-
system—referred to as Medicaid Man- tegic goals and objectives, measure its
921
§ 495.304 42 CFR Ch. IV (10–1–24 Edition)
current business processes and capa- (e) Additional requirement for the eligi-
bilities against the (MITA) business cable hospital. To be eligible for an EHR
pabilities and ultimately develops tar- incentive payment for each year for
get capabilities to transform its Med- which the eligible hospital seeks an
icaid enterprise to be consistent with EHR incentive payment, the eligible
the MITA principles. hospital must meet the following cri-
teria:
FR 54160, Sept. 4, 2012; 79 FR 52933, Sept. 4,
(1) An acute care hospital must have
2014] at least a 10 percent Medicaid patient
volume for each year for which the hos-
§ 495.304 Medicaid provider scope and pital seeks an EHR incentive payment.
eligibility. (2) A children’s hospital is exempt
(a) General rule. The following Med- from meeting a patient volume thresh-
icaid providers are eligible to partici- old.
pate in the HIT incentives program: (f) Further patient volume requirements
(1) Medicaid EPs. for the Medicaid EP. For payment year
(2) Acute care hospitals. 2013 and all subsequent payment years,
(3) Children’s hospitals. at least one clinical location used in
(b) Medicaid EP. The Medicaid profes- the calculation of patient volume must
sional eligible for an EHR incentive have Certified EHR Technology—
payment is limited to the following (1) During the payment year for
when consistent with the scope of prac- which the EP attests to having adopt-
tice regulations, as applicable for each ed, implemented or upgraded Certified
professional (§§ 440.50, 440.60, 440.100; EHR Technology (for the first payment
§§ 440.165, and 440.166): year); or
(1) A physician. (2) During the payment year for
(2) A dentist. which the EP attests it is a meaningful
(3) A certified nurse-midwife. EHR user.
(4) A nurse practitioner. [75 FR 44565, July 28, 2010, as amended at 77
(5) A physician assistant practicing FR 54160, Sept. 4, 2012]
in a Federally qualified health center
(FQHC) led by a physician assistant or § 495.306 Establishing patient volume.
a rural health clinic (RHC), that is so (a) General rule. A Medicaid provider
led by a physician assistant. must annually meet patient volume re-
(c) Additional requirements for the quirements of § 495.304, as these re-
Medicaid EP. To qualify for an EHR in- quirements are established through the
centive payment, a Medicaid EP must, State’s SMHP in accordance with the
for each year for which the EP seeks an remainder of this section.
EHR incentive payment, not be hos- (b) State option(s) through SMHP. (1) A
pital-based as defined at § 495.4 of this State must submit through the SMHP
subpart, and meet one of the following the option or options it has selected for
criteria: measuring patient volume.
(1) Have a minimum 30 percent pa- (2)(i) A State must select the method
tient volume attributable to individ- described in either paragraph (c) or
uals enrolled in a Medicaid program. paragraph (d) of this section (or both
(2) Have a minimum 20 percent pa- methods).
tient volume attributable to individ- (ii) Under paragraphs (c)(1)(i),
uals enrolled in a Medicaid program, (c)(2)(i), (c)(3)(i), (d)(1)(i), and (d)(2)(i) of
and be a pediatrician. this section, States may choose wheth-
(3) Practice predominantly in a er to allow eligible providers to cal-
FQHC or RHC and have a minimum 30 culate total Medicaid or total needy in-
percent patient volume attributable to dividual patient encounters in any rep-
needy individuals, as defined at resentative continuous 90-day period in
§ 495.302. the 12 months preceding the EP or eli-
(d) Exception. The hospital-based ex- gible hospital’s attestation or based
clusion in paragraph (c) of this section upon a representative, continuous 90-
does not apply to the Medicaid-EP day period in the calendar year pre-
qualifying based on practicing preceding the payment year for which the
dominantly at a FQHC or RHC. EP or eligible hospital is attesting.
922
(3) In addition, or as an alternative (B) All unduplicated patient encoun-

to the method selected in paragraph ters in the same 90-day period.
(b)(2) of this section, a State may se- (2) Needy individual patient volume. To
lect the method described in paragraph calculate needy individual patient vol-
(g) of this section. ume an EP must divide—
(c) Methodology, patient encounter—(1) (i)(A) The total Needy Individual pa-
EPs. To calculate Medicaid patient vol- tients assigned to the EP’s panel in
ume, an EP must divide: any representative, continuous 90-day
(i) The total Medicaid patient en- period in the either the calendar year
counters in any representative, contin- preceding the EP’s payment year, or
uous 90-day period in the calendar year the 12 months before the EP’s attesta-
preceding the EP’s payment year, or in tion when at least one Needy Indi-
the 12 months before the EP’s attesta- vidual encounter took place with the
tion; by individual in the 24 months before the
(ii) The total patient encounters in beginning of the same 90-day period;
the same 90-day period. plus
(2) Eligible hospitals. To calculate (B) Unduplicated Needy Individual
Medicaid patient volume, an eligible encounters in the same 90-day period,
hospital must divide— by
(i) The total Medicaid encounters in (ii)(A) The total patients assigned to
any representative, continuous 90-day the provider in that same 90-day period
period in the fiscal year preceding the with at least one encounter taking
hospitals’ payment year or in the 12 place with the patient during the 24
months before the hospital’s attesta- months before the beginning of the 90-
tion; by day period, plus
(ii) The total encounters in the same (B) All unduplicated patient encoun-
90-day period. ters in the same 90-day period.
(3) Needy individual patient volume. To (e) For purposes of this section, the
calculate needy individual patient vol- following rules apply:
ume, an EP must divide— (1) A Medicaid encounter means serv-
(i) The total needy individual patient ices rendered to an individual on any
encounters in any representative, con- one day where:
tinuous 90-day period in the calendar (i) Medicaid (or a Medicaid dem-
year preceding the EP’s payment year, onstration project approved under sec-
or in the 12 months before the EP’s at- tion 1115 of the Act) paid for part or all
testation; by of the service.
(ii) The total patient encounters in (ii) Medicaid (or a Medicaid dem-
the same 90-day period. onstration project approved under sec-
(d) Methodology, patient panel—(1) tion 1115 of the Act) paid all or part of
EPs. To calculate Medicaid patient vol- the individual’s premiums, co-pay-
ume, an EP must divide: ments, and cost-sharing.
(i)(A) The total Medicaid patients as- (iii) The individual was enrolled in a
signed to the EP’s panel in any rep- Medicaid program (or a Medicaid dem-
resentative, continuous 90-day period onstration project approved under sec-
in either the calendar year preceding tion 1115 of the Act) at the time the
the EP’s payment year, or the 12 billable service was provided.
months before the EP’s attestation (2) For purposes of calculating hos-
when at least one Medicaid encounter pital patient volume, both of the fol-
took place with the individual in the 24 lowing definitions in paragraphs
months before the beginning of the 90- (e)(2)(i) and (e)(2)(ii) of this section
day period; plus may apply:
(B) Unduplicated Medicaid encoun- (i) A Medicaid encounter means serv-
ters in the same 90-day period; by ices rendered to an individual per inpa-
(ii)(A) The total patients assigned to tient discharge when any of the fol-
the provider in that same 90-day period lowing occur:
with at least one encounter taking (A) Medicaid (or a Medicaid dem-
place with the patient during the 24 onstration project approved under sec-
months before the beginning of the 90- tion 1115 of the Act) paid for part or all
day period; plus of the service.
923
§ 495.308 42 CFR Ch. IV (10–1–24 Edition)
(B) Medicaid (or a Medicaid dem- review and approval through the SMHP
onstration project approved under sec- an alternative from the options in-
tion 1115 of the Act) paid all or part of cluded in paragraphs (c) and (d) of this
the individual’s premiums, co-pay- section, so long as it meets the fol-
ments, and/or cost-sharing. lowing requirements:
(C) The individual was enrolled in a (1) It is submitted consistent with all
Medicaid program (or a Medicaid dem- rules governing the SMHP at § 495.332.
onstration project approved under sec- (2) Has an auditable data source.
tion 1115 of the Act) at the time the (3) Has received input from the rel-
billable service was provided. evant stakeholder group.
(ii) A Medicaid encounter means (4) It does not result, in the aggre-
services rendered in an emergency de- gate, in fewer providers becoming eligi-
partment on any 1 day if any of the fol- ble than the methodologies in either
lowing occur: paragraphs (c) and (d) of this section.
(A) Medicaid (or a Medicaid dem- (h) Group practices. Clinics or group
onstration project approved under sec- practices will be permitted to calculate
tion 1115 of the Act) paid for part or all patient volume at the group practice/
of the service. clinic level, but only in accordance
(B) Medicaid (or a Medicaid dem- with all of the following limitations:
onstration project approved under sec- (1) The clinic or group practice’s pa-
tion 1115 of the Act) paid all or part of tient volume is appropriate as a pa-
the individual’s premiums, co-pay- tient volume methodology calculation
ments, and cost-sharing. for the EP.
(C) The individual was enrolled in a (2) There is an auditable data source
Medicaid program (or a Medicaid dem- to support the clinic’s or group prac-
onstration project approved under sec- tice’s patient volume determination.
tion 1115 of the Act) at the time the (3) All EPs in the group practice or
billable service was provided. clinic must use the same methodology
(3) For purposes of calculating needy for the payment year.
individual patient volume, a needy pa- (4) The clinic or group practice uses
tient encounter means services ren- the entire practice or clinic’s patient
dered to an individual on any 1 day if volume and does not limit patient vol-
any of the following occur: ume in any way.
(i) Medicaid or CHIP (or a Medicaid (5) If an EP works inside and outside
or CHIP demonstration project ap- of the clinic or practice, then the pa-
proved under section 1115 of the Act) tient volume calculation includes only
paid for part or all of the service. those encounters associated with the
(ii) Medicaid or CHIP (or a Medicaid clinic or group practice, and not the
or CHIP demonstration project ap- EP’s outside encounters.
proved under section 1115 of the Act) [75 FR 44565, July 28, 2010, as amended at 77
paid all or part of the individual’s pre- FR 54160, Sept. 4, 2012]
miums, co-payments, or cost-sharing.
(iii) The individual was enrolled in a § 495.308 Net average allowable costs
Medicaid program (or a Medicaid dem- as the basis for determining the in-
onstration project approved under sec- centive payment.
tion 1115 of the Act) at the time the (a) The first year of payment. (1) The
billable service was provided. incentive is intended to offset the costs
(iv) The services were furnished at no associated with the initial adoption,
cost; and calculated consistent with implementation or upgrade of certified
§ 495.310(h). electronic health records technology.
(v) The services were paid for at a re- (2) The maximum net average allow-
duced cost based on a sliding scale de- able costs for the first year are $25,000.
termined by the individual’s ability to (b) Subsequent payment years. (1) The
pay. incentive is intended to offset mainte-
(f) Exception. A children’s hospital is nance and operation of certified EHR
not required to meet Medicaid patient technology.
volume requirements. (2) The maximum net average allow-
(g) Establishing an alternative method- able costs for each subsequent year are
ology. A State may submit to CMS for $10,000.
924
§ 495.310 Medicaid provider incentive (d) Exception for EPs to switch pro-
payments. grams. An EP may change his or her
(a) Rules for Medicaid EPs. The Med- EHR incentive payment program elec-
icaid EP’s incentive payments are sub- tion once, consistent with § 495.60.
ject to all of the following limitations: (e) Limitation to one State only. A Med-
(1) First payment year. (i) For the first icaid EP or eligible hospital may re-
payment year, payment under this sub- ceive an incentive payment from only
part may not exceed 85 percent of the one State in a payment year.
maximum threshold of $25,000, which (f) Incentive payments to hospitals. In-
equals $21,250. centive payments to an eligible hos-
(ii) [Reserved] pital under this subpart are subject to
(iii) An EP may not begin receiving all of the following conditions:
payments any later than CY 2016. (1) The payment is provided over a
(2) Subsequent annual payment years. minimum of a 3-year period and max-
(i) For subsequent payment years, imum of a 6-year period.
payment may not exceed 85 percent of (2) The total incentive payment re-
the maximum threshold of $10,000, ceived over all payment years of the
which equals $8,500. program is not greater than the aggre-
(ii) [Reserved] gate EHR incentive amount, as cal-
(iii) Payments after the first pay- culated under paragraph (g) of this sec-
ment year may continue for a max- tion.
imum of 5 years. (3) No single incentive payment for a
(iv) Medicaid EPs may receive pay- payment year may exceed 50 percent of
ments on a non-consecutive, annual the aggregate EHR hospital incentive
basis. amount calculated under paragraph (g)
(v) No payments may be made after of this section for an individual hos-
CY 2021. pital.
(3) Maximum incentives. In no case (4) No incentive payments over a 2-
may a Medicaid EP participate for year period may exceed 90 percent of
more than a total of 6 years, and in no the aggregate EHR hospital incentive
case will the maximum incentive over amount calculated under paragraph (g)
a 6-year period exceed $63,750. of this section for an individual hos-
(4) Limitation. For a Medicaid EP who pital.
is a pediatrician described in paragraph (5) No hospital may begin receiving
(b) of this section payment is limited incentive payments for any year after
as follows: FY 2016, and after FY 2016, a hospital
(i) The maximum payment in the may not receive an incentive payment
first payment year is further reduced unless it received an incentive pay-
by two-thirds, which equals $14,167. ment in the prior fiscal year.
(ii) The maximum payment in subse- (6) Prior to FY 2016, payments can be
quent payment years is further reduced made to an eligible hospital on a non-
by two-thirds, which equals $5,667. consecutive, annual basis for the fiscal
(iii) In no case will the maximum in- year.
centive payment to a pediatrician (7) A multi-site hospital with one
under this limitation exceed $42,500 CMS Certification Number is consid-
over a 6-year period. ered one hospital for purposes of calcu-
(b) Optional exception for pediatricians. lating payment.
A pediatrician described in this para- (8) The aggregate EHR hospital in-
graph is a Medicaid EP who does not centive amount calculated under para-
meet the 30 percent patient volume re- graph (g) of this section is determined
quirements described in §§ 495.304 and by the State from which the eligible
495.306, but who meets the 20 percent hospital receives its first payment year
patient volume requirements described incentive. If a hospital receives incen-
in such sections. tive payments from other States in
(c) Limitation to only one EHR incen- subsequent years, total incentive pay-
tive program. An EP may only receive ments received over all payment years
an incentive payment from either of the program can be no greater than
Medicare or Medicaid in a payment the aggregate EHR incentive amount
year, but not both. calculated by the initial State.
925
§ 495.310 42 CFR Ch. IV (10–1–24 Edition)
(g) Calculation of the aggregate EHR (2) Medicaid share. The Medicaid
hospital incentive amount. The aggre- share specified under this paragraph
gate EHR hospital incentive amount is for an eligible hospital is equal to a
calculated as the product of the (over- fraction—
all EHR amount) times (the Medicaid (i) The numerator of which is the
Share). sum (for the 12-month period selected
(1) Overall EHR amount. The overall by the State and with respect to the el-
EHR amount for an eligible hospital is igible hospital) of—
based upon a theoretical 4 years of pay- (A) The estimated number of acute-
ment the hospital would receive based, care inpatient-bed-days which are at-
for each of such 4 years, upon the prod- tributable to Medicaid individuals; and
uct of the following: (B) The estimated number of acute-
(i) Initial amount. The initial amount care inpatient-bed-days which are at-
is equal to the sum of— tributable to individuals who are en-
(A) The base amount which is set at rolled in a managed care organization,
$2,000,000 for each of the theoretical 4 a pre-paid inpatient health plan, or a
years; plus pre-paid ambulatory health plan under
(B) The discharge-related amount for part 438 of this chapter; and
the most recent continuous 12-month (ii) The denominator of which is the
period selected by the State, but end- product of—
ing before the federal fiscal year that (A) The estimated total number of
serves as the first payment year. The acute-care inpatient-bed-days with re-
discharge-related amount is the sum of spect to the eligible hospital during
the following, with acute-care inpa- such period; and
tient discharges over the 12-month pe- (B) The estimated total amount of
riod and based upon the total acute- the eligible hospital’s charges during
care inpatient discharges for the eligi- such period, not including any charges
ble hospital (regardless of any source of that are attributable to charity care,
payment): divided by the estimated total amount
(1) For the first through 1,149th of the hospital’s charges during such
acute-care inpatient discharge, $0. period.
(2) For the 1,150th through the (iii) In computing acute-care inpa-
23,000th acute-care inpatient discharge, tient-bed-days under paragraph (g)(2)(i)
$200. of this section, a State may not include
(3) For any acute-care inpatient dis- estimated acute-care inpatient-bed-
charge greater than the 23,000th, $0. days attributable to individuals with
(C) For purposes of calculating the respect to whom payment may be made
discharge-related amount under para- under Medicare Part A, or acute-care
graph (g)(1)(i)(B) of this section, for the inpatient-bed-days attributable to indi-
last 3 of the theoretical 4 years of pay- viduals who are enrolled with a Medi-
ment, acute-care inpatient discharges care Advantage organization under
are assumed to increase by the pro- Medicare Part C.
vider’s average annual rate of growth (h) Approximate proxy for charity care.
for the most recent 3 years for which If the State determines that an eligible
data are available per year. Negative provider’s data are not available on
rates of growth must be applied as charity care necessary to calculate the
such. portion of the formula specified in
(ii) Medicare share. The Medicare paragraph (g)(2)(ii)(B) of this section,
share, which equals 1. the State may use that provider’s data
(iii) Transition factor. The transition on uncompensated care to determine
factor which equals as follows: an appropriate proxy for charity care,
(A) For the first of the theoretical 4 but must include a downward adjust-
years, 1. ment to eliminate bad debt from un-
(B) For the second of the theoretical compensated care data. The State must
4 years, 3⁄4. use auditable data sources.
(C) For the third of the theoretical 4 (i) Deeming. In the absence of the
years, 1⁄2. data necessary, with respect to an eli-
(D) For the fourth of the theoretical gible hospital the amount described in
4 years, 1⁄4. paragraph (g)(2)(ii)(B) of this section
926
must be deemed to be 1. In the absence approves, processes, and makes timely

of data, with respect to an eligible hos- payments using a process approved by
pital, necessary to compute the CMS.
amount described in paragraph (2) At the State’s option, CMS con-
(g)(2)(i)(B) of this section, the amount ducts the audits and handles any subse-
under such clause must be deemed to quent appeals, of whether eligible hos-
be 0. pitals are meaningful EHR users on the
(j) Dual eligibility for incentives pay- States’ behalf.
ments. A hospital may receive incentive (d) State disbursement. The State dis-
payments from both Medicare and burses an incentive payment to the
Medicaid if it meets all eligibility cri- provider based on the criteria described
teria in the payment year. in subpart A and this subpart.
(k) Payments to State-designated enti- (e) Timeframes. Payments are dis-
ties. Payments to entities promoting bursed consistent with the following
the adoption of certified EHR tech- timeframes for each type of Medicaid
nology as designated by the State must eligible provider:
meet the following requirements: (1) Medicaid EPs. States disburse pay-
(1) A Medicaid EP may reassign his ments consistent with the calendar
or her incentive payment to an entity year on a rolling basis following
promoting the adoption of certified verification of eligibility for the pay-
EHR technology, as defined in § 495.302, ment year.
and as designated by the State, only (2) Medicaid eligible hospitals. States
under the following conditions: disburse payments consistent with the
(i) The State has established a meth-
Federal fiscal year on a rolling basis
od to designate entities promoting the
following verification of eligibility for
adoption of EHR technology that com-
the payment year.
ports with the Federal definition in
§ 495.302. [75 FR 44565, July 28, 2010, as amended at 77
(ii) The State publishes and makes FR 54162, Sept. 4, 2012]
available to all EPs a voluntary mech-
anism for reassigning annual payments § 495.314 Activities required to receive
and includes information about the an incentive payment.
verification mechanism the State will (a) First payment year. (1) In the first
use to ensure that the reassignment is payment year, to receive an incentive
voluntary and that no more than 5 per- payment, the Medicaid EP or eligible
cent of the annual payment is retained hospital must meet one of the fol-
by the entity for costs not related to lowing:
certified EHR technology. (i) Demonstrate that during the pay-
(2) [Reserved] ment year, it has adopted, imple-
[75 FR 44565, July 28, 2010, as amended at 77 mented, or upgraded certified EHR
FR 54161, Sept. 4, 2012; 80 FR 62954, Oct. 16, technology, as defined in § 495.302.
2015] (ii) Demonstrate that during the
EHR reporting period for a payment
§ 495.312 Process for payments. year, it is a meaningful EHR user as
(a) General rule. States must have a defined in § 495.4.
process for making payments con- (2) A provider may notify the State
sistent with the requirements in sub- of its non-binding intention to partici-
parts A and D of this part. pate in the incentives program prior to
(b) Reporting data consistent with this having fulfilled all of the eligibility
subpart. In order to receive a payment criteria.
under this part, a provider must report (b) Subsequent payment years. (1) In
the required data under subpart A and the second, third, fourth, fifth, and
this subpart within the EHR reporting sixth payment years, to receive an in-
period described in § 495.4. centive payment, the Medicaid EP or
(c) State’s role. (1) Except as specified eligible hospital must demonstrate
in paragraph (c)(2) of this section, the that during the EHR reporting period
State determines the provider’s eligi- for the applicable payment year, it is a
bility for the EHR incentive payment meaningful EHR user, as defined in
under subparts A and D of this part and § 495.4.
927
§ 495.316 42 CFR Ch. IV (10–1–24 Edition)
(2) The automated reporting of the gram addressed individuals with unique
clinical quality measures will be ac- needs such as children.
complished using certified EHR tech- (2)(i) Subject to § 495.332, the State
nology interoperable with the system may propose a revised definition for
designated by the State to receive the Stage 1 of meaningful use of certified
data. EHR technology, subject to CMS prior
approval, but only with respect to the
§ 495.316 State monitoring and report- following objectives:
ing regarding activities required to (A) Generate lists of patients by spe-
receive an incentive payment. cific conditions to use for quality im-
(a) Subject to § 495.332 the State is re- provement, reduction of disparities, re-
sponsible for tracking and verifying search or outreach.
the activities necessary for a Medicaid (B) Capability to submit electronic
EP or eligible hospital to receive an in- data to immunization registries or im-
centive payment for each payment munization information systems and
year, as described in § 495.314. actual submission except where prohib-
(b) Subject to § 495.332, the State ited, and according to applicable law
must submit a State Medicaid HIT and practice.
Plan to CMS that includes— (C) Capability to submit electronic
(1) A detailed plan for monitoring, data on reportable (as required by
verifying and periodic auditing of the State or local law) lab results to public
requirements for receiving incentive health agencies and actual submission
payments, as described in § 495.314; and except where prohibited according to
(2) A description of the how the State applicable law and practice.
will collect and report on provider (D) Capability to submit electronic
meaningful use of certified EHR tech- syndromic surveillance data to public
nology. health agencies and actual submission
(c) Subject to §§ 495.332 and 495.352, except where prohibited and according
the State is required to submit to CMS to applicable law and practice.
annual reports, in the manner pre- (ii) Subject to § 495.332, the State may
scribed by CMS, on the following: propose a revised definition for Stage 2
(1) Provider adoption, implementa- of meaningful use of certified EHR
tion, or upgrade of certified EHR tech- technology, subject to CMS prior ap-
nology activities and payments; and proval, but only with respect to the fol-
(2) Aggregated, de-identified mean- lowing objectives:
ingful use data. (A) Generate lists of patients by spe-
(d)(1) The annual report described in cific conditions to use for quality im-
paragraph (c) of this section must in- provement, reduction of disparities, re-
clude, but is not limited to the fol- search, or outreach.
lowing: (B) Capability to submit electronic
(i) The number and type of providers data to immunization registries or im-
who qualified for an incentive payment munization information systems, ex-
on the basis of having adopted, imple- cept where prohibited, and in accord-
mented, or upgraded certified EHR ance with applicable law and practice.
technology. (C) Capability to submit electronic
(ii) Aggregated data tables rep- reportable laboratory results to public
resenting the provider adoption, imple- health agencies, except where prohib-
mentation, or upgrade of certified EHR ited, and in accordance with applicable
technology. law and practice.
(iii) The number and type of pro- (D) Capability to provide electronic
viders who qualified for an incentive syndromic surveillance data to public
payment on the basis of demonstrating health agencies, except where prohib-
that they are meaningful users of cer- ited, and in accordance with applicable
tified EHR technology; law and practice.
(iv) Aggregated data tables rep- (E) Capability to identify and report
resenting the provider’s clinical qual- cancer cases to a public health central
ity measures data; and cancer registry, except where prohib-
(v) A description and quantitative ited, and in accordance with applicable
data on how its incentive payment pro- law and practice.
928
(F) Capability to identify and report did not demonstrate meaningful use, if
specific cases to a specialized registry applicable.
(other than a cancer registry), except (2) The quarterly report described in
where prohibited, and in accordance paragraph (g) of this section is not re-
with applicable law and practice. quired to include information on EPs
(iii) Subject to § 495.332, the State who are eligible for the Medicaid EHR
may propose a revised definition for incentive program on the basis of being
Stage 3 of meaningful use of CEHRT, a nurse practitioner, certified nurse-
subject to CMS prior approval, but midwife or physician assistant.
only with respect to the public health [75 FR 44565, July 28, 2010, as amended at 77
and clinical data registry reporting ob- FR 54162, Sept. 4, 2012; 80 FR 62954, Oct. 16,
jective described in § 495.24(d)(8). 2015; 81 FR 77557, Nov. 4, 2016; 83 FR 41711,
(e) State failure to submit the re- Aug. 17, 2018]
quired reports to CMS may result in
discontinued or disallowed funding. § 495.318 State responsibilities for re-
ceiving FFP.
(f) Each State must submit to CMS
the annual report described in para- In order to be provided FFP under
graph (c) of this section within 60 days section 1903(a)(3)(F) of the Act, a State
of the end of the second quarter of the must demonstrate to the satisfaction
Federal fiscal year. of HHS, that the State is—
(g) The State must, on a quarterly (a) Using the funds provided for the
basis and in the manner prescribed by purposes of administering incentive
CMS, submit a report(s) on the fol- payments to providers under this pro-
lowing: gram, including tracking of meaningful
(1) The State and payment year to use by Medicaid providers of EHR tech-
which the quarterly report pertains. nology;
(2) Subject to paragraph (h)(2) of this (b) Conducting adequate oversight of
section, provider-level attestation data the program, including routine track-
for each eligible hospital that attests ing of meaningful use attestations and
to demonstrating meaningful use for reporting mechanisms; and
each payment year beginning with 2013 (c) Is pursuing initiatives to encour-
and ending after 2018. age the adoption of certified EHR tech-
(3) Subject to paragraph (h)(2) of this nology to promote health care quality
section, provider-level attestation data and the exchange of health care infor-
for each eligible EP that attests to mation, subject to applicable laws and
demonstrating meaningful use for each regulations governing such exchange.
payment year beginning with 2013 and § 495.320 FFP for payments to Med-
ending after 2016. icaid providers.
(h)(1) Subject to paragraph (h)(2) of
Subject to the requirements outlined
this section, the quarterly report de-
in this subpart, FFP is available at 100
scribed in paragraph (g) of this section
percent of State expenditures for pay-
must include the following for each EP
ments to Medicaid eligible providers to
and eligible hospital:
encourage the adoption and meaningful
(i) The payment year number. use of certified EHR technology.
(ii) The provider’s National Provider
Identifier or CCN, as appropriate. § 495.322 FFP for reasonable adminis-
(iii) Attestation submission date. trative expenses.
(iv) The state qualification. (a) Subject to prior approval condi-
(v) The state qualification date, tions at § 495.324, FFP is available at 90
which is the beginning date of the pro- percent in State expenditures for ad-
vider’s EHR reporting period for which ministrative activities in support of
it demonstrated meaningful use. implementing incentive payments to
(vi) The State disqualification, if ap- Medicaid eligible providers.
plicable. (b) FFP available under paragraph (a)
(vii) The State disqualification date, of this section is available only for ex-
which is the beginning date of the pro- penditures incurred on or before Sep-
vider’s EHR reporting period to which tember 30, 2022, except for expenditures
the provider attested but for which it related to audit and appeal activities
929
§ 495.324 42 CFR Ch. IV (10–1–24 Edition)
required under this subpart, which § 495.326 Disallowance of FFP.

must be incurred on or before Sep- If the HHS finds that any acquisition
tember 30, 2023. approved or modified under the provi-
[83 FR 41711, Aug. 17, 2018] sions of this subpart fails to comply
with the criteria, requirements, and
§ 495.324 Prior approval conditions. other undertakings described in the ap-
proved HIT planning advance planning
(a) A State must obtain prior written
document and HIT implementation ad-
approval as specified in paragraph (b)
vance planning document to the det-
of this section, when the State plans to riment of the proper and efficient oper-
initiate planning and implementation ation of the Medicaid program, pay-
activities in support of Medicaid pro- ment of FFP may be disallowed. In the
vider incentive payments encouraging case of a suspension of approval of a
the adoption and meaningful use of cer- HIT planning advance planning docu-
tified EHR technology with proposed ment and HIT implementation advance
Federal financial participation. planning document, suspension would
(b) To receive 90 percent match, each occur in the same manner as 45 CFR
State must receive prior approval for 205.37(c) and 307.40(a).
all of the following:
(1) The HIT advance planning docu- § 495.328 Request for reconsideration
of adverse determination.
ment and the implementation advance
planning document. If CMS disapproves a State request
(2) For the acquisition solicitation for any elements of a State’s advance
documents and any contract that a planning document or State Medicaid
State may utilize to complete activi- HIT Plan under this subpart, or deter-
mines that requirements are met for
ties under this subpart, unless specifi-
approval on a date later than the date
cally exempted by the Department of
requested, the decision notice includes
Health and Human Services, prior to the following:
release of the acquisition solicitation (a) The finding of fact upon which the
documents or prior to execution of the determination was made.
contract, when the contract is antici- (b) The procedures for appeal of the
pated to or will exceed $500,000. determination in the form of a request
(3) For contract amendments, unless for reconsideration.
specifically exempted by the Depart-
ment of Health and Human Services, § 495.330 Termination of FFP for fail-
prior to execution of the contract ure to provide access to informa-
tion.
amendment, involving contract cost in-
creases exceeding $500,000 or contract (a) HHS terminates FFP at any time
time extensions of more than 60 days. if the Medicaid agency fails to provide
(4) The State Medicaid HIT plan. State and Federal representatives with
full access to records relating to HIT
(c) Failure to submit any of the in-
planning and implementation efforts,
formation specified in paragraph (b) of
and the systems used to interoperate
this section to the satisfaction of HHS
with electronic HIT, including on-site
may result in disapproval or suspen- inspection.
sion of project funding. (b) The Department may request
(d) A State must obtain prior written such access at any time to determine
approval from HHS of its justification whether the conditions in this subpart
for a sole source acquisition, when it are being met.
plans to acquire noncompetitively
from a nongovernmental source HIT § 495.332 State Medicaid health infor-
equipment or services, with proposed mation technology (HIT) plan re-
quirements.
FFP under this subpart if the total
State and Federal acquisition cost is Each State Medicaid HIT plan must
more than $500,000. include all of the following elements:
(a) State systems. For State systems,
[75 FR 44565, July 28, 2010, as amended at 83 interoperability, and the current and
FR 41711, Aug. 17, 2018] future visions:
930
(1) A baseline assessment of the cur- (6) A description of how each State
rent HIT landscape environment in the will promote the use of data and tech-
State including the inventory of exist- nical standards to enhance data con-
ing HIT in the State. The assessment sistency and data sharing through
must include a comprehensive— common data-access mechanisms.
(i) Description of the HIT ‘‘as-is’’ (7) A description of how each State
landscape; will support integration of clinical and
(ii) Description of the HIT ‘‘to-be’’ administrative data.
landscape; and (8) A description of the process in
(iii) HIT roadmap and strategic plan place for ensuring improvements in
for the next 5 years. health outcomes, clinical quality, or
(2) A description of how the State efficiency resulting from the adoption
Medicaid HIT plan will be planned, de- of certified EHR technology by bene-
signed, developed and implemented, in- ficiaries of Medicaid incentive pay-
cluding how it will be implemented in ments and a methodology for verifying
accordance with the Medicaid Informa- such information.
tion Technology Architecture (MITA)
(9) A description of the process in
principles as described in the Medicaid
place for ensuring that any certified
Information Technology Framework
2.0. The MITA initiative— EHR technology used as the basis for a
payment incentive to Medicaid pro-
(i) Establishes national guidelines for
technologies and processes that enable viders is compatible with State or Fed-
improved program administration for eral administrative management sys-
the Medicaid enterprise; tems, including the MMIS or other
(ii) Includes business, information automated claims processing system or
and technology architectures that pro- information retrieval system and a
vide an overall framework for inter- methodology for verifying such infor-
operability, as well as processes and mation.
planning guidelines for enabling State (10) A description of how each State
Medicaid enterprises to meet common will adopt national data standards for
objectives within the framework while health and data exchange and open
supporting unique local needs; and standards for technical solutions as
(iii) Is important to the design and they become available.
development of State EHR incentive (11) A description of how the State
payment systems. intends to address the needs of under-
(3) A description of how intrastate served and vulnerable populations such
systems, including the Medicaid Man- as children, individuals with chronic
agement Information System (MMIS) conditions, Title IV–E foster care chil-
and other automated mechanized dren, individuals in long-term care set-
claims processing and information re- tings and the aged, blind, and disabled.
trieval systems— This description must address the fol-
(i) Have been considered in devel- lowing:
oping a HIT solution; and (i) Person centered goals and objec-
(ii) A plan that incorporates the de- tives and shared decision-making;
sign, development, and implementation (ii) Coordination of care across mul-
phases for interoperability of such tiple service providers, funding
State systems with a description of
sources, settings, and patient condi-
how any planned systems enhance-
tions—
ments support overall State and Med-
icaid goals. (iii) Universal design to ensure access
(4) A description of data-sharing com- by people with disabilities and older
ponents of HIT solutions. Americans; and
(5) A description of how each State (iv) Institutional discharge planning
will promote secure data exchange, and diversion activities that are tied to
where permissible under the Health In- community based service availability.
surance Portability and Accountability (b) Eligibility. For eligibility, a de-
Act (HIPAA) and other requirements scription of the process in place for all
included in ARRA. of the following:
931
§ 495.332 42 CFR Ch. IV (10–1–24 Edition)
(1) For ensuring that each EP and eli- centive payment consistent with the
gible hospital meets all provider en- criteria outlined in § 495.314 and a
rollment eligibility criteria upon en- methodology in place used to verify
rollment and re-enrollment to the Med- such information.
icaid EHR payment incentive program. (3) A description of the process in
(2) For ensuring patient volume con- place for capturing attestations from
sistent with the criteria in §§ 495.304 each EP or eligible hospital that they
and 495.306 for each EP who practices have meaningfully used certified EHR
predominantly in a FQHC or RHC and technology during the EHR reporting
for each Medicaid EP who is a physi- period, and that they have adopted, im-
cian, pediatrician, nurse practitioner, plemented, or upgraded certified EHR
certified nurse midwife or dentist and a technology and a description of the
methodology in place used to verify methodology in place used to verify
such information. such information.
(3) For ensuring that the EP or eligi- (4) A description of the process in
ble hospital is a provider who meets pa- place for capturing clinical quality
tient volume consistent with the cri- data from each EP or eligible hospital
teria in §§ 495.304 and 495.306 and a and a description of the methodology
methodology in place used to verify in place used to verify such informa-
such information. tion.
(4) For ensuring that each Medicaid
(5) A description of the process in
EP is not hospital-based and a method-
place for monitoring the compliance of
ology in place used to verify such infor-
providers coming onto the program
mation.
with different requirements depending
(5) To ensure that a hospital eligible
upon their participation year and a
for incentive payments has dem-
methodology for verifying such infor-
onstrated an average length of stay of
mation.
25 days or less and a methodology for
verifying such information. (6) A list of the specific actions
(6) For ensuring that at least one planned to implement the EHR incen-
clinical location used for the calcula- tive program, including a description
tion of the EP’s patient volume has and organizational charts for
Certified EHR Technology during the workgroups within State government
payment year for which the EP is at- including external partners.
testing. (7) A description of the process in
(c) Monitoring and validation. Subject place to ensure that no amounts higher
to paragraph (g) of this section, for than 100 percent of FFP will be claimed
monitoring and validation of informa- by the State for reimbursement of ex-
tion States must include the following: penditures for State payments to Med-
(1) A description of the process in icaid eligible providers for the certified
place for ensuring that, because of EHR technology incentive payment
CMS’ and the States’ oversight respon- program and a methodology for
sibilities, all provider information for verifying such information.
attestations including meaningful use, (8) A description of the process in
efforts to adopt, implement, or upgrade place to ensure that no amounts higher
and any information added to the CMS than 90 percent of FFP will be claimed
Single Provider Repository including by the State for administrative ex-
all information related to patient vol- penses in administering the certified
ume, NPI, Tax identification number EHR technology incentive payment
(TIN), are all true and accurate and program and a methodology for
that any concealment or falsification verifying such information.
of a material fact related to the attes- (9) A description of the process and
tation may result in prosecution under methodology for ensuring and verifying
Federal and State laws and a method- the following:
ology in place used to verify such infor- (i) Amounts received under section
mation. 1903(a)(3)(F) of the Act with respect to
(2) A description of the process in payments to a Medicaid EP or eligible
place for ensuring that the EP or eligi- hospital are paid directly to such pro-
ble hospital is eligible to receive an in- vider (or to an employer or facility to
932
which such provider has assigned pay- this chapter and a methodology for
ments) without any deduction or re- verifying such information.
bate. (3) The process in place to ensure
(ii) All incentive payment reassign- that only appropriate funding sources
ments to an entity promoting the are used to make Medicaid EHR incen-
adoption of certified EHR technology, tive payments and the methodology for
as designated by the State, are vol- verifying such information.
untary for the Medicaid EP involved. (4) The process in place and the
(iii) Entities promoting the adoption methodology for verifying that infor-
of certified EHR technology do not re- mation is available in order to ensure
tain more than 5 percent of such pay- that Medicaid EHR incentive payments
ments for costs not related to certified are made for no more than a total of 6
EHR technology (and support services years; that no EP or eligible hospital
including maintenance and training) begins receiving payments after 2016;
that is for, or is necessary for the oper- that incentive payments cease after
ation of, such technology. 2021; and that an eligible hospital does
(10) A description of the process in not receive incentive payments after
place for ensuring that each Medicaid FY 2016 unless the hospital received an
EP or eligible hospital that collects an incentive payment in the prior fiscal
EHR payment incentive has collected a year.
payment incentive from only one State (5) The process in place to ensure
even if the provider is licensed to prac- that Medicaid EHR incentive payments
tice in multiple States and a method- are not paid at amounts higher than 85
ology for verifying such information. percent of the net average allowable
(11)(i) A description of the process in cost of certified EHR technology and
place for ensuring that each EP or eli- the yearly maximum allowable pay-
gible hospital that wishes to partici- ment thresholds and a methodology for
pate in the EHR incentive payment verifying such information.
program will receive a NPI; and (6) The process in place to ensure
(ii) A description of how the NPI will that all hospital calculations and hos-
be used to coordinate with the CMS so pital payment incentives are made con-
that the EP will choose only one pro- sistent with the requirements of this
gram from which to receive the incen- part and a methodology for verifying
tive payment and the hospital pay- such information.
ments are tracked accordingly. (7) The process in place to provide for
(12) A description of the process in the timely and accurate payment of in-
place for ensuring that each EP or eli- centive payments to EPs and eligible
gible hospital who wishes to partici- hospitals, including the timeframe
pate in the EHR incentive payment specified by the State to meet the
program will provide a TIN to the timely payment requirement.
State for purposes of the incentive pay- (8) The process in place and a meth-
ment. odology for verifying such information
(d) Payments. For payments, States to provide that any monies that have
must provide descriptions of the fol- been paid inappropriately as an im-
lowing processes that are in place: proper payment or otherwise not in
(1) The process in place for ensuring compliance with this subpart will be
that there is no duplication of Medi- recouped and FFP will be repaid.
care and Medicaid incentive payments (e) For combating fraud and abuse and
to EPs and a methodology for verifying for provider appeals. (1) A description of
such information. the process in place for a provider to
(2) The process in place to ensure appeal consistent with the criteria de-
that any existing fiscal relationships scribed in § 495.370 and a methodology
with providers to disburse the incen- for verifying the following related to
tive payments through Medicaid man- the EHR incentives payment program:
aged care plans does not result in pay- (i) Incentive payments.
ments that exceed 105 percent of the (ii) Provider eligibility determina-
capitation rate, in order to comply tions.
with the Medicaid managed care incen- (iii) Demonstration of efforts to
tive payment rules at § 438.6(b)(2) of adopt, implement or upgrade and
933
§ 495.334 42 CFR Ch. IV (10–1–24 Edition)
meaningful use eligibility for incentive (g) Optional—signed agreement. At the

payments under this part. State’s option, the State may include a
(2) A description of the process in signed agreement indicating that the
place, and a methodology for verifying State does all of the following:
such information, to address Federal (1) Designates CMS to conduct all au-
laws and regulations designed to pre- dits and appeals of eligible hospitals’
vent fraud, waste, and abuse, including, meaningful use attestations.
but not limited to applicable provi- (2) Is bound by the audit and appeal
sions of Federal criminal law, the findings described in paragraph (g)(1) of
False Claims Act (32 U.S.C. 3729 et seq.), this section.
and the anti-kickback statute (section (3) Performs any necessary
1128B(b) of the Act). recoupments if audits (and any subse-
(f) Optional—proposed alternatives. A quent appeals) described in paragraph
State may choose to propose any of the (g)(1) of this section determine that an
following, but they must be included as eligible hospital was not a meaningful
an element in the State Medicaid HIT EHR user.
Plan for review and approval: (4) Is liable for any FFP granted to
(1) An alternative methodology for the State to pay eligible hospitals that,
measuring patient volume, consistent upon audit (and any subsequent appeal)
with § 495.306(g). are determined not to have been mean-
(2)(i) A revised definition of meaning- ingful EHR users.
ful use of certified EHR technology [75 FR 44565, July 28, 2010, as amended at 77
consistent with §§ 495.4 and 495.316(d)(2) FR 54162, Sept. 4, 2012; 81 FR 27901, May 6,
of this part. 2016; 83 FR 60096, Nov. 23, 2018]
(ii) Any revised definition of mean-
ingful use may not require additional § 495.334 [Reserved]
functionality beyond that of certified § 495.336 Health information tech-
EHR technology and conform with nology planning advance planning
CMS guidance on Stage 1. See also document requirements (HIT
§ 495.316(d)(2). PAPD).
(3) An alternative date within CY Each State’s HIT PAPD must contain
2021 by which all ‘‘EHR reporting peri- the following:
ods’’ (as defined under § 495.4) for the (a) A statement of need and objective
CY 2021 payment year for Medicaid EPs which clearly state the purpose and ob-
demonstrating they are meaningful jectives of the project to be accom-
EHR users must end. The alternative plished and the necessity for the
date selected by the state must be ear- project.
lier than October 31, 2021, and must not (b) A project management plan which
be any earlier than the day prior to the addresses the following:
attestation deadline for Medicaid EPs (1) The planning project organiza-
attesting to that state. tion.
(4) An alternative date within CY (2) Planning activities and
2021 by which all clinical quality meas- deliverables.
ure reporting periods for the CY 2021 (3) State and contractor resource
payment year for Medicaid EPs dem- needs.
onstrating they are meaningful EHR (4) Planning project procurement ac-
users must end. The alternative date tivities and schedule.
selected by the state must be earlier (c) A specific budget for the planning
than October 31, 2021, and must not be of the project.
any earlier than the day prior to the (d) An estimated total project cost
attestation deadline for Medicaid EPs and a prospective State and Federal
attesting to that state. cost distribution, including planning
(5) For the CY 2019 payment year and and implementation.
beyond, a state-specific listing of (e) A commitment to submit a HIT
which clinical quality measures se- implementation advance planning doc-
lected by CMS are considered to be ument.
high priority measures for purposes of (f) A commitment to conduct and
Medicaid EP clinical quality measure complete activities which will result in
reporting. the production of the State Medicaid
934
HIT plan that includes conduct of the (1) Planned annual payment
following activities: amounts;
(1) A statewide HIT environmental (2) Total of planned payment
baseline self-assessment. amounts; and
(2) An assessment of desired HIT fu- (3) Calendar year of each planned an-
ture environment. nual payment amount.
(3) Development of benchmarks and (4) A statement setting forth the se-
transition strategies to move from the curity and interface requirements to be
current environment to the desired fu- employed for all State HIT systems,
ture environment. and related systems, and the system
(g) A commitment to submit the plan failure and disaster recovery proce-
to CMS for approval. dures available.
§ 495.338 Health information tech-
nology implementation advance § 495.340 As-needed HIT PAPD update
planning document requirements and as-needed HIT IAPD update re-
(HIT IAPD). quirements.
Each State’s HIT IAPD must contain Each State must submit a HIT PAPD
the following: update or a HIT IAPD no later than 60
(a) The results of the activities con- days after the occurrence of project
ducted as a result of the HIT planning changes including but not limited to
advance planning document, including any of the following:
the approved state Medicaid HIT plan. (a) A projected cost increase of
(b) A statement of needs and objec- $100,000 or more.
tives. (b) A schedule extension of more than
(c) A statement of alternative consid- 60 days for major milestones.
erations. (c) A significant change in planning
(d) A personnel resource statement approach or implementation approach,
indicating availability of qualified and or scope of activities beyond that ap-
adequate staff, including a project di- proved in the HIT planning advance
rector to accomplish the project objec- planning document or the HIT imple-
tives. mentation advance planning document.
(e) A detailed description of the na- (d) A change in implementation con-
ture and scope of the activities to be cept or a change to the scope of the
undertaken and the methods to be used project.
to accomplish the project. (e) A change to the approved cost al-
(f) The proposed activity schedule for location methodology.
the project.
(g) A proposed budget including a § 495.342 Annual HIT IAPD require-
consideration of all HIT implementa- ments.
tion advance planning document activ-
ity costs, including but not limited to Each State is required to submit the
the following: HIT IAPD Updates 12 months from the
(1) The cost to implement and admin- date of the last CMS approved HIT
ister incentive payments. IAPD and must contain the following:
(2) Procurement or acquisition. (a) A reference to the approved HIT
(3) State personnel. PAPD/IAPD and all approved changes.
(4) Contractor services. (b) A project activity status which
(5) Hardware, software, and licensing. reports the status of the past year’s
(6) Equipment and supplies. major project tasks and milestones, ad-
(7) Training and outreach. dressing the degree of completion and
(8) Travel. tasks/milestones remaining to be com-
(9) Administrative operations. pleted and discusses past and antici-
(10) Miscellaneous expenses for the pated problems or delays in meeting
project. target dates in the approved HIT tech-
(h) An estimate of prospective cost nology PAPD/IAPD and approved
distribution to the various State and changes to it.
Federal funding sources and the pro- (c) A report of all project deliverables
posed procedures for distributing costs completed in the past year and degree
including: of completion for unfinished products.
935
§ 495.344 42 CFR Ch. IV (10–1–24 Edition)
(d) A project activity schedule for the (2) Are established to ensure that
remainder of the project. such materials and services are ob-
(e) A project expenditure status tained in a cost effective manner and
which consists of a detailed accounting in compliance with the provisions of
of all expenditures for project develop- applicable Federal statutes and execu-
ment over the past year and an expla- tive orders.
nation of the differences between pro- (3) Apply when the cost of the pro-
jected expenses in the approved HIT curement is treated as a direct cost of
PAPD/IAPD and actual expenditures an award.
for the past year. (b) Grantee responsibilities. The stand-
(f) A report of any approved or antici- ards contained in this section do not
pated changes to the allocation basis in relieve the Grantee of the contractual
the advance planning document’s ap- responsibilities arising under its con-
proved cost methodology. tract(s).
[75 FR 44565, July 28, 2010, as amended at 77 (1) The grantee is the responsible au-
FR 54162, Sept. 4, 2012] thority, without recourse to the De-
partmental awarding agency, regarding
§ 495.344 Approval of the State Med- the settlement and satisfaction of all
icaid HIT plan, the HIT PAPD and contractual and administrative issues
update, the HIT IAPD and update, arising out of procurements entered
and the annual HIT IAPD. into in support of an award or other
HHS will not approve the State Med- agreement. This includes disputes,
icaid HIT plan, HIT PAPD and update, claims, and protests of award, source
HIT–IAPD and update, or annual IAPD evaluation or other matters of a con-
if any of these documents do not in- tractual nature.
clude all of the information required (2) Matters concerning violation of
under this subpart. statute are to be referred to such Fed-
eral, State or local authority as may
§ 495.346 Access to systems and have proper jurisdiction.
records. (c) Codes of conduct. The grantee
The State agency must allow HHS must maintain written standards of
access to all records and systems oper- conduct governing the performance of
ated by the State in support of this its employees engaged in the award and
program, including cost records associ- administration of contracts.
ated with approved administrative (1) No employee, officer, or agent
funding and incentive payments to must participate in the selection,
Medicaid providers. State records re- award, or administration of a contract
lated to contractors employed for the supported by Federal funds if a real or
purpose of assisting with implementa- apparent conflict of interest would be
tion or oversight activities or pro- involved.
viding assistance, at such intervals as (2) Such a conflict would arise when
are deemed necessary by the Depart- the employee, officer, or agent, or any
ment to determine whether the condi- member of his or her immediate fam-
tions for approval are being met and to ily, his or her partner, or an organiza-
determine the efficiency, economy, and tion which employs or is about to em-
effectiveness of the program. ploy any of the parties indicated here-
in, has a financial or other interest in
§ 495.348 Procurement standards. the firm selected for an award.
(a) General rule. Procurements of HIT (3) The officers, employees, and
equipment and services are subject to agents of the grantee must neither so-
the following procurement standards in licit nor accept gratuities, favors, or
paragraphs (b) through (f) of this sec- anything of monetary value from con-
tion regardless of any conditions for tractors, or parties to sub agreements.
prior approval. These standards— (4) Grantees may set standards for
(1) Include a requirement for max- situations in which the financial inter-
imum practical open and free competi- est is not substantial or the gift is an
tion regardless of whether the procure- unsolicited item of nominal value.
ment is formally advertised or nego- (5) The standards of conduct provide
tiated. for disciplinary actions to be applied
936
for violations of such standards by offi- (ii) Requirements which the bidder or
cers, employers, or agents of the grant- offer must fulfill and all other factors
ees. to be used in evaluating bids or pro-
(d) Competition. All procurement posals.
transactions must be conducted in a (iii) A description, whenever prac-
manner to provide, to the maximum ticable, of technical requirements in
extent practical, open and free com- terms of functions to be performed or
petition. performance required, including the
(1) The grantee must be alert to orga- range of acceptable characteristics or
nizational conflicts of interest as well minimum acceptable standards.
as noncompetitive practices among (iv) The specific features of brand
contractors that may restrict or elimi- name or equal descriptions that bidders
nate competition or otherwise restrain are required to meet when such items
trade. are included in the solicitation.
(2) In order to ensure objective con- (v) The acceptance, to the extent
tractor performance and eliminate un- practicable and economically feasible,
fair competitive advantage, contrac- of products and services dimensioned in
tors that develop or draft grant appli- the metric system of measurement.
cations, or contract specifications, re- (vi) Preference, to the extent prac-
quirements, statements of work, invi- ticable and economically feasible, for
tations for bids and requests for pro- products and services that conserve
posals must be excluded from com- natural resources and protect the envi-
peting for such procurements. ronment and are energy efficient.
(3) Awards must be made to the bid- (4) Positive efforts must be made by
der or offer or whose bid or offer is re- grantees to utilize small businesses,
sponsive to the solicitation and is most minority-owned firms, and women’s
advantageous to the grantee, price, business enterprises, whenever pos-
quality, and other factors considered. sible. Grantees of Departmental awards
must take all of the following steps to
(4) Solicitations must clearly set
further this goal:
forth all requirements that the bidder
(i) Ensure that small businesses, mi-
or offer or must fulfill in order for the
nority-owned firms, and women’s busi-
bid or offer to be evaluated by the
ness enterprises are used to the fullest
grantee.
extent practicable.
(5) Any and all bids or offers may be (ii) Make information on forth-
rejected when it is in the grantee’s incoming opportunities available and ar-
terest to do so. range time frames for purchases and
(e) Procurement procedures. All grant- contracts to encourage and facilitate
ees must establish written procure- participation by small businesses, mi-
ment procedures. These procedures nority-owned firms, and women’s busi-
must provide, at a minimum, the fol- ness enterprises.
lowing: (iii) Consider in the contract process
(1) Grantees avoid purchasing unnec- whether firms competing for larger
essary items. contracts intend to subcontract with
(2) When appropriate, an analysis is small businesses, minority-owned
made of lease and purchase alter- firms, and women’s business enter-
natives to determine which would be prises.
the most economical and practical pro- (iv) Encourage contracting with con-
curement for the grantee and the Fed- sortia of small businesses, minority-
eral government. owned firms and women’s business en-
(3) Solicitations for goods and serv- terprises when a contract is too large
ices provide for all of the following: for one of these firms to handle individ-
(i) A clear and accurate description ually.
of the technical requirements for the (v) Use the services and assistance, as
material, product or service to be pro- appropriate, of such organizations as
cured. In competitive procurements, the Small Business Administration and
such a description must not contain the Department of Commerce’s Minor-
features which unduly restrict com- ity Business Development Agency in
petition. the solicitation and utilization of
937
§ 495.350 42 CFR Ch. IV (10–1–24 Edition)
small businesses, minority-owned firms up of all purchases. Grantees must

and women’s business enterprises. evaluate contractor performance and
(5) The type of procuring instruments document, as appropriate, whether con-
used (for example, fixed price contractors have met the terms, condi-
tracts, cost reimbursable contracts, tions, and specifications of the con-
purchase orders, and incentive contract.
tracts) must be determined by the (g) Additional contract requirements.
grantee but must be appropriate for The grantee must include, in addition
the particular procurement and for to provisions to define a sound and
promoting the best interest of the pro- complete agreement, the following pro-
gram or project involved. visions in all contracts, which must
(6) The ‘‘cost-plus-a-percentage-of- also be applied to subcontracts:
cost’’ or ‘‘percentage of construction (1) Contracts in excess of the sim-
cost’’ methods of contracting must not plified acquisition threshold must con-
be used. tain contractual provisions or condi-
(7) Contracts must be made only with tions that allow for administrative,
responsible contractors who possess contractual, or legal remedies in in-
the potential ability to perform suc- stances in which a contractor violates
cessfully under the terms and condi- or breaches the contract terms, and
tions of the proposed procurement. provide for such remedial actions as
(8) Consideration must be given to may be appropriate.
such matters as contractor integrity, (2) All contracts in excess of the sim-
record of past performance, financial plified acquisition threshold (currently
and technical resources or accessibility $100,000) must contain suitable provi-
to other necessary resources. sions for termination by the grantee,
(9) In certain circumstances, con- including the manner by which termi-
tracts with certain parties are re- nation must be effected and the basis
stricted by agencies’ implementation for settlement.
of Executive Orders 12549 and 12689, (h) Conditions for default or termi-
‘‘Debarment and Suspension’’ as de- nation. Such contracts must describe
scribed in 2 CFR part 376. conditions under which the contract
(10) Some form of cost or price anal- may be terminated for default as well
ysis must be made and documented in as conditions where the contract may
the procurement files in connection be terminated because of cir-
with every procurement action. cumstances beyond the control of the
(11) Price analysis may be accom- contractor.
plished in various ways, including the (i) Access to contract materials and
comparison of price quotations sub- staff. All negotiated contracts (except
mitted, market prices, and similar in- those for less than the simplified ac-
dicia, together with discounts. quisition threshold) awarded by grant-
(12) Cost analysis is the review and ees must include a provision to the ef-
evaluation of each element of cost to fect that the grantee, the Depart-
determine reasonableness, allocability, mental awarding agency, the U.S.
and allowability. Comptroller General, or any of their
(13) Procurement records and files for duly authorized representatives, must
purchases in excess of the simplified have access to any books, documents,
acquisition threshold must include the papers and records and staff of the con-
following at a minimum: tractor which are directly pertinent to
(i) Basis for contractor selection. a specific program for the purpose of
(ii) Justification for lack of competi- making audits, examinations, excerpts
tion when competitive bids or offers and transcriptions.
are not obtained.
(iii) Basis for award cost or price. § 495.350 State Medicaid agency attes-
(f) Contract administration. A system tations.
for contract administration must be (a) The State must provide assur-
maintained to ensure contractor con- ances to HHS that amounts received
formance with the terms, conditions with respect to sums expended that are
and specifications of the contract and attributable to payments to a Medicaid
to ensure adequate and timely follow provider for the adoption of EHR are
938
paid directly to such provider, or to an discrimination requirements in 45 CFR

employer or facility to which such pro- parts 80, 84, and 91.
vider has assigned payments, without (a) These regulations in 45 CFR parts
any deduction or rebate. 80, 84, and 91 prohibit individuals from
being excluded from participation in,
§ 495.352 Reporting requirements.
being denied the benefits of, or being
(a) Beginning with the first quarter otherwise subjected to discrimination
of calendar year 2016, each State must under any program or activity which
submit to HHS on a quarterly basis a received Federal financial assistance.
progress report, in the manner pre- (b) Specifically, 45 CFR part 80 pro-
scribed by HHS, documenting specific hibits discrimination on the basis of
implementation and oversight activi- race, color, or national origin; 45 CFR
ties performed during the quarter, in- part 84 prohibits discrimination on the
cluding progress in implementing the
basis of disability; and 45 CFR part 91
State’s approved Medicaid HIT plan.
prohibits discrimination on the basis of
(b) The quarterly progress reports
age.
must include, but need not be limited
to providing, updates on the following: § 495.358 Cost allocation plans.
(1) State system implementation
dates. State agencies that acquire HIT
(2) Provider outreach. equipment and services under this sub-
(3) Auditing. part are subject to cost allocation plan
(4) State-specific State Medicaid HIT requirements in 45 CFR part 95.
Plan tasks.
(5) State staffing levels and changes. § 495.360 Software and ownership
(6) The number and type of providers rights.
that qualified for an incentive payment (a) General rule. The State or local
on the basis of having adopted, imple- government must include a clause in
mented or upgraded CEHRT and the all procurement instruments that pro-
amounts of incentive payments. vides that the State or local govern-
(7) The number and type of providers ment will have all ownership rights in
that qualified for an incentive payment software or modifications thereof and
on the basis of having demonstrated associated documentation designed, de-
that they are meaningful users of veloped or installed with FFP under
CEHRT and the amounts of incentive this Subpart.
payments. (b) Federal license. HHS reserves a
(c) States must submit the quarterly royalty-free, non-exclusive, and irrev-
progress reports described in this sec-
ocable license to reproduce, publish or
tion within 30 days after the end of
otherwise use and to authorize others
each federal fiscal year quarter.
to use for Federal government pur-
[80 FR 62955, Oct. 16, 2015] poses, the software, modifications, and
documentation designed, developed or
§ 495.354 Rules for charging equip- installed with FFP under this Subpart.
ment.
(c) Proprietary software. Proprietary
Equipment acquired under this sub- operating/vendor software packages
part is subject to the public assistance such as software that is owned and li-
program requirements concerning the censed for use by third parties, which
computation of claims for Federal fi-
are provided at established catalog or
nancial participation in accordance
market prices and sold or leased to the
with the provisions of 45 CFR part 95,
general public must not be subject to
subpart G.
the ownership provisions in paragraphs
§ 495.356 Nondiscrimination require- (a) and (b) of this section.
ments. (d) Limitation. Federal financial par-
State agencies and any other bene- ticipation is not available for propri-
ficiaries or subbeneficiaries of Federal etary applications software developed
financial assistance provided under specifically for the public assistance
this subpart are subject to the non- programs covered under this subpart.
939
§ 495.362 42 CFR Ch. IV (10–1–24 Edition)
§ 495.362 Retroactive approval of FFP (2) The goals and objectives stated in
with an effective date of February the approved HIT implementation ad-
18, 2009. vance planning document and State
For administrative activities per- Medicaid HIT plan.
formed by a State, without obtaining (3) The schedule, budget, and other
prior approval, which are in support of conditions of the approved HIT imple-
planning for incentive payments to mentation advance planning document
providers, a State may request consid- and State Medicaid HIT plan.
eration of FFP by recorded request in a
§ 495.366 Financial oversight and mon-
HIT advance planning document or im- itoring of expenditures.
plementation advance planning docu-
ment update. In such a consideration, (a) General rule. (1) The State must
the agency takes into consideration have a process in place to estimate ex-
overall Federal interests which may in- penditures for the Medicaid EHR pay-
clude any of the following: ment incentive program using the Med-
(a) The acquisition must not be be- icaid Budget Expenditure System.
fore February 18, 2009. (2) The State must have a process in
(b) The acquisition must be reason- place to report actual expenditures for
able, useful, and necessary. the Medicaid EHR payment incentive
(c) The acquisition must be attrib- program using the Medicaid Budget Ex-
utable to payments for reasonable ad- penditure System.
ministrative expenses under section (3) The State must have an auto-
1903(a)(3)(F)(ii) of the Act. mated payment and information re-
trieval mechanized system, (Medicaid
§ 495.364 Review and assessment of ad- Management Information System) to
ministrative activities and expenses make EHR payment incentives, to en-
of Medicaid provider health infor- sure Medicaid provider eligibility, to
mation technology adoption and op- ensure the accuracy of payment incen-
eration. tives, and to identify potential im-
(a) CMS conducts periodic reviews on proper payments.
an as needed basis to assess the State’s (b) Provider eligibility as basis for mak-
progress described in its approved HIT ing payment. Subject to § 495.332, the
planning advance planning document State must do all of the following:
and health information technology im- (1) Collect and verify basic informa-
plementation advance planning docu- tion on Medicaid providers to assure
ment. provider enrollment eligibility upon
(b) During planning, development, enrollment or re-enrollment to the
and implementation, these reviews will Medicaid EHR payment incentive pro-
generally be limited to the overall gram.
progress, work performance, expendi- (2) Collect and verify basic informa-
ture reports, project deliverables, and tion on Medicaid providers to assure
supporting documentation. patient volume.
(c) CMS assesses the State’s overall (3) Collect and verify basic informa-
compliance with the approved advance tion on Medicaid providers to assure
planning document and provide tech- that EPs are not hospital-based includ-
nical assistance and information sharing the determination that substan-
ing from other State projects. tially all health care services are not
(d) CMS will, on a continuing basis, furnished in a hospital inpatient or
review, assess and inspect the plan- emergency room setting.
ning, design, development, implemen- (4) Collect and verify basic informa-
tation, and operation of activities and tion on Medicaid providers to assure
payments for reasonable administra- that EPs are practicing predominantly
tive expenses related to the adminis- in a Federally-qualified health center
tration of payment for Medicaid pro- or rural health clinic.
vider HIT adoption and operation pay- (5) Have a process in place to assure
ments to determine the extent to that Medicaid providers who wish to
which such activities meet the fol- participate in the EHR incentive pay-
lowing: ment program has or will have a NPI
(1) All requirements of this subpart. and will choose only one program from
940
which to receive the incentive payment begins receiving payments after 2016;
using the NPI, a TIN, and CMS’ na- that incentive payments cease after
tional provider election database. 2021; and that an eligible hospital does
(c) Meaningful use and efforts to adopt, not receive incentive payments after
implement, or upgrade to certified elec- FY 2016 unless the hospital received an
tronic health record technology to make incentive payment in the prior fiscal
payment. Subject to § 495.312, 495.314, year.
and § 495.332, the State must annually (4) Subject to § 495.332, the State
collect and verify information regard- must have a process in place to assure
ing the efforts to adopt, implement, or that only appropriate funding sources
upgrade certified EHR technology and are used to make Medicaid EHR incen-
the meaningful use of said technology tive payments.
before making any payments to pro- (5) Subject to § 495.332, the State
viders. must have a process in place to assure
(d) Claiming Federal reimbursement for that Medicaid EHR incentive payments
State expenditures. Subject to § 495.332, are not paid at amounts higher than 85
the State must do the following: percent of the net average allowable
(1) Assure that State expenditures cost of certified EHR technology and
are claimed in accordance with, includ- the yearly maximum allowable pay-
ing but not limited to, applicable Fed- ment thresholds.
eral laws, regulations, and policy guid- (6) Subject to § 495.332, the State
ance. must have a process in place to assure
(2) Have a process in place to assure that for those entities promoting the
that expenditures for administering adoption of EHR technology, the Med-
the Medicaid EHR incentive payment icaid EHR incentive payments are paid
program will not be claimed at on a voluntary basis and that these en-
amounts higher than 90 percent of the tities do not retain more than 5 per-
cost of such administration. cent of such payments for costs not re-
(3) Have a process in place to assure lated to certified EHR technology.
that expenditures for payment of Med- (7) Subject to § 495.332, the State
icaid EHR incentive payments will not must have a process in place to assure
be claimed at amounts higher than 100 that any existing fiscal relationships
percent of the cost of such payments to with providers to disburse the incen-
Medicaid providers. tive through Medicaid managed care
(e) Improper Medicaid electronic health plans does not exceed 105 percent of the
record payment incentives. (1) Subject to capitation rate, in order to comply
§ 495.332, the State must have a process with the Medicaid managed care incen-
in place to assure that no duplicate tive payment rules at § 438.6(b)(2) of
Medicaid EHR payment incentives are this chapter and a methodology for
paid between the Medicare and Med- verifying such information.
icaid programs, or paid by more than (8) The State must not request reim-
one State even if the provider is li- bursement for Federal financial par-
censed to practice in multiple States, ticipation unless all requirements of
or paid within more than one area of a this subpart have been satisfied.
State. [75 FR 44565, July 28, 2010, as amended at 75
(2) Subject to § 495.332, the State FR 81887, Dec. 29, 2010; 81 FR 27901, May 6,
must have a process in place to assure 2016]
that Medicaid EHR incentive payments
are made without reduction or rebate, § 495.368 Combating fraud and abuse.
have been paid directly to an eligible (a) General rule. (1) The State must
provider or to an employer, a facility, comply with Federal requirements to—
or an eligible third-party entity to (i) Ensure the qualifications of the
which the Medicaid eligible provider providers who request Medicaid EHR
has assigned payments. incentive payments;
(3) Subject to § 495.332, the State (ii) Detect improper payments; and
must have a process in place to assure (iii) In accordance with § 455.15 and
that that Medicaid EHR incentive pay- § 455.21 of this chapter, refer suspected
ments are made for no more than 6 cases of fraud and abuse to the Med-
years; that no EP or eligible hospital icaid Fraud Control Unit.
941
§ 495.370 42 CFR Ch. IV (10–1–24 Edition)
(2) The State must take corrective established in § 447.253(e) of this chap-
action in the case of improper EHR ter for a provider or entity to appeal
payment incentives to Medicaid pro- the following issues related to the HIT
viders. incentives payment program:
(b) Providers’ statements regarding sub- (1) Incentive payments.
mission of documentation containing fal- (2) Incentive payment amounts.
sification or concealment of a material (3) Provider eligibility determina-
fact on EHR incentive payment docu- tions.
mentation. For any forms on which a (4) Demonstration of adopting, imple-
provider submits information nec- menting, and upgrading, and meaning-
essary to the determination of eligi- ful use eligibility for incentives under
bility to receive EHR payments, the this subpart.
State must obtain a statement that (b) Subject to paragraph (a) of this
meets the following requirements: section, the State’s process must en-
(1) Is signed by the provider and con- sure the following:
tains the following statement: ‘‘This is (1) That the provider (whether an in-
to certify that the foregoing informa- dividual or an entity) has an oppor-
tion is true, accurate, and complete. I tunity to challenge the State’s deter-
understand that Medicaid EHR incen- mination under this part by submitting
tive payments submitted under this documents or data or both to support
provider number will be from Federal the provider’s claim.
funds, and that any falsification, or (2) That such process employs meth-
concealment of a material fact may be ods for conducting an appeal that are
prosecuted under Federal and State consistent with the State’s Adminis-
laws.’’ trative Procedure law(s).
(2) Appears directly above the claim- (c) The State must provide that the
ant’s signature, or if it is printed on provider (whether individual or entity)
the reverse of the form, a reference to is also given any additional appeals
the statements must appear imme- rights that would otherwise be avail-
able under procedures established by
diately preceding the provider’s signa-
the State.
ture.
(d) This section does not apply in the
(3) Is resubmitted upon a change in
case that CMS conducts the audits and
provider representative.
handles any subsequent appeals under
(4) Is updated as needed.
§ 495.312(c)(2) of this part.
(c) Overpayments. States must repay
to CMS all Federal financial participa- [75 FR 44565, July 28, 2010, as amended at 77
tion received by providers identified as FR 54161, Sept. 4, 2012]
an overpayment regardless of
recoupment from such providers, with- PART 498—APPEALS PROCEDURES
in 60 days of discovery of the overpay- FOR DETERMINATIONS THAT AF-
ment, in accordance with sections FECT PARTICIPATION IN THE
1903(a)(1), (d)(2), and (d)(3) of the Act MEDICARE PROGRAM AND FOR
and part 433 subpart F of the regula- DETERMINATIONS THAT AFFECT
tions.
(d) Complying with Federal laws and
THE PARTICIPATION OF ICFs/IID
regulations. States must comply with AND CERTAIN NFs IN THE MED-
all Federal laws and regulations de- ICAID PROGRAM
signed to prevent fraud, waste, and
abuse, including, but not limited to ap- Subpart A—General Provisions
plicable provisions of Federal criminal Sec.
law, the False Claims Act (32 U.S.C. 498.1 Statutory basis.
3729 et seq.), and the anti-kickback 498.2 Definitions.
statute (section 1128B(b) of the Act). 498.3 Scope and applicability.
498.4 NFs subject to appeals process in part
§ 495.370 Appeals process for a Med- 498.
icaid provider receiving electronic 498.5 Appeal rights.
health record incentive payments. 498.10 Appointment of representatives.
498.11 Authority of representatives.
(a) The State must have a process in 498.13 Fees for services of representatives.
place consistent with the requirements 498.15 Charge for transcripts.
942
498.17 Filing of briefs with the ALJ or De- 498.82 Request for Departmental Appeals
partmental Appeals Board, and oppor- Board review.
tunity for rebuttal. 498.83 Departmental Appeals Board action
on request for review.
Subpart B—Initial, Reconsidered, and 498.85 Procedures before the Departmental
Revised Determinations Appeals Board on review.
498.86 Evidence admissible on review.
498.20 Notice and effect of initial deter- 498.88 Decision or remand by the Depart-
minations. mental Appeals Board.
498.22 Reconsideration. 498.90 Effect of Departmental Appeals Board
498.23 Withdrawal of request for reconsider- decision.
ation.
498.95 Extension of time for seeking judicial
498.24 Reconsidered determination.
review.
498.25 Notice and effect of reconsidered de-
termination.
Subpart F—Reopening of Decisions Made
Subpart C—Reopening of Initial or by Administrative Law Judges or the
Reconsidered Determinations Departmental Appeals Board
498.30 Limitation on reopening. 498.100 Basis, timing, and authority for re-
498.32 Notice and effect of reopening and reopening an ALJ or Board decision.
vision. 498.102 Revision of reopened decision.
498.103 Notice and effect of revised decision.
Subpart D—Hearings AUTHORITY: 42 U.S.C. 1302, 1320a–7j, and
498.40 Request for hearing. 1395hh.
498.42 Parties to the hearing. SOURCE: 52 FR 22446, June 12, 1987, unless
498.44 Designation of hearing official. otherwise noted.
498.45 Disqualification of Administrative
Law Judge.
498.47 Prehearing conference. Subpart A—General Provisions
498.48 Notice of prehearing conference.
498.49 Conduct of prehearing conference. § 498.1 Statutory basis.
498.50 Record, order, and effect of pre-
hearing conference.
(a) Section 1866(h) of the Act provides
498.52 Time and place of hearing. for a hearing and for judicial review of
498.53 Change in time and place of hearing. the hearing for any institution or agen-
498.54 Joint hearings. cy dissatisfied with a determination
498.56 Hearing on new issues. that it is not a provider, or with any
498.58 Subpoenas. determination described in section
498.60 Conduct of hearing. 1866(b)(2) of the Act.
498.61 Evidence.
498.62 Witnesses. (b) Section 1866(b)(2) of the Act lists
498.63 Oral and written summation. determinations that serve as a basis for
498.64 Record of hearing. termination of a provider agreement.
498.66 Waiver of right to appear and present (c) Sections 1128 (a) and (b) of the Act
evidence. provide for exclusion of certain individ-
498.68 Dismissal of request for hearing. uals or entities because of conviction
498.69 Dismissal for abandonment.
498.70 Dismissal for cause.
of crimes related to their participation
498.71 Notice and effect of dismissal and in Medicare and section 1128(f) provides
right to request review. for hearing and judicial review for ex-
498.72 Vacating a dismissal of request for clusions.
hearing. (d) Section 1156 of the Act establishes
498.74 Administrative Law Judge’s decision. certain obligations for practitioners
498.76 Removal of hearing to Departmental
and providers of health care services,
Appeals Board.
498.78 Remand by the Administrative Law and provides sanctions and penalties
Judge. for those that fail to meet those obliga-
498.79 Timeframes for deciding an enroll- tions.
ment appeal before an ALJ. (e)–(f) [Reserved]
(g) Section 1866(j) of the Act provides
Subpart E—Departmental Appeals Board for a hearing and judicial review for
Review any provider or supplier whose applica-
498.80 Right to request Departmental Ap- tion for enrollment or reenrollment in
peals Board review of Administrative Medicare is denied or whose billing
Law Judge’s decision or dismissal. privileges are revoked.
943
§ 498.2 42 CFR Ch. IV (10–1–24 Edition)
(h) Section 1128A(c)(2) of the Act pro- review of disputed decisions made by
vides that the Secretary may not col- the operating components of the De-
lect a civil money penalty until the af- partment.
fected entity has had notice and oppor- OIG stands for the Department’s Of-
tunity for a hearing. fice of the Inspector General.
(i) Section 1819(h) of the Act— Prospective provider means any of the
(1) Provides that, for SNFs found to entities specified in the definition of
be out of compliance with the require- provider under this section that seeks
ments for participation, specified rem- to be approved for coverage of its serv-
edies may be imposed instead of, or in ices by Medicare or to have any facility
addition to, termination of the facili- or organization determined to be a de-
ty’s Medicare provider agreement; and partment of the provider or provider-
(2) Makes certain provisions of sec- based entity under § 413.65 of this chap-
tion 1128A of the Act applicable to civil ter.
money penalties imposed on SNFs. Prospective supplier means any of the
(j) Section 1891(e) of the Act provides listed entities specified in the defini-
that, for home health agencies (HHAs) tion of supplier in this section that
found to be out of compliance with the seek to be approved for coverage of its
conditions of participation, specified services by Medicare.
remedies may be imposed instead of, or Provider means any of the following:
in addition to, termination of the (1) Any of the following entities that
HHA’s Medicare provider agreement. have in effect an agreement to partici-
(k) Section 1891(f) of the Act— pate in Medicare:
(1) Requires the Secretary to develop (i) Hospital.
a range of such remedies; and (ii) Transplant center.
(2) Makes certain provisions of sec- (iii) Critical access hospital (CAH).
tion 1128A of the Act applicable to civil (iv) Skilled nursing facility (SNF).
money penalties imposed on HHAs. (v) Comprehensive outpatient reha-
(l) Section 1822 of the Act provides bilitation facility (CORF).
that for hospice programs that are no (vi) Home health agency (HHA).
longer in compliance with the condi- (vii) Hospice.
tions of participation, the Secretary (viii) Religious nonmedical health
may develop remedies to be imposed care institution (RNHCI).
instead of, or in addition to, termi- (2) Any of the following entities that
nation of the hospice program’s Medi- have in effect an agreement to partici-
care provider agreement. pate in Medicare but only to furnish
[52 FR 22446, June 12, 1987, as amended at 59 outpatient physical therapy or out-
FR 56251, Nov. 10, 1994; 61 FR 32349, June 24, patient speech pathology services.
1996; 73 FR 36462, June 27, 2008; 86 FR 62431, (i) Clinic.
Nov. 9, 2021] (ii) Rehabilitation agency.
(iii) Public health agency.
§ 498.2 Definitions. (3) An entity that has in effect an
As used in this part— agreement to participate in Medicare
Affected party means a provider, pro- but only to furnish opioid use disorder
spective provider, supplier, prospective treatment services.
supplier, or practitioner that is af- Supplier means any of the following
fected by an initial determination or entities that have in effect an agree-
by any subsequent determination or ment to participate in Medicare:
decision issued under this part, and (1) An independent laboratory.
‘‘party’’ means the affected party or (2) Supplier of durable medical equip-
CMS, as appropriate. For provider or ment prosthetics, orthotics, or supplies
supplier enrollment appeals, an af- (DMEPOS).
fected party includes CMS or a CMS (3) Ambulance service provider.
contractor. (4) Independent diagnostic testing fa-
ALJ stands for Administrative Law cility.
Judge. (5) Physician or other practitioner
Departmental Appeals Board or Board such as physician assistant.
means a Board established in the Office (6) For purposes of this part, a phys-
of the Secretary to provide impartial ical therapist in private practice, an
944
occupational therapist in private prac- comply with the requirements at

tice, or a speech-language pathologist. § 483.75(r) of this chapter.
(7) Supplier of portable X-ray serv- (3) The following parts of this chap-
ices. ter specify the applicability of the pro-
(8) Rural health clinic (RHC). visions of this part 498 to sanctions or
(9) Federally qualified health center remedies imposed on the indicated en-
(FQHC). tities or individuals:
(10) Ambulatory surgical center (i) Part 431, subpart D—for nursing
(ASC). facilities (NFs).
(11) An entity approved by CMS to (ii) Part 488, subpart E (§ 488.330(e))—
furnish outpatient diabetes self-man- for SNFs and NFs.
agement training. (iii) Part 488, subpart E (§ 488.330(e))
(12) End-stage renal disease (ESRD) and subpart F (§ 488.446)—for SNFs and
treatment facility that is approved by NFs and their administrators.
CMS as meeting the conditions for cov- (b) Initial determinations by CMS. CMS
erage of its services. makes initial determinations with re-
(13) A site approved by CMS to fur- spect to the following matters:
nish intensive cardiac rehabilitation (1) Whether a prospective provider
services. qualifies as a provider.
[52 FR 22446, June 12, 1987] (2) Whether a prospective department
of a provider, remote location of a hos-
tations affecting § 498.2, see the List of CFR pital, satellite facility, or provider-
Sections Affected, which appears in the based entity qualifies for provider-
Finding Aids section of the printed volume based status under § 413.65 of this chap-
and at www.govinfo.gov. ter, or whether such a facility or entity
currently treated as a department of a
§ 498.3 Scope and applicability. provider, remote location of a hospital,
(a) Scope. (1) This part sets forth pro- satellite facility, or a provider-based
cedures for reviewing initial deter- entity no longer qualifies for that sta-
minations that CMS makes with re- tus under § 413.65 of this chapter.
spect to the matters specified in para- (3) Whether an institution is a hos-
graph (b) of this section, and that the pital qualified to elect to claim pay-
OIG makes with respect to the matters ment for all emergency hospital serv-
specified in paragraph (c) of this sec- ices furnished in a calendar year.
tion. It also specifies, in paragraph (d) (4) Whether an institution continues
of this section, administrative actions to remain in compliance with the
that are not subject to appeal under qualifications for claiming reimburse-
this part. ment for all emergency services fur-
(2) The determinations listed in this nished in a calendar year.
section affect participation in the (5) Whether a prospective supplier
Medicare program. Many of the proce- meets the conditions for coverage of its
dures of this part also apply to other services as those conditions are set
determinations that do not affect par- forth elsewhere in this chapter.
ticipation in Medicare. Some examples (6) Whether the services of a supplier
follow: continue to meet the conditions for
(i) CMS’s determination to terminate coverage.
an NF’s Medicaid provider agreement. (7) Whether a physical therapist in
(ii) CMS’s determination to cancel independent practice or a chiropractor
the approval of an ICF/IID under sec- meets the requirements for coverage of
tion 1910(b) of the Act. his or her services as set forth in sub-
(iii) CMS’s determination, under the part D of part 486 of this chapter and
Clinical Laboratory Improvement Act § 410.22 of this chapter, respectively.
(CLIA), to impose alternative sanctions (8) The termination of a provider
or to suspend, limit, or revoke the cer- agreement in accordance with § 489.53
tificate of a laboratory even though it of this chapter, or the termination of a
does not participate in Medicare. rural health clinic agreement in ac-
(iv) CMS’s determination to impose cordance with § 405.2404 of this chapter,
sanctions on the individual who is the or the termination of a Federally
administrator of a NF for failure to qualified health center agreement in
945
§ 498.3 42 CFR Ch. IV (10–1–24 Edition)
accordance with § 405.2436 of this chap- (ii) Whether, under § 424.535(c)(2)(i) of

ter. this chapter, to add years to a pro-
(9) CMS’s cancellation, under section vider’s or supplier’s existing reenroll-
1910(b) of the Act, of an ICF/IID’s ap- ment bar; or
proval to participate in Medicaid. (iii) Whether, under § 424.535(c)(3) of
(10) Whether, for purposes of rate set- this chapter, an individual or entity
ting and reimbursement, an ESRD other than the provider or supplier
treatment facility is considered to be that is the subject of the second rev-
hospital-based or independent. ocation was the actual subject of the
(11) [Reserved] first revocation.
(12) Whether a hospital, skilled nurs- (18) The level of noncompliance found
ing facility, home health agency, or by CMS with respect to the failure of
hospice program meets or contimues to an individual who is the administrator
meet the advance directives require- of a SNF to comply with the require-
ments specified in subpart I of part 489
ments at § 483.75(r) of this chapter, and
of this chapter.
the appropriate sanction to be imposed
(13) Except as provided at paragraph
under § 488.446 of this chapter.
(d)(12) of this section for SNFs, NFs,
HHAs, and hospice programs, the find- (19) Whether a physician or practi-
ing of noncompliance leading to the tioner has failed to properly opt-out,
imposition of enforcement actions failed to maintain opt-out, failed to
specified in § 488.406, § 488.820, or timely renew opt-out, failed to pri-
§ 488.1170 of this chapter, but not the vately contract, or failed to properly
determination as to which sanction or terminate opt-out.
remedy was imposed. The scope of re- (20) An individual or entity is to be
view on the imposition of a civil money included on the preclusion list as de-
penalty is specified in § 488.438(e), fined in § 422.2 or § 423.100 of this chap-
§ 488.845(h), or § 488.1195(h) of this chapter.
ter. (c) Initial determinations by the OIG.
(14) The level of noncompliance found The OIG makes initial determinations
by CMS in a SNF, NF, HHA, or hospice with respect to the following matters:
program, but only if a successful chal- (1) The termination of a provider
lenge on this issue would affect— agreement in accordance with part
(i) The range of civil money penalty 1001, subpart C of this title.
amounts that CMS could collect (for (2) The suspension, or exclusion from
SNFs or NFs, the scope of review dur- coverage and the denial of reimburse-
ing a hearing on imposition of a civil ment for services furnished by a pro-
money penalty is set forth in vider, practitioner, or supplier, because
§ 488.438(e) of this chapter and for HHAs of fraud or abuse, or conviction of
and hospice programs, the scope of re- crimes related to participation in the
view during a hearing on the imposi- program, in accordance with part 1001,
tion of a civil money penalty is set subpart B of this title.
forth in §§ 488.845(h) and 488.1195(h) of
(3) The imposition of sanctions in ac-
this chapter); or
cordance with part 1004 of this title.
(ii) A finding of substandard quality
of care that results in the loss of ap- (d) Administrative actions that are not
proval for a SNF or NF of its nurse initial determinations. Administrative
aide training program. actions that are not initial determina-
(15) The effective date of a Medicare tion (and therefore not subject to ap-
provider agreement or supplier appeal under this part) include but are
proval. not limited to the following:
(16) The finding of substandard qual- (1) The finding that a provider or sup-
ity of care that leads to the loss by a plier determined to be in compliance
SNF or NF of the approval of its nurse with the conditions or requirements for
aide training program. participation or for coverage has defi-
(17)(i) Whether to deny or revoke a ciencies.
provider’s or supplier’s Medicare en- (2) The finding that a prospective
rollment in accordance with § 424.530 or provider does not meet the conditions
§ 424.535 of this chapter; of participation set forth elsewhere in
946
this chapter, if the prospective pro- (i) The finding that the provider’s de-
vider is, nevertheless, approved for par- ficiencies pose immediate jeopardy to
ticipation in Medicare on the basis of the health or safety of the residents or
special access certification, as provided patients;
in subpart B of part 488 of this chapter. (ii) Except as provided in paragraph
(3) The refusal to enter into a pro- (b)(13) of this section, a determination
vider agreement because the prospec- by CMS as to the provider’s level of
tive provider is unable to give satisfac- noncompliance; and
tory assurance of compliance with the (iii) For SNFs and NFs, the imposi-
requirements of title XVIII of the Act. tion of State monitoring.
(4) The finding that an entity that (11) The choice of alternative sanc-
had its provider agreement terminated tion or remedy to be imposed on a pro-
may not file another agreement be- vider or supplier.
cause the reasons for terminating the (12) The determination that the ac-
previous agreement have not been re- creditation requirements of a national
moved or there is insufficient assur- accreditation organization do not pro-
ance that the reasons for the exclusion vide (or do not continue to provide)
will not recur. reasonable assurance that the entities
(5) The determination not to rein- accredited by the accreditation organi-
state a suspended or excluded practi- zation meet the applicable long-term
tioner, provider, or supplier because care requirements, conditions for cov-
the reason for the suspension or exclu- erage, conditions of certification, con-
sion has not been removed, or there is ditions of participation, or CLIA condi-
insufficient assurance that the reason tion level requirements.
will not recur. (13) The determination that require-
(6) The finding that the services of a ments imposed on a State’s labora-
laboratory are covered as hospital serv- tories under the laws of that State do
ices or as physician’s services, rather not provide (or do not continue to pro-
than as services of an independent lab- vide) reasonable assurance that labora-
oratory, because the laboratory is not tories licensed or approved by the
independent of the hospital or of the State meet applicable CLIA require-
physician’s office. ments.
(7) The refusal to accept for filing an (14) The choice of alternative sanc-
election to claim payment for all emer- tion or remedy to be imposed on a pro-
gency hospital services furnished in a vider or supplier.
calendar year because the institution— (15) A decision by the State survey
(i) Had previously charged an indi- agency as to when to conduct an initial
vidual or other person for services fur- survey of a prospective provider or sup-
nished during that calendar year; plier.
(ii) Submitted the election after the (e) Exclusion of civil rights issues. The
close of that calendar year; or procedures in this subpart do not apply
(iii) Had previously been notified of to the adjudication of issues relating to
its failure to continue to comply. a provider’s compliance with civil
(8) The finding that the reason for rights requirements that are set forth
the revocation of a supplier’s right to in part 489 of this chapter. Those issues
accept assignment has not been re- are handled through the Department’s
moved or there is insufficient assur- Office of Civil Rights.
ance that the reason will not recur. [52 FR 22446, June 12, 1987]
(9) The finding that a hospital ac- EDITORIAL NOTE: For FEDERAL REGISTER ci-
credited by the Joint Commission on tations affecting § 498.3, see the List of CFR
Accreditation of Hospitals or the Sections Affected, which appears in the
American Osteopathic Association is Finding Aids section of the printed volume
not in compliance with a condition of and at www.govinfo.gov.
participation, and a finding that that
hospital is no longer deemed to meet § 498.4 NFs subject to appeals process
the conditions of participation. in part 498.
(10) For a SNF, NF, HHA, or hospice A NF is considered a provider for pur-
program— poses of this part when it has in effect
947
§ 498.5 42 CFR Ch. IV (10–1–24 Edition)
an agreement to participate in Med- (f) Appeal rights of suppliers and pro-

icaid, including an agreement to par- spective suppliers. (1) Any supplier or
ticipate in both Medicaid and Medicare prospective supplier dissatisfied with
and it is a— the hearing decision may request De-
(a) State-operated NF; or partmental Appeals Board review of
(b) Non State-operated NF that is the ALJ’s decision.
subject to compliance action as a re- (2) A supplier or prospective supplier
sult of— dissatisfied with an ALJ decision may
(1) A validation survey by CMS; or request Board review, and has a right
(2) CMS’s review of the State’s sur- to seek judicial review of the Board’s
vey findings. decision.
[59 FR 56252, Nov. 10, 1994] (g) Appeal rights for certain practi-
tioners. A physical therapist in inde-
§ 498.5 Appeal rights. pendent practice or a chiropractor dis-
satisfied with a determination that he
(a) Appeal rights of prospective pro-
or she does not meet the requirements
viders. (1) Any prospective provider dis-
for coverage of his or her services has
satisfied with an initial determination
the same appeal rights as suppliers
or revised initial determination that it
have under paragraphs (d), (e) and (f) of
does not qualify as a provider may re-
quest reconsideration in accordance this section.
with § 498.22(a). (h) Appeal rights for nonparticipating
(2) Any prospective provider dissatis- hospitals that furnish emergency services.
fied with a reconsidered determination A nonparticipating hospital dissatis-
under paragraph (a)(1) of this section, fied with a determination or decision
or a revised reconsidered determina- that it does not qualify to elect to
tion under § 498.30, is entitled to a hear- claim payment for all emergency serv-
ing before an ALJ. ices furnished during a calendar year
(b) Appeal rights of providers. Any pro- has the same appeal rights that pro-
vider dissatisfied with an initial deter- viders have under paragraph (a), (b),
mination to terminate its provider and (c) of this section.
agreement is entitled to a hearing be- (i) Appeal rights for suspended or ex-
fore an ALJ. cluded practitioners, providers, or sup-
(c) Appeal rights of providers and pro- pliers. (1) Any practitioner, provider, or
spective providers. Any provider or pro- supplier who has been suspended, or
spective provider dissatisfied with a whose services have been excluded
hearing decision may request Depart- from coverage in accordance with
mental Appeals Board review, and has § 498.3(c)(2), or has been sanctioned in
a right to seek judicial review of the accordance with § 498.3(c)(3), is entitled
Board’s decision. to a hearing before an ALJ.
(d) Appeal rights of prospective sup- (2) Any suspended or excluded practi-
pliers. (1) Any prospective supplier dis- tioner, provider, or supplier dissatisfied
satisfied with an initial determination with a hearing decision may request
or a revised initial determination that Departmental Appeals Board review
its services do not meet the conditions and has a right to seek judicial review
for coverage may request reconsider- of the Board’s decision by filing an ac-
ation in accordance with § 498.22(a). tion in Federal district court.
(2) Any prospective supplier dissatis- (j) Appeal rights for Medicaid ICFs/IID
fied with a reconsidered determination terminated by CMS. (1) Any Medicaid
under paragraph (d)(1) of this section, ICF/IID that has had its approval can-
or a revised reconsidered determina- celled by CMS in accordance with
tion under § 498.30, is entitled to a hear- § 498.3(b)(8) has a right to a hearing be-
ing before an ALJ. fore an ALJ, to request Departmental
(e) Appeal rights of suppliers. Any sup- Appeals Board review of the hearing
plier dissatisfied with an initial deter- decision, and to seek judicial review of
mination that the services subject to the Board’s decision.
the determination no longer meet the (2) The Medicaid agreement remains
conditions for coverage, is entitled to a in effect until the period for requesting
hearing before an ALJ. a hearing has expired or, if the facility
948
requests a hearing, until a hearing de- tions authorized under § 488.446 of this
cision is issued, unless CMS— chapter is entitled to a hearing before
(i) Makes a written determination an ALJ, to request Board review of the
that continuation of provider status hearing decision, and to seek judicial
for the SNF or ICF constitutes an im- review of the Board’s decision.
mediate and serious threat to the (n) Appeal rights of individuals and en-
health and safety of patients and speci- tities on preclusion list. (1)(i) Any indi-
fies the reasons for that determination; vidual or entity that is dissatisfied
and with an initial determination or re-
(ii) Certifies that the facility has vised initial determination that they
been notified of its deficiencies and has
are to be included on the preclusion
failed to correct them.
list (as defined in § 422.2 or § 423.100 of
(k) Appeal rights of NFs. Under the
circumstances specified in § 431.153 (g) this chapter) may request a reconsider-
and (h) of this chapter, an NF has a ation in accordance with § 498.22(a).
right to a hearing before an ALJ, to re- (ii)(A) If the individual’s or entity’s
quest Board review of the hearing deci- inclusion on the preclusion list is based
sion, and to seek judicial review of the on a Medicare revocation under § 424.535
Board’s decision. of this chapter and the individual or
(l) Appeal rights related to provider en- entity receives contemporaneous no-
rollment. (1) Any prospective provider, tice of both actions, the individual or
an existing provider, prospective sup- entity may request a joint reconsider-
plier or existing supplier dissatisfied ation of both the preclusion list inclu-
with an initial determination or re- sion and the revocation in accordance
vised initial determination related to with § 498.22(a).
the denial or revocation of Medicare (B) The individual or entity may not
billing privileges may request reconsid- submit separate reconsideration re-
eration in accordance with § 498.22(a). quests under paragraph (n)(1)(ii)(A) of
(2) CMS, a CMS contractor, any pro- this section for inclusion on the pre-
spective provider, an existing provider, clusion list or a revocation if the indi-
prospective supplier, or existing sup- vidual or entity received contempora-
plier dissatisfied with a reconsidered
neous notice of both actions.
determination under paragraph (l)(1) of
this section, or a revised reconsidered (2) If CMS or the individual or entity
determination under § 498.30, is entitled under paragraph (n)(1) of this section is
to a hearing before an ALJ. dissatisfied with a reconsidered deter-
(3) CMS, a CMS contractor, any pro- mination under paragraph (n)(1) of this
spective provider, an existing provider, section, or a revised reconsidered de-
prospective supplier, or existing sup- termination under § 498.30, CMS or the
plier dissatisfied with a hearing deci- individual or entity is entitled to a
sion may request Board review, and hearing before an ALJ.
any prospective provider, an existing (3) If CMS or the individual or entity
provider, prospective supplier, or exist- under paragraph (n)(2) of this section is
ing supplier has a right to seek judicial dissatisfied with a hearing decision as
review of the Board’s decision. described in paragraph (n)(2) of this
(4) Scope of review. For appeals of de- section, CMS or the individual or enti-
nials based on § 424.530(a)(10) of this ty may request Board review and the
chapter related to temporary mora- individual or entity has a right to seek
toria, the scope of review will be lim- judicial review of the Board’s decision.
ited to whether the temporary morato-
rium applies to the provider or supplier [52 FR 22446, June 12, 1987, as amended at 57
appealing the denial. The agency’s FR 43925, Sept. 23, 1992; 59 FR 56252, Nov. 10,
basis for imposing a temporary mora- 1994; 61 FR 32350, June 24, 1996; 73 FR 36462,
June 27, 2008; 76 FR 9512, Feb. 18, 2011; 76 FR
torium is not subject to review.
5970, Feb. 2, 2011; 78 FR 16805, Mar. 19, 2013; 79
(m) Appeal rights of an individual who
FR 72533, Dec. 5, 2014; 83 FR 16757, Apr. 16,
is the administrator of a SNF or NF. An 2018; 84 FR 15844, Apr. 16, 2019]
individual who is the administrator of
a SNF or NF who is dissatisfied with
the decision of CMS to impose sanc-
949
§ 498.10 42 CFR Ch. IV (10–1–24 Edition)
§ 498.10 Appointment of representa- the ALJ or the Departmental Appeals

tives. Board, as appropriate.
(a) An affected party may appoint as [52 FR 22446, June 12, 1987, as amended at 61
its representative anyone not disquali- FR 51021, Sept. 30, 1996]
fied or suspended from acting as a rep-
§ 498.17 Filing of briefs with the ALJ
resentative in proceedings before the or Departmental Appeals Board,
Secretary or otherwise prohibited by and opportunity for rebuttal.
law.
(a) Filing of briefs and related docu-
(b) If the representative appointed is ments. If a party files a brief or related
not an attorney, the party must file document such as a written argument,
written notice of the appointment with contention, suggested finding of fact,
CMS, the ALJ, or the Departmental conclusion of law, or any other written
Appeals Board. statement, it must submit an original
(c) If the representative appointed is and one copy to the ALJ or the Depart-
an attorney, the attorney’s statement mental Appeals Board, as appropriate.
that he or she has the authority to rep- The material may be filed by mail or in
resent the party is sufficient. person and must include a statement
certifying that a copy has been fur-
§ 498.11 Authority of representatives. nished to the other party.
(a) A representative appointed and (b) Opportunity for rebuttal. (1) The
qualified in accordance with § 498.10 other party will have 20 days from the
date of mailing or personal service to
may, on behalf of the represented
submit any rebuttal statement or addi-
party—
tional evidence. If a party submits a re-
(1) Give and accept any notice or rebuttal statement or additional evi-
quest pertinent to the proceedings set dence, it must file an original and one
forth in this part; copy with the ALJ or the Board and
(2) Present evidence and allegations furnish a copy to the other party.
as to facts and law in any proceedings (2) The ALJ or the Board will grant
affecting that party to the same extent an opportunity to reply to the rebuttal
as the party; and statement only if the party shows good
(3) Obtain information to the same cause.
extent as the party.
(b) A notice or request may be sent Subpart B—Initial, Reconsidered,
to the affected party, to the party’s and Revised Determinations
representative, or to both. A notice or
request sent to the representative has § 498.20 Notice and effect of initial de-
the same force and effect as if it had terminations.
been sent to the party. (a) Notice of initial determination—(1)
General rule. CMS or the OIG, as appro-
§ 498.13 Fees for services of represent- priate, mails notice of an initial deter-
atives. mination to the affected party, setting
Fees for any services performed on forth the basis or reasons for the deter-
behalf of an affected party by an attor- mination, the effect of the determina-
ney appointed and qualified in accord- tion, and the party’s right to reconsid-
ance with § 498.10 are not subject to the eration, if applicable, or to a hearing.
(2) Special rules: Independent labora-
provisions of section 206 of Title II of
tories and suppliers of portable x-ray serv-
the Act, which authorizes the Sec-
ices. If CMS determines that an inde-
retary to specify or limit those fees.
pendent laboratory or a supplier of
§ 498.15 Charge for transcripts. portable x-ray services no longer meets
the conditions for coverage of some or
A party that requests a transcript of all of its services, the notice—
prehearing or hearing proceedings or (i) Specifies an effective date of ter-
Board review must pay the actual or mination of coverage that is at least 15
estimated cost of preparing the tran- days after the date of the notice;
script unless, for good cause shown by (ii) Is also sent to physicians, hos-
that party, the payment is waived by pitals, and other parties that might use
950
the services of the laboratory or sup- the affected party files a written re-
plier; and quest in accordance with paragraphs
(iii) In the case of laboratories, speci- (b) and (c) of this section. For denial or
fies the categories of laboratory tests revocation of enrollment, prospective
that are no longer covered. providers and suppliers and providers
(3) Special rules: Nonparticipating hos- and suppliers have a right to reconsid-
pitals that elect to claim payment for eration.
emergency services. If CMS determines
(b) Request for reconsideration: Manner
that a nonparticipating hospital no
and timing. The affected party specified
longer qualifies to elect to claim pay-
ment for all emergency services fur- in paragraph (a) of this section, if dis-
nished in a calendar year, the notice— satisfied with the initial determination
(i) States the calendar year to which may request reconsideration by filing
the determination applies; the request—
(ii) Specifies an effective date that is (1) With CMS or with the State sur-
at least 5 days after the date of the no- vey agency, or in the case of prospec-
tice; and tive supplier the entity specified in the
(iii) Specifies that the determination notice of initial determination;
applies to services furnished, in the (2) Directly or through its legal rep-
specified calendar year, to patients ac- resentative or other authorized offi-
cepted (as inpatients or outpatients) on cial; and
or after the effective date of the deter- (3) Within 60 days from receipt of the
mination. notice of initial determination, unless
(4) Other special rules. Additional
the time is extended in accordance
rules pertaining, for example, to con-
with paragraph (d) of this section. The
tent and timing of notice, notice to the
public and to other entities, and time date of receipt will be presumed to be 5
allowed for submittal of additional in- days after the date on the notice unless
formation, are set forth elsewhere in there is a showing that it was, in fact,
this chapter, as follows: received earlier or later.
(c) Content of request. The request for
Part 405 Subpart X—for rural health clinics.
Part 416—for ambulatory surgical centers.
reconsideration must state the issues,
Part 489—for providers, when their provider or the findings of fact with which the
agreements have been terminated. affected party disagrees, and the rea-
Part 1001, Subpart B—for excluded or sus- sons for disagreement.
pended providers, suppliers, physicians, or (d) Extension of time to file a request for
practitioners.
Part 1001, Subpart C—for providers, when reconsideration. (1) If the affected party
their provider agreements are terminated is unable to file the request within the
by the OIG. 60 days specified in paragraph (b) of
Part 1004—for sanctioned providers and prac- this section, it may file a written re-
titioners. quest with CMS, stating the reasons
(b) Effect of initial determination. An why the request was not filed timely.
initial determination is binding unless (2) CMS will extend the time for fil-
it is— ing a request for reconsideration if the
(1) Reconsidered in accordance with affected party shows good cause for
§ 498.24; missing the deadline.
(2) Reversed or modified by a hearing
decision in accordance with § 498.78; or [52 FR 22446, June 12, 1987, as amended at 73
(3) Revised in accordance with § 498.32 FR 36462, June 27, 2008]
or § 498.100.
§ 498.23 Withdrawal of request for re-
§ 498.22 Reconsideration. consideration.
(a) Right to reconsideration. CMS or A request for reconsideration is con-
one of its contractors reconsiders an sidered withdrawn if the requestor files
initial determination that affects a a written withdrawal request before
prospective provider or supplier, or a CMS mails the notice of reconsidered
hospital seeking to qualify to claim determination, and CMS approves the
payment for all emergency hospital withdrawal request.
services furnished in a calendar year, if
951
§ 498.24 42 CFR Ch. IV (10–1–24 Edition)
§ 498.24 Reconsidered determination. reconsidered determination, within 12

months after the date of notice of the
When a request for reconsideration
initial determination.
has been properly filed in accordance
with § 498.22, CMS— § 498.32 Notice and effect of reopening
(a) Receives written evidence and and revision.
statements that are relevant and mate-
(a) Notice. (1) CMS or the OIG, as ap-
rial to the matters at issue and are
propriate, gives the affected party no-
submitted within a reasonable time
tice of reopening and of any revision of
after the request for reconsideration;
the reopened determination.
(b) Considers the initial determina-
(2) The notice of revised determina-
tion, the findings on which the initial
tion states the basis or reason for the
determination was based, the evidence
revised determination.
considered in making the initial deter- (3) If the determination is that a sup-
mination, and any other written evi- plier or prospective supplier does not
dence submitted under paragraph (a) of meet the conditions for coverage of its
this section, taking into account facts services, the notice specifies the condi-
relating to the status of the prospec- tions with respect to which the af-
tive provider or supplier subsequent to fected party fails to meet the require-
the initial determination; and ments of law and regulations, and in-
(c) Makes a reconsidered determina- forms the party of its right to a hear-
tion, affirming or modifying the initial ing.
determination and the findings on (b) Effect. A revised determination is
which it was based. binding unless
§ 498.25 Notice and effect of reconsid- (1) The affected party requests a
ered determination. hearing before an ALJ; or
(2) CMS or the OIG further revises
(a) Notice. (1) CMS mails notice of a the revised determination.
reconsidered determination to the af-
fected party.
(2) The notice gives the reasons for
Subpart D—Hearings
the determination. § 498.40 Request for hearing.
(3) If the determination is adverse,
the notice specifies the conditions or (a) Manner and timing of request. (1)
requirements of law or regulations that An affected party entitled to a hearing
the affected party fails to meet, and in- under § 498.5 may file a request for a
forms the party of its right to a hear- hearing with the ALJ office identified
ing. in the determination letter.
(2) The affected party or its legal rep-
(b) Effect. A reconsidered determina-
resentative or other authorized official
tion is binding unless—
must file the request in writing within
(1) CMS or the OIG, as appropriate,
60 days from receipt of the notice of
further revises the revised determina-
initial, reconsidered, or revised deter-
tion; or
mination unless that period is extended
(2) The revised determination is re-
in accordance with paragraph (c) of
versed or modified by a hearing deci-
this section. (Presumed date of receipt
sion.
is determined in accordance with
§ 498.22(b)(3)).
Subpart C—Reopening of Initial or (b) Content of request for hearing. The
Reconsidered Determinations request for hearing must—
(1) Identify the specific issues, and
§ 498.30 Limitation on reopening. the findings of fact and conclusions of
An initial or reconsidered determina- law with which the affected party dis-
tion that a prospective provider is a agrees; and
provider or that a hospital qualifies to (2) Specify the basis for contending
elect to claim payment for all emer- that the findings and conclusions are
gency services furnished in a calendar incorrect.
year may not be reopened. CMS or the (c) Extension of time for filing a request
OIG, as appropriate, may on its own for hearing. If the request was not filed
initiative, reopen any other initial or within 60 days—
952
(1) The affected party or its legal rep- ALJ’s decision or providing a new hear-
resentative or other authorized official ing before another ALJ.
may file with the ALJ a written re-
quest for extension of time stating the § 498.47 Prehearing conference.
reasons why the request was not filed (a) At any time before the hearing,
timely. the ALJ may call a prehearing con-
(2) For good cause shown, the ALJ ference for the purpose of delineating
may extend the time for filing the re- the issues in controversy, identifying
quest for hearing. the evidence and witnesses to be pre-
sented at the hearing, and obtaining
FR 36462, June 27, 2008]
stipulations accordingly.
(b) On the request of either party or
§ 498.42 Parties to the hearing. on his or her own motion, the ALJ may
adjourn the prehearing conference and
The parties to the hearing are the af- reconvene at a later date.
fected party and CMS or the OIG, as
appropriate. § 498.48 Notice of prehearing con-
ference.
§ 498.44 Designation of hearing offi- (a) Timing of notice. The ALJ will fix
cial.
a time and place for the prehearing
(a) The Secretary or his or her dele- conference and mail written notice to
gate designates an ALJ or a member or the parties at least 10 days before the
members of the Board to conduct hear- scheduled date.
ings. (b) Content of notice. The notice will
(b) If appropriate, the Secretary or inform the parties of the purpose of the
the delegate may designate another conference and specify what issues are
ALJ or another member or other mem- sought to be resolved, agreed to, or ex-
bers of the Board to conduct the hear- cluded.
ing. (c) Additional issues. Issues other than
(c) As used in this part, ‘‘ALJ’’ in- those set forth in the notice of deter-
cludes any ALJ of the Department of mination or the request for hearing
Health and Human Services or mem- may be considered at the prehearing
bers of the Board who are designated to conference if—
conduct a hearing. (1) Either party gives timely notice
to that effect to the ALJ and the other
[73 FR 36462, June 27, 2008]
party; or
§ 498.45 Disqualification of Adminis- (2) The ALJ raises the issues in the
trative Law Judge. notice of prehearing conference or at
the conference.
(a) An ALJ may not conduct a hear-
ing in a case in which he or she is prej- § 498.49 Conduct of prehearing con-
udiced or partial to the affected party ference.
or has any interest in the matter pend- (a) The prehearing conference is open
ing for decision. to the affected party or its representa-
(b) A party that objects to the ALJ tive, to the CMS or OIG representa-
designated to conduct the hearing tives and their technical advisors, and
must give notice of its objections at to any other persons whose presence
the earliest opportunity. the ALJ considers necessary or proper.
(c) The ALJ will consider the objec- (b) The ALJ may accept the agree-
tions and decide whether to withdraw ment of the parties as to the following:
or proceed with the hearing. (1) Facts that are not in controversy.
(1) If the ALJ withdraws, another (2) Questions that have been resolved
will be designated to conduct the hear- favorably to the affected party after
ing. the determination in dispute.
(2) If the ALJ does not withdraw, the (3) Remaining issues to be resolved.
objecting party may, after the hearing, (c) The ALJ may request the parties
present its objections to the Depart- to indicate the following:
mental Appeals Board as reasons for (1) The witnesses that will be present
changing, modifying, or reversing the to testify at the hearing.
953
§ 498.50 42 CFR Ch. IV (10–1–24 Edition)
(2) The qualifications of those wit- § 498.54 Joint hearings.

nesses.
When two or more affected parties
(3) The nature of other evidence to be
have requested hearings and the same
submitted.
or substantially similar matters are at
§ 498.50 Record, order, and effect of issue, the ALJ may, if all parties agree,
prehearing conference. fix a single time and place for the pre-
hearing conference or hearing and con-
(a) Record of prehearing conference. (1) duct all proceedings jointly. If joint
A record is made of all agreements and hearings are held, a single record of the
stipulations entered into at the pre- proceedings is made and a separate de-
hearing conference. cision issued with respect to each af-
(2) The record may be transcribed at fected party.
the request of either party or the ALJ.
(b) Order and opportunity to object. (1) § 498.56 Hearing on new issues.
The ALJ issues an order setting forth
the results of the prehearing con- (a) Basic rules. (1) Within the time
ference, including the agreements limits specified in paragraph (b) of this
made by the parties as to facts not in section, the ALJ may, at the request of
controversy, the matters to be consid- either party, or on his or her own mo-
ered at the hearing, and the issues to tion, provide a hearing on new issues
be resolved. that impinge on the rights of the af-
(2) Copies of the order are sent to all fected party.
parties and the parties have 10 days to (2) Except for provider or supplier en-
file objections to the order. rollment appeals which are addressed
(3) After the 10 days have elapsed, the in § 498.56(e), the ALJ may consider new
ALJ settles the order. issues even if CMS or the OIG has not
(c) Effect of prehearing conference. The made initial or reconsidered deter-
agreements and stipulations entered minations on them, and even if they
into at the prehearing conference are arose after the request for hearing was
binding on all parties, unless a party filed or after the prehearing con-
presents facts that, in the opinion of ference.
the ALJ, would make an agreement un- (3) The ALJ may give notice of hear-
reasonable or inequitable. ing on new issues at any time after the
hearing request is filed and before the
§ 498.52 Time and place of hearing. hearing record is closed.
(a) The ALJ fixes a time and place (b) Time limits. The ALJ will not con-
for the hearing and gives the parties sider any issue that arose on or after
written notice at least 10 days before any of the following dates:
the scheduled date. (1) The effective date of the termi-
(b) The notice informs the parties of nation of a provider agreement.
the general and specific issues to be re- (2) The date on which it is deter-
solved at the hearing. mined that a supplier no longer meets
the conditions for coverage of its serv-
§ 498.53 Change in time and place of ices.
hearing. (3) The effective date of the notice to
(a) The ALJ may change the time a hospital of its failure to remain in
and place for the hearing either on his compliance with the qualifications for
or her own initiative or at the request claiming reimbursement for all emer-
of a party for good cause shown, or gency services furnished to Medicare
may adjourn or postpone the hearing. beneficiaries during the calendar year.
(b) The ALJ may reopen the hearing (4) The effective date of the suspen-
for receipt of new evidence at any time sion, or of the exclusion from coverage
before mailing the notice of hearing de- of services furnished by a suspended or
cision. excluded practitioner, provider, or sup-
(c) The ALJ gives the parties reason- plier.
able notice of any change in time or (5) With respect to Medicaid SNFs or
place or any adjournment or reopening ICFs surveyed under section 1910(c) of
of the hearing. the Act—
954
(i) The completion date of the survey parties of any evidence that is excluded
or resurvey that is the basis for a pro- from the hearing.
posed cancellation of approval; or [52 FR 22446, June 12, 1987, as amended at 53
(ii) If approval was cancelled before FR 31335, Aug. 18, 1988; 73 FR 36463, June 27,
the hearings, because of immediate and 2008]
serious threat to patient health and
safety, the effective date of cancella- § 498.58 Subpoenas.
tion. (a) Basis for issuance. The ALJ, upon
(c) Notice and conduct of hearing on his or her own motion or at the request
new issues. (1) Unless the affected party of a party, may issue subpoenas if they
waives its right to appear and present are reasonably necessary for the full
evidence, notice of the time and place presentation of a case.
of hearing on any new issue will be (b) Timing of request by a party. The
given to the parties in accordance with party must file a written request for a
§ 498.52. subpoena with the ALJ at least 5 days
(2) After giving notice, the ALJ will, before the date set for the hearing.
except as provided in paragraph (d) of (c) Content of request. The request
this section, proceed to hearing on new must:
issues in the same manner as on an (1) Identify the witnesses or docu-
issue raised in the request for hearing. ments to be produced;
(2) Describe their addresses or loca-
(d) Remand to CMS or the OIG. At the
tion with sufficient particularity to
request of either party, or on his or her
permit them to be found; and
own motion, in lieu of a hearing under
(3) Specify the pertinent facts the
paragraph (c) of this section, the ALJ
party expects to establish by the wit-
may remand the case to CMS or the
nesses or documents, and indicate why
OIG for consideration of the new issue
those facts could not be established
and, if appropriate, a determination. If without use of a subpoena.
necessary, the ALJ may direct CMS or (d) Method of issuance. Subpoenas are
the OIG to return the case to the ALJ issued in the name of the Secretary,
for further proceedings. who pays the cost of issuance and the
(e) Provider and supplier enrollment ap- fees and mileage of any subpoenaed
peals: Good cause requirement—(1) Exam- witnesses.
ination of any new documentary evi-
dence. After a hearing is requested but § 498.60 Conduct of hearing.
before it is held, the ALJ will examine (a) Participants in the hearing. The
any new documentary evidence sub- hearing is open to the parties and their
mitted to the ALJ by a provider or sup- representatives and technical advisors,
plier to determine whether the pro- and to any other persons whose pres-
vider or supplier has good cause for ence the ALJ considers necessary or
submitting the evidence for the first proper.
time at the ALJ level. (b) Hearing procedures. (1) The ALJ
(2) Determining if good cause exists—(i) inquires fully into all of the matters at
If good cause exists. If the ALJ finds issue, and receives in evidence the tes-
that there is good cause for submitting timony of witnesses and any docu-
new documentary evidence for the first ments that are relevant and material.
time at the ALJ level, the ALJ must (2) If the ALJ believes that there is
include evidence and may consider it in relevant and material evidence avail-
reaching a decision. able which has not been presented at
(ii) If good cause does not exist. If the the hearing, he may, at any time be-
ALJ determines that there was not fore mailing of notice of the decision,
good cause for submitting the evidence reopen the hearing to receive that evi-
for the first time at the ALJ level, the dence.
ALJ must exclude the evidence from (3) The ALJ decides the order in
the proceeding and may not consider it which the evidence and the arguments
in reaching a decision. of the parties are presented and the
(2) Notification to all parties. As soon conduct of the hearing.
as possible, but no later than the start (c) Scope of review: Civil money pen-
of the hearing, the ALJ must notify all alty. In civil money penalty cases—
955
§ 498.61 42 CFR Ch. IV (10–1–24 Edition)
(1) The scope of review is as specified good cause, at any time before the ALJ
in §§ 488.438(e), 488.845(h), and 488.1195(g) mails notice of the hearing decision.
of this chapter; and (b) Effect of waiver. If the affected
(2) CMS’ determination as to the party waives the right to appear and
level of noncompliance of a SNF, NF, present evidence, the ALJ need not
HHA, or hospice program must be conduct an oral hearing except in one
upheld unless it is clearly erroneous. of the following circumstances:
(1) The ALJ believes that the testi-
[52 FR 22446, June 12, 1987, as amended at 61 mony of the affected party or its rep-
FR 32350, June 24, 1996; 79 FR 66118, Nov. 6,
2014; 86 FR 62431, Nov. 9, 2021]
resentatives or other witnesses is nec-
essary to clarify the facts at issue.
§ 498.61 Evidence. (2) CMS or the OIG shows good cause
for requiring the presentation of oral
Evidence may be received at the evidence.
hearing even though inadmissible (c) Dismissal for failure to appear. If,
under the rules of evidence applicable despite the waiver, the ALJ sends no-
to court procedure. The ALJ rules on tice of hearing and the affected party
the admissibility of evidence. fails to appear, or to show good cause
[59 FR 56252, Nov. 10, 1994, as amended at 61 for the failure, the ALJ will dismiss
FR 32350, June 24, 1996] the appeal in accordance with § 498.69.
(d) Hearing without oral testimony.
§ 498.62 Witnesses. When there is no oral testimony, the
Witnesses at the hearing testify ALJ will—
under oath or affirmation. The rep- (1) Make a record of the relevant
resentative of each party is permitted written evidence that was considered
to examine his or her own witnesses in making the determination being ap-
subject to interrogation by the rep- pealed, and of any additional evidence
resentative of the other party. The submitted by the parties;
ALJ may ask any questions that he or (2) Furnish to each party copies of
she deems necessary. The ALJ rules the additional evidence submitted by
upon any objection made by either the other party; and
party as to the propriety of any ques- (3) Give both parties a reasonable op-
tion. portunity for rebuttal.
(e) Handling of briefs and related state-
§ 498.63 Oral and written summation. ments. If the parties submit briefs or
other written statements of evidence
The parties to a hearing are allowed or proposed findings of facts or conclu-
a reasonable time to present oral sum- sions of law, those documents will be
mation and to file briefs or other writ- handled in accordance with § 498.17.
ten statements of proposed findings of
fact and conclusions of law. Copies of § 498.68 Dismissal of request for hear-
any briefs or other written statements ing.
must be sent in accordance with (a) The ALJ may, at any time before
§ 498.17. mailing the notice of the decision, dis-
miss a hearing request if a party with-
§ 498.64 Record of hearing.
draws its request for a hearing or the
A complete record of the proceedings affected party asks that its request be
at the hearing is made and transcribed dismissed.
in all cases. (b) An affected party may request a
dismissal by filing a written notice
§ 498.66 Waiver of right to appear and with the ALJ.
present evidence.
(a) Waiver procedures. (1) If an af- § 498.69 Dismissal for abandonment.
fected party wishes to waive its right (a) The ALJ may dismiss a request
to appear and present evidence at the for hearing if it is abandoned by the
hearing, it must file a written waiver party that requested it.
with the ALJ. (b) The ALJ may consider a request
(2) If the affected party wishes to for hearing to be abandoned if the
withdraw a waiver, it may do so, for party or its representative—
956
(1) Fails to appear at the prehearing § 498.74 Administrative Law Judge’s

conference or hearing without having decision.
previously shown good cause for not (a) Timing, basis and content. As soon
appearing; and as practical after the close of the hear-
(2) Fails to respond, within 10 days ing, the ALJ issues a written decision
after the ALJ sends a ‘‘show cause’’ no- in the case. The decision is based on
tice, with a showing of good cause. the evidence of record and contains
separate numbered findings of fact and
§ 498.70 Dismissal for cause. conclusions of law.
On his or her own motion, or on the (b) Notice and effect. A copy of the de-
motion of a party to the hearing, the cision is mailed to the parties and is
ALJ may dismiss a hearing request ei- binding on them unless—
ther entirely or as to any stated issue, (1) A party requests review by the
under any of the following cir- Departmental Appeals Board within
cumstances: the time period specified in § 498.82, and
(a) Res judicata. There has been a pre- the Board reviews the case;
vious determination or decision with (2) The Departmental Appeals Board
respect to the rights of the same af- denies the request for review and the
fected party on the same facts and law party seeks judicial review by filing an
action in a United States District
pertinent to the same issue or issues
Court or, in the case of a civil money
which has become final either by judi-
penalty, in a United States Court of
cial affirmance or, without judicial
Appeals;
consideration, because the affected
(3) The decision is revised by an ALJ
party did not timely request reconsid-
or the Departmental Appeals Board; or
eration, hearing, or review, or com- (4) The decision is a recommended de-
mence a civil action with respect to cision directed to the Board.
that determination or decision.
(b) No right to hearing. The party re- [52 FR 22446, June 12, 1987, as amended at 61
questing a hearing is not a proper FR 32351, June 24, 1996]
party or does not otherwise have a § 498.76 Removal of hearing to Depart-
right to a hearing. mental Appeals Board.
(c) Hearing request not timely filed. The
(a) At any time before the ALJ re-
affected party did not file a hearing re-
ceives oral testimony, the Board may
quest timely and the time for filing has
remove to itself any pending request
not been extended. for a hearing.
§ 498.71 Notice and effect of dismissal (b) Notice of removal is mailed to
and right to request review. each party.
(c) The Board conducts the hearing in
(a) Notice of the ALJ’s dismissal ac- accordance with the rules that apply to
tion is mailed to the parties. The no- ALJ hearings under this subpart.
tice advises the affected party of its
right to request that the dismissal be § 498.78 Remand by the Administrative
vacated as provided in § 498.72. Law Judge.
(b) The dismissal of a request for (a) If CMS requests a remand, the
hearing is binding unless it is vacated ALJ may remand any case properly be-
by the ALJ or the Departmental Ap- fore him or her to CMS.
peals Board. (b) The ALJ may remand at any time
before notice of hearing decision is
§ 498.72 Vacating a dismissal of re- mailed.
quest for hearing.
An ALJ may vacate any dismissal of FR 36463, June 27, 2008]
a request for hearing if a party files a
request to that effect within 60 days § 498.79 Timeframes for deciding an
from receipt of the notice of dismissal enrollment appeal before an ALJ.
and shows good cause for vacating the When a request for an ALJ hearing is
dismissal. (Date of receipt is deter- filed after CMS or a FFS contractor
mined in accordance with § 498.22(b)(3).) has denied an enrollment application,
957
§ 498.80 42 CFR Ch. IV (10–1–24 Edition)
the ALJ must issue a decision, dis- request for review unless it dismisses
missal order or remand to CMS, as ap- the request for one of the following
propriate, no later than the end of the reasons:
180-day period beginning from the date (1) The affected party requests dis-
the appeal was filed with an ALJ. missal of its request for review.
[73 FR 36463, June 27, 2008] (2) The affected party did not file
timely or show good cause for late fil-
ing.
Subpart E—Departmental Appeals (3) The affected party does not have a
Board Review right to review.
§ 498.80 Right to request Departmental (4) A previous determination or deci-
Appeals Board review of Adminis- sion, based on the same facts and law,
trative Law Judge’s decision or dis- and regarding the same issue, has be-
missal. come final through judicial affirmance
Either of the parties has a right to or because the affected party failed to
request Departmental Appeals Board timely request reconsideration, hear-
review of the ALJ’s decision or dis- ing, Board review, or judicial review, as
missal order, and the parties are so inappropriate.
formed in the notice of the ALJ’s ac- (c) Effect of dismissal. The dismissal of
tion. a request for Departmental Appeals
Board review is binding and not subject
§ 498.82 Request for Departmental Ap- to further review.
peals Board review. (d) Review panel. If the Board grants
(a) Manner and time of filing. (1) Any a request for review of the ALJ’s deci-
party that is dissatisfied with an ALJ’s sion, the review will be conducted by a
decision or dismissal of a hearing re- panel of at least two members of the
quest, may file a written request for re- Board, designated by the Chairperson
view by the Departmental Appeals or Deputy Chairperson, and one indi-
Board. vidual designated by the Secretary
(2) The requesting party or its rep- from the U.S Public Health Service.
resentative or other authorized official
must file the request with the OHA § 498.85 Procedures before the Depart-
mental Appeals Board on review.
within 60 days from receipt of the no-
tice of decision or dismissal, unless the The parties are given, upon request, a
Board, for good cause shown by the re- reasonable opportunity to file briefs or
questing party, extends the time for other written statements as to fact and
filing. The rules set forth in § 498.40(c) law, and to appear before the Depart-
apply to extension of time for request- mental Appeals Board to present evi-
ing Departmental Appeals Board re- dence or oral arguments. Copies of any
view. (The date of receipt of notice is brief or other written statement must
determined in accordance with be sent in accordance with § 498.17.
§ 498.22(c)(3).)
(b) Content of request for review. A re- § 498.86 Evidence admissible on re-
quest for review of an ALJ decision or view.
dismissal must specify the issues, the (a) Except for provider or supplier en-
findings of fact or conclusions of law rollment appeals, the Board may admit
with which the party disagrees, and the evidence into the record in addition to
basis for contending that the findings the evidence introduced at the ALJ
and conclusions are incorrect. hearing (or the documents considered
by the ALJ if the hearing was waived)
§ 498.83 Departmental Appeals Board if the Board considers that the addi-
action on request for review. tional evidence is relevant and mate-
(a) Request by CMS or the OIG. The rial to an issue before it.
Departmental Appeals Board may dis- (b) If it appears to the Board that ad-
miss, deny, or grant a request made by ditional relevant evidence is available,
CMS or the OIG for review of an ALJ the Board will require that it be pro-
decision or dismissal. duced.
(b) Request by the affected party. The (c) Before additional evidence is ad-
Board will grant the affected party’s mitted into the record—
958
(1) Notice is mailed to the parties (iii) May modify, affirm, or reverse
(unless they have waived notice) stat- the ALJ’s decision.
ing that evidence will be received re- (2) A copy of the Board’s decision is
garding specified issues; and mailed to each party.
(2) The parties are given a reasonable (g) When a request for Board review
time to comment and to present other of a denial of an enrollment applica-
evidence pertinent to the specified tion is filed after an ALJ has issued a
issues. decision or dismissal order, the Board
(d) If additional evidence is presented must issue a decision, dismissal order
orally to the Board, a transcript is pre- or remand to the ALJ, as appropriate,
pared and made available to any party no later than 180 days after the appeal
upon request. was received by the Board.
[52 FR 22446, June 12, 1987, as amended at 73 [52 FR 22446, June 12, 1987, as amended at 73
FR 36463, June 27, 2008] FR 36463, June 27, 2008]
§ 498.88 Decision or remand by the De- § 498.90 Effect of Departmental Ap-

partmental Appeals Board. peals Board decision.
(a) When the Departmental Appeals (a) General rule. The Board’s decision
Board reviews an ALJ’s decision or is binding unless—
order of dismissal, or receives a case (1) The affected party has a right to
remanded by a court, the Board may judicial review and timely files a civil
either issue a decision or remand the action in a United States District
case to an ALJ for a hearing and deci- Court or, in the case of a civil money
sion or a recommended decision for penalty, in a United States Court of
final decision by the Board. Appeals; or
(b) In a remanded case, the ALJ initi- (2) The Board reopens and revises its
ates additional proceedings and takes decision in accordance with § 498.102.
other actions as directed by the Board (b) Right to judicial review. Section
in its order of remand, and may take 498.5 specifies the circumstances under
other action not inconsistent with that which an affected party has a right to
order. seek judicial review.
(c) Upon completion of all action (c) Special rules: Civil money penalty—
called for by the remand order and any (1) Finality of Board’s decision. When
other consistent action, the ALJ CMS imposes a civil money penalty,
promptly makes a decision or, as speci- notice of the Board’s decision (or de-
fied by the Board, certifies the case to nial of review) is the final administra-
the Board with a recommended deci- tive action that initiates the 60-day pe-
sion. riod for seeking judicial review.
(d) The parties have 20 days from the (2) Timing for collection of civil money
date of a notice of a recommended deci- penalty. For SNFs and NFs, the rules
sion to submit to the Board any excep- that apply are those set forth in sub-
tion, objection, or comment on the part F of part 488 of this chapter.
findings of fact, conclusions of law, and
recommended decision. [61 FR 32351, June 24, 1996]
(e) After the 20-day period, the Board
issues its decision adopting, modifying § 498.95 Extension of time for seeking
judicial review.
or rejecting the ALJ’s recommended
decision. (a) Any affected party that is dissat-
(f) If the Board does not remand the isfied with an Departmental Appeals
case to an ALJ, the following rules Board decision and is entitled to judi-
apply: cial review must commence civil ac-
(1) The Board’s decision— tion within 60 days from receipt of the
(i) Is based upon the evidence in the notice of the Board’s decision (as deter-
hearing record and any further evi- mined under § 498.22(c)(3)), unless the
dence that the Board receives during Board extends the time in accordance
its review; with paragraph (c) of this section.
(ii) Is in writing and contains sepa- (b) The request for extension must be
rate numbered findings of fact and con- filed in writing with the Board before
clusions of law; and the 60-day period ends.
959
§ 498.100 42 CFR Ch. IV (10–1–24 Edition)
(c) For good cause shown, the Board the ALJ or the Departmental Appeals
may extend the time for commencing Board—
civil action. (1) Notifies the parties of the pro-
posed revision; and
Subpart F—Reopening of Deci- (2) Unless the parties waive their
sions Made by Administrative right to hearing or appearance—
Law Judges or the Depart- (i) Grants a hearing in the case of an
mental Appeals Board ALJ revision; and
(ii) Grants opportunity to appear in
§ 498.100 Basis, timing, and authority the case of a Board revision.
for reopening an ALJ or Board de- (b) Basis for revised decision and right
cision. to review. (1) If a revised decision is
(a) Basis and timing for reopening. An necessary, the ALJ or the Depart-
ALJ of Departmental Appeals Board mental Appeals Board, as appropriate,
decision may be reopened, within 60 renders it on the basis of the entire
days from the date of the notice of de- record.
cision, upon the motion of the ALJ or (2) If the decision is revised by an
the Board or upon the petition of ei- ALJ, the Departmental Appeals Board
ther party to the hearing. may review that revised decision at the
(b) Authority to reopen. (1) A decision request of either party or on its own
of the Departmental Appeals Board motion.
may be reopened only by the Depart-
mental Appeals Board. § 498.103 Notice and effect of revised
(2) A decision of an ALJ may be re- decision.
opened by that ALJ, by another ALJ if (a) Notice. The notice mailed to the
that one is not available, or by the De- parties states the basis or reason for
partmental Appeals Board. For pur- the revised decision and informs them
poses of this paragraph, an ALJ is con- of their right to Departmental Appeals
sidered to be unavailable if the ALJ Board review of an ALJ revised deci-
has died, terminated employment, or sion, or to judicial review of a Board
been transferred to another duty sta- reviewed decision.
tion, is on leave of absence, or is un- (b) Effect—(1) ALJ revised decision. An
able to conduct a hearing because of ALJ revised decision is binding unless
illness. it is reviewed by the Departmental Ap-
peals Board.
§ 498.102 Revision of reopened deci- (2) Departmental Appeals Board revised
sion. decision. A Board revised decision is
(a) Revision based on new evidence. If a binding unless a party files a civil ac-
reopened decision is to be revised on tion in a district court of the United
the basis of new evidence that was not States within the time frames specified
included in the record of that decision, in § 498.95.
960
SUBCHAPTER H—HEALTH CARE INFRASTRUCTURE AND
MODEL PROGRAMS
PART 505—ESTABLISHMENT OF THE Eligible project means the project of a

HEALTH CARE INFRASTRUCTURE qualifying hospital that is designed to
improve the health care infrastructure
IMPROVEMENT PROGRAM of the hospital, including construction,
renovation, or other capital improve-
Subpart A—Loan Criteria
ments.
Sec. Entity is an entity described in sec-
505.1 Basis and scope. tion 501(c)(3) of the Internal Revenue
505.3 Definitions. Code of 1986 and exempt from tax under
505.5 Loan criteria. section 501(a) of the code. An entity
505.7 Terms of the loan. must also have at least one existing
505.9 State and local permits. memorandum of understanding or af-
505.11 Loan application requirements and filiation agreement with a hospital lo-
procedures.
cated in the State in which the entity
Subpart B—Forgiveness of Indebtedness is located and retains clinical out-
patient treatment for cancer on site as
505.13 Conditions for loan forgiveness. well as laboratory research, education,
505.15 Plan criteria for meeting the condi- and outreach for cancer in the same fa-
tions for loan forgiveness. cility.
505.17 Reporting requirements for meeting Outreach programs mean formal can-
the conditions for loan forgiveness.
505.19 Approval or denial of loan forgive-
cer programs for teaching, diagnostic
ness. screening, therapy or treatment, pre-
vention, or interventions to enhance
AUTHORITY: Secs. 1102 and 1871 of the Social the health and knowledge of their des-
Security Act (42 U.S.C 1302 and 1395hh).
ignated population(s).
SOURCE: 70 FR 57374, Sept. 30, 2005, unless Qualifying hospital means a hospital
otherwise noted. as defined at section 1861(e) of the Act
(42 U.S,C. 1395x(e)) or an entity (as de-
Subpart A—Loan Criteria fined in this section) that is engaged in
research in the causes, prevention, and
§ 505.1 Basis and scope. treatment of cancer; and is either des-
This part implements section 1016 of ignated as a cancer center for the Na-
the Medicare Prescription Drug, Im- tional Cancer Institute; or designated
provement and Modernization Act of by the State legislature as the official
2003 (MMA) which amends section 1897 cancer institute of the State before De-
of the Act. Section 1897 of the Act as cember 8, 2003.
amended by section 6045 of the Tsu- Unique research resources means re-
nami Relief Act of 2005 authorizes the sources that are used for the purpose of
Secretary to establish a loan program discovering or testing options related
by which qualifying hospitals may to the causes, prevention, and treat-
apply for a loan for the capital costs of ment of cancer.
the health care infrastructure improve- [70 FR 57374, Sept. 30, 2005, as amended at 71
ment projects. Section 1897 of the Act FR 48143, Aug. 18, 2006]
appropriates $142,000,000 for the loan
program including program adminis- § 505.5 Loan criteria.
tration. The funds are available begin- (a) Qualifying criteria. To qualify for
ning July 1, 2004 through September 30, the loan program, the applicant must
2008. This part sets forth the criteria meet the following conditions:
that CMS uses to select among quali- (1) Meet the definition of a ‘‘quali-
fying hospitals. fying hospital’’ as set forth in § 505.3 of
this part.
§ 505.3 Definitions. (2) Request a loan for the capital
For purposes of this subpart, the fol- costs of an ‘‘eligible project’’ as defined
lowing definitions apply: in § 505.3 of this part. The capital costs
961
§ 505.7 42 CFR Ch. IV (10–1–24 Edition)
for which a qualifying hospital may ob- cation from CMS. The loan repayment
tain a loan are limited to the reason- period is 20 years.
able costs incurred by the hospital, and (c) Bankruptcy protection. In the event
capitalized on the Medicare cost re- a loan beneficiary files for bankruptcy
port, for any facility or item of equip- protection in a court of competent ju-
ment that it has acquired the posses- risdiction or otherwise proves to be in-
sion or use of at the time the loan solvent, CMS may terminate the
funding is awarded. deferment period described in para-
(b) Selection criteria. In selecting loan graph (b) of this section and require
beneficiaries, CMS prioritizes quali- immediate payment of the loan. If a
fying hospitals that meet the following loan beneficiary should file for bank-
criteria: ruptcy protection in a court of com-
(1) The hospital is located in a State petent jurisdiction or should otherwise
that, based on population density, is evidence insolvency after the
defined as a rural State. A rural State deferment period we will require imme-
is one of ten States with the lowest diate repayment of the outstanding
population density. An applicant enti- principal and interest due. Those pay-
ty is required to be located in one of ments may be deducted from any Medi-
these ten States. The ten States are care payments otherwise due that hos-
prioritized beginning with the State pital.
with the lowest population density. (d) Loan forgiveness. CMS does not re-
Population density is determined based
quire a loan beneficiary to begin mak-
on the most recent available U.S. Cen-
ing payments of principal or interest at
sus Bureau data.
the end of the 60-month deferment pe-
(2) The hospital is located in a State
riod if it determines that the loan ben-
with multiple Indian tribes in the
eficiary meets the criteria for loan for-
State. After prioritizing based on para-
giveness under section 1897 of the Act,
graph (b)(1) of this section, States are
as determined by the Secretary.
further prioritized based on the States
with the most Indian tribes. The num- (e) Default. If a loan beneficiary fails
ber of Indian tribes in a State is based to make any payment in repayment of
on the most recent data available pub- a loan under this subpart within 10
lished in ‘‘Indian Entities Recognized days of its due date, the loan bene-
and Eligible to Receive Services from ficiary may be considered to have de-
the United State Bureau of Indian Af- faulted on the loan. Upon default, all
fairs.’’ (68 FR 68180) published on De- principal and accrued interest become
cember 5, 2003. due immediately, and CMS may re-
(c) CMS will send written notice to quire immediate payment of any out-
qualifying hospitals that have been se- standing principal and interest due.
lected to participate in the loan pro- Those payments may be deducted from
gram under this part. any Medicare payments otherwise due
that hospital.
§ 505.7 Terms of the loan. (f) Loan repayment. The loan bene-
All loan beneficiaries must agree to ficiary must meet the following condi-
the following loan terms: tions:
(a) Loan obligation. An authorized of- (1) Make payments every month for
ficial of a qualifying hospital must exe- 20 years until the loan, including inter-
cute a promissory note, loan agree- est payments, are paid in full.
ment, or a form approved by CMS and (2) Pay interest on the unpaid prin-
accompanied by any other documents cipal until the full amount of principal
CMS may designate. The loan bene- has been paid.
ficiary must provide required docu- (3) Pay interest at a yearly rate
mentation in a timely manner. based upon the rate as fixed by the Sec-
(b) Schedule of loan. A loan bene- retary of the Treasury and set forth at
ficiary receives a lump sum distribu- 45 CFR 30.13(a).
tion for which payment of principal (4) If a loan beneficiary fails to make
and interest is deferred for 60 months any payment in repayment of a loan
beginning with the day of award notifi- under this subpart within 10 days of its
962
due date, that payment may be de- Subpart B—Forgiveness of

ducted from any Medicare payments Indebtedness
otherwise due to the beneficiary.
(g) Interest rate and monthly payment
SOURCE: 71 FR 48144, Aug. 18, 2006, unless
charges. CMS calculates interest otherwise noted.
charges and payments consistent with
§ 405.378 of this chapter. § 505.13 Conditions for loan forgive-
(h) Loan recipient’s right to prepay. A ness.
loan beneficiary has the right to make The Secretary may forgive a loan
payments of principal at any time be- provided under this part if the quali-
fore they are due. A loan beneficiary fying hospital—
may make full prepayment or partial (a) Has been selected to participate
prepayment without paying any pre- in the loan program specified in
payment charge. If a prepayment is § 505.5(c).
made, the loan beneficiary must pro- (b) Has established the following in
vide written notice to CMS at CMS, Di- accordance with a plan that meets the
vision of Accounting Operations, P.O. criteria specified in § 505.15:
Box 75120, Baltimore, MD 21207–0520. (1) An outreach program for cancer
prevention, early diagnosis, and treat-
§ 505.9 State and local permits. ment that provides services to a sub-
With respect to an eligible project, stantial majority of the residents of a
the provision of a loan under this part State or region, including residents of
shall not— rural areas;
(a) Relieve the beneficiary of the (2) An outreach program for cancer
loan or any obligation to obtain any prevention, early diagnosis, and treat-
required State or local permit or ap- ment that provides services to multiple
proval with respect to the project. Indian tribes; and
(b) Limit the right of any unit of (3) Unique research resources (such
State or local government to approve as population databases) or an affili-
or regulate any rate of return on priation with an entity that has unique
vate equity invested in the project. research resources.
(c) Supersede any State or local law (c) Submits to CMS, within the time-
(including any regulation) applicable frame specified by the Secretary, a—
to the construction or operation of the (1) Written request for loan forgive-
project. ness; and
(2) Loan forgiveness plan that meets
§ 505.11 Loan application require- the criteria specified in § 505.15 of this
ments and procedures. subpart.
(a) The loan application must be re- § 505.15 Plan criteria for meeting the
ceived by CMS no later than 5 p.m. conditions for loan forgiveness.
e.d.t. on December 29, 2005.
The qualifying hospital requesting
(b) The requested information must loan forgiveness must submit to CMS a
be typed or clearly printed in ink and plan specifying how it will develop, im-
the loan beneficiary must mail or de- plement, or maintain an existing out-
liver an original copy of the loan to reach program for cancer prevention,
CMS. The loan application must con- early diagnosis, and treatment for a
tain the following information: substantial majority of the residents of
(1) Qualifying hospital’s name and a State or region, including residents
street address. of rural areas and for multiple Indian
(2) Qualifying hospital’s Medicare tribes and specifying how the quali-
provider number. fying hospital will establish or main-
(3) Name, title, and telephone num- tain existing unique research resources
ber of a contact person submitting the or an affiliation with an entity that
application. has unique research resources.
(4) Provide all appropriate supporting (a) Outreach programs. The initial
documentation for each answer made plan must specify how the hospital will
on the loan application. establish or develop, implement, or
963
§ 505.17 42 CFR Ch. IV (10–1–24 Edition)
maintain existing outreach programs. with feedback regarding its loan for-
The plan must— giveness status. If CMS determines
(1) Address cancer prevention for can- that the annual report shows that the
cers that are prevalent in the des- qualifying hospital has fulfilled the
ignated populations or cancers that are conditions, plan criteria, and reporting
targeted by the qualifying hospital, requirements for loan forgiveness spec-
interventions, and goals for decreasing ified in §§ 505.13, 505.15, and 505.17, CMS
the targeted cancer rates during the will notify the qualifying hospital in
loan deferment program; and writing that the loan is forgiven.
(2) Address early diagnosis of cancers (c) Final annual reporting require-
that are prevalent in the designated ments. A qualifying hospital must sub-
populations or cancers that are tar- mit its final report to CMS at least 6
geted by the qualifying hospital, inter- months before the end of the loan
ventions, and goals for improving early deferment period specified in § 505.7(b).
diagnosis rates for the targeted can-
cer(s) during the loan deferment pe- § 505.19 Approval or denial of loan for-
riod; giveness.
(3) Address cancer treatment for can- (a) Approval of loan forgiveness. If
cers that are prevalent in the des- CMS determines that a qualifying hos-
ignated populations or cancers that are pital has met the conditions, plan cri-
targeted by the qualifying hospital, teria, and reporting requirements for
interventions, and goals for improving loan forgiveness specified in §§ 505.13,
cancer treatment rates for the targeted 505.15, and 505.17, CMS will send a writ-
cancer(s) during the loan deferment; ten notification of approval for loan
and forgiveness to the qualifying hospital
(4) Identify the measures that will be by the earlier of—
used to determine the qualifying hos- (1) 30 days from the date of receipt of
pital’s annual progress in meeting the the annual report that shows the quali-
initial goals specified in paragraphs fying hospital has satisfied the require-
(a)(1) through (a)(3) of this section. ments for loan forgiveness; or
(b) Unique research resources. The plan (2) 90 days before the end of the loan
must specify how the qualifying hos- deferment period defined in § 505.7(b).
pital will establish or maintain exist- (b) Denial of loan forgiveness. If CMS
ing unique research resources or an af- determines that a qualifying hospital
filiation with an entity that has unique has not met the conditions, plan cri-
research resources. teria, or reporting requirements for
loan forgiveness specified in § 505.13,
§ 505.17 Reporting requirements for § 505.15, or § 505.17 of this part, CMS will
meeting the conditions for loan for- send a written notification of denial of
giveness.
loan forgiveness to the qualifying hos-
(a) Annual reporting requirements. On pital at least 30 days before the end of
an annual basis, beginning one year the loan deferment period defined in
from the date that CMS notified the § 505.7(b).
qualifying hospital of the loan award,
the qualifying hospital must submit a PART 510—COMPREHENSIVE CARE
report to CMS that updates the plan
specified in § 505.15 by—
FOR JOINT REPLACEMENT MODEL
(1) Describing the qualifying hos-
Subpart A—General Provisions
pital’s progress in meeting its initial
plan goals; Sec.
(2) Describing any changes to the 510.1 Basis and scope.
qualifying hospital’s initial plan goals; 510.2 Definitions.
and
(3) Including at least one measure Subpart B—Comprehensive Care for Joint
used to track the qualifying hospital’s Replacement Program Participants
progress in meeting its plan goals. 510.100 Episodes being tested.
(b) Review of annual reports. CMS will 510.105 Geographic areas.
review each qualifying hospital’s an- 510.110 Access to records and retention.
nual report to provide the hospital 510.115 Voluntary participation election.
964
510.120 CJR participant hospital CEHRT AUTHORITY: 42 U.S.C. 1302, 1315a, and
track requirements. 1395hh.
Subpart C—Scope of Episodes
otherwise noted.
510.200 Time periods, included and excluded
services, and attribution. Subpart A—General Provisions
510.205 Beneficiary inclusion criteria.
510.210 Determination of the episode. § 510.1 Basis and scope.
Subpart D—Pricing and Payment (a) Basis. This part implements the
test of the Comprehensive Care for
510.300 Determination of episode quality-ad- Joint Replacement model under sec-
justed target prices. tion 1115A of the Act. Except as specifi-
510.301 Determination of reconciliation tar-
cally noted in this part, the regula-
get prices.
510.305 Determination of the NPRA and rections under this part must not be con-
onciliation process. strued to affect the payment, coverage,
510.310 Appeals process. program integrity, or other require-
510.315 Composite quality scores for deter- ments (such as those in parts 412 and
mining reconciliation payment eligi- 482 of this chapter) that apply to pro-
bility and quality incentive payments. viders and suppliers under this chapter.
510.320 Treatment of incentive programs or (b) Scope. This part sets forth the fol-
add-on payments under existing Medi- lowing:
care payment systems.
510.325 Allocation of payments for services
(1) The participants in the Com-
that straddle the episode. prehensive Care for Joint Replacement
model.
Subpart E—Quality Measures, Beneficiary (2) The episodes being tested in the
Protections, and Compliance Enforcement model.
(3) The methodology for pricing and
510.400 Quality measures and reporting.
payment under the model.
510.405 Beneficiary choice and beneficiary
notification. (4) Quality performance standards
510.410 Compliance enforcement. and quality reporting requirements.
(5) Safeguards to ensure preservation
Subpart F—Financial Arrangements and of beneficiary choice and beneficiary
Beneficiary Incentives notification.
510.500 Sharing arrangements under the § 510.2 Definitions.
CJR model.
510.505 Distribution arrangements. For the purposes of this part, the fol-
510.506 Downstream distribution arrange- lowing definitions are applicable unless
ments. otherwise stated:
510.510 Enforcement authority. ACO means an accountable care orga-
510.515 Beneficiary incentives under the nization, as defined at § 425.20 of this
CJR model. chapter, that participates in the
Shared Savings Program and is not in
Subpart G—Waivers
Track 3.
510.600 Waiver of direct supervision require- ACO participant has the meaning set
ment for certain post-discharge home forth in § 425.20 of this chapter.
visits. ACO provider/supplier has the mean-
510.605 Waiver of certain telehealth require- ing set forth in § 425.20 of this chapter.
ments.
510.610 Waiver of SNF 3-day rule.
Actual episode payment means the
510.615 Waiver of certain post-operative bill- sum of standardized Medicare claims
ing restrictions. payments for the items and services
510.620 Waiver of deductible and coinsur- that are included in the episode in ac-
ance that otherwise apply to reconcili- cordance with § 510.200(b), excluding the
ation payments or repayments. items and services described in
§ 510.200(d).
Subparts H–J [Reserved] Age bracket risk adjustment factor
Subpart K—Model Termination means the coefficient of risk associated
with a patient’s age bracket, cal-
510.900 Termination of the CJR model. culated as described in § 510.301(a)(1).
965
§ 510.2 42 CFR Ch. IV (10–1–24 Edition)
Alignment payment means a payment viduals or entities that enters into a

from a CJR collaborator to a partici- sharing arrangement:
pant hospital under a sharing arrange- (1) SNF.
ment, for the sole purpose of sharing (2) HHA.
the participant hospital’s responsi- (3) LTCH.
bility for making repayments to Medi- (4) IRF.
care. (5) Physician.
Anchor hospitalization means the ini- (6) Nonphysician practitioner.
tial hospital stay upon admission for a (7) Therapist in private practice.
lower extremity joint replacement, for (8) CORF.
which the institutional claim is billed
(9) Provider of outpatient therapy
through the IPPS. Anchor hospitaliza-
services.
tion also includes an inpatient hospital
(10) Physician Group Practice (PGP).
admission within 3 days after an out-
(11) Hospital.
patient Total Knee Arthroplasty (TKA)
or Total Hip Arthroplasty (THA). (12) CAH.
Anchor procedure means a TKA or (13) Non-Physician Provider Group
THA procedure that is permitted and Practice (NPPGP).
paid for by Medicare when performed (14) Therapy Group Practice (TGP).
in a hospital outpatient department CJR–HCC condition count risk adjust-
(HOPD) and billed through the OPPS, ment factor means the coefficient of
except when the beneficiary is admit- risk associated with a patient’s total
ted to an inpatient hospital stay with- number of CMS Hierarchical Condition
in 3 days after the TKA or THA. Categories, calculated as described in
Applicable discount factor means the § 510.301(a)(1).
discount percentage established by the CJR reconciliation report means the re-
participant hospital’s quality category port prepared after each reconciliation
as determined in § 510.315 and that is that CMS provides to each participant
applied to the episode benchmark price hospital notifying the participant hos-
for purposes of determining a partici- pital of the outcome of the reconcili-
pant hospital’s Medicare repayment in ation.
performance years 2 and 3. Collaboration agent means an indi-
Area means, as defined in § 400.200 of vidual or entity that is not a CJR col-
this chapter, the geographical area laborator and that is either of the fol-
within the boundaries of a State, or a lowing:
State or other jurisdiction, designated (1) A member of a PGP, NPPGP, or
as constituting an area with respect to TGP that has entered into a distribu-
which a Professional Standards Review tion arrangement with the same PGP,
Organization or a Utilization and Qual- NPPGP, or TGP in which he or she is
ity Control Peer Review Organization an owner or employee, and where the
has been or may be designated. PGP, NPPGP, or TGP is a CJR collabo-
BPCI stands for the Bundled Pay- rator.
ment for Care Improvement initiative. (2) An ACO participant or ACO pro-
BPCI Advanced stands for the Bun- vider/supplier that has entered into a
dled Payments for Care Improvement distribution arrangement with the
Advanced Model. same ACO in which it is participating,
CCN stands for CMS certification and where the ACO is a CJR collabo-
number. rator.
CEC stands for Comprehensive ESRD Composite quality score means a score
Care Initiative. computed for each participant hospital
CEHRT means certified electronic to summarize the hospital’s level of
health record technology that meets quality performance and improvement
the requirements of 45 CFR 170.102. . on specified quality measures as de-
CJR beneficiary means a beneficiary scribed in § 510.315.
who meets the beneficiary inclusion Core-based statistical area (CBSA)
criteria in § 510.205 and who is in a CJR means a statistical geographic entity
episode. consisting of the county or counties as-
CJR collaborator means an ACO or one sociated with at least one core (urban-
of the following Medicare-enrolled indi- ized area or urban cluster) of at least
966
10,000 population, plus adjacent coun- downstream collaboration agent, under

ties having a high degree of social and a downstream distribution arrange-
economic integration with the core as ment, composed only of distribution
measured through commuting ties with payments.
the counties containing the core. Dual-eligibility risk adjustment factor
CORF stands for comprehensive out- means the coefficient of risk associated
patient rehabilitation facility. with beneficiaries that are eligible for
COVID–19 Diagnosis Code means any full Medicaid benefits or beneficiaries
of the following ICD–10–CM diagnosis that are not eligible for full Medicaid
codes: benefits, calculated as described in
(1) B97.29; § 510.301(a)(1).
(2) U07.1; or EFT stands for electronic funds
(3) Any other ICD–10–CM diagnosis transfer.
code that is recommended by the Cen- Episode benchmark price means a dol-
ters for Disease Control and Prevention lar amount assigned to CJR episodes
for the coding of a confirmed case of based on historical episode payment
COVID–19. data (3 years of historical Medicare
Critical access hospital (CAH) means a payment data grouped into CJR epi-
hospital designated under subpart F of sodes according to the episode defini-
part 485 of this chapter. tion as described in § 510.200(b)) prior to
Distribution arrangement means a fi- the application of the effective dis-
nancial arrangement between a CJR count factor or applicable discount fac-
collaborator that is an ACO, PGP, tor, as described in § 510.300(c).
NPPGP, or TGP and a collaboration Episode of care (or Episode) means all
agent for the sole purpose of distrib- Medicare Part A and B items and serv-
uting some or all of a gainsharing pay- ices described in § 510.200(b) (and ex-
ment received by the ACO, PGP, cluding the items and services de-
NPPGP, or TGP. scribed in § 510.200(d)) that are fur-
Distribution payment means a pay- nished to a beneficiary described in
ment from a CJR collaborator that is § 510.205 during the time period that be-
an ACO, PGP, NPPGP, or TGP to a col- gins with the beneficiary’s admission
laboration agent, under a distribution to an anchor hospitalization or, on or
arrangement, composed only of after July 4, 2021, the date of admission
gainsharing payments. to an anchor hospitalization or the
DME stands for durable medical date of the anchor procedure, as appli-
equipment. cable, and ends on the 90th day after
Downstream collaboration agent means the following, as applicable:
an individual who is not a CJR collabo- (1) The date of discharge from the an-
rator or a collaboration agent and who chor hospitalization (with the day of
is a PGP member, an NPPGP member, discharge itself being counted as the
or a TGP member that has entered into first day of the 90-day post-discharge
a downstream distribution arrange- period); or
ment with the same PGP, NPPGP, or (2) The date of service for the anchor
TGP in which he or she is an owner or procedure.
employee, and where the PGP, NPPGP, ESRD stands for end stage renal dis-
or TGP is a collaboration agent. ease.
Downstream distribution arrangement Gainsharing payment means a pay-
means a financial arrangement be- ment from a participant hospital to a
tween a collaboration agent that is CJR collaborator, under a sharing ar-
both a PGP, NPPGP, or TGP and an rangement, composed of only reconcili-
ACO participant and a downstream col- ation payments or internal cost sav-
laboration agent for the sole purpose of ings or both.
distributing some or all of a distribu- HCAHPS stands for Hospital Con-
tion payment received by the PGP, sumer Assessment of Healthcare Pro-
NPPGP, or TGP. viders and Systems.
Downstream distribution payment HCPCS stands for Healthcare Com-
means a payment from a collaboration mon Procedure Coding System.
agent that is both a PGP, NPPGP, or HHA means a Medicare-enrolled
TGP and an ACO participant to a home health agency.
967
§ 510.2 42 CFR Ch. IV (10–1–24 Edition)
Historical episode payment means the criteria specified under § 412.108 of this
expenditures for historical episodes chapter.
that occurred during the historical pe- Member of the NPPGP or NPPGP mem-
riod used to determine the episode ber means a nonphysician practitioner
benchmark price. or therapist who is an owner or em-
Hospital means a provider subject to ployee of an NPPGP and who has reas-
the prospective payment system speci- signed to the NPPGP his or her right
fied in § 412.1(a)(1) of this chapter. to receive Medicare payment.
ICD–CM stands for International Member of the PGP or PGP member
Classification of Diseases, Clinical means a physician, nonphysician prac-
Modification. titioner, or therapist who is an owner
Inpatient prospective payment systems or employee of the PGP and who has
(IPPS) means the payment systems for reassigned to the PGP his or her right
subsection (d) hospitals as defined in to receive Medicare payment.
section 1886(d)(1)(B) of the Act. Member of the TGP or TGP member
Internal cost savings means the meas- means a therapist who is an owner or
urable, actual, and verifiable cost sav- employee of a TGP and who has reas-
ings realized by the participant hos- signed to the TGP his or her right to
pital resulting from care redesign un- receive Medicare payment.
dertaken by the participant hospital in Metropolitan Statistical Area (MSA)
connection with providing items and means a core-based statistical area as-
services to beneficiaries within specific sociated with at least one urbanized
CJR episodes of care. Internal cost sav- area that has a population of at least
ings does not include savings realized 50,000.
by any individual or entity that is not Net payment reconciliation amount
the participant hospital. (NPRA) means the amount determined
in accordance with § 510.305(e) or (m).
IPF stands for inpatient psychiatric
Nonphysician practitioner means (ex-
facility.
cept for purposes of subpart G of this
IRF stands for inpatient rehabilita-
part) one of the following:
tion facility.
(1) A physician assistant who satis-
Low-volume hospital means a hospital fies the qualifications set forth at
identified by CMS as having fewer than § 410.74(a)(2)(i) and (ii) of this chapter.
20 LEJR episodes in total across the 3 (2) A nurse practitioner who satisfies
historical years of data used to cal- the qualifications set forth at § 410.75(b)
culate the performance year 1 CJR epi- of this chapter.
sode target prices. (3) A clinical nurse specialist who
Lower-extremity joint replacement satisfies the qualifications set forth at
(LEJR) means any procedure that is § 410.76(b) of this chapter.
within MS–DRG 469 or 470, or, on or (4) A certified registered nurse anes-
after October 1, 2020, MS–DRG 521 or thetist (as defined at § 410.69(b)).
522, including lower-extremity joint re- (5) A clinical social worker (as de-
placement procedures or reattachment fined at § 410.73(a)).
of a lower extremity. (6) A registered dietician or nutrition
LTCH stands for long-term care hos- professional (as defined at § 410.134).
pital. NPI stands for National Provider
Mandatory MSA means an MSA des- Identifier.
ignated by CMS as a mandatory par- NPPGP means an entity that is en-
ticipation MSA in accordance with rolled in Medicare as a group practice,
§ 510.105(a). includes at least one owner or em-
Medicare severity diagnosis-related ployee who is a nonphysician practi-
group (MS–DRG) means, for the pur- tioner, does not include a physician
poses of this model, the classification owner or employee, and has a valid and
of inpatient hospital discharges up- active TIN.
dated in accordance with § 412.10 of this OIG stands for the Department of
chapter. Health and Human Services Office of
Medicare-dependent, small rural hos- the Inspector General.
pital (MDH) means a specific type of OP THA/OP TKA means a total hip
hospital that meets the classification arthroplasty or total knee
968
arthroplasty, respectively, for which formance year 5 is divided into two

the institutional claim is billed by the subsets, performance year subset 5.1
hospital through the OPPS. (January 1, 2020 through December 31,
OPPS stands for the outpatient pro- 2020) and performance year subset 5.2
spective payment system. (January 1, 2021 through September 30,
PAC stands for post-acute care. 2021).
Participant hospital means one of the PGP stands for physician group prac-
following: tice.
(1) During performance years 1 and 2 Physician has the meaning set forth
of the CJR model and the period from in section 1861(r) of the Act.
January 1, 2018 to January 31, 2018 of Post-episode spending amount means
performance year 3, a hospital (other the sum of Medicare Parts A and B
than a hospital excepted under payments for items and services that
§ 510.100(b)) with a CCN primary address are furnished to a beneficiary within 30
located in one of the geographic areas days after the end of the beneficiary’s
selected for participation in the CJR episode.
model in accordance with § 510.105. Provider of outpatient therapy services
(2) Between February 1, 2018 and Sep- means an entity that is enrolled in
tember 30, 2021 a hospital (other than a Medicare as a provider of therapy serv-
hospital excepted under § 510.100(b)) ices and furnishes one or more of the
that is one of the following: following:
(i) A hospital with a CCN primary ad- (1) Outpatient physical therapy serv-
dress located in a mandatory MSA as ices as defined in § 410.60 of this chap-
of February 1, 2018 that is not a rural ter.
hospital or a low-volume hospital on (2) Outpatient occupational therapy
that date. services as defined in § 410.59 of this
(ii) A hospital that is a rural hospital chapter.
or low-volume hospital with a CCN pri- (3) Outpatient speech-language pa-
mary address located in a mandatory thology services as defined in § 410.62 of
MSA that makes an election to partici- this chapter.
pate in the CJR model in accordance Quality-adjusted target price means
with § 510.115. the dollar amount assigned to CJR epi-
(iii) A hospital with a CCN primary sodes as the result of adjusting the epi-
address located in a voluntary MSA sode benchmark price by the partici-
that makes an election to participate pant hospital’s effective discount fac-
in the CJR model in accordance with tor or applicable discount factor based
§ 510.115. on the participant hospital’s quality
(3) Beginning October 1, 2021, a hos- category, as described in §§ 510.300(c)
pital that is not a rural hospital or a and 510.315(f).
low-volume hospital as defined in Quality improvement points are points
§ 510.2, as of July 4, 2021 (based on the that CMS adds to a participant hos-
date of the CMS notification letter and pital’s composite quality score for a
not the effective date of the rural re- measure if the hospital’s performance
classification, if applicable) with a CCN percentile on an individual quality
primary address located in a manda- measure for performance years 2
tory MSA. through 4 and 6 through 8, or for per-
PBPM stands for per-beneficiary-performance year subsets of performance
month. year 5, increases from the previous per-
Performance year means one of the formance year or performance year
years in which the CJR model is being subset by at least 2 deciles on the per-
tested. Performance years for the formance percentile scale, as described
model correlate to calendar years with in § 510.315(d). For performance year 1,
the exceptions of performance year 1, CMS adds quality improvement points
which is April 1, 2016 through Decem- to a participant hospital’s composite
ber 31, 2016, performance year 5, which quality score for a measure if the hos-
is January 1, 2020 through September pital’s performance percentile on an in-
30, 2021, and performance year 6 which dividual quality measure increases
is October 1, 2021 through December 31, from the corresponding time period in
2022. For reconciliation purposes, per- the previous year by at least 2 deciles
969
§ 510.100 42 CFR Ch. IV (10–1–24 Edition)
on the performance percentile scale, as Therapist means one of the following

described in § 510.315(d). individuals as defined at § 484.4 of this
Quality performance points are points chapter:
that CMS adds to a participant hos- (1) Physical therapist.
pital’s composite quality score for a (2) Occupational therapist.
measure based on the performance per- (3) Speech-language pathologist.
centile scale and for successful data Therapist in private practice means a
submission of patient-reported out- therapist that—
comes. (1) Complies with the special provi-
Reconciliation payment means a pay- sions for physical therapists in private
ment made by CMS to a CJR partici- practice in § 410.60(c) of this chapter;
pant hospital as determined in accord- (2) Complies with the special provi-
ance with § 510.305(f) or (l). sions for occupational therapists in pri-
Reconciliation target price means, for vate practice in § 410.59(c) of this chap-
performance years 6 through 8, the tar- ter; or
get price applied to an episode at rec- (3) Complies with the special provi-
onciliation, as determined in accord- sions for speech-language pathologists
ance with § 510.301. in private practice in § 410.62(c) of this
chapter.
Region means one of the nine U.S.
TIN stands for taxpayer identifica-
census divisions, as defined by the U.S.
tion number.
Census Bureau.
TKA/THA stands for total knee
Repayment amount means the amount arthroplasty/total hip arthroplasty.
owed by a participant hospital to CMS, Voluntary MSA means an MSA des-
as reflected on a reconciliation report. ignated by CMS as a voluntary partici-
Rural hospital means an IPPS hos- pation MSA in accordance with
pital that meets one of the following § 510.105(a).
definitions:
(1) Is located in a rural area as de-
FR 610, 611, Jan. 3, 2017; 82 FR 57103, Dec. 1,
fined under § 412.64 of this chapter. 2017; 85 FR 19292, Apr. 6, 2020; 85 FR 71198,
(2) Is located in a rural census tract Nov. 6, 2020; 86 FR 23569, May 3, 2021]
defined under § 412.103(a)(1) of this
chapter. Subpart B—Comprehensive Care
(3) Has reclassified as a rural hospital for Joint Replacement Pro-
under § 412.103 of this chapter.
gram Participants
Rural referral center (RRC) has the
same meaning given this term under § 510.100 Episodes being tested.
(a) Initiation of an episode. An episode
Sharing arrangement means a finan- is initiated when, with respect to a
cial arrangement between a partici- beneficiary described in § 510.205—
pant hospital and a CJR collaborator (1) The participant hospital admits
for the sole purpose of making the beneficiary for an anchor hos-
gainsharing payments or alignment pitalization; or
payments under the CJR model. (2) On or after July 4, 2021, an anchor
SNF stands for skilled nursing facil- procedure is performed at the partici-
ity. pant hospital.
Sole community hospital (SCH) means a (b) Exclusions. A hospital is excluded
hospital that meets the classification from being a participant hospital, but
criteria specified in § 412.92 of this only so long as any of the following
chapter. conditions apply:
TGP means an entity that is enrolled (1) The hospital is an episode
in Medicare as a therapy group in pri- initiator for an LEJR episode in the
vate practice, includes at least one risk-bearing period of Models 2 or 4 of
owner or employee who is a therapist BPCI.
in private practice, does not include an (2) The hospital is participating in
owner or employee who is a physician Model 1 of BPCI.
or nonphysician practitioner, and has a (3) These exclusions cease to apply as
valid and active TIN. of the date that the hospital no longer
970
meets any of the conditions specified § 510.110 Access to records and reten-
in this paragraph. tion.
[80 FR 73540, Nov. 24, 2015, as amended at 86 Participant hospitals, CJR collabo-
FR 23570, May 3, 2021] rators, collaboration agents, down-
stream collaboration agents, and any
§ 510.105 Geographic areas. other individuals or entities per-
forming CJR activities must do all of
(a) General. The geographic areas for
the following:
inclusion in the CJR model are ob- (a) Allow the Government, including
tained based on a stratified random CMS, OIG, HHS and the Comptroller
sampling of certain MSAs in the General or their designees, scheduled
United States. and unscheduled access to all books,
(1) All counties within each of the se- contracts, records, documents and
lected MSAs are selected for inclusion other evidence (including data related
in the CJR model. to utilization and payments, quality
(2) Beginning with performance year criteria, billings, lists of CJR collabo-
3, the selected MSAs are designated as rators, sharing arrangements, distribu-
either mandatory participation MSAs tion arrangements, downstream dis-
or voluntary participation MSAs. tribution arrangements and the docu-
(3) Beginning with performance year mentation required under §§ 510.500(d)
6, only the 34 MSAs designated as man- and 510.525(c)) sufficient to enable the
datory participation MSAs as of per- audit, evaluation, inspection or inves-
formance year 3. tigation of any of the following:
(b) Stratification criteria. Geographic (1) The individual’s or entity’s com-
areas in the United States are strati- pliance with CJR model requirements.
fied according to the characteristics (2) The calculation, distribution, re-
that CMS determines are necessary to ceipt, or recoupment of gainsharing
ensure that the model is tested on a payments, alignment payments, dis-
tribution payments, and downstream
broad range of different types of hos-
distribution payments.
pitals that may face different obstacles
(3) The obligation to repay any rec-
and incentives for improving quality
onciliation payments owed to CMS.
and controlling costs. (4) The quality of the services fur-
(c) Exclusions. CMS excludes from the nished to a CJR beneficiary during a
selection of geographic areas MSAs CJR episode.
that met the following criteria: (5) The sufficiency of CJR beneficiary
(1) Had fewer than 400 episodes be- notifications.
tween July 1, 2013 and June 30, 2014. (6) The accuracy of the CJR partici-
(2) Had fewer than 400 non-Model 1, 2, pant hospital’s submissions under
or 4 BPCI episodes as of October 1, 2015. CEHRT use requirements.
(3) Failed either or both of the fol- (b) Maintain all such books, con-
lowing rules regarding participation in tracts, records, documents, and other
BPCI: evidence for a period of 10 years from
(i) More than 50 percent of eligible the last day of the participant hos-
episodes initiated in a BPCI Model 2 or pital’s participation in the CJR model
4 initiating hospital. or from the date of completion of any
(ii) More than 50 percent of eligible audit, evaluation, inspection, or inves-
episodes that included SNF or HHA tigation, whichever is later, unless—
services, where the SNF or HHA serv- (1) CMS determines a particular
ices were furnished by a BPCI Model 3 record or group of records should be re-
tained for a longer period and notifies
initiating HHA or SNF.
the participant hospital at least 30 cal-
(4) For MSAs including both Mary-
endar days before the disposition date;
land and non-Maryland counties, more or
than 50 percent of eligible episodes (2) There has been a dispute or alle-
were initiated at a Maryland hospital. gation of fraud or similar fault against
[80 FR 73540, Nov. 24, 2015, as amended at 82 the participant hospital, CJR collabo-
FR 57103, Dec. 1, 2017; 86 FR 23570, May 3, rator, collaboration agents, down-
2021] stream collaboration agent, or any
971
§ 510.115 42 CFR Ch. IV (10–1–24 Edition)
other individual or entity performing (4) Is submitted in the form and man-
CJR activities in which case the ner specified by CMS.
records must be maintained for 6 years [82 FR 57103, Dec. 1, 2017]
from the date of any resulting final
resolution of the dispute or allegation § 510.120 CJR participant hospital
of fraud or similar fault. CEHRT track requirements.
[82 FR 612, Jan. 3, 2017] (a) CJR CEHRT use. For performance
years 2 through 8, CJR participant hos-
§ 510.115 Voluntary participation elec- pitals choose either of the following:
tion. (1) CEHRT use. Participant hospitals
(a) General. To continue participation attest in a form and manner specified
in performance year 3 and participate by CMS to their use of CEHRT as de-
in performance year 4 and performance fined in § 414.1305 of this chapter to doc-
year 5, the following hospitals must ument and communicate clinical care
submit a written participation election with patients and other health profes-
letter as described in paragraph (c) of sionals.
this section during the voluntary par- (2) No CEHRT use. Participant hos-
ticipation election period specified in pitals do not attest in a form and man-
paragraph (b) of this section: ner specified by CMS to their use of
(1) Hospitals (other than those ex- CEHRT as defined in § 414.1305 of this
cluded under § 510.100(b)) with a CCN chapter to document and communicate
primary address in a voluntary MSA. clinical care with patients and other
(2) Low-volume hospitals with a CCN health professionals.
primary address in a mandatory MSA. (b) Clinician financial arrangements
(3) Rural hospitals with a CCN pri- list. Each participant hospital that
mary address in a mandatory MSA. chooses CEHRT use as provided in
(b) Voluntary participation election pe- paragraph (a)(1) of this section must
riod. The voluntary participation elec- submit to CMS a clinician financial ar-
tion period begins on January 1, 2018 rangements list in a form and manner
and ends on January 31, 2018. specified by CMS on a no more than
(c) Voluntary participation election let- quarterly basis. The list must include
ter. The voluntary participation elec- the following information on individ-
tion letter serves as the model partici- uals and entities for the period of the
pation agreement. CMS accepts the CJR performance year specified by
voluntary participation election letter CMS:
if the letter meets all of the following (1) CJR collaborators. For each physi-
criteria: cian, nonphysician practitioner, or
(1) Includes the following: therapist in private practice who is a
(i) Hospital name. CJR collaborator during the period of
(ii) Hospital address. the CJR performance year specified by
(iii) Hospital CCN. CMS:
(iv) Hospital contact name, telephone (i) The name, TIN, and NPI of the
number, and email address. CJR collaborator.
(v) Model name (that is, CJR model). (ii) The start date and, if applicable,
(2) Includes a certification that the end date, for the sharing arrangement
hospital will— between the CJR participant hospital
(i) Comply with all applicable re- and the CJR collaborator.
quirements of this part and all other (2) Collaboration agents. For each phy-
laws and regulations applicable to its sician, nonphysician practitioner, or
participation in the CJR model; and therapist who is a collaboration agent
(ii) Submit data or information to during the period of the CJR perform-
CMS that is accurate, complete and ance year specified by CMS:
truthful, including, but not limited to, (i) The name and TIN of the CJR col-
the participation election letter and laborator and the name, TIN, and NPI
any quality data or other information of the collaboration agent.
that CMS uses in its reconciliation (ii) The start date and, if applicable,
processes. end date, for the distribution arrange-
(3) Is signed by the hospital adminis- ment between the CJR collaborator
trator, CFO or CEO. and the collaboration agent.
972
(3) Downstream collaboration agents. documentation of their attestation to

For each physician, nonphysician prac- CEHRT use, clinician financial ar-
titioner, or therapist who is a down- rangements lists, and clinician engage-
stream collaboration agent during the ment lists.
period of the CJR performance year (2) The participant hospital must re-
specified by CMS— tain and provide access to the required
(i) The name and TIN of the CJR col- documentation in accordance with
laborator and the name and TIN of the § 510.110.
collaboration agent and the name, TIN, [82 FR 612, Jan. 3, 2017, as amended at 82 FR
and NPI of the downstream collabora- 57103, Dec. 1, 2017; 86 FR 23570, May 3, 2021]
tion agent.
(ii) The start date and, if applicable,
end date, for the downstream distribu-
Subpart C—Scope of Episodes
tion arrangement between the collabo- § 510.200 Time periods, included and
ration agent and the downstream col- excluded services, and attribution.
laboration agent. (a) Time periods. All episodes must
(c) Clinician engagement list. Each par- begin on or after April 1, 2016 and end
ticipant hospital that chooses CEHRT on or before December 31, 2024.
use as provided in paragraph (a)(1) of (b) Included services. All Medicare
this section must submit to CMS a cli- Parts A and B items and services are
nician engagement list in a form and included in the episode, except as spec-
manner specified by CMS on a no more ified in paragraph (d) of this section.
than quarterly basis. This list must in- These services include, but are not lim-
clude the following information on in- ited to, the following:
dividuals for the period of the perform- (1) Physicians’ services.
ance year specified by CMS: (2) Inpatient hospital services (in-
(1) For each physician, nonphysician cluding hospital readmissions).
practitioner, or therapist who is not a (3) IPF services.
CJR collaborator during the period of (4) LTCH services.
the CJR model performance year speci- (5) IRF services.
fied by CMS but who does have a con- (6) SNF services.
tractual relationship with the partici- (7) HHA services.
pant hospital based at least in part on (8) Hospital outpatient services.
supporting the participant hospital’s (9) Outpatient therapy services.
quality or cost goals under the CJR (10) Clinical laboratory services.
model during the period of the per- (11) DME.
formance year specified by CMS: (12) Part B drugs and biologicals.
(i) The name, TIN, and NPI of the in- (13) Hospice services.
dividual. (14) PBPM payments under models
(ii) The start date and, if applicable, tested under section 1115A of the Act.
the end date for the contractual rela- (15) The surgeon’s Part B claim for
tionship between the individual and the LEJR procedure dated within the 3
participant hospital. days prior to an inpatient admission, if
(2) The CJR participant hospital the LEJR procedure was performed at
must retain and provide access to the the participant hospital on an out-
required documentation in accordance patient basis but the patient was sub-
with § 510.110. sequently admitted as an inpatient, re-
(d) Attestation to no individuals. If sulting in an anchor hospitalization.
there are no individuals that meet the (c) Episode attribution. All items and
requirements to be reported, as speci- services included in the episode are at-
fied in paragraphs (b)(1) through (3) or tributed to the participant hospital at
paragraph (c) of this section, the par- which the anchor hospitalization or an-
ticipant hospital must attest in a form chor procedure, as applicable, occurs.
and manner required by CMS that (d) Excluded services. The following
there are no individuals to report. items, services, and payments are ex-
(e) Documentation requirements. (1) cluded from the episode:
Each participant hospital that chooses (1) Hemophilia clotting factors pro-
CEHRT use as provided in paragraph vided in accordance with § 412.115 of
(a)(1) of this section must maintain this chapter.
973
§ 510.200 42 CFR Ch. IV (10–1–24 Edition)
(2) New technology add-on payments, care payment systems in accordance

as defined in part 412, subpart F of this with § 510.300(b)(6) of this chapter.
chapter. (6) For performance years 1 through 4
(3) Transitional pass-through pay- and for performance year subsets 5.1
ments for medical devices as defined in and 5.2, payments for otherwise in-
§ 419.66 of this chapter. cluded items and services in excess of 2
(4) Items and services unrelated to standard deviations above the mean re-
the anchor hospitalization or the an- gional episode payment in accordance
chor procedure. Excluded services in- with § 510.300(b)(5).
clude, but are not limited, to the fol- (7) For performance years 6 through 8
lowing: only, payments for otherwise included
(i) Inpatient hospital admissions for items and services in excess of the 99th
MS–DRGs that group to the following percentile of regional spending, ranked
categories of diagnoses: within each region, for each of the four
(A) Oncology. MS–DRG target price categories, as
(B) Trauma medical. specified in § 510.300(a)(1) and (6), for
(C) Chronic disease surgical, such as performance years 6 through 8, in ac-
prostatectomy. cordance with § 510.300(b)(5).
(D) Acute disease surgical, such as (e) Updating the lists of excluded serv-
appendectomy. ices. (1) The list of excluded MS–DRGs,
(ii) Medicare Part B services, as iden- ICD–CM diagnosis codes, and CMS
tified by the principal ICD–CM diag- model PBPM payments are posted on
nosis code on the claim (based on the the CMS Web site.
ICD–CM version in use during the per- (2) For performance years 1 through 5
formance year) that group to the fol- only, on an annual basis, or more fre-
lowing categories of diagnoses: quently as needed, CMS updates the
(A) Acute disease diagnoses, such as list of excluded services to reflect an-
severe head injury. nual coding changes or other issues
(B) Certain chronic disease diagnoses, brought to CMS’ attention.
as specified by CMS on a diagnosis-by- (3) For performance years 1 through 5
diagnosis basis depending on whether only, CMS applies the following stand-
the condition was likely to have been ards when revising the list of excluded
affected by the LEJR procedure and re- services for reasons other than to re-
covery period or whether substantial flect annual coding changes:
services were likely to be provided for
(i) Items or services that are directly
the chronic condition during the epi-
related to the LEJR procedure or the
sode. Such chronic disease diagnoses
quality or safety of LEJR care would
are posted on the CMS Web site and
may be revised in accordance with be included in the episode.
paragraph (e) of this section. (ii) Items or services for chronic con-
(iii) Certain PBPM payments under ditions that may be affected by the
models tested under section 1115A of LEJR procedure or post-surgical care
the Act. PBPM model payments that would be related and included in the
CMS determines to be primarily used episode.
for care coordination or care manage- (iii) Items and services for chronic
ment services for clinical conditions in conditions that are generally not af-
excluded categories of diagnoses, as de- fected by the LEJR procedure or post-
scribed in this paragraph. surgical care would be excluded from
(A) The list of excluded PBPM pay- the episode.
ments is posted on the CMS Web site (iv) Items and services for acute clin-
and are revised in accordance with ical conditions not arising from exist-
paragraph (e) of this section. ing, episode-related chronic clinical
(B) Notwithstanding the foregoing, conditions or complications of LEJR
all PBPM model payments funded from surgery would be excluded from the
CMS’ Innovation Center appropriation episode.
are excluded from the episode. (v) PBPM payments under CMS mod-
(5) Certain incentive programs and els determined to be primarily used for
add on payments under existing Medi- care coordination or care management
974
services for clinical conditions in ex- criteria in this section, the episode is
cluded categories of diagnoses, as de- canceled in accordance with § 510.210(b).
scribed in § 510.200(d), would be ex- [80 FR 73540, Nov. 24, 2015, as amended at 82
cluded from the episode. FR 613, Jan. 3, 2017; 86 FR 23571, May 3, 2021]
(4) For performance years 1 through 5
only, CMS posts the following to the § 510.210 Determination of the episode.
CMS website: (a) General. (1) An episode begins with
(i) Potential revisions to the exclu- the admission of a Medicare bene-
sion to allow for public comment; and ficiary described in § 510.205 to a partic-
(ii) An updated exclusions list after ipant hospital for an anchor hos-
consideration of public comment. pitalization and ends on the 90th day
(5) For performance years 6 through after the date of discharge, with the
8, the list of excluded services posted day of discharge itself being counted as
on the CMS website as it appears at the the first day in the 90-day post-dis-
beginning of performance year 5 will charge period.
apply and will not be updated. (2) On or after July 4, 2021, an epi-
sode—
[80 FR 73540, Nov. 24, 2015, as amended at 85 (i) Begins and ends in the manner
FR 19292, Apr. 6, 2020; 85 FR 71199, Nov. 6, specified in paragraph (a)(1) of this sec-
2020; 86 FR 23570, May 3, 2021] tion; or
(ii) Begins on the date of service of
§ 510.205 Beneficiary inclusion cri-
teria. an anchor procedure furnished to a
Medicare beneficiary described in
(a) Episodes tested in the CJR model § 510.205 and ends on the 90th day after
include only those in which care is fur- the date of service of the anchor proce-
nished to beneficiaries who meet all of dure.
the following criteria upon admission (b) Cancellation of an episode. The epi-
to the anchor hospitalization: sode is canceled and is not included in
(1) Are enrolled in Medicare Parts A the determination of NPRA as specified
and Part B. in § 510.305 if any of the following occur:
(2) Eligibility for Medicare is not on (1) The beneficiary does any of the
the basis of end stage renal disease, as following during the episode:
described in § 406.13 of this chapter. (i) Ceases to meet any criterion list-
(3) Are not enrolled in any managed ed in § 510.205.
care plan (for example, Medicare Ad- (ii) Is readmitted to any participant
vantage, health care prepayment plans, hospital for another anchor hos-
or cost-based health maintenance orga- pitalization, or, on or after July 4, 2021,
nizations). receives an anchor procedure at any
participant hospital.
(4) Are not covered under a United
(iii) Initiates an LEJR episode under
Mine Workers of America health care
BPCI.
plan. (iv) Dies.
(5) Have Medicare as their primary (2) For performance year 3, the par-
payer. ticipant hospital did not submit a par-
(6) For episodes beginning on or after ticipation election letter that was ac-
July 1, 2017, are not prospectively as- cepted by CMS to continue participa-
signed to— tion in the model.
(i) An ACO in the Next Generation
ACO model; FR 57104, Dec. 1, 2017; 86 FR 23571, May 3,
(ii) An ACO in a track of the Com- 2021]
prehensive ESRD Care Model incor-
porating downside risk for financial Subpart D—Pricing and Payment
losses; or
(iii) A Shared Savings Program ACO § 510.300 Determination of episode
in the ENHANCED track (formerly quality-adjusted target prices.
Track 3). (a) General. CMS establishes episode
(b) If at any time during the episode quality-adjusted target prices for par-
a beneficiary no longer meets all of the ticipant hospitals for each performance
975
§ 510.300 42 CFR Ch. IV (10–1–24 Edition)
year or performance year subset of the found on the CMS website. Beginning
model as specified in this section. Epi- on October 1, 2020, hip fracture episodes
sode quality-adjusted target prices are initiated by an anchor hospitalization
established according to the following: will be identified by MS–DRGs 521 and
(1) MS–DRG and fracture status. MS– 522.
DRG assigned at discharge for anchor (i) For performance years 1 through 5
hospitalization and present of hip frac- only, on an annual basis, or more fre-
ture diagnosis for anchor hospitaliza- quently as needed, CMS updates the
tion— list of ICD–CM hip fracture diagnosis
(i)(A) MS–DRG 469 with hip fracture; codes to reflect coding changes or
or other issues brought to CMS’ atten-
(B) For episodes beginning on or after tion.
October 1, 2020, MS–DRG 521; (ii) For performance years 1 through
(ii) MS–DRG 469 without hip fracture; 5 only, CMS applies the following
(iii)(A) MS–DRG 470 with hip frac- standards when revising the list of
ture; or ICD–CM hip fracture diagnosis codes.
(B) For episodes beginning on or after (A) The ICD–CM diagnosis code is suf-
October 1, 2020, MS–DRG 522; or ficiently specific that it represents a
(iv) MS–DRG 470 without hip frac- bone fracture for which a physician
ture. could determine that a hip replace-
(2) Applicable time period for perform- ment procedure, either a Partial Hip
ance year or performance year subset epi- Arthroplasty (PHA) or a THA, could be
sode quality-adjusted target prices. For the primary surgical treatment.
performance years 1 through 4 and per- (B) The ICD–CM diagnosis code is the
formance year subset 5.1 only, episode primary reason (that is, principal diag-
quality-adjusted target prices are up- nosis code) for the anchor hospitaliza-
dated to account for Medicare payment tion.
updates no less than 2 times per year, (iii) For performance years 1 through
for updated quality-adjusted target 5 only, CMS posts the following to the
prices effective October 1 and January CMS website:
1, and at other intervals if necessary. (A) Potential ICD–CM hip fracture di-
(3) Episodes that straddle performance agnosis codes for public comment; and
years, performance year subsets, or pay- (B) A final ICD–CM hip fracture diag-
ment updates. The quality-adjusted tar- nosis code list after consideration of
get price that applies to the episode is public comment.
one of the following: (iv) For performance years 6 through
(i) For episodes beginning on or after 8, the hip fracture diagnosis code list
April 1, 2016 and ending on or before posted at https://innovation.cms.gov/Files/
September 30, 2021, the date of admis- worksheets/cjr-icd10hipfracturecodes.xlsx
sion for the anchor hospitalization. as it appears at the beginning of per-
(ii) For episodes beginning on or after formance year 5 will not be updated.
July 4, 2021 and ending on or after Oc- The hip fracture diagnosis code list
tober 1, 2021, the date of the anchor will be used to identify hip fracture
procedure or the date of admission for episodes initiated by an anchor proce-
the anchor hospitalization, as applica- dure in performance years 6 through 8.
ble. (5) Quality performance. Quality-ad-
(4) Identifying episodes with hip frac- justed target prices reflect effective
ture. CMS develops a list of ICD–CM hip discount factors or applicable discount
fracture diagnosis codes that, when re- factors based on a hospital’s composite
ported in the principal diagnosis code quality score, as specified in
files on the claim for the anchor hos- §§ 510.300(c) and 510.315(f).
pitalization or anchor procedure, rep- (6) For episodes beginning on or after
resent a bone fracture for which a hip July 4, 2021 that are initiated by an an-
replacement procedure, either a partial chor procedure, permitted OP TKAs
hip arthroplasty or a total hip and OP THAs are grouped with MS–
arthroplasty, could be the primary sur- DRG 470 or MS–DRG 522 episodes as fol-
gical treatment. The list of ICD–CM lows:
hip fracture diagnosis codes used to (i) Permitted OP THAs with hip frac-
identify hip fracture episodes can be ture group with MS–DRG 522.
976
(ii) Permitted OP THAs without hip based on 100 percent regional historical
fracture and permitted OP TKAs group episode payments.
with MS–DRG 470. (4) Exception for recently merged or
(b) Episode quality-adjusted target split hospitals. Hospital-specific histor-
price. (1) CMS calculates quality-ad- ical episode payments for participant
justed target prices based on a blend of hospitals that have undergone a merg-
each participant hospital’s hospital- er, consolidation, spin off or other reor-
specific and regional episode expendi- ganization that results in a new hos-
tures. The region corresponds to the pital entity without 3 full years of his-
U.S. Census Division associated with torical claims data are determined
the primary address of the CCN of the using the historical episode payments
participant hospital and the regional attributed to their predecessor(s).
component is based on all hospitals in (5) Exception for high episode spending.
said region, except as follows. In cases (i) For performance years 1 through 4,
where an MSA selected for participa- and for performance year 5, each subset
tion in CJR spans more than one U.S. thereof, episode payments are capped
Census Division, the entire MSA will at 2 standard deviations above the
be grouped into the U.S. Census Divi- mean regional episode payment for
sion where the largest city by popu- both the hospital-specific and regional
lation in the MSA is located for qual- components of the quality-adjusted
ity-adjusted target price and reconcili- target price.
ation calculations. The calendar years
(ii) For performance years 6 through
used for historical expenditure calcula-
8, episode payments are capped at the
tions are as follows:
99th percentile of regional spending for
(i) Episodes beginning in 2012 through
each of the four MS–DRG categories, as
2014 for performance years 1 and 2.
specified in § 510.300(a)(1) and (6).
(ii) Episodes beginning in 2014
through 2016 for performance years 3 (6) Exclusion of incentive programs and
and 4. add-on payments under existing Medicare
(iii) Episodes beginning in 2016 payment systems. Certain incentive pro-
through 2018 for each of performance grams and add-on payments are ex-
year subsets 5.1 and 5.2. cluded from historical episode pay-
(iv) Episodes beginning in 2019 for ments by using, with certain modifica-
performance year 6. tions, the CMS Price (Payment) Stand-
(v) Episodes beginning in 2021 for per- ardization Detailed Methodology used
formance year 7. for the Medicare spending per bene-
(vi) Episodes beginning in 2022 for ficiary measure in the Hospital Value-
performance year 8. Based Purchasing Program.
(2) Specifically, the blend consists of (7) Communication of episode quality-
the following: adjusted target prices. CMS commu-
(i) Two-thirds of the participant hos- nicates episode quality-adjusted target
pital’s own historical episode payments prices to participant hospitals before
and one-third of the regional historical the performance period in which they
episode payments for performance apply.
years 1 and 2. (8) Inclusion of reconciliation payments
(ii) One-third of the hospital’s own and repayments. For performance years
historical episode payments and two- 3, 4, and each of performance year sub-
thirds of the regional historical episode sets 5.1 and 5.2 only, reconciliation
payments for performance year 3. payments and repayment amounts
(iii) Regional historical episode pay- under § 510.305(f)(2) and (3) and from
ments for performance year 4, for each LEJR episodes included in the BPCI
subset of performance year 5, and per- initiative are included in historical
formance years 6 through 8. episode payments.
(3) Exception for low-volume hospitals. (c) Discount factor. A participant hos-
Quality-adjusted target prices for par- pital’s episode quality-adjusted target
ticipant hospitals with fewer than 20 prices incorporate discount factors to
CJR episodes in total across the 3 his- reflect Medicare’s portion of reduced
torical years of data used to calculate expenditures from the CJR model as
the quality-adjusted target price are described in this section.
977
§ 510.301 42 CFR Ch. IV (10–1–24 Edition)
(1) Discount factors affected by the hospital’s baseline period and no less
quality incentive payments and the com- frequently than on a quarterly basis
posite quality score. In all performance throughout the hospital’s participation
years and performance year subsets, in the CJR model.
the discount factor may be affected by [80 FR 73540, Nov. 24, 2015, as amended at 81
the quality incentive payment and FR 11451, Mar. 4, 2016; 82 FR 613, Jan. 3, 2017;
composite quality score as provided in 82 FR 57104, Dec. 1, 2017; 85 FR 71199, Nov. 6,
§ 510.315 to create the effective discount 2020; 86 FR 23571, May 3, 2021]
factor or applicable discount factor
used for calculating reconciliation pay- § 510.301 Determination of reconcili-
ments and repayment amounts. The ation target prices.
quality-adjusted target prices incor- Beginning with performance year 6,
porate the effective or applicable dis- the quality-adjusted target price com-
count factor at reconciliation. puted under § 510.300 is further adjusted
(2) Discount factor for reconciliation for risk and market trends as described
payments. The discount factor for rec- in this section to arrive at the rec-
onciliation payments in all perform- onciliation target price amount, with
ance years and performance year sub- the exception of episodes that are rec-
sets is 3.0 percent. onciled in performance year 6 but sub-
(3) Discount factors for repayment ject to a performance year subset 5.2
amounts. The discount factor for repay- target price. Specifically:
ment amounts is— (a) Risk adjustment. (1) The quality-
(i) Not applicable in performance adjusted target prices computed under
year 1, as the requirement for hospital § 510.300 are risk adjusted at a bene-
repayment under the CJR model is ficiary level by a CJR HCC count risk
waived in performance year 1; adjustment factor, an age bracket risk
(ii) In performance years 2 and 3, 2.0 adjustment factor, and a dual-eligi-
percent; and bility status risk adjustment factor.
(iii) In performance years 4, each sub- All three factors are binary, yes/no
set of performance year 5, and perform- variables, meaning that a beneficiary
ance years 6 through 8, 3.0 percent. either does or does not meet the cri-
(d) Data sharing. (1) CMS makes teria for a specific variable.
available to participant hospitals, (i) The CJR HCC count risk adjust-
through the most appropriate means, ment factor uses five variables, rep-
data that CMS determines may be use- resenting beneficiaries with zero, one,
ful to participant hospitals to do the two, three, or four or more CMS–HCC
following: conditions.
(i) Determine appropriate ways to in- (ii) The age bracket risk adjustment
crease the coordination of care. factor uses four variables, representing
(ii) Improve quality. beneficiaries aged—
(iii) Enhance efficiencies in the deliv- (A) Less than 65 years;
ery of care. (B) 65 to 74 years;
(iv) Otherwise achieve the goals of (C) 75 years to 84 years; or
the CJR model described in this sec- (D) 85 years or more.
tion. (iii) The dual-eligibility status factor
(2) Beneficiary-identifiable data. (i) uses two variables, representing bene-
CMS makes beneficiary-identifiable ficiaries that are eligible for full Med-
data available to a participant hospital icaid benefits or beneficiaries that are
in accordance with applicable privacy not eligible for full Medicaid benefits.
laws and only in response to the hos- (2) All three factors are computed
pital’s request for such data for a bene- prior to the start of performance years
ficiary who has been furnished a 6 and 8 via a linear regression analysis.
billable service by the participant hos- The regression analysis is computed
pital corresponding to the episode defi- using 1 year of claims data as follows:
nitions for CJR. (i) For performance year 6, CMS uses
(ii) The minimum data necessary to claims data with dates of service dated
achieve the goals of the CJR model, as January 1, 2019 to December 31, 2019.
determined by CMS, may be provided (ii) For performance year 7, CMS uses
under this section for a participant the same regression analysis results
978
and corresponding coefficients that for age, CJR HCC count, and dual-eligi-
were calculated for performance year 6. bility status on the national average
(iii) For performance year 8, CMS target price.
uses claims data with dates of service (ii) The normalization factor is the
dated January 1, 2021 to December 31, national mean of the target price for
2021. all episode types divided by the na-
(3)(i) The dependent variable in the tional mean of the risk-adjusted target
annual regression that produces the price.
risk adjustment coefficients is equal to (iii) CMS applies the normalization
the difference between the log trans- factor to the previously calculated,
formed target price calculated under beneficiary-level, risk-adjusted target
§ 510.300 and the capped episode costs as prices specific to each episode region
described in § 510.300(b)(5)(ii). and MS–DRG combination (as specified
(ii) The independent variables are bi- in paragraph (a)(4) of this section).
nary values assigned to each CJR HCC (iv) These normalized target prices
count variable, age bracket variable are then further adjusted for market
and dual-eligibility status variable. trends (as specified in paragraph (b) of
(iii) Using these variables, the annual this section) and quality performance
regression produces exponentiated co- (as specified at § 510.300) to become the
efficients to determine the anticipated reconciliation target prices, which are
marginal effect of each risk adjust- compared to actual episode costs at
ment factor on episode costs. CMS reconciliation, as specified in
transforms, or exponentiate, these co- § 510.305(m)(1)(i).
efficients in order to ‘‘reverse’’ the pre- (b) Market trend adjustment factor. (1)
vious logarithmic transformation, and The risk-adjusted quality-adjusted tar-
the resulting coefficients are the CJR get price computed under § 510.300 and
HCC count risk adjustment factor, the paragraph (a) of this section is further
age bracket risk adjustment factor, adjusted for market trend changes at
and the dual-eligibility status factor the region and MS–DRG level.
that would be used during reconcili- (2) This adjustment is accomplished
ation for the subsequent performance by multiplying each risk-adjusted
year. quality-adjusted target price computed
(4)(i) At the time of reconciliation, under § 510.300 and paragraph (a) of this
the quality adjusted target prices com- section by the applicable market trend
puted under § 510.300 are risk adjusted adjustment factor.
at the beneficiary level by applying the (3) The applicable market trend ad-
applicable CJR HCC count risk adjust- justment factor is calculated as the
ment factor, the age bracket risk ad- percent difference between the average
justment factor, and the dual-eligi- regional MS–DRG episode costs com-
bility risk adjustment factor specific puted using the performance year
to the beneficiary in the episode. claims data and comparison average
(ii)(A) For the CJR HCC count risk regional MS–DRG fracture episode
adjustment factor, applicable means costs computed using historical cal-
the coefficient that applies to the endar year claims data used to cal-
CMS–HCC condition count for the bene- culate the regional target prices in ef-
ficiary in the episode; fect for that performance year.
(B) For the age bracket risk adjust- [86 FR 23571, May 3, 2021]
ment factor, applicable means the coef-
ficient for the age bracket into which § 510.305 Determination of the NPRA
the beneficiary falls on the first day of and reconciliation process.
the episode; and (a) General. Providers and suppliers
(C) For the dual-eligibility risk ad- furnishing items and services included
justment factor, applicable means the in the episode bill for such items and
coefficient for beneficiaries that are el- services in accordance with existing
igible for full Medicaid benefits on the rules and as if this part were not in ef-
first day of the episode. fect.
(5)(i) The risk-adjusted target prices (b) Reconciliation. (1) For performance
are normalized at reconciliation to re- years 1 through 4 and for each subset of
move the overall impact of adjusting performance year 5, CMS uses a series
979
§ 510.305 42 CFR Ch. IV (10–1–24 Edition)
of reconciliation processes, which CMS or after the effective date of the reor-
performs as described in paragraphs (d) ganization event.
and (f) of this section after the end of (2) CMS—
each performance year, to establish (i) Calculates the NPRA for each par-
final payment amounts to participant ticipant hospital in accordance with
hospitals for CJR model episodes for a paragraph (e) of this section including
given performance year. the adjustments provided for in para-
(2) For performance years 6 through graph (e)(1)(iv) of this section; and
8, CMS conducts one reconciliation (ii) Assesses whether hospitals meet
process, which CMS performs as de- specified quality requirements under
scribed in paragraphs (l) and (m) of this § 510.315.
section after the end of each perform- (e) Calculation of the NPRA for per-
ance year, to establish final payment formance years 1 through 5. By com-
amounts to participant hospitals for paring the quality-adjusted target
CJR model episodes for a given per- prices described in § 510.300 and the par-
formance year. ticipant hospital’s actual episode
(3) Following the end of each per- spending for each of performance years
formance year, for performance years 1 1 through 4, and for performance year
through 4 and for performance year 5, 5, each subset thereof, and applying the
each subset thereof, CMS determines adjustments in paragraph (e)(1)(v) of
actual episode payments for each epi- this section, CMS establishes an NPRA
sode for the performance year (other for each participant hospital for each
than episodes that have been canceled of performance years 1 through 4 and
in accordance with § 510.210(b)) and de- for performance year 5, each subset
termines the amount of a reconcili- thereof.
ation payment or repayment amount. (1) Initial calculation. In calculating
the NPRA for each participant hospital
(c) Data used. CMS uses the most re-
for each of performance years 1
cent claims data available to perform
through 4 and each of performance year
each reconciliation calculation.
subsets 5.1 and 5.2, CMS does the fol-
(d) Annual reconciliation for perform- lowing:
ance years 1 through 5. (1) Beginning 2 (i) Determines actual episode pay-
months after the end of each of per- ments for each episode included in the
formance years 1 through 4 and per- performance year or performance year
formance year subset 5.1 and 5 months subset (other than episodes that have
after the end of performance year sub- been canceled in accordance with
set 5.2, CMS does all of the following: § 510.210(b)) using claims data that is
(i) Performs a reconciliation calcula- available 2 months after the end of the
tion to establish an NPRA for each par- performance year or performance year
ticipant hospital. subset. Actual episode payments are
(ii) For participant hospitals that ex- capped, as applicable, at the amount
perience a reorganization event in determined in accordance with
which one or more hospitals reorganize § 510.300(b)(5) for the performance year
under the CCN of a participant hospital or performance year subset at the
performs— amount determined in paragraph (k) of
(A) Separate reconciliation calcula- this section for episodes affected by ex-
tions (during both initial and subse- treme and uncontrollable cir-
quent reconciliations for a perform- cumstances, or at the quality adjusted
ance year) for each predecessor partici- target price determined for that epi-
pant hospital for episodes where anchor sode under § 510.300 for an episode with
hospitalization admission occurred be- actual episode payments that include a
fore the effective date of the reorga- claim with a COVID–19 diagnosis code
nization event; and and initiate after the earlier of March
(B) Reconciliation calculations (dur- 31, 2021 or the last day of the emer-
ing both initial and subsequent rec- gency period described in paragraph
onciliations for a performance year) for (k)(4) of this section.
each new or surviving participant hos- (ii) Multiplies each episode quality-
pital for episodes where the anchor adjusted target price by the number of
hospitalization admission occurred on episodes included in the performance
980
year or performance year subset (other (1) For performance years 1 and 2, 5
than episodes that have been canceled percent of the amount calculated in
in accordance with § 510.210(b)) to which paragraph (e)(1)(iii) of this section for
that episode quality-adjusted target the performance year.
price applies. (2) For performance year 3, 10 percent
(iii) Aggregates the amounts com- of the amount calculated in paragraph
puted in paragraph (e)(1)(ii) of this sec- (e)(1)(iii) of this section for the per-
tion for all episodes included in the formance year.
performance year or performance year (3) For performance year 4 and each
subset (other than episodes that have of performance year subsets 5.1 and 5.2,
been canceled in accordance with 20 percent of the amount calculated in
§ 510.210(b)). paragraph (e)(1)(iii) of this section for
(iv) Subtracts the amount deter- the performance year or performance
mined under paragraph (e)(1)(i) of this year subset.
section from the amount determined (4) As provided in paragraph (i) of
under paragraph (e)(1)(iii) of this sec- this section, the subsequent reconcili-
tion. ation calculation reassesses the limita-
(v) Applies the following prior to de- tion on gain for a given performance
termination of the reconciliation pay- year by applying the limitations on
ment or repayment amount: gain to the aggregate of the 2 reconcili-
ation calculations.
(A) Limitation on loss. Except as pro-
(5) The post-episode spending and
vided in paragraph (e)(1)(v)(C) of this
ACO overlap calculation amounts in
section, the total amount of the NPRA
paragraphs (j)(1) and (j)(2) of this sec-
and subsequent reconciliation calcula-
tion are not subject to the limitation
tion for a performance year or perform-
on gain.
ance year subset cannot exceed the fol-
(C) Financial loss limits for rural hos-
lowing:
pitals, SCHs, MDHs, and RRCs. If a par-
(1) For performance year 2 only, 5 ticipant hospital is a rural hospital,
percent of the amount calculated in SCH, MDH, or RRC, then for perform-
paragraph (e)(1)(iii) of this section for ance year 2, the total repayment
the performance year. amount for which the participant hos-
(2) For performance year 3, 10 percent pital is responsible due to the NPRA
of the amount calculated in paragraph and subsequent reconciliation calcula-
(e)(1)(iii) of this section for the per- tion cannot exceed 3 percent of the
formance year. amount calculated in paragraph
(3) For performance year 4 and each (e)(1)(iii) of this section. For perform-
of performance year subsets 5.1 and 5.2, ance years 3 and 4 and for performance
20 percent of the amount calculated in year subsets 5.1 and 5.2, the amount
paragraph (e)(1)(iii) of this section for cannot exceed 5 percent of the amount
the performance year or performance calculated in paragraph (e)(1)(iii) of
year subset. this section.
(4) As provided in paragraph (i) of (f) Determination of reconciliation or re-
this section, the subsequent reconcili- payment amount—(1) Determination of
ation calculation reassesses the limita- the reconciliation or repayment amount.
tion on loss for a given performance (i) Subject to paragraph (f)(1)(iii) of
year by applying the limitations on this section, for performance year 1,
loss to the aggregate of the 2 reconcili- the reconciliation payment (if any) is
ation calculations. equal to the NPRA.
(5) The post-episode spending and (ii) Subject to paragraph (f)(1)(iii) of
ACO overlap calculation amounts in this section, for performance years 2
paragraphs (j)(1) and (2) of this section through 4 and for each of performance
are not subject to the limitation on year subsets 5.1 and 5.2, results from
loss. the subsequent reconciliation calcula-
(B) Limitation on gain. The total tion for a prior year’s reconciliation as
amount of the NPRA and subsequent described in paragraph (i) of this sec-
reconciliation calculation for a per- tion and the post-episode spending and
formance year or performance year ACO overlap calculations as described
subset cannot exceed the following: in paragraph (j) of this section are
981
§ 510.305 42 CFR Ch. IV (10–1–24 Edition)
added to the current year’s NPRA in (2) If the hospital’s composite quality
order to determine the reconciliation score described in § 510.315 is acceptable
payment or repayment amount. (defined as greater than or equal to 5.00
(iii) The reconciliation or repayment and less than 6.9), good (defined as
amount may be adjusted as provided in greater than or equal to 6.9 and less
§ 510.410(b). than or equal to 15.0), or excellent (de-
(iv) Results from the performance fined as greater than 15.0), and the hos-
year 6 reconciliation and post-episode pital is determined to have a positive
spending calculations as described in NPRA under § 510.305(e)), the hospital is
paragraph (m) of this section are added eligible for a reconciliation payment.
together in order to determine the rec- (3) If the hospital’s composite quality
onciliation payment or repayment score described in § 510.315 is below ac-
amount for performance year 6. ceptable, defined as less than 4.00 for a
(v) Results from the performance performance year or performance year
year 7 reconciliation and post-episode subset, the hospital is not eligible for a
spending calculations as described in reconciliation payment.
paragraph (m) of this section are added (4) If the hospital is found to be en-
together in order to determine the rec- gaged in an inappropriate and systemic
onciliation payment or repayment under delivery of care, the quality of
amount for performance year 7. the care provided must be considered
(vi) Results from the performance to be seriously compromised and the
year 8 reconciliation and post-episode hospital must be ineligible to receive
spending calculations as described in or retain a reconciliation payment for
paragraph (m) of this section are added any period in which such under deliv-
together in order to determine the rec- ery of care was found to occur.
onciliation payment or repayment (h) Reconciliation report. CMS issues
amount for performance year 8. each participant hospital a CJR rec-
(2) Reconciliation payment. If the onciliation report for the performance
amount described in paragraph (f)(1) of year or performance year subset. Each
this section is positive and the com- CJR reconciliation report contains the
posite quality score described in following:
§ 510.315 is acceptable (defined as great- (1) Information on the participant
er than or equal to 5.00 and less than hospital’s composite quality score de-
6.9), good (defined as greater than or scribed in § 510.315.
equal to 6.9 and less than or equal to (2) The total actual episode payments
15.0), or excellent (defined as greater for the participant hospital.
than 15.0), Medicare pays the partici- (3) The NPRA.
pant hospital a reconciliation payment (4) Whether the participant hospital
in an amount equal to the amount de- is eligible for a reconciliation payment
scribed in paragraph (f)(1) of this sec- or must make a repayment to Medi-
tion. care.
(3) Repayment amount. If the amount (5) As applicable, the NPRA and sub-
described in paragraph (f)(1) of this sec- sequent reconciliation calculation
tion is negative, the participant hos- amount for the previous performance
pital pays to Medicare an amount year or performance year subset.
equal to the amount described in para- (6) As applicable, the post-episode
graph (f)(1) of this section, in accord- spending amount and ACO overlap cal-
ance with § 405.371 of this chapter. CMS culation for the previous performance
waives this requirement for perform- year or performance year subset.
ance year 1. (7) The reconciliation payment or re-
(g) Determination of eligibility for rec- payment amount.
onciliation based on quality. (1) CMS as- (i) Subsequent reconciliation calcula-
sesses each participant hospital’s per- tion. (1) Fourteen months after the end
formance on quality metrics, as de- of each of performance years 1 through
scribed in § 510.315, to determine wheth- 4 and performance year subset 5.1 and
er the participant hospital is eligible seventeen months after the end of per-
to receive a reconciliation payment for formance year subset 5.2, CMS per-
a performance year or performance forms an additional calculation, using
year subset. claims data available at that time, to
982
account for final claims run-out and downside risk for CJR episodes that
any additional episode cancelations initiate after July 1, 2017).
due to overlap between the CJR model (iv) The Next Generation ACO model
and other CMS models and programs, (excluding CJR episodes that initiate
or for other reasons as specified in on or after July 1, 2017).
§ 510.210(b). (2) If the average post-episode Medi-
(2) The subsequent calculation for care Parts A and B payments for a par-
each of performance years 1 through 4 ticipant hospital in the prior perform-
and performance year subset 5.1 occurs ance year or performance year subset
concurrently with the first reconcili- is greater than 3 standard deviations
ation process for the following per- above the regional average post-epi-
formance year (or in the case of per- sode payments for the same perform-
formance year subset 5.1, with the first ance year or performance year subset,
reconciliation of performance year sub- then the spending amount exceeding 3
set 5.2). If the result of the subsequent standard deviations above the regional
calculation is different than zero, CMS average post-episode payments for the
applies the stop-loss and stop-gain lim- same performance year or performance
its in paragraph (e) of this section to year subset is subtracted from the net
the aggregate calculation of the reconciliation or added to the repay-
amounts described in paragraphs
ment amount for the subsequent per-
(e)(1)(iv) and (i)(1) of this section for
formance year for years 1 through 4
that performance year or performance
and performance year subset 5.1, and
year subset (the initial reconciliation
assessed independently for performance
and the subsequent reconciliation cal-
year subset 5.2.
culation) to ensure such amount does
not exceed the applicable stop-loss or (k) Extreme and uncontrollable cir-
stop-gain limits. The subsequent rec- cumstances adjustment. (1) The episode
onciliation calculation for performance spending adjustments specified in para-
year subset 5.2 will occur independ- graph (k)(2) of this section apply for a
ently in 2023. participant hospital that has a CCN
(j) Additional adjustments to the rec- primary address that meets both of the
onciliation payment or repayment following:
amount. (1) In order to account for (i) Is located in an emergency area
shared savings payments, CMS will re- during an emergency period, as those
duce the reconciliation payment or in- terms are defined in section 1135(g) of
crease the repayment amount for the the Act, for which the Secretary has
subsequent performance year (for per- issued a waiver under section 1135; and
formance years 1 through 4 and per- (ii) Is located in a county, parish, or
formance year subset 5.1) by the tribal government designated in a
amount of the participant hospital’s major disaster declaration under the
discount percentage that is paid to the Stafford Act.
ACO in the prior performance year as (2)(i) For a non-fracture episode with
shared savings. (This amount will be a date of admission to the anchor hos-
assessed independently for performance pitalization that is on or within 30 days
year subset 5.2 in 2023.) This adjust- before the date that the emergency pe-
ment is made only when the partici- riod (as defined in section 1135(g) of the
pant hospital is a participant or pro- Act) begins, actual episode payments
vider/supplier in the ACO and the bene- are capped at the target price deter-
ficiary in the CJR episode is assigned mined for that episode under § 510.300.
to one of the following ACO models or (ii) For a fracture episode with a date
programs: of admission to the anchor hospitaliza-
(i) The Pioneer ACO model. tion that is on or within 30 days before
(ii) The Medicare Shared Savings or after the date that the emergency
Program (excluding Track 3 for CJR period (as defined in section 1135(g) of
episodes that initiate on or after July the Act) begins, actual episode pay-
1, 2017). ments are capped at the target price
(iii) The Comprehensive ESRD Care determined for that episode under
Initiative (excluding a track with § 510.300.
983
§ 510.305 42 CFR Ch. IV (10–1–24 Edition)
(3) The following is an extreme and paragraph (m) of this section including
uncontrollable circumstances adjust- the adjustments provided for in para-
ment for 2019 Novel Coronavirus (pre- graph (m)(1)(vii) of this section; and
viously referred to as 2019–nCoV, now (ii) Assesses whether participant hos-
as COVID–19): pitals meet specified quality require-
(i) The episode spending adjustments ments under § 510.315.
specified in paragraph (k)(4) of this sec- (m) Calculation of the NPRA for per-
tion apply for a participant hospital formance years 6 through 8. By com-
that has a CCN primary address that is paring the reconciliation target prices
located in an emergency area during an described in § 510.301 and the partici-
emergency period, as those terms are pant hospital’s actual episode spending
defined in section 1135(g) of the Act, for for the performance year and applying
which the Secretary issued a waiver or the adjustments in paragraph
modification of requirements under (m)(1)(vii) of this section, CMS estab-
section 1135 of the Act on March 13, lishes an NPRA for each participant
2020. hospital for each of performance years
(ii) [Reserved] 6 through 8.
(4) For a fracture or non-fracture epi- (1) In calculating the NPRA for each
sode with a date of admission to the participant hospital for each perform-
anchor hospitalization that is on or ance year, CMS does the following:
within 30 days before the date that the (i) Determines actual episode pay-
emergency period (as defined in section ments for each episode included in the
1135(g) of the Act) begins or that occurs performance year (other than episodes
on or before March 31, 2021 or the last that have been canceled in accordance
day of such emergency period, which- with § 510.210(b)) using claims data that
ever is earlier, actual episode pay- is available 6 months after the end of
ments are capped at the quality ad- the performance year. Actual episode
justed target price determined for that payments are capped at the amount de-
episode under § 510.300. termined in accordance with
(l) Annual reconciliation for perform- § 510.300(b)(5)(ii) for the performance
ance years 6 through 8. (1) Beginning 6 year, the amount determined in para-
months after the end of each of per- graph (k) of this section for episodes af-
formance years 6 through 8, CMS does fected by extreme and uncontrollable
all of the following: circumstances, or the target price de-
(i) Performs a reconciliation calcula- termined for that episode under
tion to establish an NPRA for each par- § 510.300 for episodes that contain a
ticipant hospital. COVID–19 Diagnosis Code as defined in
(ii) For participant hospitals that ex- § 510.2.
perience a reorganization event in (ii) Multiplies each episode reconcili-
which one or more hospitals reorganize ation target price by the number of
under the CCN of a participant hos- episodes included in the performance
pital, performs— year (other than episodes that have
(A) Separate reconciliation calcula- been canceled in accordance with
tions for each predecessor participant § 510.210(b)) to which that episode rec-
hospital for episodes where the anchor onciliation target price applies.
hospitalization admission or the an- (iii) Aggregates the amounts com-
chor procedure occurred before the ef- puted in paragraph (m)(1)(ii) of this
fective date of the reorganization section for all episodes included in the
event; and performance year (other than episodes
(B) Reconciliation calculations for that have been canceled in accordance
each new or surviving participant hos- with § 510.210(b)).
pital for episodes where the anchor (iv) Subtracts the amount deter-
hospitalization admission or anchor mined under paragraph (m)(1)(i) of this
procedure occurred on or after the ef- section from the amount determined
fective date of the reorganization under paragraph (m)(1)(iii) of this sec-
event. tion.
(2) CMS— (v) Performs an additional calcula-
(i) Calculates the NPRA for each par- tion using claims data available at
ticipant hospital in accordance with that time, to account for any episode
984
cancelations due to overlap between not be incorporated due to inaccurate

the CJR model and other CMS models amendatory instruction.
and programs, or for other reasons as
specified in § 510.210(b). § 510.310 Appeals process.
(vi) Conducts a post-episode spending (a) Notice of calculation error (first level
calculation as follows: If the average of appeal). Subject to the limitations
post-episode Medicare Parts A and B on review in subpart D of this part, if
payments for a participant hospital in a participant hospital wishes to dispute
the performance year being reconciled calculations involving a matter related
is greater than 3 standard deviations to payment, reconciliation amounts,
above the regional average post-epi- repayment amounts, the use of quality
sode payments for that same perform- measure results in determining the
ance year, then the spending amount composite quality score, or the appli-
exceeding 3 standard deviations above cation of the composite quality score
the regional average post-episode pay-
during reconciliation, the participant
ments for the same performance year is
hospital is required to provide written
subtracted from the net reconciliation
notice of the calculation error, in a
or added to the repayment for that per-
form and manner specified by CMS.
formance year.
(vii) Applies the following prior to (1) Unless the participant hospital
determination of the reconciliation provides such notice, CMS deems final
payment or repayment amount: the CJR reconciliation report 45 cal-
(A) Limitation on loss. Except as pro- endar days after it is issued and pro-
vided in paragraph (m)(1)(vii)(C) of this ceeds with the payment or repayment
section, the total amount of the NPRA processes as applicable.
for a performance year cannot exceed (2) If CMS receives a notice of a cal-
20 percent of the amount calculated in culation error within 45 calendar days
paragraph (m)(1)(iii) of this section for of the issuance of the reconciliation re-
the performance year. The post-episode port, CMS responds in writing within
spending calculation amount in para- 30 calendar days to either confirm that
graph (m)(vi) of this section is not sub- there was an error in the calculation or
ject to the limitation on loss. verify that the calculation is correct,
(B) Limitation on gain. The total although CMS reserves the right to an
amount of the NPRA for a performance extension upon written notice to the
year cannot exceed 20 percent of the participant hospital.
amount calculated in paragraph (3) Only participant hospitals may
(m)(1)(iii) of this section for the per- use the dispute resolution process de-
formance year. The post-episode spend- scribed in this part.
ing calculation amount in paragraph
(4) Only participant hospitals may
(m)(vi) of this section are not subject
use the notice of calculation error
to the limitation on gain.
(C) Limitation on loss for certain pro- process described in this part.
viders. Financial loss limits for rural (b) Dispute resolution process (second
hospitals, SCHs, MDHs, and RRCs for level of appeal). (1) If the participant
performance years 6 through 8. If a par- hospital is dissatisfied with CMS’s re-
ticipant hospital is a rural hospital, sponse to the notice of a calculation
SCH, MDH, or RRC, the amount cannot error, the participant hospital may re-
exceed 5 percent of the amount cal- quest a reconsideration review in a
culated in paragraph (m)(1)(iii) of this form and manner as specified by CMS.
section. (2) The reconsideration review re-
(2) [Reserved] quest must provide a detailed expla-
nation of the basis for the dispute and
FR 11451, Mar. 4, 2016; 82 FR 613, Jan. 3, 2017; include supporting documentation for
82 FR 57104, Dec. 1, 2017; 85 FR 19292, Apr. 6, the participant hospital’s assertion
2020; 85 FR 71199, Nov. 6, 2020; 86 FR 23572, that CMS or its representatives did not
May 3, 2021] accurately calculate the NPRA, the
EDITORIAL NOTE: At 86 FR 23572, May 3, reconciliation payment, or the repay-
2021, § 510.305 was amended in part by revising ment amount in accordance with
paragraph (i); however, the amendment could § 510.305.
985
§ 510.315 42 CFR Ch. IV (10–1–24 Edition)
(3) If CMS does not receive a request (e) Limitations on review. In accord-
for reconsideration from the partici- ance with section 1115A(d)(2) of the
pant hospital within 10 calendar days Act, there is no administrative or judi-
of the issue date of CMS’s response to cial review under sections 1869 or 1878
the participant hospital’s notice of cal- of the Act or otherwise for the fol-
culation error, then CMS’s response to lowing:
the calculation error is deemed final (1) The selection of models for testing
and CMS proceeds with reconciliation or expansion under section 1115A of the
payment or repayment processes, as Act.
applicable, as described in § 510.305. (2) The selection of organizations,
(4) A CMS reconsideration official no- sites, or participants to test those
tifies the participant hospital in writ- models selected.
ing within 15 calendar days of receiving (3) The elements, parameters, scope,
the participant hospital’s review re- and duration of such models for testing
quest of the following: or dissemination.
(i) The issues in dispute. (4) Determinations regarding budget
(ii) The review procedures. neutrality under section 1115A(b)(3) of
(iii) The procedures (including for- Act.
mat and deadlines) for submission of (5) The termination or modification
briefs and evidence. of the design and implementation of a
(5) The provisions at § 425.804(b), (c), model under section 1115A(b)(3)(B) of
and (e) of this chapter are applicable to Act.
reviews conducted in accordance with
(6) Decisions about expansion of the
the reconsideration review process for
duration and scope of a model under
CJR.
section 1115A(c) of the Act, including
(6) The CMS reconsideration official
the determination that a model is not
makes all reasonable efforts to issue a
expected to meet criteria described in
written determination within 30 days
section 1115A(c)(1) or (2) of the Act.
of the deadline for submission of briefs
and evidence. The determination is [80 FR 73540, Nov. 24, 2015, as amended at 82
final and binding. FR 615, Jan. 3, 2017; 86 FR 23573, May 3, 2021]
(c) Exception to the process. If the par-
ticipant hospital contests a matter § 510.315 Composite quality scores for
that does not involve an issue con- determining reconciliation payment
eligibility and quality incentive
tained in, or a calculation that contrib- payments.
utes to, a CJR reconciliation report, a
notice of calculation error is not re- (a) General. A participant hospital’s
quired. In these instances, if CMS does eligibility for a reconciliation payment
not receive a request for reconsider- under § 510.305(g), and the determina-
ation from the participant hospital tion of quality incentive payments
within 10 calendar days of the notice of under paragraph (f) of this section, for
the initial determination, the initial a performance year or performance
determination is deemed final and CMS year subset depend on the hospital’s
proceeds with action indicated in the composite quality score (including any
initial determination. This does not quality performance points and quality
apply to the limitations on review in improvement points earned) for that
paragraph (e) of this section. performance year or performance year
(d) Notice of a participant hospital’s subset.
termination from the CJR model. If a par- (b) Composite quality score. CMS cal-
ticipant hospital receives notification culates a composite quality score for
that it has been terminated from the each participant hospital for each per-
CJR model, it must provide a written formance year or performance year
notice to CMS requesting review of the subset which equals the sum of the fol-
termination within 10 calendar days of lowing:
the notice. CMS has 30 days to respond (1) The hospital’s quality perform-
to the participant hospital’s request ance points for the hospital-level risk-
for review. If the participant hospital standardized complication rate fol-
fails to notify CMS, the termination is lowing elective primary total hip
deemed final. arthroplasty and/or total knee
986
arthroplasty measure (NQF #1550) de- based on the following performance

scribed in § 510.400(a)(1). This measure percentile scale:
is weighted at 50 percent of the com- (i) 8.00 points for ≥90th.
posite quality score. (ii) 7.40 points for ≥80th and <90th.
(2) The hospital’s quality perform- (iii) 6.80 points for ≥70th and <80th.
ance points for the Hospital Consumer (iv) 6.20 points for ≥60th and <70th.
Assessment of Healthcare Providers
(v) 5.60 points for ≥50th and <60th.
and Systems Survey measure (NQF
(vi) 5.00 points for ≥40th and <50th.
#0166) described in § 510.400(a)(2). This
measure is weighted at 40 percent of (vii) 4.40 points for ≥30th and <40th.
the composite quality score. (viii) 0.0 points for <30th.
(3) Any additional quality improve- (d) Quality improvement points. (1) For
ment points the hospital may earn as a performance year 1, if a participant
result of demonstrating improvement hospital’s quality performance per-
on either or both of the quality meas- centile on an individual measure de-
ures in paragraphs (b)(1) and (2) of this scribed in § 510.400(a) increases from the
section, as described in paragraph (d) of corresponding time period in the pre-
this section. vious year by at least 2 deciles on the
(4) If applicable, 2 additional points performance percentile scale, then the
for successful THA/TKA voluntary data hospitals is eligible to receive quality
submission of patient-reported out- improvement points equal to 10 percent
comes and limited risk variable data, of the total available point for that in-
as described in § 510.400(b). Successful dividual measure up to a maximum
submission is weighted at 10 percent of composite quality score of 20 points.
the composite quality score. (2) For each of performance years 2
(c) Quality performance points. CMS through 4, each of performance year
computes quality performance points subsets 5.1 and 5.2, and each of perform-
for each quality measure based on the ance years 6 through 8, if a participant
participant hospital’s performance rel- hospital’s quality performance per-
ative to the distribution of perform- centile on an individual measure de-
ance of all subsection (d) hospitals that scribed in § 510.400(a) increases from the
are eligible for payment under IPPS previous performance year or perform-
and meet the minimum patient case or ance year subset by at least 2 deciles
survey count for that measure. on the performance percentile scale,
(1) For the hospital-level risk-stand- then the hospital is eligible to receive
ardized complication rate following quality improvement points equal to 10
elective primary total hip arthroplasty percent of the total available point for
and/or total knee arthroplasty measure
that individual measure up to a max-
(NQF #1550) described in § 510.400(a)(1),
imum composite quality score of 20
CMS assigns the participant hospital
points.
measure value to a performance per-
centile and then quality performance (e) Exception for hospitals without a
points are assigned based on the fol- measure value. In the case of a partici-
lowing performance percentile scale: pant hospital without a measure value
(i) 10.00 points for ≥90th. that would allow CMS to assign quality
(ii) 9.25 points for ≥80th and <90th. performance points for that quality
(iii) 8.50 points for ≥70th and <80th; measure, CMS assigns the 50th per-
(iv) 7.75 points for ≥60th and <70th. centile quality performance points to
(v) 7.00 points for ≥50th and <60th. the hospital for the individual meas-
(vi) 6.25 points for ≥40th and <50th. ure.
(vii) 5.50 points for ≥30th and <40th. (1) A participant hospital will not
(viii) 0.0 points for <30th. have a measure value for the—
(2) For the Hospital Consumer As- (i) Hospital-level risk-standardized
sessment of Healthcare Providers and complication rate following elective
Systems Survey measure (NQF #0166) primary total hip arthroplasty and/or
described in § 510.400(a)(2), CMS assigns total knee arthroplasty measure (NQF
the participant hospital measure value #1550) described in § 510.400(a)(1) if the
to a performance percentile and qual- hospital does not meet the minimum 25
ity performance points are assigned case count; or
987
§ 510.320 42 CFR Ch. IV (10–1–24 Edition)
(ii) Hospital Consumer Assessment of § 510.320 Treatment of incentive pro-

Healthcare Providers and Systems Sur- grams or add-on payments under
vey measure (NQF #0166) described in existing Medicare payment systems.
§ 510.400(a)(2) if the hospital does not The CJR model does not replace any
meet the minimum of 100 completed existing Medicare incentive programs
survey and does not have 4 consecutive or add-on payments. The target price
quarters of HCAHPS data. and NPRA for a participant hospital
(ii) For either of the measures de- are independent of, and do not affect,
scribed in paragraphs (e)(1) or (2) of any incentive programs or add-on pay-
this section, if CMS identifies an error ments under existing Medicare pay-
in the data used to calculate the meas- ment systems.
ure and suppresses the measure value. § 510.325 Allocation of payments for
(f) Quality incentive payments. CMS services that straddle the episode.
provides incentive payments to partici-
(a) General. Services included in the
pant hospitals that demonstrate good episode that straddle the episode are
or excellent quality performance on prorated so that only the portion at-
the composite quality scores described tributable to care furnished during the
in paragraph (b) of this section. These episode are included in the calculation
incentive payments are implemented of actual episode payments.
in the form of the following reductions (b) Proration of services. Payments for
to the effective discount factors or ap- services that straddle the episode are
plicable discount factors described in prorated using the following method-
§ 510.300(c): ology:
(1) Performance years 1 through 5. For (1) Non-IPPS inpatient services and
performance years 1 through 5— other inpatient services. Non-IPPS inpa-
(i) A 1.0 percentage point reduction tient services, and services furnished
to the effective discount factor or ap- by other inpatient providers that ex-
plicable discount factor for participant tend beyond the end of the episode are
hospitals with good quality perform- prorated according to the percentage of
ance, defined as composite quality the actual length of stay (in days) that
scores that are greater than or equal to falls within the episode.
(2) Home health agency services. Home
6.9 and less than or equal to 15.0; or
health services paid under the prospec-
(ii) A 1.5 percentage point reduction tive payment system in part 484, sub-
to the effective discount factor or ap- part E of this chapter are prorated ac-
plicable discount factor for participant cording to the percentage of days,
hospitals with excellent quality per- starting with the first billable service
formance, defined as composite quality date (‘‘start of care date’’) and through
scores that are greater than 15.0. and including the last billable service
(2) Performance years 6 through 8. For date, that occur during the episode.
performance years 6 through 8— This methodology is applied in the
(i) A 1.5-percentage point reduction same way if the home health services
to the effective discount factor or ap- begin (the start of care date) prior to
plicable discount factor for participant the start of the episode.
hospitals with good quality perform- (3) IPPS services. IPPS claim amounts
ance, defined as composite quality that extend beyond the end of the epi-
scores that are greater than or equal to sode are prorated according to the geo-
6.9 and less than or equal to 15.0; or metric mean length of stay, using the
(ii) A 3-percentage point reduction to following methodology:
the effective discount factor or applica- (i) The first day of the IPPS stay is
counted as 2 days.
ble discount factor for participant hos-
(ii) If the actual length of stay that
pitals with excellent quality perform-
occurred during the episode is equal to
ance, defined as composite quality or greater than the MS–DRG geometric
scores that are greater than 15.0. mean, the normal MS–DRG payment is
[80 FR 73540, Nov. 24, 2015, as amended at 82 fully allocated to the episode.
FR 615, Jan. 3, 2017; 85 FR 71201, Nov. 6, 2020; (iii) If the actual length of stay that
86 FR 23573, May 3, 2021] occurred during the episode is less than
988
the geometric mean, the normal MS– (i) Date of birth.

DRG payment amount is allocated to (ii) Race.
the episode based on the number of in- (iii) Ethnicity.
patient days that fall within the epi- (iv) Date of admission to anchor hos-
sode. pitalization.
(iv) If the full amount is not allo- (v) Date of eligible THA/TKA proce-
cated to the episode, any remainder dure.
amount is allocated to the post-episode (vi) Medicare Health Insurance Claim
spending calculation (defined in § 510.2). Number.
(vii) Body mass index.
Subpart E—Quality Measures, (viii) Use of chronic (≥90 day) nar-
Beneficiary Protections, and cotics.
Compliance Enforcement (ix) Total painful joint count.
(x) Quantified spinal pain.
§ 510.400 Quality measures and report- (xi) Single Item Health Literacy
ing. Screening (SILS2) questionnaire.
(a) Reporting of quality measures. The (2) Hospitals must also submit the
following quality measures are used for amount of requested THA/TKA patient-
public reporting, for determining reported outcomes data required for
whether a participant hospital is eligi- each performance year or performance
ble for reconciliation payments under year subset of the model in order to be
§ 510.305(g), and whether a participant considered successful in submitting
hospital is eligible for quality incen- voluntary data.
tive payments under § 510.315(f) in the (i) The amount of requested THA/
performance year or performance year TKA patient-reported outcomes data to
subset: submit, in order to be considered suc-
(1) Hospital-level risk-standardized cessful will increase each subsequent
complication rate following elective year of the model over the first 5 years
primary total hip arthroplasty and/or of the model (with the exception of per-
total knee arthroplasty. formance year subset 5.2, for which
(2) Hospital Consumer Assessment of CMS will request the same amount of
Healthcare Providers and Systems Sur- THA/TKA patient-reported outcomes
vey. data as performance year subset 5.1,
(b) Requirements for successful vol- updated to reflect the timeframe appli-
untary data submission of patient-re- cable to performance year subset 5.2).
ported outcomes and limited risk variable (ii) A phase-in approach that deter-
data. To be eligible to receive the addi- mines the amount of requested THA/
tional points added to the composite TKA patient-reported outcomes data to
quality score for successful voluntary submit over performance years 1
data submission of patient-reported through 4 and performance year subset
outcomes and limited risk variable 5.1 (with the exception of performance
data, as described in § 510.315(b)(4), par- year subset 5.2, for which CMS will re-
ticipant hospitals must submit the quest the same amount of THA/TKA
THA/TKA patient-reported outcome patient-reported outcomes as perform-
and limited risk variable data re- ance year subset 5.1, updated to reflect
quested by CMS related to the pre- and the timeframe applicable to perform-
post-operative periods for elective pri- ance year subset 5.2) of the model will
mary total hip and/or total knee be applied so that in year 1 successful
arthroplasty procedures. The data submission of data would mean CMS
must be submitted within 60 days of received all requested THA/TKA pa-
the end of the most recent performance tient-reported outcomes and limited
period and be accompanied by the pa- risk variable data on both of the fol-
tient-reported outcomes and limited lowing:
risk variable data (eleven elements fi- (A) Greater than or equal to 50 per-
nalized) as outlined in § 510.315(b)(4). cent of eligible procedures or greater
(1) For each eligible procedure all than or equal to 50 eligible patients
eleven risk variable data elements are during the data collection period.
required to be submitted. The eleven (B) Submission of requested THA/
risk variables are as follows: TKA PRO and limited risk variable
989
§ 510.400 42 CFR Ch. IV (10–1–24 Edition)
data is completed within 60 days of the or ≥200 procedures performed between

most recent performance period. July 1, 2019 and June 30, 2020, unless
(3) For years 1 through 5 of the model CMS requests a more limited data set,
an increasing amount of data is rein which case, submit all requested
quested by CMS for each performance data elements.
period as follows: (vi) Year 5 (subset 5.2, January 1,
(i) Year 1 (2016). Submit pre-operative 2021–September 30, 2021). Submit—
data on primary elective THA/TKA (A) Post-operative data on primary
procedures for ≥50% or ≥50 eligible pro- elective THA/TKA procedures for ≥80%
cedures performed between July 1, 2016 or ≥200 procedures performed between
and August 31, 2016, unless CMS re- July 1, 2019 and June 30, 2020; and
quests a more limited data set, in (B) Pre-operative data on primary
which case, submit all requested data elective THA/TKA procedures for ≥80%
elements. or ≥200 procedures performed between
(ii) Year 2 (2017). Submit— July 1, 2020 and June 30, 2021, unless
(A) Post-operative data on primary CMS requests a more limited data set,
elective THA/TKA procedures for ≥50% in which case, submit all requested
or ≥50 eligible procedures performed be- data elements.
tween July 1, 2016 through August 31, (4) For years 6 through 8 of the model
2016; and the following data are requested by
(B) Pre-operative data on primary CMS for each performance period as
elective THA/TKA procedures for ≥60% follows:
or ≥75 procedures performed between (i) Year 6 (October 1, 2021 to Decem-
September 1, 2016 through June 30, 2017, ber 31, 2022). Submit—
unless CMS requests a more limited (A) Post-operative data on primary
data set, in which case, submit all re- elective THA/TKA procedures for ≥80%
quested data elements. or ≥200 procedures performed between
(iii) Year 3 (2018). Submit— July 1, 2019 and June 30, 2020; and
(A) POST-operative data on primary (B) Pre-operative data on primary
elective THA/TKA procedures for ≥60% elective THA/TKA procedures for ≥80%
or ≥75 procedures performed between or ≥300 procedures performed between
September 1, 2016 and June 30, 2017; and July 1, 2021 and June 30, 2022.
(B) Pre-operative data on primary (ii) Year 7 (2023). Submit—
elective THA/TKA procedures for ≥70% (A) Post-operative data on primary
or ≥100 procedures performed between elective THA/TKA procedures for ≥80%
July 1, 2017 and June 30, 2018, unless or ≥300 procedures performed between
CMS requests a more limited data set, July 1, 2021 and June 30, 2022; and
in which case, submit all requested (B) Pre-operative data on primary
data elements. elective THA/TKA procedures for ≥85%
(iv) Year 4 (2019). Submit— or ≥400 procedures performed between
(A) Post-operative data on primary July 1, 2022 and June 30, 2023.
elective THA/TKA procedures for ≥70% (iii) Year 8 (2024). Submit—
or ≥100 procedures performed between (A) Post-operative data on primary
July 1, 2017 and June 30, 2018; and elective THA/TKA procedures for ≥85%
(B) Pre-operative data on primary or ≥400 procedures performed between
elective THA/TKA procedures for ≥80% July 1, 2022 and June 30, 2023; and
or ≥200 procedures performed between (B) Pre-operative data on primary
July 1, 2018 and June 30, 2019, unless elective THA/TKA procedures for ≥90%
CMS requests a more limited data set, or ≥500 procedures performed between
in which case, submit all requested July 1, 2023 and June 30, 2024.
data elements. (c) Public reporting. CMS—
(v) Year 5 (subset 5.1, January 1, 2020– (1) Makes the quality measurement
December 31, 2020). Submit— results calculated for the complication
(A) Post-operative data on primary and patient survey quality measures
elective THA/TKA procedures for ≥80% described in paragraph (a) of this sec-
or ≥200 procedures performed between tion for each participant hospital in
July 1, 2018 and June 30, 2019 and each performance year publicly avail-
(B) Pre-operative data on primary able on the CMS Web site in a form and
elective THA/TKA procedures for ≥80% manner as determined by CMS;
990
(2) Shares each participant hospital’s cation—(i) Notification to beneficiaries.

quality metrics with the hospital prior Each participant hospital must provide
to display on the Web site; and written notification to any Medicare
(3) Does not publicly report the vol- beneficiary that meets the criteria in
untary patient-reported outcomes and § 510.205 of his or her inclusion in the
limited risk variable data during this CJR model.
model, but indicates whether a hospital (ii) Timing of notification. Prior to dis-
has successfully submitted such data in charge from the anchor hospitaliza-
accordance with § 510.400(b). tion, or prior to discharge from the an-
[80 FR 73540, Nov. 24, 2015, as amended at 82 chor procedure, as applicable, the par-
FR 615, Jan. 3, 2017; 85 FR 71201, Nov. 6, 2020; ticipant hospital must provide the CJR
86 FR 23574, May 3, 2021; 86 FR 36229, July 9, beneficiary with a participant hospital
2021] beneficiary notification as described in
paragraph (b)(1)(iv) of this section.
§ 510.405 Beneficiary choice and bene-
ficiary notification. (iii) List of beneficaries receiving a noti-
fication. The participant hospital must
(a) Beneficiary choice. The CJR model be able to generate a list of all bene-
does not restrict Medicare beneficiaries receiving such notification,
ficiaries’ ability to choose any Medi- including the date on which the notifi-
care enrolled provider or supplier, or cation was provided to the beneficiary,
any physician or practitioner who has to CMS or its designee upon request.
opted out of Medicare. (iv) Content of notification. The bene-
(1) As part of discharge planning and ficiary notification must contain all of
referral, participant hospitals must the following:
provide a complete list of HHAs, SNFs,
(A) A detailed explanation of the
IRFs, or LTCHs that are participating
model and how it might be expected to
in the Medicare program, and that
affect the beneficiary’s care.
serve the geographic area (as defined
by the HHA) in which the patient re- (B) Notification that the beneficiary
sides, or in the case of a SNF, IRF, or retains freedom of choice to choose
LTCH, in the geographic area re- providers and services.
quested by the patient. (C) Explanation of how patients can
(i) This list must be presented to CJR access care records and claims data
beneficiaries for whom home health through an available patient portal,
care, SNF, IRF, or LTCH services are and how they can share access to their
medically necessary. Blue Button® electronic health infor-
(ii) Participant hospitals must speci- mation with caregivers.
fy on the list those post-acute care pro- (D) A statement that all existing
viders on the list with whom they have Medicare beneficiary protections con-
a sharing arrangement. tinue to be available to the bene-
(iii) Participant hospitals may rec- ficiary. These include the ability to re-
ommend preferred providers and support concerns of substandard care to
pliers, consistent with applicable stat- Quality Improvement Organizations or
utes and regulations. the 1–800–MEDICARE helpline.
(iv) Participant hospitals may not (E) A list of the providers, suppliers,
limit beneficiary choice to any list of and ACOs with whom the CJR partici-
providers or suppliers in any manner pant hospital has a sharing arrange-
other than that permitted under appli- ment. This requirement may be ful-
cable statutes and regulations. filled by the participant hospital in-
(v) Participant hospitals must take cluding in the detailed notification a
into account patient and family pref- Web address where beneficiaries may
erences when they are expressed. access the list.
(2) Participant hospitals may not (2) CJR collaborator notice. A partici-
charge any CJR collaborator a fee to be pant hospital must require every CJR
included on any list of preferred pro- collaborator to provide written notice
viders or suppliers, nor may the partic- to applicable CJR beneficiaries of the
ipant hospital accept such payments. structure of the CJR model and the ex-
(b) Required beneficiary notification— istence of its sharing arrangement with
(1) Participant hospital beneficiary notifi- the participant hospital.
991
§ 510.405 42 CFR Ch. IV (10–1–24 Edition)
(i) With the exception of ACOs, PGPs, CJR episode to provide written notice
NPPGPs, and TGPs, a CJR participant to the beneficiary of the structure of
hospital must require every CJR col- the model and the existence of the en-
laborator that furnishes an item or tity’s sharing arrangement. The notice
service to a CJR beneficiary during a must be provided no later than the
CJR episode to provide written notice time at which the beneficiary first re-
to the beneficiary of the structure of ceives an item or service from any ACO
the model and the existence of the in- participant or ACO provider/supplier
dividual’s or entity’s sharing arrange- and the required ACO notice may be
ment. The notice must be provided no provided by that ACO participant or
later than the time at which the bene- ACO provider/supplier respectively. In
ficiary first receives an item or service circumstances where, due to the pa-
from the CJR collaborator during a tient’s condition, it is not feasible to
CJR episode. In circumstances where, provide notice at such times, the no-
due to the patient’s condition, it is not tice must be provided to the bene-
feasible to provide notification at such ficiary or his or her representative as
time, the notification must be provided soon as is reasonably practicable. The
to the beneficiary or his or her rep- ACO must be able to generate a list of
resentative as soon as is reasonably all beneficiaries who received such a
practicable. The CJR collaborator notice, including the date on which the
must be able to generate a list of all notice was provided to the beneficiary,
beneficiaries who received such a no- to CMS upon request.
tice, including the date on which the
(3) Discharge planning notice. A par-
notice was provided to the beneficiary,
ticipant hospital must provide the ben-
to CMS upon request.
eficiary with a written notice of any
(ii) A participant hospital must re-
potential financial liability associated
quire every PGP, NPPGP, or TGP that
with non-covered services rec-
is a CJR collaborator where a member
ommended or presented as an option as
of the PGP, member of the NPPGP, or
part of discharge planning, no later
member of the TGP furnishes an item
than the time that the beneficiary dis-
or service to a CJR beneficiary during
cusses a particular post-acute care op-
a CJR episode to provide written notice
to the beneficiary of the structure of tion or at the time the beneficiary is
the model and the existence of the en- discharged from an anchor procedure
tity’s sharing arrangement. The notice or anchor hospitalization, whichever
must be provided no later than the occurs earlier.
time at which the beneficiary first re- (i) If the participant hospital knows
ceives an item or service from any or should have known that the bene-
member of the PGP, member of the ficiary is considering or has decided to
NPPGP, or member of the TGP, and receive a non-covered post-acute care
the required PGP, NPPGP, or TGP no- service or other non-covered associated
tice may be provided by that member service or supply, the participant hos-
respectively. In circumstances where, pital must notify the beneficiary that
due to the patient’s condition, it is not the service would not be covered by
feasible to provide notice at such Medicare.
times, the notice must be provided to (ii) If the participant hospital is dis-
the beneficiary or his or her represent- charging a beneficiary to a SNF prior
ative as soon as is reasonably prac- to the occurrence of a 3-day hospital
ticable. The PGP, NPPGP, or TGP stay, and the beneficiary is being
must be able to generate a list of all transferred to or is considering a SNF
beneficiaries who received such a no- that would not qualify under the SNF
tice, including the date on which the 3-day waiver in § 510.610, the partici-
notice was provided to the beneficiary, pant hospital must notify the bene-
to CMS upon request. ficiary in accordance with paragraph
(iii) A participant hospital must re- (b)(3)(i) of this section that the bene-
quire every ACO that is a CJR collabo- ficiary will be responsible for payment
rator where an ACO participant or ACO for the services furnished by the SNF
provider/supplier furnishes an item or during that stay, except those services
service to a CJR beneficiary during a that would be covered by Medicare
992
Part B during a non-covered inpatient that is noncompliant with the require-

SNF stay. ments of this part.
(4) Access to records and retention. (iii) Takes any action that threatens
Lists of beneficiaries that receive noti- the health or safety of patients;
fications or notices must be retained, (iv) Avoids at-risk Medicare bene-
and access provided to CMS, or its des- ficiaries, as this term is defined in
ignees, in accordance with § 510.110. § 425.20;
[80 FR 73540, Nov. 24, 2015, as amended at 82 (v) Avoids patients on the basis of
FR 616, Jan. 3, 2017; 86 FR 23574, May 3, 2021] payer status;
(vi) Is subject to sanctions or final
§ 510.410 Compliance enforcement. actions of an accrediting organization
(a) General. Participant hospitals or federal, state, or local government
must comply with all of the require- agency that could lead to the inability
ments outlined in this part. Except as to comply with the requirements and
specifically noted in this part, the reg- provisions of this part;
ulations under this part must not be (vii) Takes any action that CMS de-
construed to affect the payment, cov- termines for program integrity reasons
erage, program integrity, or other re- is not in the best interests of the CJR
quirements (such as those in parts 412 model, or fails to take any action that
and 482 of this chapter) that apply to CMS determines for program integrity
providers and suppliers under this reasons should have been taken to fur-
chapter. ther the best interests of the CJR
(b) Failure to comply. (1) CMS may model;
take one or more of the remedial ac- (viii) Is subject to action by HHS (in-
tions set forth in paragraph (b)(2) of cluding OIG and CMS) or the Depart-
this section if a participant hospital or ment of Justice to redress an allega-
its related CJR collaborators, collabo- tion of fraud or significant misconduct,
ration agents, or downstream collabo- including intervening in a False Claims
ration agents— Act qui tam matter, issuing a pre-de-
(i) Fails to comply with any require- mand or demand letter under a civil
ments of this part or is identified as sanction authority, or similar actions;
noncompliant through monitoring by or
HHS (including CMS and OIG) of the (ix) Is subject to action involving
CJR model, including but not limited violations of the physician self-referral
to the following: law, civil monetary penalties law, fed-
(A) Avoiding potentially high cost eral anti-kickback statute, antitrust
patients. laws, or any other applicable Medicare
(B) Targeting potentially low cost laws, rules, or regulations that are rel-
patients. evant to the CJR model.
(C) Failing to provide medically ap-
(2) Remedial actions include the fol-
propriate services or systematically
lowing:
engaging in the over or under delivery
of appropriate care. (i) Issuing a warning letter to the
(D) Failing to provide beneficiaries participant hospital.
with complete and accurate informa- (ii) Requiring the participant hos-
tion, including required notices. pital to develop a corrective action
(E) Failing to allow beneficiary plan, commonly referred to as a CAP.
choice of medically necessary options, (iii) Reducing or eliminating a par-
including non-surgical options. ticipant hospital’s reconciliation pay-
(F) Failing to follow the requirement.
ments related to sharing arrange- (iv) Requiring a participant hospital
ments. to terminate a sharing arrangement
(G) Failing to participate in CJR with a CJR collaborator and prohib-
model-related evaluation activities iting further engagement in sharing ar-
conducted by CMS or its contractors or rangements with the participant hos-
both. pital by that CJR collaborator.
(ii) Has signed a sharing arrange- (v) Terminating the participant hos-
ment, distribution arrangement, or pital’s participation in the CJR model.
downstream distribution arrangement Where a participant is terminated from
993
§ 510.500 42 CFR Ch. IV (10–1–24 Edition)
the CJR model, the participant hos- stream collaboration agent. A selec-
pital will remain liable for all negative tion criterion that considers whether a
NPRA generated from episodes of care potential CJR collaborator has per-
that ended prior to termination. formed a reasonable minimum number
(3) CMS may add a 25 percent penalty of services that would qualify as CJR
to a repayment amount on the partici- activities will be deemed not to violate
pant hospital’s reconciliation report if the volume or value standard if the
all of the following conditions are met: purpose of the criterion is to ensure
(i) CMS has required a corrective ac- the quality of care furnished to CJR
tion plan from a participant hospital; beneficiaries.
(ii) The participant hospital owes a (4) If a participant hospital enters
repayment amount to CMS; and into a sharing arrangement, its compli-
(iii) The participant hospital fails to ance program must include oversight
timely comply with the corrective ac- of sharing arrangements and compli-
tion plan or is noncompliant with the ance with the applicable requirements
CJR model’s requirements. of the CJR model.
(b) Requirements. (1) A sharing ar-
rangement must be in writing and
FR 617, Jan. 3, 2017; 82 FR 57104, Dec. 1, 2017]
signed by the parties, and entered into
before care is furnished to CJR bene-
Subpart F—Financial Arrange- ficiaries under the sharing arrange-
ments and Beneficiary Incen- ment.
tives (2) Participation in a sharing ar-
rangement must be voluntary and
§ 510.500 Sharing arrangements under without penalty for nonparticipation.
the CJR model. (3) The sharing arrangement must re-
(a) General. (1) A participant hospital quire the CJR collaborator and its em-
may enter into a sharing arrangement ployees, contractors (including collabo-
with a CJR collaborator to make a ration agents), and subcontractors (in-
gainsharing payment, or to receive an cluding downstream collaboration
alignment payment, or both. A partici- agents) to comply with all of the fol-
pant hospital must not make a lowing:
gainsharing payment or receive an (i) The applicable provisions of this
alignment payment except in accord- part (including requirements regarding
ance with a sharing arrangement. beneficiary notifications, access to
(2) A sharing arrangement must com- records, record retention, and partici-
ply with the provisions of this section pation in any evaluation, monitoring,
and all other applicable laws and regu- compliance, and enforcement activities
lations, including the applicable fraud performed by CMS or its designees).
and abuse laws and all applicable pay- (ii) All applicable Medicare provider
ment and coverage requirements. enrollment requirements at § 424.500 of
(3) Participant hospitals must de- this chapter, including having a valid
velop, maintain, and use a set of writ- and active TIN or NPI, during the term
ten policies for selecting individuals of the sharing arrangement.
and entities to be CJR collaborators. (iii) All other applicable laws and
These policies must contain criteria re- regulations.
lated to, and inclusive of, the quality (4) The sharing arrangement must re-
of care delivered by the potential CJR quire the CJR collaborator to have or
collaborator. The selection criteria be covered by a compliance program
cannot be based directly or indirectly that includes oversight of the sharing
on the volume or value of past or an- arrangement and compliance with the
ticipated referrals or business other- requirements of the CJR model that
wise generated by, between or among apply to its role as a CJR collaborator,
the participant hospital, any CJR col- including any distribution arrange-
laborator, any collaboration agent, any ments.
downstream collaboration agent, or (5) The sharing arrangement must
any individual or entity affiliated with not pose a risk to beneficiary access,
a participant hospital, CJR collabo- beneficiary freedom of choice, or qual-
rator, collaboration agent, or down- ity of care.
994
(6) The board or other governing body (iv) Be clearly identified as a

of the participant hospital must have gainsharing payment at the time it is
responsibility for overseeing the par- paid.
ticipant hospital’s participation in the (2)(i) To be eligible to receive a
CJR model, its arrangements with CJR gainsharing payment, a CJR collabo-
collaborators, its payment of rator must meet quality of care cri-
gainsharing payments, its receipt of teria for the performance year for
alignment payments, and its use of which the participant hospital accrued
beneficiary incentives in the CJR the internal cost savings or earned the
model. reconciliation payment that comprises
(7) The written agreement memori- the gainsharing payment. The quality
alizing a sharing arrangement must of care criteria must be established by
specify the following:
the participant hospital and directly
(i) The purpose and scope of the shar-
related to the CJR episode.
ing arrangement.
(ii) The obligations of the parties, in- (ii) To be eligible to receive a
cluding specified CJR activities and gainsharing payment, or to be required
other services to be performed by the to make an alignment payment, a CJR
parties under the sharing arrangement. collaborator other than ACO, PGP,
(iii) The date of the sharing arrange- NPPGP, or TGP must have directly
ment. furnished a billable item or service to a
(iv) The financial or economic terms CJR beneficiary during a CJR episode
for payment, including the following: that occurred in the same performance
(A) Eligibility criteria for a year for which the participant hospital
gainsharing payment. accrued the internal cost savings or
(B) Eligibility criteria for an align- earned the reconciliation payment that
ment payment. comprises the gainsharing payment or
(C) Frequency of gainsharing or was assessed a repayment amount.
alignment payment. (iii) To be eligible to receive a
(D) Methodology and accounting for- gainsharing payment, or to be required
mula for determining the amount of a to make an alignment payment, a CJR
gainsharing payment or alignment collaborator that is a PGP, NPPGP, or
payment. TGP must meet the following criteria:
(8) The sharing arrangement must (A) The PGP, NPPGP, or TGP must
not— have billed for an item or service that
(i) Induce the participant hospital, was rendered by one or more PGP
CJR collaborator, or any employees, member, NPPGP member, or TGP
contractors, or subcontractors of the member respectively to a CJR bene-
participant hospital or CJR collabo-
ficiary during a CJR episode that oc-
rator to reduce or limit medically nec-
curred during the same performance
essary services to any Medicare bene-
year for which the participant hospital
ficiary; or
(ii) Restrict the ability of a CJR col- accrued the internal cost savings or
laborator to make decisions in the best earned the reconciliation payment that
interests of its patients, including the comprises the gainsharing payment or
selection of devices, supplies, and was assessed a repayment amount.
treatments. (B) The PGP, NPPGP, or TGP must
(c) Gainsharing payment, alignment have contributed to CJR activities and
payment, and internal cost savings condi- been clinically involved in the care of
tions and restrictions. (1) Gainsharing CJR beneficiaries during the same per-
payments, if any, must— formance year for which the CJR par-
(i) Be derived solely from reconcili- ticipant hospital accrued the internal
ation payments, or internal cost sav- cost savings or earned the reconcili-
ings, or both; ation payment that comprises the
(ii) Be distributed on an annual basis gainsharing payment or was assessed a
(not more than once per calendar year); repayment amount. For example, a
(iii) Not be a loan, advance payment, PGP, NPPGP, or TGP might have been
or payment for referrals or other busi- clinically involved in the care of CJR
ness; and beneficiaries by—
995
§ 510.500 42 CFR Ch. IV (10–1–24 Edition)
(1) Providing care coordination serv- pants, ACO providers/suppliers, the

ices to beneficiaries during and/or after participant hospital, and post-acute
inpatient admission; care providers), implementing strate-
(2) Engaging with a participant hos- gies designed to address and manage
pital in care redesign strategies, and the comorbidities of CJR beneficiaries.
actually performing a role in imple- (3)(i) The methodology for accruing,
menting such strategies, that are de- calculating and verifying internal cost
signed to improve the quality of care savings must be transparent, measur-
for CJR episodes and reduce CJR epi- able, and verifiable in accordance with
sode spending; or generally accepted accounting prin-
(3) In coordination with other pro- ciples (GAAP) and Government Audit-
viders and suppliers (such as PGP ing Standards (The Yellow Book).
members, NPPGP members, or TGP (ii) The methodology used to cal-
members; the participant hospital; and culate internal cost savings must re-
post-acute care providers), imple- flect the actual, internal cost savings
menting strategies designed to address achieved by the participant hospital
and manage the comorbidities of CJR through the documented implementa-
beneficiaries. tion of CJR activities identified by the
(iv) To be eligible to receive a participant hospital and must ex-
gainsharing payment, or to be required clude—
to make an alignment payment, a CJR (A) Any savings realized by any indi-
collaborator that is an ACO must meet vidual or entity that is not the partici-
the following criteria: pant hospital; and
(A) The ACO must have had an ACO (B) ‘‘Paper’’ savings from accounting
provider/supplier that directly fur- conventions or past investment in fixed
nished, or an ACO participant that costs.
billed for, an item or service that was (4) The total amount of a gainsharing
rendered to a CJR beneficiary during a payment for a performance year paid
CJR episode that occurred during the to a CJR collaborator must not exceed
same performance year for which the the following:
participant hospital accrued the inter- (i) For episodes beginning on or after
nal cost savings or earned the rec- April 1, 2016 and ending on or before
onciliation payment that comprises September 30, 2021, in the case of a CJR
the gainsharing payment or was as- collaborator who is a physician or non-
sessed a repayment amount; and physician practitioner, 50 percent of
(B) The ACO must have contributed the Medicare-approved amounts under
to CJR activities and been clinically the PFS for items and services fur-
involved in the care of CJR bene- nished by that physician or non-physi-
ficiaries during the same performance cian practitioner to the participant
year for which the participant hospital hospital’s CJR beneficiaries during
accrued the internal cost savings or CJR model episodes that occurred dur-
earned the reconciliation payment that ing the same performance year for
comprises the gainsharing payment or which the participant hospital accrued
was assessed the repayment amount. the internal cost savings or earned the
For example, an ACO might be have reconciliation payment that comprises
been clinically involved in the care of the gainsharing payment being made.
CJR beneficiaries by— (ii) For episodes beginning on or after
(1) Providing care coordination serv- April 1, 2016 and ending on or before
ices to CJR beneficiaries during and/or September 30, 2021, in the case of a CJR
after inpatient admission; collaborator that is a PGP or NPPGP,
(2) Engaging with a participant hos- 50 percent of the Medicare-approved
pital in care redesign strategies, and amounts under the PFS for items and
actually performing a role in imple- services billed by that PGP or NPPGP
menting such strategies, that are de- and furnished to the participant hos-
signed to improve the quality of care pital’s CJR beneficiaries by the PGP
and reduce spending for CJR episodes; members or NPPGP members respec-
or tively during CJR model episodes that
(3) In coordination with providers occurred during the same performance
and suppliers (such as ACO partici- year for which the participant hospital
996
accrued the internal cost savings or ment amount reflected in a reconcili-

earned the reconciliation payment that ation report;
comprises the gainsharing payment (ii) Loans, advance payments, or pay-
being made. ments for referrals or other business;
(5) The amount of any gainsharing or
payments must be determined in ac- (iii) Assessed by a participant hos-
cordance with a methodology that is pital if it does not owe a repayment
substantially based on quality of care amount.
and the provision of CJR activities.
(11) The participant hospital must
The methodology may take into ac-
not receive any amounts under a shar-
count the amount of such CJR activi-
ties provided by a CJR collaborator rel- ing arrangement from a CJR collabo-
ative to other CJR collaborators. rator that are not alignment pay-
(6) For a performance year, the ag- ments.
gregate amount of all gainsharing pay- (12) For a performance year, the ag-
ments that are derived from a rec- gregate amount of all alignment pay-
onciliation payment the CJR partici- ments received by the participant hos-
pant hospital receives from CMS must pital must not exceed 50 percent of the
not exceed the amount of that rec- participant hospital’s repayment
onciliation payment. amount.
(7) No entity or individual, whether a (13) The aggregate amount of all
party to a sharing arrangement or not, alignment payments from a CJR col-
may condition the opportunity to laborator to the participant hospital
make or receive gainsharing payments may not be greater than—
or to make or receive alignment pay- (i) With respect to a CJR collabo-
ments directly or indirectly on the vol- rator other than an ACO, 25 percent of
ume or value of past or anticipated re- the participant hospital’s repayment
ferrals or business otherwise generated amount.
by, between or among the participant
(ii) With respect to a CJR collabo-
hospital, any CJR collaborator, any
collaboration agent, any downstream rator that is an ACO, 50 percent of the
collaboration agent, or any individual participant hospital’s repayment
or entity affiliated with a participant amount.
hospital, CJR collaborator, collabora- (14) The amount of any alignment
tion agent, or downstream collabora- payments must be determined in ac-
tion agent. cordance with a methodology that does
(8) A participant hospital must not not directly account for the volume or
make a gainsharing payment to a CJR value of past or anticipated referrals or
collaborator if CMS has notified the business otherwise generated by, be-
participant hospital that such collabo- tween or among the participant hos-
rator is subject to any action for non- pital, any CJR collaborator, any col-
compliance with this part or the fraud laboration agent, any downstream col-
and abuse laws, or for the provision of laboration agent, or any individual or
substandard care to CJR beneficiaries entity affiliated with a participant hos-
or other integrity problems. pital, CJR collaborator, collaboration
(9) The sharing arrangement must reagent, or downstream collaboration
quire the participant hospital to reagent.
coup any gainsharing payment that (15) All gainsharing payments and
contained funds derived from a CMS any alignment payments must be ad-
overpayment on a reconciliation report
ministered by the participant hospital
or was based on the submission of false
in accordance with generally accepted
or fraudulent data.
(10) Alignment payments from a CJR accounting principles (GAAP) and Gov-
collaborator to a participant hospital ernment Auditing Standards (The Yel-
may be made at any interval that is low Book).
agreed upon by both parties, and must (16) All gainsharing payments and
not be— alignment payments must be made by
(i) Issued, distributed, or paid prior check, electronic funds transfer, or an-
to the calculation by CMS of a repay- other traceable cash transaction.
997
§ 510.505 42 CFR Ch. IV (10–1–24 Edition)
(d) Documentation requirements. (1) umentation in accordance with

Participant hospitals must—(i) Docu- § 510.110.
ment the sharing arrangement contem-
[82 FR 617, Jan. 3, 2017, as amended at 86 FR
poraneously with the establishment of 23575, May 3, 2021]
the arrangement;
(ii) Publicly post (and update on at § 510.505 Distribution arrangements.
least a quarterly basis) on a Web page
on the CJR participant hospital’s Web (a) General. (1) An ACO, PGP,
site— NPPGP, or TGP that has entered into
(A) Accurate current and historical a sharing arrangement with a partici-
lists of all CJR collaborators, including pant hospital may distribute all or a
CJR collaborator names and addresses. portion of any gainsharing payment it
(B) Written policies for selecting in- receives from the participant hospital
dividuals and entities to be CJR col- only in accordance with a distribution
laborators required by § 510.500(a)(3). arrangement.
(iii) Maintain and require each CJR (2) All distribution arrangements
collaborator to maintain contempora- must comply with the provisions of
neous documentation with respect to this section and all other applicable
the payment or receipt of any laws and regulations, including the
gainsharing payment or alignment fraud and abuse laws.
payment that includes at a minimum: (b) Requirements. (1) All distribution
(A) Nature of the payment arrangements must be in writing and
(gainsharing payment or alignment signed by the parties, contain the date
payment); of the agreement, and be entered into
(B) Identity of the parties making before care is furnished to CJR bene-
and receiving the payment; ficiaries under the distribution ar-
(C) Date of the payment; rangement.
(D) Amount of the payment; (2) Participation in a distribution ar-
(E) Date and amount of any rangement must be voluntary and
recoupment of all or a portion of a CJR without penalty for nonparticipation.
collaborator’s gainsharing payment. (3) The distribution arrangement
(F) Explanation for each recoupment, must require the collaboration agent
such as whether the CJR collaborator to comply with all applicable laws and
received a gainsharing payment that regulations.
contained funds derived from a CMS (4) The opportunity to make or re-
overpayment on a reconciliation receive a distribution payment must not
port, or was based on the submission of be conditioned directly or indirectly on
false or fraudulent data. the volume or value of past or antici-
(2) The participant hospital must pated referrals or business otherwise
keep records of all of the following: generated by, between or among the
(i) Its process for determining and participant hospital, any CJR collabo-
verifying its potential and current CJR rator, any collaboration agent, any
collaborators’ eligibility to participate downstream collaboration agent, or
in Medicare. any individual or entity affiliated with
(ii) Its plan to track internal cost a participant hospital, CJR collabo-
savings. rator, collaboration agent, or down-
(iii) Information on the accounting stream collaboration agent.
systems used to track internal cost (5) The amount of any distribution
savings. payments from an ACO, from an
(iv) A description of current health NPPGP to an NPPGP member, or from
information technology, including sys- a TGP to a TGP member must be de-
tems to track reconciliation payments termined in accordance with a method-
and internal cost savings. ology that is substantially based on
(v) Its plan to track gainsharing pay- quality of care and the provision of
ments and alignment payments. CJR activities and that may take into
(3) The participant hospital must re- account the amount of such CJR ac-
tain and provide access to, and must tivities provided by a collaboration
require each CJR collaborator to retain agent relative to other collaboration
and provide access to, the required doc- agents.
998
(6) The amount of any distribution CJR model episodes that occurred dur-
payments from a PGP must be deter- ing the same performance year for
mined either in a manner that com- which the participant hospital accrued
plies with § 411.352(g) of this chapter or the internal cost savings or earned the
in accordance with a methodology that reconciliation payment that comprises
is substantially based on quality of the gainsharing payment being distrib-
care and the provision of CJR activi- uted.
ties and that may take into account (9) With respect to the distribution of
the amount of such CJR activities pro- any gainsharing payment received by
vided by a collaboration agent relative an ACO, PGP, NPPGP, or TGP, the
to other collaboration agents.
total amount of all distribution pay-
(7) Except for a distribution payment
ments must not exceed the amount of
from a PGP to a PGP member that
complies with § 411.352(g) of this chap- the gainsharing payment received by
ter, a collaboration agent is eligible to the CJR collaborator from the partici-
receive a distribution payment only if pant hospital.
the collaboration agent furnished or (10) All distribution payments must
billed for an item or service rendered be made by check, electronic funds
to a CJR beneficiary during a CJR epi- transfer, or another traceable cash
sode that occurred during the same transaction.
performance year for which the partici- (11) The collaboration agent must re-
pant hospital accrued the internal cost tain the ability to make decisions in
savings or earned the reconciliation the best interests of the patient, in-
payment that comprises the cluding the selection of devices, sup-
gainsharing payment being distributed. plies, and treatments.
(8) Except for a distribution payment (12) The distribution arrangement
from a PGP to a PGP member that must not—
complies with § 411.352(g) of this chap- (i) Induce the collaboration agent to
ter, the total amount of distribution reduce or limit medically necessary
payments for a performance year paid
items and services to any Medicare
to a collaboration agent must not ex-
beneficiary; or
ceed the following:
(i) For episodes beginning on or after (ii) Reward the provision of items
April 1, 2016 and ending on or before and services that are medically unnec-
September 30, 2021, in the case of a col- essary.
laboration agent that is a physician or (13) The CJR collaborator must main-
non-physician practitioner, 50 percent tain contemporaneous documentation
of the total Medicare-approved regarding distribution arrangements in
amounts under the PFS for items and accordance with § 510.110, including the
services furnished by the collaboration following:
agent to the participant hospital’s CJR (i) The relevant written agreements;
beneficiaries during CJR model epi- (ii) The date and amount of any dis-
sodes that occurred during the same tribution payment(s);
performance year for which the partici- (iii) The identity of each collabora-
pant hospital accrued the internal cost tion agent that received a distribution
savings or earned the reconciliation payment; and
payment that comprises the (iv) A description of the methodology
gainsharing payment being distributed.
and accounting formula for deter-
(ii) For episodes beginning on or after
mining the amount of any distribution
April 1, 2016 and ending on or before
September 30, 2021, in the case of a col- payment.
laboration agent that is a PGP or (14) The CJR collaborator may not
NPPGP, 50 percent of the total Medi- enter into a distribution arrangement
care-approved amounts under the PFS with any individual or entity that has
for items and services billed by that a sharing arrangement with the same
PGP or NPPGP for items and services participant hospital.
furnished by PGP members or NPPGP (15) The CJR collaborator must re-
member respectively to the participant tain and provide access to, and must
hospital’s CJR beneficiaries during require collaboration agents to retain
999
§ 510.506 42 CFR Ch. IV (10–1–24 Edition)
and provide access to, the required doc- amount of such CJR activities provided
umentation in accordance with by a downstream collaboration agent
§ 510.110. relative to other downstream collabo-
ration agents.
23575, May 3, 2021] (6) The amount of any downstream
distribution payments from a PGP
§ 510.506 Downstream distribution ar- must be determined either in a manner
rangements. that complies with § 411.352(g) of this
(a) General. (1) An ACO participant chapter or in accordance with a meth-
that is a PGP, NPPGP, or TGP and odology that is substantially based on
that has entered into a distribution ar- quality of care and the provision CJR
rangement with a CJR collaborator activities and that may take into ac-
that is an ACO may distribute all or a count the amount of such CJR activi-
portion of any distribution payment it ties provided by a downstream collabo-
receives from the CJR collaborator ration agent relative to other down-
only in accordance with downstream stream collaboration agents.
distribution arrangement. (7) Except for a downstream distribu-
(2) All downstream distribution ar- tion payment from a PGP to a PGP
rangements must comply with the pro- member that complies with § 411.352(g)
visions of this section and all applica- of this chapter, a downstream collabo-
ble laws and regulations, including the ration agent is eligible to receive a
fraud and abuse laws. downstream distribution payment only
(b) Requirements. (1) All downstream if the downstream collaboration agent
distribution arrangements must be in furnished an item or service by the
writing and signed by the parties, con- downstream collaboration agent to a
tain the date of the agreement, and be CJR beneficiary during a CJR episode
entered into before care is furnished to that occurred during the same perform-
CJR beneficiaries under the down- ance year for which the participant
stream distribution arrangement. hospital accrued the internal cost sav-
(2) Participation in a downstream ings or earned the reconciliation pay-
distribution arrangement must be vol- ment that comprises the gainsharing
untary and without penalty for nonpayment from which the ACO made the
participation. distribution payment to the PGP,
(3) The downstream distribution ar- NPPGP, or TGP that is an ACO partici-
rangement must require the down- pant.
stream collaboration agent to comply (8) Except for a downstream distribu-
with all applicable laws and regulation payment from a PGP to a PGP
tions. member that complies with § 411.352(g)
(4) The opportunity to make or re- of this chapter, for episodes beginning
ceive a downstream distribution pay- on or after April 1, 2016 and ending on
ment must not be conditioned directly or before September 30, 2021 the total
or indirectly on the volume or value of amount of downstream distribution
past or anticipated referrals or busi- payments for a performance year paid
ness otherwise generated by, between to a downstream collaboration agent
or among the participant hospital, any who is a physician or non-physician
CJR collaborator, any collaboration practitioner and is either a member of
agent, any downstream collaboration a PGP or a member of an NPPGP must
agent, or any individual or entity af- not exceed 50 percent of the total Medi-
filiated with a participant hospital, care-approved amounts under the PFS
CJR collaborator, collaboration agent, for items and services furnished by the
or downstream collaboration agent. downstream collaboration agent to the
(5) The amount of any downstream participant hospital’s CJR bene-
distribution payments from an NPPGP ficiaries during a CJR model episode
to an NPPGP member or from a TGP that occurred during the same perform-
to a TGP member must be determined ance year for which the participant
in accordance with a methodology that hospital accrued the internal cost sav-
is substantially based on quality of ings or earned the reconciliation pay-
care and the provision CJR activities ment that comprises the distribution
and that may take into account the payment being distributed.
1000
(9) The total amount of all down- § 510.510 Enforcement authority.

stream distribution payments made to
(a) OIG authority. OIG authority is
downstream collaboration agents must
not limited or restricted by the provi-
not exceed the amount of the distribu-
sions of the CJR model, including the
tion payment received by the PGP,
authority to audit, evaluate, inves-
NPPGP, or TGP from the ACO. tigate, or inspect the participant hos-
(10) All downstream distribution pay- pital, CJR collaborators, or any other
ments must be made by check, elec- person or entity or their records, data,
tronic funds transfer, or another trace- or information, without limitation.
able cash transaction. (b) Other authorities. None of the pro-
(11) The downstream collaboration visions of the CJR model limits or re-
agent must retain his or her ability to stricts the authority of any other gov-
make decisions in the best interests of ernment agency permitted by law to
the patient, including the selection of audit, evaluate, investigate, or inspect
devices, supplies, and treatments. the participant hospital, CJR collabo-
(12) The downstream distribution ar- rators, or any other person or entity or
rangement must not— their records, data, or information,
(i) Induce the downstream collabora- without limitation.
tion agent to reduce or limit medically
necessary services to any Medicare § 510.515 Beneficiary incentives under
beneficiary; or the CJR model.
(ii) Reward the provision of items (a) General. Participant hospitals
and services that are medically unnec- may choose to provide in-kind patient
essary. engagement incentives to beneficiaries
(13) The PGP, NPPGP, or TGP must in a CJR episode, subject to the fol-
maintain contemporaneous docu- lowing conditions:
mentation regarding downstream dis- (1) The incentive must be provided
tribution arrangements in accordance directly by the participant hospital or
with § 510.110, including the following: by an agent of the hospital under the
(i) The relevant written agreements. hospital’s direction and control to the
(ii) The date and amount of any beneficiary during a CJR episode of
downstream distribution payment. care.
(iii) The identity of each downstream (2) The item or service provided must
collaboration agent that received a be reasonably connected to medical
downstream distribution payment. care provided to a beneficiary during a
(iv) A description of the methodology CJR episode of care.
and accounting formula for deter- (3) The item or service must be a pre-
mining the amount of any downstream ventive care item or service or an item
distribution payment. or service that advances a clinical
goal, as listed in paragraph (c) of this
(14) The PGP, NPPGP, or TGP may
section, for a beneficiary in a CJR epi-
not enter into a downstream distribu-
sode by engaging the beneficiary in
tion arrangement with any PGP mem-
better managing his or her own health.
ber, NPPGP member, or TGP member
(4) The item or service must not be
who has—
tied to the receipt of items or services
(i) A sharing arrangement with a par-
outside the CJR episode of care.
ticipant hospital.
(5) The item or service must not be
(ii) A distribution arrangement with tied to the receipt of items or services
the ACO that the PGP, NPPGP, or TGP from a particular provider or supplier.
is a participant in.
(6) The availability of the items or
(15) The PGP, NPPGP, or TGP must services must not be advertised or pro-
retain and provide access to, and must moted except that a beneficiary may
require downstream collaboration be made aware of the availability of
agents to retain and provide access to, the items or services at the time the
the required documentation in accord- beneficiary could reasonably benefit
ance with § 510.110. from them.
[82 FR 621, Jan. 3, 2017, as amended at 86 FR (7) The cost of the items or services
23575, May 3, 2021] must not be shifted to another federal
1001
§ 510.600 42 CFR Ch. IV (10–1–24 Edition)
health care program, as defined at sec- poraneous documentation of any at-

tion 1128B(f) of the Act. tempt to retrieve technology at the
(b) Technology provided to a CJR bene- end of a CJR episode as described in
ficiary. Beneficiary engagement incen- paragraph (b)(3) of this section.
tives involving technology are subject (4) The CJR participant hospital
to the following additional conditions: must retain and provide access to the
(1) Items or services involving tech- required documentation in accordance
nology provided to a beneficiary may with § 510.110.
not exceed $1,000 in retail value for any [80 FR 73540, Nov. 24, 2015, as amended at 82
one beneficiary in any one CJR epi- FR 621, Jan. 3, 2017]
sode.
(2) Items or services involving tech- Subpart G—Waivers
nology provided to a beneficiary must
be the minimum necessary to advance § 510.600 Waiver of direct supervision
a clinical goal, as listed in paragraph requirement for certain post-dis-
(c) of this section, for a beneficiary in charge home visits.
a CJR episode. (a) General. CMS waives the require-
(3) Items of technology exceeding $100 ment in § 410.26(b)(5) of this chapter
in retail value must— that services and supplies furnished in-
(i) Remain the property of the CJR cident to a physician’s service must be
participant; and furnished under the direct supervision
(ii) Be retrieved from the beneficiary of the physician (or other practitioner)
at the end of the CJR episode. The par- to permit home visits as specified in
ticipant hospital must document all re- this section. The services furnished
trieval attempts, including the ulti- under this waiver are not considered to
mate date of retrieval. Documented, be ‘‘hospital services,’’ even when fur-
diligent, good faith attempts to re- nished by the clinical staff of the hos-
trieve items of technology will be pital.
deemed to meet the retrieval require- (b) General supervision of qualified per-
ment. sonnel. The waiver of the direct super-
(c) Clinical goals of the CJR model. The vision requirement in § 410.26(b)(5) of
following are the clinical goals of the this chapter applies only in the fol-
CJR model, which may be advanced lowing circumstances:
through beneficiary incentives: (1) The home visit is furnished during
(1) Beneficiary adherence to drug the episode to a beneficiary who has
regimens. been discharged from an anchor hos-
(2) Beneficiary adherence to a care pitalization or anchor procedure.
plan. (2) The home visit is furnished at the
(3) Reduction of readmissions and beneficiary’s home or place of resi-
complications resulting from LEJR dence.
procedures. (3) The beneficiary does not qualify
(4) Management of chronic diseases for home health services under sections
and conditions that may be affected by 1835(a) and 1814(a) of the Act at the
the LEJR procedure. time of any such home visit.
(d) Documentation of beneficiary incen- (4) The visit is furnished by clinical
tives. (1) Participant hospitals must staff under the general supervision of a
maintain documentation of items and physician or non-physician practi-
services furnished as beneficiary incen- tioner. Clinical staff are individuals
tives that exceed $25 in retail value. who work under the supervision of a
(2) The documentation must be estab- physician or other qualified health care
lished contemporaneously with the professional, and who are allowed by
provision of the items and services and law, regulation, and facility policy to
must include at least the following: perform or assist in the performance of
(i) The date the incentive is provided. a specific professional service, but do
(ii) The identity of the beneficiary to not individually report that profes-
whom the item or service was provided. sional service.
(3) The documentation regarding (5) No more than 9 visits are fur-
items of technology exceeding $100 in nished to the beneficiary during the
retail value must also include contem- episode.
1002
(c) Payment. Up to 9 post-discharge (d) Other requirements. All other re-

home visits per CJR episode may be quirements for Medicare coverage and
billed under Part B by the physician or payment of telehealth services con-
nonphysician practitioner or by the tinue to apply, including the list of
participant hospital to which the su- specific services approved to be fur-
pervising physician has reassigned his nished by telehealth.
or her billing rights. [80 FR 73540, Nov. 24, 2015, as amended at 82
(d) Other requirements. All other Medi- FR 57104, Dec. 1, 2017]
care rules for coverage and payment of
services incident to a physician’s serv- § 510.610 Waiver of SNF 3-day rule.
ice continue to apply. (a) Waiver of the SNF 3-day rule—(1)
[80 FR 73540, Nov. 24, 2015, as amended at 86 Performance year—(i) Performance years
FR 23575, May 3, 2021] 2 through 5. For episodes being tested
in performance years 2 through 5 of the
§ 510.605 Waiver of certain telehealth CJR model, CMS waives the SNF 3-day
requirements. rule for coverage of a SNF stay for a
(a) Waiver of the geographic site re- beneficiary who is a CJR beneficiary on
quirements. Except for the geographic the date of discharge from the anchor
site requirements for a face-to-face en- hospitalization, but only if the SNF is
counter for home health certification, identified on the applicable calendar
CMS waives the geographic site re- quarter list of qualified SNFs at the
quirements of section 1834(m)(4)(C)(i)(I) time of the CJR beneficiary’s admis-
through (III) of the Act for episodes sion to the SNF.
(ii) Performance years 6 through 8. (A)
being tested in the CJR model, but
For episodes being tested in perform-
only for services that—
ance years 6 through 8 of the CJR
(1) May be furnished via telehealth
model, CMS waives the SNF 3-day rule
under existing requirements; and for coverage of a SNF stay within 30
(2) Are included in the episode in ac- days of the date of discharge from the
cordance with § 510.200(b). anchor hospitalization for a bene-
(b) Waiver of the originating site re- ficiary who is a CJR beneficiary on the
quirements. Except for the originating date of discharge from the anchor hos-
site requirements for a face-to-face en- pitalization, but only if the SNF is
counter for home health certification, identified on the applicable calendar
CMS waives the originating site re- quarter list of qualified SNFs at the
quirements under section time of the CJR beneficiary’s admis-
1834(m)(4)(C)(ii)(I) through (VIII) of the sion to the SNF.
Act for episodes being tested in the (B) For episodes being tested in per-
CJR model to permit a telehealth visit formance years 6 through 8 of the CJR
to originate in the beneficiary’s home model, CMS waives the SNF 3-day rule
or place of residence, but only for serv- for coverage of a SNF stay within 30
ices that— days of the date of service of the an-
(1) May be furnished via telehealth chor procedure for a beneficiary who is
under existing requirements; and a CJR beneficiary on the date of serv-
(2) Are included in the CJR episode in ice of the anchor procedure, but only if
accordance with § 510.200(b). the SNF is identified on the applicable
(c) Waiver of selected payment provi- calendar quarter list of qualified SNFs
sions. (1) CMS waives the payment re- at the time of the CJR beneficiary’s ad-
quirements under section 1834(m)(2)(A) mission to the SNF.
so that the facility fee normally paid (2) Determination of qualified SNFs.
by Medicare to an originating site for a CMS determines the qualified SNFs for
telehealth service is not paid if the each calendar quarter based on a re-
service is originated in the bene- view of the most recent rolling 12
ficiary’s home or place of residence. months of overall star ratings on the
(2) CMS waives the payment require- Five-Star Quality Rating System for
ments under section 1834(m)(2)(B) of SNFs on the Nursing Home Compare
the Act to allow the distant site pay- website. Qualified SNFs are rated an
ment for telehealth home visit HCPCS overall of 3 stars or better for at least
codes unique to this model. 7 of the 12 months.
1003
§ 510.615 42 CFR Ch. IV (10–1–24 Edition)
(3) Posting of qualified SNFs. CMS home visits described under § 510.600,
posts to the CMS website the list of including those related to recovery
qualified SNFs in advance of the cal- from the surgery, as described in para-
endar quarter. graph (b) of this section, for episodes
(b) Financial liability for non-covered being tested in the CJR model.
SNF services. If CMS determines that (b) Services to which the waiver applies.
the waiver requirements specified in Up to 9 post-discharge home visits, in-
paragraph (a) of this section were not cluding those related to recovery from
met, the following apply: the surgery, per CJR episode may be
(1) CMS makes no payment to a SNF billed separately under Part B by the
for SNF services if the SNF admits a physician or nonphysician practitioner,
CJR beneficiary who has not had a or by the participant hospital to which
qualifying inpatient stay or anchor the physician or nonphysician practi-
procedure. tioner has reassigned his or her billing
(2) In the event that CMS makes no rights.
payment for SNF services furnished by (c) Other requirements. All other Medi-
a SNF as a result of paragraph (b)(1) of care rules for global surgery billing
this section, the beneficiary protec- during the 90-day post-operative period
tions specified in paragraph (b)(3) of continue to apply.
this section apply, unless the partici-
pant hospital has provided the bene- § 510.620 Waiver of deductible and co-
insurance that otherwise apply to
ficiary with a discharge planning no- reconciliation payments or repay-
tice in accordance with § 510.405(b)(3). ments.
(3) If the participant hospital does
not provide the beneficiary with a dis- (a) Waiver of deductible and coinsur-
charge planning notice in accordance ance. CMS waives the requirements of
with § 510.405(b)(3)— sections 1813 and 1833(a) of the Act for
(i) The SNF must not charge the ben- Medicare Part A and Part B payment
eficiary for the expenses incurred for systems only to the extent necessary
such services; to make reconciliation payments or re-
(ii) The SNF must return to the bene- ceive repayments based on the NPRA
ficiary any monies collected for such that reflect the episode payment meth-
services; and odology under the final payment model
(iii) The participant hospital is finan- for CJR participant hospitals.
cially liable for the expenses incurred (b) Reconciliation payments or repay-
for such services. ments. Reconciliation payments or re-
(4) If the participant hospital pro- payments do not affect the beneficiary
vided a discharge planning notice to cost-sharing amounts for the Part A
the beneficiary in accordance with and Part B services provided under the
§ 510.405(b)(3), then normal SNF cov- CJR model.
erage requirements apply and the bene- [80 FR 73540, Nov. 24, 2015, as amended at 82
ficiary may be financially liable for FR 622, Jan. 3, 2017]
non-covered SNF services.
(c) Other requirements. All other Medi- Subparts H–J [Reserved]
care rules for coverage and payment of
Part A-covered services continue to Subpart K—Model Termination
apply except as otherwise waived in
this part. § 510.900 Termination of the CJR
model.
23575, May 3, 2021] CMS may terminate the CJR model
for reasons including but not limited to
§ 510.615 Waiver of certain post-opera- the following:
tive billing restrictions. (a) CMS determines that it no longer
(a) Waiver to permit certain services to has the funds to support the CJR
be billed separately during the 90-day model.
post-operative global surgical period. (b) CMS terminates the model in ac-
CMS waives the billing requirements cordance with section 1115A(b)(3)(B) of
for global surgeries to allow the sepa- the Act. As provided by section
rate billing of certain post-discharge 1115A(d)(2) of the Act, termination of
1004
the model is not subject to administra- 512.270 Treatment of add-on payments

tive or judicial review. under existing Medicare payment sys-
tems.
PART 512—STANDARD PROVISIONS DATA REPORTING

FOR INNOVATION CENTER MOD- 512.275 Quality measures, clinical data, and
ELS AND SPECIFIC PROVISIONS reporting.
FOR CERTAIN MODELS MEDICARE PROGRAM WAIVERS
Subpart A—General Provisions Related to 512.280 RO Model Medicare program waiv-

ers.
Innovation Center Models
RECONCILIATION AND REVIEW PROCESS
Sec.
512.100 Basis and scope. 512.285 Reconciliation process.
512.110 Definitions. 512.290 Timely error notice and reconsider-
512.120 Beneficiary protections. ation review process.
512.130 Cooperation in model evaluation and 512.292 Overlap with other models tested
monitoring. under Section 1115A and CMS programs.
512.135 Audits and record retention. 512.294 Extreme and uncontrollable cir-
512.140 Rights in data and intellectual prop- cumstances.
erty.
512.150 Monitoring and compliance. Subpart C—ESRD Treatment Choices
512.160 Remedial action. Model
512.165 Innovation center model termi- GENERAL
nation by CMS.
512.170 Limitations on review. 512.300 Basis and scope.
512.180 Miscellaneous provisions on bank- 512.310 Definitions.
ruptcy and other notifications.
ESRD TREATMENT CHOICES MODEL SCOPE AND
PARTICIPANTS
Subpart B—Radiation Oncology Model
512.320 Duration.
GENERAL 512.325 Participant selection and geographic
512.200 Basis and scope of subpart. areas.
512.205 Definitions. 512.330 Beneficiary notification.
RO MODEL PARTICIPATION HOME DIALYSIS PAYMENT ADJUSTMENT
512.210 RO participants and geographic 512.340 Payments subject to the facility

areas. HDPA.
512.345 Payments subject to the clinician
512.215 Beneficiary population.
HDPA.
512.217 Identification of individual practi-
512.350 Schedule of home dialysis payment
tioners.
adjustments.
512.220 RO participant compliance with RO
Model requirements. PERFORMANCE PAYMENT ADJUSTMENT
512.225 Beneficiary notification.
512.355 Schedule of performance assessment
SCOPE OF RO EPISODES BEING TESTED and performance payment adjustment.
512.360 Beneficiary population and attribu-
512.230 Criteria for determining cancer tion.
types. 512.365 Performance assessment.
512.235 Included RT services. 512.370 Benchmarking and scoring.
512.240 Included modalities. 512.375 Payments subject to adjustment.
512.245 Included RO episodes. 512.380 PPA amounts and schedule.
512.385 PPA exclusions.
PRICING METHODOLOGY
512.390 Notification, data sharing, and tar-
512.250 Determination of national base geted review.
rates.
512.255 Determination of participant-spe- QUALITY MONITORING
cific professional episode payment and 512.395 Quality measures.
participant-specific technical episode
payment amounts. MEDICARE PROGRAM WAIVERS
BILLING AND PAYMENT 512.397 ETC Model Medicare program waiv-

ers and additional flexibilities.
512.260 Billing.
512.265 Payment. Subpart D [Reserved]
1005
§ 512.100 42 CFR Ch. IV (10–1–24 Edition)
Subpart E—Transforming Episode 512.584 Cooperation in model evaluation and

Accountability Model (TEAM) monitoring.
512.586 Audits and record retention.
GENERAL 512.588 Rights in data and intellectual prop-
512.500 Basis and scope of subpart. erty.
512.505 Definitions. 512.590 Monitoring and compliance.
512.592 Remedial action.
TEAM PARTICIPATION 512.594 Limitations on review.
512.510 Voluntary opt-in participation. 512.595 Bankruptcy and other notifications.
512.515 Geographic areas. 512.596 Termination of TEAM or TEAM par-
512.520 Participation tracks. ticipant from model by CMS.
512.522 APM options. 512.598 Decarbonization and resilience ini-
tiative.
SCOPE OF EPISODES BEING TESTED
AUTHORITY: 42 U.S.C. 1302, 1315a, and
512.525 Episodes. 1395hh.
512.535 Beneficiary inclusion criteria.
SOURCE: 85 FR 61362, Sept. 29, 2020, unless
512.537 Determination of the episode.
otherwise noted.
PRICING METHODOLOGY
512.540 Determination of preliminary target Subpart A—General Provisions Re-
prices. lated to Innovation Center
512.545 Determination of reconciliation tar- Models
get prices.
QUALITY MEASURES AND COMPOSITE QUALITY

SCORE (a) Basis. This subpart implements
512.547 Quality measures, composite quality certain general provisions for the Radi-
score, and display of quality measures. ation Oncology Model implemented
under subpart B (RO Model) and the
RECONCILIATION AND REVIEW PROCESS End-Stage Renal Disease (ESRD)
512.550 Reconciliation process and deter- Treatment Choices Model implemented
mination of the reconciliation payment under subpart C (ETC Model), collec-
or repayment amount. tively referred to in this subpart as In-
512.552 Treatment of incentive programs or novation Center models. Except as spe-
add-on payments under existing Medi- cifically noted in this part, the regula-
care payment systems.
512.555 Proration of payments for services
tions do not affect the applicability of
that extend beyond an episode. other provisions affecting providers
512.560 Appeals process. and suppliers under Medicare Fee-For-
512.561 Reconsideration review processes. Service (FFS), including provisions re-
garding payment, coverage, or program
DATA SHARING AND OTHER REQUIREMENTS integrity.
512.562 Data sharing with TEAM partici- (b) Scope. The regulations in this sub-
pants. part apply to model participants in the
512.563 Health equity reporting. RO Model (except as otherwise noted in
512.564 Referral to primary care services. § 512.160(b)(6)) and to model partici-
FINANCIAL ARRANGEMENTS AND BENEFICIARY pants in the ETC Model. This subpart
INCENTIVES sets forth the following:
512.565 Sharing arrangements. (1) Basis and scope.
512.568 Distribution arrangements. (2) Beneficiary protections.
512.570 Downstream distribution arrange- (3) Model participant requirements
ments. for participation in model evaluation
512.575 TEAM beneficiary incentives. and monitoring, and record retention.
512.576 Application of the CMS-sponsored (4) Rights in data and intellectual
model arrangements and patient incen-
tives safe harbor.
property.
(5) Monitoring and compliance.
MEDICARE PROGRAM WAIVERS (6) Remedial action and termination
512.580 TEAM Medicare Program waivers. by CMS.
(7) Limitations on review.
GENERAL PROVISIONS (8) Miscellaneous provisions on bank-
512.582 Beneficiary protections. ruptcy and notification.
1006
§ 512.110 Definitions. nition of ‘‘marketing’’ as that term is

defined at 45 CFR 164.501.
For purposes of this part, the fol-
lowing terms are defined as follows un- Downstream participant means an in-
less otherwise stated: dividual or entity that has entered into
Beneficiary means an individual who a written arrangement with a model
is enrolled in Medicare FFS. participant under which the down-
Change in control means any of the stream participant engages in one or
following: more Innovation Center model activi-
(1) The acquisition by any ‘‘person’’ ties.
(as this term is used in sections 13(d) Innovation Center model means the RO
and 14(d) of the Securities Exchange Model implemented under subpart B or
Act of 1934) of beneficial ownership the ETC Model implemented under sub-
(within the meaning of Rule 13d–3 pro- part C.
mulgated under the Securities Ex- Innovation Center model activities
change Act of 1934), directly or indi- means any activities impacting the
rectly, of voting securities of the care of model beneficiaries related to
model participant representing more the test of the Innovation Center
than 50 percent of the model partici- model under the terms of this part.
pant’s outstanding voting securities or Medically necessary means reasonable
rights to acquire such securities. and necessary for the diagnosis or
(2) The acquisition of the model par- treatment of an illness or injury, or to
ticipant by any individual or entity. improve the functioning of a mal-
(3) The sale, lease, exchange or other formed body member.
transfer (in one transaction or a series
Model beneficiary means a beneficiary
of transactions) of all or substantially
attributed to a model participant or
all of the assets of the model partici-
pant. otherwise included in an Innovation
Center model under the terms of this
(4) The approval and completion of a
plan of liquidation of the model partic- part.
ipant, or an agreement for the sale or Model participant means an individual
liquidation of the model participant. or entity that is identified as a partici-
Covered services means the scope of pant in the Innovation Center model
health care benefits described in sec- under the terms of this part.
tions 1812 and 1832 of the Act for which Model-specific payment means a pay-
payment is available under Part A or ment made by CMS only to model par-
Part B of Title XVIII of the Act. ticipants, or a payment adjustment
Days means calendar days. made only to payments made to model
Descriptive model materials and activi- participants, under the terms of the In-
ties means general audience materials novation Center model that is not ap-
such as brochures, advertisements, out- plicable to any other providers or sup-
reach events, letters to beneficiaries, pliers.
web pages, mailings, social media, or Provider means a ‘‘provider of serv-
other materials or activities distrib- ices’’ as defined under section 1861(u) of
uted or conducted by or on behalf of the Act and codified in the definition of
the model participant or its down- ‘‘provider’’ at § 400.202 of this chapter.
stream participants when used to edu- Supplier means a supplier as defined
cate, notify, or contact beneficiaries in section 1861(d) of the Act and codi-
regarding the Innovation Center model. fied at § 400.202 of this chapter.
The following communications are not
U.S. Territories means American
descriptive model materials and activi-
ties: Communications that do not di- Samoa, the Federated States of Micro-
rectly or indirectly reference the Inno- nesia, Guam, the Marshall Islands, and
vation Center model (for example, in- the Commonwealth of the Northern
formation about care coordination gen- Mariana Islands, Palau, Puerto Rico,
erally); information on specific medical U.S. Minor Outlying Islands, and the
conditions; referrals for health care U.S. Virgin Islands.
items and services; and any other ma-
terials that are excepted from the defi-
1007
§ 512.120 42 CFR Ch. IV (10–1–24 Edition)
§ 512.120 Beneficiary protections. ‘‘The statements contained in this doc-

(a) Beneficiary freedom of choice. (1) ument are solely those of the authors
The model participant and its down- and do not necessarily reflect the views
stream model participants must not re- or policies of the Centers for Medicare
strict beneficiaries’ ability to choose & Medicaid Services (CMS). The au-
to receive care from any provider or thors assume responsibility for the ac-
supplier. curacy and completeness of the infor-
(2) The model participant and its mation contained in this document.’’
downstream model participants must (3) The model participant and its
not commit any act or omission, nor downstream participants must retain
adopt any policy that inhibits bene- copies of all written and electronic de-
ficiaries from exercising their freedom scriptive model materials and activi-
to choose to receive care from any pro- ties and appropriate records for all
vider or supplier or from any health other descriptive model materials and
care provider who has opted out of activities in a manner consistent with
Medicare. The model participant and
§ 512.135(c).
its downstream model participants
may communicate to model bene- (4) CMS reserves the right to review,
ficiaries the benefits of receiving care or have a designee review, descriptive
with the model participant, if other- model materials and activities to de-
wise consistent with the requirements termine whether or not the content is
of this part and applicable law. materially inaccurate or misleading.
(b) Availability of services. (1) The This review takes place at a time and
model participant and its downstream in a manner specified by CMS once the
participants must continue to make descriptive model materials and activi-
medically necessary covered services ties are in use by the model partici-
available to beneficiaries to the extent pant.
required by applicable law. Model bene-
ficiaries and their assignees retain § 512.130 Cooperation in model evalua-
their rights to appeal claims in accord- tion and monitoring.
ance with part 405, subpart I of this The model participant and its down-
chapter. stream participants must comply with
(2) The model participant and its
the requirements of § 403.1110(b) of this
downstream participants must not
chapter and must otherwise cooperate
take any action to select or avoid
with CMS’ model evaluation and moni-
treating certain Medicare beneficiaries
based on their income levels or based toring activities as may be necessary
on factors that would render the bene- to enable CMS to evaluate the Innova-
ficiary an ‘‘at-risk beneficiary’’ as de- tion Center model in accordance with
fined at § 425.20 of this chapter. section 1115A(b)(4) of the Act and to
(3) The model participant and its conduct monitoring activities under
downstream participants must not § 512.150, including producing such data
take any action to selectively target or as may be required by CMS to evaluate
engage beneficiaries who are relatively or monitor the Innovation Center
healthy or otherwise expected to im- model, which may include protected
prove the model participant’s or down- health information as defined in 45
stream participant’s financial or qual- CFR 160.103 and other individually-
ity performance, a practice commonly identifiable data.
referred to as ‘‘cherry-picking.’’
(c) Descriptive model materials and ac- § 512.135 Audits and record retention.
tivities. (1) The model participant and (a) Right to audit. The Federal gov-
its downstream participants must not ernment, including CMS, HHS, and the
use or distribute descriptive model ma-
Comptroller General, or their des-
terials and activities that are materi-
ignees, has the right to audit, inspect,
ally inaccurate or misleading.
(2) The model participant and its investigate, and evaluate any docu-
downstream participants must include ments and other evidence regarding
the following statement on all descrip- implementation of an Innovation Cen-
tive model materials and activities: ter model.
1008
(b) Access to records. The model par- tained for an additional 6 years from
ticipant and its downstream partici- the date of any resulting final resolu-
pants must maintain and give the Fed- tion of the termination, dispute, or al-
eral government, including CMS, HHS, legation of fraud or similar fault.
and the Comptroller General, or their (2) If CMS notifies the model partici-
designees, access to all such documents pant of the special need to retain
and other evidence sufficient to enable records in accordance with paragraph
the audit, evaluation, inspection, or in- (c)(1)(i) of this section or there has
vestigation of the implementation of been a termination, dispute, or allega-
the Innovation Center model, including tion of fraud or similar fault against
without limitation, documents and
the model participant or its down-
other evidence regarding all of the fol-
stream participants described in para-
lowing:
(1) The model participant’s and its graph (c)(1)(ii) of this section, the
downstream participants’ compliance model participant must notify its
with the terms of the Innovation Cen- downstream participants of this need
ter model, including this subpart. to retain records for the additional pe-
(2) The accuracy of model-specific riod specified by CMS.
payments made under the Innovation
Center model. § 512.140 Rights in data and intellec-
(3) The model participant’s payment tual property.
of amounts owed to CMS under the In- (a) CMS may—
novation Center model. (1) Use any data obtained under
(4) Quality measure information and §§ 512.130, 512.135, and 512.150 to evaluate
the quality of services performed under and monitor the Innovation Center
the terms of the Innovation Center model; and
model, including this subpart. (2) Disseminate quantitative and
(5) Utilization of items and services qualitative results and successful care
furnished under the Innovation Center management techniques, including fac-
model. tors associated with performance, to
(6) The ability of the model partici-
other providers and suppliers and to
pant to bear the risk of potential losses
the public. Data disseminated may in-
and to repay any losses to CMS, as ap-
plicable. clude patient—
(7) Patient safety. (i) De-identified results of patient ex-
(8) Other program integrity issues. perience of care and quality of life sur-
(c) Record retention. (1) The model veys, and
participant and its downstream partici- (ii) De-identified measure results cal-
pants must maintain the documents culated based upon claims, medical
and other evidence described in para- records, and other data sources.
graph (b) of this section and other evi- (b) Notwithstanding any other provi-
dence for a period of six years from the sion of this part, for all data that CMS
last payment determination for the confirms to be proprietary trade secret
model participant under the Innova- information and technology of the
tion Center model or from the date of model participant or its downstream
completion of any audit, evaluation, participants, CMS or its designee(s)
inspection, or investigation, whichever will not release this data without the
is later, unless— express written consent of the model
(i) CMS determines there is a special participant or its downstream partici-
need to retain a particular record or pant, unless such release is required by
group of records for a longer period and law.
notifies the model participant at least
(c) If the model participant or its
30 days before the normal disposition
date; or downstream participant wishes to pro-
(ii) There has been a termination, tect any proprietary or confidential in-
dispute, or allegation of fraud or simi- formation that it submits to CMS or
lar fault against the model participant its designee, the model participant or
or its downstream participants, in its downstream participant must label
which case the records must be main- or otherwise identify the information
1009
§ 512.150 42 CFR Ch. IV (10–1–24 Edition)
as proprietary or confidential. Such as- Innovation Center model and the moni-
sertions are subject to review and con- toring of the model participant’s com-
firmation by CMS prior to CMS’ acting pliance with the terms of the Innova-
upon such assertions. tion Center model, including this sub-
part.
§ 512.150 Monitoring and compliance. (2) CMS or its designee provides, to
(a) Compliance with laws. The model the extent practicable, the model par-
participant and each of its downstream ticipant or downstream participant
participants must comply with all ap- with no less than 15 days advance no-
plicable laws and regulations. tice of any site visit. CMS—
(b) CMS monitoring and compliance ac- (i) Will attempt, to the extent prac-
tivities. (1) CMS may conduct moni- ticable, to accommodate a request for
toring activities to ensure compliance particular dates in scheduling site vis-
by the model participant and each of its.
its downstream participants with the (ii) Will not accept a date request
terms of the Innovation Center model from a model participant or down-
including this subpart; to understand stream participant that is more than 60
model participants’ use of model-spe- days after the date of the CMS initial
cific payments; and to promote the site visit notice.
safety of beneficiaries and the integ- (3) The model participant and its
rity of the Innovation Center model. downstream participants must ensure
Such monitoring activities may in- that personnel with the appropriate re-
clude, without limitation, all of the sponsibilities and knowledge associ-
following: ated with the purpose of the site visit
(i) Documentation requests sent to are available during all site visits.
the model participant and its down- (4) Additionally, CMS may perform
stream participants, including surveys unannounced site visits at the office of
and questionnaires. the model participant and any of its
(ii) Audits of claims data, quality downstream participants at any time
measures, medical records, and other to investigate concerns about the
data from the model participant and health or safety of beneficiaries or
its downstream participants. other patients or other program integ-
(iii) Interviews with members of the rity issues.
staff and leadership of the model par- (5) Nothing in this part shall be con-
ticipant and its downstream partici- strued to limit or otherwise prevent
pants. CMS from performing site visits per-
(iv) Interviews with beneficiaries and mitted or required by applicable law.
their caregivers. (d) Reopening of payment determina-
(v) Site visits to the model partici- tions. (1) CMS may reopen a model-spe-
pant and its downstream participants, cific payment determination on its own
performed in a manner consistent with motion or at the request of a model
paragraph (c) of this section. participant, within 4 years from the
(vi) Monitoring quality outcomes and date of the determination, for good
clinical data, if applicable. cause (as defined at § 405.986 of this
(vii) Tracking patient complaints chapter).
and appeals. (2) CMS may reopen a model-specific
(2) In conducting monitoring and payment determination at any time if
oversight activities, CMS or its des- there exists reliable evidence (as de-
ignees may use any relevant data or in- fined in § 405.902 of this chapter) that
formation including without limitation the determination was procured by
all Medicare claims submitted for fraud or similar fault (as defined in
items or services furnished to model § 405.902 of this chapter).
beneficiaries. (3) CMS’s decision regarding whether
(c) Site visits. (1) In a manner con- to reopen a model-specific payment de-
sistent with § 512.130, the model partici- termination is binding and not subject
pant and its downstream participants to appeal.
must cooperate in periodic site visits (e) OIG authority. Nothing contained
performed by CMS or its designees in in the terms of the Innovation Center
order to facilitate the evaluation of the Model or this part limits or restricts
1010
the authority of the HHS Office of In- medial action described in paragraph
spector General or any other Federal (a) of this section has taken place, CMS
government authority, including its may take one or more of the following
authority to audit, evaluate, inves- remedial actions:
tigate, or inspect the model participant (1) Notify the model participant and,
or its downstream participants for vio- if appropriate, require the model par-
lations of any Federal statutes, rules, ticipant to notify its downstream par-
or regulations. ticipants of the violation.
(2) Require the model participant to
§ 512.160 Remedial action. provide additional information to CMS
(a) Grounds for remedial action. CMS or its designees.
may take one or more remedial actions (3) Subject the model participant to
described in paragraph (b) of this sec- additional monitoring, auditing, or
tion if CMS determines that the model both.
participant or a downstream partici- (4) Prohibit the model participant
pant: from distributing model-specific pay-
(1) Has failed to comply with any of ments, as applicable.
the terms of the Innovation Center (5) Require the model participant to
Model, including this subpart. terminate, immediately or by a dead-
(2) Has failed to comply with any ap- line specified by CMS, its agreement
plicable Medicare program require- with a downstream participant with re-
ment, rule, or regulation. spect to the Innovation Center model.
(3) Has taken any action that threat- (6) In the ETC Model only:
ens the health or safety of a bene- (i) Terminate the ETC Participant
ficiary or other patient. from the ETC Model.
(4) Has submitted false data or made (ii) Suspend or terminate the ability
false representations, warranties, or of the ETC Participant, pursuant to
certifications in connection with any § 512.397(c), to reduce or waive the coin-
aspect of the Innovation Center model. surance for kidney disease patient edu-
(5) Has undergone a change in control cation services.
that presents a program integrity risk. (7) Require the model participant to
(6) Is subject to any sanctions of an submit a corrective action plan in a
accrediting organization or a Federal, form and manner and by a deadline
State, or local government agency. specified by CMS.
(7) Is subject to investigation or ac- (8) Discontinue the provision of data
tion by HHS (including the HHS Office sharing and reports to the model par-
of Inspector General and CMS) or the ticipant.
Department of Justice due to an alle- (9) Recoup model-specific payments.
gation of fraud or significant mis- (10) Reduce or eliminate a model-spe-
conduct, including being subject to the cific payment otherwise owed to the
filing of a complaint or filing of a model participant.
criminal charge, being subject to an in- (11) Such other action as may be per-
dictment, being named as a defendant mitted under the terms of this part.
in a False Claims Act qui tam matter [85 FR 61362, Sept. 29, 2020, as amended at 86
in which the Federal government has FR 62020, Nov. 8, 2021]
intervened, or similar action.
(8) Has failed to demonstrate im- § 512.165 Innovation center model ter-
proved performance following any re- mination by CMS.
medial action imposed under this sec- (a) CMS may terminate an Innova-
tion. tion Center model for reasons includ-
(9) For the ETC Model only, has mis- ing, but not limited to, the following:
used or disclosed the beneficiary-iden- (1) CMS determines that it no longer
tifiable data in a manner that violates has the funds to support the Innovation
any applicable statutory or regulatory Center model.
requirements or that is otherwise non- (2) CMS terminates the Innovation
compliant with the provisions of the Center model in accordance with sec-
applicable data sharing agreement. tion 1115A(b)(3)(B) of the Act.
(b) Remedial actions. If CMS deter- (b) If CMS terminates an Innovation
mines that one or more grounds for re- Center model, CMS provides written
1011
§ 512.170 42 CFR Ch. IV (10–1–24 Edition)
notice to the model participant speci- to CMS and to the U.S. Attorney’s Of-
fying the grounds for model termi- fice in the district where the bank-
nation and the effective date of such ruptcy was filed, unless final payment
termination. has been made by either CMS or the
model participant under the terms of
§ 512.170 Limitations on review. each model tested under section 1115A
There is no administrative or judicial of the Act in which the model partici-
review under sections 1869 or 1878 of the pant is participating or has partici-
Act or otherwise for all of the fol- pated and all administrative or judicial
lowing: review proceedings relating to any pay-
(a) The selection of models for test- ments under such models have been
ing or expansion under section 1115A of fully and finally resolved. The notice of
the Act. bankruptcy must be sent by certified
(b) The selection of organizations, mail no later than 5 days after the pe-
sites, or participants, including model tition has been filed and must contain
participants, to test the Innovation a copy of the filed bankruptcy petition
Center models selected, including a de- (including its docket number), and a
cision by CMS to remove a model par- list of all models tested under section
ticipant or to require a model partici- 1115A of the Act in which the model
pant to remove a downstream partici- participant is participating or has par-
pant from the Innovation Center ticipated. This list need not identify a
model. model tested under section 1115A of the
(c) The elements, parameters, scope, Act in which the model participant
and duration of such Innovation Center participated if final payment has been
models for testing or dissemination, in- made under the terms of the model and
cluding without limitation the fol- all administrative or judicial review
lowing: proceedings regarding model-specific
(1) The selection of quality perform- payments between the model partici-
ance standards for the Innovation Cen- pant and CMS have been fully and fi-
ter model by CMS. nally resolved with respect to that
(2) The methodology used by CMS to model. The notice to CMS must be ad-
assess the quality of care furnished by dressed to the CMS Office of Financial
the model participant.
Management at 7500 Security Boule-
(3) The methodology used by CMS to
vard, Mailstop C3–01–24, Baltimore, MD
attribute model beneficiaries to the
21244 or such other address as may be
model participant, if applicable.
specified on the CMS website for pur-
(d) Determinations regarding budget
poses of receiving such notices.
neutrality under section 1115A(b)(3) of
the Act. (b) Notice of legal name change. A
(e) The termination or modification model participant must furnish written
of the design and implementation of an notice to CMS at least 30 days after
Innovation Center model under section any change in its legal name becomes
1115A(b)(3)(B) of the Act. effective. The notice of legal name
(f) Determinations about expansion change must be in a form and manner
of the duration and scope of an Innova- specified by CMS and must include a
tion Center model under section copy of the legal document effecting
1115A(c) of the Act, including the deter- the name change, which must be au-
mination that an Innovation Center thenticated by the appropriate State
model is not expected to meet criteria official.
described in paragraph (a) or (b) of such (c) Notice of change in control. (1) A
section. model participant must furnish written
notice to CMS in a form and manner
§ 512.180 Miscellaneous provisions on specified by CMS at least 90 days before
bankruptcy and other notifications. any change in control becomes effec-
(a) Notice of bankruptcy. If the model tive.
participant has filed a bankruptcy peti- (2)(i) If CMS determines, in accord-
tion, whether voluntary or involun- ance with § 512.160(a)(5), that a model
tary, the model participant must pro- participant’s change in control would
vide written notice of the bankruptcy present a program integrity risk, CMS
1012
may take remedial action against the Baseline period means the three cal-
model participant under § 512.160(b). endar year period that begins on Janu-
(ii) CMS may also require immediate ary 1 no fewer than five years but no
reconciliation and payment of all mon- more than six years prior to the start
ies owed to CMS by a model partici- of the model performance period during
pant that is subject to a change in con- which episodes must initiate in order
trol. to be used in the calculation of the na-
tional base rates, each RO participant’s
Subpart B—Radiation Oncology historical experience adjustment for
Model the PC or TC or both for the model per-
formance period, and the RO partici-
GENERAL pant’s case mix adjustment for the PC
or TC or both for PY1. The baseline pe-
§ 512.200 Basis and scope of subpart. riod is January 1, 2017 through Decem-
(a) Basis. This subpart implements ber 31, 2019, unless the RO Model is pro-
the test of the Radiation Oncology hibited by law from starting in cal-
(RO) Model under section 1115A(b) of endar year (CY) 2022, in which case the
the Act. Except as specifically noted in baseline period will be delayed based
this subpart, the regulations under this on the new model performance period
subpart do not affect the applicability (for example, if the model performance
of other regulations affecting providers period starts any time in CY 2023, then
and suppliers under Medicare FFS, in- the baseline period would be CY 2018
cluding the applicability of regulations through CY 2020).
regarding payment, coverage, and pro- Blend means the weight given to an
gram integrity. RO participant’s historical experience
adjustment relative to the geographi-
(b) Scope. This subpart sets forth the
cally-adjusted trended national base
following:
rate in the calculation of its partici-
(1) RO Model participation.
pant-specific episode payment
(2) Episodes being tested under the
amounts.
RO Model.
CAH means Critical Access Hospital.
(3) Methodology for pricing.
CEHRT means Certified Electronic
(4) Billing and payment under the RO Health Record Technology.
Model. Clean period means the 28-day period
(5) Data reporting requirements. after an RO episode has ended, during
(6) Medicare program waivers. which time an RO participant must bill
(7) Payment reconciliation and re- for medically necessary RT services
view processes. furnished to the RO beneficiary in ac-
(c) RO participants are subject to the cordance with Medicare FFS billing
general provisions for Innovation Cen- rules.
ter models specified in subpart A of Core-Based Statistical Area (CBSA)
this part 512 and in subpart K of part means a statistical geographic area,
403 of this chapter. based on the definition as identified by
the Office of Management and Budget,
with a population of at least 10,000,
For purposes of this subpart, the fol- which consists of a county or counties
lowing definitions apply: anchored by at least one core (urban-
Aggregate quality score (AQS) means ized area or urban cluster), plus adja-
the numeric score calculated for each cent counties having a high degree of
RO participant based on its perform- social and economic integration with
ance on, and reporting of, quality the core (as measured through com-
measures and clinical data. The AQS is muting ties with the counties con-
used to determine an RO participant’s taining the core).
quality reconciliation payment Discount factor means the percentage
amount. by which CMS reduces payment of the
APM means Alternative Payment professional component and technical
Model. component.
ASC means Ambulatory Surgery Cen- (1) The reduction of payment occurs
ter. after the trend factor, the geographic
1013
§ 512.205 42 CFR Ch. IV (10–1–24 Edition)
adjustment, and the RO Model-specific Included cancer types means the can-
adjustments have been applied, but be- cer types determined by the criteria
fore beneficiary cost-sharing and set forth in § 512.230, which are included
standard CMS adjustments, including in the RO Model test.
sequestration, have been applied. Included RT services means the RT
(2) The discount factor does not vary services identified at § 512.235, which
by cancer type. are included in the RO Model test.
(3) The discount factor for the profes- Incomplete episode means an RO epi-
sional component is 3.5 percent; the sode that is deemed not to have oc-
discount factor for the technical com- curred because:
ponent is 4.5 percent.
(1) A Technical participant or a Dual
Dual participant means an RO partici-
participant does not furnish a tech-
pant that furnishes both the profes-
sional component and technical compo- nical component to an RO beneficiary
nent of RT services of an RO episode within 28 days following a Professional
through a freestanding radiation ther- participant or the Dual participant fur-
apy center, identified by a single TIN. nishing an initial treatment planning
Duplicate RT service means any in- service to that RO beneficiary;
cluded RT service that is furnished to (2) An RO beneficiary ceases to have
an RO beneficiary by an RT provider or traditional FFS Medicare as his or her
RT supplier that is not excluded from primary payer at any time after the
participation in the RO Model at initial treatment planning service is
§ 512.210(b), and that did not initiate furnished and before the date of service
the PC or TC of the RO beneficiary’s on a claim with an RO Model-specific
RO episode. Such services are furnished HCPCS code and an EOE modifier; or
in addition to the RT services fur- (3) An RO beneficiary switches RT
nished by the RO participant that ini- provider or RT supplier before all in-
tiated the PC or TC and continues to cluded RT services in the RO episode
furnish care to the RO beneficiary dur- have been furnished.
ing the RO episode. Individual practitioner means a Medi-
Episode means the 90-day period of care-enrolled physician (identified by
RT services that begins on the date of an NPI) who furnishes RT services to
service that an RT provider or RT sup- Medicare FFS beneficiaries, and has re-
plier that is not an RO participant fur- assigned his or her billing rights to the
nishes an initial treatment planning TIN of an RO participant.
service to a beneficiary, provided that Individual practitioner list means a list
an RT provider or RT supplier fur- of individual practitioners who furnish
nishes a technical component RT serv- RT services under the TIN of a Dual
ice to the beneficiary within 28 days of participant or a Professional partici-
such initial treatment planning serv-
pant, which is annually compiled by
ice. Additional criteria for con-
CMS and which the RO participant
structing episodes to be included in de-
must review, revise, and certify in ac-
termining the national base rates are
cordance with § 512.217. The individual
set forth in § 512.250.
practitioner list is used for the RO
EOE stands for ‘‘end of episode’’ and
means the end of an RO episode. Model as a Participation List as de-
EUC stands for ‘‘extreme and uncon- fined in § 414.1305 of this chapter.
trollable circumstance’’ and means a Initial reconciliation means the first
circumstance that is beyond the con- reconciliation of a PY that occurs as
trol of one or more RO participants, early as August following the applica-
adversely impacts such RO partici- ble PY.
pants’ ability to deliver care in accord- Legacy CCN means a CMS certifi-
ance with the RO Model’s require- cation number (CCN) that an RO par-
ments, and affects an entire region or ticipant that is a hospital outpatient
locale. department (HOPD) or its prede-
HCPCS means Healthcare Common cessor(s) previously used to bill Medi-
Procedure Coding System. care for included RT services but no
HOPD means hospital outpatient de- longer uses to bill Medicare for in-
partment. cluded RT services.
1014
Legacy TIN means a taxpayer identi- on January 1 and ending on December

fication number (TIN) that an RO par- 31 during the model performance pe-
ticipant that is a PGP, or a free- riod, unless the model performance pe-
standing radiation therapy center, or riod begins on a date other than Janu-
its predecessor(s) previously used to ary 1, in which case, the first perform-
bill Medicare for included RT services ance year (PY1) begins on that date
but no longer uses to bill Medicare for and ends on December 31 of the same
included RT services. year.
MIPS means Merit based Incentive QP means Qualifying APM Partici-
Payment System. pants.
Model performance period means the 5 Reconciliation payment means a pay-
performance years (PYs) during which ment made by CMS to an RO partici-
RO episodes initiate and terminate. pant, as determined in accordance with
CMS will establish the start and end § 512.285.
dates of the model performance period Repayment amount means the amount
for the RO Model through future rule- owed by an RO participant to CMS, as
making. determined in accordance with § 512.285.
National base rate means the total Reconciliation report means the an-
payment amount for the relevant com- nual report issued by CMS to an RO
ponent of an RO episode, before appli- participant for each PY, which speci-
cation of the trend factor, discount fac- fies the RO participant’s reconciliation
tor, adjustments, and applicable with- payment amount or repayment
holds, for each of the included cancer amount.
types. RO beneficiary means a Medicare ben-
NPI means National Provider Identi- eficiary who meets all of the bene-
fier. ficiary inclusion criteria at § 512.215(a)
OPPS means outpatient prospective and whose RO episode meets all the cri-
payment system. teria defined at § 512.245.
Participant-specific professional episode RO episode means the 90-day period
payment means a payment which is cal- that, as set forth in § 512.245, begins on
culated by CMS as set forth in § 512.255 the date of service that a Professional
and which is paid by CMS to a Profes- participant or a Dual participant fur-
sional participant or Dual participant nishes an initial treatment planning
as set forth in § 512.265, for the provi- service to an RO beneficiary in a free-
sion of the professional component to standing radiation therapy center or
an RO beneficiary during an RO epi- an HOPD, provided that a Technical
sode. participant or the same Dual partici-
Participant-specific technical episode pant furnishes a technical component
payment means a payment which is cal- RT service to the RO beneficiary with-
culated by CMS as set forth in § 512.255 in 28 days of such RT treatment plan-
and which is paid by CMS to a Tech- ning service.
nical participant or Dual participant in RO participant means a Medicare-en-
accordance with § 512.265, for the provi- rolled PGP, freestanding radiation
sion of the technical component to an therapy center, or HOPD that partici-
RO beneficiary during an RO episode. pates in the RO Model in accordance
PGP means physician group practice. with § 512.210. An RO participant may
PPS means prospective payment sys- be a Dual participant, Professional par-
tem. ticipant, or Technical participant.
Professional component (PC) means the RT provider means a Medicare-en-
included RT services that may only be rolled HOPD that furnishes RT serv-
furnished by a physician. ices.
Professional participant means an RO RT services are the treatment plan-
participant that is a Medicare-enrolled ning, technical preparation, special
PGP identified by a single TIN that services (such as simulation), treat-
furnishes only the PC of an RO episode. ment delivery, and treatment manage-
PSO means patient safety organiza- ment services associated with cancer
tion. treatment that uses high doses of radi-
PY stands for performance year and ation to kill cancer cells and shrink tu-
means each 12-month period beginning mors.
1015
§ 512.210 42 CFR Ch. IV (10–1–24 Edition)
RT supplier means a Medicare-en- RT services that are identified after

rolled PGP or freestanding radiation the initial reconciliation and after a
therapy center that furnishes RT serv- 12-month claims run-out for all RO epi-
ices. sodes initiated in the applicable PY.
SOE stands for ‘‘start of episode’’ and
means the start of an RO episode. FR 86304, Dec. 29, 2020; 86 FR 63994, Nov. 16,
Stop-loss limit means the set percent- 2021; 87 FR 52704, Aug. 29, 2022]
age at which loss is limited under the
EDITORIAL NOTE: At 85 FR 86304, Dec. 29,
Model used to calculate the stop-loss
2020, this section was amended, effective Dec.
reconciliation amount. 4, 2020; however, due to a publication error,
Stop-loss reconciliation amount means the amendments were codified at 86 FR 33902,
the amount set forth in § 512.285(f) owed June 28, 2021.
by CMS for the loss incurred under the
Model to RO participants that have RO MODEL PARTICIPATION
fewer than 60 episodes during the base-
line period and were furnishing in- § 512.210 RO participants and geo-
cluded RT services before the start of graphic areas.
the model performance period in the (a) RO participants. Unless otherwise
CBSAs selected for participation. specified in paragraph (b) or (c) of this
Technical component (TC) means the section, any Medicare-enrolled PGP,
included RT services that are not fur- freestanding radiation therapy center,
nished by a physician, including the or HOPD that furnishes included RT
provision of equipment, supplies, per- services in a 5-digit ZIP Code linked to
sonnel, and administrative costs re- a CBSA selected for participation to an
lated to RT services. RO beneficiary for an RO episode that
Technical participant means an RO begins and ends during the model per-
participant that is a Medicare-enrolled formance period must participate in
HOPD or freestanding radiation ther- the RO Model.
apy center, identified by a single CMS (b) Participant exclusions. A PGP,
Certification Number (CCN) or TIN, freestanding radiation therapy center,
which furnishes only the TC of an RO or HOPD is excluded from participation
episode. in the RO Model if it:
TIN means Taxpayer Identification (1) Furnishes RT services only in
Number. Maryland;
Track One means a track for Profes- (2) Furnishes RT services only in
sional participants and Dual partici- Vermont;
pants that meet all RO Model require- (3) Furnishes RT services only in U.S.
ments as specified in § 512.220, including Territories;
use of CEHRT. (4) Is classified as an ambulatory sur-
Track Two means a track for Profes- gery center (ASC), critical access hos-
sional participants and Dual partici- pital (CAH), or Prospective Payment
pants that meet all RO Model require- System (PPS)-exempt cancer hospital;
ments as specified in § 512.220, except or
for use of CEHRT. (5) Participates in the Pennsylvania
Track Three means a track for Profes- Rural Health Model; or
sional participants and Dual partici- (6) Participates in the Community
pants who do not meet one or more of Transformation Track of the Commu-
the RO Model requirements set forth at nity Health Access and Rural Trans-
§ 512.220(a); and for all Technical par- formation (CHART) Model as a partici-
ticipants. pating hospital.
Trend factor means an adjustment ap- (c) Low volume opt-out. A PGP, free-
plied to the national base rates that standing radiation therapy center, or
updates those rates to reflect current HOPD that would otherwise be re-
trends in the OPPS and PFS rates for quired to participate in the RO Model
RT services. may choose to opt-out of the RO Model
True-up reconciliation means the proc- as follows:
ess to calculate additional reconcili- (1) If the PGP, freestanding radiation
ation payments or repayment amounts therapy center, or HOPD furnished
for incomplete episodes and duplicate fewer than 20 episodes in the calendar
1016
year that is two years prior to the comparison groups to contain approxi-
start of PY1 across all CBSAs selected mately 30 percent of all episodes in eli-
for participation, it may opt out of the gible geographic areas (CBSAs).
RO Model for PY1. (e) Notice of change in TIN or CCN. An
(2) If the PGP, freestanding radiation RO participant must furnish written
therapy center, or HOPD furnished notice to CMS in a form and manner
fewer than 20 episodes in the calendar specified by CMS at least 90 days before
year that is two years prior to the the effective date of any change in TIN
start of PY2 across all CBSAs selected or CCN that is used to bill Medicare.
for participation, it may opt out of the [85 FR 61362, Sept. 29, 2020, as amended at 85
RO Model for PY2. FR 86304, Dec. 29, 2020; 86 FR 63994, Nov. 16,
(3) If the PGP, freestanding radiation 2021]
therapy center, or HOPD furnished
fewer than 20 RO episodes in PY1 2020, this section was amended, effective Dec.
across all CBSAs selected for participa- 4, 2020; however, due to a publication error,
tion, and PY1 begins on January 1, it the amendments were codified at 86 FR 33902,
may choose to opt out of the RO Model June 28, 2021.
for PY3. In the event that PY1 begins
on a date other than January 1, the § 512.215 Beneficiary population.
PGP, freestanding radiation therapy (a) Beneficiary inclusion criteria. An
center, or HOPD may opt-out of the RO individual is an RO beneficiary if:
Model for PY3 if the total number of (1) The individual receives included
furnished episodes of the calendar year RT services from an RO participant
in which PY1 began and RO episodes in that billed the SOE modifier for the PC
PY1 is fewer than 20 across all CBSAs or TC of an RO episode during the
selected for participation. Model performance period for an in-
(4) If the PGP, freestanding radiation cluded cancer type; and
therapy center, or HOPD furnished (2) At the time that the initial treat-
fewer than 20 RO episodes in PY2 ment planning service of an RO episode
across all CBSAs selected for participa- is furnished by an RO participant, the
tion, it may opt out of the RO Model individual:
for PY4. (i) Is eligible for Medicare Part A and
(5) If the PGP, freestanding radiation enrolled in Medicare Part B;
therapy center, or HOPD furnished (ii) Has traditional FFS Medicare as
fewer than 20 RO episodes in PY3 his or her primary payer (for example,
across all CBSAs selected for participa- is not enrolled in a PACE plan, Medi-
tion, it may opt out of the RO Model care Advantage or another managed
for PY5. care plan, or United Mine Workers in-
(6) At least 30 days prior to the start surance); and
of each PY, CMS provides notice to RO (iii) Is not in a Medicare hospice ben-
participants eligible for the low vol- efit period.
ume opt-out for the upcoming PY of (b) Any individual enrolled in a clin-
such eligibility. The RO participant ical trial for RT services for which
must attest that it intends to opt out Medicare pays routine costs is an RO
of the RO Model prior to the start of beneficiary if the individual satisfies
the upcoming PY. all of the beneficiary inclusion criteria
(7) An entity is not eligible for the in paragraph (a) of this section.
low-volume opt out if its current TIN
or CCN, or its legacy TIN or legacy § 512.217 Identification of individual
CCN, or both were used to bill Medicare practitioners.
for 20 or more episodes or RO episodes, (a) General. Upon the start of each
as applicable, of RT services in the two PY, CMS creates and provides to each
years prior to the applicable PY across RO participant that is a PGP or a free-
all CBSAs selected for participation. standing radiation therapy center an
(d) Selected CBSAs. CMS randomly se- individual practitioner list identifying
lects CBSAs to identify RT providers by NPI each individual practitioner as-
and RT suppliers to participate in the sociated with the RO participant. For
RO Model through a stratified sample RO participants that begin participa-
design, allowing for participant and tion in the RO Model after the start of
1017
§ 512.217 42 CFR Ch. IV (10–1–24 Edition)
a PY, but at least 30 days prior to the made based on their participation in
last QP determination date as specified the RO Model; and
at § 414.1325 of this chapter, CMS cre- (d) Changes to the individual practi-
ates and provides an individual practitioner list—(1) Additions. (i) An RO par-
tioner list to that RO participant. ticipant must notify CMS of an addi-
(b) Review of individual practitioner tion to its individual practitioner list
list. Up until the last QP determination when an eligible clinician reassigns his
date as specified at § 414.1325 of this or her rights to receive payment from
chapter, the RO participant must re- Medicare to the RO participant. The
view the individual practitioner list, notice must be submitted in the form
correct any inaccuracies in accordance and manner specified by CMS up until
with paragraph (d) of this section, and the last QP determination date as spec-
certify the list (as corrected, if applica- ified at § 414.1325 of this chapter.
ble) in a form and manner specified by (ii) If the RO participant timely sub-
CMS and in accordance with paragraph mits notice to CMS, then the addition
(c) of this section. The RO participant of an individual practitioner to the RO
participant’s individual practitioner
may correct any inaccuracies in its in-
list is effective on the date specified in
dividual practitioner list until the last
the notice furnished to CMS, but no
QP determination date as specified at
earlier than 30 days before the date of
§ 414.1325 of this chapter. Any Dual par-
the notice. If the RO participant fails
ticipant, Professional participant, or
to submit timely notice to CMS, then
Technical participant that is a free-
the addition of an individual practi-
standing radiation therapy center and
tioner to the individual practitioner
joins the RO Model after the start of a
list is effective on the date of the no-
PY must review and certify its indi- tice.
vidual practitioner list by the last QP (2) Removals. (i) An RO participant
determination date as specified at must notify CMS when an individual
§ 414.1325 of this chapter. on the RO participant’s individual
(c) List certification. (1) Up until the practitioner list ceases to be an indi-
last QP determination date as specified vidual practitioner up until the last QP
at § 414.1325 of this chapter, an indi- determination date as specified at
vidual with the authority to legally § 414.1325 of this chapter. The notice
bind the RO participant must certify must be submitted in the form and
the accuracy, completeness, and truth- manner specified by CMS.
fulness of the individual practitioner (ii) The removal of an individual
list to the best of his or her knowledge, practitioner from the RO participant’s
information, and belief. individual practitioner list is effective
(2) All Medicare-enrolled individual on the date specified in the notice fur-
practitioners that have reassigned nished to CMS. If the RO participant
their right to receive Medicare pay- fails to submit a timely notice of the
ment for provision of RT services to removal, then the removal is effective
the TIN of the RO participant must be on the date that the individual ceases
included on the RO participant’s indi- to be an individual practitioner.
vidual practitioner list and each indi- (e) Update to Medicare enrollment in-
vidual practitioner must agree to com- formation. The RO participant must en-
ply with the requirements of the RO sure that all changes to enrollment in-
Model before the RO participant cer- formation for an RO participant and its
tifies the individual practitioner list. individual practitioners, including
(3) If the RO participant does not cer- changes to reassignment of the right to
tify the individual practitioner list in receive Medicare payment, are re-
PY2 through PY5: ported to CMS consistent with § 424.516
(i) Eligible clinicians in the RO of this chapter.
Model will not be considered partici- [85 FR 61362, Sept. 29, 2020, as amended at 85
pants in a MIPS APM for purposes of FR 86304, Dec. 29, 2020; 86 FR 63995, Nov. 16,
MIPS reporting and scoring rules; 2021]
(ii) Eligible clinicians in the RO EDITORIAL NOTE: At 85 FR 86304, Dec. 29,
Model will not have Qualifying APM 2020, this section was amended, effective Dec.
Participant (‘‘QP’’) determinations 4, 2020; however, due to a publication error,
1018
the amendments were codified at 86 FR 33902, (A) 50 percent of new patients in PY1,
June 28, 2021. (B) 55 percent of new patients in PY2,
(C) 60 percent of new patients in PY3,
§ 512.220 RO participant compliance (D) 65 percent of new patients in PY4,
with RO Model requirements. (E) 70 percent of new patients in PY5.
(a) RO participant-specific require- (3) Starting in PY1, at such times and
ments. (1) An RO participant must sat- in the form and manner specified by
isfy the requirements of this section to CMS, each Technical participant and
be included in Track One under the RO Dual participant must annually attest
Model in a particular PY. An RO par- to whether it actively participates
ticipant that meets all of these RO with a AHRQ-listed patient safety or-
Model requirements in a particular PY, ganization (PSO). Examples include
excluding use of CEHRT, will be in maintaining a contractual or similar
Track Two for such PY. An RO partici- relationship with a PSO for the receipt
pant that does not meet one or more of and review of patient safety work prod-
the RO Model requirements in para- uct.
graph (a) of this section in a particular (b) CEHRT. (1) RO participants must
PY will be in Track Three for such PY. use CEHRT, and ensure that their indi-
(2) Each Professional participant and vidual practitioners use CEHRT, in a
Dual participant must ensure its indi- manner sufficient to meet the applica-
vidual practitioners: ble requirements of the Advanced APM
(i) Starting in PY1, discuss goals of criteria as specified at § 414.1415(a)(1)(i)
care with each RO beneficiary before of this chapter.
initiating treatment and communicate (2) Within 30 days of the start of PY1
to the RO beneficiary whether the and each subsequent PY, the RO par-
treatment intent is curative or pallia- ticipant must certify its use of CEHRT
tive; throughout such PY in a manner suffi-
(ii) Starting in PY1, adhere to na- cient to meet the requirements set
tionally recognized, evidence-based forth in § 414.1415(a)(1)(i) of this chap-
clinical treatment guidelines when ap- ter.
propriate in treating RO beneficiaries (3) An RO participant that joins the
or, alternatively, document in the med- RO Model at any time during an ongo-
ical record the extent of and rationale ing PY must certify their use of
for any departure from these guide- CEHRT by the last QP determination
lines; date as specified at § 414.1325 of this
(iii) Starting in PY1, assess each RO chapter.
beneficiary’s tumor, node, and metas- [85 FR 61362, Sept. 29, 2020, as amended at 85
tasis cancer stage for the CMS-speci- FR 86304, Dec. 29, 2020; 86 FR 63995, Nov. 16,
fied cancer diagnoses; 2021]
(iv) Starting in PY1, assess the RO
beneficiary’s performance status as a 2020, this section was amended, effective Dec.
quantitative measure determined by 4, 2020; however, due to a publication error,
the physician; the amendments were codified at 86 FR 33902,
(v) Starting in PY1, send a treatment June 28, 2021.
summary to each RO beneficiary’s re-
ferring physician within 3 months of § 512.225 Beneficiary notification.
the end of treatment to coordinate (a) General. Starting in PY1, each
care; Professional participant and Dual par-
(vi) Starting in PY1, discuss with ticipant must notify each RO bene-
each RO beneficiary prior to treatment ficiary to whom it furnishes included
delivery his or her inclusion in, and RT services—
cost-sharing responsibilities under, the (1) That the RO participant is par-
RO Model; and ticipating in the RO Model;
(vii) Starting in PY1, perform and (2) That the RO beneficiary has the
document Peer Review (audit and feed- opportunity to decline claims data
back on treatment plans) before 25 per- sharing for care coordination and qual-
cent of the total prescribed dose has ity improvement purposes. If an RO
been delivered and within 2 weeks of beneficiary declines claims data shar-
the start of treatment for: ing for care coordination and quality
1019
§ 512.230 42 CFR Ch. IV (10–1–24 Edition)
improvement purposes, then the RO sociated with each included cancer

participant must inform CMS within 30 type.
days of receiving notification from the
RO beneficiary that the beneficiary is FR 63996, Nov. 16, 2021]
declining to have his or her claims data
shared in that manner; and, § 512.235 Included RT services.
(3) Of the RO beneficiary’s cost-shar-
ing responsibilities. (a) Only the following RT services
(b) Form and manner of notification. furnished using an included modality
Notification of the information speci- identified at § 512.240 for an included
fied in paragraph (a) of this section cancer type are included RT services
must be carried out by an RO partici- that are paid for by CMS under
pant by providing each RO beneficiary § 512.265:
with a CMS-developed standardized (1) Treatment planning;
written notice during the RO bene- (2) Technical preparation and special
ficiary’s initial treatment planning services;
session. The RO participants must fur- (3) Treatment delivery; and,
nish the notice to the RO beneficiary (4) Treatment management.
in the form and manner specified by (b) All other RT services furnished by
CMS. an RO participant during the Model
(c) Applicability of general Innovation performance period are subject to
Center provisions. The beneficiary noti- Medicare FFS payment rules.
fications under this section are not de-
scriptive model materials and activi- § 512.240 Included modalities.
ties under § 512.120(c). The requirement
The modalities included in the RO
described in § 512.120(c)(2) does not
Model are 3-dimensional conformal RT
apply to the standardized written no-
(3DCRT), intensity-modulated RT
tice described in paragraph (b) of this
section. (IMRT), stereotactic radiosurgery
(SRS), stereotactic body RT (SBRT),
SCOPE OF RO EPISODES BEING TESTED proton beam therapy (PBT), and
image-guided radiation therapy
§ 512.230 Criteria for determining can- (IGRT).
cer types.
[86 FR 63996, Nov. 16, 2021]
(a) Included cancer types. CMS in-
cludes in the RO Model cancer types § 512.245 Included RO episodes.
that satisfy the following criteria:
(1) The cancer type is commonly (a) General. Any RO episode that be-
treated with radiation per nationally gins on or after the first day of the
recognized, evidence-based clinical model performance period and ends on
treatment guidelines; or before the last day of the model per-
(2) The cancer type has one or more formance period is included in the
associated current ICD–10 codes that model performance period.
have demonstrated pricing stability; (b) Death or election of hospice benefit.
and An RO episode is included in, and paid
(3) The Secretary has not determined for under, the RO Model if the RO bene-
that the cancer type is not suitable for ficiary dies after the TC of an RO epi-
inclusion in the RO Model. sode has been initiated, or if the RO
(b) Removing cancer types. CMS re- beneficiary elects the Medicare hospice
moves cancer types in the RO Model if benefit after the initial treatment
it determines: planning service, provided that the TC
(1) That there is a ≥10 percent error is initiated within 28 days following
in established national base rates; or the initial treatment planning service.
(2) The cancer type does not meet the Each RO participant will receive both
criteria set forth in paragraph (a) of installments of the episode payment
this section. under such circumstances, regardless
(c) ICD–10 codes for included cancer of whether the RO beneficiary dies or
types. CMS displays on the RO Model elects the Medicare hospice benefit be-
website no later than 30 days prior to fore the relevant course of RT treat-
each PY the ICD–10 diagnosis codes as- ment has ended.
1020
(c) Clean periods. An RO episode must § 512.255 Determination of participant-

not be initiated for the same RO bene- specific professional episode pay-
ficiary during a clean period. ment and participant-specific tech-
nical episode payment amounts.
FR 86305, Dec. 29, 2020; 86 FR 63996, Nov. 16, (a) Thirty days before the start of
2021] each PY, CMS provides each RO partic-
EDITORIAL NOTE: At 85 FR 86305, Dec. 29, ipant its case mix and historical expe-
2020, this section was amended, effective Dec. rience adjustments for both the PC and
4, 2020; however, due to a publication error, TC as calculated in paragraphs (c)(3)
the amendments were codified at 86 FR 33902, and (4) of this section. If an RO partici-
June 28, 2021.
pant is not eligible to receive a histor-
PRICING METHODOLOGY ical experience adjustment or case mix
adjustment as described under para-
§ 512.250 Determination of national graph (c)(7) of this section, then CMS
base rates. provides a zero value for those adjust-
CMS determines a national base rate ments.
for the PC and TC for each included (b) Any episode used to calculate the
cancer type. participant-specific professional epi-
(a) National base rates are the histor- sode payment amounts and the partici-
ical average cost for an episode of care pant-specific technical episode pay-
for each of the included cancer types ment amounts for an RO participant is
prior to the Model performance period. subject to the exclusions described in
(b) National base rates are deter- § 512.250(b)(1) and (2).
mined in the following manner:
(c) CMS calculates the participant-
(1) CMS excludes from episode pric-
specific professional episode payment
ing and RO episode pricing any claim
containing an RT service furnished: amounts and participant-specific tech-
(i) In Maryland, Vermont, or any of nical episode payment amounts for
the U.S. Territories; each included cancer type using the
(ii) In the inpatient setting; following:
(iii) By an entity classified as an (1) Trend factors. For every PY, CMS
ASC, CAH, or PPS-exempt cancer hos- adjusts the national base rates for the
pital; or PC and TC of each cancer type by cal-
(iv) By an HOPD participating in the culating a separate trend factor for the
Pennsylvania Rural Health Model at PC and TC of each included cancer
the time the RT service was furnished. type.
(2) CMS excludes the following epi- (2) Geographic adjustment. CMS ad-
sodes from the determination of the justs the trended national base rates
national base rates: prior to applying each RO participant’s
(i) Episodes that are not linked to a case mix and historical experience, and
CBSA selected for participation in the prior to applying the discounts and
RO Model; withholds, for local cost and wage indi-
(ii) Episodes that are not attributed ces based on where RT services are fur-
to an RT provider or RT supplier;
nished, as described by existing geo-
(iii) Episodes that are not assigned
graphic adjustment processes in the
an included cancer type; or
(iv) Episodes for which the total al- OPPS and PFS.
lowed amount for RT services listed on (3) Case mix adjustment. CMS estab-
claims used to calculate an episode’s lishes and applies a case mix adjust-
payment amount is not greater than $0. ment to the national base rate after
(3) CMS calculates the episode the trend factor and geographic adjust-
amount CMS paid on average to RT ment have applied. The case mix ad-
providers and RT suppliers for the PC justment reflects episode or RO episode
and TC for each of the included cancer characteristics that may be beyond the
types in the HOPD setting, creating control of RO participants such as can-
the RO Model’s national base rates. cer type, age, sex, presence of a major
[85 FR 61362, Sept. 29, 2020, as amended at 86 procedure, death during the episode,
FR 63996, Nov. 16, 2021] and presence of chemotherapy.
1021
§ 512.255 42 CFR Ch. IV (10–1–24 Edition)
(4) Historical experience adjustment. episodes in the rolling 3-year period

CMS establishes and applies a histor- used to determine the case mix adjust-
ical experience adjustment to the na- ment for each PY and that have never
tional base rate after the trend factor, received a case mix adjustment do not
geographic adjustment, and case mix receive a case mix adjustment for that
adjustment have been applied. The his- PY.
torical experience adjustments reflect (iv) RO participants that have fewer
each RO participant’s actual historical than 60 episodes in the baseline period
experience. and were furnishing included RT serv-
(5) Blend. CMS blends each RO par- ices in the CBSAs selected for partici-
ticipant’s historical experience adjust- pation before the start of the model
ment and the geographically-adjusted performance period are eligible to re-
trended national base rate. The blend ceive a stop-loss reconciliation
for RO participants with a professional amount, if applicable, as described in
historical experience adjustment or § 512.285(f).
technical historical experience adjust- (8) Discount factor. CMS reduces each
ment with a value equal to or less than episode payment by the discount factor
zero is 90/10, meaning the calculation of after applying the trend factor, geo-
the participant-specific episode pay- graphic adjustment, and case mix and
ment amount is weighted according to historical experience adjustments to
90 percent of the RO participant’s his- the national base rate.
torical experience adjustment and 10 (9) Incorrect payment withhold. To ac-
percent of the geographically-adjusted count for duplicate RT services and in-
trended national base for PY1 through complete episodes:
PY5. The blend for RO participants (i) CMS withholds from each RO par-
with a professional historical experi- ticipant 1 percent from each episode
ence adjustment or technical historical payment, after applying the trend fac-
experience adjustment of more than tor, geographic adjustment, case mix
zero is 90/10 in PY1, 85/15 in PY2, 80/20 in and historical experience adjustments,
PY3, 75/25 in PY4, and 70/30 in PY5. and discount to the national base rate.
(6) Changes in business structure. (i) (ii) CMS determines during the an-
RO participants must notify CMS in nual reconciliation process set forth at
writing of a merger, acquisition, or § 512.285 whether an RO participant is
other new clinical or business relation- eligible to receive a portion or all of
ship, at least 90 days before the date of the withheld amount or whether any
the change as described in § 424.516. payment is owed to CMS.
(ii) CMS updates case mix and histor- (10) Quality withhold. In accordance
ical experience adjustments according with § 414.1415(b)(1) of this chapter,
to the relevant treatment history that CMS withholds 2 percent from each
applies as a result of a merger, acquisi- professional episode payment after ap-
tion, or other new clinical or business plying the trend factor, geographic ad-
relationship in the RO participant’s justment, case mix and historical expe-
case mix and historical experience ad- rience adjustments, and discount fac-
justment calculations from the effec- tor to the national base rate. RO par-
tive date of the change. ticipants may earn back this withhold,
(7) Adjustments for RO participants in part or in full, based on their AQS.
with fewer than 60 episodes during the (11) Patient experience withhold. Start-
baseline period. (i) RO participants that ing in PY3,
have fewer than 60 episodes in the base- (i) CMS withholds 1 percent from
line period do not receive a historical each technical episode payment after
experience adjustment during the applying the trend factor, geographic
model performance period. adjustment, case mix and historical ex-
(ii) RO participants that have fewer perience adjustments, and discount fac-
than 60 episodes in the baseline period tor to the national base rate.
do not receive a case mix adjustment (ii) RO participants may earn back
for PY1. their patient-experience withhold, in
(iii) RO participants that have fewer part or in full, based on their results
than 60 episodes in the baseline period from the CAHPS® Cancer Care Radi-
that continue to have fewer than 60 ation Therapy survey.
1022
(12) Coinsurance. RO participants may the RO participant’s legacy TIN(s) or

collect beneficiary coinsurance pay- legacy CCN(s), and current TIN or CCN,
ments for services furnished under the during the 3-year period that deter-
RO Model in multiple installments mines the case mix adjustment for
under a payment plan. each PY.
(i) The availability of payment plans (ii) CMS calculates the RO partici-
may not be used as a marketing tool to pant’s historical experience adjust-
influence beneficiary choice of health ments in accordance with paragraph
care provider. (c)(4) of this section based on all epi-
(ii) RO participants offering a pay- sodes attributed to the RO partici-
ment plan may inform the RO bene- pant’s legacy TIN(s) or legacy CCN(s),
ficiary of the availability of the pay- and current TIN or CCN, during the
ment plan prior to or during the initial baseline period.
treatment planning session and as nec-
essary thereafter. [85 FR 61362, Sept. 29, 2020, as amended at 85
FR 86305, Dec. 29, 2020; 86 FR 63996, Nov. 16,
(iii) The beneficiary coinsurance pay- 2021]
ment equals 20 percent of the episode
payment amount to be paid to the RO EDITORIAL NOTE: At 85 FR 86305, Dec. 29,
participant(s) prior to the application 2020, this section was amended, effective Dec.
of sequestration for the billed RO 4, 2020; however, due to a publication error,
the amendments were codified at 86 FR 33902,
Model-specific HCPCS code with a SOE June 28, 2021.
modifier and for the billed RO Model-
specific HCPCS code with an EOE BILLING AND PAYMENT
modifier for the PC and TC, except as
provided in paragraph (c)(12)(iv) and(v) § 512.260 Billing.
of this section.
(a) Reassignment of billing rights. Each
(iv) In the case of incomplete epi-
Professional participant and Dual par-
sodes, the beneficiary coinsurance pay-
ticipant must ensure that its indi-
ment equals 20 percent of the FFS
vidual practitioners reassign their bill-
amounts that would have been paid in
ing rights to the TIN of the Profes-
the absence of the RO Model for the
sional participant or Dual participant.
services furnished by the RO partici-
pant that initiated the PC and the RO (b) Billing under the RO Model. (1)
participant that initiated the TC (if ap- Professional participants and Dual par-
plicable). ticipants must bill an RO Model-spe-
(v) In the case of duplicate RT serv- cific HCPCS code and a SOE modifier
ices, the beneficiary coinsurance pay- to indicate that the treatment plan-
ment equals 20 percent of the episode ning service has been furnished and
payment amount to be paid to the RO that an RO episode has been initiated.
participant(s) per § 512.255(c)(12)(iii) and (2) Dual participants and Technical
20 percent of the FFS amount to the participants must bill an RO Model-
RT provider and/or RT supplier fur- specific HCPCS code and SOE modifier
nishing one or more duplicate RT serv- to indicate that a treatment delivery
ices. service was furnished.
(13) Sequestration. In accordance with (3) RO participants must bill the
applicable law, CMS deducts a percent- same RO Model-specific HCPCS code
age from each episode payment after that initiated the RO episode and an
applying the trend factor, geographic EOE modifier to indicate that the RO
adjustment, case mix and historical ex- episode has ended.
perience adjustments, discount, with- (4) RO participants may submit a
holds, and coinsurance to the national claim with an EOE modifier only after
base rate. the RT course of treatment has ended,
(14) Modifications to the participant- except that such claim must not be
specific adjustments for changes in TINs submitted earlier than 28 days after
or CCNs. (i) CMS calculates the RO par- the date of the initial treatment plan-
ticipant’s case mix adjustments in ac- ning service.
cordance with paragraph (c)(3) of this (c) Billing for RT services performed
section based on all episodes and RO during a clean period. RO participants
episodes, as applicable, attributed to must bill for any medically necessary
1023
§ 512.265 42 CFR Ch. IV (10–1–24 Edition)
RT services furnished to an RO bene- amount, whether or not the RT pro-

ficiary during a clean period in accord- vider or RT supplier that furnished
ance with existing FFS billing proc- such services is an RO participant.
esses in the OPPS and PFS.
(d) Submission of no-pay claims. RO § 512.270 Treatment of add-on pay-
participants must submit no-pay ments under existing Medicare pay-
ment systems.
claims for any medically necessary in-
cluded RT services furnished to an RO (a) CMS does not make separate
beneficiary during an RO episode pur- Medicare FFS payments to RO partici-
suant to existing FFS billing processes pants for any included RT services that
in the OPPS and PFS. are furnished to an RO beneficiary dur-
ing an RO episode.
§ 512.265 Payment. (b) An RO participant may receive
(a) Payment for episodes. CMS pays an Medicare FFS payment for items and
RO participant for all included RT services furnished to an RO beneficiary
services furnished to an RO beneficiary during an RO episode, provided that
during a completed RO episode as fol- any such other item or service is not
lows: an included RT service.
(1) CMS pays a Professional partici- DATA REPORTING
pant a participant-specific professional
episode payment for the professional § 512.275 Quality measures, clinical
component furnished to an RO bene- data, and reporting.
ficiary during an RO episode. (a) Data privacy compliance. The RO
(2) CMS pays a Technical participant participant must—
a participant-specific technical episode (1) Comply with all applicable laws
payment for the technical component pertaining to any patient-identifiable
furnished to an RO beneficiary during data requested from CMS under the
an RO episode. terms of the Innovation Center model,
(3) CMS pays a Dual participant a including any patient-identifiable de-
participant-specific professional epi- rivative data, as well as the terms of
sode payment and a participant-spe- any attestation or agreement entered
cific technical episode payment for the into by the RO participant with CMS
professional component and technical as a condition of receiving that data.
component furnished to an RO bene- Such laws may include, without limita-
ficiary during an RO episode. tion, the privacy and security rules
(b) Payment installments. CMS makes promulgated under the Health Insur-
each of the payments described in para- ance Portability and Accountability
graph (a) of this section in two equal Act of 1996 (HIPAA), as modified, and
installments, as follows: the Health Information Technology for
(1) CMS pays one-half of a partici- Economic and Clinical Health Act
pant-specific professional episode pay- (HITECH).
ment to a Professional participant or (2) Contractually bind all down-
Dual participant or one-half of the par- stream recipients of CMS data to the
ticipant-specific technical episode pay- same terms and conditions to which
ment to a Technical participant or the RO participant was itself bound in
Dual participant after the RO partici- its agreements with CMS as a condi-
pant bills an RO Model-specific HCPCS tion of the downstream recipient’s re-
code with a SOE modifier. ceipt of the data from the RO partici-
(2) CMS pays the remaining half of a pant.
participant-specific professional epi- (b) RO participant public release of pa-
sode payment to a Professional partici- tient de-identified information. The RO
pant or Dual participant or one-half of participant must include the dis-
the participant-specific technical epi- claimer codified at § 512.120(c)(2) on the
sode payment to a Technical partici- first page of any publicly-released doc-
pant or Dual participant after the RO ument, the contents of which materi-
participant bills an RO Model-specific ally and substantially references or is
HCPCS code with an EOE modifier. materially and substantially based
(c) Duplicate RT services. Duplicate upon the RO participant’s participa-
RT services are reimbursed at the FFS tion in the RO Model, including but not
1024
limited to press releases, journal arti- apply the MIPS payment adjustment
cles, research articles, descriptive arti- factor, and, as applicable, the addi-
cles, external reports, and statistical/ tional MIPS payment adjustment fac-
analytical materials. tor (collectively referred to as the
(c) Reporting quality measures and clin- MIPS payment adjustment factors) to
ical data elements. In addition to report- the TC of RO Model payments to the
ing described in other provisions in extent that the MIPS payment adjust-
this part, Professional participants and ment factors would otherwise apply to
Dual participants must report selected the TC of RO Model payments.
quality measures on all patients and (d) APM Incentive Payment. CMS
clinical data elements describing can- waives the requirements of § 414.1450(b)
cer stage, disease characteristics, of this chapter such that technical
treatment intent, and specific treat- component payment amounts under
ment plan information on beneficiaries the RO Model shall not be considered
treated for specified cancer types, in in calculation of the aggregate pay-
the form, manner, and at a time speci- ment amount for covered professional
fied by CMS. services as defined in section
(d) Technical participants and reporting 1848(k)(3)(A) of the Act for the APM In-
of quality measures and clinical data ele- centive Payment made under
ments. Technical participants that are § 414.1450(b)(1) of this chapter.
freestanding radiation therapy centers (e) PFS Relativity Adjuster. CMS
and also begin furnishing the profes- waives the requirement to apply the
sional component during the model PFS Relativity Adjuster to RO Model-
performance period must: specific APCs for RO participants that
(1) Notify CMS no later than 30 days are non-excepted off-campus provider-
after the technical participant begins based departments (PBDs) identified by
furnishing the professional component, section 603 of the Bipartisan Budget
in a form and manner specified by Act of 2015 (Pub. L. 114–74), which
CMS; and amended section 1833(t)(1)(B)(v) and
(2) Report quality measures and clin- added paragraph (t)(21) to the Social
ical data elements by the next submis- Security Act.
sion period, as described in paragraph (f) General payment waivers. CMS
(c) of this section. waives the following sections of the
Act solely for the purposes of testing
FR 63996, Nov. 16, 2021] the RO Model:
(1) 1833(t)(1)(A).
MEDICARE PROGRAM WAIVERS (2) 1833(t)(16)(D).
(3) 1848(a)(1).
§ 512.280 RO Model Medicare program (4) [Reserved].
waivers. (5) 1869 claims appeals procedures.
(a) General. The Secretary may waive [85 FR 61362, Sept. 29, 2020, as amended at 86
certain requirements of title XVIII of FR 63997, Nov. 16, 2021]
the Act as necessary solely for pur-
poses of testing of the RO Model. Such RECONCILIATION AND REVIEW PROCESS
waivers apply only to the participants
in the RO Model. § 512.285 Reconciliation process.
(b) Hospital Outpatient Quality Report- (a) General. CMS conducts an initial
ing (OQR) Program. CMS waives the ap- reconciliation and a true-up reconcili-
plication of the Hospital OQR Program ation for each RO participant for each
2.0 percentage point reduction under PY in accordance with this section.
section 1833(t)(17) of the Act for only (b) Annual reconciliation calculations.
those Ambulatory Payment Classifica- (1) To determine the reconciliation
tions (APCs) that include only RO payment or the repayment amount
Model-specific HCPCS codes during the based on RO episodes initiated in a PY,
Model performance period. CMS performs the following steps:
(c) Merit-based Incentive Payment Sys- (i) CMS calculates an RO partici-
tem (MIPS). CMS waives the require- pant’s incorrect episode payment rec-
ment under section 1848(q)(6)(E) of the onciliation amount as described in
Act and § 414.1405(e) of this chapter to paragraph (c) of this section.
1025
§ 512.285 42 CFR Ch. IV (10–1–24 Edition)
(ii) CMS calculates the RO partici- any included RT services furnished

pant’s quality reconciliation amount during such incomplete episodes, as de-
as described in paragraph (d) of this termined by no-pay claims. CMS owes
section, if applicable. this sum to the RO participant for such
(iii) CMS calculates the RO partici- incomplete episodes.
pant’s patient experience reconcili- (ii) The sum of the participant-spe-
ation amount, as described in para- cific episode payment amounts paid to
graph (e) of this section, if applicable. the RO participant for such incomplete
(iv) CMS calculates the stop-loss rec- episodes initiated in the PY.
onciliation amount, as described in (4) Total incorrect episode payment
paragraph (f) of this section, if applica- amount. CMS calculates the total in-
ble. correct episode payment amount as fol-
(v) CMS adds, as applicable, the in- lows:
correct episode payment reconciliation (i) If the sum described in paragraph
amount, any quality reconciliation (c)(3)(i) of this section is more than the
payment amount, any patient experi- sum described in paragraph (c)(3)(ii) of
ence reconciliation amount, and any this section, the difference is sub-
stop-loss reconciliation payment tracted from the total duplicate RT
amount. The sum of these amounts re- services amount described in paragraph
sults in a reconciliation payment or re- (c)(2) of this section and the resulting
payment amount. amount is the total incorrect episode
(2) CMS calculations use claims data payment amount.
available at the time of reconciliation. (ii) If the sum described in paragraph
(c) Incorrect episode payment reconcili- (c)(3)(i) of this section is less than the
ation amount. CMS calculates the in- sum described in paragraph (c)(3)(ii) of
correct episode payment reconciliation this section, the difference is added to
amount as follows: the total duplicate RT services amount
(1) Total incorrect payment withhold described in paragraph (c)(2) of this
amount. CMS calculates the total in- section and the resulting amount is the
correct payment withhold amount by total incorrect episode payment
adding the incorrect payment withhold amount.
amount for each episode initiated in (5) Incorrect episode payment reconcili-
the PY. ation amount. If the total incorrect epi-
(2) Total duplicate RT services amount. sode payment amount represents
CMS calculates the total duplicate RT money owed by the RO participant to
services amount by adding all FFS CMS, CMS subtracts the total incor-
amounts for duplicate RT services fur- rect episode payment amount from the
nished during each episode initiated in total incorrect payment withhold
the PY. The duplicate RT services amount. In the case that the total in-
amount is capped for each episode and correct episode payment amount rep-
will not be more than the participant- resents money owed by CMS to the RO
specific professional episode payment participant, CMS adds the total incor-
amount or participant-specific tech- rect episode payment amount to the
nical episode payment amount received total incorrect payment withhold
by the RO participant for an RO epi- amount. The resulting amount is the
sode, even if the duplicate RT services RO participant’s incorrect episode pay-
amount exceeds the participant-spe- ment reconciliation amount.
cific professional episode payment (d) Quality reconciliation payment
amount or the participant-specific amount. For Professional participants
technical episode payment amount. and Dual participants, CMS determines
(3) Total incomplete episode amount. the quality reconciliation payment
For incomplete episodes initiated in amount for each PY by multiplying the
the PY, CMS determines the total in- participant’s AQS (as a percentage) by
complete episode amount by calcu- the total quality withhold amount for
lating the difference between the fol- all RO episodes initiated during the
lowing amounts: PY.
(i) The sum of all FFS amounts that (e) Patient experience reconciliation
would have been paid to the RO partici- amount. For PY3 and subsequent PYs,
pant in the absence of the RO Model for CMS determines the patient experience
1026
reconciliation amount for RO partici- previous PY as a result of the true-up

pants by multiplying the participant’s reconciliation.
AQS (as a percentage) by the total pa- (3) The net reconciliation payment or
tient experience withhold amount for repayment amount owed.
all RO episodes initiated during the (i) Payment of amounts owed. (1) CMS
PY. issues a reconciliation payment to the
(f) Stop-loss reconciliation amount. RO participant in the amount specified
CMS determines the stop-loss rec- in the reconciliation report 30 days
onciliation amount for RO participants after the reconciliation report is
that have fewer than 60 episodes during deemed final.
the baseline period and were furnishing (2) The RO participant must pay a re-
included RT services before the start of payment amount to CMS in the
the model performance period in the amount specified in the reconciliation
CBSAs selected for participation by— report by a deadline specified by CMS.
(1) Using no-pay claims, CMS cal- If the RO participant fails to timely
culates the total FFS amount by sum- pay the full repayment amount, CMS
ming the FFS amounts that would recoups the repayment amount from
have been paid to the RO participant in any payments otherwise owed by CMS
the absence of the RO Model for all in- to the RO participant, including Medi-
cluded RT services furnished during care payments for items and services
the RO episodes initiated in the PY; unrelated to the RO Model.
and (3) No coinsurance is owed by an RO
(2) CMS calculates the sum of all par- beneficiary with respect to any repay-
ticipant-specific professional episode ment amount or reconciliation pay-
payments and participant-specific ment.
technical episode payments paid to the
RO participant for the RO episodes ini- FR 86305, Dec. 29, 2020; 86 FR 63997, Nov. 16,
tiated in the PY. 2021]
(3) If the total FFS amount exceeds
the sum of the participant-specific epi- 2020, this section was amended, effective Dec.
sode payment amounts for the PY by 4, 2020; however, due to a publication error,
more than 20 percent then CMS owes the amendments were codified at 86 FR 33902,
the RO participant the amount that ex- June 28, 2021.
ceeds 20 percent, either increasing the
amount of the RO participant’s rec- § 512.290 Timely error notice and re-
onciliation payment or reducing the consideration review process.
amount of the RO’s participant’s rec- (a) Timely error notice. Subject to the
onciliation repayment. limitations on review in § 512.170, an RO
(g) True-up reconciliation. CMS con- participant that identifies and wishes
ducts a true-up reconciliation in the to contest a suspected error in the cal-
same manner described in paragraph culation of its reconciliation payment
(b) of this section (except that the or repayment amount or AQS must
quality reconciliation payment provide written notice of the suspected
amount and the patient experience rec- calculation error to CMS within 45
onciliation amount are not calculated) days of the date of the reconciliation
to determine any additional reconcili- report. Such timely error notice must
ation payment or repayment amount be in a form and manner specified by
that are identified using 12-months of CMS. RO participants are not per-
claims run-out. mitted to contest the RO Model pricing
(h) Reconciliation report. CMS issues methodology or AQS methodology.
each RO participant a reconciliation (1) Unless a timely error notice is re-
report for each PY. Each reconciliation ceived by CMS within 45 days of the
report contains the following: date of issuance of a reconciliation re-
(1) The RO participant’s reconcili- port, the reconciliation payment or re-
ation payment or repayment amount, payment amount determination speci-
if any, for the relevant PY. fied in that reconciliation report is
(2) Any additional reconciliation pay- deemed binding and not subject to fur-
ment or repayment amount owed for a ther review.
1027
§ 512.292 42 CFR Ch. IV (10–1–24 Edition)
(2) If CMS receives a timely error no- (B) Was not involved in the respond-
tice, then CMS responds in writing ing to the RO participant’s timely
within 30 days either to confirm that error notice.
there was an error in the calculation or (ii) Notification to the RO participant.
to verify that the calculation is cor- The CMS-designated reconsideration
rect. CMS may extend the deadline for official makes reasonable efforts to no-
its response upon written notice to the tify the RO participant and CMS in
RO participant. writing within 15 days of receiving the
(3) Only the RO participant may use RO participant’s reconsideration re-
the timely error notice process de- view request of the following:
scribed in this paragraph and the re- (A) The issue(s) in dispute;
consideration review process described (B) The briefing schedule; and
in paragraph (b) of this section. (C) The review procedures.
(b) Reconsideration review—(1) Recon- (5) Resolution review. The CMS recon-
sideration request by an RO participant. sideration official makes all reasonable
(i) If the RO participant is dissatisfied efforts to complete the on-the-record
with CMS’ response to the timely error resolution review and issue a written
notice, then the RO participant may determination no later than 60 days
request a reconsideration review as after the submission of the final posi-
specified in paragraph (b)(2) of this section paper in accordance with the re-
tion. consideration official’s briefing sched-
(ii) If CMS does not receive a request ule.
for reconsideration from the RO partic-
ipant within 10 days of the issue date of § 512.292 Overlap with other models
tested under Section 1115A and
CMS’ response to the RO participant’s CMS programs.
timely error notice, then CMS’ re-
sponse to the timely error notice is Participant-specific professional epi-
deemed binding and not subject to fur- sode payments and Participant-specific
ther review. technical episode payments made
(2) Submission of a reconsideration re- under the RO Model are not adjusted to
quest—(i) Information needed in the re- reflect payments made under models
consideration request. The reconsider- being tested under 1115A of the Act or
ation review request must— the Medicare Shared Savings Program
(A) Provide a detailed explanation of under section 1899 of the Act.
the basis for the dispute; and [86 FR 63997, Nov. 16, 2021]
(B) Include supporting documenta-
tion for the RO participant’s assertion § 512.294 Extreme and uncontrollable
that CMS or its representatives did not circumstances.
accurately calculate the reconciliation (a) General. If CMS determines that
payment or repayment amount or AQS there is an EUC pursuant to paragraph
in accordance with the terms of this (b) of this section, CMS may grant RO
subpart. participants exceptions to the RO
(3) Form, manner, and deadline for sub- Model requirements under paragraph
mission of the reconsideration request. (c) of this section and revise the RO
The information specified in paragraph Model’s pricing methodology under
(b)(2)(i) of this section must be sub- paragraphs (e) and (f) of this section.
mitted— (b) Determination factors. CMS deter-
(i) In a form and manner specified by mines whether there is an EUC based
CMS; and on the following factors:
(ii) Within 10 days of the date of the (1) Whether the RO participants are
CMS response described in paragraph furnishing services within a geographic
(a)(2) of this section. area considered to be within an ‘‘emer-
(4) Designation of and notification from gency area’’ during an ‘‘emergency pe-
a CMS-designated reconsideration official. riod’’ as defined in section 1135(g) of
(i) Designation of reconsideration offi- the Social Security Act;
cial. CMS designates a reconsideration (2) Whether the geographic area with-
official who— in a county, parish, U.S. territory, or
(A) Is authorized to receive such re- tribal government designated under
quests; and the Stafford Act served as a condition
1028
precedent for the Secretary’s exercise during the next reconciliation and
of the 1135 waiver authority, or the Na- award all possible points in the subse-
tional Emergencies Act; or quent AQS calculation amount or to
(3) Whether a state of emergency has not apply the quality withhold to RO
been declared in the geographic area. Model payments during the EUC if
(c) Modified requirements. CMS may CMS removes the quality measure and
grant RO Participants exceptions to clinical data element reporting re-
the following RO Model requirements: quirements pursuant to paragraph
(1) Reporting requirements. CMS may (c)(1) of this section.
delay or exempt RO participants from
[86 FR 63997, Nov. 16, 2021]
one or more of the RO Model’s quality
measure or clinical data element re-
porting requirements if an EUC im- Subpart C—ESRD Treatment
pacts the RO participants’ ability to Choices Model
comply with quality measure or clin-
ical data element reporting require- GENERAL
ments. § 512.300 Basis and scope.
(2) Other requirements. CMS may issue
a notice on the RO Model website that (a) Basis. This subpart implements
may waive compliance with or modify the test of the End-Stage Renal Dis-
the following RO Model requirements: ease (ESRD) Treatment Choices (ETC)
(i) The requirement set forth at Model under section 1115A(b) of the
§ 512.220(a)(2)(vii) that RO participants Act. Except as specifically noted in
provide Peer Review (audit and feed- this subpart, the regulations under this
back on treatment plans). subpart must not be construed to affect
(ii) The requirement set forth at the applicability of other provisions af-
§ 512.220(a)(3) that RO participants ac- fecting providers and suppliers under
tively engage with an AHRQ-listed pa- Medicare FFS, including the applica-
tient safety organization (PSO). bility of provisions regarding payment,
(d) Model performance period. If CMS coverage, or program integrity.
determines that the EUC affects the (b) Scope. This subpart sets forth the
United States and if CMS determines following:
that the EUC would impact RO partici- (1) The duration of the ETC Model.
pants’ ability to implement the re- (2) The method for selecting ETC
quirements of the RO Model prior to Participants.
the start of the model performance pe- (3) The schedule and methodologies
riod, CMS may amend the model per- for the Home Dialysis Payment Adjust-
formance period. ment and Performance Payment Ad-
(e) Trend factor. If CMS determines justment.
that the EUC affects the entire United (4) The methodology for ETC Partici-
States, and if CMS determines that as pant performance assessment for pur-
a result of the EUC, the trend factor poses of the Performance Payment Ad-
(specific to the PC, TC, or both for an justment, including beneficiary attri-
included cancer type) for the upcoming bution, benchmarking and scoring, and
PY has increased or decreased by more calculating the Modality Performance
than 10 percent compared to the cor- Score.
responding trend factor of the previous (5) Monitoring and evaluation, in-
CY when FFS payment rates are held cluding quality measure reporting.
constant with the previous CY, CMS (6) Medicare payment waivers.
may modify the trend factor calcula-
tion for the PC, TC, or both the PC and § 512.310 Definitions.
TC of an included cancer type in a For purposes of this subpart, the fol-
manner that ensures the trend factor is lowing definitions apply.
consistent with the average utilization Adjusted ESRD PPS per Treatment
from the previous CY. Base Rate means the per treatment
(f) Quality withhold. In response to a payment amount as defined in § 413.230
national, regional, or local event, CMS of this chapter, including patient-level
may adjust the quality withhold by adjustments and facility-level adjust-
choosing to repay the quality withhold ments, and excluding any applicable
1029
§ 512.310 42 CFR Ch. IV (10–1–24 Edition)
training adjustment, add-on payment nosis code documented on any Medi-

amount, outlier payment amount, care claim.
transitional drug add-on payment ad- ESRD facility means an ESRD facility
justment (TDAPA) amount, and transi- as specified in § 413.171 of this chapter.
tional add-on payment adjustment for ETC Participant means an ESRD fa-
new and innovative equipment and sup- cility or Managing Clinician that is re-
plies (TPNIES) amount. quired to participate in the ETC Model
Benchmark Year (BY) means the 12- pursuant to § 512.325(a).
month period that begins 18 months
Facility Home Dialysis Payment Adjust-
prior to the start of a given measure-
ment (Facility HDPA) means the pay-
ment year (MY) from which data are
used to construct benchmarks against ment adjustment to the Adjusted
which to score an ETC Participant’s ESRD PPS per Treatment Base Rate
achievement and improvement on the for an ESRD facility that is an ETC
home dialysis rate and transplant rate Participant for the ESRD facility’s
for the purpose of calculating the ETC home dialysis claims, as described in
Participant’s MPS. §§ 512.340 and 512.350.
Clinical staff means a licensed social Facility Performance Payment Adjust-
worker or registered dietician/nutri- ment (Facility PPA) means the payment
tion professional who furnishes serv- adjustment to the Adjusted ESRD PPS
ices for which payment may be made per treatment base rate for an ESRD
under the physician fee schedule under facility that is an ETC Participant
the direction of and incident to the based on the ESRD facility’s MPS, as
services of the Managing Clinician who described in §§ 512.375(a) and 512.380.
is an ETC Participant. Health Equity Incentive means the
Clinician Home Dialysis Payment Ad- amount added to the ETC Participant’s
justment (Clinician HDPA) means the improvement score, calculated as de-
payment adjustment to the MCP for a scribed in § 512.370(c)(1), if the ETC Par-
Managing Clinician who is an ETC Par- ticipant’s aggregation group dem-
ticipant, for the Managing Clinician’s
onstrated sufficient improvement on
home dialysis claims, as described in
the home dialysis rate or transplant
§§ 512.345 and 512.350.
Clinician Performance Payment Adjust- rate for attributed beneficiaries who
ment (Clinician PPA) means the pay- are dual eligible or Medicare Low In-
ment adjustment to the MCP for a come Subsidy (LIS) recipients between
Managing Clinician who is an ETC Par- the Benchmark Year and the MY.
ticipant based on the Managing Clini- Home Dialysis Payment Adjustment
cian’s MPS, as described in §§ 512.375(b) (HDPA) means either the Facility
and 512.380. HDPA or the Clinician HDPA.
Comparison Geographic Area(s) means Home dialysis rate means the rate of
those HRRs that are not Selected Geo- ESRD Beneficiaries attributed to the
graphic Areas. ETC Participant who dialyzed at home
ESRD Beneficiary means a beneficiary during the relevant MY, as described in
who meets either of the following: § 512.365(b).
(1) Is receiving dialysis or other serv- Hospital referral regions (HRRs) means
ices for end-stage renal disease, up to the regional markets for tertiary med-
and including the month in which the ical care derived from Medicare claims
beneficiary receives a kidney trans- data as defined by the Dartmouth
plant up to and including the month in Atlas Project at https://
which the beneficiary receives a kidney www.dartmouthatlas.org/.
transplant.
Kidney transplant means a kidney
(2) Has already received a kidney
transplant and has a non-AKI dialysis transplant, alone or in conjunction
or MCP claim— with any other organ.
(i) At least 12 months after the bene- Living donor transplant (LDT) Bene-
ficiary’s latest transplant date; or ficiary means an ESRD Beneficiary who
(ii) Less than 12 months after the received a kidney transplant from a
beneficiary’s latest transplant date and living donor.
has a kidney transplant failure diag-
1030
Living donor transplant rate means the fined at § 410.48(a) of this chapter) who
rate of ESRD Beneficiaries and, if ap- is an ETC Participant.
plicable, Pre-emptive LDT Bene- Selected Geographic Area(s) are those
ficiaries attributed to the ETC Partici- HRRs selected by CMS pursuant to
pant who received a kidney transplant § 512.325(b) for purposes of selecting
from a living donor during the MY, as ESRD facilities and Managing Clini-
described in § 512.365(c)(1)(ii) and cians required to participate in the
§ 512.365(c)(2)(ii). ETC Model as ETC Participants.
Managing Clinician means a Medi- Subsidiary ESRD facility is an ESRD
care-enrolled physician or non-physi- facility owned in whole or in part by
cian practitioner, identified by a Na- another legal entity.
tional Provider Identifier (NPI), who Taxpayer Identification Number (TIN)
furnishes and bills the MCP for man-
means a Federal taxpayer identifica-
aging one or more adult ESRD Bene-
tion number or employer identification
ficiaries.
number as defined by the Internal Rev-
Measurement Year (MY) means the 12-
enue Service in 26 CFR 301.6109–1.
month period for which achievement
and improvement on the home dialysis Transplant rate means the sum of the
rate and transplant rate are assessed transplant waitlist rate and the living
for the purpose of calculating the ETC donor transplant rate, as described in
Participant’s MPS and corresponding § 512.365(c).
PPA. Each MY included in the ETC Transplant waitlist rate means the
Model and its corresponding PPA Pe- rate of ESRD Beneficiaries attributed
riod are specified in § 512.355(c). to the ETC Participant who were on
Modality Performance Score (MPS) the kidney transplant waitlist during
means the numeric performance score the MY, as described in § 512.365(c)(1)(i)–
calculated for each ETC Participant (ii) and § 512.365(c)(2)(i)–(ii).
based on the ETC Participant’s home [85 FR 61362, Sept. 29, 2020, as amended at 86
dialysis rate and transplant rate, as de- FR 62020, Nov. 8, 2021]
scribed in § 512.370(a), which is used to
determine the amount of the ETC Par- ESRD TREATMENT CHOICES MODEL
ticipant’s PPA, as described in § 512.380. SCOPE AND PARTICIPANTS
Monthly capitation payment (MCP)
means the monthly capitated payment § 512.320 Duration.
made for each ESRD Beneficiary to
CMS will apply the payment adjust-
cover all routine professional services
ments described in this subpart under
related to treatment of the patient’s
the ETC Model to claims with claim
renal condition furnished by the physi-
service dates beginning on or after Jan-
cian or non-physician practitioner as
specified in § 414.314 of this chapter. uary 1, 2021, and ending on or before
National Provider Identifier (NPI) June 30, 2027.
means the standard unique health iden- § 512.325 Participant selection and ge-
tifier used by health care providers for ographic areas.
billing payors, assigned by the Na-
tional Plan and Provider Enumeration (a) Selected participants. All Medicare-
System (NPPES) in 45 CFR part 162. certified ESRD facilities and Medicare-
Performance Payment Adjustment enrolled Managing Clinicians located
(PPA) means either the Facility PPA in a selected geographic area are re-
or the Clinician PPA. quired to participate in the ETC Model.
Performance Payment Adjustment Pe- (b) Selected Geographic Areas. CMS es-
riod (PPA Period) means the six-month tablishes the Selected Geographic
period during which a PPA is applied in Areas by selecting all HRRs for which
accordance with § 512.380. at least 20 percent of the component
Pre-emptive LDT Beneficiary means a zip codes are located in Maryland, and
beneficiary who received a kidney a random sample of 30 percent of HRRs,
transplant from a living donor prior to stratified by Census-defined regions
beginning dialysis. (Northeast, South, Midwest, and West).
Qualified staff means both clinical CMS excludes all U.S. Territories from
staff and any qualified person (as de- the Selected Geographic Areas.
1031
§ 512.330 42 CFR Ch. IV (10–1–24 Edition)
§ 512.330 Beneficiary notification. ing a calendar year subject to adjust-

ment as described in § 512.350 and the
(a) General. ETC Participants must
prominently display informational ma- beneficiary is at least 18 years old be-
terials in each of their office or facility fore the first day of the month.
locations where beneficiaries receive
§ 512.345 Payments subject to the Cli-
treatment to notify beneficiaries that nician HDPA.
the ETC Participant is participating in
the ETC Model. CMS provides the ETC CMS adjusts the amount otherwise
Participant with a template for these paid under Medicare Part B with re-
materials, indicating the required con- spect to MCP claims on claim lines
tent that the ETC Participant must with CPT codes 90965 and 90966 by the
not change and places where the ETC Clinician HDPA when the claim is sub-
Participant may insert its own original mitted by a Managing Clinician who is
content. The CMS-provided template an ETC Participant with a claim serv-
for the beneficiary notification will in- ice date during a calendar year subject
clude, without limitation, the fol- to adjustment as described in § 512.350
lowing information: and the beneficiary is at least 18 years
(1) A notification that the ETC Par- old before the first day of the month.
ticipant is participating in the ETC
Model; § 512.350 Schedule of home dialysis
(2) Instructions on how to contact payment adjustments.
the ESRD Network Organizations with CMS adjusts the payments specified
any questions or concerns about the in § 512.340 by the Facility HDPA and
ETC Participant’s participation in the adjusts the payments specified in
Model; § 512.345 by the Clinician HDPA, accord-
(3) An affirmation of the ESRD Bene- ing to the following schedule:
ficiary’s protections under Medicare, (a) Calendar year 2021: +3 percent.
including the beneficiary’s freedom to (b) Calendar year 2022: +2 percent.
choose his or her provider or supplier
(c) Calendar year 2023: +1 percent.
and to select the treatment modality
of his or her choice. PERFORMANCE PAYMENT ADJUSTMENT
(b) Applicability of general Innovation
Center model provisions. The require- § 512.355 Schedule of performance as-
ment described in § 512.120(c)(2) shall sessment and performance payment
not apply to the CMS-provided mate- adjustment.
rials described in paragraph (a) of this
(a) Measurement Years. CMS assesses
section. All other ETC Participant
ETC Participant performance on the
communications that are descriptive
home dialysis rate and the transplant
model materials and activities as de-
rate during each of the MYs. The first
fined under § 512.110 must meet the re-
MY begins on January 1, 2021, and the
quirements described in § 512.120(c).
final MY ends on June 30, 2026.
HOME DIALYSIS PAYMENT ADJUSTMENT (b) Performance Payment Adjustment
Period. CMS adjusts payments for ETC
§ 512.340 Payments subject to the Fa- Participants by the PPA during each of
cility HDPA. the PPA Periods, each of which cor-
CMS adjusts the Adjusted ESRD PPS responds to a MY. The first PPA Period
per Treatment Base Rate by the Facil- begins on July 1, 2022, and the final
ity HDPA on claim lines with Type of PPA Period ends on June 30, 2027.
Bill 072X, and with condition codes 74 (c) Measurement Years and Perform-
or 76, when the claim is submitted by ance Payment Adjustment Periods. MYs
an ESRD facility that is an ETC Par- and PPA Periods follow the following
ticipant with a claim service date dur- schedule:
1032
§ 512.360 Beneficiary population and at any point during the month, the
attribution. beneficiary—
(a) General. Except as provided in (1) Is not enrolled in Medicare Part
B;
paragraph (b) of this section, CMS at-
tributes ESRD Beneficiaries to an ETC (2) Is enrolled in Medicare Advan-
tage, a cost plan, or other Medicare
Participant for each month during a
managed care plan;
MY based on the ESRD Beneficiary’s
(3) Does not reside in the United
receipt of services specified in para-
States;
graph (c) of this section during that
(4) Is younger than 18 years of age be-
month, for the purpose of assessing the
fore the first day of the month of the
ETC Participant’s performance on the
claim service date;
home dialysis rate and transplant rate
(5) Has elected hospice;
during that MY. Except as provided in
(6) Is receiving dialysis only for any
paragraph (b) of this section, CMS at- acute kidney injury (AKI);
tributes Pre-emptive LDT Bene-
(7) Has a diagnosis of dementia at
ficiaries to a Managing Clinician for any point during the month of the
one or more months during a MY based claim service date or the preceding 12
on the Pre-emptive LDT Beneficiary’s months, as identified using the most
receipt of services specified in para- recent dementia-related criteria at the
graph (c)(2) of this section during that time of beneficiary attribution, using
MY, for the purpose of assessing the the CMS–HCC (Hierarchical Condition
Managing Clinician’s performance on Category) Risk Adjustment Model ICD–
the living donor transplant rate during 10–CM Mappings; or
that MY. CMS attributes ESRD Bene- (8) Is residing in or receiving dialysis
ficiaries and, if applicable, Pre-emptive in a skilled nursing facility (SNF) or
LDT Beneficiaries to the ETC Partici- nursing facility.
pant for each month during a MY ret- (c) Attribution services—(1) ESRD facil-
rospectively after the end of the MY. ity beneficiary attribution. To be attrib-
CMS attributes an ESRD Beneficiary uted to an ESRD facility that is an
to no more than one ESRD facility and ETC Participant for a month, an ESRD
no more than one Managing Clinician Beneficiary must not be excluded based
for a given month during a given MY. on the criteria specified in paragraph
CMS attributes a Pre-emptive LDT (b) of this section and must have re-
Beneficiary to no more than one Man- ceived renal dialysis services during
aging Clinician for a given MY. the month from the ESRD facility.
(b) Exclusions from attribution. CMS CMS does not attribute Pre-emptive
does not attribute an ESRD Bene- LDT Beneficiaries to ESRD facilities.
ficiary or Pre-emptive LDT Beneficiary (i) An ESRD Beneficiary is attributed
to an ETC Participant for a month if, to the ESRD facility at which the
1033
§ 512.360 42 CFR Ch. IV (10–1–24 Edition)
ESRD Beneficiary received the plu- beneficiary has had the most claims
rality of his or her dialysis treatments between the start of the MY and the
in that month, other than renal dialy- month in which the beneficiary re-
sis services for AKI, as identified by ceived the transplant for all months
claims with Type of Bill 072X, with between the start of the MY and the
claim service dates at the claim header month of the transplant.
through date during the month. (A) If no Managing Clinician has had
(ii) If the ESRD Beneficiary receives the plurality of claims for a given Pre-
an equal number of dialysis treatments emptive LDT Beneficiary such that
from two or more ESRD facilities in a multiple Managing Clinicians each had
given month, CMS attributes the the same number of claims for that
ESRD Beneficiary to the ESRD facility beneficiary during the MY, the Pre-
at which the beneficiary received the emptive LDT Beneficiary is attributed
earliest dialysis treatment that month. to the Managing Clinician associated
If the ESRD Beneficiary receives an with the latest claim service date at
equal number of dialysis treatments the claim line through date during the
from two or more ESRD facilities in a MY up to and including the month of
given month and the ESRD beneficiary the transplant.
received the earliest dialysis treatment (B) If no Managing Clinician had the
that month from more than one ESRD plurality of claims for a given Pre-
facility, CMS attributes the bene- emptive LDT Beneficiary such that
ficiary to one of the ESRD facilities multiple Managing Clinicians each had
that furnished the earliest dialysis the same number of services for that
treatment that month at random. beneficiary during the MY, and more
(2) Managing Clinician beneficiary at- than one of those Managing Clinicians
tribution. (i) An ESRD beneficiary who had the latest claim service date at the
is not excluded based on the criteria in claim line through date during the MY
paragraph (b) of this section is attrib- up to and including the month of the
uted to a Managing Clinician who is an transplant, the Pre-emptive LDT Bene-
ETC Participant for a month if that ficiary is randomly attributed to one of
Managing Clinician submitted an MCP these Managing Clinicians.
claim for services furnished to the ben- (iii) For MY3 through MY10, a Pre-
eficiary, identified with CPT codes emptive LDT Beneficiary who is not
90957, 90958, 90959, 90960, 90961, 90962, excluded based on the criteria in para-
90965, or 90966, with claim service dates graph (b) of this section is attributed
at the claim line through date during to the Managing Clinician who sub-
the month. mitted the most claims for services
(A) If more than one Managing Clini- furnished to the beneficiary in the 365
cian submits a claim for the MCP fur- days preceding the date in which the
nished to a single ESRD Beneficiary beneficiary received the transplant.
with a claim service date at the claim (A) If no Managing Clinician has had
line during the month, the ESRD Bene- the most claims for a given Pre-
ficiary is attributed to the Managing emptive LDT Beneficiary such that
Clinician associated with the earliest multiple Managing Clinicians each had
claim service date at the claim line the same number of claims for that
through date during the month. beneficiary in the 365 days preceding
(B) If more than one Managing Clini- the date of the transplant, the Pre-
cian submits a claim for the MCP fur- emptive LDT Beneficiary is attributed
nished to a single ESRD Beneficiary to the Managing Clinician associated
with the same earliest claim service with the latest claim service date at
date at the claim line through date for the claim line through date during the
the month, the ESRD Beneficiary is 365 days preceding the date of the
randomly attributed to one of these transplant.
Managing Clinicians. (B) If no Managing Clinician had the
(ii) For MY1 and MY2, a Pre-emptive most claims for a given Pre-emptive
LDT Beneficiary who is not excluded LDT Beneficiary such that multiple
based on the criteria in paragraph (b) Managing Clinicians each had the same
of this section is attributed to the number of claims for that beneficiary
Managing Clinician with whom the in the 365 days preceding the date of
1034
the transplant, and more than one of treatment beneficiary years plus one
those Managing Clinicians had the lat- half the total number of self dialysis
est claim service date at the claim line treatment beneficiary years for attrib-
through date during the 365 days pre- uted ESRD Beneficiaries during the
ceding the date of the transplant, the MY. For MY3 through MY10, the nu-
Pre-emptive LDT Beneficiary is ran- merator is the total number of home
domly attributed to one of these Man- dialysis treatment beneficiary years,
aging Clinicians. plus one half the total number of self
(C) The Pre-emptive LDT Beneficiary dialysis treatment beneficiary years,
is considered eligible for attribution plus one half the total number of noc-
under this paragraph (c)(2)(iii) if the
turnal in center dialysis beneficiary
Pre-emptive LDT Beneficiary has at
years for attributed ESRD Bene-
least 1-eligible month during the 12-
ficiaries during the MY.
month period that includes the month
of the transplant and the 11 months (A) Home dialysis treatment bene-
prior to the month of the transplant. ficiary years included in the numerator
An eligible month refers to a month are composed of those months during
during which the Pre-emptive LDT which attributed ESRD Beneficiaries
Beneficiary not does not meet exclu- received maintenance dialysis at home,
sion criteria in paragraph (b) of this such that 1-beneficiary year is com-
section. prised of 12-beneficiary months.
Months in which an attributed ESRD
FR 62021, Nov. 8, 2021] Beneficiary received maintenance di-
alysis at home are identified by claims
§ 512.365 Performance assessment. with Type of Bill 072X and condition
(a) General. For each MY, CMS sepa- codes 74 or 76.
rately assesses the home dialysis rate (B) Self dialysis treatment bene-
and the transplant rate for each ETC ficiary years included in the numerator
Participant based on the population of are composed of those months during
ESRD Beneficiaries and, if applicable, which attributed ESRD Beneficiaries
Pre-emptive LDT Beneficiaries attrib- received self dialysis in center, such
uted to the ETC Participant under that 1-beneficiary year is comprised of
§ 512.360. Information used to calculate 12-beneficiary months. Months in
the home dialysis rate and the trans- which an attributed ESRD Beneficiary
plant rate includes Medicare claims received self dialysis are identified by
data, Medicare administrative data, claims with Type of Bill 072X and con-
and data from the Scientific Registry dition code 72.
of Transplant Recipients. (C) Nocturnal in center dialysis bene-
(b) Home dialysis rate. CMS calculates ficiary years included in the numerator
the home dialysis rate for ESRD facili- are composed of those months during
ties and Managing Clinicians as fol- which attributed ESRD Beneficiaries
lows. received nocturnal in center dialysis,
(1) Home dialysis rate for ESRD facili- such that 1-beneficiary year is com-
ties. (i) The denominator is the total di-
prised of 12-beneficiary months.
alysis treatment beneficiary years for
Months in which an attributed ESRD
attributed ESRD Beneficiaries during
Beneficiary received nocturnal in cen-
the MY. Dialysis treatment beneficiary
ter dialysis are identified by claims
years included in the denominator are
with Type of Bill 072X and modifier UJ.
composed of those months during
which an attributed ESRD Beneficiary (iii) Information used to calculate
received maintenance dialysis at home the ESRD facility home dialysis rate
or in an ESRD facility, such that one includes Medicare claims data and
beneficiary year is composed of 12 ben- Medicare administrative data.
eficiary months. Months during which (iv) The ESRD facility home dialysis
attributed ESRD Beneficiaries received rate is aggregated, as described in
maintenance dialysis are identified by paragraph (e)(1) of this section.
claims with Type of Bill 072X. (2) Home dialysis rate for Managing Cli-
(ii) For MY1 and MY2, the numerator nicians. (i) The denominator is the
is the total number of home dialysis total dialysis treatment beneficiary
1035
§ 512.365 42 CFR Ch. IV (10–1–24 Edition)
years for attributed ESRD Bene- Beneficiary received nocturnal in cen-

ficiaries during the MY. Dialysis treat- ter dialysis are identified by claims
ment beneficiary years included in the with Type of Bill 072X and modifier UJ.
denominator are composed of those (iii) Information used to calculate
months during which an attributed the Managing Clinician home dialysis
ESRD Beneficiary received mainte- rate includes Medicare claims data and
nance dialysis at home or in an ESRD Medicare administrative data.
facility, such that one beneficiary year (iv) The Managing Clinician home di-
is comprised of 12 beneficiary months. alysis rate is aggregated, as described
Months during which an attributed in paragraph (e)(2) of this section.
ESRD Beneficiary received mainte- (c) Transplant rate. CMS calculates
nance dialysis are identified by claims the transplant rate for ETC Partici-
with CPT codes 90957, 90958, 90959, 90960, pants as follows.
90961, 90962, 90965, or 90966. (1) Transplant rate for ESRD facilities.
(ii) For MY1 and MY2, the numerator The transplant rate for ESRD facilities
is the total number of home dialysis is the sum of the transplant waitlist
treatment beneficiary years for attrib- rate for ESRD facilities, as described
uted ESRD Beneficiaries during the in paragraph (c)(1)(i) of this section,
MY plus one half the total number of and the living donor transplant rate for
self dialysis treatment beneficiary ESRD facilities, as described in para-
years. For MY3 through MY10, the nu- graph (c)(1)(ii) of this section.
merator is the total number of home (i) Transplant waitlist rate for ESRD
dialysis treatment beneficiary years, facilities. (A) The denominator is the
plus one half the total number of self total dialysis treatment beneficiary
dialysis treatment beneficiary years, years for attributed ESRD Bene-
plus one half the total number of noc- ficiaries during the MY. Dialysis treat-
turnal in center dialysis beneficiary ment beneficiary years included in the
years for attributed ESRD Bene- denominator are composed of those
ficiaries during the MY. months during which an attributed
(A) Home dialysis treatment bene- ESRD beneficiary received mainte-
ficiary years included in the numerator nance dialysis at home or in an ESRD
are composed of those months during facility, such that 1-beneficiary year is
which attributed ESRD Beneficiaries comprised of 12-beneficiary months.
received maintenance dialysis at home, For MY1 and MY2, months during
such that 1-beneficiary year is com- which an attributed ESRD Beneficiary
prised of 12-beneficiary months. received maintenance dialysis are iden-
Months in which an attributed ESRD tified by claims with Type of Bill 072X,
Beneficiary received maintenance di- excluding claims for beneficiaries who
alysis at home are identified by claims were 75 years of age or older at any
with CPT codes 90965 or 90966. point during the month. For MY3
(B) Self-dialysis treatment bene- through MY10, months during which an
ficiary years included in the numerator attributed ESRD Beneficiary received
are composed of those months during maintenance dialysis are identified by
which attributed ESRD Beneficiaries claims with Type of Bill 072X, exclud-
received self dialysis in center, such ing claims for beneficiaries who were 75
that 1-beneficiary year is comprised of years of age or older at any point dur-
12-beneficiary months. Months in ing the month, or had a vital solid
which an attributed ESRD Beneficiary organ cancer diagnosis and were receiv-
received self dialysis are identified by ing treatment with chemotherapy or
claims with Type of Bill 072X and con- radiation for vital solid organ cancer
dition code 72. during the MY.
(C) Nocturnal in center dialysis bene- (1) An attributed ESRD Beneficiary
ficiary years included in the numerator had a diagnosis of vital solid organ
are composed of those months during cancer in an MY if the beneficiary had
which attributed ESRD Beneficiaries any of the following diagnosis codes on
received nocturnal in center dialysis, any claim during the MY or the 6
such that 1-beneficiary year is com- months prior to the start of the MY:
prised of 12-beneficiary months. C22.0, C22.1, C22.2, C22.3, C22.4, C22.7,
Months in which an attributed ESRD C22.8, C22.9, C34.10–C34.12, C34.2, C34.30–
1036
C34.32, C34.80–C34.82, C34.90–C34.92, DW12B7Z, DW12B8Z, DW12B9Z,

C38.0, C38.8, C46.50–C46.52, C64.1, C64.2, DW12BB1, DW12BBZ, DW12BCZ,
C64.2, C78.00–C78.02, C78.7, C79.00–C79.02, DW12BYZ, DW22DZZ, DW22HZZ,
C7A.090, C7A.093, or C7B.02. DW22JZZ, DWY27ZZ, DWY28ZZ,
(2) An attributed ESRD Beneficiary DWY2FZZ, DW030ZZ, DW031ZZ,
received treatment with chemotherapy DW032ZZ, DW033Z0, DW033ZZ,
or radiation for vital solid organ can- DW034ZZ, DW035ZZ, DW036ZZ,
cer during the MY if the beneficiary DW1397Z, DW1398Z, DW1399Z, DW139BZ,
had a claim with any of the following DW139CZ, DW139YZ, DW13B6Z,
procedure codes on any claim during DW13B7Z, DW13B8Z, DW13B9Z,
the MY or the 6 months prior to the DW13BB1, DW13BBZ, DW13BCZ,
start of the MY: DB13BYZ, DW23DZZ, DW23HZZ,
(i) CPT® 96401–96402, 96405–96406, 96409, DW23JZZ, DWY37ZZ, DWY38ZZ,
96411, 96413, 96415–96417, 96420, 96422– DWY3FZZ, DW050ZZ, DW051ZZ,
26423, 96425, 96440, 96446, 96549, 77373, DW052ZZ, DW053Z0, DW053ZZ,
77401–77402, 77407, 77412, 77423, 77424– DW054ZZ, DW055ZZ, DW056ZZ,
77425, 77520, 77522–77523, 77525, 77761– DWY57ZZ, DWY58ZZ, DWY5FZZ,
77763, 77770–77772, 77778, 77789, 77799, DWY5GDZ, DWY5GFZ, DWY5GGZ,
79005, 79101, 79200, 79300, 79403, 79440, DWY5GHZ, DWY5GYZ.
79445, 79999. (B) The numerator is the total num-
(ii) ICD–10–PCS® DB020ZZ, DB021ZZ, ber of attributed beneficiary years for
DB022ZZ, DB023Z0, DB023ZZ, DB024ZZ, which attributed ESRD Beneficiaries
DB025ZZ, DB026ZZ, DB1297Z, DB1298Z, were on the kidney transplant waitlist.
DB1299Z, DB129BZ, DB129CZ, DB129YZ, Months during which an attributed
DB12B6Z, DB12B7Z, DB12B8Z, DB12B9Z, ESRD Beneficiary was on the kidney
DB12BB1, DB12BBZ, DB12BCZ, transplant waitlist are identified using
DB12BYZ, DB22DZZ, DB22HZZ, data from the SRTR database.
DB22JZZ, DBY27ZZ, DBY28ZZ, (ii) Living donor transplant rate for
DBY2FZZ, DBY2KZZ, DB070ZZ, ESRD facilities. (A) The denominator is
DB071ZZ, DB072ZZ, DB073Z0, DB073ZZ, the total dialysis treatment bene-
DB074ZZ, DB075ZZ, DB076ZZ, DB1797Z, ficiary years for attributed ESRD
DB1798Z, DB1799Z, DB179BZ, DB179CZ, Beneficiaries during the MY. Dialysis
DB179YZ, DB17B6Z, DB17B7Z, DB17B8Z, treatment beneficiary years included
DB17B9Z, DB17BB1, DB17BBZ, in the denominator are composed of
DB17BCZ, DB17BYZ, DB27DZZ, those months during which an attrib-
DB27HZZ, DB27JZZ, DBY77ZZ, uted ESRD Beneficiary received main-
DBY78ZZ, DBY7FZZ, DBY7KZZ, tenance dialysis at home or in an
DF000ZZ, DF001ZZ, DF002ZZ, DF003Z0, ESRD facility, such that 1-beneficiary
DF003ZZ, DF004ZZ, DF005ZZ, DF006ZZ, year is comprised of 12-beneficiary
DF1097Z, DF1098Z, DF1099Z, DF109BZ, months. For MY1 and MY2, months
DF109CZ, DF109YZ, DF10B6Z, DF10B7Z, during which an attributed ESRD Ben-
DF10B8Z, DF10B9Z, DF10BB1, eficiary received maintenance dialysis
DF10BBZ, DF10BCZ, DF10BYZ, are identified by claims with Type of
DF20DZZ, DF20HZZ, DF20JZZ, Bill 072X, excluding claims for bene-
DFY07ZZ, DFY08ZZ, DFY0CZZ, ficiaries who were 75 years of age or
DFY0FZZ, DFY0KZZ, DT000ZZ, older at any point during the month.
DT001ZZ, DT002ZZ, DT003Z0, DT003ZZ, For MY3 through MY10, months during
DT004ZZ, DT005ZZ, DT006ZZ, DT1097Z, which an attributed ESRD Beneficiary
DT1098Z, DT1099Z, DT109BZ, DT109CZ, received maintenance dialysis are iden-
DT109YZ, DT10B6Z, DT10B7Z, DT10B8Z, tified by claims with Type of Bill 072X,
DT10B9Z, DT10BB1, DT10BBZ, excluding claims for beneficiaries who
DT10BCZ, DT10BYZ, DT20DZZ, were 75 years of age or older at any
DT20HZZ, DT20JZZ, DTY07ZZ, point during the month, or had a vital
DTY08ZZ, DTY0CZZ, DTY0FZZ, solid organ cancer diagnosis and were
DW020ZZ, DW021ZZ, DW022ZZ, receiving treatment with chemo-
DW023Z0, DW023ZZ, DW024ZZ, therapy or radiation for vital solid
DW025ZZ, DW026ZZ, DW1297Z, organ cancer during the MY. Months in
DW1298Z, DW1299Z, DW129BZ, which an attributed ESRD Beneficiary
DW129CZ, DW129YZ, DW12B6Z, had a diagnosis of vital solid organ
1037
§ 512.365 42 CFR Ch. IV (10–1–24 Edition)
cancer are identified as described in ESRD Beneficiary received mainte-

paragraph (c)(1)(i)(A)(1) of this section. nance dialysis are identified by claims
Months in which an attributed ESRD with CPT codes 90957, 90958, 90959, 90960,
Beneficiary received treatment with 90961, 90962, 90965, or 90966, excluding
chemotherapy or radiation for vital claims for beneficiaries who were 75
solid organ cancer are identified as de- years of age or older at any point dur-
scribed in paragraph (c)(1)(i)(A)(2) of ing the month, or had a vital solid
this section. organ cancer diagnosis and were receiv-
(B) The numerator is the total num- ing treatment with chemotherapy or
ber of attributed beneficiary years for radiation for vital solid organ cancer
LDT Beneficiaries during the MY. Ben- during the MY. Months in which an at-
eficiary years for LDT Beneficiaries in- tributed ESRD Beneficiary had a diag-
cluded in the numerator are composed nosis of vital solid organ cancer are
of those months between the beginning identified as described in paragraph
of the MY up to and including the (c)(1)(i)(A)(1) of this section. Months in
month of the transplant for LDT Bene- which an attributed ESRD Beneficiary
ficiaries attributed to an ESRD facility received treatment with chemotherapy
during the month of the transplant. or radiation for vital solid organ can-
LDT Beneficiaries are identified using cer are identified as described in para-
information about living donor trans- graph (c)(1)(i)(A)(2) of this section.
plants from the SRTR Database and (B) The numerator is the total num-
Medicare claims data. ber of attributed beneficiary years for
(iii) The ESRD facility transplant
which attributed ESRD Beneficiaries
waitlist rate is risk adjusted, as de-
were on the kidney transplant waitlist.
scribed in paragraph (d) of this section.
Months during which an attributed
The ESRD facility transplant rate is
ESRD Beneficiary was on the kidney
aggregated, as described in paragraph
transplant waitlist are identified using
(e)(1) of this section.
data from the SRTR database.
(2) Transplant rate for Managing Clini-
cians. The transplant rate for Man- (ii) Living donor transplant rate for
aging Clinicians is the sum of the Managing Clinicians. (A) The denomi-
transplant waitlist rate for Managing nator is the sum of the total dialysis
Clinicians, as described in paragraph treatment beneficiary years for attrib-
(c)(2)(i) of this section, and the living uted ESRD Beneficiaries during the
donor transplant rate for Managing MY and the total Pre-emptive LDT
Clinicians, as described in paragraph beneficiary years for attributed bene-
(c)(2)(ii) of this section. ficiaries during the MY.
(i) Transplant waitlist rate for Man- (1) Dialysis treatment beneficiary
aging Clinicians. (A) The denominator is years included in the denominator are
the total dialysis treatment bene- composed of those months during
ficiary years for attributed ESRD which an attributed ESRD Beneficiary
Beneficiaries during the MY. Dialysis received maintenance dialysis at home
treatment beneficiary years included or in an ESRD facility, such that 1-
in the denominator are composed of beneficiary year is comprised of 12-ben-
those months during which an attrib- eficiary months. For MY1 and MY2,
uted ESRD Beneficiary received main- months during which an attributed
tenance dialysis at home or in an ESRD Beneficiary received mainte-
ESRD facility, such that 1-beneficiary nance dialysis are identified by claims
year is comprised of 12-beneficiary with CPT codes 90957, 90958, 90959, 90960,
months. For MY1 and MY2, months 90961, 90962, 90965, or 90966, excluding
during which an attributed ESRD Ben- claims for beneficiaries who were 75
eficiary received maintenance dialysis years of age or older at any point dur-
are identified by claims with CPT ing the month. For MY3 through MY10,
codes 90957, 90958, 90959, 90960, 90961, months during which an attributed
90962, 90965, or 90966, excluding claims ESRD Beneficiary received mainte-
for beneficiaries who were 75 years of nance dialysis are identified by claims
age or older at any point during the with CPT codes 90957, 90958, 90959, 90960,
month. For MY3 through MY10, 90961, 90962, 90965, or 90966, excluding
months during which an attributed claims for beneficiaries who were 75
1038
years of age or older at any point dur- to a Managing Clinician, from the be-
ing the month, or had a vital solid ginning of the MY up to and including
organ cancer diagnosis and were receiv- the month of the transplant. LDT
ing treatment with chemotherapy or Beneficiaries are identified using infor-
radiation for vital solid organ cancer mation about living donor transplants
during the MY. Months in which an at- from the SRTR Database and Medicare
tributed ESRD Beneficiary had a vital claims data.
solid organ cancer diagnosis are identi- (2) Beneficiary years for Pre-emptive
fied as described in paragraph LDT Beneficiaries included in the nu-
(c)(1)(i)(A)(1) of this section. Months in merator are composed of those months
which an attributed ESRD Beneficiary during which a Pre-emptive LDT Bene-
received treatment with chemotherapy ficiary is attributed to a Managing Cli-
or radiation for vital solid organ can- nician, from the beginning of the MY
cer are identified as described in para- up to and including the month of the
graph (c)(1)(i)(A)(2) of this section. transplant. Pre-emptive LDT Bene-
(2) MY1 and MY2, Pre-emptive LDT ficiaries are identified using informa-
beneficiary years included in the de- tion about living donor transplants
nominator are composed of those from the SRTR Database and Medicare
months during which a Pre-emptive claims data.
LDT Beneficiary is attributed to a (iii) The Managing Clinician trans-
Managing Clinician, from the begin- plant waitlist rate is risk adjusted, as
ning of the MY up to and including the described in paragraph (d) of this sec-
month of the living donor transplant. tion. The Managing Clinician trans-
For MY3 through MY10, Pre-emptive plant rate is aggregated, as described
LDT beneficiary years included in the in paragraph (e)(2) of this section.
denominator are composed of those (d) Risk adjustment. (1) CMS risk ad-
months during which a Pre-emptive justs the transplant waitlist rate based
LDT Beneficiary is attributed to a on beneficiary age with separate risk
Managing Clinician, from the begin- coefficients for the following age cat-
ning of the MY up to and including the egories of beneficiaries, with age com-
month of the living donor transplant, puted on the last day of each month of
excluding beneficiaries who had a vital the MY:
solid organ cancer diagnosis and were (i) 18 to 55.
receiving treatment with chemo- (ii) 56 to 70.
therapy or radiation for vital solid (iii) 71 to 74.
organ cancer during the MY. Months in (2) CMS risk adjusts the transplant
which an attributed ESRD Beneficiary waitlist rate to account for the relative
had a vital solid organ cancer diagnosis percentage of the population of bene-
are identified as described in paragraph ficiaries attributed to the ETC Partici-
(c)(1)(i)(A)(1) of this section. Months in pant in each age category relative to
which an attributed ESRD Beneficiary the national age distribution of bene-
received treatment with chemotherapy ficiaries not excluded from attribution.
or radiation for vital solid organ can- (e) Aggregation—(1) Aggregation for
cer are identified as described in para- ESRD facilities. An ESRD facility’s
graph (c)(1)(i)(A)(2) of this section. Pre- home dialysis rate and transplant rate
emptive LDT Beneficiaries are identi- are aggregated to the ESRD facility’s
fied using information about living aggregation group. The aggregation
donor transplants from the SRTR group for a Subsidiary ESRD facility
Database and Medicare claims data. includes all ESRD facilities owned in
(B) The numerator is the sum of the whole or in part by the same legal enti-
total number of attributed beneficiary ty located in the HRR in which the
years for LDT Beneficiaries during the ESRD facility is located. An ESRD fa-
MY and the total number of attributed cility that is not a Subsidiary ESRD
beneficiary years for Pre-emptive LDT facility is not included in an aggrega-
Beneficiaries during the MY. tion group.
(1) Beneficiary years for LDT Bene- (2) Aggregation for Managing Clini-
ficiaries included in the numerator are cians. A Managing Clinician’s home di-
composed of those months during alysis rate and transplant rate are ag-
which an LDT Beneficiary is attributed gregated to the Managing Clinician’s
1039
§ 512.370 42 CFR Ch. IV (10–1–24 Edition)
aggregation group. The aggregation transplant rate, as described in para-

group for a Managing Clinician who graph (d) of this section.
is— (ii) The ETC Participant’s MPS de-
(i) In a group practice is the practice termines the ETC Participant’s PPA,
group level, as identified by practice as described in § 512.380.
TIN; or (b) Achievement Scoring. CMS assesses
(ii) A solo practitioner is the indi- ETC Participant performance at the
vidual clinician level, as identified by aggregation group level on the home
NPI. dialysis rate and transplant rate
against achievement benchmarks con-
[85 FR 61362, Sept. 29, 2020, as amended at 86 structed based on the home dialysis
FR 62021, Nov. 8, 2021]
rate and transplant rate among aggre-
§ 512.370 Benchmarking and scoring. gation groups of ESRD facilities and
Managing Clinicians located in Com-
(a) General. (1) CMS assesses the parison Geographic Areas during the
home dialysis rate and transplant rate Benchmark Year. Achievement bench-
for each ETC Participant against the marks are calculated as described in
applicable benchmarks to calculate paragraph (b)(1) of this section and, for
an— MY3 through MY10, are stratified as
(i) Achievement score, as described in described in paragraph (b)(2) of this
paragraph (b) of this section; and section. For MY5 through MY10, the
(ii) Improvement score, as described ETC Participant’s achievement score is
in paragraph (c) of this section. subject to the restriction described in
(2)(i) CMS calculates the ETC Par- paragraph (b)(3) of this section.
ticipant’s MPS as the weighted sum of (1) Achievement benchmarks. CMS uses
the higher of the achievement score or the following scoring methodology to
the improvement score for the ETC assess an ETC Participant’s achieve-
Participant’s home dialysis rate and ment score.
TABLE 1 TO § 512.370(b)(1)—ETC MODEL SCHEDULE OF PPA ACHIEVMENT BENCHMARKS BY
MEASUREMENT YEAR
MY1 and MY2 MY3 and MY4 MY5 and MY6 MY7 and MY8 MY9 and MY10 Points
90th+ Percentile 1.1 * (90th+ Per- 1.2 * (90th+ Per- 1.3 * (90th+ Per- 1.4 * (90th+ Per- 2
of benchmark centile of centile of centile of centile of
rates for Com- benchmark benchmark benchmark benchmark
parison Geo- rates for Com- rates for Com- rates for Com- rates for Com-
graphic Areas parison Geo- parison Geo- parison Geo- parison Geo-
during the graphic Areas graphic Areas graphic Areas graphic Areas
Benchmark during the during the during the during the
Year. Benchmark Benchmark Benchmark Benchmark
Year). Year). Year). Year).
75th+ Percentile 1.1 * (75th+ Per- 1.2 * (75th+ Per- 1.3 * (75th+ Per- 1.4 * (75th+ Per- 1.5
Benchmark during the. during the during the during the
Year. Benchmark Year) Benchmark Benchmark Benchmark
Year). Year). Year).
50th+ Percentile 1.1 * (50th+ Per- 1.2 * (50th+ Per- 1.3 * (50th+ Per- 1.4 * (50th+ Per- 1
1040
TABLE 1 TO § 512.370(b)(1)—ETC MODEL SCHEDULE OF PPA ACHIEVMENT BENCHMARKS BY

MEASUREMENT YEAR—Continued
MY1 and MY2 MY3 and MY4 MY5 and MY6 MY7 and MY8 MY9 and MY10 Points
30th+ Percentile 1.1 * (30th+ Per- 1.2 * (30th+ Per- 1.3 * (30th+ Per- 1.4 * (30th+ Per- 0.5
<30th Percentile 1.1 * (<30th Per- 1.2 * (<30th Per- 1.3 * (<30th Per- 1.4 * (<30th Per- 0
(2) Stratifying achievement benchmarks. group’s historical performance on the

For MY3 through MY10, CMS stratifies home dialysis rate and transplant rate
achievement benchmarks based on the during the Benchmark Year to cal-
proportion of beneficiary years attrib- culate the ETC Participant’s improve-
uted to the aggregation group for ment score, as specified in paragraph
which attributed beneficiaries are dual (c)(1) of this section. For MY3 through
eligible or LIS recipients during the MY10, CMS assesses ETC Participant
MY. An ESRD Beneficiary or Pre- improvement on the home dialysis rate
emptive LDT Beneficiary is considered and transplant rate for ESRD Bene-
to be dual eligible or a LIS recipient ficiaries and, if applicable, Pre-emptive
for a given month if at any point dur- LDT Beneficiaries, who are dual eligi-
ing the month the beneficiary was dual ble or LIS recipients to determine
eligible or an LIS recipient based on whether to add the Health Equity In-
Medicare administrative data. CMS centive to the ETC Participant’s im-
stratifies the achievement benchmarks provement score, as specified in para-
into the following two strata: graph (c)(2) of this section.
(i) Stratum 1: 50 percent or more of at- (1) Improvement score calculation. CMS
tributed beneficiary years during the uses the following scoring methodology
MY are for beneficiaries who are dual to assess an ETC Participant’s im-
eligible or LIS recipients. provement score.
(ii) Stratum 2: Less than 50 percent of (i) Greater than 10 percent improve-
attributed beneficiary years during the ment relative to the Benchmark Year
MY are for beneficiaries who are dual rate: 1.5 points
eligible or LIS recipients. (ii) Greater than 5 percent improve-
(3) For MY5 through MY10, CMS will ment relative to the Benchmark Year
assign an achievement score to an ETC rate: 1 point
Participant for the home dialysis rate (iii) Greater than 0 percent improve-
or the transplant rate only if the ETC ment relative to the Benchmark Year
Participant’s aggregation group has a rate: 0.5 points
home dialysis rate or a transplant rate (iv) Less than or equal to the Bench-
greater than zero for the MY. mark Year rate: 0 points
(c) Improvement scoring. CMS assesses (v) For MY3 through MY10, when cal-
ETC Participant improvement on the culating improvement benchmarks
home dialysis rate and transplant rate constructed based on the ETC Partici-
against benchmarks constructed based pant’s aggregation group’s historical
on the ETC Participant’s aggregation performance on the home dialysis rate
1041
§ 512.370 42 CFR Ch. IV (10–1–24 Edition)
and transplant rate during the Bench- home dialysis rate for the MY, cal-
mark Year, CMS adds one beneficiary culated as specified in this paragraph
month to the numerator of the home (c)(2), is at least 2.5-percentage points
dialysis rate and adds one beneficiary higher than the transplant rate for the
month to the numerator of the trans- Benchmark Year, calculated as speci-
plant rate, such that the Benchmark fied in this paragraph (c)(2). If the ETC
Year rates cannot be equal to zero. Participant earns the Health Equity
(2) Health Equity Incentive. CMS cal- Incentive for the transplant rate im-
culates the ETC Participant’s aggrega- provement score, CMS adds 0.5 points
tion group’s home dialysis rate and to the ETC Participant’s transplant
transplant rate as specified in rate improvement score, calculated as
§§ 512.365(b) and 512.365(c), respectively, specified in paragraph (c)(1) of this sec-
using only attributed beneficiary years tion, unless the ETC Participant is in-
comprised of months during the MY in eligible to receive the Home Equity In-
which ESRD Beneficiaries and, if appli- centive as specified in paragraph
cable, Pre-emptive LDT Beneficiaries, (c)(2)(iii) of this section.
are dual eligible or LIS recipients.
(iii) An ETC Participant in an aggre-
CMS also calculates the threshold for
gation group with fewer than 11-attrib-
earning the Health Equity Incentive
uted beneficiary years comprised of
based on the ETC Participant’s aggre-
months in which ESRD Beneficiaries
gation group’s historical performance
and, if applicable, Pre-emptive LDT
on the home dialysis rate and trans-
plant rate during the Benchmark Year, Beneficiaries, are dual eligible or LIS
using only attributed beneficiary years recipients, during either the Bench-
comprised of months during the Bench- mark Year or the MY is ineligible to
mark Year in which ESRD Bene- earn the Health Equity Incentive.
ficiaries and, if applicable, Pre-emptive (d) Modality Performance Score. (1) For
LDT Beneficiaries, are dual eligible or MY1 and MY2, CMS calculates the ETC
LIS recipients. An ESRD Beneficiary Participant’s MPS as the higher of
or Pre-emptive LDT Beneficiary is con- ETC Participant’s achievement score
sidered to be dual eligible or a LIS re- or improvement score for the home di-
cipient for a given month if at any alysis rate, together with the higher of
point during the month the beneficiary the ETC Participant’s achievement
was dual eligible or a LIS recipient. score or improvement score for the
CMS determines whether a beneficiary transplant rate, weighted such that the
was dual eligible or a LIS recipient ETC Participant’s score for the home
based on Medicare administrative data. dialysis rate constitutes 2⁄3 of the MPS
(i) The ETC Participant earns the and the ETC Participant’s score for the
Health Equity Incentive for the home transplant rate constitutes 1⁄3 of the
dialysis rate improvement score if the MPS. CMS uses the following formula
home dialysis rate for the MY, cal- to calculate the ETC Participant’s
culated as specified in this paragraph MPS for MY1 and MY2:
(c)(2), is at least 2.5-percentage points Modality Performance Score = 2 × (Higher
higher than the home dialysis rate for of the home dialysis achievement or
the Benchmark Year, calculated as improvement score) + (Higher of the
specified in this paragraph (c)(2). If the transplant achievement or improve-
ETC Participant earns the Health Eq-
ment score)
uity Incentive for the home dialysis
rate improvement score, CMS adds 0.5 (2) For MY3 through MY10, CMS cal-
points to the ETC Participant’s home culates the ETC Participant’s MPS as
dialysis rate improvement score, cal- the higher of the ETC Participant’s
culated as specified in paragraph (c)(1) achievement score for the home dialy-
of this section, unless the ETC Partici- sis rate or the sum of the ETC Partici-
pant is ineligible to receive the Home pant’s improvement score for the home
Equity Incentive as specified in para- dialysis rate calculated as specified in
graph (c)(2)(iii) of this section. paragraph (c)(1) of this section and, if
(ii) The ETC Participant earns the applicable, the Health Equity Incen-
Health Equity Incentive for the trans- tive, calculated as described in para-
plant rate improvement score if the graph (c)(2)(i) of this section, together
1042
with the higher of the ETC Partici- § 512.375 Payments subject to adjust-
pant’s achievement score for the trans- ment.
plant rate or the sum of the ETC Par- (a) Facility PPA. CMS adjusts the Ad-
ticipant’s improvement score for the justed ESRD PPS per Treatment Base
transplant rate calculated as specified Rate by the Facility PPA on claim
in paragraph (c)(1) of this section and, lines with Type of Bill 072X, when the
if applicable, the Heath Equity Incen- claim is submitted by an ETC Partici-
tive, calculated as described in para- pant that is an ESRD facility and the
graph (c)(2)(ii) of this section, weighted beneficiary is at least 18 years old be-
such that the ETC Participant’s score fore the first day of the month, on
for the home dialysis rate constitutes claims with claim service dates during
2⁄3 of the MPS and the ETC Partici- the applicable PPA Period as described
pant’s score for the transplant rate in § 512.355(c).
constitutes 1⁄3 of the MPS. CMS uses (b) Clinician PPA. CMS adjusts the
the following formula to calculate the amount otherwise paid under Medicare
ETC Participant’s MPS for MY3 Part B with respect to MCP claims on
through MY10: claim lines with CPT codes 90957, 90958,
90959, 90960, 90961, 90962, 90965 and 90966
Modality Performance Score = 2 × (Higher by the Clinician PPA when the claim is
of the home dialysis achievement or submitted by an ETC Participant who
(home dialysis improvement score + is a Managing Clinician and the bene-
Health Equity Bonus †)) + (Higher of ficiary is at least 18 years old before
the transplant achievement or the first day of the month, on claims
(transplant improvement score + with claim service dates during the ap-
Health Equity Bonus†)) plicable PPA Period as described in
† The Health Equity Incentive is ap- § 512.355(c).
plied to the home dialysis improve-
§ 512.380 PPA Amounts and schedules.
ment score or transplant improve-
ment score only if earned by the ETC CMS adjusts the payments described
Participant. in § 512.375 based on the ETC Partici-
pant’s MPS calculated as described in
[85 FR 61362, Sept. 29, 2020, as amended at 86 § 512.370(d) according to the following
FR 62023, Nov. 8, 2021; 87 FR 67302, Nov. 7, amounts and schedules in Table 1 and
2022]
Table 2 to § 512.380.
1043
§ 512.385 42 CFR Ch. IV (10–1–24 Edition)
§ 512.385 PPA exclusions. (b) Data sharing with ETC Partici-

pants. CMS shares certain beneficiary-
(a) ESRD facilities. CMS excludes an
identifiable data as described in para-
aggregation group (as described in graph (b)(1) of this section and certain
§ 512.365(e)(1) of Subsidiary ESRD facili- aggregate data as described in para-
ties with fewer than 11 attributed graph (b)(2) of this section with ETC
ESRD beneficiary years during an MY Participants regarding their attributed
from the applicability of the Facility beneficiaries and performance under
PPA for the corresponding PPA Period. the ETC Model.
CMS excludes ESRD facilities that are (1) Beneficiary-identifiable data. CMS
not Subsidiary ESRD facilities with shares beneficiary-identifiable data
fewer than 11 attributed ESRD bene- with ETC Participants as follows:
ficiary years during an MY from the (i) CMS will make available certain
applicability of the Facility PPA for beneficiary-identifiable data for re-
the corresponding PPA Period. trieval by ETC Participants no later
(b) Managing Clinicians. CMS excludes than one month before the start of
an aggregation group (as described in each PPA Period, in a form and man-
§ 512.365(e)(2)) of Managing Clinicians ner specified by CMS. ETC Partici-
with fewer than 11 attributed ESRD pants may retrieve this data at any
beneficiary years during an MY from point during the relevant PPA Period.
the applicability of the Clinician PPA (ii) This beneficiary-identifiable data
for the corresponding PPA Period. includes, when available, the following
information for each PPA Period:
§ 512.390 Notification, data sharing, (A) The ETC Participant’s attributed
and targeted review.
beneficiaries’ names, Medicare Bene-
(a) Notification. CMS will notify each ficiary Identifiers, dates of birth, dual
ETC Participant, in a form and manner eligible status, and LIS recipient sta-
determined by CMS, of the ETC Par- tus.
ticipant’s attributed beneficiaries, (B) Data regarding the ETC Partici-
MPS, and PPA for a PPA Period no pant’s performance under the ETC
later than one month before the start Model, including, for each attributed
of the applicable PPA Period. beneficiary, as applicable: the number
1044
of months the beneficiary was attrib- compliant with the provisions of the
uted to the ETC Participant, home di- data sharing agreement, CMS may
alysis months, self-dialysis months, deem the ETC Participant ineligible to
nocturnal in-center dialysis months, retrieve beneficiary-identifiable data
transplant waitlist months, and under paragraph (b)(1)(i) of this section
months following a living donor trans- for any amount of time, and the ETC
plant. Participant may be subject to addi-
(iii) CMS shares this beneficiary- tional sanctions and penalties avail-
identifiable data on the condition that able under the law.
the ETC Participants observe all rel- (2) Aggregate data. CMS shares aggre-
evant statutory and regulatory provi- gate performance data with ETC Par-
sions regarding the appropriate use of ticipants as follows:
data and the confidentiality and pri- (i) CMS will make available certain
vacy of individually identifiable health aggregate data for retrieval by the ETC
information as would apply to a cov- Participant, in a form and manner to
ered entity under the regulations found be specified by CMS, no later than one
at 45 CFR parts 160 and 164 promul- month before each PPA Period.
gated under the Health Insurance Port- (ii) This aggregate data includes,
ability and Accountability Act of 1996 when available, the following informa-
(HIPAA), as amended, and comply with tion for each PPA Period, de-identified
the terms of the data sharing agree- in accordance with 45 CFR 164.514(b):
ment described in paragraph (b)(1)(iv) (A) The ETC Participant’s perform-
of this section. ance scores on the home dialysis rate,
(iv) If an ETC Participant wishes to transplant waitlist rate, living donor
retrieve the beneficiary-identifiable transplant rate, and the Health Equity
data specified in paragraph (b)(1)(ii) of Incentive.
this section, the ETC Participant must (B) The ETC Participant’s aggrega-
complete and submit, on at least an an- tion group’s scores on the home dialy-
nual basis, a signed data sharing agree- sis rate, transplant waitlist rate, and
ment, to be provided in a form and living donor transplant rate, and the
manner specified by CMS, under which Health Equity Incentive.
the ETC Participant agrees: (C) Information on how the ETC Par-
(A) To comply with the requirements ticipant’s and ETC Participant’s aggre-
for use and disclosure of this bene- gation group’s scores relate to the
ficiary-identifiable data that are im- achievement benchmark and improve-
posed on covered entities by the ment benchmark.
HIPAA regulations and the require- (D) The ETC Participant’s MPS and
ments of the ETC Model set forth in PPA for the corresponding PPA Period.
this part. (c) Targeted review process. An ETC
(B) To comply with additional pri- Participant may request a targeted re-
vacy, security, breach notification, and view of the calculation of the MPS. Re-
data retention requirements specified quests for targeted review are limited
by CMS in the data sharing agreement. to the calculation of the MPS, and may
(C) To contractually bind each down- not be submitted in regards to: The
stream recipient of the beneficiary- methodology used to determine the
identifiable data that is a business as- MPS; or the establishment of the home
sociate of the ETC Participant to the dialysis rate methodology, transplant
same terms and conditions to which rate methodology, achievement and
the ETC Participant is itself bound in improvement benchmarks and
its data sharing agreement with CMS benchmarking methodology, or PPA
as a condition of the business associ- amounts. The process for targeted re-
ate’s receipt of the beneficiary-identifi- views is as follows:
able data retrieved by the ETC Partici- (1) An ETC Participant has 90 days
pant under the ETC Model. (or a later date specified by CMS) to
(D) That if the ETC Participant mis- submit a request for a targeted review,
uses or discloses the beneficiary-identi- which begins on the day CMS makes
fiable data in a manner that violates available the MPS.
any applicable statutory or regulatory (2) CMS will respond to each request
requirements or that is otherwise non- for targeted review timely submitted
1045
§ 512.395 42 CFR Ch. IV (10–1–24 Edition)
and determine whether a targeted re- QUALITY MONITORING

view is warranted.
(3) The ETC Participant may include § 512.395 Quality measures.
additional information in support of CMS collects data on these two qual-
the request for targeted review at the ity measures for ESRD facilities that
time the request is submitted. If CMS are ETC Participants to monitor for
requests additional information from changes in quality outcomes. CMS con-
the ETC Participant, it must be products data collection and measure cal-
vided and received within 30 days of the culation using claims data and other
request. Non-responsiveness to the re- Medicare administrative data, includ-
quest for additional information may ing enrollment data:
result in the closure of the targeted re- (a) Standardized Mortality Ratio
view request. (SMR); NQF #0369.
(4) If, upon completion of a targeted (b) Standardized Hospitalization
review, CMS finds that there was an Ratio (SHR); NQF #1463.
error in the calculation of the ETC
Participant’s MPS such that an incor- MEDICARE PROGRAM WAIVERS
rect PPA has been applied during the
PPA period, CMS shall notify the ETC § 512.397 ETC Model Medicare pro-
Participant and must resolve any re- gram waivers and additional flexi-
sulting discrepancy in payment that bilities.
arises from the application of an incor- The following provisions are waived
rect PPA in a time and manner deter- solely for purposes of testing the ETC
mined by CMS. Model.
(d) Review of targeted review decisions. (a)(1) Medicare payment waivers. CMS
The Administrator may review a tar- waives the requirements of sections
geted review request when administra- 1833(a), 1833(b), 1848(a)(1), 1881(b), and
tive review is requested by an ETC Par- 1881(h)(1)(A) of the Act only to the ex-
ticipant within 15-calendar days of a tent necessary to make the payment
targeted review request determination adjustments under the ETC Model de-
made by CMS. scribed in this subpart.
(1) Administrative review. Within 45 (2) Beneficiary cost sharing. The pay-
days of the date of the ETC Partici- ment adjustments under the ETC
pant’s request for administrative re- Model described in this subpart do not
view, the CMS Administrator may act affect the beneficiary cost-sharing
as follows: amounts for Part B services furnished
(i) Decline to review a targeted re- by ETC Participants under the ETC
view request determination made by Model.
CMS; (b) CMS waives the following require-
(ii) Render a final decision based on ments of title XVIII of the Act solely
the CMS Administrator’s review of the for purposes of testing the ETC Model:
targeted review request determination; (1) CMS waives the requirement
or under section 1861(ggg)(2)(A)(i) of the
(iii) Choose to take no action on the Act and § 410.48(a) of this chapter that
request for administrative review. only doctors, physician assistants,
(2) Administrative review determina- nurse practitioners, and clinical nurse
tions. The targeted review determina- specialists can furnish kidney disease
tion made by the CMS Administrator is patient education services to allow
final if the CMS Administrator de- kidney disease patient education serv-
clines an ETC Participant’s request for ices to be provided by clinical staff (as
administrative review or if the CMS defined at § 512.310) under the direction
Administrator does not take any ac- of and incident to the services of the
tion on the ETC Participant’s request Managing Clinician who is an ETC Par-
for administrative review by the end of ticipant. The kidney disease patient
the 45-day period described in para- education services may be furnished
graph (d)(1) of this section. CMS–1782–F only by qualified staff (as defined at
[85 FR 61362, Sept. 29, 2020, as amended at 86 § 512.310). Beginning MY5, only clinical
FR 62024, Nov. 8, 2021; 88 FR 76506, Nov. 6, staff that are not leased from or other-
2023] wise provided by an ESRD facility or
1046
related entity may furnish kidney dis- locations specified in § 410.78(b)(3) of

ease patient education services pursu- this chapter.
ant to the waiver described in this sec- (c)(1) For kidney disease patient edu-
tion. cation services furnished on or after
(2) CMS waives the requirement that January 1, 2022, an ETC Participant
kidney disease patient education serv- may reduce or waive the 20 percent co-
ices are covered only for Stage IV insurance requirement under section
chronic kidney disease (CKD) patients 1833 of the Act if all of the following
under section 1861(ggg)(1)(A) of the Act conditions are satisfied:
and § 410.48(b)(1) of this chapter to per- (i) The individual or entity that fur-
mit beneficiaries diagnosed with CKD nished the kidney disease patient edu-
Stage V or within the first 6 months of cation services is qualified staff.
starting dialysis to receive kidney dis- (ii) The qualified staff are not leased
ease patient education services. from or otherwise provided by an
(3) CMS waives the requirement that ESRD facility or related entity.
the content of kidney disease patient (iii) The kidney disease patient edu-
education services include the manage- cation services were furnished to a ben-
ment of co-morbidities, including for eficiary described in § 410.48(b) or
the purpose of delaying the need for di- § 512.397(b)(2) who did not have sec-
alysis, under § 410.48(d)(1) of this chap- ondary insurance that provides cost-
ter when such services are furnished to sharing support for kidney disease pa-
beneficiaries with CKD Stage V or tient education services on the date
the services were furnished.
ESRD, unless such content is relevant
(iv) The kidney disease patient edu-
for the beneficiary.
cation services were furnished in com-
(4) CMS waives the requirement that
pliance with the applicable provisions
an outcomes assessment designed to of § 410.48 and § 512.397(b).
measure beneficiary knowledge about (v) The ETC Participant bears the
CKD and its treatment be performed as full cost of the reduction or waiver of
part of a kidney disease patient edu- the 20 percent coinsurance requirement
cation service under § 410.48(d)(5)(iii) of under section 1833 of the Act. The re-
this chapter, provided that such out- duction or waiver of the 20 percent co-
comes assessment is performed by insurance requirement under section
qualified staff within one month of the 1833 of the Act shall not be financed by
final kidney disease patient education a third party, including but not limited
service. to an ESRD facility or related entity.
(5) Beginning the upon the expiration (2) The ETC Participant must main-
of the Public Health Emergency (PHE) tain and provide the government with
for the COVID–19 pandemic, CMS access to records of the following infor-
waives the geographic and site of serv- mation in accordance with § 512.135(b)
ice originating site requirements in and (c):
sections 1834(m)(4)(B) and 1834(m)(4)(C) (i) The identity of the qualified staff
of the Act and § 410.78(b)(3) and (4) of who furnished the kidney disease pa-
this chapter for purposes of kidney dis- tient education services for which the
ease patient education services fur- coinsurance was reduced or waived and
nished by qualified staff via telehealth the date such services were furnished.
in accordance with this section, regard- (ii) The identity of the beneficiary
less of the location of the beneficiary who received the kidney disease pa-
or qualified staff. Beginning the upon tient education services for which the
the expiration of the Public Health coinsurance was reduced or waived.
Emergency (PHE) for the COVID–19 (iii) Evidence that the beneficiary
pandemic, CMS also waives the re- who received the kidney disease pa-
quirement in section 1834(m)(2)(B) of tient education services coinsurance
the Act and § 414.65(b) of this chapter waiver was eligible to receive the kid-
that CMS pay a facility fee to the orig- ney disease patient education services
inating site with respect to telehealth under the ETC Model and did not have
services furnished to a beneficiary in secondary insurance that provides
accordance with this section at an cost-sharing support for kidney disease
originating site that is not one of the patient education services.
1047
§ 512.500 42 CFR Ch. IV (10–1–24 Edition)
(iv) The amount of the kidney disease (14) Remedial action.

patient education coinsurance reduc- (15) Limitations on review.
tion or waiver provided by the ETC (16) Miscellaneous provisions on
Participant. bankruptcy and other notifications.
(3) The Federal anti-kickback stat- (17) Model termination by CMS.
ute safe harbor for CMS-sponsored (18) Decarbonization and resilience
model patient incentives (42 CFR initiative.
1001.952(ii)(2)) is available to protect
the kidney disease patient education § 512.505 Definitions.
coinsurance waivers that satisfy the For the purposes of this part, the fol-
requirements of such safe harbor and lowing definitions are applicable unless
paragraph (c)(1) of this section. otherwise stated:
[85 FR 61362, Sept. 29, 2020, as amended at 86 AAPM stands for Advanced Alter-
FR 62025, Nov. 8, 2021; 87 FR 67302, Nov. 7, native Payment Model.
2022] AAPM option means the advanced al-
ternative payment model option of
Subpart D [Reserved] TEAM for Track 2 and Track 3 TEAM
participants that provide their CMS
Subpart E—Transforming Episode EHR Certification ID and attest to
their use of CEHRT in accordance with
Accountability Model (TEAM) § 512.522.
ACO means an accountable care orga-
SOURCE: 89 FR 69914, Aug. 28, 2024, unless nization, as defined at § 425.20 of this
otherwise noted. chapter.
GENERAL ACO participant has the meaning set
forth in § 425.20 of this chapter.
§ 512.500 Basis and scope of subpart. ACO provider/supplier has the mean-
(a) Basis. This subpart implements ing set forth in § 425.20 of this chapter.
the test of the Transforming Episode Acute care hospital means a provider
Accountability Model (TEAM) under subject to the prospective payment
section 1115A(b) of the Act. Except as system specified in § 412.1(a)(1) of this
specifically noted in this part, the reg- chapter.
ulations under this subpart do not af- Age bracket risk adjustment factor
fect the applicability of other provi- means the coefficient of risk associated
sions affecting providers and suppliers with a patient’s age bracket, cal-
under Medicare FFS, including the ap- culated as described in § 512.545(a)(1).
plicability of provisions regarding pay- Aggregated reconciliation target price
ment, coverage, and program integrity. refers to the sum of the reconciliation
(b) Scope. This subpart sets forth the target prices for all episodes attributed
following: to a given TEAM participant for a
(1) Participation in TEAM. given performance year.
(2) Scope of episodes being tested. Alignment payment means a payment
(3) Pricing methodology. from a TEAM collaborator to a TEAM
(4) Quality measures and quality re- participant under a sharing arrange-
porting requirements. ment, for the sole purpose of sharing
(5) Reconciliation and review proc- the TEAM participant’s responsibility
esses. for making repayments to Medicare.
(6) Data sharing and other require- AMI stands for acute myocardial in-
ments farction
(7) Financial arrangements and bene- Anchor hospitalization means the ini-
ficiary incentives. tial hospital stay upon admission for
(8) Medicare program waivers an episode category included in TEAM,
(9) Beneficiary protections. as described in § 512.525(c), for which
(10) Cooperation in model evaluation the institutional claim is billed
and monitoring. through the inpatient prospective pay-
(11) Audits and record retention. ment system (IPPS).
(12) Rights in data and intellectual Anchor procedure means a procedure
property. related to an episode category, as de-
(13) Monitoring and compliance. scribed in § 512.525(c), included in
1048
TEAM that is permitted and paid for CEHRT means certified electronic
by Medicare when performed in a hos- health record technology that meets
pital outpatient department (HOPD) the requirements set forth in § 414.1305
and billed through the Hospital Out- of this chapter.
patient Prospective Payment System Change in control means any of the
(OPPS). following:
ADI stands for Area Deprivation (1) The acquisition by any ‘‘person’’
Index. (as this term is used in sections 13(d)
APM stands for Alternative Payment and 14(d) of the Securities Exchange
Model. Act of 1934) of beneficial ownership
APM Entity means an entity as de- (within the meaning of Rule 13d–3 pro-
fined in § 414.1305 of this chapter. mulgated under the Securities Ex-
Baseline episode spending refers to change Act of 1934), directly or indi-
total episode spending by all providers rectly, of voting securities of the
and suppliers associated with a given TEAM participant representing more
MS–DRG/HCPCS episode type for all than 50 percent of the TEAM partici-
hospitals in a given region during the pant’s outstanding voting securities or
baseline period. rights to acquire such securities.
Baseline period means the 3-year his- (2) The acquisition of the TEAM par-
torical period used to construct the ticipant by any individual or entity.
preliminary target price and reconcili- (3) The sale, lease, exchange, or other
ation target price for a given perform- transfer (in one transaction or a series
ance year. of transactions) of all or substantially
all of the assets of the TEAM partici-
Baseline year means any one of the 3
pant.
years included in the baseline period.
(4) The approval and completion of a
Benchmark price means average
plan of liquidation of the TEAM partic-
standardized episode spending by all
ipant, or an agreement for the sale or
providers and suppliers associated with
liquidation of the TEAM participant.
a given MS–DRG/HCPCS episode type
CJR stands for the Comprehensive
for all hospitals in a given region dur-
Care for Joint Replacement Model,
ing the applicable baseline period.
which is an episode-based payment
Beneficiary means an individual who model tested by the CMS Innovation
is enrolled in Medicare FFS. Center from April 2016 to December
Beneficiary who is dually eligible 2024.
means a beneficiary enrolled in both Clinician engagement list means the
Medicare and full Medicaid benefits. list of eligible clinicians or MIPS eligi-
BPCI stands for Bundled Payments ble clinicians that participate in
for Care Improvement, which was an TEAM activities and have a contrac-
episodelbased payment initiative with tual relationship with the TEAM par-
four models tested by the CMS Innova- ticipant, and who are not listed on the
tion Center from April 2013 to Sep- financial arrangements list, as de-
tember 2018. scribed in § 512.522(c).
BPCI Advanced stands for the Bun- CMS Electronic Health Record (EHR)
dled Payments for Care Improvement Certification ID means the identifica-
Advanced Model, which is an episode- tion number that represents the com-
based payment model tested by the bination of Certified Health Informa-
CMS Innovation Center from October tion Technology that is owned and
2018 to December 2025. used by providers and hospitals to pro-
CABG (Coronary Artery Bypass Graft vide care to their patients and is gen-
Surgery) means any coronary erated by the Certified Health Informa-
revascularization procedure paid tion Technology Product List.
through the IPPS under MS–DRGs 231– Collaboration agent means an indi-
236, including both elective CABG and vidual or entity that is not a TEAM
CABG procedures performed during ini- collaborator and that is either of the
tial acute myocardial infarction (AMI) following:
treatment. (1) A member of a PGP, NPPGP, or
CCN stands for CMS certification TGP that has entered into a distribu-
number. tion arrangement with the same PGP,
1049
§ 512.505 42 CFR Ch. IV (10–1–24 Edition)
NPPGP, or TGP in which he or she is metrics and questions related to emis-

an owner or employee, and where the sions in accordance with § 512.598.
PGP, NPPGP, or TGP is a TEAM col- Descriptive TEAM materials and activi-
laborator. ties means general audience materials
(2) An ACO participant or ACO pro- such as brochures, advertisements, out-
vider/supplier that has entered into a reach events, letters to beneficiaries,
distribution arrangement with the web pages, mailings, social media, or
same ACO in which it is participating, other materials or activities distrib-
and where the ACO is a TEAM collabo- uted or conducted by or on behalf of
rator. the TEAM participant or its down-
Composite quality score (CQS) means a stream participants when used to edu-
score computed for each TEAM partici- cate, notify, or contact beneficiaries
pant to summarize the TEAM partici- regarding TEAM. All of the following
pant’s level of quality performance and communications are not descriptive
improvement on specified quality TEAM materials and activities:
measures as described in § 512.547. (1) Communications that do not di-
Core-based statistical area (CBSA) rectly or indirectly reference TEAM
means a statistical geographic entity (for example, information about care
defined by the Office of Management coordination generally).
and Budget (OMB) consisting of the (2) Information on specific medical
county or counties associated with at conditions.
least one core (urbanized area or urban (3) Referrals for health care items
cluster) of at least 10,000 population, and services, except as required by
plus adjacent counties having a high § 512.564.
degree of social and economic integra- (4) Any other materials that are ex-
tion with the core as measured through cepted from the definition of ‘‘mar-
commuting ties with the counties con- keting’’ as that term is defined at 45
taining the core. CFR 164.501.
CORF stands for comprehensive out- Discount factor means a set percent-
patient rehabilitation facility. age included in the preliminary target
price and reconciliation target price
Covered services means the scope of
intended to reflect Medicare’s poten-
health care benefits described in sec-
tial savings from TEAM.
tions 1812 and 1832 of the Act for which
Distribution arrangement means a fi-
payment is available under Part A or
nancial arrangement between a TEAM
Part B of Title XVIII of the Act.
collaborator that is an ACO, PGP,
Critical access hospital (CAH) means a
NPPGP, or TGP and a collaboration
hospital designated under subpart F of
agent for the sole purpose of distrib-
part 485 of this chapter.
uting some or all of a gainsharing pay-
CQS adjustment amount means the ment received by the ACO, PGP,
amount subtracted from the positive or NPPGP, or TGP.
negative reconciliation amount to gen- Distribution payment means a pay-
erate the reconciliation payment or re- ment from a TEAM collaborator that is
payment amount. an ACO, PGP, NPPGP, or TGP to a col-
CQS adjustment percentage means the laboration agent, under a distribution
percentage CMS applies to the positive arrangement, composed only of
or negative reconciliation amount gainsharing payments.
based on the TEAM participant’s CQS DME stands for durable medical
performance. equipment.
CQS baseline period means the time Downstream collaboration agent means
period used to benchmark quality an individual who is not a TEAM col-
measure performance. laborator or a collaboration agent and
Days means calendar days. who is a member of a PGP, NPPGP, or
Decarbonization and Resilience Initia- TGP that has entered into a down-
tive means an initiative for TEAM par- stream distribution arrangement with
ticipants that includes technical as- the same PGP, NPPGP, or TGP in
sistance on decarbonization and a vol- which he or she is an owner or em-
untary reporting program where TEAM ployee, and where the PGP, NPPGP, or
participants may annually report TGP is a collaboration agent.
1050
Downstream distribution arrangement Financial arrangements list means the

means a financial arrangement be- list of eligible clinicians or MIPS eligi-
tween a collaboration agent that is ble clinicians that have a financial ar-
both a PGP, NPPGP, or TGP and an rangement with the TEAM participant,
ACO participant and a downstream col- TEAM collaborator, collaboration
laboration agent for the sole purpose of agent, and downstream collaboration
sharing a distribution payment reagent, as described in § 512.522(b).
ceived by the PGP, NPPGP, or TGP. Gainsharing payment means a pay-
Downstream participant means an in- ment from a TEAM participant to a
dividual or entity that has entered into TEAM collaborator, under a sharing
a written arrangement with a TEAM arrangement, composed of only rec-
participant, TEAM collaborator, col- onciliation payments, internal cost
laboration agent, or downstream col- savings, or both.
laboration agent under which the
HCPCS stands for Healthcare Com-
downstream participant engages in one
mon Procedure Coding System, which
or more TEAM activities.
is used to bill for items and services.
EHR stands for electronic health
Health disparities mean preventable
record.
differences in the burden of disease, in-
Eligible clinician means a clinician as
jury, violence, or opportunities to
defined in § 414.1305 of this chapter.
achieve optimal health, health quality,
Episode category means one of the five
or health outcomes that are experi-
episodes tested in TEAM as described
enced by one or more underserved com-
at § 512.525(d).
munities within the TEAM partici-
Episode means all Medicare Part A
pant’s population of TEAM bene-
and B items and services described in
ficiaries that the TEAM participant
§ 512.525(e) (and excluding the items and
services described in § 512.525(f)) that will aim to reduce.
are furnished to a beneficiary described Health equity goal means a targeted
in § 512.535 during the time period that outcome relative to health equity plan
begins on the date of the beneficiary’s performance measures.
admission to an anchor hospitalization Health equity plan means a document
or the date of the anchor procedure, as that identifies health equity goals,
described at § 512.525(c), and ends on the intervention strategies, and perform-
30th day following the date of dis- ance measures to improve health dis-
charge from the anchor hospitalization parities identified within the TEAM
or anchor procedure, with the date of participant’s population of TEAM
discharge or date of the anchor proce- beneficiaries that the TEAM partici-
dure itself being counted as the first pant will aim to reduce as described in
day in the 30-day post-discharge period, § 512.563.
as described at § 512.537. If an anchor Health equity plan intervention strategy
hospitalization is initiated on the same means the initiative the TEAM partici-
day as or in the 3 days following an pant creates and implements to reduce
outpatient procedure that could ini- the identified health disparities as part
tiate an anchor procedure for the same of the health equity plan.
episode category, the outpatient proce- Health equity plan performance meas-
dure initiates an anchor hospitaliza- ure means a quantitative metric that
tion and the anchor hospitalization
the TEAM participant uses to measure
start date is that of the outpatient pro-
changes in health disparities arising
cedure.
from the health equity plan interven-
Essential access community hospital
tion strategies.
means a hospital as defined under
§ 412.109 of this chapter. Health-related social need means an
Final normalization factor refers to the unmet, adverse social condition that
national mean of the benchmark price can contribute to poor health outcomes
for each MS–DRG/HCPCS episode type and is a result of underlying social de-
divided by the national mean of the terminants of health, which refer to
risk-adjusted benchmark price for the the conditions in the environments
same MS–DRG/HCPCS episode type. where people are born, live, learn,
1051
§ 512.505 42 CFR Ch. IV (10–1–24 Edition)
work, play, worship, and age that af- ble hospitals are required to partici-
fect a wide range of health, func- pate in TEAM.
tioning, and quality-of-life outcomes MDC stands for Major Diagnostic
and risks. Category.
HHA means a Medicare-enrolled Medically necessary means reasonable
home health agency. and necessary for the diagnosis or
High-cost outlier cap refers to the 99th treatment of an illness or injury, or to
percentile of regional spending for a improve the functioning of a mal-
given MS–DRG/HCPCS episode type in formed body member.
a given region, which is the amount at Medicare Severity Diagnosis-Related
which episode spending would be Group (MS–DRG) means, for the pur-
capped for purposes of determining poses of this model, the classification
baseline and performance year episode of inpatient hospital discharges up-
spending. dated in accordance with § 412.10 of this
Hospital means a hospital as defined chapter.
in section 1886(d)(1)(B) of the Act. Medicare-dependent, small rural hos-
Hospital discharge planning means the pital (MDH) means a specific type of
standards set forth in § 482.43 of this hospital that meets the classification
chapter. criteria specified under § 412.108 of this
ICD–CM stands for International chapter.
Classification of Diseases, Clinical Member of the NPPGP or NPPGP mem-
Modification. ber means a nonphysician practitioner
Internal cost savings means the meas- or therapist who is an owner or em-
urable, actual, and verifiable cost sav- ployee of an NPPGP and who has reas-
ings realized by the TEAM participant signed to the NPPGP his or her right
resulting from care redesign under- to receive Medicare payment.
taken by the TEAM participant in con- Member of the PGP or PGP member
nection with providing items and serv- means a physician, nonphysician prac-
ices to TEAM beneficiaries within an titioner, or therapist who is an owner
episode. Internal cost savings does not or employee of the PGP and who has
include savings realized by any indi- reassigned to the PGP his or her right
vidual or entity that is not the TEAM to receive Medicare payment.
participant. Member of the TGP or TGP member
IPF stands for inpatient psychiatric means a therapist who is an owner or
facility. employee of a TGP and who has reas-
IPPS stands for Inpatient Prospective signed to the TGP his or her right to
Payment System, which is the pay- receive Medicare payment.
ment system for subsection (d) hos- MIPS stands for Merit-based Incen-
pitals as defined in section 1886(d)(1)(B) tive Payment System.
of the Act. MIPS eligible clinician means a clini-
IRF stands for inpatient rehabilita- cian as defined in § 414.1305 of this chap-
tion facility. ter.
LIS stands for Medicare Part D Low- Model performance period means the
Income Subsidy. 60-month period from January 1, 2026,
Lower-Extremity Joint Replacement to December 31, 2030, during which
(LEJR) means any hip, knee, or ankle TEAM is being tested and the TEAM
replacement that is paid under MS– participant is held accountable for
DRG 469, 470, 521, or 522 through the spending and quality.
IPPS or HCPCS code 27447, 27130, or Model start date means January 1,
27702 through the OPPS. 2026, the start of the model perform-
LTCH stands for long-term care hos- ance period.
pital. MS–DRG/HCPCS episode type refers to
Major Bowel Procedure means any the subset of episodes within an epi-
small or large bowel procedure paid sode category that are associated with
through the IPPS under MS–DRG 329– a given MS–DRG/HCPCS, as set forth
331. at § 512.540(a)(1).
Mandatory CBSA means a core-based Non-AAPM option means the option of
statistical area selected by CMS in ac- TEAM for TEAM participants in Track
cordance with § 512.515 where all eligi- 1 or for TEAM participants in Track 2
1052
or Track 3 that do not attest to use of cluded in the episode in accordance

CEHRT as described in § 512.522. with § 512.525(e), excluding the items
Nonphysician practitioner means one and services described in § 512.525(f).
of the following: PGP stands for physician group prac-
(1) A physician assistant who satis- tice.
fies the qualifications set forth at Physician has the meaning set forth
§ 410.74(a)(2)(i) and (ii) of this chapter. in section 1861(r) of the Act.
(2) A nurse practitioner who satisfies Post-episode spending amount means
the qualifications set forth at § 410.75(b) the sum of all Medicare Parts A and B
of this chapter. payments for items and services fur-
(3) A clinical nurse specialist who nished to a beneficiary within 30 days
satisfies the qualifications set forth at after the end of an episode and includes
§ 410.76(b) of this chapter. the prorated portion of services that
(4) A certified registered nurse anes- began during the episode and extended
thetist (as defined at § 410.69(b) of this into the 30-day post-episode period.
chapter). Preliminary target price refers to the
(5) A clinical social worker (as de- target price provided to the TEAM par-
fined at § 410.73(a) of this chapter). ticipant prior to the start of the per-
(6) A registered dietician or nutrition formance year, which is subject to ad-
professional (as defined at § 410.134 of justment at reconciliation, as set forth
this chapter). at § 512.540.
NPI stands for National Provider Primary care services has the meaning
Identifier. set forth in section 1842(i)(4) of the Act.
NPPGP stands for Non-Physician Prospective normalization factor refers
Provider Group Practice, which means to the multiplier incorporated into the
an entity that is enrolled in Medicare preliminary target price to ensure that
as a group practice, includes at least the average of the total risk-adjusted
one owner or employee who is a non- preliminary target price does not ex-
physician practitioner, does not in- ceed the average of the total non-risk
clude a physician owner or employee, adjusted preliminary target price, cal-
and has a valid and active TIN. culated as set forth in § 512.540(b)(6).
NPRA stands for Net Payment Rec- Prospective trend factor refers to the
onciliation Amount, which means the multiplier incorporated into the pre-
dollar amount representing the dif- liminary target price to estimate
ference between the reconciliation tar- changes in spending patterns between
get price and performance year spend- the baseline period and the perform-
ing, after adjustments for quality and ance year, calculated as set forth in
stop-gain/stop-loss limits, but prior to § 512.540(b)(7).
the post-episode spending adjustment. Provider means a ‘‘provider of serv-
OIG stands for the Department of ices’’ as defined under section 1861(u) of
Health and Human Services Office of the Act and codified in the definition of
the Inspector General. ‘‘provider’’ at § 400.202 of this chapter.
OP means an outpatient procedure Provider of outpatient therapy services
for which the institutional claim is means an entity that is enrolled in
billed by the hospital through the Medicare as a provider of therapy serv-
OPPS. ices and furnishes one or more of the
OPPS stands for the Outpatient Pro- following:
spective Payment System. (1) Outpatient physical therapy serv-
PAC stands for post-acute care. ices as defined in § 410.60 of this chap-
PBPM stands for per-beneficiary-per- ter.
month. (2) Outpatient occupational therapy
Performance year means a 12-month services as defined in § 410.59 of this
period beginning on January 1 and end- chapter.
ing on December 31 of each year during (3) Outpatient speech-language pa-
the model performance period. thology services as defined in § 410.62 of
Performance year spending means the this chapter.
sum of standardized Medicare claims QP stands for Qualifying APM Par-
payments during the performance year ticipant as defined in § 414.1305 of this
for the items and services that are in- chapter.
1053
§ 512.505 42 CFR Ch. IV (10–1–24 Edition)
Quality-adjusted reconciliation amount considered dually eligible for Medicare

refers to the dollar amount rep- and Medicaid across all PPS acute care
resenting the difference between the hospitals in the baseline period.
reconciliation target price and per- (2) Exceeds the 75th percentile of the
formance year spending, after adjust- proportion of Medicare beneficiaries
ments for quality, but prior to applica- partially or fully eligible to receive
tion of stop-gain/stop-loss limits and Part D low-income subsidies across all
the post-episode spending adjustment. PPS acute care hospitals in the base-
Raw quality measure score means the line period.
quality measure value as obtained from Scaled quality measure score means the
the Hospital Inpatient Quality Report- score equal to the percentile to which
ing Program and the Hospital-Acquired the TEAM participant’s raw quality
Condition Reduction Program. measure score would have belonged in
Reconciliation amount means the dol- the CQS baseline period.
lar amount representing the difference Sharing arrangement means a finan-
between the reconciliation target price cial arrangement between a TEAM par-
and performance year spending, prior ticipant and a TEAM collaborator for
to adjustments for quality, stop-gain/ the sole purpose of making gainsharing
stop-loss limits, and post-episode payments or alignment payments
spending. under TEAM.
Reconciliation payment amount means SNF stands for skilled nursing facil-
the amount that CMS may owe to a ity.
TEAM participant after reconciliation Sole community hospital (SCH) means a
as determined in accordance with hospital that meets the classification
§ 512.550(g). criteria specified in § 412.92 of this
Reconciliation target price means the chapter.
target price applied to an episode at Spinal Fusion means any cervical,
reconciliation, as determined in ac- thoracic, or lumbar spinal fusion proce-
cordance with § 512.545. dure paid through the IPPS under MS–
Region means one of the nine U.S. DRG 402, 426, 427, 428, 429, 430, 447, 448,
census divisions, as defined by the U.S. 450, 451, 471, 472, or 473, or through the
Census Bureau. OPPS under HCPCS codes 22551, 22554,
Reorganization event refers to a merg- 22612, 22630, or 22633.
er, consolidation, spin off or other re- Supplier means a supplier as defined
structuring that results in a new hos- in section 1861(d) of the Act and codi-
pital entity under a given CCN. fied at § 400.202 of this chapter.
Repayment amount means the amount Surgical Hip and Femur Fracture Treat-
that the TEAM participant may owe to ment (SHFFT) means a hip fixation pro-
Medicare after reconciliation as deter- cedure, with or without fracture reduc-
mined in accordance with § 512.550(g). tion, but excluding joint replacement,
Retrospective trend factor refers to the that is paid through the IPPS under
multiplier incorporated into the rec- MS–DRGs 480–482.
onciliation target price to estimate re- TAA stands for total ankle
alized changes in spending patterns arthroplasty.
during the performance year, cal- TEAM activities mean any activity re-
culated as set forth in § 512.545(f). lated to promoting accountability for
Rural hospital means an IPPS hos- the quality, cost, and overall care for
pital that meets one of the following TEAM beneficiaries and performance
criteria: in the model, including managing and
(1) Is located in a rural area as de- coordinating care; encouraging invest-
fined under § 412.64 of this chapter. ment in infrastructure and redesigned
(2) Is located in a rural census tract care processes for high quality and effi-
defined under § 412.103(a)(1) of this cient service delivery; or carrying out
chapter. any other obligation or duty under the
Safety Net hospital means an IPPS model.
hospital that meets at least one of the TEAM beneficiary means a beneficiary
following criteria: who meets the beneficiary inclusion
(1) Exceeds the 75th percentile of the criteria in § 512.535 and who is in an epi-
proportion of Medicare beneficiaries sode.
1054
TEAM collaborator means an ACO or ipant of the outcome of the reconcili-

one of the following Medicare-enrolled ation.
individuals or entities that enters into TGP or therapy group practice means
a sharing arrangement: an entity that is enrolled in Medicare
(1) SNF. as a therapy group in private practice,
(2) HHA. includes at least one owner or em-
(3) LTCH. ployee who is a therapist in private
(4) IRF. practice, does not include an owner or
(5) Physician. employee who is a physician or non-
(6) Nonphysician practitioner. physician practitioner, and has a valid
(7) Therapist in private practice. and active TIN.
(8) CORF. THA means total hip arthroplasty.
(9) Provider of outpatient therapy Therapist means one of the following
services. individuals as defined at § 484.4 of this
(10) PGP. chapter:
(11) Hospital. (1) Physical therapist.
(12) CAH. (2) Occupational therapist.
(13) NPPGP. (3) Speech-language pathologist.
(14) Therapy Group Practice (TGP). Therapist in private practice means a
TEAM data sharing agreement means therapist that—
an agreement entered into between the (1) Complies with the special provi-
TEAM participant and CMS that in- sions for physical therapists in private
cludes the terms and conditions for any practice in § 410.60(c) of this chapter;
beneficiary-identifiable data shared (2) Complies with the special provi-
with the TEAM participant under sions for occupational therapists in pri-
§ 512.562. vate practice in § 410.59(c) of this chap-
TEAM HCC count refers to the TEAM ter; or
Hierarchical Condition Category count, (3) Complies with the special provi-
which is a categorical risk adjustment sions for speech-language pathologists
variable designed to reflect a bene- in private practice in § 410.62(c) of this
ficiary’s overall health status during a chapter.
lookback period by grouping similar TIN stands for taxpayer identifica-
diagnoses into one related category tion number.
and counting the total number of diag- TKA stands for total knee
nostic categories that apply to the ben- arthroplasty.
eficiary. Track 1 means a participation track
TEAM participant means an acute in TEAM in which any TEAM partici-
care hospital that either— pant may participate for the first per-
(1) Initiates episodes and is paid formance year and only TEAM partici-
under the IPPS with a CCN primary pants who are a safety net hospital, as
address located in one of the manda- defined in § 512.505, may participate for
tory CBSAs selected for participation performance years 1 through 3 of the
in TEAM in accordance with § 512.515; model. TEAM participants in Track 1
or are subject to all of the following:
(2) Makes a voluntary opt-in partici- (1) CQS adjustment percentage de-
pation election to participate in TEAM scribed in § 512.550(d)(1)(i).
in accordance with § 512.510 and is ac- (2) Limitations on gain described in
cepted to participate in TEAM by CMS. § 512.550(e)(2).
TEAM payment means a payment (3) The calculation of the reconcili-
made by CMS only to TEAM partici- ation payment described in § 512.550(g).
pants, or a payment adjustment made Track 2 means a participation track
only to payments made to TEAM par- in TEAM in which certain TEAM par-
ticipants, under the terms of TEAM ticipants, as described in § 512.520(b)(4),
that is not applicable to any other pro- may request to participate in for per-
viders or suppliers. formance years 2 through 5. TEAM par-
TEAM reconciliation report means the ticipants in Track 2 are subject to all
report prepared after each reconcili- of the following:
ation that CMS provides to the TEAM (1) CQS adjustment percentage de-
participant notifying the TEAM partic- scribed in § 512.550(d)(1)(ii).
1055
§ 512.510 42 CFR Ch. IV (10–1–24 Edition)
(2) Limitations on gain and loss de- until the last day of the last perform-
scribed in § 512.550(e)(2) and ance year, December 31, 2024; or
§ 512.550(e)(3). (2) Be a hospital participating in the
(3) The calculation of the reconcili- BPCI Advanced model, either as a par-
ation payment or repayment amount ticipant or downstream episode
described in § 512.550(g). initiator, that participates in BPCI Ad-
Track 3 means a participation track vanced until the last day of the last
in TEAM in which a TEAM participant performance period, December 31, 2025.
may participate in for performance (c) Voluntary participation election pe-
years 1 through 5. TEAM participants riod. The voluntary participation elec-
in Track 3 are subject to all of the fol- tion period begins on January 1, 2025
lowing: and ends on January 31, 2025.
(1) CQS adjustment percentage de- (d) Voluntary participation election let-
scribed in § 512.550(d)(1)(iii). ter. The voluntary participation elec-
(2) Limitations on loss and gain de- tion letter serves as the model partici-
scribed in § 512.550(e)(1) and in pation agreement. CMS may accept the
§ 512.550(e)(2). voluntary participation election letter
(3) The calculation of the reconcili- if the letter meets all of the following
ation payment or repayment amount criteria:
described in § 512.550(g). (1) Includes all of the following:
Underserved community means a popu- (i) Hospital name.
lation sharing a particular char- (ii) Hospital address.
acteristic, including geography, that (iii) Hospital CCN.
has been systematically denied a full (iv) Hospital contact name, telephone
opportunity to participate in aspects of number, and email address.
economic, social, and civic life. (v) Model name (TEAM).
U.S. Territories means American (2) Includes a certification that the
Samoa, the Federated States of Micro- hospital will—
nesia, Guam, the Marshall Islands, and (i) Comply with all applicable re-
the Commonwealth of the Northern quirements of this part and all other
Mariana Islands, Palau, Puerto Rico, laws and regulations applicable to its
U.S. Minor Outlying Islands, and the participation in TEAM; and
U.S. Virgin Islands. (ii) Submit data or information to
Weighted scaled score means the CMS that is accurate, complete and
scaled quality measure score multi- truthful, including, but not limited to,
plied by its normalized weight. the participation election letter and
any other data or information that
TEAM PARTICIPATION CMS uses for purposes of TEAM.
(3) Is signed by the hospital adminis-
§ 512.510 Voluntary opt-in participa- trator, chief financial officer, or chief
tion. executive officer with authority to
(a) General. Hospitals that wish to bind the hospital.
voluntarily opt-in to TEAM for the full (4) Is submitted in the form and man-
duration of the model performance pe- ner specified by CMS.
riod must submit a written participa- (e) CMS rejection of participation letter.
tion election letter as described in CMS may reject a participation elec-
paragraph (d) of this section during the tion letter for reasons including, but
voluntary participation election period not limited to, program integrity con-
specified in paragraph (c) of this sec- cerns or ineligibility, and notifies the
tion. hospital of the rejection within 30 days
(b) Eligibility. A hospital must not be of the determination.
located in a mandatory CBSA selected
for TEAM participation, in accordance § 512.515 Geographic areas.
with § 512.515, and must satisfy one of (a) General. CMS uses stratified ran-
the following criteria to be eligible for dom sampling to select the mandatory
voluntary opt-in participation elec- CBSAs included in TEAM.
tion— (b) Exclusions. CMS excludes from the
(1) Be a participant hospital in the selection of geographic areas CBSAs
CJR model that participates in CJR that meet any of the following criteria:
1056
(1) Are located entirely in the State (4)(i) CMS recategorizes CBSAs still
of Maryland. remaining in the first 16 strata with at
(2) Are located partially in Maryland, least one hospital participating in
and in which more than 50 percent of BPCI Advanced or CJR as of January 1,
the five episode categories tested in 2024 or those located in the states of
TEAM were initiated at a Maryland Vermont, Connecticut, or Hawaii into
hospital between January 1, 2022 and an 18th stratum.
June 30, 2023. (ii) CMS assigns a selection prob-
(3) Did not have at least one episode ability of 20 percent to the 18th stra-
for at least one of the five episode cat- tum.
egories tested in TEAM between Janu- (d) Random selection into TEAM. CMS
ary 1, 2022 and June 30, 2023. randomly selects mandatory CBSAs
(c) Stratification. (1) Based on the me- into TEAM from each of the 18 strata
dian for each of the following four according to selection probabilities de-
metrics, CMS designates the CBSAs scribed in paragraph (c) of this section.
that are not excluded in accordance
with paragraph (b) of this section as § 512.520 Participation tracks.
‘‘high’’ and ‘‘low’’: (a) For performance year 1: (1) Any
(i) Average episode spend for a broad TEAM participant may choose to par-
set of episode categories tested in the ticipate in Track 1 or Track 3.
BPCI Advanced Model, as described in (2) The TEAM participant must no-
§ 512.505, between January 1, 2022 and tify CMS of its track choice, prior to
June 30, 2023. performance year 1, in a form and man-
(ii) Number of acute care hospitals ner and by a date specified by CMS.
paid under the IPPS between January (3) CMS assigns the TEAM partici-
1, 2022 and June 30, 2023. pant to Track 1 for performance year 1
(iii) Past exposure to CMS’ bundled if a TEAM participant does not choose
payment models, which are Bundled a track in the form and manner and by
Payments for Care Improvement the date specified by CMS.
(BPCI) Models 2, 3, and 4, as described (b) For performance years 2 through 5:
in § 512.505, Comprehensive Care for (1) CMS assigns a TEAM participant to
Joint Replacement (CJR) as described participate in Track 3 unless the
in § 512.505, or BPCI Advanced between TEAM participant requests to partici-
October 1, 2013 and December 31, 2022. pate in Track 1 or Track 2 and receives
(iv) Number of Safety Net hospitals approval from CMS to participate in
in 2022 that have initiated at least one Track 1 or Track 2, with the exception
episode between January 1, 2022 and that a TEAM participant cannot re-
June 30, 2023 for at least one of the five quest participation in Track 1 for per-
episode categories tested in TEAM. formance years 4 and 5.
(2)(i) CMS stratifies the CBSAs into (2) The TEAM participant must no-
mutually exclusive groups cor- tify CMS of its Track 1 or Track 2 re-
responding to the 16 unique combina- quest prior to performance year 2, and
tions of these ‘‘high’’ and ‘‘low’’ des- prior to every performance year there-
ignations. after, as applicable, in a form and man-
(ii) CMS assigns selection prob- ner and by a date specified by CMS.
abilities ranging from 20 percent to 33.3 (3) CMS does not approve a TEAM
percent to each of the 16 strata, with a participant’s request to participate in
higher selection probability for strata Track 1 submitted in accordance with
containing CBSAs with a high number paragraph (b)(2) of this section unless
of safety net hospitals or low past ex- the TEAM participant is a safety net
posure to bundles and a lower selection hospital, as defined in § 512.505, at the
probability for all other strata. time of the request.
(3)(i) CMS recategorizes outlier (4) CMS does not approve a TEAM
CBSAs in these 16 strata with a very participant’s request to participate in
high number of safety net hospitals Track 2 submitted in accordance with
into a 17th stratum. paragraph (b)(2) of this section unless
(ii) CMS assigns a selection prob- the TEAM participant is one of the fol-
ability of 50 percent to the 17th stra- lowing hospital types at the time of
tum. the request:
1057
§ 512.522 42 CFR Ch. IV (10–1–24 Edition)
(i) Medicare-dependent hospital (as CEHRT as defined in § 414.1305 of this

defined in § 512.505). chapter.
(ii) Rural hospital (as defined in (b) Financial arrangements list. A
§ 512.505). TEAM participant with TEAM collabo-
(iii) Safety Net hospital (as defined rators, collaboration agents, or down-
in § 512.505). stream collaboration agents during a
(iv) Sole community hospital (as de- performance year must submit to CMS
fined in § 512.505). a financial arrangements list in a form
(v) Essential access community hos- and manner and by a date specified by
pital (as defined in § 512.505). CMS on a quarterly basis for each per-
(5) A TEAM participant who does not formance year. The financial arrange-
notify CMS of its Track 1 or Track 2 ments list must include the following:
request prior to a given performance (1) TEAM collaborators. For each phy-
year in the form and manner and by sician, nonphysician practitioner, or
the date specified by CMS or who is not therapist who is a TEAM collaborator
a safety net hospital, as defined as de- during the performance year:
fined in § 512.505, or one of the hospital (i) The name, TIN, and NPI of the
types specified in paragraph (b)(4) of TEAM collaborator.
this section at the time of the request (ii) The start date and, if applicable,
is assigned to Track 3 for the applica- end date, for the sharing arrangement
ble performance year. between the TEAM participant and the
TEAM collaborator.
§ 512.522 APM options. (2) Collaboration agents. For each phy-
(a) TEAM APM options. For perform- sician, nonphysician practitioner, or
ance years 1 through 5, a TEAM partic- therapist who is a collaboration agent
ipant may choose either of the fol- during the performance year:
lowing options based on their CEHRT (i) The name, TIN, and NPI of the
use and track participation: collaboration agent and the name and
(1) AAPM option. A TEAM participant TIN of the TEAM collaborator with
participating in Track 2 or Track 3 which the collaboration agent has en-
may select the AAPM option by attest- tered into a distribution arrangement.
ing in a form and manner and by a date (ii) The start date and, if applicable,
specified by CMS to their use of end date, for the distribution arrange-
CEHRT, as defined in § 414.1305 of this ment between the TEAM collaborator
chapter, on an annual basis prior to the and the collaboration agent.
start of each performance year. (3) Downstream collaboration agents.
(i) A TEAM participant that selects For each physician, nonphysician prac-
the AAPM option as provided for in titioner, or therapist who is a down-
paragraph (a)(1) must provide their stream collaboration agent during the
CMS electronic health record certifi- performance year:
cation ID in a form and manner and by (i) The name, TIN, and NPI of the
a date specified by CMS on annual downstream collaboration agent and
basis prior to the end of each perform- the name and TIN of the collaboration
ance year. agent with which the downstream col-
(ii) A TEAM participant that selects laboration agent has entered into a
the AAPM option as provided for in downstream distribution arrangement.
paragraph (a)(1) must retain docu- (ii) The start date and, if applicable,
mentation of their attestation to end date, for the downstream distribu-
CEHRT use and provide access to the tion arrangement between the collabo-
documentation in accordance with ration agent and the downstream col-
§ 512.586. laboration agent.
(2) Non-AAPM option. CMS assigns (c) Clinician engagement list. A TEAM
the TEAM participant to the non- participant must submit to CMS a cli-
AAPM option if the TEAM participant nician engagement list in a form and
is in Track 1 or if the TEAM partici- manner and by a date specified by CMS
pant is in Track 2 or Track 3 and does on a quarterly basis during each per-
not attest in a form and manner and by formance year. The clinician engage-
a date specified by CMS to their use of ment list must include the following:
1058
(1) For each physician, nonphysician 3 days following an outpatient proce-

practitioner, or therapist who is not on dure that could initiate an anchor pro-
a TEAM participant’s financial ar- cedure for the same episode category,
rangements list during the perform- the episode start date is that of the
ance year but who does have a contrac- outpatient procedure rather than the
tual relationship with the TEAM par- admission date, and an anchor proce-
ticipant and participates in TEAM ac- dure is not initiated.
tivities during the performance year: (d) Episode categories. The MS–DRGs
(i) The name, TIN, and NPI of the and HCPCS codes included in the epi-
physician, nonphysician practitioner, sodes are as follows:
or therapist. (1) Lower Extremity Joint Replacement
(ii) The start date and, if applicable,
(LEJR): (i) IPPS discharge under MS–
the end date for the contractual rela-
DRG 469, 470, 521, or 522; or
tionship between the physician, non-
physician practitioner, or therapist (ii) OPPS claim for HCPCS codes
and the TEAM participant. 27447, 27130, or 27702.
(d) Attestation to no individuals. A (2) Surgical Hip/Femur Fracture Treat-
TEAM participant with no individuals ment (SHFFT). IPPS discharge under
that meet the criteria specified in MS–DRG 480 to 482.
paragraphs (b)(1) through (3) of this (3) Coronary Artery Bypass Graft Sur-
section for the financial arrangements gery (CABG). IPPS discharge under MS–
list or paragraph (c) of this section for DRG 231 to 236.
the clinician engagement list must at- (4) Spinal Fusion: (i) IPPS discharge
test in a form and manner and by a under MS–DRG 402, 426, 427, 428, 429,
date specified by CMS that there are no 430, 447, 448, 450, 451, 471, 472, 473; or
financial arrangements or clinician en- (ii) OPPS claim for HCPCS codes
gagements to report. 22551, 22554, 22612, 22630, or 22633.
(e) Documentation requirements. A (5) Major Bowel Procedure. IPPS dis-
TEAM participant that submits a fi- charge under MS–DRG 329 to 331.
nancial arrangements list specified in (e) Included services. All Medicare
paragraph (b) of this section or a clini- Part A and B items and services are in-
cian engagement list specified in para-
cluded in the episode, except as speci-
graph (c) of this section must retain
fied in paragraph (f) of this section.
and provide access to the documenta-
These services include, but are not lim-
tion in accordance with § 512.586.
ited to, the following:
SCOPE OF EPISODES BEING TESTED (1) Physicians’ services.
(2) Inpatient hospital services (in-
§ 512.525 Episodes. cluding hospital readmissions).
(a) Time periods. All episodes must (3) IPF services.
begin on or after January 1, 2026 and (4) LTCH services.
end on or before December 31, 2030. (5) IRF services.
(b) Episode attribution. All items and (6) SNF services.
services included in the episode are at- (7) HHA services.
tributed to the TEAM participant at (8) Hospital outpatient services.
which the anchor hospitalization or an- (9) Outpatient therapy services.
chor procedure, as applicable, occurs.
(10) Clinical laboratory services.
(c) Episode initiation. An episode is
initiated by— (11) DME.
(1) A beneficiary’s admission to a (12) Part B drugs and biologicals, ex-
TEAM participant for an anchor hos- cept for those excluded under para-
pitalization that is paid under a MS– graph (f) of this section.
DRG specified in paragraph (d) of this (13) Hospice services.
section; or (14) Part B professional claims dated
(2) A beneficiary’s receipt of an an- in the 3 days prior to an anchor hos-
chor procedure billed under a HCPCS pitalization if a claim for the surgical
code specified in paragraph (d) of this procedure for the same episode cat-
section. If an anchor hospitalization is egory is not detected as part of the
initiated on the same day as or in the hospitalization because the procedure
1059
§ 512.535 42 CFR Ch. IV (10–1–24 Edition)
was performed by the TEAM partici- (iii) HCPCS codes corresponding to

pant on an outpatient basis, but the pa- clotting factors for hemophilia pa-
tient was subsequently admitted as an tients, identified in the quarterly aver-
inpatient. age sales price file for certain Medicare
(f) Excluded services. The following Part B drugs and biologicals as HCPCS
items, services, and payments are ex- codes with clotting factor equal to 1,
cluded from the episode: HCPCS codes for new hemophilia clot-
(1) Select items and services consid- ting factors not included in the base-
ered unrelated to the anchor hos- line period, and other HCPCS codes
pitalization or the anchor procedure identified as hemophilia.
for episodes in the baseline period and (6) Part B payments for low-volume
performance year, including, but not drugs, high-cost drugs and biologicals,
limited to, the following: and blood clotting factors for hemo-
(i) Inpatient hospital admissions for philia for episodes initiated in the per-
MS–DRGs that group to the following formance year, billed on outpatient,
categories of diagnoses: carrier, and DME claims, defined as—
(A) Oncology. (i) Drug/biological HCPCS codes that
(B) Trauma medical. were not captured in the baseline pe-
(C) Organ transplant. riod and appear in 10 or fewer episodes
(D) Ventricular shunt. in the performance year;
(ii) Inpatient hospital admissions (ii) Drug/biological HCPCS codes that
that fall into the following Major Diag- were not included in the baseline pe-
nostic Categories (MDCs): riod, appear in more than 10 episodes in
(A) MDC 02 (Diseases and Disorders of the performance year, and have a mean
the Eye). cost of greater than $25,000 per episode
(B) MDC 14 (Pregnancy, Childbirth, in the performance year; and
and Puerperium). (iii) Drug/biological HCPCS codes
(C) MDC 15 (Newborns). that were not included in the baseline
(D) MDC 25 (Human Immuno- period, appear in more than 10 episodes
deficiency Virus). in the performance year, have a mean
(2) New technology add-on payments, cost of $25,000 or less per episode in the
as defined in part 412, subpart F of this performance year, and correspond to a
chapter for episodes in the baseline pe- drug/biological that appears in the
riod and performance year. baseline period but was assigned a new
(3) Transitional pass-through pay- HCPCS code between the baseline pe-
ments for medical devices as defined in riod and the performance year.
§ 419.66 of this chapter for episodes ini- (iv) HCPCS codes for new hemophilia
tiated in the baseline period and per- clotting factors not included in the
formance year. baseline period.
(4) Hemophilia clotting factors pro-
(g) TEAM exclusions List. The list of
vided in accordance with § 412.115 of
excluded MS–DRGs, MDCs, and HCPCS
this chapter for episodes in the base-
codes is posted on the CMS website.
line period and performance year.
(5) Part B payments for low-volume (h) Updating the TEAM exclusions list.
drugs, high-cost drugs and biologicals, The list of excluded services is updated
and blood clotting factors for hemo- through rulemaking to reflect all of
philia for episodes in the baseline pe- the following:
riod and performance year, billed on (1) Changes to the MS–DRGs under
outpatient, carrier, and DME claims, the IPPS.
defined as— (2) Coding changes.
(i) Drug/biological HCPCS codes that (3) Other issues brought to CMS’ at-
are billed in fewer than 31 episodes in tention.
total across all episodes in TEAM dur-
ing the baseline period; § 512.535 Beneficiary inclusion cri-
(ii) Drug/biological HCPCS codes that teria.
are billed in at least 31 episodes in the (a) Episodes tested in TEAM include
baseline period and have a mean cost of only those in which care is furnished to
greater than $25,000 per episode in the beneficiaries who meet all of the fol-
baseline period; and lowing criteria upon admission for an
1060
anchor procedure or anchor hos- gency disaster declaration under the

pitalization: Stafford Act.
(1) Are enrolled in Medicare Parts A (ii) The date of admission to the an-
and B. chor hospitalization or the date of the
(2) Are not eligible for Medicare on anchor procedure is during an emer-
the basis of having end stage renal dis- gency period (as defined in section
ease, as described in § 406.13 of this 1135(g) of the Act) or in the 30 days be-
chapter. fore the date that the emergency pe-
(3) Are not enrolled in any managed riod (as defined in section 1135(g) of the
care plan (for example, Medicare Ad- Act) begins.
vantage, health care prepayment plans, PRICING METHODOLOGY
or cost-based health maintenance orga-
nizations). § 512.540 Determination of preliminary
(4) Are not covered under a United target prices.
Mine Workers of America health care (a) Preliminary target price application.
plan. CMS establishes preliminary target
(5) Have Medicare as their primary prices for TEAM participants for each
payer. performance year of the model as fol-
(b) The episode is canceled in accord- lows:
ance with § 512.537(b) if at any time dur- (1) MS–DRG/HCPCS episode type. CMS
ing the episode a beneficiary no longer uses the MS–DRGs and, as applicable,
meets all criteria in this section. HCPCS codes specified in § 512.525(d)
when calculating the preliminary tar-
§ 512.537 Determination of the episode. get prices for each MS–DRG/HCPCS
(a) Episode conclusion. (1) An episode episode type.
ends on the 30th day following the date (i) CMS determines a separate pre-
of the anchor procedure or the date of liminary target price for each of the 24
discharge from the anchor hospitaliza- MS–DRGs specified in § 512.525(d).
tion, as applicable, with the date of the (ii) Preliminary target prices for a
anchor procedure or the date of dis- subset of the MS–DRGs specified in
charge from the anchor hospitalization § 512.525(d) include certain HCPCS codes
being counted as the first day in the 30- as follows:
day post-discharge period. (A) HCPCS 27130 and 27447 are in-
(b) Cancellation of an episode. The epi- cluded in MS–DRG 470.
sode is canceled and is not included in (B) HCPCS 27702 is included in MS–
the reconciliation calculation as speci- DRG 469.
fied in § 512.545 if any of the following (C) HCPCS 22551 and 22554 are in-
occur: cluded in MS–DRG 473.
(D) HCPCS 22612 and 22630 are in-
(1) The beneficiary ceases to meet
cluded in MS–DRG 451.
any criterion listed in § 512.535.
(E) HCPCS 22633 is included in MS–
(2) The beneficiary dies during the DRG 402.
anchor hospitalization or the out- (2) Applicable time period for prelimi-
patient stay for the anchor procedure. nary target prices. CMS calculates pre-
(3) The episode qualifies for cancella- liminary target prices for each MS–
tion due to extreme and uncontrollable DRG/HCPCS episode type and region
circumstances. An extreme and uncon- for each performance year and applies
trollable circumstance occurs if both of the preliminary target price to each
the following criteria are met: episode based on the episode’s date of
(i) The TEAM participant has a CCN discharge from the anchor hospitaliza-
primary address that— tion or the episode’s date of the anchor
(A) Is located in an emergency area, procedure, as applicable.
as those terms are defined in section (3) Episodes that begin in one perform-
1135(g) of the Act, for which the Sec- ance year and end in the subsequent per-
retary has issued a waiver under sec- formance year. CMS applies the prelimi-
tion 1135 of the Act; and nary target price to the episode based
(B) Is located in a county, parish, or on the date of discharge from the an-
tribal government designated in a chor hospitalization or the date of the
major disaster declaration or emer- anchor procedure, as applicable, but
1061
§ 512.540 42 CFR Ch. IV (10–1–24 Edition)
reconciles the episode based on the end percentile of regional spending for each
date of the episode. of the MS–DRG/HCPCS episode types
(b) Preliminary target price calculation. specified in § 512.540(a)(1)(ii).
(1) CMS calculates preliminary target (5) Exclusion of incentive programs and
prices based on average baseline epi- add-on payments under existing Medicare
sode spending for the region where the payment systems. Certain Medicare in-
TEAM participant is located. centive programs and add-on payments
(i) The region used for calculating are excluded from baseline episode
the preliminary target price cor- spending by using, with certain modi-
responds to the U.S. Census Division fications, the CMS Price (Payment)
associated with the primary address of Standardization Detailed Methodology
the CCN of the TEAM participant, and used for the Medicare spending per ben-
the regional episode spending amount eficiary measure in the Hospital Value-
is based on all hospitals in the region, Based Purchasing Program.
except as specified in § 512.540(b)(1)(ii). (6) Prospective normalization factor.
(ii) In cases where a TEAM partici- Based on the episodes in the most re-
pant is located in a mandatory CBSA cent calendar year of the baseline pe-
selected for participation in TEAM riod, CMS calculates a prospective nor-
which spans more than one region, the malization factor, which is a multiplier
TEAM participant and all other hos- that ensures that the average risk ad-
pitals in the mandatory CBSA are justed target price does not exceed the
grouped into the region where the most average unadjusted target price, by
populous city in the mandatory CBSA doing the following:
is located for pricing and payment cal-
(i) CMS applies risk adjustment mul-
culations.
tipliers, as specified in § 512.545(a)(1)
(2) CMS uses the following baseline
through (3), to the most recent baseline
periods to determine baseline episode
year episodes to calculate the esti-
spending:
mated risk-adjusted target price for all
(i) Performance Year 1: Episodes be-
performance year episodes.
ginning on January 1, 2022 through De-
cember 31, 2024. (ii) CMS divides the mean of the pre-
(ii) Performance Year 2: Episodes be- liminary target price for each episode
ginning on January 1, 2023 through De- across all hospitals and regions by the
cember 31, 2025. mean of the estimated risk-adjusted
(iii) Performance Year 3: Episodes be- target price calculated in
ginning on January 1, 2024 through De- § 512.540(b)(6)(i) for the same episode
cember 31, 2026. types across all hospitals and regions.
(iv) Performance Year 4: Episodes be- (7) Prospective trend factor. CMS cal-
ginning on January 1, 2025 through De- culates the following:
cember 31, 2027. (i) The average regional episode
(v) Performance Year 5: Episodes be- spending for each MS–DRG/HCPCS epi-
ginning on January 1, 2026 through De- sode type using the most recent cal-
cember 31, 2028. endar year of the applicable baseline
(3) CMS calculates the benchmark period.
price as the weighted average of base- (ii) The difference between the aver-
line episode spending, applying the fol- age regional spending for each MS–
lowing weights: DRG/HCPCS episode type during the
(i) Baseline episode spending from most recent calendar year of the base-
baseline year 1 is weighted at 17 per- line period and the average regional
cent. spending for each MS–DRG/HCPCS epi-
(ii) Baseline episode spending from sode type during the first years of the
baseline year 2 is weighted at 33 per- baseline period to determine the pro-
cent. spective trend factor.
(iii) Baseline episode spending from (8) Communication of preliminary target
baseline year 3 is weighted at 50 per- prices. CMS communicates the prelimi-
cent. nary target prices for each MS–DRG/
(4) Exception for high episode spending. HCPCS episode type for each region to
CMS applies a high-cost outlier cap to the TEAM participant before the per-
baseline episode spending at the 99th formance year in which they apply.
1062
(c) Discount factor. CMS incorporates (ii) Do not meet any of the three
an episode category specific discount measures of social need in
factor of 1.5 percent for CABG and § 512.545(a)(1)(iii)(A).
Major Bowel episodes and 2 percent for (4) The hospital bed size risk adjust-
LEJR, SHFFT, and Spinal Fusion epi- ment factor uses four variables based
sodes to the TEAM participant’s pre- on the TEAM participant’s characteris-
liminary episode target prices intended tics:
to reflect Medicare’s potential savings (i) 250 beds or fewer.
from TEAM. (ii) 251–500 beds.
(iii) 501–850 beds.
§ 512.545 Determination of reconcili- (iv) 850 beds or more.
ation target prices.
(5) The safety net hospital risk ad-
CMS calculates the reconciliation justment factor is based on the TEAM
target price as follows: participant meeting the definition of
(a) CMS risk adjusts the preliminary safety net hospital, as defined in
episode target prices computed under § 512.505.
§ 512.540 at the beneficiary level using a (6) Episode category-specific bene-
TEAM Hierarchical Condition Cat- ficiary level risk adjustment factors
egory (HCC) count risk adjustment fac- represent the presence or absence in
tor, an age bracket risk adjustment beneficiaries, as of the first day of the
factor, a social need risk adjustment episode, of each of the following condi-
factor, and at the hospital level using a tions:
hospital bed size risk adjustment fac- (i) CABG episode category.
tor and a safety net hospital risk ad- (A) Prior post-acute care use.
justment factor, and at the episode cat- (B) HCC 18: Diabetes with Chronic
egory-specific beneficiary level using Complications.
factors specified in paragraph (a)(6)(i) (C) HCC 46: Severe Hematological
through (v) of this section. Disorders.
(1) The TEAM HCC count risk adjust- (D) HCC 58: Major Depressive, Bipo-
ment factor uses five variables, rep- lar, and Paranoid Disorders.
resenting beneficiaries with zero, one, (E) HCC 84: Cardio-Respiratory Fail-
two, three, or four or more CMS–HCC ure and Shock.
conditions based on a lookback period (F) HCC 85: Congestive Heart Failure.
that ends on the day prior to the an- (G) HCC 86: Acute Myocardial Infarc-
chor hospitalization or anchor proce- tion.
dure. (H) HCC 96: Specified Heart Arrhyth-
(2) The age bracket risk adjustment mias.
factor uses four variables, representing (I) HCC 103: Hemiplegia/Hemiparesis.
beneficiaries in the following age (J) HCC 111: Chronic Obstructive Pul-
groups as of the first day of the epi- monary Disease.
sode: (K) HCC 112: Fibrosis of Lung and
(i) Less than 65 years. Other Chronic Lung Disorders.
(ii) 65 to less than 75 years. (L) HCC 134: Dialysis Status.
(iii) 75 years to less than 85 years. (ii) LEJR episode category.
(iv) 85 years or more. (A) Ankle procedure or reattach-
(3) The social need risk adjustment ment, partial hip procedure, partial
factor uses two variables, representing knee arthroplasty, total hip
beneficiaries that, as of the first day of arthroplasty or hip resurfacing proce-
the episode— dure, and total knee arthroplasty.
(i) Meet one or more of the following (B) Disability as the original reason
measures of social need: for Medicare enrollment.
(A) State ADI above the 8th decile. (C) Dementia without complications.
(B) National ADI above the 80th per- (D) Prior post-acute care use.
centile. (E) HCC 8: Metastatic Cancer and
(C) Eligibility for the low-income Acute Leukemia.
subsidy. (F) HCC 18: Diabetes with Chronic
(D) Eligibility for full Medicaid bene- Complications.
fits. (G) HCC 22: Morbid Obesity.
1063
§ 512.545 42 CFR Ch. IV (10–1–24 Edition)
(H) HCC 58: Major Depressive, Bipo- (M) HCC 157: Pressure Ulcer of Skin
lar, and Paranoid Disorders. with Necrosis Through to Muscle, Ten-
(I) HCC 78: Parkinson’s and Hunting- don, or Bone.
ton’s Diseases. (N) HCC 158: Pressure Ulcer of Skin
(J) HCC 85: Congestive Heart Failure. with Full Thickness Skin Loss.
(K) HCC 86: Acute Myocardial Infarc- (O) HCC 161: Chronic Ulcer of Skin,
tion. Except Pressure.
(L) HCC 103: Hemiplegia/Hemiparesis. (P) HCC 170: Hip Fracture/Disloca-
(M) HCC 111: Chronic Obstructive tion.
Pulmonary Disease. (v) Spinal Fusion episode category.
(N) HCC 112: Fibrosis of Lung and (A) Prior post-acute care use.
Other Chronic Lung Disorders. (B) HCC 8: Metastatic Cancer and
(O) HCC 134: Dialysis Status. Acute Leukemia.
(P) HCC 170: Hip Fracture/Disloca- (C) HCC 18: Diabetes with Chronic
tion. Complications.
(iii) Major Bowel Procedure episode (D) HCC 22: Morbid Obesity.
category. (E) HCC 40: Rheumatoid Arthritis
(A) Long-term institutional care use. and Inflammatory Connective Tissue
(B) HCC 11: Colorectal, Bladder, and Disease.
Other Cancers. (F) HCC 58: Major Depressive, Bipo-
(C) HCC 18: Diabetes with Chronic lar, and Paranoid Disorders.
Complications.
(G) HCC 85: Congestive Heart Failure.
(D) HCC 21: Protein-Calorie Malnutri-
(H) HCC 86: Acute Myocardial Infarc-
tion.
tion.
(E) HCC 33: Intestinal Obstruction/
Perforation. (I) HCC 96: Specified Heart Arrhyth-
(F) HCC 82: Respirator Dependence/ mias.
Tracheostomy Status. (J) HCC 103: Hemiplegia/Hemiparesis.
(G) HCC 85: Congestive Heart Failure. (K) HCC 111: Chronic Obstructive Pul-
(H) HCC 86: Acute Myocardial Infarc- monary Disease.
tion. (L) HCC 112: Fibrosis of Lung and
(I) HCC 103: Hemiplegia/Hemiparesis. Other Chronic Lung Disorders.
(J) HCC 111: Chronic Obstructive Pul- (M) HCC 134: Dialysis Status.
monary Disease. (b) All risk adjustment factors are
(K) HCC 112: Fibrosis of Lung and computed prior to the start of the per-
Other Chronic Lung Disorders. formance year via a linear regression
(L) HCC 134: Dialysis Status. analysis. The regression analysis is
(M) HCC 188: Artificial Openings for computed using 3 years of claims data
Feeding or Elimination. as follows:
(iv) SHFFT episode category. (1) For performance year 1, CMS uses
(A) HCC 18: Diabetes with Chronic claims data with dates of service dated
Complications. January 1, 2022 to December 31, 2024.
(B) HCC 22: Morbid Obesity. (2) For performance year 2, CMS uses
(C) HCC 82: Respirator Dependence/ claims data with dates of service dated
Tracheostomy Status. January 1, 2023 to December 31, 2025.
(D) HCC 83: Respiratory Arrest. (3) For performance year 3, CMS uses
(E) HCC 84: Cardio-Respiratory Fail- claims data with dates of service dated
ure and Shock. January 1, 2024 to December 31, 2026.
(F) HCC 85: Congestive Heart Failure. (4) For performance year 4, CMS uses
(G) HCC 86: Acute Myocardial Infarc- claims data with dates of service dated
tion. January 1, 2025 to December 31, 2027.
(H) HCC 96: Specified Heart Arrhyth- (5) For performance year 5, CMS uses
mias. claims data with dates of service dated
(I) HCC 103: Hemiplegia/Hemiparesis. January 1, 2026 to December 30, 2028.
(J) HCC 111: Chronic Obstructive Pul- (c) The annual linear regression anal-
monary Disease. ysis produces exponentiated coeffi-
(K) HCC 112: Fibrosis of Lung and cients to determine the anticipated
Other Chronic Lung Disorders. marginal effect of each risk adjust-
(L) HCC 134: Dialysis Status. ment factor on episode costs. CMS
1064
transforms, or exponentiates, these co- prices, which are compared to perform-

efficients, and the resulting coeffi- ance year spending at reconciliation,
cients are the beneficiary and hospital- as specified in § 512.550(c).
level risk adjustment factors, specified
in paragraphs (a)(1) through (6) of this QUALITY MEASURES AND COMPOSITE
section, that would be used during rec- QUALITY SCORE
onciliation for the subsequent perform-
ance year. § 512.547 Quality measures, composite
quality score, and display of quality
(d) At the time of reconciliation, the measures.
preliminary target prices computed
under § 512.540 are risk adjusted by ap- (a) Quality measures. CMS calculates
plying the applicable beneficiary level the quality measures used to evaluate
and hospital-level risk adjustment fac- the TEAM participant’s performance
tors specific to the beneficiary in the using Medicare claims data or patient-
episode, as set forth in paragraphs reported outcomes data that TEAM
(a)(1) through (6) of this section. participants report under the Hospital
(e) The risk-adjusted preliminary Inpatient Quality Reporting Program
target prices are normalized at rec- and the Hospital-Acquired Condition
onciliation to ensure that the average Reduction Program. The following
of the total risk-adjusted preliminary quality measures and CQS baseline pe-
target price does not exceed the aver- riods are used for public reporting and
age of the total non-risk adjusted pre- for determining the TEAM partici-
liminary target price. pant’s CQS as described in paragraph
(1) The final normalization factor at (b) of this section:
reconciliation— (1) For performance year 1:
(i) Is the national mean of the bench- (i) For all episode categories: Hybrid
mark price for each MS–DRG/HCPCS Hospital-Wide All-Cause Readmission
episode type divided by the national Measure with Claims and Electronic
mean of the risk-adjusted benchmark Health Record Data (CMIT ID #356)
price for the same MS–DRG/HCPCS epi- with a CY 2025 CQS baseline period;
sode type. (ii) For all episode categories: CMS
(ii) As applied, cannot exceed ±5 per- Patient Safety and Adverse Events
cent of the prospective normalization Composite (CMS PSI 90) (CMIT ID #135)
factor (as specified in § 512.540(b)(6)). with a CY 2025 CQS baseline period; and
(2) CMS applies the final normaliza- (iii) For LEJR episodes: Hospital-
tion factor to the previously cal- Level Total Hip and/or Total Knee
culated, beneficiary and provider level, Arthroplasty (THA/TKA) Patient-Re-
risk-adjusted target prices specific to ported Outcome-Based Performance
each region and MS–DRG/HCPCS epi- Measure (PRO–PM) (CMIT ID #1618)
sode type. with a CY 2025 CQS baseline period.
(f) Retrospective trend factor. CMS cal- (2) For performance years 2 through
culates the average regional capped 5:
performance year episode spending for (i) For all episode categories: Hybrid
each MS–DRG/HCPCS episode type di- Hospital-Wide All-Cause Readmission
vided by the average regional capped Measure with Claims and Electronic
baseline period episode spending for Health Record Data (CMIT ID #356)
each MS–DRG/HCPCS episode type. with a CY 2025 CQS baseline period;
(1) The retrospective trend factor is (ii) For all episode categories: Hos-
capped so that the maximum difference pital Harm—Falls with Injury (CMIT
cannot exceed ±3 percent of the pro- ID #1518) with a CY 2026 CQS baseline
spective trend factor (as specified in period;
§ 512.540(b)(7)). (iii) For all episode categories: Hos-
(2) CMS applies the capped retrospec- pital Harm—Postoperative Respiratory
tive trend factor to the previously cal- Failure (CMIT ID #1788) with a CY 2026
culated normalized, risk adjusted tar- CQS baseline period;
get prices specific to each region and (iv) For all episode categories: Thir-
MS–DRG/HCPCS episode type, as speci- ty-day Risk-Standardized Death Rate
fied in paragraph (e)(2) of this section, among Surgical Inpatients with Com-
to calculate the reconciliation target plications (Failure-to-Rescue) (CMIT
1065
§ 512.547 42 CFR Ch. IV (10–1–24 Edition)
ID #134) with a CY 2026 CQS baseline tients with Complications (Failure-to-

period; and Rescue) (CMIT ID #134) measure:
(v) For LEJR episodes: Hospital- (1) CMS assigns a scaled quality
Level Total Hip and/or Total Knee measure score of 0 if the TEAM partici-
Arthroplasty (THA/TKA) Patient-Re- pant has a raw quality measure score
ported Outcome-Based Performance greater than the maximum of the raw
Measure (PRO–PM) (CMIT ID #1618) quality measure scores in the CQS
with a CY 2025 CQS baseline period. baseline period.
(b) Calculation of the composite quality (2) CMS assigns a scaled quality
score (CQS). (1) CMS converts the measure score of 100 if the TEAM par-
TEAM participant’s raw quality meas- ticipant has a raw quality score less
ure score for the performance year into than the minimum of the raw scores in
a scaled quality measure score by com- the CQS baseline period.
paring the raw quality measure score (D) CMS does not assign a scaled
to the distribution of raw quality quality measure score if the TEAM
measure score percentiles among a na- participant has no raw quality measure
tional cohort of hospitals, consisting of score.
TEAM participants and hospitals not (2) CMS calculates a normalized
participating in TEAM, in the CQS weight for each quality measure by di-
baseline period. viding the TEAM participant’s volume
(i) CMS assigns a scaled quality of attributed episodes for a given qual-
measure score equal to the percentile ity measure by the total volume of all
to which the TEAM Participant’s raw the TEAM participant’s attributed epi-
quality measure score would have be- sodes.
longed in the CQS baseline period. (3) CMS calculates a weighted scaled
(A) CMS assigns the higher scaled score for each quality measure by mul-
quality measure score if the TEAM tiplying each quality measure’s scaled
participant’s raw quality measure quality measure score, computed under
score straddles two percentiles in the paragraph (b)(2) of this section, by its
CQS baseline period. normalized weight, computed under
(B) For the Hospital-Level Total Hip paragraph (b)(3) of this section.
and/or Total Knee Arthroplasty (THA/ (4) CMS sums each quality measure’s
TKA) Patient-Reported Outcome-Based weighted scaled score, computed under
Performance Measure (PRO–PM) paragraph (b)(4) of this section, to con-
(CMIT ID #1618): struct the CQS.
(1) CMS assigns a scaled quality (c) Display of quality measures. CMS
measure score of 100 if the TEAM par- does all of the following:
ticipant’s raw quality measure score is (1) Displays quality measure results
greater than the maximum of the raw on the publicly available CMS website
quality measure scores in the CQS that is specific to TEAM, in a form and
baseline period.
manner consistent with other publicly
(2) CMS assigns a scaled quality reported measures.
measure score of 0 if the raw quality
(2) Shares quality measures with the
measure score is less than the min-
TEAM participant prior to display on
imum of the raw quality measure
the CMS website.
scores in the baseline period.
(3) Uses the following time periods to
(C) For the Hybrid Hospital-Wide All-
share quality measure performance:
Cause Readmission Measure with
Claims and Electronic Health Record (i) Quality measure performance in
Data (CMIT ID #356) measure, the CMS performance year 1 is reported in 2027.
Patient Safety and Adverse Events (ii) Quality measure performance in
Composite (CMS PSI 90) (CMIT ID #135) performance year 2 is reported in 2028.
measure, the Hospital Harm—Falls (iii) Quality measure performance in
with Injury (CMIT ID #1518) measure, performance year 3 is reported in 2029.
the Hospital Harm—Postoperative Res- (iv) Quality measure performance in
piratory Failure (CMIT ID #1788) meas- performance year 4 is reported in 2030.
ure, and the Thirty-day Risk-Standard- (v) Quality measure performance in
ized Death Rate among Surgical Inpa- performance year 5 is reported in 2031.
1066
RECONCILIATION AND REVIEW PROCESS with § 512.540 to calculate the reconcili-

ation target prices.
§ 512.550 Reconciliation process and (4) CMS aggregates the reconciliation
determination of the reconciliation target prices computed in accordance
payment or repayment amount.
with paragraph (c)(3) of this section for
(a) General. Providers and suppliers all episodes included in the perform-
furnishing items and services included ance year (other than episodes that
in the episode bill for such items and have been canceled in accordance with
services in accordance with existing § 512.537(b)).
Medicare rules. (5) CMS subtracts the performance
(b) Reconciliation process. Six months year spending amount determined
after the end of each performance year, under paragraph (c)(1–2) of this section
CMS does the following: from the aggregated reconciliation tar-
(1) Performs a reconciliation calcula- get price amount determined under
tion to establish a reconciliation pay- paragraph (c)(4) of this section to de-
ment or repayment amount for each termine the reconciliation amount.
TEAM participant. (d) Calculation of the quality-adjusted
(2) For TEAM participants that expe- reconciliation amount. CMS adjusts the
rience a reorganization event in which reconciliation amount based on the
one or more hospitals reorganize under Composite Quality Score as follows:
the CCN of a TEAM participant, per- (1) CMS calculates a CQS adjustment
forms— percentage based on a TEAM partici-
(i) Separate reconciliation calcula- pant’s CQS, computed in accordance
tions for each predecessor TEAM par- with § 512.547(b).
ticipant for episodes where the anchor (i) CMS applies a CQS adjustment
hospitalization admission or the an- percentage up to 10 percent for positive
chor procedure occurred before the ef- reconciliation amounts for TEAM par-
fective date of the reorganization ticipants in Track 1.
event; and (ii) CMS applies a CQS adjustment
(ii) Reconciliation calculations for percentage up to 10 percent for positive
each new or surviving TEAM partici- reconciliation amounts and up to 15
pant for episodes where the anchor hos- percent for negative reconciliation
pitalization admission or anchor proce- amounts for TEAM participants in
dure occurred on or after the effective Track 2.
date of the reorganization event. (iii) CMS applies a CQS adjustment
(c) Calculation of the reconciliation percentage up to 10 percent for positive
amount. CMS compares the reconcili- reconciliation amounts and up to 10
ation target prices described in § 512.545 percent for negative reconciliation
and the TEAM participant’s perform- amounts for TEAM participants in
ance year spending to establish a rec- Track 3.
onciliation amount for the TEAM par- (2) CMS multiplies the CQS adjust-
ticipant for each performance year as ment percentage, computed under
follows: paragraph (d)(1) of this section, by the
(1) CMS determines the performance TEAM participant’s positive or nega-
year spending for each episode included tive reconciliation amount calculated
in the performance year (other than in paragraph (c) of this section to con-
episodes that have been canceled in ac- struct the CQS adjustment amount.
cordance with § 512.537(b)) using claims (3) CMS subtracts the CQS adjust-
data that is available 6 months after ment amount, computed from para-
the end of the performance year. graph (d)(2) of this section, from the
(2) CMS calculates and applies the positive or negative reconciliation
high-cost outlier cap for performance amount calculated in paragraph (c) of
year episode spending by applying the this section to construct the quality-
calculation described in § 512.540(b)(4) adjusted reconciliation amount.
to performance year episode spending. (e) Calculation of the net payment rec-
(3) CMS applies the adjustments onciliation amount (NPRA). CMS applies
specified in § 512.545 to the preliminary stop-loss and stop gain limits to the
target prices computed in accordance quality-adjusted reconciliation amount
1067
§ 512.550 42 CFR Ch. IV (10–1–24 Edition)
computed in paragraph (d) of this sec- regional average post-episode spending

tion to calculate the NPRA as follows: amount for the performance year is
(1) Limitation on loss. For TEAM par- subtracted from the NPRA for that
ticipants in Track 3, except as provided performance year.
in paragraph (e)(3) of this section, the (g) Calculation of the reconciliation
repayment amount for a performance payment or repayment amount. (1) CMS
year cannot exceed 20 percent of the applies the results of the post-episode
aggregated reconciliation target price spending calculation set forth in para-
amount calculated in paragraph (c)(3) graph (f) of this section to the NPRA as
of this section for the performance follows:
year. The post-episode spending cal- (i) For TEAM participants whose
culation amount in paragraph (f) of post-episode spending amount does not
this section is not subject to the limi- exceed the limit calculated in para-
tation on loss. graph (f) of this section, the reconcili-
(2) Limitation on gain. (i) For TEAM ation payment or repayment amount is
participants in Track 1, the reconcili- equal to the NPRA.
ation payment amount for a perform- (ii) If the TEAM participant’s post-
ance year cannot exceed 10 percent of episode spending exceeds the limit cal-
the aggregated reconciliation target culated in paragraph (f) of this section,
price amount calculated in accordance CMS subtracts the amount of post-epi-
with paragraph (c)(3) of this section for sode spending exceeding the limit from
the performance year. the NPRA to calculate the reconcili-
(ii) For TEAM participants in Tracks ation payment or repayment amount.
2, the reconciliation payment amount (2) If the amount calculated in para-
for a performance year cannot exceed 5 graph (g)(1) of this section is positive,
percent of the aggregated reconcili- the TEAM participant is owed a rec-
ation target price amount calculated in onciliation payment in that amount, to
accordance with paragraph (c)(3) of this be paid by CMS in one lump sum pay-
section for the performance year. ment.
(iii) For TEAM participants in Track (3) If the amount calculated in para-
3, the reconciliation payment amount graph (g)(1) of this section is negative,
for a performance year cannot exceed CMS determines the repayment
20 percent of the aggregated reconcili- amount as follows:
ation target price amount calculated in (i) For TEAM participants in Track
accordance with paragraph (c)(3) of this 1, the TEAM participant does not owe
section for the performance year. a repayment amount.
(iv) The post-episode spending (ii) For TEAM participants in Track
amount calculated in accordance with 2 or Track 3 for Performance Years 1–
paragraph (f) of this section is not sub- 5, as applicable, the Team participant
ject to the limitation on gain. owes that amount as a repayment to
(3) Limitation on loss for certain pro- CMS.
viders. For performance years 2–5, the (h) TEAM reconciliation report. CMS
repayment amount for a TEAM partici- issues each TEAM participant a TEAM
pant in Track 2 defined at § 512.505, reconciliation report for the perform-
must not exceed 5 percent of the aggre- ance year. Each TEAM reconciliation
gated reconciliation target price report contains the following:
amount calculated in accordance with (1) The total performance year spend-
paragraph (c)(3) of this section. ing for the TEAM participant.
(f) Post-episode spending calculation. (2) The TEAM participant’s reconcili-
CMS calculates the post-episode spend- ation target prices.
ing amount as follows: If the average (3) The TEAM participant’s reconcili-
post-episode spending amount for a ation amount.
TEAM participant in the performance (4) The TEAM participant’s com-
year being reconciled is greater than 3 posite quality score calculated in ac-
standard deviations above the regional cordance with § 512.547(b).
average post-episode spending amount (5) The TEAM participant’s quality-
for the performance year, then the adjusted reconciliation amount.
post-episode spending amount that ex- (6) The stop-loss and stop-gain limits
ceeds 3 standard deviations above the that apply to the TEAM participant.
1068
(7) The TEAM participant’s NPRA. (ii) If the actual length of stay that
(8) The TEAM participant’s post-epi- occurred during the episode is equal to
sode spending amount, if applicable. or greater than the MS–DRG geometric
(9) The amount of any reconciliation mean, the full MS–DRG payment is al-
payment owed to the TEAM partici- located to the episode.
pant or repayment owed by the TEAM (iii) If the actual length of stay that
participant to CMS for the perform- occurred during the episode is less than
ance year, if applicable. the MS–DRG geometric mean length of
stay, the MS–DRG payment amount is
§ 512.552 Treatment of incentive pro- allocated to the episode based on the
grams or add-on payments under number of inpatient days that fall
existing Medicare payment systems. within the episode.
The TEAM does not replace any ex- (4) If the full amount of the payment
isting Medicare incentive programs or is not allocated to the episode, any re-
add-on payments. The TEAM payments mainder amount is allocated to the
are independent of, and do not affect, post-episode spending calculation (de-
any incentive programs or add-on pay- fined in § 512.550(f)).
ments under existing Medicare pay-
ment systems. § 512.560 Appeals process.
(a) Notice of calculation error (first level
§ 512.555 Proration of payments for of appeal). Subject to the limitations
services that extend beyond an epi- on review in § 512.594, if a TEAM partic-
sode.
ipant wishes to dispute calculations in-
(a) General. CMS prorates services involving a matter related to payment,
cluded in the episode that extend be- reconciliation amounts, repayment
yond the episode so that only those amounts, the use of quality measure
portions of the services that were fur- results in determining the composite
nished during the episode are included quality score, or the application of the
in the calculation of the actual episode composite quality score during rec-
payments. onciliation, the TEAM participant is
(b) Proration of services. CMS prorates required to provide written notice of
payments for services that extend be- the calculation error, in a form and
yond the episode for the purposes of manner and by a date specified by
calculating both baseline episode CMS.
spending and performance year spend- (1) Unless the TEAM participant pro-
ing using the following methodology: vides such written notice, CMS deems
(1) Non-IPPS inpatient services. Non- the TEAM reconciliation report to be
IPPS inpatient services that extend be- final 30 calendar days after it is issued
yond the end of the episode are pro- and proceeds with the payment or re-
rated according to the percentage of payment processes as applicable.
the actual length of stay (in days) that (2) If CMS receives a notice of a cal-
falls within the episode. culation error within 30 calendar days
(2) Home health agency services. Home of the issuance of the TEAM reconcili-
health agency services paid under the ation report, CMS responds in writing
Medicare prospective payment system within 30 calendar days to either con-
in accordance with part 484, subpart E firm that there was an error in the cal-
of this chapter that extend beyond the culation or verify that the calculation
episode are prorated according to the is correct. CMS reserves the right to
percentage of days, starting with the extend the time for its response upon
first billable service date and through written notice to the TEAM partici-
and including the last billable service pant.
date, that occur during the episode. (3) Only TEAM participants may use
(3) IPPS services. IPPS services that the calculation error process described
extend beyond the end of the episode in this part.
are prorated according to the MS–DRG (b) Exception to the appeals process. If
geometric mean length of stay, using the TEAM participant contests a mat-
the following methodology: ter that does not involve an issue con-
(i) The first day of the IPPS stay is tained in, or a calculation that contrib-
counted as 2 days. utes to, a TEAM reconciliation report,
1069
§ 512.561 42 CFR Ch. IV (10–1–24 Edition)
a notice of calculation error is not re- (i) The review procedures.

quired. In these instances, if CMS does (ii) A schedule that permits each
not receive a request for reconsider- party to submit position papers and
ation from the TEAM participant with- supporting documentation in support
in 10 calendar days of the notice of the of the party’s position for consider-
initial reconciliation, the initial deter- ation by the reconsideration official.
mination is deemed final and CMS pro- (4) The TEAM participant must sat-
ceeds with the action indicated in the isfy the notice of calculation error re-
initial determination. This does not quirements specified in this part before
apply to the limitations on review in submitting a reconsideration request
§ 512.594. under paragraph (b) of this section.
(c) Standards for reconsideration. (1)
§ 512.561 Reconsideration review proc-
esses. The parties must continue to fulfill all
responsibilities and obligations under
(a) Applicability of this section. This TEAM during the course of any dispute
section is applicable only where sec- arising under this part.
tion 1869 of the Act has been waived or (2) The reconsideration consists of a
is not applicable for TEAM partici- review of documentation that is sub-
pants. This section is only applicable mitted timely and in accordance with
to TEAM participants. the standards specified by the reconsid-
(b) Right to reconsideration. The eration official.
TEAM participant may request recon-
(3) The burden of proof is on the
sideration of a determination made by
TEAM participant to demonstrate to
CMS only if such reconsideration is not
the reconsideration official with clear
precluded by section 1115A(d)(2) of the
and convincing evidence that the deter-
Act or this subpart.
mination is inconsistent with the
(1) A request for reconsideration by
terms of this subpart.
the TEAM participant must satisfy the
(d) Reconsideration determination. (1)
following criteria:
The reconsideration determination is
(i) The request must be submitted to
based solely upon—
a designee of CMS (‘‘Reconsideration
Official’’) who— (i) Position papers and supporting
(A) Is authorized to receive such re- documentation that are timely sub-
quests; and mitted to the reconsideration official
(B) Did not participate in the deter- per the schedule defined in paragraph
mination that is the subject of the re- (b)(3)(ii) and meet the standards for
consideration request or, if applicable, submission under paragraph (b)(1) of
the notice of calculation error process. this section; and
(ii) The request must include a copy (ii) Documents and data that were
of the initial determination issued by timely submitted to CMS in the re-
CMS and contain a detailed, written quired format before CMS made the de-
explanation of the basis for the dis- termination that is the subject of the
pute, including supporting documenta- reconsideration request.
tion. (2) The reconsideration official issues
(iii) The request must be made within the reconsideration determination to
30 days of the date of the initial deter- CMS and to the TEAM participant in
mination for which reconsideration is writing.
being requested via email to an address (3) Absent unusual circumstances, in
as specified by CMS. which case the reconsideration official
(2) Requests that do not meet the re- reserves the right to an extension upon
quirements of paragraph (b)(1) of this written notice to the TEAM partici-
section are denied. pant, the reconsideration determina-
(3) Within 10 business days of receiv- tion is issued within 60 days of receipt
ing a request for reconsideration, the of timely filed position papers and sup-
Reconsideration Official sends the par- porting documentation per the sched-
ties a written acknowledgement of re- ule defined in paragraph (b)(3)(ii) of
ceipt of the reconsideration request. this section.
This acknowledgement sets forth the (4) The reconsideration determina-
following: tion is final and binding 30 days after
1070
its issuance, unless the TEAM partici- DATA SHARING AND OTHER
pant or CMS timely requests review of REQUIREMENTS
the reconsideration determination in
accordance with paragraphs (e)(1) and § 512.562 Data sharing with TEAM par-
ticipants.
(2) of this section.
(e) CMS Administrator review. The (a) General. CMS shares certain bene-
TEAM participant or CMS may request ficiary-identifiable data as described in
that the CMS Administrator review the paragraphs (b), (c), and (e) of this sec-
reconsideration determination. tion and certain regional aggregate
data as described in paragraph (d) of
(1) The request must be made via
this section with TEAM participants
email within 30 days of the date of the
regarding TEAM beneficiaries and per-
reconsideration determination to the formance under the model.
address specified by CMS. (b) Beneficiary-identifiable claims data.
(2) The request must include a copy CMS shares beneficiary-identifiable
of the reconsideration determination claims data with TEAM participants as
and a detailed written explanation of follows:
why the TEAM participant or CMS dis- (1) CMS makes available certain ben-
agrees with the reconsideration deter- eficiary-identifiable claims data de-
mination. scribed in paragraph (b)(5) of this sec-
(3) The CMS Administrator promptly tion for TEAM participants to request
sends the parties a written acknowl- for purposes of conducting health care
edgement of receipt of the request for operations work that falls within the
review. first or second paragraph of the defini-
(4) The CMS Administrator sends the tion of health care operations at 45
parties notice of the following: CFR 164.501 regarding their TEAM
(i) Whether the request for review is beneficiaries.
granted or denied. (2) A TEAM participant that wishes
to receive beneficiary-identifiable
(ii) If the request for review is grant-
claims data for its TEAM beneficiaries
ed, the review procedures and a sched- must do all of the following:
ule that permits each party to submit (i) Submit a formal request for the
a brief in support of the party’s posi- data on at least an annual basis in a
tion for consideration by the CMS Ad- manner and form and by a date speci-
ministrator. fied by CMS, indicating their selection
(5) If the request for review is denied, of summary beneficiary-identifiable
the reconsideration determination is data, raw beneficiary-identifiable data,
final and binding as of the date the re- or both, and attest that—
quest for review is denied. (A) The TEAM participant is request-
(6) If the request for review is granting claims data of TEAM beneficiaries
ed— who would be in an episode during the
(i) The record for review consists baseline period or performance year, as
solely of— a HIPAA covered entity.
(A) Timely submitted briefs and the (B) The TEAM participant’s request
evidence contained in the record of the reflects the minimum data necessary,
proceedings before the reconsideration as set forth in paragraph (c) of this sec-
official; and tion, for the TEAM participant to con-
duct health care operations work that
(B) Evidence as set forth in the docu-
falls within the first or second para-
ments and data described in paragraph graph of the definition of health care
(d)(1)(ii) of this section; operations at 45 CFR 164.501.
(ii) The CMS Administrator reviews (C) The TEAM participant’s use of
the record and issues to CMS and to claims data is limited to developing
the TEAM participant a written deter- processes and engaging in appropriate
mination; and activities related to coordinating care,
(iii) The written determination of the improving the quality and efficiency of
CMS Administrator is final and binding care, and conducting population-based
as of the date the written determina- activities relating to improving health
tion is sent. or reducing health care costs that are
1071
§ 512.562 42 CFR Ch. IV (10–1–24 Edition)
applied uniformly to all TEAM bene- (5) Claim ID.

ficiaries, in an episode during the base- (6) The from and through dates of
line period or performance year, and service.
that these data are not to be used to (7) The provider or supplier ID.
reduce, limit or restrict care for spe- (8) The claim payment type.
cific Medicare beneficiaries. (9) Date of birth and death, if applica-
(ii) Sign and submit a TEAM data ble.
sharing agreement, as defined in
(10) Tax identification number.
§ 512.505, with CMS as set forth in para-
graph (e) of this section. (11) National provider identifier.
(3) CMS shares this beneficiary-iden- (d) Regional aggregate data. (1) CMS
tifiable claims data with a TEAM par- shares regional aggregate data for the
ticipant in accordance with applicable 3-year baseline period and performance
privacy and security laws and estab- years with TEAM participants as fol-
lished privacy and security protec- lows:
tions. (i) Shares 3-year baseline period re-
(4) CMS omits from the beneficiary- gional aggregate data annually at least
identifiable claims data any informa- 1 month before the performance year,
tion that is subject to the regulations based on the baseline periods described
in 42 CFR part 2 governing the con- in § 512.540(b)(2).
fidentiality of substance use disorder (ii) Shares performance year regional
patient records. aggregate data on a monthly basis dur-
(5) The beneficiary-identifiable ing the performance year and for up to
claims data includes, when available, 6 months after the performance year.
the following: (2) Regional aggregate data—
(i) Unrefined (raw) Medicare Parts A (i) Is aggregated based on all Parts A
and B beneficiary-identifiable claims and B claims associated with episodes
data for TEAM beneficiaries in an epi- in TEAM for the U.S. Census Division
sode during the 3-year baseline period in which the TEAM participant is lo-
and performance year. cated;
(ii) Summarized (summary) Medicare (ii) Summarizes average episode
Parts A and B beneficiary-identifiable spending for episodes in TEAM in the
claims data for TEAM beneficiaries in U.S. Census Division in which the
an episode during the 3-year baseline TEAM participant is located; and
period and performance year.
(iii) Is de-identified in accordance
(6) CMS makes available the bene-
with 45 CFR 164.514(b).
ficiary-identifiable claims data for re-
trieval by TEAM participants at the (e) TEAM data sharing agreement. (1)
following frequency: A TEAM participant who wishes to re-
(i) Annually, at least 1 month prior trieve the beneficiary-identifiable data
to every performance year for baseline specified in paragraph (b) of this sec-
period data, based on the baseline peri- tion, must complete and submit, on at
ods described in § 512.540(b)(2). least an annual basis, a signed TEAM
(ii) Monthly during the performance data sharing agreement, as defined in
year and for up to 6 months after the § 512.505, to be provided in a form and
performance year for performance year manner and by a date specified by
data. CMS, under which the TEAM partici-
(c) Minimum necessary data. The pant agrees:
TEAM participant must limit its re- (i) To comply with the requirements
quest for beneficiary-identifiable data for use and disclosure of this bene-
under paragraph (b) of this section to ficiary-identifiable data that are im-
the minimum necessary Parts A and B posed on covered entities by the
data elements which may include, but HIPAA regulations and the require-
are not limited to the following: ments of the TEAM set forth in this
(1) Medicare beneficiary identifier part.
(ID). (ii) To comply with additional pri-
(2) Procedure code. vacy, security, breach notification, and
(3) Gender. data retention requirements specified
(4) Diagnosis code. by CMS.
1072
(iii) To contractually bind each voluntarily submit aggregated health-

downstream recipient of the bene- related social needs screening and
ficiary-identifiable data that is a busi- screened-positive data in a form and
ness associate of the TEAM participant manner and by the dates specified by
to the same terms and conditions to CMS. The health-related social needs
which the TEAM participant is itself screening and reporting must include
bound in its TEAM data sharing agree- the elements specified in paragraph
ment with CMS as a condition of the (a)(2) of this section.
business associate’s receipt of the bene- (2) CMS uses the following measures
ficiary-identifiable data retrieved by from the Hospital Inpatient Quality
the TEAM participant under TEAM. Reporting Program for the TEAM par-
(iv) That if the TEAM participant ticipants who opt to voluntarily sub-
misuses or discloses the beneficiary- mit aggregated health-related social
identifiable data in a manner that vio- needs screening and screened-positive
lates any applicable statutory or regu- data.
latory requirements or that is other- (i) Screening for Social Drivers of
wise non-compliant with the provisions Health (SDOH–1; CMIT ID #1664).
of the TEAM data sharing agreement, (ii) Screen Positive Rate for Social
CMS may deem the TEAM participant Drivers of Health (SDOH–2; CMIT ID
ineligible to retrieve beneficiary-iden-
#1662).
tifiable data under paragraph (b) of
(3) For all performance years, TEAM
this section for any amount of time,
participants that voluntarily submit
and the TEAM participant may be sub-
ject to additional sanctions and pen- data health-related social needs screen-
alties available under the law. ing and screened-positive data as speci-
(2) A TEAM participant must comply fied in paragraphs (b)(1) and (2) of this
with all applicable laws and the terms section may voluntarily submit infor-
of the TEAM data sharing agreement mation on referral policies and proce-
in order to retrieve the beneficiary- dures for beneficiaries that screen posi-
identifiable data. tive for health-related social needs in a
form and manner and by dates specified
§ 512.563 Health equity reporting. by CMS.
(a) Health equity plans. (1) The TEAM (c) Demographic data collection and re-
participant may voluntarily submit a porting. For all performance years, the
health equity plan to CMS for each per- TEAM participant may voluntarily col-
formance year that includes the ele- lect and submit to CMS, in a form and
ments specified in paragraph (a)(2) of manner and by the dates specified by
this section, in a form and manner and CMS, demographic data of TEAM bene-
by the date specified by CMS. ficiaries that are willing to share de-
(2) Health equity plans must include mographic data elements with the
the following elements: TEAM participant and CMS.
(i) Identifies health disparities in the
§ 512.564 Referral to primary care
TEAM participant’s population of services.
TEAM beneficiaries.
(ii) Identifies health equity goals and (a) A TEAM participant must include
describes how the TEAM participant in hospital discharge planning a refer-
uses the health equity goals to monitor ral to a supplier of primary care serv-
and evaluate progress in reducing the ices for a TEAM beneficiary, on or
identified health disparities. prior to discharge from an anchor hos-
(iii) Describes the health equity plan pitalization or anchor procedure.
intervention strategy. (b) In making the referral described
(iv) Identifies health equity plan per- in paragraph (a) of this section, the
formance measure(s), the data sources TEAM participant must comply with
used to construct the performance beneficiary freedom of choice, as de-
measures, and an approach to monitor scribed in § 512.582(a).
and evaluate the measures. (c) A TEAM participant that does not
(b) Health-related social needs screen- comply with paragraph (a) of this sec-
ing and reporting. (1) For all perform- tion, may be subject to remedial action
ance years, the TEAM participant may as described in § 512.592.
1073
§ 512.565 42 CFR Ch. IV (10–1–24 Edition)
FINANCIAL ARRANGEMENTS AND (b) Requirements. (1) A sharing ar-

BENEFICIARY INCENTIVES rangement must be in writing and
signed by the parties, and entered into
§ 512.565 Sharing arrangements. before care is furnished to TEAM bene-
(a) General. (1) A TEAM participant ficiaries under the sharing arrange-
may enter into a sharing arrangement ment.
with a TEAM collaborator to make a (2) Participation in a sharing ar-
gainsharing payment, or to receive an rangement must be voluntary and
alignment payment, or both. A TEAM without penalty for nonparticipation.
participant must not make a (3) The sharing arrangement must re-
gainsharing payment to a TEAM col- quire the TEAM collaborator and its
laborator or receive an alignment pay- employees, contractors (including col-
ment from a TEAM collaborator except laboration agents), and subcontractors
in accordance with a sharing arrange- (including downstream collaboration
ment. agents) to comply with all of the fol-
lowing:
(2) A sharing arrangement must com-
(i) The applicable provisions of this
ply with the provisions of this section
part (including requirements regarding
and all other applicable laws and regu-
beneficiary notifications, access to
lations, including the applicable fraud
records, record retention, and partici-
and abuse laws and all applicable pay-
pation in any evaluation, monitoring,
ment and coverage requirements.
compliance, and enforcement activities
(3) TEAM participants must develop, performed by CMS or its designees).
maintain, and use a set of written poli- (ii) All applicable Medicare provider
cies for selecting individuals and enti- enrollment requirements at § 424.500 of
ties to be TEAM collaborators. this chapter, including having a valid
(i) These policies must contain cri- and active TIN or NPI, during the term
teria related to, and inclusive of, the of the sharing arrangement.
quality of care delivered by the poten- (iii) All other applicable laws and
tial TEAM collaborator and the provi- regulations.
sion of TEAM activities. (4) The sharing arrangement must re-
(ii) The selection criteria cannot be quire the TEAM collaborator to have
based directly or indirectly on the vol- or be covered by a compliance program
ume or value of past or anticipated re- that includes oversight of the sharing
ferrals or business otherwise generated arrangement and compliance with the
by, between or among the TEAM par- requirements of TEAM that apply to
ticipant, any TEAM collaborator, any its role as a TEAM collaborator, in-
collaboration agent, any downstream cluding any distribution arrangements.
collaboration agent, or any individual (5) The sharing arrangement must
or entity affiliated with a TEAM par- not pose a risk to beneficiary access,
ticipant, TEAM collaborator, collabo- beneficiary freedom of choice, or qual-
ration agent, or downstream collabora- ity of care.
tion agent. (6) The board or other governing body
(iii) A selection criterion that con- of the TEAM participant must have re-
siders whether a potential TEAM col- sponsibility for overseeing the TEAM
laborator has performed a reasonable participant’s participation in TEAM,
minimum number of services that its arrangements with TEAM collabo-
would qualify as TEAM activities, as rators, its payment of gainsharing pay-
determined by the TEAM participant, ments, its receipt of alignment pay-
will be deemed not to violate the vol- ments, and its use of beneficiary incen-
ume or value standard if the purpose of tives in TEAM.
the criterion is to ensure the quality of (7) The specifics of the agreement
care furnished to TEAM beneficiaries. must be documented in writing and
(4) If a TEAM participant enters into must be made available to CMS upon
a sharing arrangement, its compliance request (as outlined in § 512.590).
program must include oversight of (8) The sharing arrangement must
sharing arrangements and compliance specify the following:
with the applicable requirements of (i) The purpose and scope of the shar-
TEAM. ing arrangement.
1074
(ii) The obligations of the parties, in- (ii) To be eligible to receive a

cluding specified TEAM activities and gainsharing payment, or to be required
other services to be performed by the to make an alignment payment, a
parties under the sharing arrangement. TEAM collaborator other than ACO,
(iii) The date range for which the PGP, NPPGP, or TGP must have di-
sharing arrangement is effective. rectly furnished a billable item or serv-
(iv) The financial or economic terms ice to a TEAM beneficiary during an
for payment, including the following: episode that was attributed to the
(A) Eligibility criteria for a same performance year for which the
gainsharing payment. TEAM participant accrued the internal
(B) Eligibility criteria for an align- cost savings or earned the reconcili-
ment payment. ation payment amount or repayment
(C) Frequency of gainsharing or amount that comprises the gainsharing
alignment payments. payment or the alignment payment.
(D) Methodology and accounting for- (iii) To be eligible to receive a
mula for determining the amount of a gainsharing payment, or to be required
gainsharing payment or alignment to make an alignment payment, a
payment. TEAM collaborator that is a PGP,
NPPGP, or TGP must meet the fol-
(9) The sharing arrangement must
lowing criteria:
not—
(A) The PGP, NPPGP, or TGP must
(i) Induce the TEAM participant,
have billed for an item or service that
TEAM collaborator, or any employees,
was rendered by one or more PGP
contractors, or subcontractors of the
member, NPPGP member, or TGP
TEAM participant or TEAM collabo-
member respectively to a TEAM bene-
rator to reduce or limit medically nec-
ficiary during an episode that was at-
essary services to any Medicare bene-
tributed to the same performance year
ficiary; or
for which the TEAM participant ac-
(ii) Restrict the ability of a TEAM crued the internal cost savings or
collaborator to make decisions in the earned the reconciliation payment
best interests of its patients, including amount or repayment amount that
the selection of devices, supplies, and comprises the gainsharing payment or
treatments. the alignment payment.
(c) Gainsharing payment, alignment (B) The PGP, NPPGP, or TGP must
payment, and internal cost savings condi- have contributed to TEAM activities
tions and restrictions. (1) Gainsharing and been clinically involved in the care
payments, if any, must— of TEAM beneficiaries during the same
(i) Be derived solely from reconcili- performance year for which the TEAM
ation payment amounts, or internal participant accrued the internal cost
cost savings, or both; savings or earned the reconciliation
(ii) Be distributed on an annual basis payment amount or repayment amount
(not more than once per calendar year); that comprises the gainsharing pay-
(iii) Not be a loan, advance payment, ment or the alignment payment. A
or payment for referrals or other busi- non-exhaustive list of examples where,
ness; and a PGP, NPPGP, or TGP might have
(iv) Be clearly identified as a been clinically involved in the care of
gainsharing payment at the time it is TEAM beneficiaries includes—
paid. (1) Providing care coordination serv-
(2)(i) To be eligible to receive a ices to TEAM beneficiaries during or
gainsharing payment, a TEAM collabo- after inpatient admission;
rator must meet quality of care cri- (2) Engaging with a TEAM partici-
teria for the performance year for pant in care redesign strategies, and
which the TEAM participant accrued performing a role in implementing
the internal cost savings or earned the such strategies, that are designed to
reconciliation payment that comprises improve the quality of care for epi-
the gainsharing payment. The quality- sodes and reduce episode spending; or
of-care criteria must be established by (3) In coordination with other pro-
the TEAM participant and directly re- viders and suppliers (such as PGP
late to the episode. members, NPPGP members, or TGP
1075
§ 512.565 42 CFR Ch. IV (10–1–24 Edition)
members; the TEAM participant; and erally accepted accounting principles

post-acute care providers), imple- (GAAP) and Government Auditing
menting strategies designed to address Standards (The Yellow Book).
and manage the comorbidities of (ii) Used to calculate internal cost
TEAM beneficiaries. savings must reflect the actual, inter-
(iv) To be eligible to receive a nal cost savings achieved by the TEAM
gainsharing payment, or to be required participant through the documented
to make an alignment payment, a implementation of TEAM activities
TEAM collaborator that is an ACO identified by the TEAM participant
must meet the following criteria: and must exclude—
(A) The ACO must have had an ACO (A) Any savings realized by any indi-
provider/supplier that directly fur- vidual or entity that is not the TEAM
nished, or an ACO participant that participant; and
billed for, an item or service that was (B) ‘‘Paper’’ savings from accounting
rendered to a TEAM beneficiary during conventions or past investment in fixed
an episode that was attributed to the costs.
same performance year for which the (4) The amount of any gainsharing
TEAM participant accrued the internal payments must be determined in ac-
cost savings or earned the reconcili- cordance with a methodology that is
ation payment amount or repayment based solely on quality of care and the
amount that comprises the gainsharing provision of TEAM activities. The
payment or the alignment payment; methodology may take into account
and the amount of TEAM activities pro-
(B) The ACO must have contributed vided by a TEAM collaborator relative
to TEAM activities and been clinically to other TEAM collaborators.
involved in the care of TEAM bene- (5) For a performance year, the ag-
ficiaries during the performance year gregate amount of all gainsharing pay-
for which the TEAM participant ac- ments that are derived from reconcili-
crued the internal cost savings or ation payment amounts must not ex-
earned the reconciliation payment ceed the amount of that year’s rec-
amount or repayment amount that onciliation payment amount.
comprises the gainsharing payment or (6) No entity or individual, whether a
the alignment payment. A non-exhaus- party to a sharing arrangement or not,
tive list of ways in which an ACO may condition the opportunity to
might have been clinically involved in make or receive gainsharing payments
the care of TEAM beneficiaries could or to make or receive alignment pay-
include— ments directly or indirectly on the vol-
(1) Providing care coordination serv- ume or value of past or anticipated re-
ices to TEAM beneficiaries during and/ ferrals or business otherwise generated
or after inpatient admission; by, between or among the TEAM par-
(2) Engaging with a TEAM partici- ticipant, any TEAM collaborator, any
pant in care redesign strategies and collaboration agent, any downstream
performing a role in implementing collaboration agent, or any individual
such strategies that are designed to or entity affiliated with a TEAM par-
improve the quality of care and reduce ticipant, TEAM collaborator, collabo-
spending for episodes; or ration agent, or downstream collabora-
(3) In coordination with providers tion agent.
and suppliers (such as ACO partici- (7) A TEAM participant must not
pants, ACO providers/suppliers, the make a gainsharing payment to a
TEAM participant, and post-acute care TEAM collaborator if CMS has notified
providers), implementing strategies de- the TEAM participant that such TEAM
signed to address and manage the collaborator is subject to any action by
comorbidities of TEAM beneficiaries. CMS, HHS or any other governmental
(3) The methodology for accruing, entity, or its designees, for noncompli-
calculating and verifying internal cost ance with this part or the fraud and
savings will be determined by the abuse laws, for the provision of sub-
TEAM participant. The methodology— standard care to TEAM beneficiaries or
(i) Must be transparent, measurable, other integrity problems, or for any
and verifiable in accordance with gen- other program integrity problems or
1076
noncompliance with any other laws or (14) All gainsharing payments and
regulations. any alignment payments must be ad-
(8) The sharing arrangement must re- ministered by the TEAM participant in
quire the TEAM participant to recoup accordance with generally accepted ac-
any gainsharing payment that con- counting principles (GAAP) and Gov-
tained funds derived from a CMS over- ernment Auditing Standards (The Yel-
payment on a reconciliation payment low Book).
amount or was based on the submission (15) All gainsharing payments and
of false or fraudulent data. alignment payments must be made by
(9) Alignment payments from a check, electronic funds transfer, or an-
TEAM collaborator to a TEAM partici- other traceable cash transaction.
pant may be made at any interval that (d) Documentation requirements. (1)
is agreed upon by both parties, and TEAM participants must—
must not be— (i) Document the sharing arrange-
(i) Issued, distributed, or paid prior ment contemporaneously with the es-
to the calculation by CMS of a repay- tablishment of the arrangement;
ment amount; payment; (ii) Publicly post (and update on at
(ii) Loans, advance payments, or pay- least a quarterly basis) on a web page
ments for referrals or other business; on the TEAM participant’s website—
or (A) Accurate lists of all current
(iii) Assessed by a TEAM participant TEAM collaborators, including the
in the absence of a repayment amount. TEAM collaborators’ names and ad-
(10) The TEAM participant must not dresses as well as accurate historical
receive any amounts under a sharing lists of all TEAM collaborators.
arrangement from a TEAM collabo- (B) Written policies for selecting in-
rator that are not alignment pay- dividuals and entities to be TEAM col-
ments. laborators as required by § 512.565(a)(3).
(11) For a performance year, the ag-
(iii) Maintain, and require each
gregate amount of all alignment pay-
TEAM collaborator to maintain, con-
ments received by the TEAM partici-
temporaneous documentation with re-
pant must not exceed 50 percent of the
spect to the payment or receipt of any
TEAM participant’s repayment
gainsharing payment or alignment
amount.
payment that includes, at a min-
(12) The aggregate amount of all
imum—
alignment payments from a TEAM col-
(A) Nature of the payment
laborator to the TEAM participant
(gainsharing payment or alignment
may not be greater than—
payment);
(i) With respect to a TEAM collabo-
rator other than an ACO, 25 percent of (B) Identity of the parties making
the TEAM participant’s repayment and receiving the payment;
amount. (C) Date of the payment;
(ii) With respect to a TEAM collabo- (D) Amount of the payment; and
rator that is an ACO, 50 percent of the (E) Date and amount of any
TEAM participant’s repayment recoupment of all or a portion of a
amount. TEAM collaborator’s gainsharing pay-
(13) The amount of any alignment ment.
payments must be determined in ac- (F) Explanation for each recoupment,
cordance with a methodology that does such as whether the TEAM collabo-
not directly account for the volume or rator received a gainsharing payment
value of past or anticipated referrals or that contained funds derived from a
business otherwise generated by, be- CMS overpayment of a reconciliation
tween or among the TEAM participant, payment or was based on the submis-
any TEAM collaborator, any collabora- sion of false or fraudulent data.
tion agent, any downstream collabora- (2) The TEAM participant must keep
tion agent, or any individual or entity records of all of the following:
affiliated with a TEAM participant, (i) Its process for determining and
TEAM collaborator, collaboration verifying its potential and current
agent, or downstream collaboration TEAM collaborators’ eligibility to par-
agent. ticipate in Medicare.
1077
§ 512.568 42 CFR Ch. IV (10–1–24 Edition)
(ii) Its plan to track internal cost rator, collaboration agent, or down-
savings. stream collaboration agent.
(iii) Information on the accounting (5) The amount of any distribution
systems used to track internal cost payments from an ACO, from an
savings. NPPGP to an NPPGP member, or from
(iv) A description of current health a TGP to a TGP member, must be de-
information technology, including sys- termined in accordance with a method-
tems to track reconciliation payment ology that is solely based on quality of
amounts, repayment amounts, and in- care and the provision of TEAM activi-
ternal cost savings. ties and that may take into account
(v) Its plan to track gainsharing pay- the amount of such TEAM activities
ments and alignment payments.
provided by a collaboration agent rel-
(3) The TEAM participant must re-
ative to other collaboration agents.
tain and provide access to and must re-
quire each TEAM collaborator to re- (6) The amount of any distribution
tain and provide access to, the required payments from a PGP must be deter-
documentation in accordance with mined in accordance with a method-
§ 512.586. ology that is solely based on quality of
care and the provision of TEAM activi-
§ 512.568 Distribution arrangements. ties and that may take into account
(a) General. (1) An ACO, PGP, the amount of such TEAM activities
NPPGP, or TGP that is a TEAM col- provided by a collaboration agent rel-
laborator and has entered into a shar- ative to other collaboration agents.
ing arrangement with a TEAM partici- (7) A collaboration agent is eligible
pant may distribute all or a portion of to receive a distribution payment only
any gainsharing payment it receives if the collaboration agent furnished or
from the TEAM participant only in ac- billed for an item or service rendered
cordance with a distribution arrange- to a TEAM beneficiary during an epi-
ment. sode that was attributed to the same
(2) All distribution arrangements performance year for which the TEAM
must comply with the provisions of participant accrued the internal cost
this section and all other applicable savings or earned the reconciliation
laws and regulations, including the payment amount that comprises the
fraud and abuse laws. gainsharing payment being distributed.
(b) Requirements. (1) All distribution (8) With respect to the distribution of
arrangements must be in writing and any gainsharing payment received by
signed by the parties, contain the effec- an ACO, PGP, NPPGP, or TGP, the
tive date of the agreement, and be en- total amount of all distribution pay-
tered into before care is furnished to ments for a performance year must not
TEAM beneficiaries under the distribu- exceed the amount of the gainsharing
tion arrangement. payment received by the TEAM col-
(2) Participation in a distribution ar- laborator from the TEAM participant
rangement must be voluntary and for the same performance year.
without penalty for nonparticipation.
(9) All distribution payments must be
(3) The distribution arrangement
made by check, electronic funds trans-
must require the collaboration agent
fer, or another traceable cash trans-
to comply with all applicable laws and
action.
regulations.
(4) The opportunity to make or re- (10) The collaboration agent must re-
ceive a distribution payment must not tain the ability to make decisions in
be conditioned directly or indirectly on the best interests of the patient, in-
the volume or value of past or antici- cluding the selection of devices, sup-
pated referrals or business otherwise plies, and treatments.
generated by, between or among the (11) The distribution arrangement
TEAM participant, any TEAM collabo- must not—
rator, any collaboration agent, any (i) Induce the collaboration agent to
downstream collaboration agent, or reduce or limit medically necessary
any individual or entity affiliated with items and services to any Medicare
a TEAM participant, TEAM collabo- beneficiary; or
1078
(ii) Reward the provision of items (3) The downstream distribution ar-
and services that are medically unnec- rangement must require the down-
essary. stream collaboration agent to comply
(12) The TEAM collaborator must with all applicable laws and regula-
maintain contemporaneous docu- tions.
mentation regarding distribution ar- (4) The opportunity to make or re-
rangements in accordance with ceive a downstream distribution pay-
§ 512.586, including all of the following: ment must not be conditioned directly
(i) The relevant written agreements. or indirectly on the volume or value of
(ii) The date and amount of any dis- past or anticipated referrals or busi-
tribution payment(s). ness otherwise generated by, between
(iii) The identity of each collabora- or among the TEAM participant, any
tion agent that received a distribution TEAM collaborator, any collaboration
payment. agent, any downstream collaboration
(iv) A description of the methodology agent, or any individual or entity af-
and accounting formula for deter- filiated with a TEAM participant,
mining the amount of any distribution TEAM collaborator, collaboration
payment. agent, or downstream collaboration
(13) The TEAM collaborator may not agent.
enter into a distribution arrangement (5) The amount of any downstream
with any individual or entity that has distribution payments from an NPPGP
a sharing arrangement with the same to an NPPGP member or from a TGP
TEAM participant. to a TGP member must be determined
(14) The TEAM collaborator must rein accordance with a methodology that
tain and provide access to and must re- is solely based on quality of care and
quire collaboration agents to retain the provision of TEAM activities and
and provide access to, the required doc- that may take into account the
umentation in accordance with amount of such TEAM activities pro-
§ 512.586. vided by a downstream collaboration
agent relative to other downstream
§ 512.570 Downstream distribution ar- collaboration agents.
rangements. (6) The amount of any downstream
(a) General. (1) An ACO participant distribution payments from a PGP
that is a PGP, NPPGP, or TGP and must be determined in accordance with
that has entered into a distribution ar- a methodology that is solely based on
rangement with a TEAM collaborator quality of care and the provision of
that is an ACO, may distribute all or a TEAM activities and that may take
portion of any distribution payment it into account the amount of such TEAM
receives from the TEAM collaborator activities provided by a downstream
only in accordance with a downstream collaboration agent relative to other
distribution arrangement. downstream collaboration agents.
(2) All downstream distribution ar- (7) A downstream collaboration agent
rangements must comply with the pro- is eligible to receive a downstream dis-
visions of this section and all applica- tribution payment only if the down-
ble laws and regulations, including the stream collaboration agent furnished
fraud and abuse laws. an item or service to a TEAM bene-
(b) Requirements. (1) All downstream ficiary during an episode that is attrib-
distribution arrangements must be in uted to the same performance year for
writing and signed by the parties, con- which the TEAM participant accrued
tain the effective date of the agree- the internal cost savings or earned the
ment, and be entered into before care is reconciliation payment amount that
furnished to TEAM beneficiaries under comprises the gainsharing payment
the downstream distribution arrange- from which the ACO made the distribu-
ment. tion payment to the PGP, NPPGP, or
(2) Participation in a downstream TGP that is an ACO participant.
distribution arrangement must be vol- (8) The total amount of all down-
untary and without penalty for non- stream distribution payments made to
participation. downstream collaboration agents must
1079
§ 512.575 42 CFR Ch. IV (10–1–24 Edition)
not exceed the amount of the distribu- TEAM beneficiaries in an episode, sub-
tion payment received by the PGP, ject to the following conditions:
NPPGP, or TGP from the ACO. (1) The incentive must be provided
(9) All downstream distribution pay- directly by the TEAM participant or by
ments must be made by check, elec- an agent of the TEAM participant
tronic funds transfer, or another trace- under the TEAM participant’s direc-
able cash transaction. tion and control to the TEAM bene-
(10) The downstream collaboration ficiary during an episode.
agent must retain his or her ability to (2) The item or service provided must
make decisions in the best interests of be reasonably connected to medical
the beneficiary, including the selection care provided to a TEAM beneficiary
of devices, supplies, and treatments. during an episode.
(11) The downstream distribution ar- (3) The item or service must be a pre-
rangement must not— ventive care item or service or an item
(i) Induce the downstream collabora- or service that advances a clinical
tion agent to reduce or limit medically goal, as listed in paragraph (c) of this
necessary services to any Medicare section, for a TEAM beneficiary in an
beneficiary; or episode by engaging the TEAM bene-
(ii) Reward the provision of items ficiary in better managing his or her
and services that are medically unnec- own health.
essary. (4) The item or service must not be
(12) The PGP, NPPGP, or TGP must tied to the receipt of items or services
maintain contemporaneous docu- outside the episode.
mentation regarding downstream dis- (5) The item or service must not be
tribution arrangements in accordance tied to the receipt of items or services
with § 512.586, including the following: from a particular provider or supplier.
(i) The relevant written agreements. (6) The availability of the items or
services must not be advertised or pro-
(ii) The date and amount of any
moted, except that a TEAM beneficiary
downstream distribution payment.
may be made aware of the availability
(iii) The identity of each downstream
of the items or services at the time the
collaboration agent that received a
TEAM beneficiary could reasonably
downstream distribution payment.
benefit from them.
(iv) A description of the methodology (7) The cost of the items or services
and accounting formula for deter- must not be shifted to any Federal
mining the amount of any downstream health care program, as defined at sec-
distribution payment. tion 1128B(f) of the Act.
(13) The PGP, NPPGP, or TGP may (b) Technology provided to a TEAM
not enter into a downstream distribu- beneficiary. TEAM beneficiary engage-
tion arrangement with any PGP mem- ment incentives involving technology
ber, NPPGP member, or TGP member are subject to the following additional
who has— conditions:
(i) A sharing arrangement with a (1) Items or services involving tech-
TEAM participant. nology provided to a TEAM beneficiary
(ii) A distribution arrangement with may not exceed $1,000 in retail value
the ACO that the PGP, NPPGP, or TGP for any one TEAM beneficiary during
is a participant in. any one episode.
(14) The PGP, NPPGP, or TGP must (2) Items or services involving tech-
retain and provide access to, and must nology provided to a TEAM beneficiary
require downstream collaboration must be the minimum necessary to ad-
agents to retain and provide access to, vance a clinical goal, as listed in para-
the required documentation in accord- graph (c) of this section, for a bene-
ance with § 512.586. ficiary in an episode.
(3) Items of technology exceeding $75
§ 512.575 TEAM beneficiary incentives. in retail value must—
(a) General. TEAM participants may (i) Remain the property of the TEAM
choose to provide in-kind patient en- participant; and
gagement incentives including but not (ii) Be retrieved from the TEAM ben-
limited to items of technology to eficiary at the end of the episode, with
1080
documentation of the ultimate date of § 512.576 Application of the CMS-spon-

retrieval. The TEAM participant must sored model arrangements and pa-
document all retrieval attempts. In tient incentives safe harbor.
cases when the item of technology is (a) Application of the CMS-sponsored
not able to be retrieved, the TEAM par- model arrangements safe harbor. CMS
ticipant must determine why the item has determined that the Federal Anti-
was not retrievable. If it was deter- Kickback Statute Safe Harbor for
mined that the item was misappro- CMS-sponsored model arrangements (42
priated (if it were sold, for example), CFR 1001.952(ii)(1)) is available to pro-
the TEAM participant must take steps tect remuneration furnished in TEAM
to prevent future beneficiary incen- in the form of the sharing arrange-
tives for that TEAM beneficiary. Fol- ment’s gainsharing payments and
lowing this process, documented, dili- alignment payments, the distribution
gent, good faith attempts to retrieve arrangement’s distribution payments,
items of technology will be deemed to and the downstream distribution ar-
meet the retrieval requirement. rangement’s distribution payments
(c) Clinical goals of TEAM. The fol- that meet all safe harbor requirements
lowing are the clinical goals of TEAM, set forth in 42 CFR 1001.952(ii), and
which may be advanced through TEAM §§ 512.565, 512.568, 512.570.
beneficiary incentives: (b) Application of the CMS-sponsored
(1) Beneficiary adherence to drug model patient incentives safe harbor. CMS
regimens. has determined that the Federal Anti-
Kickback Statute Safe Harbor for
(2) Beneficiary adherence to a care
CMS-sponsored model patient incen-
plan.
tives (42 CFR 1001.952(ii)(2)) is available
(3) Reduction of readmissions and to protect TEAM beneficiary incen-
complications following an episode. tives that meet all safe harbor require-
(4) Management of chronic diseases ments set forth in 42 CFR 1001.952(ii)
and conditions that may be affected by and § 512.575.
the TEAM procedure.
(d) Documentation of TEAM beneficiary MEDICARE PROGRAM WAIVERS
incentives. (1) TEAM participants must
maintain documentation of items and § 512.580 TEAM Medicare Program
services furnished as beneficiary incen- Waivers
tives that exceed $25 in retail value. (a) Waiver of certain telehealth require-
(2) The documentation must be estab- ments—(1) Waiver of the geographic site
lished contemporaneously with the requirements. Except for the geographic
provision of the items and services site requirements for a face-to-face en-
with a record established and main- counter for home health certification,
tained to include at least the following: CMS waives the geographic site re-
(i) The date the incentive is provided. quirements of section 1834(m)(4)(C)(i)(I)
through (III) of the Act for episodes
(ii) The identity of the TEAM bene-
being tested in TEAM solely for serv-
ficiary to whom the item or service
ices that—
was provided.
(i) May be furnished via telehealth
(3) The documentation regarding
under existing Medicare program re-
items of technology exceeding $75 in quirements; and
retail value must also include contem-
(ii) Are included in the episode in ac-
poraneous documentation of any at- cordance with § 512.525(e).
tempt to retrieve technology at the
(2) Waiver of the originating site re-
end of an episode, or why the items quirements. Except for the originating
were not retrievable, as described in site requirements for a face-to-face en-
paragraph (b)(3) of this section. counter for home health certification,
(4) The TEAM participant must re- CMS waives the originating site re-
tain and provide access to the required quirements under section
documentation in accordance with 1834(m)(4)I(ii)(I) through (VIII) of the
§ 512.586. Act for episodes to permit a telehealth
visit to originate in the beneficiary’s
1081
§ 512.580 42 CFR Ch. IV (10–1–24 Edition)
home or place of residence solely for website. Qualified SNFs are rated an
services that— overall of 3 stars or better for at least
(i) May be furnished via telehealth 7 of the 12 months.
under existing Medicare program re- (4) Posting of qualified SNFs. CMS
quirements; and posts to the CMS website the list of
(ii) Are included in the episode in ac- qualified SNFs in advance of the cal-
cordance with § 512.525(e). endar quarter.
(3) Waiver of selected payment provi-
(5) Financial liability for non-covered
sions. (i) CMS waives the payment re-
SNF services. If CMS determines that
quirements under section 1834(m)(2)(A)
of the Act so that the facility fee nor- the waiver requirements specified in
mally paid by Medicare to an origi- paragraph (b) of this section were not
nating site for a telehealth service is met, the following apply:
not paid if the service is originated in (i) CMS makes no payment to a SNF
the beneficiary’s home or place of resi- for SNF services if the SNF admits a
dence. TEAM beneficiary who has not had a
(ii) CMS waives the payment require- qualifying anchor hospitalization or
ments under section 1834(m)(2)(B) of anchor procedure.
the Act to allow the distant site pay- (ii) In the event that CMS makes no
ment for telehealth home visit HCPCS payment for SNF services furnished by
codes unique to TEAM. a SNF as a result of paragraph (b)(5)(i)
(4) Other requirements. All other re- of this section, the beneficiary protec-
quirements for Medicare coverage and tions specified in paragraph (b)(5)(iii)
payment of telehealth services con- of this section apply, unless the TEAM
tinue to apply, including the list of
participant has provided the bene-
specific services approved to be fur-
ficiary with a discharge planning no-
nished by telehealth.
(b) Waiver of the SNF 3-day rule—(1) tice in accordance with § 512.582(b)(3).
Episodes initiated by an anchor hos- (iii) If the TEAM participant does not
pitalization. CMS waives the SNF 3-day provide the beneficiary with a dis-
rule for coverage of a SNF stay within charge planning notice in accordance
30 days of the date of discharge from with § 512.582(b)(3)—
the anchor hospitalization for a bene- (A) The SNF must not charge the
ficiary who is a TEAM beneficiary on beneficiary for the expenses incurred
the date of discharge from the anchor for such services;
hospitalization if the SNF is identified (B) The SNF must return to the bene-
on the applicable calendar quarter list ficiary any monies collected for such
of qualified SNFs at the time of the services; and
TEAM beneficiary’s admission to the (C) The TEAM participant is finan-
SNF. cially liable for the expenses incurred
(2) Episodes initiated by an anchor pro- for such services.
cedure. CMS waives the SNF 3-day rule
(6) Coverage of SNF services and dis-
for coverage of a SNF stay within 30
days of the date of service of the an- charge planning notification. If the
chor procedure for a beneficiary who is TEAM participant provided a discharge
a TEAM beneficiary on the date of planning notice to the beneficiary in
service of the anchor procedure if the accordance with § 512.582(b)(3), then
SNF is identified on the applicable cal- normal SNF coverage requirements
endar quarter list of qualified SNFs at apply, and the beneficiary may be fi-
the time of the TEAM beneficiary’s ad- nancially liable for non-covered SNF
mission to the SNF. services.
(3) Determination of qualified SNFs. (c) Other requirements. All other Medi-
CMS determines the qualified SNFs for care rules for coverage and payment of
each calendar quarter based on a re- Part A-covered services continue to
view of the most recent rolling 12 apply except as otherwise waived in
months of overall star ratings on the this part.
Five-Star Quality Rating System for
SNFs on the Nursing Home Compare
1082
GENERAL PROVISIONS be included on any list of preferred pro-

viders or suppliers, nor may the TEAM
§ 512.582 Beneficiary protections. participant accept such payments.
(a) Beneficiary freedom of choice. (1) A (b) Required beneficiary notification—
TEAM participant, TEAM collabo- (1) TEAM participant beneficiary notifi-
rators, collaboration agents, down- cation—(i) Notification to beneficiaries.
stream collaboration agent and down- Each TEAM participant must provide
stream participants must not restrict written notification to any TEAM ben-
Medicare beneficiaries’ ability to eficiary that meets the criteria in
choose to receive care from any pro- § 512.535 of his or her inclusion in the
vider or supplier. TEAM model.
(2) The TEAM participant and its (ii) Timing of notification. Prior to dis-
downstream participants must not charge from the anchor hospitaliza-
commit any act or omission, nor adopt tion, or prior to discharge from the an-
any policy that inhibits beneficiaries chor procedure, as applicable, the
from exercising their freedom to TEAM participant must provide the
choose to receive care from any pro- TEAM beneficiary with a beneficiary
vider or supplier or from any health notification as described in paragraph
care provider who has opted out of (b)(1)(iv) of this section.
Medicare. The TEAM participant and (iii) List of beneficiaries who have re-
its downstream participants may com- ceived a notification. The TEAM partici-
municate to TEAM beneficiaries the pant must be able to generate a list of
benefits of receiving care with the all beneficiaries who have received
TEAM participant, if otherwise con- such notification, including the date on
sistent with the requirements of this which the notification was provided to
part and applicable law. the beneficiary, to CMS or its designee
(3) As part of discharge planning and upon request.
referral, TEAM participants must pro- (iv) Content of notification. The bene-
vide a complete list of HHAs, SNFs, ficiary notification must contain all of
IRFs, or LTCHs that are participating the following:
in the Medicare program, and that (A) A detailed explanation of TEAM
serve the geographic area (as defined and how it might be expected to affect
by the HHA) in which the patient re- the beneficiary’s care.
sides, or in the case of a SNF, IRF, or (B) Notification that the beneficiary
LTCH, in the geographic area re- retains freedom of choice to choose
quested by the patient. providers and services.
(i) This list must be presented to (C) Explanation of how patients can
TEAM beneficiaries for whom home access care records and claims data
health care, SNF, IRF, or LTCH serv- through an available patient portal, if
ices are medically necessary. applicable, and how they can share ac-
(ii) TEAM participants must specify cess to their Blue Button® electronic
on the list those post-acute care pro- health information with caregivers.
viders on the list with whom they have (D) Explanation of the type of bene-
a sharing arrangement. ficiary-identifiable claims data the
(iii) TEAM participants may rec- TEAM participant may receive.
ommend preferred providers and sup- (E) A statement that all existing
pliers, consistent with applicable stat- Medicare beneficiary protections con-
utes and regulations. tinue to be available to the TEAM ben-
(iv) TEAM participants may not eficiary. These include the ability to
limit beneficiary choice to any list of report concerns of substandard care to
providers or suppliers in any manner Quality Improvement Organizations or
other than as permitted under applica- the 1–800–MEDICARE helpline.
ble statutes and regulations. (F) A list of the providers, suppliers,
(v) TEAM participants must take and ACOs with whom the TEAM partic-
into account patient and family pref- ipant has a sharing arrangement. This
erences for choice of provider and sup- requirement may be fulfilled by the
plier when they are expressed. TEAM participant including in the de-
(4) TEAM participants may not tailed notification a Web address where
charge any TEAM collaborator a fee to beneficiaries may access the list.
1083
§ 512.582 42 CFR Ch. IV (10–1–24 Edition)
(2) TEAM collaborator notice. A TEAM sible to provide notice at such times,
participant must require every TEAM the notice must be provided to the ben-
collaborator to provide written notice eficiary or his or her representative as
to applicable TEAM beneficiaries of soon as is reasonably practicable.
TEAM, including information on the (B) The PGP, NPPGP, or TGP must
quality and payment incentives under be able to provide a list of all bene-
TEAM, and the existence of its sharing ficiaries who received such a notice, in-
arrangement with the TEAM partici- cluding the date on which the notice
pant. was provided to the beneficiary, to
(i) With the exception of ACOs, PGPs, CMS upon request.
NPPGPs, and TGPs, a TEAM partici- (iii) A TEAM participant must re-
pant must require every TEAM col- quire every ACO that is a TEAM col-
laborator that furnishes an item or laborator where an ACO participant or
service to a TEAM beneficiary during ACO provider/supplier furnishes an
an episode to provide written notice to item or service to a TEAM beneficiary
the beneficiary of TEAM, including during an episode to provide written
basic information on the quality and notice to the beneficiary of TEAM, in-
payment incentives under TEAM, and cluding basic information on the qual-
the existence of the TEAM collabo- ity and payment incentives under
rator’s sharing arrangement. TEAM, and the existence of the enti-
(A) The notice must be provided no ty’s sharing arrangement.
later than the time at which the bene-
(A)(1) The notice must be provided no
ficiary first receives an item or service
later than the time at which the bene-
from the TEAM collaborator during an
ficiary first receives an item or service
episode. In circumstances where, due to
from any ACO participant or ACO pro-
the patient’s condition, it is not fea-
vider/supplier and the required ACO no-
sible to provide notification at such
tice may be provided by that ACO par-
time, the notification must be provided
ticipant or ACO provider/supplier re-
to the beneficiary or his or her rep-
spectively.
resentative as soon as is reasonably
practicable. (2) In circumstances where, due to
(B) The TEAM collaborator must be the patient’s condition, it is not fea-
able to provide a list of all bene- sible to provide notice at such times,
ficiaries who received such a notice, in- the notice must be provided to the ben-
cluding the date on which the notice eficiary or his or her representative as
was provided to the beneficiary, to soon as is reasonably practicable.
CMS upon request. (B) The ACO must be able to provide
(ii) A TEAM participant must require a list of all beneficiaries who received
every PGP, NPPGP, or TGP that is a such a notice, including the date on
TEAM collaborator where a member of which the notice was provided to the
the PGP, member of the NPPGP, or beneficiary, to CMS upon request.
member of the TGP furnishes an item (3) Discharge planning notice. A TEAM
or service to a TEAM beneficiary dur- participant must provide the bene-
ing an episode to provide written no- ficiary with a written notice of any po-
tice to the beneficiary of TEAM, in- tential financial liability associated
cluding basic information on the qual- with non-covered services rec-
ity and payment incentives under ommended or presented as an option as
TEAM, and the existence of the enti- part of discharge planning, no later
ty’s sharing arrangement. than the time that the beneficiary dis-
(A)(1) The notice must be provided no cusses a particular post-acute care op-
later than the time at which the bene- tion or at the time the beneficiary is
ficiary first receives an item or service discharged from an anchor procedure
from any member of the PGP, member or anchor hospitalization, whichever
of the NPPGP, or member of the TGP, occurs earlier.
and the required PGP, NPPGP, or TGP (i) If the TEAM participant knows or
notice may be provided by that mem- should have known that the bene-
ber respectively. ficiary is considering or has decided to
(2) In circumstances where, due to receive a non-covered post-acute care
the patient’s condition, it is not fea- service or other non-covered associated
1084
service or supply, the TEAM partici- tive TEAM materials and activities:
pant must notify the beneficiary in ‘‘The statements contained in this doc-
writing that the service would not be ument are solely those of the authors
covered by Medicare. and do not necessarily reflect the views
(ii) If the TEAM participant is dis- or policies of the Centers for Medicare
charging a beneficiary to a SNF after & Medicaid Services (CMS). The au-
an inpatient hospital stay, and the ben- thors assume responsibility for the ac-
eficiary is being transferred to or is curacy and completeness of the infor-
considering a SNF that would not qual- mation contained in this document.’’
ify under the SNF 3-day waiver in (3) The TEAM participant and its
§ 512.580, the TEAM participant must downstream participants must retain
notify the beneficiary in accordance copies of all written and electronic de-
with paragraph (b)(3)(i) of this section scriptive TEAM materials and activi-
that the beneficiary will be responsible ties and appropriate records for all
for payment for the services furnished other descriptive TEAM materials and
by the SNF during that stay, except activities in a manner consistent with
those services that would be covered by § 512.135(c).
Medicare Part B during a non-covered (4) CMS reserves the right to review,
inpatient SNF stay. or have a designee review, descriptive
(4) Access to records and retention. TEAM materials and activities to de-
Lists of beneficiaries that receive noti- termine whether or not the content is
fications or notices must be retained, materially inaccurate or misleading.
and access provided to CMS, or its des- This review takes place at a time and
ignees, in accordance with § 512.586. in a manner specified by CMS once the
(c) Availability of services. (1) The descriptive TEAM materials and ac-
TEAM participant and its downstream tivities are in use by the TEAM partic-
participants must continue to make ipant.
medically necessary covered services
available to beneficiaries to the extent § 512.584 Cooperation in model evalua-
required by applicable law. TEAM tion and monitoring.
beneficiaries and their assignees retain
their rights to appeal claims in accord- The TEAM participant and its TEAM
ance with part 405, subpart I of this collaborators must comply with the re-
chapter. quirements of § 403.1110(b) of this chap-
(2) The TEAM participant and its ter and must otherwise cooperate with
downstream participants must not CMS’ TEAM evaluation and moni-
take any action to select or avoid toring activities as may be necessary
treating certain Medicare beneficiaries to enable CMS to evaluate TEAM in ac-
based on their income levels or based cordance with section 1115A(b)(4) of the
on factors that would render the bene- Act and to conduct monitoring activi-
ficiary an ‘‘at-risk beneficiary’’ as de- ties under § 512.590, including producing
fined at § 425.20 of this chapter. such data as may be required by CMS
(3) The TEAM participant and its to evaluate or monitor TEAM, which
downstream participants must not may include protected health informa-
take any action to selectively target or tion as defined in 45 CFR 160.103 and
engage beneficiaries who are relatively other individually-identifiable data.
healthy or otherwise expected to im-
§ 512.586 Audits and record retention.
prove the TEAM participant’s or down-
stream participant’s financial or qual- (a) Right to audit. The Federal gov-
ity performance. ernment, including CMS, HHS, and the
(d) Descriptive TEAM materials and ac- Comptroller General, or their des-
tivities. (1) The TEAM participant and ignees, has the right to audit, inspect,
its downstream participants must not investigate, and evaluate any docu-
use or distribute descriptive TEAM ma- ments and other evidence regarding
terials and activities that are materi- implementation of TEAM.
ally inaccurate or misleading. (b) Access to records. The TEAM par-
(2) The TEAM participant and its ticipant and its TEAM collaborators
downstream participants must include must maintain and give the Federal
the following statement on all descrip- government, including CMS, HHS, and
1085
§ 512.588 42 CFR Ch. IV (10–1–24 Edition)
the Comptroller General, or their des- the TEAM participant or its down-
ignees, access to all such documents stream participants described in para-
and other evidence sufficient to enable graph (c)(1)(ii) of this section, the
the audit, evaluation, inspection, or in- TEAM participant must notify its
vestigation of the implementation of downstream participants of this need
TEAM, including without limitation, to retain records for the additional pe-
documents and other evidence regard- riod specified by CMS.
ing all of the following:
(1) The TEAM participant’s and its § 512.588 Rights in data and intellec-
downstream participants’ compliance tual property.
with the terms of TEAM. (a) CMS may—
(2) The accuracy of TEAM reconcili- (1) Use any data obtained under
ation payment amounts and repayment §§ 512.584, 512.586, or 512.590 to evaluate
amounts. and monitor TEAM; and
(3) The TEAM participant’s payment (2) Disseminate quantitative and
of amounts owed to CMS under TEAM. qualitative results and successful care
(4) Quality measure information and management techniques, including fac-
the quality of services performed under tors associated with performance, to
the terms of TEAM. other providers and suppliers and to
(5) Utilization of items and services the public. Data disseminated may in-
furnished under TEAM. clude patient—
(6) The ability of the TEAM partici- (i) De-identified results of patient ex-
pant to bear the risk of potential losses perience of care and quality of life sur-
and to repay any losses to CMS, as ap- veys, and patient; and
plicable. (ii) De-identified measure results cal-
(7) Patient safety. culated based upon claims, medical
(8) Other program integrity issues. records, and other data sources.
(c) Record retention. (1) The TEAM (b) Notwithstanding any other provi-
participant and its downstream partici- sion of this part, for all data that CMS
pants must maintain the documents confirms to be proprietary trade secret
and other evidence described in para- information and technology of the
graph (b) of this section and other evi- TEAM participant or its downstream
dence for a period of 6 years from the participants, CMS or its designee(s)
last payment determination for the will not release this data without the
TEAM participant under TEAM or express written consent of the TEAM
from the date of completion of any participant or its downstream partici-
audit, evaluation, inspection, or inves- pant, unless such release is required by
tigation, whichever is later, unless— law.
(i) CMS determines there is a special (c) If the TEAM participant or its
need to retain a particular record or downstream participant wishes to pro-
group of records for a longer period and tect any proprietary or confidential in-
notifies the TEAM participant at least formation that it submits to CMS or
30 days before the normal disposition its designee, the TEAM participant or
date; or its downstream participant must label
(ii) There has been a termination, or otherwise identify the information
dispute, or allegation of fraud or simi- as proprietary or confidential. Such as-
lar fault against the TEAM participant sertions are subject to review and con-
or its downstream participants, in firmation by CMS prior to CMS’ acting
which case the records must be main- upon such assertions.
tained for an additional 6 years from
the date of any resulting final resolu- § 512.590 Monitoring and compliance.
tion of the termination, dispute, or al- (a) Compliance with laws. The TEAM
legation of fraud or similar fault. participant and each of its downstream
(2) If CMS notifies the TEAM partici- participants must comply with all ap-
pant of the special need to retain plicable laws and regulations.
records in accordance with paragraph (b) CMS monitoring and compliance ac-
(c)(1)(i) of this section or there has tivities. (1) CMS staff, or its approved
been a termination, dispute, or allega- designee, may conduct monitoring ac-
tion of fraud or similar fault against tivities to ensure compliance by the
1086
TEAM participant and each of its stream participant that is more than 60
downstream participants with the days after the date of the CMS initial
terms of TEAM under this subpart to— site visit notice.
(i) Understand TEAM participants’ (3) The TEAM participant and its
use of TEAM payments; and downstream participants must ensure
(ii) Promote the safety of bene- that personnel with the appropriate re-
ficiaries and the integrity of TEAM. sponsibilities and knowledge associ-
(2) Monitoring activities may in- ated with the purpose of the site visit
clude, without limitation, all of the are available during all site visits.
following: (4) CMS may perform unannounced
(i) Documentation requests sent to site visits at the office of the TEAM
the TEAM participant and its down- participant and any of its downstream
stream participants, including surveys participants at any time to investigate
and questionnaires. concerns about the health or safety of
(ii) Audits of claims data, quality beneficiaries or other patients or other
measures, medical records, and other program integrity issues.
data from the TEAM participant and (5) Nothing in this part shall be con-
its downstream participants. strued to limit or otherwise prevent
(iii) Interviews with members of the CMS from performing site visits per-
staff and leadership of the TEAM par- mitted or required by applicable law.
ticipant and its downstream partici- (d) Reopening of payment determina-
pants. tions. (1) CMS may reopen a TEAM pay-
(iv) Interviews with beneficiaries and ment determination on its own motion
their caregivers. or at the request of a TEAM partici-
(v) Site visits to the TEAM participant, within 4 years from the date of
pant and its downstream participants, the determination, for good cause (as
performed in a manner consistent with defined at § 405.986 of this chapter).
paragraph (c) of this section. (2) CMS may reopen a TEAM pay-
(vi) Monitoring quality outcomes and ment determination at any time if
clinical data, if applicable. there exists reliable evidence (as de-
(vii) Tracking patient complaints fined in § 405.902 of this chapter) that
and appeals. the determination was procured by
(3) In conducting monitoring and fraud or similar fault (as defined in
oversight activities, CMS or its des- § 405.902 of this chapter).
ignees may use any relevant data or in- (3) CMS’s decision regarding whether
formation including without limitation to reopen a TEAM payment determina-
all Medicare claims submitted for tion is binding and not subject to ap-
items or services furnished to TEAM peal.
beneficiaries. (e) OIG authority. Nothing contained
(c) Site visits. (1) In a manner con- in the terms of TEAM limits or re-
sistent with § 512.584, the TEAM partic- stricts the authority of the HHS Office
ipant and its downstream participants of Inspector General or any other Fed-
must cooperate in periodic site visits eral government authority, including
performed by CMS or its designees in its authority to audit, evaluate, inves-
order to facilitate the evaluation of tigate, or inspect the TEAM partici-
TEAM and the monitoring of the pant or its downstream participants for
TEAM participant’s compliance with violations of any Federal statutes,
the terms of TEAM. rules, or regulations.
(2) CMS or its designee provides, to
the extent practicable, the TEAM par- § 512.592 Remedial action.
ticipant or downstream participant (a) Grounds for remedial action. CMS
with no less than 15 days advance no- may take one or more remedial actions
tice of any site visit. CMS— described in paragraph (b) of this sec-
(i) Attempts, to the extent prac- tion if CMS determines that the TEAM
ticable, to accommodate a request for participant or a downstream partici-
particular dates in scheduling site vis- pant:
its; and (1) Has failed to comply with any of
(ii) Does not accept a date request the terms of TEAM, included in this
from a TEAM participant or down- subpart.
1087
§ 512.594 42 CFR Ch. IV (10–1–24 Edition)
(2) Has failed to comply with any ap- (4) Prohibit the TEAM participant
plicable Medicare program require- from distributing TEAM payments, as
ment, rule, or regulation. applicable.
(3) Has taken any action that threat- (5) Require the TEAM participant to
ens the health or safety of a bene- terminate, immediately or by a dead-
ficiary or other patient. line specified by CMS, its agreement
(4) Has submitted false data or made with a downstream participant with re-
false representations, warranties, or spect to TEAM.
certifications in connection with any (6) Require the TEAM participant to
aspect of TEAM. submit a corrective action plan in a
(5) Has undergone a change in control form and manner and by a date speci-
fied by CMS.
that presents a program integrity risk.
(7) Discontinue the provision of data
(6) Is subject to any sanctions of an sharing and reports to the TEAM par-
accrediting organization or a Federal, ticipant.
State, or local government agency. (8) Recoup TEAM payments.
(7) Is subject to investigation or ac- (9) Reduce or eliminate a TEAM pay-
tion by HHS (including the HHS Office ment otherwise owed to the TEAM par-
of Inspector General and CMS) or the ticipant.
Department of Justice due to an alle- (10) Such other action as may be per-
gation of fraud or significant mis- mitted under the terms of this part.
conduct, including any of the fol-
lowing: § 512.594 Limitations on review.
(i) Being subject to the filing of a There is no administrative or judicial
complaint or filing of a criminal review under sections 1869 or 1878 of the
charge. Act or otherwise for all of the fol-
(ii) Being subject to an indictment. lowing:
(iii) Being named as a defendant in a (a) The selection of models for test-
False Claims Act qui tam matter in ing or expansion under section 1115A of
which the Federal government has in- the Act.
tervened, or similar action. (b) The selection of organizations,
(8) Has failed to demonstrate im- sites, or participants to test TEAM, in-
proved performance following any re- cluding a decision by CMS to remove a
medial action imposed under this sec- TEAM participant or to require a
tion. TEAM participant to remove a down-
(9) Has misused or disclosed bene- stream participant from TEAM.
ficiary-identifiable data in a manner (c) The elements, parameters, scope,
and duration of testing or dissemina-
that violates any applicable statutory
tion, including without limitation the
or regulatory requirements or that is
following:
otherwise non-compliant with the pro-
(1) The selection of quality perform-
visions of the TEAM data sharing
ance standards for TEAM by CMS.
agreement.
(2) The methodology used by CMS to
(b) Remedial actions. If CMS deter- assess the quality of care furnished by
mines that one or more grounds for re- the TEAM participant.
medial action described in paragraph (3) The methodology used by CMS to
(a) of this section has taken place, CMS attribute TEAM beneficiaries to the
may take one or more of the following TEAM participant, if applicable.
remedial actions: (d) Determinations regarding budget
(1) Notify the TEAM participant and, neutrality under section 1115A(b)(3) of
if appropriate, require the TEAM par- the Act.
ticipant to notify its downstream par- (e) The termination or modification
ticipants of the violation. of the design and implementation of
(2) Require the TEAM participant to TEAM under section 1115A(b)(3)(B) of
provide additional information to CMS the Act.
or its designees. (f) Determinations about expansion
(3) Subject the TEAM participant to of the duration and scope of TEAM
additional monitoring, auditing, or under section 1115A(c) of the Act, in-
both. cluding the determination that TEAM
1088
is not expected to meet criteria de- (ii) Require immediate reconciliation

scribed in paragraph (a) or (b) of this and payment of all monies owed to
section. CMS by a TEAM participant that is
subject to a change in control.
§ 512.595 Bankruptcy and other notifi-
cations. § 512.596 Termination of TEAM or
(a) Notice of bankruptcy. If the TEAM TEAM participant from model by
participant has filed a bankruptcy peti- CMS.
tion, whether voluntary or involun- (a) Termination of TEAM. (1) CMS
tary, the TEAM participant must pro- may terminate TEAM for reasons in-
vide written notice of the bankruptcy cluding, but not limited to, the fol-
to CMS and to the U.S. Attorney’s Of- lowing:
fice in the district where the bank- (i) CMS determines that it no longer
ruptcy was filed, unless final payment has the funds to support TEAM.
has been made by either CMS or the (ii) CMS terminates TEAM in accord-
TEAM participant under the terms of ance with section 1115A(b)(3)(B) of the
TEAM and all administrative or judi-
Act.
cial review proceedings relating to any
(2) If CMS terminates TEAM, CMS
TEAM payments have been fully and fi-
nally resolved. provides written notice to the TEAM
participant specifying the grounds for
(1) The notice of bankruptcy must be
sent by certified mail no later than 5 termination and the effective date of
days after the petition has been filed such termination.
and must contain a copy of the filed (b) Notice of a TEAM participant’s ter-
bankruptcy petition (including its mination from TEAM. If a TEAM partic-
docket number). ipant receives notification that it has
(2) The notice to CMS must be ad- been terminated from TEAM and wish-
dressed to the CMS Office of Financial es to dispute the termination, it must
Management at 7500 Security Boule- provide a written notice to CMS re-
vard, Mailstop C3–01–24, Baltimore, MD questing review of the termination
21244 or such other address as may be within 10 calendar days of the notice.
specified on the CMS website for pur- (1) CMS has 30 days to respond to the
poses of receiving such notices. TEAM participant’s request for review.
(b) Notice of legal name change. A (2) If the TEAM participant fails to
TEAM participant must furnish writ- notify CMS, the termination is deemed
ten notice to CMS within 30 days of final.
any change in its legal name becomes
effective. The notice of legal name § 512.598 Decarbonization and resil-
change must meet all of the following: ience initiative.
(1) Be in a form and manner specified (a) Voluntary reporting. A TEAM par-
by CMS. ticipant may elect to respond to ques-
(2) Include a copy of the legal docu- tions and report metrics related to the
ment effecting the name change, which TEAM participant’s, or the TEAM par-
must be authenticated by the appro- ticipant’s corporate affiliate’s, emis-
priate State official. sions to CMS on an annual basis fol-
(c) Notice of change in control. (1) A lowing each performance period. Vol-
TEAM participant must furnish writ- untary reporting includes the following
ten notice to CMS in a form and man-
metrics:
ner specified by CMS at least 90 days
(1) Organizational questions, which
before any change in control becomes
effective. are a set of questions about the TEAM
participants’ sustainability team and
(2) If CMS determines, in accordance
with § 512.592(a)(5), that a TEAM par- sustainability activities.
ticipant’s change in control would (2) Building energy metrics, which
present a program integrity risk, CMS are a set of metrics related to meas-
may— uring and reporting GHG emissions re-
(i) Take remedial action against the lated to energy use at TEAM partici-
TEAM participant under § 512.160(b). pant facilities.
1089
§ 512.598 42 CFR Ch. IV (10–1–24 Edition)
(i) Building energy metrics are based (iii) Assessment questions on key ac-
on the ENERGY STAR® Portfolio Man- tions to reduce transportation emis-
ager® guidelines for the time of sub- sions.
mission. TEAM participants reporting (b) Manner and timing of reporting. (1)
these metrics must submit using EN- If the TEAM participant elects to re-
ERGY STAR Portfolio Manager in the port the metrics in paragraph (b) of
manner described in paragraph (b) of this section to CMS, such information
this section. must be reported to CMS in a form and
(ii) Metrics to be collected include all manner specified by CMS for each per-
of the following: formance year, including the use of
(A) ENERGY STAR® Score for Hos- ENERGY STAR® Portfolio Manager®
pitals as defined in the ENERGY for the building energy metrics at
STAR® Portfolio Manager® as well as paragraph (a)(2) of this section and a
supporting data which may include en- survey and questionnaire for questions
ergy use intensity, electricity, natural and metrics at paragraphs (a)(1), (3),
gas, and other source emissions and and (4) of this section.
normalizing factors such as building (2) If the TEAM participant chooses
size, number of full-time equivalent to participate, the TEAM participant
workers, number of staffed beds, num- must report the information to CMS—
ber of magnetic resonance imaging ma-
(i) No later than 120 days in the year
chines, zip codes, and heating and cool-
following the performance year; or
ing days, as specified in the ENERGY
STAR® Portfolio Manager®. (ii) A later date as specified by CMS.
(B) Energy cost, to capture total en- (c) Individualized feedback reports; rec-
ergy costs, as specified in the ENERGY ognition. If a TEAM participant elects
STAR® Portfolio Manager®. to report all the metrics specified in
(C) Total, direct, and indirect GHG paragraph (a) of this section to CMS, in
emissions and emissions intensity as the manner specified in paragraph (b)
specified in the ENERGY STAR® Port- of this section, CMS annually provides
folio Manager®. the TEAM participant with the fol-
(3) Anesthetic gas metrics, which are lowing:
a set of metrics related to measuring (1) Individualized feedback reports,
and managing emissions from anes- which may summarize facilities’ emis-
thetic gas which include all of the fol- sions metrics and may include bench-
lowing: marks, as feasible, for normalized
(i) Total greenhouse gas emissions metrics to compare facilities, in aggre-
from inhaled anesthetics based on pur- gate, to other TEAM participants in
chase records. the Decarbonization and Resilience Ini-
(ii) Normalization factors that may tiative. A TEAM participant that re-
include information on anesthetic ceives individualized feedback reports
hours, operating rooms, or MAC-hour from CMS must request approval from
equivalents. CMS in writing and receive written ap-
(iii) Assessment questions based on proval from CMS prior to publication
key actions recommended for reducing or public disclosure of data or informa-
emissions for anesthetic gases. tion contained in the individualized
(4) Transportation metrics, which are feedback reports.
a set metrics that focus on greenhouse (2) Publicly reported hospital rec-
gases related to leased or owned vehi- ognition for the TEAM participant’s
cles and may include any of the fol- commitment to decarbonization
lowing: through a hospital recognition badge
(i) Gallons for owned and leased vehi- publicly reported on a CMS website,
cles. which may include recognition of the
(ii) Normalization factors that may TEAM participant’s corporate affili-
include patient encounter volume and ates when such data has been sub-
the number of full-time equivalent mitted as specified in paragraph (a) of
(FTE) employees. this section.
1090
SUBCHAPTER I—BASIC HEALTH PROGRAM
PART 600—ADMINISTRATION, ELI- 600.340 Periodic determination and renewal

of BHP eligibility.
GIBILITY, ESSENTIAL HEALTH BEN- 600.345 Eligibility verification.
EFITS, PERFORMANCE STAND- 600.350 Privacy and security of information.
ARDS, SERVICE DELIVERY RE-
QUIREMENTS, PREMIUM AND Subpart E—Standard Health Plan
COST SHARING, ALLOTMENTS, 600.400 Basis, scope, and applicability.
AND RECONCILATION 600.405 Standard health plan coverage.
600.410 Competitive contracting process.
Subpart A—General Provisions and 600.415 Contracting qualifications and re-
quirements.
Definitions 600.420 Enhanced availability of standard
Sec. health plans.
600.1 Scope. 600.425 Coordination with other insurance
600.5 Definitions and use of terms. affordability programs.
Subpart B—Establishment and Certification Subpart F—Enrollee Financial

of State Basic Health Programs Responsibilities
600.100 Program description. 600.500 Basis, scope, and applicability.

600.105 Basis, scope, and applicability of 600.505 Premiums.
subpart B. 600.510 Cost-sharing.
600.110 BHP Blueprint. 600.515 Public schedule of enrollee premium
600.115 Development and submission of the and cost sharing.
BHP Blueprint. 600.520 General cost-sharing protections.
600.120 Certification of a BHP Blueprint. 600.525 Disenrollment procedures and con-
600.125 Revisions to a certified BHP Blue- sequences for nonpayment of premiums.
print.
600.130 Withdrawal of a BHP Blueprint prior Subpart G—Payment to States
to implementation. 600.600 Basis, scope, and applicability.
600.135 Notice and timing of HHS action on 600.605 BHP payment methodology.
an initial BHP Blueprint submission. 600.610 Secretarial determination of BHP
600.140 State termination of a BHP. payment amount.
600.142 HHS withdrawal of certification and 600.615 Deposit of Federal BHP payment.
termination of a BHP.
600.145 State program administration and Subpart H—BHP Trust Fund
operation.
600.150 Enrollment assistance and informa- 600.700 Basis, scope, and applicability.
tion requirements. 600.705 BHP trust fund.
600.155 Tribal consultation. 600.710 Fiscal policies and accountability.
600.160 Protections for American Indian and 600.715 Corrective action, restitution, and
Alaska Natives. disallowance of questioned BHP trans-
600.165 Nondiscrimination standards. actions.
600.170 Annual report content and timing.
AUTHORITY: Section 1331 of the Patient
Subpart C—Federal Program Protection and Affordable Care Act of 2010
(Pub. L. 111–148, 124 Stat. 119), as amended by
Administration
the Health Care and Education Reconcili-
600.200 Federal program compliance reviews ation Act of 2010 (Pub. L. 111–152, 124 Stat
and audits. 1029).
SOURCE: 79 FR 14140, Mar. 12, 2014, unless
Subpart D—Eligibility and Enrollment otherwise noted.
600.300 Basis, scope, and applicability.
600.305 Eligible individuals. Subpart A—General Provisions
600.310 Application. and Definitions
600.315 Certified application counselors.
600.320 Determination of eligibility for and § 600.1 Scope.
enrollment in a standard health plan.
600.330 Coordination with other insurance Section 1331 of the Affordable Care
affordability programs. Act, provides for the establishment of
600.335 Appeals. the Basic Health Program (BHP) under
1091
§ 600.5 42 CFR Ch. IV (10–1–24 Edition)
which a State may enter into contracts mined in accordance with imple-
for standard health plans providing at menting regulations at 45 CFR 156.100
least essential health benefits to eligi- through 156.110 and 156.122 regarding
ble individuals in lieu of offering such prescription drugs.
individuals the opportunity to enroll in Family and family size is as defined at
coverage through an Affordable Insur- 26 CFR 1.36B–1(d).
ance Exchange. States that elect to op- Federal fiscal year means the time pe-
erate a BHP will receive federal fund- riod beginning October 1st and ending
ing based on the amount of the pre- September 30th.
mium tax credit and cost-sharing re-
Federal poverty level or FPL means the
ductions that would have been avail-
most recently published Federal pov-
able if enrollees had obtained coverage
erty level, updated periodically in the
through the Exchange.
FEDERAL REGISTER by the secretary of
§ 600.5 Definitions and use of terms. Health and Human Services under the
authority of 42 U.S.C. 9902(2).
For purposes of this part, the fol-
lowing definitions apply: Household income is as defined in 26
Advance payments of the premium tax CFR 1.36B–1(e)(1) and is determined in
credit means payment of the tax credit the same way as it is for purposes of
authorized by 26 U.S.C. 36B and its im- eligibility for coverage through the Ex-
plementing regulations, which are pro- change.
vided on an advance basis to an eligible Indian means any individual as de-
individual enrolled in a QHP through fined in section 4 (d) of the Indian Self-
an Exchange in accordance with sec- Determination and Education Assist-
tions 1402 and 1412 of the Affordable ance Act (Pub. L 93–638).
Care Act. Interim certification is an approval
Affordable Care Act is the Patient status for the initial design of a state’s
Protection and Affordable Care Act of Basic Health Program. It does not con-
2010 (Pub. L. 111–148) as amended by the fer any permission to begin enrollment
Health Care and Education Reconcili- or seek federal funding.
ation Act of 2010 (Pub. L. 111–152). Lawfully present has the meaning
Basic Health Program (BHP) Blueprint given in 45 CFR 152.2.
is the operational plan that a State Minimum essential coverage has the
must submit to the Secretary of Health meaning set forth at 26 CFR 1.5000A–2,
and Human Services (HHS) for certifi- including coverage recognized by the
cation to operate a BHP. Secretary as minimum essential cov-
Certification means authority to oper- erage pursuant to 26 CFR 1.5000A–2(f).
ate the program which is required for Under that authority, the Secretary
program operations but it does not cre- recognizes coverage through a BHP
ate an obligation on the part of the standard health plan as minimum es-
State to implement a BHP. sential coverage.
Code means the Internal Revenue
Modified adjusted gross income is as de-
Code of 1986.
Cost sharing means any expenditure fined in 26 CFR 1–36B–1(e)(2).
required by or on behalf of an enrollee Network of health care providers means
with respect to covered health benefits; an entity capable of meeting the provi-
such term includes deductibles, coin- sion and administration of standard
surance, copayments, or similar health plan coverage, including but not
charges, but excludes premiums, bal- limited to, the provision of benefits,
ance billing amounts for non-network administration of premiums and appli-
providers and spending for non-covered cable cost sharing and execution of in-
services. novative features, such as care coordi-
Enrollee means an eligible individual nation and care management, and
who is enrolled in a standard health other requirements as specified under
plan contracted to operate as part of a the Basic Health Program. Such enti-
BHP. ties may include but are not limited to:
Essential health benefits means the Accountable Care Organizations, Inde-
benefits described under section 1302(b) pendent Physician Associations, or a
of the Affordable Care Act, as deter- large health system.
1092
Premium means any enrollment fee, Lawfully present has the meaning given in
premium, or other similar charge paid 45 CFR 155.20.
to the standard health plan offeror.
Preventive health services and items in- * * * * *
cludes those services and items speci-
fied in 45 CFR 147.130(a). Subpart B—Establishment and
Program year means a calendar year Certification of State Basic
for which a standard health plan pro- Health Programs
vides coverage for eligible BHP enroll-
ees. § 600.100 Program description.
Qualified health plan or QHP means a A State Basic Health Program (BHP)
health plan that has in effect a certifi- is operated consistent with a BHP
cation that it meets the standards de- Blueprint that has been certified by
scribed in subpart C of 45 CFR part 156 the Secretary to meet the require-
issued or recognized by each Exchange ments of this part. The BHP Blueprint
through which such plan is offered in is developed by the State for certifi-
accordance with the process described cation by the Secretary in accordance
in subpart K of 45 CFR part 156, except with the processes described in this
that such term must not include a subpart.
qualified health plan which is a cata-
strophic plan described in 45 CFR § 600.105 Basis, scope, and applica-
155.20. bility of subpart B.
Reference plan is a synonym for the (a) Statutory basis. This subpart im-
EHB base benchmark plan and is de- plements the following sections of the
fined at 45 CFR 156.100. Act:
Regional compact means an agreement (1) Section 1331(a)(1) which defines a
between two or more States to jointly Basic Health Program.
procure and enter into contracts with (2) Section 1331(a)(2) which requires
standard health plan offeror(s) for the the Secretary to certify a Basic Health
administration and provision of a Program before it may become oper-
standard health plan under the BHP to ational.
eligible individuals in such States. (3) Section 1331(f) which requires Sec-
Residency is determined in accord- retarial oversight through annual re-
ance with 45 CFR 155.305(a)(3). views.
Single streamlined application has the (b) Scope and applicability. (1) This
same meaning as application defined at subpart sets forth provisions governing
42 CFR 431.907(b)(1) of this chapter and the administration of the BHP, the
45 CFR 155.405(a) and (b). general requirements for development
Standard health plan means a health of a BHP Blueprint required for certifi-
benefits package, or product, that is cation, for program operations and for
provided by the standard health plan voluntary program termination.
offeror. (2) This subpart applies to all States
Standard health plan offeror means an that submit a BHP Blueprint and re-
entity that is eligible to enter into quest certification to operate a BHP.
contracts with the State for the admin-
istration and provision of a standard § 600.110 BHP Blueprint.
health plan under the BHP. The BHP Blueprint is a comprehen-
State means each of the 50 states and sive written document submitted by
the District of Columbia as defined by the State to the Secretary for certifi-
section 1304 of the Act. cation of a BHP in the form and man-
ner specified by HHS which will include
EFFECTIVE DATE NOTE: At 89 FR 39436, May an opportunity for states to submit a
8, 2024, § 600.5 was amended by revising the
definition of ‘‘Lawfully present,’’ effective
limited set of elements necessary for
Nov. 1, 2024. For the convenience of the user, interim certification at the state op-
the revised text is set forth as follows: tion. The program must be adminis-
tered in accordance with all aspects of
§ 600.5 Definitions and use of terms. section 1331 of the Affordable Care Act
and other applicable law, this chapter,
* * * * * and the certified BHP Blueprint.
1093
§ 600.115 42 CFR Ch. IV (10–1–24 Edition)
(a) Content of a Blueprint. The Blue- ing how it will address potential fraud,
print will establish compliance with waste, and abuse and ensure consumer
applicable requirements by including a protections.
description, or if applicable, an assur- (14) An operational assessment estab-
ance of the following: lishing operating agency readiness.
(1) The minimum benefits offered (15) A transition plan if a state par-
under a standard health plan that ticipating in 2015 plans to propose an
assures inclusion of essential health alternative enrollment strategy for ini-
benefits as described in section 1302(b) tial implementation consistent with
of the Affordable Care Act, in accord-
§ 600.145. Such a transition plan must
ance with § 600.405.
include a plan for coordination of this
(2) The competitive process, con-
sistent with § 600.410, that the State initial implementation strategy with
will undertake to contract for the pro- the Exchange operating in the state,
vision of standard health plans. and if beneficiaries will be
(3) The standard contract require- transitioning from Medicaid, with the
ments, consistent with § 600.415, that Medicaid agency.
the State will incorporate in its stand- (b) Funding plan. (1) The BHP Blue-
ard health plan contracts. print must be accompanied by a fund-
(4) The methods by which the State ing plan that describes the enrollment
will enhance the availability of stand- and cost projections for the first 12
ard health plan coverage as described months of operation and the funding
in § 600.420. sources, if any, beyond the BHP trust
(5) The methods by which the State fund.
will ensure and promote coordination (2) The funding plan must dem-
with other insurance affordability pro- onstrate that Federal funds will only
grams as described in § 600.425. be used to reduce premiums and cost-
(6) The premium standards set forth sharing or to provide additional bene-
in § 600.505. fits.
(7) The cost sharing imposed under
(c) Transparency. HHS shall make a
the BHP, consistent with the standards
State’s BHP Blueprint available on line
described in § 600.510.
(8) The disenrollment procedures and after it is submitted for certification,
consequences for nonpayment of pre- and will update the posted Blueprint to
miums consistent with § 600.525, respec- the extent that it is later revised by
tively. the state.
(9) The standards, consistent with
§ 600.115 Development and submission
§ 600.305 used to determine eligibility
of the BHP Blueprint.
for the program.
(10) The State’s policies regarding en- (a) State authority to submit the State
rollment, disenrollment and Blueprint. A State BHP Blueprint must
verification consistent with §§ 600.320 be signed by the State’s Governor or by
and 600.345, along with a plan to ensure the official with delegated authority
coordination with and eliminate gaps from the Governor to sign it. A State
in coverage for individuals may choose to submit its BHP Blue-
transitioning to other insurance afford- print in two parts: The first limited
ability programs. submission to secure interim certifi-
(11) The fiscal policies and account- cation and the second full submission
ability procedures, consistent with to secure full certification.
§ 600.710. (b) State Basic Health Program offi-
(12) The process by which BHP trust cials. The State must identify in the
fund trustees shall be appointed, the
BHP Blueprint the agency and officials
qualifications and responsibilities of
within that agency, by position or
such trustees, and any arrangements to
insure or indemnify such trustees title, who are responsible for program
against claims for breaches of their fi- administration, operations, and finan-
duciary responsibilities. cial oversight.
(13) A description of how the State (c) Opportunity for public comment.
will ensure program integrity, includ- The State must provide an opportunity
1094
for public comment on the BHP Blue- fraud, waste or abuse by the BHP agen-
print content described in § 600.110 be- cy or the State consistent with
fore submission to the Secretary for § 600.142.
certification. (d) Blueprint approval standards for
(1) The State must seek public com- certification. The Secretary will certify
ment on any significant subsequent re- a BHP Blueprint provided it meets all
visions prior to submission of those re- of the following standards:
visions to the Secretary for certifi- (1) The Blueprint contains sufficient
cation. Significant revisions are those information for the Secretary to deter-
that alter core program operations re- mine that the BHP will comply with
quired by § 600.145(f), as well as changes the requirements of section 1331 of the
that alter the BHP standard health
Affordable Care Act and this part.
plan benefit package, or enrollment,
disenrollment and verification policies. (2) The BHP Blueprint demonstrates
(2) The process of seeking public adequate planning for the integration
comment must include Federally rec- of BHP with other insurance afford-
ognized tribes as defined in the Feder- ability programs in a manner that will
ally Recognized Indian Tribe List Act permit a seamless, coordinated experi-
of 1994, 25 U.S.C. 479a, located in the ence for a potentially eligible indi-
State. vidual.
(d) Submission and timing. The BHP (3) The Blueprint is a complete and
Blueprint must be submitted in a man- comprehensive description of the BHP
ner and format specified by HHS. and its operations, demonstrating thor-
States may not implement the BHP ough planning and a concrete program
prior to receiving full certification. design, without reserved decisions on
The date of implementation for this operational features.
purpose is the first day enrollees would
receive coverage under the BHP. Fol- § 600.125 Revisions to a certified BHP
lowing the 2015 initial implementation Blueprint.
year, a state implementing a BHP (a) Submission of revisions. A State
must coordinate implementation with may seek to revise its certified Blue-
open enrollment of the state’s ex- print in whole or in part at any time
change. through the submission of a revised
Blueprint to HHS. A State must sub-
§ 600.120 Certification of a BHP Blue- mit a revised Blueprint to HHS when-
print.
ever necessary to reflect—
(a) Effective date of certification. The (1) Changes in Federal law, regula-
effective date of either interim or full tions, policy interpretations, or court
certification is the date of signature by decisions that affect provisions in the
the Secretary. certified Blueprint;
(b) Payments for periods prior to certifi-
(2) Significant changes that alter
cation. No payment may be made under
core program operations under
this part for periods of BHP operation
600.145(f) or the BHP benefit package;
prior to the date of full certification.
or
(c) Period in which a certified Blueprint
remains in effect. The certified Blue- (3) Changes to enrollment,
print remains in effect until: disenrollment, and verification policies
(1) The Blueprint is replaced by Sec- described in the certified Blueprint.
retarial certification of updated Blue- (b) Submission and effective dates. The
print containing revisions submitted effective date of a revised Blueprint
by the State. may not be earlier than the first day of
(2) The State terminates the program the quarter in which an approvable re-
consistent with § 600.140. vision is submitted to HHS. A revised
(3) The Secretary makes a finding Blueprint is deemed received when
that the BHP Blueprint no longer HHS receives an electronic copy of a
meets the standards for certification cover letter signed by the Governor or
based on findings in the annual review, Governor’s designee and a copy of the
or reports significant evidence of bene- currently approved Blueprint with pro-
ficiary harm, financial malfeasance, posed changes in track changes.
1095
§ 600.130 42 CFR Ch. IV (10–1–24 Edition)
(c) Timing of HHS review. (1) A revised (4) The Secretary withdraws certifi-
Blueprint will be deemed approved un- cation of a BHP under 600.142.
less HHS, within 90 calendar days after (e) Withdrawal of a revised Blueprint.
receipt of the revised Blueprint, sends A State may withdraw a proposed
the State— Blueprint revision during HHS’ review
(i) Written notice of disapproval; or if the State has not yet implemented
(ii) Written notice of additional in- the proposed changes and provides
formation it needs in order to make a written notice to HHS.
final determination. (f) Reconsideration of decision. HHS
(2) If HHS requests additional infor- will accept a State request for recon-
mation, the 90-day review period for sideration of a decision not to certify a
HHS action on the revised Blueprint— revised Blueprint and provide an im-
partial review against the standards
(i) Stops on the day HHS sends a
for certification if requested.
written request for additional informa-
(g) Public health emergency. For the
tion or the next business day if the re-
Public Health Emergency, as defined in
quest is sent on a Federal holiday or
§ 400.200 of this chapter, the State may
weekend; and
submit to the Secretary for review and
(ii) Resumes on the next calendar day certification a revised Blueprint, in the
of the original 90-day review period form and manner specified by HHS,
after HHS receives a complete response that makes temporary significant
from the State including all the re- changes to its BHP that are directly
quested additional information, unless related to the Public Health Emer-
the information is received after 5 p.m. gency and would increase enrollee ac-
eastern standard time on a day prior to cess to coverage. Such revised Blue-
a non-business day or any time on a prints may have an effective date ret-
non-business day, in which case the re- roactive to the first day of the Public
view period resumes on the following Health Emergency and through the
business day. last day of the Public Health Emer-
(3) The 90-day review period cannot gency, or a later date if requested by
stop or end on a non-business day. If the State and certified by HHS. Such
the 90th calendar day falls on a non- revised Blueprints are not subject to
business day, HHS will consider the the public comment requirements
90th day to be the next business day. under § 600.115(c).
(4) HHS may send written notice of
its need for additional information as [88 FR 79553, Nov. 16, 2023]
many times as necessary to obtain the § 600.130 Withdrawal of a BHP Blue-
complete information necessary to re- print prior to implementation.
view the revised Blueprint.
To the extent that a State has not
(5) HHS may disapprove a Blueprint
enrolled eligible individuals into the
that is not consistent with section 1331
BHP:
of the ACA or the regulations set forth
(a) The State may submit a written
in this Part at any time during the re-
request to stop any further consider-
view process, including when the 90-day
ation of a previously submitted BHP
review clock is stopped due to a re-
Blueprint, whether certified or not.
quest for additional information.
(b) The written request must be
(d) Continued operation. The State is signed by the governor, or the State of-
responsible for continuing to operate ficial delegated to sign the BHP Blue-
under the terms of the existing cer- print by the governor.
tified Blueprint until and unless— (c) HHS will respond with a written
(1) The State adopts a revised Blue- confirmation that the State has with-
print by obtaining approval by HHS drawn the Blueprint.
under this section;
(2) The State follows the procedures § 600.135 Notice and timing of HHS ac-
described in § 600.140(a) for terminating tion on an initial BHP Blueprint
a BHP; submission.
(3) The State follows the procedures (a) Timely response. HHS will act on
described in § 600.140(b) for suspending a all initial Blueprint certification re-
BHP; quests in a timely manner.
1096
(b) Issues preventing certification. HHS offerors fulfill their obligation to cover
will notify the State in writing of any benefits for each enrollee.
impediments to certification that arise (6) Fulfill data reporting require-
in reviewing a proposed BHP Blueprint. ments to HHS.
(c) Reconsideration of decision. HHS (7) Complete the annual financial
will accept a State request for recon- reconciliation process with HHS to en-
sideration of a certification decision sure full compliance with Federal fi-
and provide an impartial review nancial obligations.
against the standards for certification (8) Refund any remaining balance in
if requested. the BHP trust fund.
[79 FR 14140, Mar. 12, 2014, as amended at 88 (b) If a State decides to suspend its
FR 79554, Nov. 16, 2023] BHP, or to request an extension of a
previously-approved suspension, the
§ 600.140 State termination of a BHP. State must:
A State that no longer wishes to op- (1) Submit to the Secretary a suspen-
erate a BHP may terminate or suspend sion application or a suspension exten-
its BHP. sion application, as applicable. The
(a) If a State decides to terminate its suspension or suspension extension ap-
BHP, the State must complete all of plication must:
the following prior to the effective date (i) Demonstrate that the benefits
of the termination or the indicated BHP-eligible individuals will receive
dates: during the suspension are at least
(1) Submit written notice to the Sec- equal to the benefits provided under
retary no later than 120 days prior to the certified BHP Blueprint in effect
the proposed termination date accom- on the effective date of suspension;
panied by a proposed transition plan
(ii) Demonstrate that the median ac-
that describes procedures to assist con-
tuarial value of the coverage provided
sumers with transitioning to other in-
to the BHP-eligible individuals during
surance affordability programs.
(2) Resolve concerns expressed by the the suspension is no less than the me-
Secretary and obtain approval by the dian actuarial value of the coverage
Secretary of the transition plan. under the certified BHP Blueprint in
(3) Submit written notice to all par- effect on the effective date of suspen-
ticipating standard health plan sion;
offerors, and enrollees that it intends (iii) Demonstrate that the premiums
to terminate the program at least 90 imposed on BHP-eligible individuals
days prior to the termination date. The during the suspension are no higher
notices to enrollees must include infor- than the premiums charged under the
mation regarding the State’s assess- certified BHP Blueprint in effect on
ment of their eligibility for all other the effective date of suspension, except
insurance affordability programs in the that premiums imposed during the sus-
State. Notices must meet the accessi- pension may be adjusted for inflation,
bility and readability standards at 45 as measured by the Consumer Price
CFR 155.230(b). Index;
(4) Transmit all information provided (iv) Demonstrate that the eligibility
as part of an application, and any in- criteria for coverage during the suspen-
formation obtained or verified by the sion is not more restrictive than the
State or other agencies administering criteria described in § 600.305;
insurance affordability programs via (v) Describe the period, not to exceed
secure electronic interface, promptly 5 years, that the State intends to sus-
and without undue delay to the agency pend its BHP or to extend a previously-
administering the Exchange and the approved suspension;
Medicaid agency as appropriate. (vi) Be submitted at least 9 months
(5) Fulfill its contractual obligations in advance of the proposed effective
to participating standard health plan date of the suspension or extension, ex-
offerors including the payment of all cept States seeking to suspend a BHP
negotiated rates for participants, as in 2024 must submit an application
well as plan oversight ensuring that within 30 days of the effective date of
participating standard health plan this provision; and
1097
§ 600.142 42 CFR Ch. IV (10–1–24 Edition)
(vii) Include an evaluation of the cov- program for any reason, or if HHS finds
erage provided to BHP eligible individ- significant evidence of beneficiary
uals during the suspension period, if harm, financial malfeasance, fraud,
the State is seeking an extension. waste, or abuse by the BHP agency or
(2) Resolve concerns expressed by the State consistent with § 600.142 of
HHS and obtain approval by the Sec- this part. If HHS withdraws the ap-
retary of the suspension or suspension proved suspension plan, the State must
extension application. Suspensions reinstate its BHP under the terms of
may not be in effect prior to approval this part, or terminate the program
by HHS, except for States seeking to under paragraph (a) of this section.
suspend a BHP in 2024. (1) The Secretary may withdraw ap-
(3) At least 90 days prior to the effec- proval of a suspension under this sec-
tive date of the suspension, provide tion only after the Secretary provides
written notice to all enrollees and par- the State with notice of the findings
ticipating standard health plan offerors upon which the Secretary is basing the
that it intends to suspend the program, withdrawal; a reasonable period for the
if the enrollees will experience a State to address the finding; and an op-
change in coverage, or standard health portunity for a hearing before issuing a
plan offerors will experience a change final finding.
in the terms of coverage. The notices (2) The Secretary must make every
to enrollees must include information reasonable effort to work with the
regarding the State’s assessment of State to resolve proposed findings
their eligibility for all other insurance without withdrawing approval of a sus-
affordability programs in the State. pension and in the event of a decision
Notices must meet the accessibility to withdraw approval, will accept a re-
and readability standards at 45 CFR quest from the State for reconsider-
155.230(b). ation.
(4) Within 12 months of the suspen- (3) The effective date of an HHS de-
sion effective date, submit to HHS the termination withdrawing approval of
data required by § 600.610 to complete the suspension plan shall not be earlier
the financial reconciliation process than 120 days following issuance of a
with HHS. final finding under paragraph (d)(1) of
(5) Submit the annual report required this section.
by § 600.170(a)(2), describing the balance (4) Within 30 days following a final
of the trust fund, and any interest ac- finding under paragraph (d)(1) of this
crued on such amount. section, the State must submit a tran-
(6) Annually, remit to HHS any inter- sition plan to HHS.
est that has accrued on the balance of
the BHP trust fund during the suspen- [79 FR 14140, Mar. 12, 2014, as amended at 88
sion period in the form and manner FR 79554, Nov. 16, 2023]
specified by HHS.
(7) At least 9 months before the end § 600.142 HHS withdrawal of certifi-
cation and termination of a BHP.
of the suspension period described in
paragraph (b)(1)(iv) of this section, or (a) The Secretary may withdraw cer-
earlier date elected by the State, the tification for a BHP Blueprint based on
State must submit to HHS a transition a finding that the BHP Blueprint no
plan that describes how the State will longer meets the standards for certifi-
reinstate its BHP consistent with the cation based on findings in the annual
requirements of this part, or terminate review, findings from a program review
the program in accordance with para- conducted in accordance with § 600.200
graph (a) of this section. The State or from significant evidence of bene-
must meet the noticing requirements ficiary harm, financial malfeasance,
of paragraph (b)(3) of this section prior fraud, waste or abuse.
to terminating or reinstating the BHP. (b) Withdrawal of certification for a
(c) The Secretary may withdraw ap- BHP Blueprint shall occur only after
proval of the suspension plan, if the the Secretary provides the State with
terms of paragraph (b) of this section notice of the proposed finding that the
are not met, if the State ends imple- standards for certification are not met
mentation of the alternative coverage or evidence of harm or misconduct in
1098
program operations, a reasonable pe- (e) Transition plan. States imple-

riod for the State to address the find- menting in 2015 may identify a transi-
ing (either by substantiating compli- tion period following initial implemen-
ance with the standards for certifi- tation during which the state may pro-
cation or submitting revisions to the pose alternative enrollment strategies
Blueprint, or securing HHS approval of for approval. The transition plan is re-
a corrective action plan), and an oppor- quired to be submitted as part of the
tunity for a hearing before issuing a state’s BHP Blueprint consistent with
final finding. § 600.110.
(c) The Secretary shall make every (f) Core operations. A State operating
reasonable effort to resolve proposed a BHP must perform all of the fol-
findings without requiring withdrawal lowing core operating functions:
of BHP certification and in the event of (1) Eligibility determinations as
a decision to withdraw certification, specified in § 600.320.
will accept a request from the State for (2) Eligibility and health services ap-
reconsideration. peals as specified in 600.335.
(d) The effective date of an HHS de- (3) Contracting with standard health
termination withdrawing BHP certifi- plan offerors as specified in § 600.410.
cation shall not be earlier than 120 (4) Oversight and financial integrity
days following a final finding of non- including, but not limited to, operation
compliance with the standards for cer- of the Trust Fund specified at §§ 600.705
tification. and 600.710, compliance with annual re-
(e) Within 30 days following a final porting at § 600.170, and providing data
finding of noncompliance with the required by § 600.610 for Federal funding
standards for certification, the State and reconciliation processes.
shall submit a transition plan that de- (5) Consumer assistance as required
scribes procedures to assist consumers in § 600.150.
with transitioning to other insurance (6) Extending protections to Amer-
affordability programs, and shall com- ican Indian/Alaska Natives specified at
ply with the procedures described in § 600.160, as well as comply with the
§ 600.140(a)(2) through (8). Civil Rights and nondiscrimination
provisions specified at § 600.165.
§ 600.145 State program administra- (7) Data collection and reporting as
tion and operation. necessary for efficient and effective op-
(a) Program operation. The State must eration of the program and as specified
implement its BHP in accordance with: by HHS to support program oversight.
(1) The approved and fully certified (8) If necessary, program termination
State BHP Blueprint, any approved procedures at § 600.145.
modifications to the State BHP Blue- [79 FR 14140, Mar. 12, 2014, as amended at 88
print and the requirements of this FR 79555, Nov. 16, 2023]
chapter and applicable law; or
(2) The approved suspension applica- § 600.150 Enrollment assistance and in-
tion described in § 600.140. formation requirements.
(b) Eligibility. All persons have a right (a) Information disclosure. (1) The
to apply for a determination of eligi- State must make accurate, easily un-
bility and, if eligible, to be enrolled derstood information available to po-
into coverage that conforms to the reg- tential applicants and enrollees about
ulations in this part. the BHP coverage option along with in-
(c) Statewide program operation. A formation about other insurance af-
state choosing to operate a BHP must fordability programs.
operate it statewide. (2) The State must provide accessible
(d) No caps on program enrollment. A information on coverage, including ad-
State implementing a BHP must not be ditional benefits that may be provided
permitted to limit enrollment by set- outside of the standard health plan
ting an income level below the income coverage, any tiers of coverage it has
standard prescribed in section 1331 of built into the BHP, including who is el-
the Affordable Care Act, having a fixed igible for each tier.
enrollment cap or imposing waiting (3) The State must require partici-
lists. pating standard health plans to provide
1099
§ 600.155 42 CFR Ch. IV (10–1–24 Edition)
clear information on premiums; cov- § 600.165 Nondiscrimination stand-

ered services including any limits on ards.
amount, duration and scope of those (a) The State and standard health
services; applicable cost-sharing using plans, must comply with all applicable
a standard format supplied by the civil rights statutes and requirements,
State, and other data specified in, and including Title VI of the Civil Rights
in accordance with, 45 CFR 156.220. Act of 1964, Title II of the Americans
(4) The State must provide informa- with Disabilities Act of 1990, Section
tion in a manner consistent with 45 504 of the Rehabilitation Act of 1973,
CFR 155.205(c). the Age Discrimination Act of 1975,
(5) The State must require partici- Section 1557 of the Affordable Care Act,
pating standard health plans to make and 45 CFR part 80, part 84, and part 91
publicly available, and keep up to date and 28 CFR part 35.
(at least quarterly), the names and lo- (b) The State must comply with the
cations of currently participating pro- nondiscrimination provision at 45 CFR
viders. 155.120(c)(2).
(b) [Reserved] § 600.170 Annual report content and
timing.
§ 600.155 Tribal consultation.
(a) Content. (1) The State that is op-
The State must consult with Indian erating a BHP must submit an annual
tribes located in the State on the de- report that includes any evidence of
velopment and execution of the BHP fraud, waste, or abuse on the part of
Blueprint using the tribal consultation participating providers, plans, or the
policy approved by the State Exchange. State BHP agency known to the State,
and a detailed data-driven review of
§ 600.160 Protections for American In- compliance with the following:
dian and Alaska Natives. (i) Eligibility verification require-
(a) Enrollment. Indians must be ex- ments for program participation as
tended the same special enrollment specified in § 600.345.
status in BHP standard health plans as (ii) Limitations on the use of Federal
applicable to enrollment in a QHP funds received by the BHP as specified
through the Exchange under 45 CFR in § 600.705.
155.420(d)(8). Indians will be allowed to (iii) Requirements to collect quality
enroll in, or change enrollment in, and performance measures from all
standard health plans one time per participating standard health plans fo-
month. cusing on quality of care and improved
(b) Cost sharing. No cost sharing may health outcomes as specified in sec-
be imposed on Indians under the stand- tions 1311(c)(3) and (4) of the Affordable
ard health plan. Care Act and as further described in
§ 600.415.
(c) Payments to providers. Equal to the
(iv) Requirements specified by the
protection extended to Indian health
Secretary at least 120 days prior to the
providers providing services to Indians date of the annual report as requiring
enrolled in a QHP in the individual further study to assess continued State
market through an Exchange at 45 CFR compliance with Federal law, regula-
156.430(g), BHP offerors may not reduce tions and the terms of the State’s cer-
the payment for services to Indian tified Blueprint, based on a Federal re-
health providers by the amount of any view of the BHP pursuant to § 600.200,
cost-sharing that would be due from and/or a list of any outstanding rec-
the Indian but for the prohibition in ommendations from any audit or eval-
paragraph (b) of this section. uation conducted by the HHS Office of
(d) Requirement. Standard health Inspector General that have not been
plans must pay primary to health pro- fully implemented, including a state-
grams operated by the Indian Health ment describing the status of imple-
Service, Indian tribes, tribal organiza- mentation and why implementation is
tions, and urban Indian organizations not complete.
for services that are covered by a (2) A State that has suspended its
standard health plan. BHP under § 600.140(b) of this part must
1100
submit an annual report that includes the date of the issuance of the Federal
the following: compliance review.
(i) The balance of the BHP trust fund (2) Requirements with which the
and any interest accrued on that bal- State BHP does not appear to be in
ance; compliance that could be the basis for
(ii) An assurance that the coverage withdrawal of BHP certification. Such
provided to individuals who would be findings must be resolved by the State
eligible for a BHP under § 600.305 of this (either by substantiating compliance
part continues to meet the standards with the standards for certification or
described in § 600.140(b)(1)(i), (ii), and submitting revisions to the Blueprint).
(iii) of this part; and If not resolved, such action items can
(iii) Any additional information spec- be the basis for a proposed finding for
ified by the Secretary at least 120 days
withdrawal of BHP certification.
prior to the date of the annual report.
(3) Requirements with which the
(b) Timing. The annual reports, in the
format specified by the Secretary, are State BHP does not appear to be in
due 60 days after the end of each oper- compliance and are not a basis for
ational year. Information that may be withdrawal of BHP certification but re-
required to secure the release of fund- quire revision to the Blueprint must be
ing for the subsequent year may be re- resolved by the State. If not resolved,
quested in advance. such action items can be the basis for
denial of other Blueprint revisions.
FR 79555, Nov. 16, 2023]
(4) Improper use of BHP trust fund re-
sources. The State and the BHP trust-
ees shall be given an opportunity to re-
Subpart C—Federal Program view and resolve concerns regarding
Administration improper use of BHP trust funds, in-
§ 600.200 Federal program compliance cluding failure to use these funds as
reviews and audits. specified in § 600.705. As indicated in
§ 600.715(a) through (c), the state may
(a) Federal compliance review of the
do this either by substantiating the
State BHP. To determine whether the
proper use of trust fund resources as
State is complying with the Federal re-
quirements and the provisions of its specified in § 600.705(c) or by taking cor-
BHP Blueprint, HHS may review, as rective action, which include changes
needed, but no less frequently than an- to procedures to ensure proper use of
nually, the compliance of the State trust fund resources, and restitution of
BHP with applicable laws, regulations improperly used resources to the trust
and interpretive guidance. This review fund.
may be based on the State’s annual re- (c) The HHS Office of Inspector Gen-
port submitted under § 600.170, or may eral (OIG) may periodically audit State
be based on direct Federal review of operations and standard health plan
State administration of the BHP Blue- practices as described in § 430.33 of this
print through analysis of the State’s chapter. Final reports on those audits
policies and procedures, reviews of shall be transmitted to both the State
agency operation, examination of sam- and the Secretary for actions on find-
ples of individual case records, and ad- ings. The State and the BHP trustees
ditional reports and/or data as deter- shall be given an opportunity to re-
mined by the Secretary. solve concerns about improper use of
(b) Action on compliance review find- BHP trust funds as indicated in
ings. The compliance review will iden- § 600.715(a) through (c): either by sub-
tify the following action items: stantiating the proper use of trust
(1) Requirements that need further fund, or by taking corrective action
study or data to assess continued State
that includes changes to procedures to
compliance with Federal law, regula-
ensure proper use of trust fund re-
tions and the terms of the State’s cer-
sources, and restitution of improperly
tified Blueprint. Such findings must be
addressed in the next State annual reused resources to the trust fund.
port due no more than 120 days after
1101
§ 600.300 42 CFR Ch. IV (10–1–24 Edition)
Subpart D—Eligibility and (6) Are not incarcerated, other than

Enrollment during a period pending disposition of
charges.
§ 600.300 Basis, scope, and applica- (b) Eligibility restrictions. With the ex-
bility. ception of during an approved imple-
(a) Statutory basis. This subpart inter- mentation period specified in a transi-
prets and implements section 1331(e) of tion plan in accordance with § 600.145,
the Affordable Care Act, which sets the State may not impose conditions of
forth eligibility standards for the BHP eligibility other than those identified
and prohibits eligible individuals from in this section, including, but not lim-
being treated as qualified individuals ited to, restrictions on eligibility based
under section 1312 of the Affordable on geographic location or imposition of
Care Act and enrolling in qualified an enrollment cap or a waiting period
health plans offered through the Ex-
for individuals previously eligible for
change.
or enrolled in other coverage.
(b) Scope and applicability. This sub-
part sets forth the requirements for all § 600.310 Application.
BHPs established under section 1331 of
the Affordable Care Act regarding eli- (a) Single streamlined application. The
gibility standards and application State must use the single streamlined
screening and enrollment procedures. application used by the State in ac-
cordance with § 435.907(b) of this chap-
§ 600.305 Eligible individuals. ter and 45 CFR 155.405(a) and (b).
(a) Eligibility standards The State (b) Opportunity to apply and assistance
must determine individuals eligible to with application. The terms of §§ 435.906,
enroll in a standard health plan if they: 435.907(g) and 435.908 of this chapter, re-
(1) Are residents of the State. quiring the State to provide individ-
(2) Have household income which ex- uals the opportunity to apply and re-
ceeds 133 percent but does not exceed ceive assistance with an application in
200 percent of the FPL for the applica- the Medicaid program, apply in the
ble family size, or, in the case of an in- same manner to States in the adminis-
dividual who is a lawfully present non-
tration of the BHP.
citizen, ineligible for Medicaid or CHIP
due to such immigration status, whose (c) Authorized representatives. The
household income is between zero and State may choose to permit the use of
200 percent of the FPL for the applica- an authorized representative des-
ble family size. ignated by an applicant or beneficiary
(3) Are not eligible to enroll in min- to assist with the individual’s applica-
imum essential coverage (other than a tion, eligibility renewal and other on-
standard health plan). If an individual going communication with the BHP. If
meets all other eligibility standards, the State chooses this option, the
and— State must follow the standards set
(i) Is eligible for, or enrolled in, cov- forth at either 45 CFR 155.227 or 42 CFR
erage that does not meet the definition 435.923.
of minimum essential coverage, includ-
ing Medicaid that is not minimum es- § 600.315 Certified application coun-
sential coverage, the individual is eli- selors.
gible to enroll in a standard health The State may have a program to
plan without regard to eligibility or certify application counselors to assist
enrollment in Medicaid; or individuals to apply for enrollment in
(ii) Is eligible for Employer Spon- the BHP and other insurance afford-
sored Insurance (ESI) that is
ability programs. If the State chooses
unaffordable (as determined under sec-
this option, the State must follow the
tion 36B(c)(2)(C) of the Internal Rev-
procedures and standards for such a
enue Code), the individual is eligible to
enroll in a standard health plan. program set forth in the regulations at
(4) Are 64 years of age or younger. either 45 CFR 155.225 or 42 CFR 435.908.
(5) Are either a citizen or lawfully
present non-citizen.
1102
§ 600.320 Determination of eligibility § 600.330 Coordination with other in-

for and enrollment in a standard surance affordability programs.
health plan. (a) Coordination. The State must es-
(a) Determining eligibility to enroll tablish eligibility and enrollment
in a standard health plan may be per- mechanisms and procedures to maxi-
formed by a State or through delega- mize coordination with the Exchange,
tion to a local governmental entity, in- Medicaid, and Children’s Health Insur-
cluding a governmental entity that de- ance Program (CHIP). The terms of 45
termines eligibility for Medicaid or CFR 155.345(a) regarding the agree-
ments between insurance affordability
CHIP, and may be delegated by the
programs apply to a BHP. The State
State to an Exchange that is a govern-
BHP agency must fulfill the require-
ment agency. ments of § 435.1200(d), (e)(1)(ii), and
(b) Timely determinations. The terms (e)(3) of this chapter and, if applicable,
of 42 CFR 435.912 (relating to timely de- paragraph (c) of this section for BHP
terminations of eligibility under the eligible individuals.
Medicaid program) apply to eligibility (b) Coordinated determinations of eligi-
determinations for enrollment in a bility. The agency administering BHP
standard health plan exclusive of must establish and maintain processes
§ 435.912(c)(3)(i). The standards estab- to make income eligibility determina-
lished by the State must be included in tions using modified adjusted gross in-
the BHP Blueprint. come, and to ensure that applications
(c) Effective date of eligibility. The received by the agency, to the extent
State must establish a uniform method warranted and permitted under delega-
of determining the effective date of eli- tions from other agencies admin-
gibility for enrollment in a standard istering insurance affordability pro-
health plan which— grams, also result in eligibility assess-
ments or determinations for those
(1) Follows the Exchange effective
other programs. The BHP must also ac-
date standards at 45 CFR 155.420(b)(1);
cept applications transferred from
(2) Follows the Medicaid effective other agencies administering insurance
date standards at § 435.915 of this chap- affordability programs, and ensure that
ter exclusive of § 435.915(a);or individuals assessed or determined eli-
(3) Follows an effective date of eligi- gible for BHP by such other agencies
bility of the first day of the month fol- are afforded the opportunity to enroll
lowing the month in which BHP eligi- in a standard health plan without
bility is determined; or undue delay. Individuals submitting
(4) Follows an effective date of eligi- applications to any of the aforemen-
bility standard established by the tioned agencies must not be required to
State and subject to HHS approval to duplicate the submission of informa-
ensure that the effective date is: tion.
(i) No later than the first day of the (c) Account transfers. The agency ad-
second month following the date that ministering the BHP must participate
an individual has been determined in the secure exchange of information
BHP-eligible; and with agencies administering other in-
surance affordability programs, using
(ii) No more restrictive than para-
the standards set forth under 45 CFR
graphs (c)(1) through (3) of this section.
155.345(h) regarding electronic account
(d) Enrollment periods. The State must transfers.
either offer enrollment and special en- (d) Notification to referring agency. The
rollment periods no more restrictive terms in § 435.1200(d)(5) regarding the
than those required for an Exchange at notification to other programs of the
45 CFR 155.410 and 155.420 or follow the final determination of eligibility apply
Medicaid process permitting contin- equally to States administering a BHP.
uous open enrollment throughout the (e) Notice of decision concerning eligi-
year. bility. Every application for BHP shall
result in a determination of eligibility
FR 26419, Apr. 15, 2024]
or ineligibility, unless the application
has been withdrawn, the applicant has
1103
§ 600.335 42 CFR Ch. IV (10–1–24 Edition)
died, or the applicant cannot be lo- (3) The agency to which eligibility
cated. Written notices of eligibility de- determinations or appeals decisions are
terminations shall be provided and delegated informs applicants and bene-
shall be coordinated with other insur- ficiaries how they can directly contact
ance affordability programs and Med- and obtain information from the agen-
icaid. Electronic notices shall be pro- cy.
vided to the extent consistent with (d) Accessibility. Notices must be pro-
§ 435.918(b). vided and the appeals process must be
(f) Accessibility. Eligibility notices conducted in a manner accessible to in-
must be written in plain language and dividuals with limited English pro-
be provided in a manner which ensures ficiency and persons with disabilities.
individuals with disabilities are pro-
vided with effective communication [79 FR 14140, Mar. 12, 2014, as amended at 88
and takes steps to provide meaningful FR 79555, Nov. 16, 2023]
access to eligible individuals with lim-
§ 600.340 Periodic redetermination
ited English proficiency. and renewal of BHP eligibility.
(a) Periodic review of eligibility. An in-
FR 79555, Nov. 16, 2023; 89 FR 22878, Apr. 2,
2024] dividual is subject to periodic review of
eligibility every 12 months unless the
§ 600.335 Appeals. eligibility is redetermined sooner based
(a) Notice of eligibility appeal rights. on new information received and
Eligibility determinations must in- verified from enrollee reports or data
clude a notice of the right to appeal sources. The State must require enroll-
the determination, and instructions re- ees to report changes in circumstances,
garding how to file an appeal. at least to the extent that they would
(b) Appeals process. Individuals must be required to report such changes if
be given the opportunity to appeal the enrolled in coverage through the Ex-
following actions through the appeals change, consistent with 45 CFR
rules of the State’s Medicaid program, 155.330(b).
unless granted an exception under (b) Renewal of coverage. If an enrollee
paragraph (c) of this section: remains eligible for coverage in the
(1) BHP eligibility determinations; BHP, the enrollee will be afforded no-
and tice of a reasonable opportunity at
(2) Delay, denial, reduction, suspen- least annually to change plans to the
sion, or termination of health services, extent the BHP offers a choice of plans,
in whole or in part, including a deter- and shall remain in the plan selected
mination about the type or level of for the previous year unless such en-
service, after individuals exhaust ap- rollee terminates coverage from the
peals or grievances through the BHP plan by selecting a new plan or with-
standard health plans. drawing from a plan, or the plan is no
(c) Exception. Subject to HHS ap- longer available as a standard health
proval, a state may request to follow plan in BHP. Enrollees in plans that
an appeals process for BHP eligibility are no longer available will be given a
determinations and health service mat- reasonable opportunity to select a new
ters that differs from the State’s Med- plan, and if they do not select a new
icaid program. In its request, the State plan will be enrolled in another plan
must provide a clear description of the pursuant to a methodology set forth in
responsibilities and functions dele- the State’s Blueprint.
gated to such an entity and ensure (c) Procedures. The State shall choose
that: to apply equally all the redetermina-
(1) The State has oversight of any en- tion procedures described in either 45
tity delegated the authority to admin- CFR 155.335 or 42 CFR 435.916(a) in ad-
ister appeals; ministering a BHP.
(2) The agency to which eligibility (d) Verification. The State must verify
determinations or appeals decisions are information needed to redetermine and
delegated complies with all relevant renew eligibility in accordance with
Federal and State law, regulations and § 600.345 and comply with the require-
policies; and ments set forth in § 600.330 relating to
1104
screening individuals for other insur- (b) Scope and applicability. This sub-
ance affordability programs and trans- part consists of provisions relating to
mitting such individuals’ electronic ac- all BHPs for the delivery of, at a min-
counts and other relevant information imum, the ten essential health benefits
to the other program, as appropriate. as described in section 1302(b) of the Af-
(e) Notice to enrollee. The State must fordable Care Act, the contracting
provide an enrollee with an annual no- process by which States must contract
tice of redetermination of eligibility. for the provision of standard health
The annual notice should include all plans, the minimum requirements
current information used for the most States must include in their standard
recent eligibility determination. The health plan contracts, the minimum
enrollee is required to report any coverage standards provided by the
changes with respect to information standard health plan offeror, and other
listed within the notice within 30 days applicable requirements to enhance the
of the date of the notice. The State coordination of the provision of stand-
must verify information in accordance
ard health plan coverage.
with § 600.345.
(f) Continuous eligibility. The state is § 600.405 Standard health plan cov-
not required to redetermine eligibility erage.
of BHP enrollees more frequently than
every 12 months, regardless of changes (a) Essential Health Benefits (EHB).
of circumstances, as long as the enroll- Standard health plan coverage must in-
ees are under age 65, are not otherwise clude, at a minimum, the essential
enrolled in minimum essential cov- health benefits as determined and spec-
erage and remain residents of the ified under 45 CFR 156.110, and 45 CFR
State. 156.122 regarding prescription drugs, ex-
cept that States may select more than
§ 600.345 Eligibility verification. one base benchmark option from those
(a) The State must verify the eligi- codified at 45 CFR 156.100 for estab-
bility of an applicant or beneficiary for lishing essential health benefits for
BHP consistent either with the stand- standard health plans. Additionally,
ards and procedures set forth in— States must comply with 45 CFR
(1) Medicaid regulations at §§ 435.945 156.122(a)(2) by requiring participating
through 435.956 of this chapter; or plans to submit their drug list to the
(2) Exchange regulations at 45 CFR State.
155.315 and 155.320. (b) Additional required benefits. Where
(b) [Reserved] the standard health plan for BHP is
subject to State insurance mandates,
§ 600.350 Privacy and security of infor- the State shall adopt the determina-
mation. tion of the Exchange at 45 CFR
The State must comply with the 155.170(a)(3) in determining which bene-
standards and procedures set forth in fits enacted after December 31, 2011 are
45 CFR 155.260(b) and (c) as are applica- in addition to EHB.
ble to the operation of the BHP. (c) Periodic review. Essential health
benefits must include any changes re-
Subpart E—Standard Health Plan sulting from periodic reviews required
by section 1302(b)(4)(G) of the Afford-
§ 600.400 Basis, scope, and applica- able Care Act. The provision of such es-
bility. sential health benefits must meet all
(a) Statutory basis. This subpart im- the requirements of 45 CFR 156.115.
plements sections 1331(b), (c), and (g) of (d) Non-discrimination in benefit de-
the Affordable Care Act, which set sign. The terms of 45 CFR 156.125 ap-
forth provisions regarding the min- plies to standard health plans offered
imum coverage standards under BHP, under the BHP.
as well as the delivery of such cov- (e) Compliance. The State and stand-
erage, including the contracting proc- ard health plans must comply with pro-
ess for standard health plan offerors hibitions on federal funding for abor-
participating in the BHP. tion services at 45 CFR 156.280.
1105
§ 600.410 42 CFR Ch. IV (10–1–24 Edition)
§ 600.410 Competitive contracting (iii) Establishment of provider-pa-

process. tient relationships that maximize pa-
(a) General requirement. In order to re- tient involvement in their health care
ceive initial HHS certification as de- decision-making, including the use of
scribed in § 600.120, the State must as- incentives for appropriate health care
sure in its BHP Blueprint that it com- utilization and patient choice of pro-
plies with the requirements set forth in vider.
this section. (e) Other considerations: The State
(b) Contracting process. The State shall also include in its competitive
must: process criteria to ensure:
(1) Conduct the contracting process (1) Consideration of health care needs
in a manner providing full and open of enrollees;
competition consistent with the stand- (2) Local availability of, and access,
ards of 45 CFR 92.36(b) through (i); to health care providers to ensure the
(2) Include a negotiation of the ele- appropriate number, mix and geo-
ments described in paragraph (d) of graphic distribution to meet the needs
this section on a fair and adequate of the anticipated number of enrollees
basis; and in the service area (including but not
(3) Consider the additional elements limited to services provided by essen-
described in paragraph (e) of this sec- tial community providers, as defined in
tion. 45 CFR 156.235) so that access to serv-
(c) Initial implementation exceptions. ices is at least sufficient to meet the
(1) If a State is not able to implement access standards applicable under 42
a competitive contracting process de- CFR part 438, subpart D, or 45 CFR
scribed in paragraph (b) of this section 156.230 and 156.235;
for program year 2015, the State must (3) Use of a managed care process, or
include a justification as to why it can- a similar process to improve the qual-
not meet the conditions in paragraph ity, accessibility, appropriate utiliza-
(b), as well as a description of the proc- tion, and efficiency of services provided
ess it will use to enter into contracts to enrollees;
for the provision of standard health (4) Performance measures and stand-
plans under BHP. ards focused on quality of care and im-
(2) The State must include a proposed proved health outcomes as specified in
timeline that implements a competi- § 600.415;
tive contracting process, as described (5) Coordination between other
in paragraph (b) of this section, for pro- health insurance affordability pro-
gram year 2016. grams to ensure enrollee continuity of
(3) Initial implementation exceptions care as described in § 600.425; and
are subject to HHS approval consistent
(6) Measures to prevent, identify, and
with the BHP Blueprint review process
address fraud, waste and abuse and en-
established in § 600.120, and may only be
sure consumer protections.
in effect for benefit year 2015.
(d) Negotiation criteria. The State (f) Discrimination. Nothing in the
must assure that its competitive con- competitive process shall permit or en-
tracting process includes the negotia- courage discrimination in enrollment
tion of: based on pre-existing conditions or
(1) Premiums and cost sharing, con- other health status-related factors.
sistent with the requirements at
§ 600.415 Contracting qualifications
§§ 600.505 and 600.510(e); and requirements.
(2) Benefits, consistent with the re-
quirements at § 600.405; (a) Eligible offerors for standard health
(3) Inclusion of innovative features, plan contracts. A State may enter into
such as: contracts for the administration and
(i) Care coordination and care man- provision of standard health plans
agement for enrollees, with a par- under the BHP with, but not limited
ticular focus on enrollees with chronic to, the following entities:
health conditions; (1) Licensed health maintenance or-
(ii) Incentives for the use of preven- ganization.
tive services; and (2) Licensed health insurance insurer.
1106
(3) Network of health care providers that the State has reviewed its com-
demonstrating capacity to meet the petitive contracting process to deter-
criteria set forth in § 600.410(d). mine the following:
(4) Non-licensed health maintenance (i) Whether all contract requirements
organizations participating in Med- and qualifications are required under
icaid and/or CHIP. the federal framework for BHP;
(b) General contract requirements. (1) A (ii) Whether additional negotiating
State contracting with eligible stand- flexibility would be consistent with the
ard health plan offerors described in minimum statutory requirements and
paragraph (a) of this section must in- available BHP funding: and
clude contract provisions addressing (iii) Whether potential bidders have
network adequacy, service provision received sufficient information to en-
and authorization, quality and per- courage participation in the BHP com-
formance, enrollment procedures, petitive contracting process.
disenrollment procedures, noticing and (b) Use of regional compacts. (1) A
appeals, provisions protecting the pri- State may enter into a joint procure-
vacy and security of personally identi- ment with other States to negotiate
fiable information, and other applica- and contract with standard health plan
ble contract requirements as deter- offerors to administer and provide
mined by the Secretary to the extent standard health plans statewide, or in
that the service delivery model fur- geographically specific areas within
thers the objectives of the program. the States, to BHP enrollees residing
(2) All contracts under this part must in the participating regional compact
include provisions that define a sound States.
and complete procurement contract, as (2) A State electing the option de-
required by 45 CFR 92.36(i). scribed in paragraph (b)(1) of this sec-
(3) To the extent that the standard tion that also contracts for the provi-
health plan is health insurance cov- sion of a geographically specific stand-
erage offered by a health insurance ard health plan must assure that en-
issuer, the contract must provide that rollees, regardless of residency within
the medical loss ratio is at least 85 per- the State, continue to have choice of at
cent. least two standard health plans.
(c) Notification of State election. To re- (3) A State electing the option de-
ceive HHS certification, the State scribed in paragraph (b)(1) of this sec-
must include in its BHP Blueprint the tion must include in its BHP Blueprint
standard set of contract requirements all of the following:
described in paragraph (b) of this sec- (i) The other State(s) entering into
tion that will be incorporated into its the regional compact.
standard health plan contracts. (ii) The specific areas within the par-
ticipating States that the standard
§ 600.420 Enhanced availability of health plans will operate, if applicable.
standard health plans. (A) If the State contracts for the pro-
(a) Choice of standard health plans vision of a geographically specific
offerors. (1) The State must assure that standard health plan, the State must
standard health plans from at least two describe in its BHP Blueprint how it
offerors are available to enrollees will assure that enrollees, regardless of
under BHP. This assurance shall be relocation within the State, continue to
flected in the BHP Blueprint, which if have choice of at least two standard
applicable, shall also include a descrip- health plan offerors.
tion of how it will further ensure en- (B) [Reserved]
rollee choice of standard health plans. (iii) An assurance that the competi-
(2) If a State is not able to assure tive contracting process used in the
choice of standard health plan offerors, joint procurement of the standard
the State may request an exception to health plans complies with the require-
the requirement set forth in paragraph ments set forth in § 600.410.
(a)(1) of this section, which must in- (iv) Any variations that may occur as
clude a justification as to why it can- a result of regional differences between
not assure choice of standard health the participating states with respect to
plan offeror as well as demonstrate benefit packages, premiums and cost
1107
§ 600.425 42 CFR Ch. IV (10–1–24 Edition)
sharing, contracting requirements and (iii) The consequences for an enrollee

other applicable elements as deter- or applicant who does not pay a pre-
mined by HHS. mium.
(b) [Reserved]
§ 600.425 Coordination with other in-
surance affordability programs. § 600.510 Cost-sharing.
A State must ensure coordination for (a) Cost-sharing requirements. (1) For
the provision of health care services to cost sharing imposed on enrollees, the
promote enrollee continuity of care be- State must assure the following:
tween Medicaid, CHIP, Exchange and (i) The cost sharing imposed on en-
any other state-administered health in- rollees meet the standards detailed in
surance programs. The State’s BHP § 600.520(c).
Blueprint must describe how it will en- (ii) The establishment of an effective
sure such coordination. system to monitor and track the cost-
sharing standards consistent with
Subpart F—Enrollee Financial § 600.520(b) through (d).
Responsibilities (2) This assurance must be reflected
in the BHP Blueprint, which shall also
§ 600.500 Basis, scope, and applica- include the group or groups of enrollees
bility. subject to the cost sharing.
(a) Statutory basis. This subpart im- (b) Cost sharing for preventive health
plements section 1331(a) of the Afford- services. A State may not impose cost
able Care Act, which sets forth provi- sharing with respect to the preventive
sions regarding the establishment of health services or items, as defined in,
the BHP and requirements regarding and in accordance with 45 CFR 147.130.
monthly premiums and cost sharing for
enrollees. § 600.515 Public schedule of enrollee
(b) Scope and applicability. This sub- premium and cost sharing.
part consists of provisions relating to (a) The State must ensure that appli-
the imposition of monthly premiums cants and enrollees have access to in-
and cost-sharing under all state BHPs. formation about all of the following,
either upon request or through an
§ 600.505 Premiums. Internet Web site:
(a) Premium requirements. (1) For pre- (1) The amount of and types of en-
miums imposed on enrollees, the State rollee premiums and cost sharing for
must assure that the monthly premium each standard health plan that would
imposed on any enrollee does not ex- apply for individuals at different in-
ceed the monthly premium that the en- come levels.
rollee would have been required to pay (2) The consequences for an applicant
had he or she enrolled in a plan with a or an enrollee who does not pay a pre-
premium equal to the premium of the mium.
applicable benchmark plan, as defined (b) The information described in
in 26 CFR 1.36B–3(f). The State must as- paragraph (a) of this section must be
sure that when determining the made available to applicants for stand-
amount of the enrollee’s monthly pre- ard health plan coverage and enrollees
mium, the State took into account rein such coverage, at the time of enroll-
ductions in the premium resulting ment and reenrollment, after a redeter-
from the premium tax credit that mination of eligibility, when pre-
would have been paid on the enrollee’s miums, cost sharing, and annual limi-
behalf. tations on cost sharing are revised, and
(2) This assurance must be reflected upon request by the individual.
in the BHP Blueprint, which shall also
include: § 600.520 General cost-sharing protec-
(i) The group or groups of enrollees tions.
subject to premiums. (a) Cost-sharing protections for lower
(ii) The collection method and proce- income enrollees. The State may vary
dure for the payment of an enrollee’s premiums and cost sharing based on
premium. household income only in a manner
1108
that does not favor enrollees with high- (3) A State electing to enroll eligible
er income over enrollees with lower in- individuals throughout the year must
come. provide an enrollee a 30-day grace pe-
(b) Cost-sharing protections to ensure riod to pay any required premium prior
enrollment of Indians. A State must en- to disenrollment.
sure that standard health plans meet (b) Consequences of nonpayment of pre-
the standards in accordance with 45 mium. (1) A State electing to enroll eli-
CFR 156.420(b)(1) and (d). gible individuals in accordance with 45
(c) Cost-sharing standards. A State CFR 155.410 and 155.420 may not restrict
must ensure that standard health plans reenrollment to BHP beyond the next
meet: open enrollment period.
(1) The standards in accordance with (2) A State electing to enroll eligible
45 CFR 156.420(c) and (e); and individuals throughout the year must
(2) The cost-sharing reduction stand- comply with the reenrollment stand-
ards in accordance with 45 CFR ards set forth in § 457.570(c) of this
156.420(a)(1) for an enrollee with house- chapter.
hold income at or below 150 percent of
the FPL, and 45 CFR 156.420(a)(2) for an FR 22878, Apr. 2, 2024]
enrollee with household income above
150 percent of the FPL.
(3) The State must establish an effec- Subpart G—Payment to States
tive system to monitor compliance § 600.600 Basis, scope, and applica-
with the cost-sharing reduction stand- bility.
ards in paragraph (c) of this section,
and the cost-sharing protections to en- (a) Statutory basis. This subpart im-
sure enrollment of Indians in para- plements section 1331(d)(1) and (3) of
graph (b) of this section to ensure that the Affordable Care Act regarding the
enrollees are not held responsible for transfer of Federal funds to a State’s
such monitoring activity. BHP trust fund and the Federal pay-
(d) Acceptance of certain third party ment amount to a State for the provi-
payments. States must ensure that sion of BHP.
standard health plans must accept pre- (b) Scope and applicability. This sub-
mium and cost-sharing payments from part consists of provisions relating to
the following third party entities on the methodology used to calculate the
behalf of plan enrollees: amount of payment to a state in a
(1) Ryan White HIV/AIDS Programs given Federal fiscal year for the provi-
under title XXVI of the Public Health sion of BHP and the process and proce-
Service Act; dures by which the Secretary estab-
(2) Indian tribes, tribal organizations lishes a State’s BHP payment amount.
or urban Indian organizations; and
§ 600.605 BHP payment methodology.
(3) State and federal government pro-
grams. (a) General calculation. The Federal
payment for an eligible individual in a
§ 600.525 Disenrollment procedures given Federal fiscal year is the sum of
and consequences for nonpayment the premium tax credit component, as
of premiums. described in paragraph (a)(1) of this
(a) Disenrollment procedures due to section, and the cost-sharing reduction
nonpayment of premium. (1) A State component, as described in paragraph
must assure that it is in compliance (a)(2) of this section.
with the disenrollment procedures de- (1) Premium tax credit component. The
scribed in 45 CFR 155.430. This assur- premium tax credit component equals
ance must be reflected in the state’s 95 percent of the premium tax credit
BHP Blueprint. for which the eligible individual would
(2) A State electing to enroll eligible have qualified had he or she been en-
individuals in accordance with 45 CFR rolled in a qualified health plan
155.410 and 155.420 must comply with through an Exchange in a given cal-
the premium grace period standards set endar year, adjusted by the relevant
forth in 45 CFR 156.270 for required pre- factors described in paragraph (b) of
mium payment prior to disenrollment. this section.
1109
§ 600.610 42 CFR Ch. IV (10–1–24 Edition)
(2) Cost-sharing reduction component. § 600.610 Secretarial determination of

The cost-sharing reduction component BHP payment amount.
equals 95 percent of the cost of the (a) Proposed payment notice. (1) Begin-
cost-sharing reductions for which the ning in FY 2015, the Secretary will de-
eligible individual would have qualified termine and publish in a FEDERAL REG-
had he or she been enrolled in a quali- ISTER document the BHP payment
fied health plan through an Exchange methodology for the next calendar year
in a given calendar year adjusted by or, beginning in calendar year 2022, for
the relevant factors described in para- multiple calendar years. Beginning in
graph (b) of this section. calendar year 2023—
(b) Relevant factors in the payment (i) In years in which the Secretary
methodology. In determining the pre- does not publish a new BHP method-
mium tax credit and cost-sharing re- ology, the Secretary will update the
duction components described in para- values of factors needed to calculate
graph (a) of this section, the Secretary the Federal BHP payments via sub reg-
will consider the following factors to ulatory guidance, as appropriate.
determine applicable adjustments: (ii) In years that the Secretary pub-
(1) Age of the enrollee; lishes a revised payment methodology,
(2) Income of the enrollee; the Secretary will publish a proposed
(3) Self-only or family coverage; BHP payment methodology upon re-
ceiving certification from the Chief Ac-
(4) Geographic differences in average
tuary of CMS.
spending for health care across rating
(2) A State may be required to sub-
areas;
mit data in accordance with the pub-
(5) Health status of the enrollee for lished proposed payment document in
purposes of determining risk adjust- order for the Secretary to determine
ment payments and reinsurance pay- the State’s payment rate as described
ments had the enrollee been enrolled in in paragraph (b) of this section.
a qualified health plan through an Ex- (b) Final payment notice. (1) Beginning
change; in calendar year 2023, in years that the
(6) Reconciliation of the premium tax Secretary publishes a revised payment
credit or cost-sharing reductions had methodology, the Secretary will deter-
such reconciliation occurred if an en- mine and publish the final BHP pay-
rollee had been enrolled in a qualified ment methodology and BHP payment
health plan through an Exchange; amounts in a FEDERAL REGISTER docu-
(7) Marketplace experience in other ment.
states with respect to Exchange par- (2) Calculation of payment rates. State
ticipation and the effect of the prepayment rates are determined by the
mium tax credit and cost-sharing re- Secretary using the final BHP payment
ductions provided to residents, particu- methodology, data requested in the
larly those residents with income proposed payment notice described in
below 200 percent of the FPL; and paragraph (a) of this section, and, if
(8) Other factors affecting the devel- needed, other applicable data as deter-
opment of the methodology as determined by the Secretary.
mined by the Secretary. (c) State specific aggregate BHP pay-
(c) Annual adjustments to payment ment amounts—(1) Prospective aggregate
methodology. The Secretary will adjust payment amount. The Secretary will de-
termine, on a quarterly basis, the pro-
the payment methodology on a pro-
spective aggregate BHP payment
spective basis to adjust for any changes
amount by multiplying the payment
in the calculation of the premium tax rates described in paragraph (b) of this
credit and cost-sharing reduction com- section by the projected number of en-
ponents to the extent that necessary rollees. This calculation would be made
data is available for the Secretary to for each category of enrollees based on
prospectively determine all relevant enrollee characteristics and the other
factors, as specified in paragraph (b) of relevant factors considered when deter-
this section. mining the payment methodology. The
prospective aggregate BHP payment
1110
amount would be the sum of the pay- § 600.615 Deposit of Federal BHP pay-
ments determined for each category of ment.
enrollees for a State. HHS will make quarterly deposits
(2) Retrospective adjustment to state into the state’s BHP trust fund based
specific aggregate payment amount for en- on the aggregate quarterly payment
rollment and errors. (i) Sixty days after amounts described in § 600.610(c).
the end of each fiscal year quarter, the
Secretary will calculate a retrospec- Subpart H—BHP Trust Fund
tive adjustment to the previous quar-
ter’s specific aggregate payment § 600.700 Basis, scope, and applica-
amount by multiplying the payment bility.
rates described in paragraph (b) of this (a) Statutory basis. This subpart im-
section by actual enrollment for the re- plements section 1331(d)(2) of the Af-
spective quarter. This calculation fordable Care Act, which set forth pro-
would be made for each category of en- visions regarding BHP trust fund ex-
rollees based on enrollee characteris- penditures, fiscal policies and account-
tics and the other relevant factors con- ability standards and restitution to the
sidered when determining the payment BHP trust fund for unallowable expend-
methodology. The adjusted BHP pay- itures.
ment amount would be the sum of the (b) Scope and applicability. This sub-
payments determined for each category part sets forth a framework for BHP
of enrollees for a State. trust funds and accounting, estab-
(ii) Upon determination that a math- lishing sound fiscal policies and ac-
ematical error occurred during the ap- countability standards and procedures
plication or development of the BHP for the restitution of unallowable BHP
funding methodology, the Secretary trust fund expenditures.
will recalculate the state’s BHP pay- § 600.705 BHP trust fund.
ment amount and make any necessary
adjustments in accordance with para- (a) Establishment of BHP trust fund. (1)
The State must establish a BHP trust
graph (c)(2)(iv) of this section.
fund with an independent entity, or in
(iii) To the extent that the final pay- a segregated account within the
ment notice described in paragraph (b) State’s fund structure.
of this section permits retrospective (2) The State must identify trustees
adjustments to the state’s BHP pay- responsible for oversight of the BHP
ment amount (due to the lack of nec- trust fund.
essary data for the Secretary to pro- (3) Trustees must specify individuals
spectively determine the relevant fac- with the power to authorize with-
tors comprising the premium tax credit drawal of funds for allowable trust fund
and cost-sharing reductions compo- expenditures.
nents of the BHP funding method- (b) Non-Federal deposits. The State
ology), the Secretary will recalculate may deposit non-Federal funds, includ-
the state’s BHP payment amount and ing such funds from enrollees, pro-
make any necessary adjustments in ac- viders or other third parties for stand-
cordance with paragraph (c)(2)(iv) of ard health plan coverage, into its BHP
this section. trust fund. Upon deposit, such funds
(iv) Any difference in the adjusted will be considered BHP trust funds,
payment and the prospective aggregate must remain in the BHP trust fund and
payment amount will result in either: meet the standards described in para-
(A) A deposit of the difference graphs (c) and (d) of this section.
amount into the State’s BHP trust (c) Allowable trust fund expenditures.
fund; or BHP trust funds may only be used to:
(1) Reduce premiums and cost shar-
(B) A reduction in the upcoming
ing for eligible individuals enrolled in
quarter’s prospective aggregate pay-
standard health plans under BHP; or
ment as described in paragraph (c)(1) of
(2) Provide additional benefits for eli-
this section by the difference amount. gible individuals enrolled in standard
[79 FR 14140, Mar. 12, 2014, as amended at 87 health plans as determined by the
FR 77742, Dec. 20, 2022] State.
1111
§ 600.710 42 CFR Ch. IV (10–1–24 Edition)
(d) Limitations. BHP trust funds may (c) Independent audit. Conduct an
not be expended for any purpose other independent audit of BHP trust fund
than those specified in paragraph (c) of expenditures, consistent with the
this section. In addition, BHP trust standards set forth in chapter 3 of the
funds may not be used for other pur- Government Accountability Office’s
poses including but not limited to: Government Auditing Standards, over
(1) Determining the amount of non- a 3-year period to determine that the
Federal funds for the purposes of meet- expenditures made during the 3-year
ing matching or expenditure require- period were allowable as described in
ments for Federal funding; § 600.705(b) and in accord with other ap-
(2) Program administration of BHP plicable Federal requirements. The
or any other program; independent audit may be conducted as
(3) Payment to providers not associ- a sub-audit of the single state audit
ated with BHP services or require- conducted in accordance with OMB Cir-
ments; or cular A–133, and must follow the cost
(4) Coverage for individuals not eligi- accounting principles in OMB Circular
ble for BHP. A–87.
(e) Year-to-year carryover of trust (d) Annual reports. Publish annual re-
funds. A State may maintain a surplus, ports on the use of funds, including a
or reserve, of funds in its trust through separate line item that tracks the use
the carryover of unexpended funds of funds described in § 600.705(e) to fur-
from year-to-year. Expenditures from ther reduce premiums and cost sharing,
this surplus must be made in accord- or for the provision of additional bene-
ance with paragraphs (b) and (c) of this fits within 10 days of approval by the
section. trustees. If applicable for the reporting
year, the annual report must also con-
§ 600.710 Fiscal policies and account- tain the findings for the audit con-
ability. ducted in accordance with paragraph
(c) of this section.
The BHP administering agency must (e) Restitution. Establish and main-
assure the fiscal policies and account- tain BHP trust fund restitution proce-
ability set forth in paragraphs (a) dures.
through (g) of this section. This assur-
(f) Record retention. Retain records for
ance must be reflected in the BHP
3 years from date of submission of a
Blueprint.
final expenditure report.
(a) Accounting records. Maintain an (g) Record retention related to audit
accounting system and supporting fis- findings. If any litigation, claim, finan-
cal records to assure that the BHP cial management review, or audit is
trust funds are maintained and ex- started before the expiration of the 3-
pended in accord with applicable Fed- year period, the records shall be re-
eral requirements, such as OMB Circu- tained until all litigation, claims or
lars A–87 and A–133. audit findings involving the records
(b) Annual certification. Obtain an an- have been resolved and final action
nual certification from the BHP trust- taken.
ees, the State’s chief financial officer,
or designee, certifying all of the fol- § 600.715 Corrective action, restitution,
lowing: and disallowance of questioned
(1) The State’s BHP trust fund finan- BHP transactions.
cial statements for the fiscal year. (a) Corrective action. When a question
(2) The BHP trust funds are not being has been raised concerning the author-
used as the non-Federal share for purity for BHP trust fund expenditures in
poses of meeting any matching or ex- an OIG report, other HHS compliance
penditure requirement of any Feder- review, State audit or otherwise, the
ally-funded program. BHP trustees and the State shall re-
(3) The use of BHP trust funds is in view the issues and develop a written
accordance with Federal requirements response no later than 60 days upon re-
consistent with those specified for the ceipt of such a report, unless otherwise
administration and provision of the specified in the report, review or audit.
program. To the extent determined necessary in
1112
that review, the BHP trustees and (2) A brief written explanation of the
State shall implement changes to fis- basis for the determination that the
cal procedures to ensure proper use of expenditures were improper; and
trust fund resources. (3) Procedures for administrative re-
(b) Restitution. To the extent that the consideration of the disallowance based
State and BHP trustees determine that on a final determination.
BHP trust funds may not have been (e) Administrative reconsideration of
properly spent, they must ensure res- BHP trust fund disallowances. (1) BHP
titution to the BHP trust fund of the
Trustees or the State may request re-
funds in question. Restitution may be
consideration of a disallowance within
made directly by the BHP trustees, by
60 days after receipt of the disallow-
the State, or by a liable third party.
The State or the BHP trustees may ance notice described in paragraph
enter into indemnification agreements (d)(1) of this section by submitting a
assigning liability for restitution of written request for review, along with
funds to the BHP trust fund. any relevant evidence, documentation,
(c) Timing of restitution. Restitution or explanation, to HHS.
to the BHP trust fund for any unallow- (2) After receipt of a reconsideration
able expenditure may occur in a lump request, if the Secretary (or a des-
sum amount, or in equal installment ignated hearing officer) determines
amounts. Restitution to the BHP trust that further proceedings would be war-
fund cannot exceed a 2-year period ranted, the Secretary may issue a re-
from the date of the written response quest for further information by a spe-
in accordance with paragraph (a) of cific date, or may schedule a hearing to
this section. obtain further evidence or argument.
(d) HHS disallowance of improper BHP (3) The Secretary, or designee, shall
trust fund expenditures. The State shall issue a final decision within 90 days
return to HHS the amount of federal after the later of the date of receipt of
BHP funding that HHS has determined the reconsideration request or date of
was expended for unauthorized pur- the last scheduled proceeding or sub-
poses, when no provision has been mission.
made to restore the funding to the BHP (f) Return of disallowed BHP funding.
trust fund in accordance with para-
Disallowed federal BHP funding must
graph (b) of this section (unless the res-
be returned to HHS within 60 days after
titution does not comply with the tim-
the later of the date of the disallow-
ing conditions described in paragraphs
(c) of this section). When HHS deter- ance notice or the final administrative
mines that federal BHP funding is not reconsideration upholding the dis-
allowable, HHS will provide written no- allowance. Such repayment cannot be
tice to the state and BHP Trustees con- made from BHP trust funds, but must
taining: be made with other, non-Federal funds.
(1) The date or dates of the improper
expenditures from the BHP trust fund; PARTS 601–699 [RESERVED]
1113
CHAPTER V—OFFICE OF INSPECTOR
GENERAL-HEALTH CARE, DEPARTMENT OF
HEALTH AND HUMAN SERVICES
EDITORIAL NOTE: Nomenclature changes to chapter V appear at 66 FR 39452, July 31, 2001,
and 67 FR 36540, May 24, 2002.
SUBCHAPTER A—GENERAL PROVISIONS
Part Page
1000 Introduction; general definitions ............................ 1117
SUBCHAPTER B—OIG AUTHORITIES
1001 Program integrity—Medicare and State health

care programs ....................................................... 1119
1002 Program integrity—State-initiated exclusions
from Medicaid ...................................................... 1183
1003 Civil money penalties, assessments and exclusions 1186
1004 Imposition of sanctions on health care practi-
tioners and providers of health care services by a
Quality Improvement Organization ..................... 1209
1005 Appeals of exclusions, civil money penalties and
assessments .......................................................... 1218
1006 Investigational inquiries ......................................... 1227
1007 State Medicaid fraud control units ......................... 1228
1008 Advisory opinions by the OIG ................................. 1238
1009–1099 [Reserved]
1115
SUBCHAPTER A—GENERAL PROVISIONS
PART 1000—INTRODUCTION; ESRD stands for end-stage renal dis-

GENERAL DEFINITIONS ease.
Exclusion means that items and serv-
Subpart A [Reserved] ices furnished, ordered, or prescribed
by a specified individual or entity will
Subpart B—Definitions not be reimbursed under Medicare,
Medicaid, or any other Federal health
Sec. care programs until the individual or
1000.10 General definitions.
entity is reinstated by OIG.
AUTHORITY: 42 U.S.C. 1320 and 1395hh. Federal health care program means
SOURCE: 51 FR 34766, Sept. 30, 1986, unless any plan or program that provides
otherwise noted. health benefits, whether directly,
through insurance, or otherwise, which
Subpart A [Reserved] is funded directly, in whole or in part,
by the United States Government
(other than the Federal Employees
Subpart B—Definitions Health Benefits Program), or any State
§ 1000.10 General definitions. health care program as defined in this
section.
In this chapter, unless the context FR stands for FEDERAL REGISTER.
indicates otherwise— Furnished refers to items or services
Act means the Social Security Act, provided or supplied, directly or indi-
and titles referred to are titles of that rectly, by any individual or entity.
Act. HHS stands for the Department of
Administrator means the Adminis- Health and Human Services.
trator, Centers for Medicare & Med- HHA stands for home health agency.
icaid Services (CMS), formerly the HMO stands for health maintenance
Health Care Financing Administration organization.
(HCFA). ICF stands for intermediate care fa-
ALJ means an Administrative Law cility.
Judge. Indirectly, as used in the definition of
Beneficiary means any individual eli- ‘‘furnished’’ in this section, means the
gible to have benefits paid to him or provision or supply of items and serv-
her, or on his or her behalf, under ices manufactured, distributed, sup-
Medicare or any State health care pro- plied, or otherwise provided by individ-
gram. uals or entities that do not directly re-
CFR stands for Code of Federal Regu- quest or receive payment from Medi-
lations. care, Medicaid, or other Federal health
CMS stands for Centers for Medicare care programs, but that provide items
& Medicaid Services, formerly the and services to providers, practi-
Health Care Financing Administration tioners, or suppliers who request or re-
(HCFA). ceive payment from these programs for
Department means the Department of such items or services.
Health and Human Services (HHS), for- Inspector General means the Inspector
merly the Department of Health, Edu- General for Health and Human Serv-
cation, and Welfare. ices.
Directly, as used in the definition of Medicaid means medical assistance
‘‘furnished’’ in this section, means the provided under a State plan approved
provision or supply of items and serv- under Title XIX of the Act.
ices by individuals or entities (includ- Medicare means the health insurance
ing items and services provided or sup- program for the aged and disabled
plied by them but manufactured, or- under Title XVIII of the Act.
dered, or prescribed by another indi- OIG means the Office of Inspector
vidual or entity) who request or receive General within HHS.
payment from Medicare, Medicaid, or QIO means a quality improvement
other Federal health care programs. organization as that term is used in
1117
§ 1000.10 42 CFR Ch. V (10–1–24 Edition)
section 1152 of the Act (42 U.S.C. 1320c– lotment to a State under such title
1) and its implementing regulations. (Maternal and Child Health Services
Secretary means the Secretary of the Block Grant program),
Department or his or her designees. (3) Any program receiving funds
SNF stands for skilled nursing facil- under subtitle A of Title XX of the Act
ity. or from any allotment to a State under
Social security benefits means monthly such subtitle (Block Grants to States
cash benefits payable under section 202 for Social Services), or
or 223 of the Act. (4) A State child health plan ap-
SSA stands for Social Security Ad- proved under Title XXI (Children’s
ministration. Health Insurance Program).
State includes the 50 States, the Dis-
United States means the fifty States,
trict of Columbia, Puerto Rico, the
Virgin Islands, Guam, American the District of Columbia, the Common-
Samoa, the Northern Mariana Islands, wealth of Puerto Rico, the Virgin Is-
and the Trust Territory of the Pacific lands, Guam, American Samoa, and the
Islands. Northern Mariana Islands.
State health care program means: U.S.C. stands for United States Code.
(1) A State plan approved under Title [51 FR 34766, Sept. 30, 1986, as amended at 57
XIX of the Act (Medicaid), FR 3329, Jan. 29, 1992; 63 FR 46685, Sept. 2,
(2) Any program receiving funds 1998; 66 FR 39452, July 31, 2001; 82 FR 4111,
under Title V of the Act or from an al- Jan. 12, 2017]
1118
SUBCHAPTER B—OIG AUTHORITIES
PART 1001—PROGRAM INTEG- Subpart E—Notice and Appeals

RITY—MEDICARE AND STATE 1001.2001 Notice of intent to exclude.
HEALTH CARE PROGRAMS 1001.2002 Notice of exclusion.
1001.2003 Notice of proposal to exclude.
Subpart A—General Provisions 1001.2004 Notice to State agencies.
1001.2005 Notice to State licensing agencies.
Sec.
1001.2006 Notice to others regarding exclu-
1001.1 Scope and purpose.
1001.2 Definitions. sion.
1001.2007 Appeal of exclusions.
Subpart B—Mandatory Exclusions
Subpart F—Reinstatement into the
1001.101 Basis for liability. Programs
1001.102 Length of exclusion.
1001.3001 Timing and method of request for
Subpart C—Permissive Exclusions reinstatement.
1001.3002 Basis for reinstatement.
1001.201 Conviction relating to program or
1001.3003 Approval of request for reinstate-
health care fraud.
ment.
1001.301 Conviction relating to obstruction
of an investigation or audit. 1001.3004 Denial of request for reinstate-
1001.401 Conviction relating to controlled ment.
substances. 1001.3005 Withdrawal of exclusion for re-
1001.501 License revocation or suspension. versed or vacated decisions.
1001.601 Exclusion or suspension under a AUTHORITY: 42 U.S.C. 1302; 1320a–7; 1320a–7b;
Federal or State health care program. 1395u(j); 1395u(k); 1395w–104(e)(6), 1395y(d);
1001.701 Excessive claims or furnishing of
1395y(e); 1395cc(b)(2)(D), (E), and (F); 1395hh;
unnecessary or substandard items and
1842(j)(1)(D)(iv), 1842(k)(1), and sec. 2455, Pub.
services.
L. 103–355, 108 Stat. 3327 (31 U.S.C. 6101 note).
1001.801 Failure of HMOs and CMPs to fur-
nish medically necessary items and serv- SOURCE: 57 FR 3330, Jan. 29, 1992, unless
ices. otherwise noted.
1001.901 False or improper claims.
1001.951 Fraud and kickbacks and other pro-
hibited activities. Subpart A—General Provisions
1001.952 Exceptions.
1001.1001 Exclusion of entities owned or con- § 1001.1 Scope and purpose.
trolled by a sanctioned person.
(a) The regulations in this part speci-
1001.1101 Failure to disclose certain infor-
mation. fy certain bases upon which individuals
1001.1201 Failure to provide payment infor- and entities may, or in some cases
mation. must, be excluded from participation
1001.1301 Failure to grant immediate access. in Medicare, Medicaid and all other
1001.1401 Violations of PPS corrective ac- Federal health care programs. They
tion.
also state the effect of exclusion, the
1001.1501 Default of health education loan or
scholarship obligations. factors that will be considered in deter-
1001.1551 Exclusion of individuals with own- mining the length of any exclusion, the
ership or control interest in sanctioned provisions governing notices of exclu-
entities. sions, and the process by which an ex-
1001.1552 Making false statements or mis- cluded individual or entity may seek
representation of material facts.
1001.1601 Violations of the limitations on
reinstatement into the programs.
physician charges. (b) The regulations in this part are
1001.1701 Billing for services of assistant at applicable to and binding on the Office
surgery during cataract operations. of Inspector General (OIG) in imposing
APPENDIX A TO SUBPART C OF PART 1001 and proposing exclusions, as well as to
Administrative Law Judges (ALJs), the
Subpart D—Waivers and Effect of Exclusion Departmental Appeals Board (DAB),
1001.1801 Waivers of exclusions. and federal courts in reviewing the im-
1001.1901 Scope and effect of exclusion. position of exclusions by the OIG (and,
1119
§ 1001.2 42 CFR Ch. V (10–1–24 Edition)
where applicable, in imposing exclu- Indirect ownership interest includes an

sions proposed by the OIG). ownership interest through any other
entities that ultimately have an own-
FR 5618, Jan. 22, 1993; 64 FR 39426, July 22, ership interest in the entity in issue.
1999] (For example, an individual has a 10-
percent ownership interest in the enti-
§ 1001.2 Definitions. ty at issue if he or she has a 20-percent
ownership interest in a corporation
For purposes of this part:
that wholly owns a subsidiary that is a
Agent means any person who has ex-
50-percent owner of the entity in issue.)
press or implied authority to obligate
Managing employee means an indi-
or act on behalf of an entity.
vidual (including a general manager,
Controlled substance means a drug or
business manager, administrator, or di-
other substance, or immediate pre-
rector) who exercises operational or
cursor:
managerial control over the entity or
(a) Included in schedules I, II, III, IV part thereof or directly or indirectly
or V of part B of subchapter I in 21 conducts the day-to-day operations of
U.S.C. chapter 13, or the entity or part thereof.
(b) That is deemed a controlled sub- Member of household means, with re-
stance by the law of any State. spect to a person, any individual with
Convicted means that— whom the person is sharing a common
(a) A judgment of conviction has abode as part of a single-family unit,
been entered against an individual or including domestic employees and oth-
entity by a Federal, State or local ers who live together as a family unit.
court, regardless of whether: A roomer or boarder is not considered
(1) There is a post-trial motion or an a member of household.
appeal pending, or Ownership interest means an interest
(2) The judgment of conviction or in:
other record relating to the criminal (1) The capital, the stock, or the prof-
conduct has been expunged or other- its of the entity, or
wise removed; (2) Any mortgage, deed, trust or note,
(b) A Federal, State or local court or other obligation secured in whole or
has made a finding of guilt against an in part by the property or assets of the
individual or entity; entity.
(c) A Federal, State or local court Ownership or control interest means,
has accepted a plea of guilty or nolo with respect to an entity, a person who
contendere by an individual or entity; (1) Has a direct or an indirect owner-
or ship interest (or any combination
(d) An individual or entity has en- thereof) of 5 percent or more in the en-
tered into participation in a first of- tity;
fender, deferred adjudication or other (2) Is the owner of a whole or part in-
program or arrangement where judg- terest in any mortgage, deed of trust,
ment of conviction has been withheld. note, or other obligation secured (in
HHS means Department of Health whole or in part) by the entity or any
and Human Services. of the property assets thereof, if such
Immediate family member means a per- interest is equal to or exceeds 5 percent
son’s husband or wife; natural or adop- of the total property and assets of the
tive parent; child or sibling; step- entity;
parent, stepchild, stepbrother, or step- (3) Is an officer or a director of the
sister; father-, mother-, daughter-, son- entity;
, brother- or sister-in-law; grandparent (4) Is a partner in the entity if the
or grandchild; or spouse of a grand- entity is organized as a partnership;
parent or grandchild. (5) Is an agent of the entity; or
Incarceration means imprisonment or (6) Is a managing employee of the en-
any type of confinement with or with- tity.
out supervised release, including, but Patient means any individual who is
not limited to, community confine- receiving health care items or services,
ment, house arrest and home deten- including any item or service provided
tion. to meet his or her physical, mental or
1120
Office of Inspector General—Health Care, HHS § 1001.101
emotional needs or well-being (includ- Subpart B—Mandatory Exclusions

ing a resident receiving care in a facil-
ity as described in part 483 of this chap- § 1001.101 Basis for liability.
ter), whether or not reimbursed under The OIG will exclude any individual
Medicare, Medicaid and any other Fed- or entity that—
eral health care program and regard- (a) Has been convicted of a criminal
less of the location in which such item offense related to the delivery of an
or service is provided. item or service under Medicare or a
Professionally recognized standards of State health care program, including
health care are Statewide or national the performance of management or ad-
standards of care, whether in writing ministrative services relating to the
or not, that professional peers of the delivery of items or services under any
individual or entity whose provision of such program;
(b) Has been convicted, under Federal
care is an issue, recognize as applying
or State law, of a criminal offense re-
to those peers practicing or providing
lated to the neglect or abuse of a pa-
care within a State. When the Depart- tient, in connection with the delivery
ment has declared a treatment modal- of a health care item or service, includ-
ity not to be safe and effective, practi- ing any offense that the OIG concludes
tioners who employ such a treatment entailed, or resulted in, neglect or
modality will be deemed not to meet abuse of patients (the delivery of a
professionally recognized standards of health care item or service includes
health care. This definition will not be the provision of any item or service to
construed to mean that all other treat- an individual to meet his or her phys-
ments meet professionally recognized ical, mental or emotional needs or
standards. well-being, whether or not reimbursed
Sole community physician means a under Medicare, Medicaid or any Fed-
physician who is the only physician eral health care program);
who provides primary care services to (c) Has been convicted, under Federal
Federal or State health care program or State law, of a felony that occurred
beneficiaries within a defined service after August 21, 1996, relating to fraud,
area. theft, embezzlement, breach of fidu-
Sole source of essential specialized serv- ciary responsibility, or other financial
misconduct—
ices in the community means that an in-
(1) In connection with the delivery of
dividual or entity—
a health care item or service, including
(1) Is the only practitioner, supplier the performance of management or ad-
or provider furnishing specialized serv- ministrative services relating to the
ices in an area designated by the delivery of such items or services, or
Health Resources Services Administra- (2) With respect to any act or omis-
tion as a health professional shortage sion in a health care program (other
area for that medical specialty, as list- than Medicare and a State health care
ed in 42 part 5, appendices B–F; program) operated by, or financed in
(2) Is a sole community hospital, as whole or in part, by any Federal, State
defined in § 412.92 of this title; or or local government agency; or
(3) Is the only source of specialized (d) Has been convicted, under Federal
services in a reasonably defined service or State law, of a felony that occurred
area where services by a non-specialist after August 21, 1996 relating to the un-
could not be substituted for the source lawful manufacture, distribution, pre-
without jeopardizing the health or scription or dispensing of a controlled
safety of beneficiaries. substance, as defined under Federal or
State Medicaid Fraud Control Unit State law. This applies to any indi-
vidual or entity that—
means a unit certified by the Secretary
(1) Is, or has ever been, a health care
as meeting the criteria of 42 U.S.C.
practitioner, provider, or supplier or
1396b(q) and § 1002.305 of this chapter. furnished or furnishes items or serv-
[57 FR 3330, Jan. 29, 1992, as amended at 63 ices;
FR 46686, Sept. 2, 1998; 64 FR 39426, July 22, (2) Holds, or has held, a direct or an
1999; 82 FR 4111, Jan. 12, 2017] indirect ownership or control interest
1121
§ 1001.102 42 CFR Ch. V (10–1–24 Edition)
in an entity that furnished or furnishes those that formed the basis for the ex-
items or services or is, or has ever clusion; or
been, an officer, director, agent, or (9) The individual or entity has been
managing employee of such an entity; the subject of any other adverse action
or by any Federal, State or local govern-
(3) Is, or has ever been, employed in ment agency or board if the adverse ac-
any capacity in the health care indus- tion is based on the same set of cir-
try. cumstances that serves as the basis for
the imposition of the exclusion.
(c) Only if any of the aggravating fac-
FR 11932, Mar. 18, 2002; 82 FR 4112, Jan. 12,
2017] tors set forth in paragraph (b) of this
section justifies an exclusion longer
§ 1001.102 Length of exclusion. than 5 years, may mitigating factors be
considered as a basis for reducing the
(a) No exclusion imposed in accord- period of exclusion to no less than 5
ance with § 1001.101 will be for less than years. Only the following factors may
5 years. be considered mitigating—
(b) Any of the following factors may (1) In the case of an exclusion under
be considered to be aggravating and a § 1001.101(a), whether the individual or
basis for lengthening the period of ex- entity was convicted of three or fewer
clusion— misdemeanor offenses and the entire
(1) The acts resulting in the convic- amount of financial loss (both actual
tion, or similar acts, caused, or were loss and intended loss) to Medicare or
intended to cause, a financial loss to a any other Federal, State, or local gov-
government agency or program or to ernmental health care program due to
one or more other entities of $50,000 or the acts that resulted in the convic-
more. (The entire amount of financial tion, and similar acts, is less than
loss to such government agencies or $5,000;
programs or to other entities, includ- (2) The record in the criminal pro-
ing any amounts resulting from similar ceedings, including sentencing docu-
acts not adjudicated, will be considered ments, demonstrates that the court de-
regardless of whether full or partial termined that the individual had a
restitution has been made); mental, emotional or physical condi-
(2) The acts that resulted in the con- tion before or during the commission of
viction, or similar acts, were com- the offense that reduced the individ-
mitted over a period of one year or ual’s culpability; or
more; (3) The individual’s or entity’s co-
(3) The acts that resulted in the con- operation with Federal or State offi-
viction, or similar acts, had a signifi- cials resulted in—
cant adverse physical, mental or finan- (i) Others being convicted or ex-
cial impact on one or more program cluded from Medicare, Medicaid and all
beneficiaries or other individuals; other Federal health care programs,
(4) In convictions involving patient (ii) Additional cases being inves-
abuse or neglect, the action that re- tigated or reports being issued by the
sulted in the conviction was premedi- appropriate law enforcement agency
tated, was part of a continuing pattern identifying program vulnerabilities or
of behavior, or consisted of non-consen- weaknesses, or
sual sexual acts; (iii) The imposition against anyone
(5) The sentence imposed by the of a civil money penalty or assessment
court included incarceration; under part 1003 of this chapter.
(6) The convicted individual or entity (d) In the case of an exclusion under
has a prior criminal, civil or adminis- this subpart, based on a conviction oc-
trative sanction record; curring on or after August 5, 1997, an
(7) The individual or entity has pre- exclusion will be—
viously been convicted of a criminal of- (1) For not less than 10 years if the
fense involving the same or similar cir- individual has been convicted on one
cumstances; previous occasion of one or more of-
(8) The individual or entity has been fenses for which an exclusion may be
convicted of other offenses besides effected under section 1128(a) of the
1122
Act. (The aggravating and mitigating ably could have been expected to cause,
factors in paragraphs (b) and (c) of this a financial loss of $50,000 or more to a
section can be used to impose a period government agency or program or to
of time in excess of the 10-year manda- one or more other entities or had a sig-
tory exclusion); or nificant financial impact on program
(2) Permanent if the individual has beneficiaries or other individuals. (The
been convicted on two or more previous entire amount of financial loss will be
occasions of one or more offenses for considered, including any amounts re-
which an exclusion may be effected sulting from similar acts not adju-
under section 1128(a) of the Act. dicated, regardless of whether full or
[57 FR 3330, Jan. 29, 1992, as amended at 63 partial restitution has been made);
FR 46686, Sept. 2, 1998; 63 FR 57918, Oct. 29, (ii) The acts that resulted in the con-
1998; 64 FR 39426, July 22, 1999; 67 FR 11932, viction, or similar acts, were com-
Mar. 18, 2002; 82 FR 4112, Jan. 12, 2017]
mitted over a period of one year or
more;
Subpart C—Permissive Exclusions (iii) The acts that resulted in the
§ 1001.201 Conviction relating to pro- conviction, or similar acts, had a sig-
gram or health care fraud. nificant adverse physical or mental im-
pact on one or more program bene-
(a) Circumstance for exclusion. The
ficiaries or other individuals;
OIG may exclude an individual or enti-
ty convicted under Federal or State (iv) The sentence imposed by the
law of— court included incarceration;
(1) A misdemeanor relating to fraud, (v) Whether the individual or entity
theft, embezzlement, breach of fidu- has a documented history of criminal,
ciary responsibility, or other financial civil or administrative wrongdoing; or
misconduct— (vi) Whether the individual or entity
(i) In connection with the delivery of has been convicted of other offenses be-
any health care item or service, includ- sides those that formed the basis for
ing the performance of management or the exclusion; or
administrative services relating to the (vii) Whether the individual or entity
delivery of such items or services, or has been the subject of any other ad-
(ii) With respect to any act or omis- verse action by any Federal, State, or
sion in a health care program, other local government agency or board if
than Medicare and a State health care the adverse action is based on the same
program, operated by, or financed in set of circumstances that serves as the
whole or in part by, any Federal, State basis for the imposition of the exclu-
or local government agency; or sion.
(2) Fraud, theft, embezzlement, (3) Only the following factors may be
breach of fiduciary responsibility, or considered as mitigating and a basis
other financial misconduct with re- for reducing the period of exclusion—
spect to any act or omission in a pro-
(i) The individual or entity was con-
gram, other than a health care pro-
victed of three or fewer offenses, and
gram, operated by or financed in whole
the entire amount of financial loss
or in part by any Federal, State or
local government agency. (both actual loss and reasonably ex-
(b) Length of exclusion. (1) An exclu- pected loss) to a government agency or
sion imposed in accordance with this program or to other individuals or en-
section will be for a period of 3 years, tities due to the acts that resulted in
unless aggravating or mitigating fac- the conviction and similar acts is less
tors listed in paragraphs (b)(2) and than $5,000;
(b)(3) of this section form a basis for (ii) The record in the criminal pro-
lengthening or shortening that period. ceedings, including sentencing docu-
(2) Any of the following factors may ments, demonstrates that the court de-
be considered to be aggravating and a termined that the individual had a
basis for lengthening the period of ex- mental, emotional, or physical condi-
clusion— tion, before or during the commission
(i) The acts resulting in the convic- of the offense, that reduced the individ-
tion, or similar acts, caused or reason- ual’s culpability; or
1123
§ 1001.301 42 CFR Ch. V (10–1–24 Edition)
(iii) The individual’s or entity’s co- (iv) The sentence imposed by the
operation with Federal or State offi- court included incarceration;
cials resulted in— (v) Whether the individual or entity
(A) Others being convicted or ex- has a documented history of criminal,
cluded from Medicare, Medicaid or any civil or administrative wrongdoing; or
of the other Federal health care pro- (vi) Whether the individual or entity
grams, or has been convicted of other offenses be-
(B) Additional cases being inves- sides those that formed the basis for
tigated or reports being issued by the the exclusion;
appropriate law enforcement agency (vii) Whether the individual or entity
identifying program vulnerabilities or has been the subject of any other ad-
weaknesses, or
verse action by any Federal, State or
(C) The imposition of a civil money local government agency or board if
penalty against others; or
the adverse action is based on the same
(iv) Alternative sources of the type of
set of circumstances that serves as the
health care items or services furnished
basis for the imposition of the exclu-
by the individual or entity are not
sion; or
available.
(viii) The acts resulting in the con-
[57 FR 3330, Jan. 29, 1992, as amended at 63 viction, or similar acts, caused, or rea-
FR 46687, Sept. 2, 1998; 64 FR 39426, July 22, sonably could have been expected to
1999; 67 FR 11932, Mar. 18, 2002; 67 FR 21579,
May 1, 2002; 82 FR 4112, Jan. 12, 2017]
cause, a financial loss of $50,000 or
more to a government agency or pro-
§ 1001.301 Conviction relating to ob- gram or to one or more other entities
struction of an investigation or or had a significant financial impact
audit. on program beneficiaries or other indi-
(a) Circumstance for exclusion. The viduals. (The entire amount of finan-
OIG may exclude an individual or enti- cial loss or intended loss identified in
ty that has been convicted, under Fed- the investigation or audit will be con-
eral or State law, in connection with sidered, including any amounts result-
the interference with or obstruction of ing from similar acts not adjudicated,
any investigation or audit related to— regardless of whether full or partial
(1) Any offense described in § 1001.101 restitution has been made).
or § 1001.201; or (3) Only the following factors may be
(2) The use of funds received, directly considered as mitigating and a basis
or indirectly, from any Federal health for reducing the period of exclusion—
care program. (i) The record of the criminal pro-
(b) Length of exclusion. (1) An exclu- ceedings, including sentencing docu-
sion imposed in accordance with this ments, demonstrates that the court de-
section will be for a period of three termined that the individual had a
years, unless aggravating or mitigating mental, emotional, or physical condi-
factors listed in paragraphs (b)(2) and tion, before or during the commission
(3) of this section form the basis for of the offense, that reduced the individ-
lengthening or shortening that period. ual’s culpability; or
(2) Any of the following factors may (ii) The individual’s or entity’s co-
be considered to be aggravating and a
operation with Federal or State offi-
basis for lengthening the period of ex-
cials resulted in—
clusion—
(A) Others being convicted or ex-
(i) The interference or obstruction
caused the expenditure of significant cluded from Medicare, Medicaid and all
additional time or resources; other Federal health care programs,
(ii) The interference or obstruction (B) Additional cases being inves-
had a significant adverse physical or tigated or reports being issued by the
mental impact on one or more program appropriate law enforcement agency
beneficiaries or other individuals; identifying program vulnerabilities or
(iii) The interference or obstruction weaknesses, or
also affected a civil or administrative (C) The imposition of a civil money
investigation; penalty against others; or
1124
(iii) Alternative sources of the type (iv) Whether the individual or entity
of health care items or services fur- has a documented history of criminal,
nished by the individual or entity are civil, or administrative wrongdoing;
not available. (v) Whether the individual or entity
[57 FR 3329, Jan. 29, 1992; 57 FR 9669, Mar. 20, has been convicted of other offenses be-
1992; 63 FR 46687, Sept. 2, 1998; 64 FR 39426, sides those that formed the basis for
July 22, 1999; 82 FR 4112, Jan. 12, 2017] the exclusion; or
(vi) Whether the individual or entity
§ 1001.401 Conviction relating to con-
trolled substances. has been the subject of any other ad-
verse action by any Federal, State, or
(a) Circumstance for exclusion. The local government agency or board if
OIG may exclude an individual or enti- the adverse action is based on the same
ty convicted under Federal or State
set of circumstances that serves as the
law of a misdemeanor relating to the
basis for the imposition of the exclu-
unlawful manufacture, distribution,
sion.
prescription, or dispensing of a con-
trolled substance, as defined under (3) Only the following factor may be
Federal or State law. This section ap- considered to be mitigating and to be a
plies to any individual or entity that— basis for shortening the period of ex-
(1) Is, or has ever been, a health care clusion: The individual’s or entity’s co-
practitioner, provider, or supplier or operation with Federal or State offi-
furnished or furnishes items or serv- cials resulted in—
ices; (i) Others being convicted or ex-
(2) Holds, or held, a direct or indirect cluded from Medicare, Medicaid, and
ownership or control interest in an en- any other Federal health care program;
tity that furnished or furnishes items (ii) Additional cases being inves-
or services or is or has ever been an of- tigated or reports being issued by the
ficer, director, agent, or managing em- appropriate law enforcement agency
ployee of such an entity; or identifying program vulnerabilities or
(3) Is, or has ever been, employed in weaknesses; or
any capacity in the health care indus-
(iii) The imposition of a civil money
try.
penalty against others.
(b) For purposes of this section, the
definition of controlled substance will be [57 FR 3330, Jan. 29, 1992, as amended at 63
the definition that applies to the law FR 46687, Sept. 2, 1998; 64 FR 39426, July 22,
forming the basis for the conviction. 1999; 82 FR 4113, Jan. 12, 2017]
(c) Length of exclusion. (1) An exclu-
sion imposed in accordance with this § 1001.501 License revocation or sus-
section will be for a period of 3 years, pension.
unless aggravating or mitigating fac- (a) Circumstance for exclusion. The
tors listed in paragraphs (c)(2) and (3) OIG may exclude an individual or enti-
of this section form a basis for length- ty that has—
ening or shortening that period. (1) Had a license to provide health
(2) Any of the following factors may care revoked or suspended by any State
be considered to be aggravating and to
licensing authority, or has otherwise
be a basis for lengthening the period of
lost such a license (including the right
exclusion—
to apply for or renew such a license),
(i) The acts that resulted in the con-
viction or similar acts were committed for reasons bearing on the individual’s
over a period of one year or more; or entity’s professional competence,
(ii) The acts that resulted in the con- professional performance or financial
viction or similar acts had a signifi- integrity; or
cant adverse mental, physical or finan- (2) Has surrendered such a license
cial impact on program beneficiaries or while a formal disciplinary proceeding
other individuals or the Medicare, Med- concerning the individual’s or entity’s
icaid or other Federal health care pro- professional competence, professional
grams; performance or financial integrity was
(iii) The sentence imposed by the pending before a State licensing au-
court included incarceration; thority.
1125
§ 1001.501 42 CFR Ch. V (10–1–24 Edition)
(b) Length of exclusion. (1) Except as (i) The individual or entity obtains
provided in paragraph (b)(2) of this sec- the license in the State where the li-
tion, an exclusion imposed in accord- cense was originally revoked, sus-
ance with this section will not be for a pended, surrendered, or otherwise lost
period of time less than the period dur- or
ing which an individual’s or entity’s li- (ii) The individual meets the condi-
cense is revoked, suspended, or other- tions for early reinstatement set forth
wise not in effect as a result of, or in in paragraph (c) of this section.
connection with, a State licensing (c) Consideration of early reinstate-
agency action. ment. (1) If an individual or entity that
(2) Any of the following factors may is excluded in accordance with this sec-
be considered aggravating and a basis tion fully and accurately discloses the
for lengthening the period of exclu- circumstances surrounding the action
sion— that formed the basis for the exclusion
(i) The acts that resulted in the rev- to a licensing authority of a different
ocation, suspension or loss of the indi- State or to a different licensing au-
vidual’s or entity’s license to provide thority in the same State and that li-
health care had or could have had a censing authority grants the individual
significant adverse physical, emotional or entity a new health care license or
or financial impact on one or more pro- has decided to take no adverse action
gram beneficiaries or other individuals; as to a currently held health care li-
cense, the OIG will consider a request
(ii) Whether the individual or entity
for early reinstatement. The OIG will
has a documented history of criminal,
consider the following factors in deter-
civil or administrative wrongdoing;
mining whether a request for early re-
(iii) The acts, or similar acts, had or instatement under this paragraph (c)(1)
could have had a significant adverse will be granted:
impact on the financial integrity of the (i) The circumstances that formed
programs; or the basis for the exclusion;
(iv) The individual or entity has been (ii) Whether the second licensing au-
the subject of any other adverse action thority is in a state that is not the in-
by any other Federal, State or local dividual’s primary place of practice;
government agency or board, if the ad- (iii) Evidence that the second licens-
verse action is based on the same set of ing authority was aware of the cir-
circumstances that serves as the basis cumstances surrounding the action
for the imposition of the exclusion. that formed the basis for the exclusion;
(3) Only if any of the aggravating fac- (iv) Whether the individual has dem-
tors listed in paragraph (b)(2) of this onstrated that he or she has satisfac-
section justifies a longer exclusion torily resolved any underlying problem
may a mitigating factor be considered that caused or contributed to the basis
as a basis for reducing the period of ex- for the initial licensing action;
clusion to a period not less than that (v) The benefits to the Federal health
set forth in paragraph (b)(1) of this sec- care programs and program bene-
tion. Only the following factor may be ficiaries of early reinstatement;
considered mitigating: The individual’s (vi) The risks to the Federal health
or entity’s cooperation with a State li- care programs and program bene-
censing authority resulted in— ficiaries of early reinstatement;
(i) The sanctioning of other individ- (vii) Any additional or pending li-
uals or entities, or cense actions in any State;
(ii) Additional cases being inves- (viii) Any ongoing investigations in-
tigated or reports being issued by the volving the individual; and
appropriate law enforcement agency (ix) All the factors set forth in
identifying program vulnerabilities or § 1001.3002(b).
weaknesses. (2) If an exclusion has been imposed
(4) When an individual or entity has under this section and the individual
been excluded under this section, the does not have a valid health care li-
OIG will consider a request for rein- cense of any kind in any State, that in-
statement in accordance with dividual may request the OIG to con-
§ 1001.3001 if: sider whether he or she may be eligible
1126
for early reinstatement. The OIG will (i) Any Federal program involving
consider the following factors in deter- the provision of health care, or
mining whether a request for early re- (ii) A State health care program, for
instatement under this paragraph (c)(2) reasons bearing on the individual’s or
will be granted: entity’s professional competence, pro-
(i) The length of time the individual fessional performance or financial in-
has been excluded. The OIG will apply tegrity.
a presumption against early reinstate- (2) The term ‘‘or otherwise sanc-
ment under paragraph (c)(2) of this sec- tioned’’ in paragraph (a)(1) of this sec-
tion if the person has been excluded for tion is intended to cover all actions
less than 3 years; however, if the rev- that limit the ability of a person to
ocation or suspension on which the ex- participate in the program at issue re-
clusion is based was for a set period gardless of what such an action is
longer than 3 years, the presumption called, and includes situations where
against early reinstatement will be co- an individual or entity voluntarily
terminous with the period set by the li- withdraws from a program to avoid a
censing board; formal sanction.
(ii) The circumstances that formed (b) Length of exclusion. (1) An exclu-
the basis for the exclusion; sion imposed in accordance with this
(iii) Whether the individual has dem- section will not be for a period of time
onstrated that he or she has satisfac- less than the period during which the
torily resolved any underlying problem individual or entity is excluded or sus-
that caused or contributed to the basis pended from a Federal or State health
for the initial licensing action; care program.
(iv) The benefits to the Federal (2) Any of the following factors may
health care programs and program be considered aggravating and a basis
beneficiaries of early reinstatement; for lengthening the period of exclu-
(v) The risks to the Federal health sion—
care programs and program bene- (i) The acts that resulted in the ex-
ficiaries of early reinstatement; clusion, suspension or other sanction
(vi) Any additional or pending license under Medicare, Medicaid and all other
actions in any State; Federal health care programs had, or
could have had, a significant adverse
(vii) Any ongoing investigations in-
impact on Federal or State health care
volving the individual; and
programs or the beneficiaries of those
(viii) All the factors set forth in programs or other individuals;
§ 1001.3002(b). (ii) Whether the individual or entity
(3) Notwithstanding paragraphs (c)(1) has a documented history of criminal,
and (2) of this section, if an individual’s civil or administrative wrongdoing; or
license revocation or suspension was (iii) The individual or entity has been
for reasons related to patient abuse or the subject of any other adverse action
neglect, the OIG will not consider an by any Federal, State or local govern-
application for early reinstatement. ment agency or board, if the adverse
(4) Except for § 1001.3002(a)(1)(i), all action is based on the same set of cir-
the provisions of subpart F (§§ 1001.3001 cumstances that serves as the basis for
through 1001.3005) apply to early rein- the imposition of the exclusion.
statements under this section. (3) Only if any of the aggravating fac-
[57 FR 3330, Jan. 29, 1992, as amended at 63 tors listed in paragraph (b)(2) of this
FR 46688, Sept. 2, 1998; 82 FR 4113, Jan. 12, section justifies a longer exclusion
2017] may a mitigating factor be considered
as a basis for reducing the period of ex-
§ 1001.601 Exclusion or suspension clusion to a period not less than that
under a Federal or State health set forth in paragraph (b)(1) of this sec-
care program. tion. Only the following factor may be
(a) Circumstance for exclusion. (1) The considered mitigating: The individual’s
OIG may exclude an individual or enti- or entity’s cooperation with Federal or
ty suspended or excluded from partici- State officials resulted in—
pation, or otherwise sanctioned, (i) The sanctioning of other individ-
under— uals or entities, or
1127
§ 1001.701 42 CFR Ch. V (10–1–24 Edition)
(ii) Additional cases being inves- (c) Exceptions. An individual or enti-

tigated or reports being issued by the ty will not be excluded for—
appropriate law enforcement agency (1) Submitting, or causing to be sub-
identifying program vulnerabilities or mitted, bills or requests for payment
weaknesses. that contain charges or costs substan-
(4) If the individual or entity is eligi- tially in excess of usual charges or
ble to apply for reinstatement in ac- costs when such charges or costs are
cordance with § 1001.3001 and the sole due to unusual circumstances or med-
reason why the State or Federal health ical complications requiring additional
care program denied reinstatement to time, effort, expense or other good
that program is the existing exclusion cause; or
imposed by the OIG as a result of the (2) Furnishing, or causing to be fur-
original State or Federal health care nished, items or services in excess of
program action, the OIG will consider a the needs of patients, when the items
request for reinstatement. or services were ordered by a physician
[57 FR 3330, Jan. 29, 1992, as amended at 63 or other authorized individual, and the
FR 46688, Sept. 2, 1998; 82 FR 4114, Jan. 12, individual or entity furnishing the
2017] items or services was not in a position
to determine medical necessity or to
§ 1001.701 Excessive claims or fur- refuse to comply with the order of the
nishing of unnecessary or sub-
standard items and services. physician or other authorized indi-
vidual.
(a) Circumstance for exclusion. The (d) Length of exclusion. (1) An exclu-
OIG may exclude an individual or enti- sion imposed in accordance with this
ty that has— section will be for a period of 3 years,
(1) Submitted, or caused to be sub- unless aggravating or mitigating fac-
mitted, bills or requests for payments tors set forth in paragraphs (d)(2) and
under Medicare or any of the State (d)(3) of this section form a basis for
health care programs containing lengthening or shortening the period.
charges or costs for items or services In no case may the period be shorter
furnished that are substantially in ex- than 1 year for any exclusion taken in
cess of such individual’s or entity’s accordance with paragraph (a)(2) of
usual charges or costs for such items or this section.
services; or
(2) Any of the following factors may
(2) Furnished, or caused to be fur-
be considered aggravating and a basis
nished, to patients (whether or not cov-
for lengthening the period of exclu-
ered by Medicare or any of the State
sion—
health care programs) any items or
services substantially in excess of the (i) The violations were serious in na-
patient’s needs, or of a quality that ture, and occurred over a period of one
fails to meet professionally recognized year or more;
standards of health care. (ii) The violations had a significant
(b) The OIG’s determination under adverse physical, mental or financial
paragraph (a)(2) of this section—that impact on program beneficiaries or
the items or services furnished were ex- other individuals;
cessive or of unacceptable quality—will (iii) Whether the individual or entity
be made on the basis of information, has a documented history of criminal,
including sanction reports, from the civil or administrative wrongdoing;
following sources: (iv) The violation resulted in finan-
(1) The QIO for the area served by the cial loss to Medicare, Medicaid, or any
individual or entity; other Federal health care program of
(2) State or local licensing or certifi- $15,000 or more; or
cation authorities; (v) The individual or entity has been
(3) Fiscal agents or contractors, or the subject of any other adverse action
private insurance companies; by any Federal, State or local govern-
(4) State or local professional soci- ment agency or board, if the adverse
eties; or action is based on the same set of cir-
(5) Any other sources deemed appro- cumstances that serves as the basis for
priate by the OIG. the imposition of the exclusion.
1128
(3) Only the following factor may be (6) Any other sources deemed appro-
considered mitigating and a basis for priate by the OIG.
reducing the period of exclusion: (c) Length of exclusion. (1) An exclu-
Whether there were few violations and sion imposed in accordance with this
they occurred over a short period of section will be for a period of 3 years,
time. unless aggravating or mitigating fac-
[57 FR 3330, Jan. 29, 1992, as amended at 63 tors set forth in paragraphs (c)(2) and
FR 46688, Sept. 2, 1998; 82 FR 4114, Jan. 12, (c)(3) of this section form a basis for
2017] lengthening or shortening the period.
(2) Any of the following factors may
§ 1001.801 Failure of HMOs and CMPs be considered aggravating and a basis
to furnish medically necessary for lengthening the period of exclu-
items and services. sion—
(a) Circumstances for exclusion. The (i) The entity failed to provide a
OIG may exclude an entity— large number or a variety of items or
(1) That is a— services;
(i) Health maintenance organization (ii) The failures occurred over a
(HMO), as defined in section 1903(m) of lengthy period of time;
the Act, providing items or services (iii) The entity’s failure to provide a
under a State Medicaid Plan; necessary item or service that had or
(ii) Primary care case management could have had a serious adverse effect;
system providing services, in accord- (iv) Whether the individual or entity
ance with a waiver approved under sec- has a documented history of criminal,
tion 1915(b)(1) of the Act; or civil or administrative wrongdoing; or
(iii) HMO or competitive medical (v) The individual or entity has been
plan providing items or services in ac- the subject of any other adverse action
cordance with a risk-sharing contract by any Federal, State or local govern-
under section 1876 of the Act; ment agency or board, if the adverse
(2) That has failed substantially to action is based on the same set of cir-
provide medically necessary items and cumstances that serves as the basis for
services that are required under a plan, the imposition of the exclusion.
waiver or contract described in para- (3) Only the following factors may be
graph (a)(1) of this section to be pro- considered as mitigating and a basis
vided to individuals covered by such for reducing the period of exclusion—
plan, waiver or contract; and (i) There were few violations and
(3) Where such failure has adversely they occurred over a short period of
affected or has a substantial likelihood time; or
of adversely affecting covered individ-
(ii) The entity took corrective action
uals.
upon learning of impermissible activi-
(b) The OIG’s determination under
ties by an employee or contractor.
paragraph (a)(2) of this section—that
the medically necessary items and [57 FR 3330, Jan. 29, 1992, as amended at 63
services required under law or contract FR 46688, Sept. 2, 1998; 82 FR 4114, Jan. 12,
were not provided—will be made on the 2017]
basis of information, including sanc-
tion reports, from the following § 1001.901 False or improper claims.
sources: (a) Circumstance for exclusion. The
(1) The QIO or other quality assur- OIG may exclude any individual or en-
ance organization under contract with tity that it determines has committed
a State Medicaid plan for the area an act described in section 1128A of the
served by the HMO or competitive med- Act. The imposition of a civil money
ical plan; penalty or assessment is not a pre-
(2) State or local licensing or certifi- requisite for an exclusion under this
cation authorities; section.
(3) Fiscal agents or contractors, or (b) Length of exclusion. In deter-
private insurance companies; mining the length of an exclusion im-
(4) State or local professional soci- posed in accordance with this section,
eties; the OIG will consider the following fac-
(5) CMS’s HMO compliance office; or tors—
1129
§ 1001.951 42 CFR Ch. V (10–1–24 Edition)
(1) The nature and circumstances termining the length of exclusion in

surrounding the actions that are the accordance with this section—
basis for liability, including the period (i) The nature and circumstances of
of time over which the acts occurred, the acts and other similar acts;
the number of acts, whether there is (ii) The nature and extent of any ad-
evidence of a pattern and the amount verse physical, mental, financial or
claimed; other impact the conduct had on pro-
(2) The degree of culpability; gram beneficiaries or other individuals
(3) Whether the individual or entity or the Medicare, Medicaid and all other
has a documented history of criminal, Federal health care programs;
civil or administrative wrongdoing (iii) Whether the individual or entity
(The lack of any prior record is to be has a documented history of criminal,
considered neutral); civil or administrative wrongdoing
(4) The individual or entity has been (The lack of any prior record is to be
the subject of any other adverse action considered neutral);
by any Federal, State or local govern- (iv) The individual or entity has been
ment agency or board, if the adverse the subject of any other adverse action
action is based on the same set of cir- by any Federal, State or local govern-
cumstances that serves as the basis for ment agency or board, if the adverse
the imposition of the exclusion; or action is based on the same set of cir-
(5) Other matters as justice may re- cumstances that serves as the basis for
quire. the imposition of the exclusion; or
(c) Limitations. The OIG may not im- (v) Any other facts bearing on the na-
pose an exclusion under this section ture and seriousness of the individual’s
more than 10 years after the date when or entity’s misconduct.
an act which is described in section (2) It will be considered a mitigating
1128A of the Act occurred. factor if—
(i) The individual had a documented
FR 46689, Sept. 2, 1998; 82 FR 4114, Jan. 12,
mental, emotional, or physical condi-
2017] tion before or during the commission of
the prohibited act(s) that reduced the
§ 1001.951 Fraud and kickbacks and individual’s culpability for the acts in
other prohibited activities. question; or
(a) Circumstance for exclusion. (1) Ex- (ii) The individual’s or entity’s co-
cept as provided for in paragraph operation with Federal or State offi-
(a)(2)(ii) of this section, the OIG may cials resulted in the—
exclude any individual or entity that it (A) Sanctioning of other individuals
determines has committed an act de- or entities, or
scribed in section 1128B(b) of the Act. (B) Imposition of a civil money pen-
(2) With respect to acts described in alty against others.
section 1128B of the Act, the OIG— (c) Limitations. The OIG may not im-
(i) May exclude any individual or en- pose an exclusion under this section
tity that it determines has knowingly more than 10 years after the date when
and willfully solicited, received, offered an act which is described in section
or paid any remuneration in the man- 1128B(b) of the Act occurred.
ner and for the purposes described [57 FR 3330, Jan. 29, 1992, as amended at 63
therein, irrespective of whether the in- FR 46689, Sept. 2, 1998; 67 FR 11933, Mar. 18,
dividual or entity may be able to prove 2002; 82 FR 4114, Jan. 12, 2017]
that the remuneration was also in-
tended for some other purpose; and § 1001.952 Exceptions.
(ii) Will not exclude any individual or The following payment practices
entity if that individual or entity can shall not be treated as a criminal of-
prove that the remuneration that is fense under section 1128B of the Act
the subject of the exclusion is exempt- and shall not serve as the basis for an
ed from serving as the basis for an ex- exclusion:
clusion. (a) Investment interests. As used in
(b) Length of exclusion. (1) The fol- section 1128B of the Act, ‘‘remunera-
lowing factors will be considered in de- tion’’ does not include any payment
1130
that is a return on an investment in- lowing eight applicable standards must

terest, such as a dividend or interest be met—
income, made to an investor as long as (i) No more than 40 percent of the
all of the applicable standards are met value of the investment interests of
within one of the following three cat- each class of investment interests may
egories of entities: be held in the previous fiscal year or
(1) If, within the previous fiscal year previous 12 month period by investors
or previous 12 month period, the entity who are in a position to make or influ-
possesses more than $50,000,000 in ence referrals to, furnish items or serv-
undepreciated net tangible assets ices to, or otherwise generate business
(based on the net acquisition cost of for the entity. (For purposes of para-
purchasing such assets from an unre- graph (a)(2)(i) of this section, equiva-
lated entity) related to the furnishing lent classes of equity investments may
of health care items and services, all of be combined, and equivalent classes of
the following five standards must be debt instruments may be combined.)
met— (ii) The terms on which an invest-
(i) With respect to an investment in- ment interest is offered to a passive in-
terest that is an equity security, the vestor, if any, who is in a position to
equity security must be registered with make or influence referrals to, furnish
the Securities and Exchange Commis- items or services to, or otherwise gen-
sion under 15 U.S.C. 781 (b) or (g). erate business for the entity must be
(ii) The investment interest of an inno different from the terms offered to
vestor in a position to make or influ- other passive investors.
ence referrals to, furnish items or serv- (iii) The terms on which an invest-
ices to, or otherwise generate business ment interest is offered to an investor
for the entity must be obtained on who is in a position to make or influ-
terms (including any direct or indirect ence referrals to, furnish items or serv-
transferability restrictions) and at a ices to, or otherwise generate business
price equally available to the public for the entity must not be related to
when trading on a registered securities the previous or expected volume of re-
exchange, such as the New York Stock ferrals, items or services furnished, or
Exchange or the American Stock Ex- the amount of business otherwise gen-
change, or in accordance with the Na- erated from that investor to the entity.
tional Association of Securities Deal- (iv) There is no requirement that a
ers Automated Quotation System. passive investor, if any, make referrals
(iii) The entity or any investor must to, be in a position to make or influ-
not market or furnish the entity’s ence referrals to, furnish items or serv-
items or services (or those of another ices to, or otherwise generate business
entity as part of a cross referral agree- for the entity as a condition for re-
ment) to passive investors differently maining as an investor.
than to non-investors. (v) The entity or any investor must
(iv) The entity or any investor (or not market or furnish the entity’s
other individual or entity acting on be- items or services (or those of another
half of the entity or any investor in the entity as part of a cross referral agree-
entity) must not loan funds to or guar- ment) to passive investors differently
antee a loan for an investor who is in a than to non-investors.
position to make or influence referrals (vi) No more than 40 percent of the
to, furnish items or services to, or oth- entity’s gross revenue related to the
erwise generate business for the entity furnishing of health care items and
if the investor uses any part of such services in the previous fiscal year or
loan to obtain the investment interest. previous 12-month period may come
(v) The amount of payment to an in- from referrals or business otherwise
vestor in return for the investment in- generated from investors.
terest must be directly proportional to (vii) The entity or any investor (or
the amount of the capital investment other individual or entity acting on be-
of that investor. half of the entity or any investor in the
(2) If the entity possesses investment entity) must not loan funds to or guar-
interests that are held by either active antee a loan for an investor who is in a
or passive investors, all of the fol- position to make or influence referrals
1131
§ 1001.952 42 CFR Ch. V (10–1–24 Edition)
to, furnish items or services to, or oth- ment) to passive investors differently
erwise generate business for the entity than to non-investors.
if the investor uses any part of such (F) At least 75 percent of the dollar
loan to obtain the investment interest. volume of the entity’s business in the
(viii) The amount of payment to an previous fiscal year or previous 12-
investor in return for the investment month period must be derived from the
interest must be directly proportional service of persons who reside in an un-
to the amount of the capital invest- derserved area or are members of medi-
ment (including the fair market value cally underserved populations.
of any pre-operational services ren- (G) The entity or any investor (or
dered) of that investor. other individual or entity acting on be-
(3)(i) If the entity possesses invest- half of the entity or any investor in the
ment interests that are held by either entity) must not loan funds to or guar-
active or passive investors and is lo- antee a loan for an investor who is in a
cated in an underserved area, all of the position to make or influence referrals
following eight standards must be to, furnish items or services to, or oth-
met— erwise generate business for the entity
(A) No more than 50 percent of the if the investor uses any part of such
value of the investment interests of loan to obtain the investment interest.
each class of investments may be held (H) The amount of payment to an in-
in the previous fiscal year or previous vestor in return for the investment in-
12-month period by investors who are terest must be directly proportional to
in a position to make or influence re- the amount of the capital investment
ferrals to, furnish items or services to, (including the fair market value of any
or otherwise generate business for, the pre-operational services rendered) of
entity. (For purposes of paragraph that investor.
(a)(3)(i)(A) of this section, equivalent (ii) If an entity that otherwise meets
classes of equity investments may be all of the above standards is located in
combined, and equivalent classes of an area that was an underserved area
debt instruments may be combined.) at the time of the initial investment,
(B) The terms on which an invest- but subsequently ceases to be an under-
ment interest is offered to a passive in- served area, the entity will be deemed
vestor, if any, who is in a position to to comply with paragraph (a)(3)(i) of
make or influence referrals to, furnish this section for a period equal to the
items or services to, or otherwise gen- lesser of:
erate business for the entity must be (A) The current term of the invest-
no different from the terms offered to ment remaining after the date upon
other passive investors. which the area ceased to be an under-
(C) The terms on which an invest- served area or
ment interest is offered to an investor (B) Three years from the date the
who is in a position to make or influ- area ceased to be an underserved area.
ence referrals to, furnish items or serv- (4) For purposes of paragraph (a) of
ices to, or otherwise generate business this section, the following terms apply.
for the entity must not be related to Active investor means an investor either
the previous or expected volume of re- who is responsible for the day-to-day
ferrals, items or services furnished, or management of the entity and is a
the amount of business otherwise gen- bona fide general partner in a partner-
erated from that investor to the entity. ship under the Uniform Partnership
(D) There is no requirement that a Act or who agrees in writing to under-
passive investor, if any, make referrals take liability for the actions of the en-
to, be in a position to make or influ- tity’s agents acting within the scope of
ence referrals to, furnish items or serv- their agency. Investment interest means
ices to, or otherwise generate business a security issued by an entity, and may
for the entity as a condition for re- include the following classes of invest-
maining as an investor. ments: shares in a corporation, inter-
(E) The entity or any investor must ests or units in a partnership or lim-
not market or furnish the entity’s ited liability company, bonds, deben-
items or services (or those of another tures, notes, or other debt instruments.
entity as part of a cross-referral agree- Investor means an individual or entity
1132
either who directly holds an invest- the rental. Note that for purposes of
ment interest in an entity, or who paragraph (b) of this section, the term
holds such investment interest indi- fair market value means the value of the
rectly by, including but not limited to, rental property for general commercial
such means as having a family member purposes, but shall not be adjusted to
hold such investment interest or hold- reflect the additional value that one
ing a legal or beneficial interest in an- party (either the prospective lessee or
other entity (such as a trust or holding lessor) would attribute to the property
company) that holds such investment as a result of its proximity or conven-
interest. Passive investor means an in- ience to sources of referrals or business
vestor who is not an active investor, otherwise generated for which payment
such as a limited partner in a partner- may be made in whole or in part under
ship under the Uniform Partnership Medicare, Medicaid and all other Fed-
Act, a shareholder in a corporation, or eral health care programs.
a holder of a debt security. Underserved (c) Equipment rental. As used in sec-
area means any defined geographic area tion 1128B of the Act, ‘‘remuneration’’
that is designated as a Medically Un- does not include any payment made by
derserved Area (MUA) in accordance a lessee of equipment to the lessor of
with regulations issued by the Depart- the equipment for the use of the equip-
ment. Medically underserved population ment, as long as all of the following six
means a Medically Underserved Popu- standards are met—
lation (MUP) in accordance with regu- (1) The lease agreement is set out in
lations issued by the Department. writing and signed by the parties.
(b) Space rental. As used in section (2) The lease covers all of the equip-
1128B of the Act, ‘‘remuneration’’ does ment leased between the parties for the
not include any payment made by a term of the lease and specifies the
lessee to a lessor for the use of prem- equipment covered by the lease.
ises, as long as all of the following six (3) If the lease is intended to provide
standards are met— the lessee with use of the equipment
(1) The lease agreement is set out in for periodic intervals of time, rather
writing and signed by the parties. than on a full-time basis for the term
(2) The lease covers all of the prem- of the lease, the lease specifies exactly
ises leased between the parties for the the schedule of such intervals, their
term of the lease and specifies the precise length, and the exact rent for
premises covered by the lease. such interval.
(3) If the lease is intended to provide (4) The term of the lease is for not
the lessee with access to the premises less than one year.
for periodic intervals of time, rather (5) The aggregate rental charge is set
than on a full-time basis for the term in advance, is consistent with fair mar-
of the lease, the lease specifies exactly ket value in arms-length transactions
the schedule of such intervals, their and is not determined in a manner that
precise length, and the exact rent for takes into account the volume or value
such intervals. of any referrals or business otherwise
(4) The term of the lease is for not generated between the parties for
less than one year. which payment may be made in whole
(5) The aggregate rental charge is set or in part under Medicare, Medicaid or
in advance, is consistent with fair mar- all other Federal health care programs.
ket value in arms-length transactions (6) The aggregate equipment rental
and is not determined in a manner that does not exceed that which is reason-
takes into account the volume or value ably necessary to accomplish the com-
of any referrals or business otherwise mercially reasonable business purpose
generated between the parties for of the rental. Note that for purposes of
which payment may be made in whole paragraph (c) of this section, the term
or in part under Medicare, Medicaid or fair market value means that the value
other Federal health care programs. of the equipment when obtained from a
(6) The aggregate space rented does manufacturer or professional dis-
not exceed that which is reasonably tributor, but shall not be adjusted to
necessary to accomplish the commer- reflect the additional value one party
cially reasonable business purpose of (either the prospective lessee or lessor)
1133
§ 1001.952 42 CFR Ch. V (10–1–24 Edition)
would attribute to the equipment as a (B) Have benchmarks that are used
result of its proximity or convenience to quantify:
to sources of referrals or business oth- (1) Improvements in, or the mainte-
erwise generated for which payment nance of improvements in, the quality
may be made in whole or in part under of patient care;
Medicare, Medicaid or other Federal (2) A material reduction in costs to
health care programs. or growth in expenditures of payors
(d) Personal services and management while maintaining or improving qual-
contracts and outcomes-based payment ity of care for patients; or
arrangements. (1) As used in section (3) Both.
1128B of the Act, ‘‘remuneration’’ does (ii) The methodology for determining
not include any payment made by a the aggregate compensation (including
principal to an agent as compensation any outcomes-based payments) paid be-
for the services of the agent, as long as tween or among the parties over the
all of the following standards are met: term of the agreement is: Set in ad-
(i) The agency agreement is set out vance; commercially reasonable; con-
in writing and signed by the parties. sistent with fair market value; and not
(ii) The agency agreement covers all determined in a manner that directly
of the services the agent provides to takes into account the volume or value
the principal for the term of the agree- of any referrals or business otherwise
ment and specifies the services to be generated between the parties for
provided by the agent. which payment may be made in whole
(iii) The term of the agreement is not or in part by a Federal health care pro-
less than 1 year. gram.
(iv) The methodology for deter- (iii) The agreement between the par-
mining the compensation paid to the ties is set out in writing and signed by
agent over the term of the agreement the parties in advance of, or contem-
is set in advance, is consistent with poraneous with, the commencement of
fair market value in arm’s-length the terms of the outcomes-based pay-
transactions, and is not determined in ment arrangement. The writing states
a manner that takes into account the at a minimum: A general description of
volume or value of any referrals or the services to be performed by the
business otherwise generated between parties for the term of the agreement;
the parties for which payment may be the outcome measure(s) the agent must
made in whole or in part under Medi- achieve to receive an outcomes-based
care, Medicaid, or other Federal health payment; the clinical evidence or cred-
care programs. ible medical support relied upon by the
(v) The services performed under the parties to select the outcome meas-
agreement do not involve the coun- ure(s); and the schedule for the parties
seling or promotion of a business ar- to regularly monitor and assess the
rangement or other activity that vio- outcome measure(s).
lates any State or Federal law. (iv) The agreement neither limits
(vi) The aggregate services con- any party’s ability to make decisions
tracted for do not exceed those which in their patients’ best interest nor in-
are reasonably necessary to accomplish duces any party to reduce or limit
the commercially reasonable business medically necessary items or services.
purpose of the services. (v) The term of the agreement is not
(2) As used in section 1128B of the less than 1 year.
Act, ‘‘remuneration’’ does not include (vi) The services performed under the
any outcomes-based payment as long agreement do not involve the coun-
as all of the standards in paragraphs seling or promotion of a business ar-
(d)(2)(i) through (viii) of this section rangement or other activity that vio-
are met: lates any State or Federal law.
(i) To receive an outcomes-based pay- (vii) For each outcome measure
ment, the agent achieves one or more under the agreement, the parties:
legitimate outcome measures that: (A) Regularly monitor and assess the
(A) Are selected based on clinical evi- agent’s performance, including the im-
dence or credible medical support; and pact of the outcomes-based payment
1134
arrangement on patient quality of (B) Related solely to the achieve-

care; and ment of internal cost savings for the
(B) Periodically assess, and as nec- principal; or
essary revise, benchmarks and remu- (C) Based solely on patient satisfac-
neration under the arrangement to en- tion or patient convenience measures.
sure that the remuneration is con- (e) Sale of practice. (1) As used in sec-
sistent with fair market value in an tion 1128B of the Act, ‘‘remuneration’’
arm’s length transaction as required by does not include any payment made to
paragraph (d)(2)(ii) of this section dur- a practitioner by another practitioner
ing the term of the agreement. where the former practitioner is selling
(viii) The principal has policies and his or her practice to the latter practi-
procedures to promptly address and tioner, as long as both of the following
correct identified material perform- two standards are met—
ance failures or material deficiencies (i) The period from the date of the
in quality of care resulting from the first agreement pertaining to the sale
outcomes-based payment arrangement. to the completion of the sale is not
(3) For purposes of this paragraph (d): more than one year.
(i) An agent of a principal is any per- (ii) The practitioner who is selling
son other than a bona fide employee of his or her practice will not be in a pro-
the principal who has an agreement to fessional position to make referrals to,
perform services for or on behalf of the or otherwise generate business for, the
principal. purchasing practitioner for which pay-
(ii) Outcomes-based payments are ment may be made in whole or in part
limited to payments between or among under Medicare, Medicaid or other Fed-
a principal and an agent that: eral health care programs after 1 year
(A) Reward the agent for successfully from the date of the first agreement
achieving an outcome measure de- pertaining to the sale.
scribed in paragraph (d)(2)(i) of this (2) As used in section 1128B of the
section; or Act, ‘‘remuneration’’ does not include
(B) Recoup from or reduce payment any payment made to a practitioner by
to an agent for failure to achieve an a hospital or other entity where the
outcome measure described in para- practitioner is selling his or her prac-
graph (d)(2)(i) of this section. tice to the hospital or other entity, so
(iii) Outcomes-based payments ex- long as the following four standards
clude any payments: are met:
(A) Made directly or indirectly by the (i) The period from the date of the
following entities: first agreement pertaining to the sale
(1) A pharmaceutical manufacturer, to the completion date of the sale is
distributor, or wholesaler; not more than three years.
(2) A pharmacy benefit manager; (ii) The practitioner who is selling
(3) A laboratory company; his or her practice will not be in a pro-
(4) A pharmacy that primarily com- fessional position after completion of
pounds drugs or primarily dispenses the sale to make or influence referrals
compounded drugs; to, or otherwise generate business for,
(5) A manufacturer of a device or the purchasing hospital or entity for
medical supply as defined in paragraph which payment may be made under
(ee)(14)(iv) of this section; Medicare, Medicaid or other Federal
(6) A medical device distributor or health care programs.
wholesaler that is not otherwise a (iii) The practice being acquired
manufacturer of a device or medical must be located in a Health Profes-
supply, as defined in paragraph sional Shortage Area (HPSA), as de-
(ee)(14)(iv) of this section; or fined in Departmental regulations, for
(7) An entity or individual that sells the practitioner’s specialty area.
or rents durable medical equipment, (iv) Commencing at the time of the
prosthetics, orthotics, or supplies cov- first agreement pertaining to the sale,
ered by a Federal health care program the purchasing hospital or entity must
(other than a pharmacy or a physician, diligently and in good faith engage in
provider, or other entity that pri- commercially reasonable recruitment
marily furnishes services); or activities that:
1135
§ 1001.952 42 CFR Ch. V (10–1–24 Edition)
(A) May reasonably be expected to re- (iii) The manner in which it selects a
sult in the recruitment of a new practi- particular participant from this group
tioner to take over the acquired prac- for that person;
tice within a one year period and (iv) The nature of the relationship
(B) Will satisfy the conditions of the between the referral service and the
practitioner recruitment safe harbor in group of participants to whom it could
accordance with paragraph (n) of this make the referral; and
section. (v) The nature of any restrictions
(f) Referral services. As used in section that would exclude such an individual
1128B of the Act, ‘‘remuneration’’ does or entity from continuing as a partici-
not include any payment or exchange pant.
of anything of value between an indi- (g) Warranties. As used in section
vidual or entity (‘‘participant’’) and 1128B of the Act, ‘‘remuneration’’ does
another entity serving as a referral not include any payment or exchange
service (‘‘referral service’’), as long as of anything of value under a warranty
all of the following four standards are provided by a manufacturer or supplier
met— of one or more items and services (pro-
(1) The referral service does not ex- vided the warranty covers at least one
clude as a participant in the referral item) to the buyer (such as a health
service any individual or entity who care provider or beneficiary) of the
meets the qualifications for participa- items and services, as long as the buyer
tion. complies with all of the following
(2) Any payment the participant standards in paragraphs (g)(1) and (2) of
makes to the referral service is as- this section and the manufacturer or
sessed equally against and collected supplier complies with all of the fol-
equally from all participants and is lowing standards in paragraphs (g)(3)
based only on the cost of operating the through (6) of this section:
referral service, and not on the volume (1) The buyer (unless the buyer is a
or value of any referrals to or business Federal health care program bene-
otherwise generated by either party for ficiary) must fully and accurately re-
the other party for which payment port any price reduction of an item or
may be made in whole or in part under service (including a free item or serv-
Medicare, Medicaid, or other Federal ice) that was obtained as part of the
health care programs. warranty in the applicable cost report-
(3) The referral service imposes no re- ing mechanism or claim for payment
quirements on the manner in which the filed with the Department or a State
participant provides services to a re- agency.
ferred person, except that the referral (2) The buyer must provide, upon re-
service may require that the partici- quest by the Secretary or a State agen-
pant charge the person referred at the cy, information provided by the manu-
same rate as it charges other persons facturer or supplier as specified in
not referred by the referral service, or paragraph (g)(3) of this section.
that these services be furnished free of (3) The manufacturer or supplier
charge or at reduced charge. must comply with either of the fol-
(4) The referral service makes the following standards:
lowing five disclosures to each person (i) The manufacturer or supplier
seeking a referral, with each such dis- must fully and accurately report any
closure maintained by the referral price reduction of an item or service
service in a written record certifying (including free items and services) that
such disclosure and signed by either the buyer obtained as part of the war-
such person seeking a referral or by the ranty on the invoice or statement sub-
individual making the disclosure on be- mitted to the buyer and inform the
half of the referral service— buyer of its obligations under para-
(i) The manner in which it selects the graphs (g)(1) and (2) of this section.
group of participants in the referral (ii) When the amount of any price re-
service to which it could make a refer- duction is not known at the time of
ral; sale, the manufacturer or supplier
(ii) Whether the participant has paid must fully and accurately report the
a fee to the referral service; existence of a warranty on the invoice
1136
or statement, inform the buyer of its seller and a buyer for purposes other
obligations under paragraphs (g)(1) and than resell of such item or bundle of
(g)(2) of this section, and when any items; or
price reduction becomes known, pro- (iii) A manufacturer’s or supplier’s
vide the buyer with documentation of agreement to replace another manufac-
the calculation of the price reduction turer’s or supplier’s defective item or
resulting from the warranty. bundle of items (which is covered by an
(4) The manufacturer or supplier agreement made in accordance with
must not pay any remuneration to any this paragraph (g)), on terms equal to
individual (other than a beneficiary) or the agreement that it replaces.
entity for any medical, surgical, or (h) Discounts. As used in section 1128B
hospital expense incurred by a bene- of the Act, ‘‘remuneration’’ does not
ficiary other than for the cost of the include a discount, as defined in para-
items and services subject to the war- graph (h)(5) of this section, on an item
ranty. or service for which payment may be
(5) If a manufacturer or supplier of- made in whole or in part under Medi-
fers a warranty for more than one item care, Medicaid or other Federal health
or one or more items and related serv- care programs for a buyer as long as
ices, the federally reimbursable items the buyer complies with the applicable
and services subject to the warranty standards of paragraph (h)(1) of this
must be reimbursed by the same Fed- section; a seller as long as the seller
eral health care program and in the complies with the applicable standards
same Federal health care program pay- of paragraph (h)(2) of this section; and
ment. an offeror of a discount who is not a
(6) The manufacturer or supplier seller under paragraph (h)(2) of this
must not condition a warranty on a section so long as such offeror complies
buyer’s exclusive use of, or a minimum with the applicable standards of para-
purchase of, any of the manufacturer’s graph (h)(3) of this section.
or supplier’s items or services. (1) With respect to the following
(7) For purposes of this paragraph (g), three categories of buyers, the buyer
the term warranty means: must comply with all of the applicable
(i) Any written affirmation of fact or standards within one of the three fol-
written promise made in connection lowing categories—
with the sale of an item or bundle of (i) If the buyer is an entity which is
items, or services in combination with a health maintenance organization
one or more related items, by a manu- (HMO) or a competitive medical plan
facturer or supplier to a buyer, which (CMP) acting in accordance with a risk
affirmation of fact or written promise contract under section 1876(g) or
relates to the nature of the quality of 1903(m) of the Act, or under another
workmanship and affirms or promises State health care program, it need not
that such quality or workmanship is report the discount except as otherwise
defect free or will meet a specified may be required under the risk con-
level of performance over a specified tract.
period of time; (ii) If the buyer is an entity which re-
(ii) Any undertaking in writing in ports its costs on a cost report required
connection with the sale by a manufac- by the Department or a State health
turer or supplier of an item or bundle care program, it must comply with all
of items, or services in combination of the following four standards—
with one or more related items, to re- (A) The discount must be earned
fund, repair, replace, or take other re- based on purchases of that same good
medial action with respect to such or service bought within a single fiscal
item or bundle of items in the event year of the buyer;
that such item or bundle of items, or (B) The buyer must claim the benefit
services in combination with one or of the discount in the fiscal year in
more related items, fails to meet the which the discount is earned or the fol-
specifications set forth in the under- lowing year;
taking which written affirmation, (C) The buyer must fully and accu-
promise, or undertaking becomes part rately report the discount in the appli-
of the basis of the bargain between a cable cost report; and
1137
§ 1001.952 42 CFR Ch. V (10–1–24 Edition)
(D) the buyer must provide, upon re- accurately report such discount on the
quest by the Secretary or a State agen- invoice, coupon or statement sub-
cy, information provided by the seller mitted to the buyer; inform the buyer
as specified in paragraph (h)(2)(ii) of in a manner that is reasonably cal-
this section, or information provided culated to give notice to the buyer of
by the offeror as specified in paragraph its obligations to report such discount
(h)(3)(ii) of this section. and to provide information upon re-
(iii) If the buyer is an individual or quest under paragraph (h)(1) of this
entity in whose name a claim or re- section; and refrain from doing any-
quest for payment is submitted for the thing that would impede the buyer
discounted item or service and pay- from meeting its obligations under this
ment may be made, in whole or in part, paragraph; or
under Medicare, Medicaid or other Fed- (B) Where the value of the discount is
eral health care programs (not includ- not known at the time of sale, the sell-
ing individuals or entities defined as er must fully and accurately report the
buyers in paragraph (h)(1)(i) or (h)(1)(ii) existence of a discount program on the
of this section), the buyer must comply invoice, coupon or statement sub-
with both of the following standards— mitted to the buyer; inform the buyer
(A) The discount must be made at the in a manner reasonably calculated to
time of the sale of the good or service give notice to the buyer of its obliga-
or the terms of the rebate must be tions to report such discount and to
fixed and disclosed in writing to the provide information upon request
buyer at the time of the initial sale of under paragraph (h)(1) of this section;
the good or service; and when the value of the discount becomes
(B) the buyer (if submitting the known, provide the buyer with docu-
claim) must provide, upon request by mentation of the calculation of the dis-
the Secretary or a State agency, infor- count identifying the specific goods or
mation provided by the seller as speci- services purchased to which the dis-
fied in paragraph (h)(2)(iii)(B) of this count will be applied; and refrain from
section, or information provided by the
doing anything which would impede
offeror as specified in paragraph
the buyer from meeting its obligations
(h)(3)(iii)(A) of this section.
under this paragraph.
(2) The seller is an individual or enti-
ty that supplies an item or service for (iii) If the buyer is an individual or
which payment may be made, in whole entity not included in paragraph
or in part, under Medicare, Medicaid or (h)(2)(i) or (h)(2)(ii) of this section, the
other Federal health care programs to seller must comply with either of the
the buyer and who permits a discount following two standards—
to be taken off the buyer’s purchase (A) Where the seller submits a claim
price. The seller must comply with all or request for payment on behalf of the
of the applicable standards within one buyer and the item or service is sepa-
of the following three categories— rately claimed, the seller must provide,
(i) If the buyer is an entity which is upon request by the Secretary or a
an HMO a CMP acting in accordance State agency, information provided by
with a risk contract under section the offeror as specified in paragraph
1876(g) or 1903(m) of the Act, or under (h)(3)(iii)(A) of this section; or
another State health care program, the (B) Where the buyer submits a claim,
seller need not report the discount to the seller must fully and accurately re-
the buyer for purposes of this provi- port such discount on the invoice, cou-
sion. pon or statement submitted to the
(ii) If the buyer is an entity that re- buyer; inform the buyer in a manner
ports its costs on a cost report required reasonably calculated to give notice to
by the Department or a State agency, the buyer of its obligations to report
the seller must comply with either of such discount and to provide informa-
the following two standards— tion upon request under paragraph
(A) Where a discount is required to be (h)(1) of this section; and refrain from
reported to Medicare or a State health doing anything that would impede the
care program under paragraph (h)(1) of buyer from meeting its obligations
this section, the seller must fully and under this paragraph.
1138
(3) The offeror of a discount is an in- meet its obligations under this para-
dividual or entity who is not a seller graph.
under paragraph (h)(2) of this section, (4) For purposes of this paragraph, a
but promotes the purchase of an item rebate is any discount the terms of
or service by a buyer under paragraph which are fixed and disclosed in writing
(h)(1) of this section at a reduced price to the buyer at the time of the initial
for which payment may be made, in purchase to which the discount applies,
whole or in part, under Medicare, Med- but which is not given at the time of
icaid or other Federal health care pro- sale.
grams. The offeror must comply with (5) For purposes of this paragraph,
all of the applicable standards within the term discount means a reduction in
the following three categories— the amount a buyer (who buys either
(i) If the buyer is an entity which is directly or through a wholesaler or a
an HMO or a CMP acting in accordance group purchasing organization) is
with a risk contract under section charged for an item or service based on
1876(g) or 1903(m) of the Act, or under an arms-length transaction. The term
another State health care program, the discount does not include—
offeror need not report the discount to (i) Cash payment or cash equivalents
the buyer for purposes of this provi- (except that rebates as defined in para-
sion. graph (h)(4) of this section may be in
(ii) If the buyer is an entity that re- the form of a check);
ports its costs on a cost report required (ii) Supplying one good or service
by the Department or a State agency, without charge or at a reduced charge
the offeror must comply with the fol- to induce the purchase of a different
lowing two standards— good or service, unless the goods and
(A) The offeror must inform the services are reimbursed by the same
buyer in a manner reasonably cal- Federal health care program using the
culated to give notice to the buyer of same methodology and the reduced
its obligations to report such a discharge is fully disclosed to the Federal
count and to provide information upon health care program and accurately re-
request under paragraph (h)(1) of this flected where appropriate, and as ap-
section; and propriate, to the reimbursement meth-
(B) The offeror of the discount must odology;
refrain from doing anything that would (iii) A reduction in price applicable
impede the buyer’s ability to meet its to one payer but not to Medicare, Med-
obligations under this paragraph. icaid or other Federal health care pro-
(iii) If the buyer is an individual or grams;
entity in whose name a request for (iv) A routine reduction or waiver of
payment is submitted for the dis- any coinsurance or deductible amount
counted item or service and payment owed by a program beneficiary;
may be made, in whole or in part, (v) Warranties;
under Medicare, Medicaid or other Fed- (vi) Services provided in accordance
eral health care programs (not includ- with a personal or management serv-
ing individuals or entities defined as ices contract;
buyers in paragraph (h)(1)(i) or (h)(1)(ii) (vii) Other remuneration, in cash or
of this section), the offeror must com- in kind, not explicitly described in this
ply with the following two standards— paragraph (h)(5); or
(A) The offeror must inform the indi- (viii) A reduction in price or other re-
vidual or entity submitting the claim muneration in connection with the sale
or request for payment in a manner or purchase of a prescription pharma-
reasonably calculated to give notice to ceutical product from a manufacturer
the individual or entity of its obliga- to a plan sponsor under Medicare Part
tions to report such a discount and to D either directly to the plan sponsor
provide information upon request under Medicare Part D, or indirectly
under paragraphs (h)(1) and (h)(2) of through a pharmacy benefit manager
this section; and acting under contract with a plan spon-
(B) The offeror of the discount must sor under Medicare Part D, unless it is
refrain from doing anything that would a price reduction or rebate that is re-
impede the buyer’s or seller’s ability to quired by law.
1139
§ 1001.952 42 CFR Ch. V (10–1–24 Edition)
(6) For purposes of this paragraph (h), the purchase price of the goods or serv-
the term manufacturer carries the ices, the agreement specifies the
meaning ascribed to it in Social Secu- amount (or if not known, the max-
rity Act section 1927(k)(5). imum amount) the GPO will be paid by
(7) For purposes of this paragraph (h), each vendor (where such amount may
the terms wholesaler and distributor be a fixed sum or a fixed percentage of
are used interchangeably and carry the the value of purchases made from the
same meaning as the term ‘‘whole- vendor by the members of the group
saler’’ defined in Social Security Act under the contract between the vendor
section 1927(k)(11). and the GPO).
(8) For purposes of this paragraph (h), (2) Where the entity which receives
the term pharmacy benefit manager or the goods or service from the vendor is
PBM means any entity that provides a health care provider of services, the
pharmacy benefit management on be- GPO must disclose in writing to the en-
half of a health plan that manages pre- tity at least annually, and to the Sec-
scription drug coverage. retary upon request, the amount re-
(9) For purposes of this paragraph (h), ceived from each vendor with respect
a prescription pharmaceutical product to purchases made by or on behalf of
means either a drug or biological prod- the entity. Note that for purposes of
uct as those terms are described in So- paragraph (j) of this section, the term
cial Security Act section 1927(k)(2)(A), group purchasing organization (GPO)
(B), and (C). means an entity authorized to act as a
(i) Employees. As used in section 1128B purchasing agent for a group of individ-
of the Act, ‘‘remuneration’’ does not uals or entities who are furnishing
include any amount paid by an em- services for which payment may be
ployer to an employee, who has a bona made in whole or in part under Medi-
fide employment relationship with the care, Medicaid or other Federal health
employer, for employment in the fur- care programs, and who are neither
nishing of any item or service for wholly-owned by the GPO nor subsidi-
which payment may be made in whole aries of a parent corporation that
or in part under Medicare, Medicaid or wholly owns the GPO (either directly
other Federal health care programs. or through another wholly-owned enti-
For purposes of paragraph (i) of this ty).
section, the term employee has the (k) Waiver of beneficiary copayment,
same meaning as it does for purposes of coinsurance and deductible amounts. As
26 U.S.C. 3121(d)(2). used in section 1128B of the Act, ‘‘re-
(j) Group purchasing organizations. As muneration’’ does not include any re-
used in section 1128B of the Act, ‘‘reduction or waiver of a Federal health
muneration’’ does not include any pay- care program beneficiary’s obligation
ment by a vendor of goods or services to pay copayment, coinsurance or de-
to a group purchasing organization ductible (for purposes of this subpara-
(GPO), as part of an agreement to fur- graph (k) ‘‘cost-sharing’’) amounts as
nish such goods or services to an indi- long as all the standards are met with-
vidual or entity as long as both of the in one of the following categories of
following two standards are met— health care providers or suppliers.
(1) The GPO must have a written (1) If the cost-sharing amounts are
agreement with each individual or en- owed to a hospital for inpatient hos-
tity, for which items or services are pital services for which a Federal
furnished, that provides for either of health care program pays under the
the following— prospective payment system, the hos-
(i) The agreement states that partici- pital must comply with all of the fol-
pating vendors from which the indi- lowing three standards:
vidual or entity will purchase goods or (i) The hospital must not later claim
services will pay a fee to the GPO of 3 the amount reduced or waived as a bad
percent or less of the purchase price of debt for payment purposes under a Fed-
the goods or services provided by that eral health care program or otherwise
vendor. shift the burden of the reduction or
(ii) In the event the fee paid to the waiver onto a Federal health care pro-
GPO is not fixed at 3 percent or less of gram, other payers, or individuals.
1140
(ii) The hospital must offer to reduce after making reasonable collection ef-
or waive the cost-sharing amounts forts.
without regard to the reason for admis- (4) If the cost-sharing amounts are
sion, the length of stay of the bene- owed to an ambulance provider or sup-
ficiary, or the diagnostic related group plier for emergency ambulance services
for which the claim for reimbursement for which a Federal health care pro-
is filed. gram pays under a fee-for-service pay-
(iii) The hospital’s offer to reduce or ment system and all the following con-
waive the cost-sharing amounts must ditions are met:
not be made as part of a price reduc- (i) The ambulance provider or sup-
tion agreement between a hospital and plier is owned and operated by a State,
a third-party payer (including a health a political subdivision of a State, or a
plan as defined in paragraph (l)(2) of tribal health care program, as that
this section), unless the agreement is term is defined in section 4 of the In-
part of a contract for the furnishing of dian Health Care Improvement Act;
items or services to a beneficiary of a (ii) The ambulance provider or sup-
Medicare supplemental policy issued plier engaged in an emergency re-
under the terms of section 1882(t)(1) of sponse, as defined in 42 CFR 414.605;
the Act. (iii) The ambulance provider or sup-
(2) If the cost-sharing amounts are plier offers the reduction or waiver on
owed by an individual who qualifies for a uniform basis to all of its residents or
subsidized services under a provision of (if applicable) tribal members, or to all
the Public Health Services Act or individuals transported; and
under Titles V or XIX of the Act to a (iv) The ambulance provider or sup-
federally qualified health care center plier must not later claim the amount
or other health care facility under any reduced or waived as a bad debt for
Public Health Services Act grant pro- payment purposes under a Federal
gram or under Title V of the Act, the health care program or otherwise shift
health care center or facility may re- the burden of the reduction or waiver
duce or waive the cost-sharing onto a Federal health care program,
amounts for items or services for which other payers, or individuals.
payment may be made in whole or in (l) Increased coverage, reduced cost-
part by a Federal health care program. sharing amounts, or reduced premium
(3) If the cost-sharing amounts are amounts offered by health plans. (1) As
owed to a pharmacy (including, but not used in section 1128B of the Act, ‘‘re-
limited to, pharmacies of the Indian muneration’’ does not include the addi-
Health Service, Indian tribes, tribal or- tional coverage of any item or service
ganizations, and urban Indian organi- offered by a health plan to an enrollee
zations) for cost-sharing imposed under or the reduction of some or all of the
a Federal health care program, the enrollee’s obligation to pay the health
pharmacy may reduce or waive the plan or a contract health care provider
cost-sharing amounts if: for cost-sharing amounts (such as coin-
(i) The waiver or reduction is not of- surance, deductible, or copayment
fered as part of an advertisement or so- amounts) or for premium amounts at-
licitation; and tributable to items or services covered
(ii) Except for waivers or reductions by the health plan, the Medicare pro-
offered to subsidy-eligible individuals gram, or a State health care program,
(as defined in section 1860D–14(a)(3)) to as long as the health plan complies
which only requirement in paragraph with all of the standards within one of
(k)(3)(i) of this section applies: the following two categories of health
(A) The pharmacy does not routinely plans:
waive or reduce cost-sharing amounts; (i) If the health plan is a risk-based
and health maintenance organization, com-
(B) The pharmacy waives the cost- petitive medical plan, prepaid health
sharing amounts only after deter- plan, or other health plan under con-
mining in good faith that the indi- tract with CMS or a State health care
vidual is in financial need or after fail- program and operating in accordance
ing to collect the cost-sharing amounts with section 1876(g) or 1903(m) of the
1141
§ 1001.952 42 CFR Ch. V (10–1–24 Edition)
Act, under a Federal statutory dem- Health plan means an entity that fur-
onstration authority, or under other nishes or arranges under agreement
Federal statutory or regulatory au- with contract health care providers for
thority, it must offer the same in- the furnishing of items or services to
creased coverage or reduced cost-shar- enrollees, or furnishes insurance cov-
ing or premium amounts to all Medi- erage for the provision of such items
care or State health care program en- and services, in exchange for a pre-
rollees covered by the contract unless mium or a fee, where such entity:
otherwise approved by CMS or by a (i) Operates in accordance with a con-
State health care program. tract, agreement or statutory dem-
(ii) If the health plan is a health onstration authority approved by CMS
maintenance organization, competitive or a State health care program;
medical plan, health care prepayment (ii) Charges a premium and its pre-
plan, prepaid health plan or other mium structure is regulated under a
health plan that has executed a con- State insurance statute or a State ena-
tract or agreement with CMS or with a bling statute governing health mainte-
State health care program to receive nance organizations or preferred pro-
payment for enrollees on a reasonable vider organizations;
cost or similar basis, it must comply (iii) Is an employer, if the enrollees
with both of the following two stand- of the plan are current or retired em-
ards— ployees, or is a union welfare fund, if
(A) The health plan must offer the the enrollees of the plan are union
same increased coverage or reduced members; or
cost-sharing or premium amounts to (iv) Is licensed in the State, is under
all Medicare or State health care pro- contract with an employer, union wel-
gram enrollees covered by the contract fare fund, or a company furnishing
or agreement unless otherwise ap- health insurance coverage as described
proved by CMS or by a State health in conditions (ii) and (iii) of this defini-
care program; and tion, and is paid a fee for the adminis-
(B) The health plan must not claim tration of the plan which reflects the
the costs of the increased coverage or fair market value of those services.
the reduced cost-sharing or premium (m) Price reductions offered to health
amounts as a bad debt for payment plans. (1) As used in section 1128B of
purposes under Medicare or a State the Act, ‘‘remuneration’’ does not in-
health care program or otherwise shift clude a reduction in price a contract
the burden of the increased coverage or health care provider offers to a health
reduced cost-sharing or premium plan in accordance with the terms of a
amounts to the extent that increased written agreement between the con-
payments are claimed from Medicare tract health care provider and the
or a State health care program. health plan for the sole purpose of fur-
(2) For purposes of paragraph (l) of nishing to enrollees items or services
this section, the terms— that are covered by the health plan,
Contract health care provider means an Medicare, or a State health care pro-
individual or entity under contract gram, as long as both the health plan
with a health plan to furnish items or and contract health care provider com-
services to enrollees who are covered ply with all of the applicable standards
by the health plan, Medicare, or a within one of the following four cat-
State health care program. egories of health plans:
Enrollee means an individual who has (i) If the health plan is a risk-based
entered into a contractual relationship health maintenance organization, com-
with a health plan (or on whose behalf petitive medical plan, or prepaid
an employer, or other private or gov- health plan under contract with CMS
ernmental entity has entered into such or a State agency and operating in ac-
a relationship) under which the indi- cordance with section 1876(g) or 1903(m)
vidual is entitled to receive specified of the Act, under a Federal statutory
health care items and services, or in- demonstration authority, or under
surance coverage for such items and other Federal statutory or regulatory
services, in return for payment of a authority, the contract health care
premium or a fee. provider must not claim payment in
1142
any form from the Department or the provider must comply with all of the
State agency for items or services fur- following six standards—
nished in accordance with the agree- (A) The term of the agreement be-
ment except as approved by CMS or the tween the health plan and the contract
State health care program, or other- health care provider must be for not
wise shift the burden of such an agree- less than one year;
ment to the extent that increased pay- (B) The agreement between the
ments are claimed from Medicare or a health plan and the contract health
State health care program. care provider must specify in advance
(ii) If the health plan is a health the covered items and services to be
maintenance organization, competitive furnished to enrollees, which party is
medical plan, health care prepayment to file claims or requests for payment
plan, prepaid health plan, or other with Medicare or the State health care
health plan that has executed a con- program for such items and services,
tract or agreement with CMS or a and the schedule of fees the contract
State health care program to receive health care provider will charge for
payment for enrollees on a reasonable furnishing such items and services to
cost or similar basis, the health plan enrollees;
and contract health care provider must (C) The fee schedule contained in the
comply with all of the following four agreement between the health plan and
standards— the contract health care provider must
(A) The term of the agreement be- remain in effect throughout the term
tween the health plan and the contract of the agreement, unless a fee increase
health care provider must be for not results directly from a payment update
less than one year; authorized by Medicare or the State
health care program;
(B) The agreement between the
(D) The party submitting claims or
health plan and the contract health
requests for payment from Medicare or
care provider must specify in advance
the State health care program for
the covered items and services to be
items and services furnished in accord-
furnished to enrollees, and the method-
ance with the agreement must not
ology for computing the payment to claim or request payment for amounts
the contract health care provider; in excess of the fee schedule;
(C) The health plan must fully and (E) The contract health care provider
accurately report, on the applicable and the health plan must fully and ac-
cost report or other claim form filed curately report on any cost report filed
with the Department or the State with Medicare or a State health care
health care program, the amount it has program the fee schedule amounts
paid the contract health care provider charged in accordance with the agree-
under the agreement for the covered ment and, upon request, will report to
items and services furnished to enroll- the Medicare or a State health care
ees; and program the terms of the agreement
(D) The contract health care provider and the amounts paid in accordance
must not claim payment in any form with the agreement; and
from the Department or the State (F) The party to the agreement,
health care program for items or serv- which does not have the responsibility
ices furnished in accordance with the under the agreement for filing claims
agreement except as approved by CMS or requests for payment, must not
or the State health care program, or claim or request payment in any form
otherwise shift the burden of such an from the Department or the State
agreement to the extent that increased health care program for items or serv-
payments are claimed from Medicare ices furnished in accordance with the
or a State health care program. agreement, or otherwise shift the bur-
(iii) If the health plan is not de- den of such an agreement to the extent
scribed in paragraphs (m)(1)(i) or that increased payments are claimed
(m)(1)(ii) of this section and the con- from Medicare or a State health care
tract health care provider is not paid program.
on an at-risk, capitated basis, both the (iv) If the health plan is not described
health plan and contract health care in paragraphs (m)(1)(i) or (m)(1)(ii) of
1143
§ 1001.952 42 CFR Ch. V (10–1–24 Edition)
this section, and the contract health her current specialty for less than one
care provider is paid on an at-risk, year to locate, or to induce any other
capitated basis, both the health plan practitioner to relocate, his or her pri-
and contract health care provider must mary place of practice into a HPSA for
comply with all of the following five his or her specialty area, as defined in
standards— Departmental regulations, that is
(A) The term of the agreement be- served by the entity, as long as all of
tween the health plan and the contract the following nine standards are met—
health provider must be for not less (1) The arrangement is set forth in a
than one year; written agreement signed by the par-
(B) The agreement between the ties that specifies the benefits provided
health plan and the contract health by the entity, the terms under which
provider must specify in advance the the benefits are to be provided, and the
covered items and services to be fur- obligations of each party.
nished to enrollees and the total (2) If a practitioner is leaving an es-
amount per enrollee (which may be ex- tablished practice, at least 75 percent
pressed in a per month or other time of the revenues of the new practice
period basis) the contract health care must be generated from new patients
provider will be paid by the health plan not previously seen by the practitioner
for furnishing such items and services at his or her former practice.
to enrollees and must set forth any co-
(3) The benefits are provided by the
payments, if any, to be paid by enroll-
entity for a period not in excess of 3
ees to the contract health care pro-
years, and the terms of the agreement
vider for covered services;
are not renegotiated during this 3-year
(C) The payment amount contained
period in any substantial aspect; pro-
in the agreement between the health
vided, however, that if the HPSA to
care plan and the contract health care
which the practitioner was recruited
provider must remain in effect
ceases to be a HPSA during the term of
throughout the term of the agreement;
the written agreement, the payments
(D) The contract health care provider
made under the written agreement will
and the health plan must fully and ac-
curately report to the Medicare and continue to satisfy this paragraph for
State health care program upon re- the duration of the written agreement
quest, the terms of the agreement and (not to exceed 3 years).
the amounts paid in accordance with (4) There is no requirement that the
the agreement; and practitioner make referrals to, be in a
(E) The contract health care provider position to make or influence referrals
must not claim or request payment in to, or otherwise generate business for
any form from the Department, a State the entity as a condition for receiving
health care program or an enrollee the benefits; provided, however, that
(other than copayment amounts de- for purposes of this paragraph, the en-
scribed in paragraph (m)(2)(iv)(B) of tity may require as a condition for re-
this section) and the health plan must ceiving benefits that the practitioner
not pay the contract care provider in maintain staff privileges at the entity.
excess of the amounts described in (5) The practitioner is not restricted
paragraph (m)(2)(iv)(B) of this section from establishing staff privileges at,
for items and services covered by the referring any service to, or otherwise
agreement. generating any business for any other
(2) For purposes of this paragraph, entity of his or her choosing.
the terms contract health care provider, (6) The amount or value of the bene-
enrollee, and health plan have the same fits provided by the entity may not
meaning as in paragraph (l)(2) of this vary (or be adjusted or renegotiated) in
section. any manner based on the volume or
(n) Practitioner recruitment. As used in value of any expected referrals to or
section 1128B of the Act, ‘‘remunera- business otherwise generated for the
tion’’ does not include any payment or entity by the practitioner for which
exchange of anything of value by an payment may be made in whole or in
entity in order to induce a practitioner part under Medicare, Medicaid or any
who has been practicing within his or other Federal health care programs.
1144
(7) The practitioner agrees to treat (ii) Thereafter, for each additional
patients receiving medical benefits or coverage period (not to exceed one
assistance under any Federal health year), at least 75 percent of the practi-
care program in a nondiscriminatory tioner’s obstetrical patients treated
manner. under the prior coverage period (not to
(8) At least 75 percent of the revenues exceed one year) must have—
of the new practice must be generated (A) Resided in a HPSA or MUA, as
from patients residing in a HPSA or a defined in paragraph (a) of this section;
Medically Underserved Area (MUA) or or
who are part of a Medically Under- (B) Been part of a MUP, as defined in
served Population (MUP), all as defined paragraph (a) of this section.
in paragraph (a) of this section. (3) There is no requirement that the
(9) The payment or exchange of any- practitioner make referrals to, or oth-
thing of value may not directly or indi- erwise generate business for, the entity
rectly benefit any person (other than as a condition for receiving the bene-
the practitioner being recruited) or en- fits.
tity in a position to make or influence (4) The practitioner is not restricted
referrals to the entity providing the re- from establishing staff privileges at,
cruitment payments or benefits of referring any service to, or otherwise
items or services payable by a Federal generating any business for any other
health care program. entity of his or her choosing.
(5) The amount of payment may not
(o) Obstetrical malpractice insurance
vary based on the volume or value of
subsidies. As used in section 1128B of
any previous or expected referrals to or
the Act, ‘‘remuneration’’ does not in-
business otherwise generated for the
clude any payment made by a hospital
entity by the practitioner for which
or other entity to another entity that
payment may be made in whole or in
is providing malpractice insurance (in-
part under Medicare, Medicaid or any
cluding a self-funded entity), where
other Federal health care programs.
such payment is used to pay for some
(6) The practitioner must treat ob-
or all of the costs of malpractice insur-
stetrical patients who receive medical
ance premiums for a practitioner (in- benefits or assistance under any Fed-
cluding a certified nurse-midwife as de- eral health care program in a non-
fined in section 1861(gg) of the Act) who discriminatory manner.
engages in obstetrical practice as a (7) The insurance is a bona fide mal-
routine part of his or her medical prac- practice insurance policy or program,
tice in a primary care HPSA, as long as and the premium, if any, is calculated
all of the following seven standards are based on a bona fide assessment of the
met— liability risk covered under the insur-
(1) The payment is made in accordance. For purposes of paragraph (o) of
ance with a written agreement between this section, costs of malpractice insur-
the entity paying the premiums and ance premiums means:
the practitioner, which sets out the (i) For practitioners who engage in
payments to be made by the entity, obstetrical practice full-time, any
and the terms under which the pay- costs attributable to malpractice in-
ments are to be provided. surance; or
(2)(i) The practitioner must certify (ii) For practitioners who engage in
that for the initial coverage period (not obstetrical practice on a part-time or
to exceed one year) the practitioner sporadic basis, the costs:
has a reasonable basis for believing (A) Attributable exclusively to the
that at least 75 percent of the practi- obstetrical portion of the practitioner’s
tioner’s obstetrical patients treated malpractice insurance and
under the coverage of the malpractice (B) Related exclusively to obstetrical
insurance will either— services provided in a primary care
(A) Reside in a HPSA or MUA, as de- HPSA.
fined in paragraph (a) of this section; (p) Investments in group practices. As
or used in section 1128B of the Act, ‘‘re-
(B) Be part of a MUP, as defined in muneration’’ does not include any pay-
paragraph (a) of this section. ment that is a return on an investment
1145
§ 1001.952 42 CFR Ch. V (10–1–24 Edition)
interest, such as a dividend or interest ment that is a return on an investment

income, made to a solo or group practi- interest, such as a dividend or interest
tioner investing in his or her own prac- income, made to an investor, as long as
tice or group practice if the following the investment entity is a certified
four standards are met— ambulatory surgical center (ASC)
(1) The equity interests in the prac- under part 416 of this title, whose oper-
tice or group must be held by licensed ating and recovery room space is dedi-
health care professionals who practice cated exclusively to the ASC, patients
in the practice or group. referred to the investment entity by an
(2) The equity interests must be in investor are fully informed of the in-
the practice or group itself, and not vestor’s investment interest, and all of
some subdivision of the practice or the applicable standards are met with-
group. in one of the following four cat-
(3) In the case of group practices, the egories—
practice must: (1) Surgeon-owned ASCs—If all of the
(i) Meet the definition of ‘‘group investors are general surgeons or sur-
practice’’ in section 1877(h)(4) of the geons engaged in the same surgical spe-
Social Security Act and implementing cialty, who are in a position to refer
regulations; and patients directly to the entity and per-
(ii) Be a unified business with cen- form surgery on such referred patients;
tralized decision-making, pooling of ex- surgical group practices (as defined in
penses and revenues, and a compensa- this paragraph) composed exclusively
tion/profit distribution system that is of such surgeons; or investors who are
not based on satellite offices operating not employed by the entity or by any
substantially as if they were separate investor, are not in a position to pro-
enterprises or profit centers. vide items or services to the entity or
(4) Revenues from ancillary services, any of its investors, and are not in a
if any, must be derived from ‘‘in-office position to make or influence referrals
ancillary services’’ that meet the defi- directly or indirectly to the entity or
nition of such term in section 1877(b)(2) any of its investors, all of the following
of the Act and implementing regula- six standards must be met—
tions. (i) The terms on which an investment
(q) Cooperative hospital service organi- interest is offered to an investor must
zations. As used in section 1128B of the not be related to the previous or ex-
Act, ‘‘remuneration’’ does not include pected volume of referrals, services fur-
any payment made between a coopera- nished, or the amount of business oth-
tive hospital service organization erwise generated from that investor to
(CHSO) and its patron-hospital, both of the entity.
which are described in section 501(e) of (ii) At least one-third of each surgeon
the Internal Revenue Code of 1986 and investor’s medical practice income
are tax-exempt under section 501(c)(3) from all sources for the previous fiscal
of the Internal Revenue Code, where year or previous 12-month period must
the CHSO is wholly owned by two or be derived from the surgeon’s perform-
more patron-hospitals, as long as the ance of procedures (as defined in this
following standards are met— paragraph).
(1) If the patron-hospital makes a (iii) The entity or any investor (or
payment to the CHSO, the payment other individual or entity acting on be-
must be for the purpose of paying for half of the entity or any investor) must
the bona fide operating expenses of the not loan funds to or guarantee a loan
CHSO, or for an investor if the investor uses any
(2) If the CHSO makes a payment to part of such loan to obtain the invest-
the patron-hospital, the payment must ment interest.
be for the purpose of paying a distribu- (iv) The amount of payment to an in-
tion of net earnings required to be vestor in return for the investment
made under section 501(e)(2) of the In- must be directly proportional to the
ternal Revenue Code of 1986. amount of the capital investment (in-
(r) Ambulatory surgical centers. As cluding the fair market value of any
used in section 1128B of the Act, ‘‘re- pre-operational services rendered) of
muneration’’ does not include any pay- that investor.
1146
(v) All ancillary services for Federal (v) All ancillary services for Federal
health care program beneficiaries per- health care program beneficiaries per-
formed at the entity must be directly formed at the entity must be directly
and integrally related to primary pro- and integrally related to primary pro-
cedures performed at the entity, and cedures performed at the entity, and
none may be separately billed to Medi- none may be separately billed to Medi-
care or other Federal health care pro- care or other Federal health care pro-
grams. grams.
(vi) The entity and any surgeon in- (vi) The entity and any physician in-
vestors must treat patients receiving vestors must treat patients receiving
medical benefits or assistance under medical benefits or assistance under
any Federal health care program in a any Federal health care program in a
nondiscriminatory manner. nondiscriminatory manner.
(2) Single-Specialty ASCs—If all of the (3) Multi-Specialty ASCs—If all of the
investors are physicians engaged in the investors are physicians who are in a
same medical practice specialty who position to refer patients directly to
are in a position to refer patients di- the entity and perform procedures on
rectly to the entity and perform proce- such referred patients; group practices,
dures on such referred patients; group as defined in this paragraph, composed
practices (as defined in this paragraph) exclusively of such physicians; or in-
composed exclusively of such physi- vestors who are not employed by the
cians; or investors who are not em- entity or by any investor, are not in a
ployed by the entity or by any inves- position to provide items or services to
tor, are not in a position to provide the entity or any of its investors, and
items or services to the entity or any are not in a position to make or influ-
of its investors, and are not in a posi- ence referrals directly or indirectly to
tion to make or influence referrals di- the entity or any of its investors, all of
the following seven standards must be
rectly or indirectly to the entity or
met—
any of its investors, all of the following
(i) The terms on which an investment
six standards must be met—
interest is offered to an investor must
(i) The terms on which an investment not be related to the previous or ex-
interest is offered to an investor must pected volume of referrals, services fur-
not be related to the previous or ex- nished, or the amount of business oth-
pected volume of referrals, services fur- erwise generated from that investor to
nished, or the amount of business oth- the entity.
erwise generated from that investor to (ii) At least one-third of each physi-
the entity. cian investor’s medical practice in-
(ii) At least one-third of each physi- come from all sources for the previous
cian investor’s medical practice in- fiscal year or previous 12-month period
come from all sources for the previous must be derived from the physician’s
fiscal year or previous 12-month period performance of procedures (as defined
must be derived from the surgeon’s per- in this paragraph).
formance of procedures (as defined in (iii) At least one-third of the proce-
this paragraph). dures (as defined in this paragraph)
(iii) The entity or any investor (or performed by each physician investor
other individual or entity acting on be- for the previous fiscal year or previous
half of the entity or any investor) must 12-month period must be performed at
not loan funds to or guarantee a loan the investment entity.
for an investor if the investor uses any (iv) The entity or any investor (or
part of such loan to obtain the invest- other individual or entity acting on be-
ment interest. half of the entity or any investor) must
(iv) The amount of payment to an in- not loan funds to or guarantee a loan
vestor in return for the investment for an investor if the investor uses any
must be directly proportional to the part of such loan to obtain the invest-
amount of the capital investment (in- ment interest.
cluding the fair market value of any (v) The amount of payment to an in-
pre-operational services rendered) of vestor in return for the investment
that investor. must be directly proportional to the
1147
§ 1001.952 42 CFR Ch. V (10–1–24 Edition)
amount of the capital investment (in- program in a nondiscriminatory man-

cluding the fair market value of any ner.
pre-operational services rendered) of (v) The entity may not use space, in-
that investor. cluding, but not limited to, operating
(vi) All ancillary services for Federal and recovery room space, located in or
health care program beneficiaries per- owned by any hospital investor, unless
formed at the entity must be directly such space is leased from the hospital
and integrally related to primary pro- in accordance with a lease that com-
cedures performed at the entity, and plies with all the standards of the
none may be separately billed to Medi- space rental safe harbor set forth in
care or other Federal health care pro- paragraph (b) of this section; nor may
grams. it use equipment owned by or services
(vii) The entity and any physician in- provided by the hospital unless such
vestors must treat patients receiving equipment is leased in accordance with
medical benefits or assistance under a lease that complies with the equip-
any Federal health care program in a ment rental safe harbor set forth in
nondiscriminatory manner. paragraph (c) of this section, and such
(4) Hospital/Physician ASCs—If at services are provided in accordance
least one investor is a hospital, and all with a contract that complies with the
of the remaining investors are physi- personal services and management con-
cians who meet the requirements of tracts safe harbor set forth in para-
paragraphs (r)(1), (r)(2) or (r)(3) of this graph (d) of this section.
section; group practices (as defined in (vi) All ancillary services for Federal
this paragraph) composed of such phy- health care program beneficiaries per-
sicians; surgical group practices (as de- formed at the entity must be directly
fined in this paragraph); or investors and integrally related to primary pro-
who are not employed by the entity or cedures performed at the entity, and
by any investor, are not in a position none may be separately billed to Medi-
to provide items or services to the enti- care or other Federal health care pro-
ty or any of its investors, and are not grams.
in a position to refer patients directly (vii) The hospital may not include on
or indirectly to the entity or any of its its cost report or any claim for pay-
investors, all of the following eight ment from a Federal health care pro-
standards must be met— gram any costs associated with the
(i) The terms on which an investment ASC (unless such costs are required to
interest is offered to an investor must be included by a Federal health care
not be related to the previous or ex- program).
pected volume of referrals, services fur- (viii) The hospital may not be in a
nished, or the amount of business oth- position to make or influence referrals
erwise generated from that investor to directly or indirectly to any investor
the entity. or the entity.
(ii) The entity or any investor (or (5) For purposes of paragraph (r) of
other individual or entity acting on be- this section, procedures means any pro-
half of the entity or any investor) must cedure or procedures on the list of
not loan funds to or guarantee a loan Medicare-covered procedures for ambu-
for an investor if the investor uses any latory surgical centers in accordance
part of such loan to obtain the invest- with regulations issued by the Depart-
ment interest. ment and group practice means a group
(iii) The amount of payment to an in- practice that meets all of the standards
vestor in return for the investment of paragraph (p) of this section. Sur-
must be directly proportional to the gical group practice means a group prac-
amount of the capital investment (in- tice that meets all of the standards of
cluding the fair market value of any paragraph (p) of this section and is
pre-operational services rendered) of composed exclusively of surgeons who
that investor. meet the requirements of paragraph
(iv) The entity and any hospital or (r)(1) of this section.
physician investor must treat patients (s) Referral arrangements for specialty
receiving medical benefits or assist- services. As used in section 1128B of the
ance under any Federal health care Act, ‘‘remuneration’’ does not include
1148
any exchange of value among individ- services covered under the agreement,
uals and entities where one party except for:
agrees to refer a patient to the other (i) HMOs and competitive medical
party for the provision of a specialty plans with cost-based contracts under
service payable in whole or in part section 1876 of the Act where the agree-
under Medicare, Medicaid or any other ment with the eligible managed care
Federal health care programs in return organization sets out the arrangements
for an agreement on the part of the in accordance with which the first tier
other party to refer that patient back contractor is billing the Federal health
at a mutually agreed upon time or cir- care program;
cumstance as long as the following four (ii) Federally qualified HMOs without
standards are met— a contract under sections 1854 or 1876 of
(1) The mutually agreed upon time or the Act, where the agreement with the
circumstance for referring the patient eligible managed care organization sets
back to the originating individual or out the arrangements in accordance
entity is clinically appropriate. with which the first tier contractor is
(2) The service for which the referral billing the Federal health care pro-
is made is not within the medical ex- gram; or
pertise of the referring individual or (iii) First tier contractors that are
entity, but is within the special exper- Federally qualified health centers that
tise of the other party receiving the re- claim supplemental payments from a
ferral. Federal health care program.
(3) The parties receive no payment (B) In establishing the terms of the
from each other for the referral and do agreement, neither party gives or re-
not share or split a global fee from any ceives remuneration in return for or to
Federal health care program in connec- induce the provision or acceptance of
tion with the referred patient. business (other than business covered
(4) Unless both parties belong to the by the agreement) for which payment
same group practice as defined in para- may be made in whole or in part by a
graph (p) of this section, the only ex- Federal health care program on a fee-
change of value between the parties is for-service or cost basis.
the remuneration the parties receive (C) Neither party to the agreement
directly from third-party payors or the shifts the financial burden of the agree-
patient compensating the parties for ment to the extent that increased pay-
the services they each have furnished ments are claimed from a Federal
to the patient. health care program.
(t) Price reductions offered to eligible (ii) A first tier contractor and a
managed care organizations. (1) As used downstream contractor or between two
in section 1128(B) of the Act, ‘‘remu- downstream contractors to provide or
neration’’ does not include any pay- arrange for items or services, as long
ment between: as the following four standards are
(i) An eligible managed care organi- met—
zation and any first tier contractor for (A) The parties have an agreement
providing or arranging for items or that:
services, as long as the following three (1) Is set out in writing and signed by
standards are met— both parties;
(A) The eligible managed care organi- (2) Specifies the items and services
zation and the first tier contractor covered by the agreement;
have an agreement that: (3) Is for a period of at least one year;
(1) Is set out in writing and signed by and
both parties; (4) Specifies that the party providing
(2) Specifies the items and services the items or services cannot claim pay-
covered by the agreement; ment in any form from a Federal
(3) Is for a period of at least one year; health care program for items or serv-
and ices covered under the agreement.
(4) Specifies that the first tier con- (B) In establishing the terms of the
tractor cannot claim payment in any agreement, neither party gives or re-
form directly or indirectly from a Fed- ceives remuneration in return for or to
eral health care program for items or induce the provision or acceptance of
1149
§ 1001.952 42 CFR Ch. V (10–1–24 Edition)
business (other than business covered (D) Any other health plans that pro-
by the agreement) for which payment vide or arrange for items and services
may be made in whole or in part by a for Medicaid enrollees in accordance
Federal health care program on a fee- with a risk-based contract with a State
for-service or cost basis. agency subject to the upper payment
(C) Neither party shifts the financial limits in § 447.361 of this title or an
burden of the agreement to the extent equivalent payment cap approved by
that increased payments are claimed the Secretary;
from a Federal health care program. (E) Programs For All Inclusive Care
(D) The agreement between the eligi- For The Elderly (PACE) under sections
ble managed care organization and 1894 and 1934 of the Act, except for for-
first tier contractor covering the items profit demonstrations under sections
or services that are covered by the 4801(h) and 4802(h) of Pub. L. 105–33; or
agreement between the parties does (F) A Federally qualified HMO.
not involve: (iii) First tier contractor means an in-
(1) A Federally qualified health cen- dividual or entity that has a contract
ter receiving supplemental payments; directly with an eligible managed care
(2) A HMO or CMP with a cost-based organization to provide or arrange for
contract under section 1876 of the Act; items or services.
or (iv) Items and services means health
(3) A Federally qualified HMO, unless care items, devices, supplies or services
the items or services are covered by a or those services reasonably related to
risk based contract under sections 1854 the provision of health care items, de-
or 1876 of the Act. vices, supplies or services including,
(2) For purposes of this paragraph, but not limited to, non-emergency
the following terms are defined as fol- transportation, patient education, at-
lows: tendant services, social services (e.g.,
(i) Downstream contractor means an case management), utilization review
individual or entity that has a sub- and quality assurance. Marketing and
contract directly or indirectly with a other pre-enrollment activities are not
first tier contractor for the provision ‘‘items or services’’ for purposes of this
or arrangement of items or services section.
that are covered by an agreement be- (u) Price reductions offered by contrac-
tween an eligible managed care organi- tors with substantial financial risk to
zation and the first tier contractor.
managed care organizations. (1) As used
(ii) Eligible managed care organization 1
in section 1128(B) of the Act, ‘‘remu-
means—
neration’’ does not include any pay-
(A) A HMO or CMP with a risk or
ment between:
cost based contract in accordance with
(i) A qualified managed care plan and
section 1876 of the Act;
a first tier contractor for providing or
(B) Any Medicare Part C health plan
that receives a capitated payment from arranging for items or services, where
Medicare and which must have its total the following five standards are met—
Medicare beneficiary cost sharing ap- (A) The agreement between the quali-
proved by CMS under section 1854 of fied managed care plan and first tier
the Act; contractor must:
(C) Medicaid managed care organiza- (1) Be in writing and signed by the
tions as defined in section 1903(m)(1)(A) parties;
that provide or arrange for items or (2) Specify the items and services
services for Medicaid enrollees under a covered by the agreement;
contract in accordance with section (3) Be for a period of a least one year;
1903(m) of the Act (except for fee-for- (4) Require participation in a quality
service plans or medical savings ac- assurance program that promotes the
counts); coordination of care, protects against
underutilization and specifies patient
1 The eligible managed care organizations goals, including measurable outcomes
in paragraphs (u)(2)(ii)(A)–(F) of this section where appropriate; and
are only eligible with respect to items or (5) Specify a methodology for deter-
services covered by the contracts specified in mining payment that is commercially
those paragraphs. reasonable and consistent with fair
1150
market value established in an arms- (v) Alternatively, for a first tier con-
length transaction and includes the in- tractor that is a physician, the quali-
tervals at which payments will be fied managed care plan has placed the
made and the formula for calculating physician at risk for referral services
incentives and penalties, if any. in an amount that exceeds the substan-
(B) If a first tier contractor has an tial financial risk threshold set forth
investment interest in a qualified man- in 42 CFR 417.479(f) and the arrange-
aged care plan, the investment interest ment is in compliance with the stop-
must meet the criteria of paragraph loss and beneficiary survey require-
(a)(1) of this section. ments of 42 CFR 417.479(g).
(C) The first tier contractor must (D) Payments for items and services
have substantial financial risk for the reimbursable by Federal health care
cost or utilization of services it is obli- program must comply with the fol-
gated to provide through one of the following two standards—
lowing four payment methodologies: (1) The qualified managed care plan
(1) A periodic fixed payment per pa- (or in the case of a self-funded em-
tient that does not take into account ployer plan that contracts with a
the dates services are provided, the fre- qualified managed care plan to provide
quency of services, or the extent or administrative services, the self-funded
kind of services provided; employer plan) must submit the claims
directly to the Federal health care pro-
(2) Percentage of premium;
gram, in accordance with a valid reas-
(3) Inpatient Federal health care pro- signment agreement, for items or serv-
gram diagnosis-related groups (DRGs) ices reimbursed by the Federal health
(other than those for psychiatric serv- care program. (Notwithstanding the
ices); foregoing, inpatient hospital services,
(4) Bonus and withhold arrange- other than psychiatric services, will be
ments, provided— deemed to comply if the hospital is re-
(i) The target payment for first tier imbursed by a Federal health care pro-
contractors that are individuals or gram under a DRG methodology.)
non-institutional providers is at least (2) Payments to first tier contractors
20 percent greater than the minimum and any downstream contractors for
payment, and for first tier contractors providing or arranging for items or
that are institutional providers, i.e., services reimbursed by a Federal
hospitals and nursing homes, is at least health care program must be identical
10 percent greater than the minimum to payment arrangements to or be-
payment; tween such parties for the same items
(ii) The amount at risk, i.e., the or services provided to other bene-
bonus or withhold, is earned by a first ficiaries with similar health status,
tier contractor in direct proportion to provided that such payments may be
the ratio of the contractor’s actual uti- adjusted where the adjustments are re-
lization to its target utilization; lated to utilization patterns or costs of
(iii) In calculating the percentage in providing items or services to the rel-
accordance with paragraph evant population.
(u)(1)(i)(C)(4)(i) of this section, both the (E) In establishing the terms of an
target payment amount and the min- arrangement—
imum payment amount include any (1) Neither party gives or receives re-
performance bonus, e.g., payments for muneration in return for or to induce
timely submission of paperwork, con- the provision or acceptance of business
tinuing medical education, meeting at- (other than business covered by the ar-
tendance, etc., at a level achieved by 75 rangement) for which payment may be
percent of the first tier contractors made in whole or in part by a Federal
who are eligible for such payments; health care program on a fee-for-serv-
(iv) Payment amounts, including any ice or cost basis; and
bonus or withhold amounts, are reason- (2) Neither party to the arrangement
able given the historical utilization shifts the financial burden of such ar-
patterns and costs for the same or com- rangement to the extent that increased
parable populations in similar man- payments are claimed from a Federal
aged care arrangements; and health care program.
1151
§ 1001.952 42 CFR Ch. V (10–1–24 Edition)
(ii) A first tier contractor and a qualified managed care plan’s perform-
downstream contractor, or between ance (or combination thereof).
downstream contractors, to provide or (iv) Items and services means health
arrange for items or services, as long care items, devices, supplies or services
as the following three standards are or those services reasonably related to
met— the provision of health care items, de-
(A) Both parties are being paid for vices, supplies or services including,
the provision or arrangement of items but not limited to, non-emergency
or services in accordance with one of transportation, patient education, at-
the payment methodologies set out in tendant services, social services (e.g.,
paragraph (u)(1)(i)(C) of this section; case management), utilization review
(B) Payment arrangements for items and quality assurance. Marketing or
and services reimbursable by a Federal other pre-enrollment activities are not
health care program comply with para- ‘‘items or services’’ for purposes of this
graph (u)(1)(i)(D) of this section; and definition in this paragraph.
(C) In establishing the terms of an ar- (v) Minimum payment is the guaran-
rangement— teed amount that a provider is entitled
(1) Neither party gives or receives re- to receive under an agreement with a
muneration in return for or to induce first tier or downstream contractor or
the provision or acceptance of business a qualified managed care plan.
(other than business covered by the ar- (vi) Qualified managed care plan
rangement) for which payment may be means a health plan as defined in para-
made in whole or in part by a Federal graph (l)(2) of this section that:
health care program on a fee-for-serv- (A) Provides a comprehensive range
ice or cost basis; and of health services;
(2) Neither party to the arrangement (B) Provides or arranges for—
shifts the financial burden of the ar- (1) Reasonable utilization goals to
rangement to the extent that increased avoid inappropriate utilization;
payments are claimed from a Federal (2) An operational utilization review
health care program. program;
(2) For purposes of this paragraph, (3) A quality assurance program that
the following terms are defined as fol- promotes the coordination of care, pro-
lows: tects against underutilization, and
(i) Downstream contractor means an specifies patient goals, including meas-
individual or entity that has a sub- urable outcomes where appropriate;
contract directly or indirectly with a (4) Grievance and hearing procedures;
first tier contractor for the provision (5) Protection of enrollees from in-
or arrangement of items or services curring financial liability other than
that are covered by an agreement be- copayments and deductibles; and
tween a qualified managed care plan (6) Treatment for Federal health care
and the first tier contractor. program beneficiaries that is not dif-
(ii) First tier contractor means an indi- ferent than treatment for other enroll-
vidual or entity that has a contract di- ees because of their status as Federal
rectly with a qualified managed care health care program beneficiaries; and
plan to provide or arrange for items or (C) Covers a beneficiary population of
services. which either—
(iii) Is obligated to provide for a con- (1) No more than 10 percent are Medi-
tractor refers to items or services: care beneficiaries, not including per-
(A) Provided directly by an indi- sons for whom a Federal health care
vidual or entity and its employees; program is the secondary payer; or
(B) For which an individual or entity (2) No more than 50 percent are Medi-
is financially responsible, but which care beneficiaries (not including per-
are provided by downstream contrac- sons for whom a Federal health care
tors; program is the secondary payer), pro-
(C) For which an individual or entity vided that payment of premiums is on
makes referrals or arrangements; or a periodic basis that does not take into
(D) For which an individual or entity account the dates services are ren-
receives financial incentives based on dered, the frequency of services, or the
its own, its provider group’s, or its extent or kind of services rendered, and
1152
provided further that such periodic (2) To qualify under paragraph (v) of
payments for the non-Federal health this section, the ambulance replen-
care program beneficiaries do not take ishing arrangement must satisfy all of
into account the number of Federal the following four conditions—
health care program fee-for-service (i)(A) Under no circumstances may
beneficiaries covered by the agreement the ambulance provider (or first re-
or the amount of services generated by sponder) and the receiving facility both
such beneficiaries. bill for the same replenished drug or
(vii) Target payment means the fair supply. Replenished drugs or supplies
market value payment established may only be billed (including claiming
through arms length negotiations that bad debt) to a Federal health care pro-
will be earned by an individual or enti- gram by either the ambulance provider
ty that: (or first responder) or the receiving fa-
(A) Is dependent on the individual or cility.
entity’s meeting a utilization target or (B) All billing or claims submission
range of utilization targets that are set by the receiving facility, ambulance
consistent with historical utilization provider or first responder for replen-
rates for the same or comparable popu- ished drugs and medical supplies used
lations in similar managed care ar- in connection with the transport of a
rangements, whether based on its own, Federal health care program bene-
its provider group’s or the qualified ficiary must comply with all applicable
managed care plan’s utilization (or a Federal health care program payment
and coverage rules and regulations.
combination thereof); and
(C) Compliance with paragraph
(B) Does not include any bonus or
(v)(2)(i)(B) of this section will be deter-
fees that the individual or entity may
mined separately for the receiving fa-
earn from exceeding the utilization cility and the ambulance provider (and
target. first responder, if any), so long as the
(v) Ambulance replenishing. (1) As used receiving facility, ambulance provider
in section 1128B of the Act, ‘‘remu- (or first responder) refrains from doing
neration’’ does not include any gift or anything that would impede the other
transfer of drugs or medical supplies party or parties from meeting their ob-
(including linens) by a hospital or ligations under paragraph (v)(2)(i)(B).
other receiving facility to an ambu- (ii)(A) The receiving facility or am-
lance provider for the purpose of re- bulance provider, or both, must
plenishing comparable drugs or med- (1) Maintain records of the replen-
ical supplies (including linens) used by ished drugs and medical supplies and
the ambulance provider (or a first re- the patient transport to which the re-
sponder) in connection with the trans- plenished drugs and medical supplies
port of a patient by ambulance to the related;
hospital or other receiving facility if (2) Provide a copy of such records to
all of the standards in paragraph (v)(2) the other party within a reasonable
of this section are satisfied and all of time (unless the other party is sepa-
the applicable standards in either para- rately maintaining records of the re-
graph (v)(3)(i), (v)(3)(ii) or (v)(3)(iii) of plenished drugs and medical supplies);
this section are satisfied. However, to and
qualify under paragraph (v), the ambu- (3) Make those records available to
lance that is replenished must be used the Secretary promptly upon request.
to provide emergency ambulance serv- (B) A pre-hospital care report (in-
ices an average of three times per cluding, but not limited to, a trip
week, as measured over a reasonable sheet, patient care report or patient
period of time. Drugs and medical sup- encounter report) prepared by the am-
plies (including linens) initially used bulance provider and filed with the re-
by a first responder and replenished at ceiving facility will meet the require-
the scene of the illness or injury by the ments of paragraph (v)(2)(ii)(A) of this
ambulance provider that transports the section, provided that it documents the
patient to the hospital or other receiv- specific type and amount of medical
ing facility will be deemed to have supplies and drugs used on the patient
been used by the ambulance provider. and subsequently replenished.
1153
§ 1001.952 42 CFR Ch. V (10–1–24 Edition)
(C) For purposes of paragraph each category, the receiving facility

(v)(2)(ii) of this section, documentation may limit its replenishing arrange-
may be maintained and, if required, ments to the replenishing of emergency
filed with the other party in hard copy ambulance transports only. A receiving
or electronically. If a replenishing ar- facility may offer replenishing to one
rangement includes linens, documenta- or more of the categories—
tion need not be maintained for their (1) All ambulance providers that do
exchange. If documentation is not not bill any patient or insurer (includ-
maintained for the exchange of linens, ing Federal health care programs) for
the receiving facility will be presumed ambulance services, regardless of the
to have provided an exchange of com- payor or the patient’s ability to pay
parable clean linens for soiled linens (i.e., ambulance providers, such as vol-
for each ambulance transport of a pa-
unteer companies, that provide ambu-
tient to the receiving facility. Records
lance services without charge to any
required under paragraph (v)(2)(ii)(A)
person or entity);
of this section must be maintained for
5 years. (2) All not-for-profit and State or
(iii) The replenishing arrangement local government ambulance service
must not take into account the volume providers (including, but not limited
or value of any referrals or business to, municipal and volunteer ambulance
otherwise generated between the par- services providers); or
ties for which payment may be made in (3) All ambulance service providers.
whole or in part under any Federal (B)(1) The replenishing arrangement
health care program (other than the re- must be conducted in an open and pub-
ferral of the particular patient to lic manner. A replenishing arrange-
whom the replenished drugs and med- ment will be considered to be con-
ical supplies were furnished). ducted in an open and public manner if
(iv) The receiving facility and the one of the following two conditions are
ambulance provider otherwise comply satisfied:
with all Federal, State, and local laws (i) A written disclosure of the replen-
regulating ambulance services, includ- ishing program is posted conspicuously
ing, but not limited to, emergency in the receiving facility’s emergency
services, and the provision of drugs and room or other location where the am-
medical supplies, including, but not bulance providers deliver patients and
limited to, laws relating to the han- copies are made available upon request
dling of controlled substances. to ambulance providers, Government
(3) To qualify under paragraph (v) of
representatives, and members of the
this section, the arrangement must
public (subject to reasonable
satisfy all of the standards in one of the
photocopying charges). The written
following three categories:
disclosure can take any reasonable
(i) General replenishing. (A) The re-
ceiving facility must replenish medical form and should include the category
supplies or drugs on an equal basis for of ambulance service providers that
all ambulance providers that bring pa- qualifies for replenishment; the drugs
tients to the receiving facility in any or medical supplies included in the re-
one of the categories described in para- plenishment program; and the proce-
graph (v)(3)(i)(A)(1), (2), or (3) of this dures for documenting the replenish-
section. A receiving facility may offer ment. A sample disclosure form is in-
replenishing to one or more of the cat- cluded in appendix A to subpart C of
egories and may offer different replen- this part for illustrative purposes only.
ishing arrangements to different cat- No written contracts between the par-
egories, so long as the replenishing is ties are required for purposes of para-
conducted uniformly within each cat- graph (v)(3)(i)(B)(1)(i) of this section; or
egory. For example, a receiving facility (ii) The replenishment arrangement
may offer to replenish a broader array operates in accordance with a plan or
of drugs or supplies for ambulance pro- protocol of general application promul-
viders that do no not charge for their gated by an Emergency Medical Serv-
services than for ambulance providers ices (EMS) Council or comparable enti-
that charge for their services. Within ty, agency or organization, provided a
1154
copy of the plan or protocol is avail- include a provider of ambulance trans-

able upon request to ambulance pro- port services that provides only non-
viders, Government representatives emergency transport services.
and members of the public (subject to (iii) A first responder includes, but is
reasonable photocopying charges). not limited to, a fire department, para-
While parties are encouraged to par- medic service or search and rescue
ticipate in collaborative, comprehen- squad that responds to an emergency
sive, community-wide EMS systems to call (through 9–1–1 or other emergency
improve the delivery of EMS in their access number) and treats the patient,
local communities, nothing in this but does not transport the patient to
paragraph shall be construed as requir- the hospital or other receiving facility.
ing the involvement of such organiza- (iv) An emergency ambulance service is
tions or the development or implemen- a transport by ambulance initiated as a
tation of ambulance replenishment result of a call through 9–1–1 or other
plans or protocols by such organiza- emergency access number or a call
tions. from another acute care facility unable
(2) Nothing in this paragraph (v)(3)(i) to provide the higher level care re-
shall be construed as requiring disclo- quired by the patient and available at
sure of confidential proprietary or fi- the receiving facility.
nancial information related to the re- (v) Medical supplies includes linens,
plenishing arrangement (including, but unless otherwise provided.
not limited to, information about cost, (w) Health centers. As used in section
pricing or the volume of replenished 1128B of the Act, ‘‘remuneration’’ does
drugs or supplies) to ambulance pro- not include the transfer of any goods,
viders or members of the general pub- items, services, donations or loans
lic. (whether the donation or loan is in
(ii) Fair market value replenishing. (A) cash or in-kind), or combination there-
Except as otherwise provided in para- of from an individual or entity to a
graph (v)(3)(ii)(B) of this section, the health center (as defined in this para-
ambulance provider must pay the re- graph), as long as the following nine
ceiving facility fair market value, standards are met—
based on an arms-length transaction, (1)(i) The transfer is made pursuant
for replenished medical supplies; and to a contract, lease, grant, loan, or
(B) If payment is not made at the other agreement that—
same time as the replenishing of the (A) Is set out in writing;
medical supplies, the receiving facility (B) Is signed by the parties; and
and the ambulance provider must make (C) Covers, and specifies the amount
commercially reasonable payment ar- of, all goods, items, services, dona-
rangements in advance. tions, or loans to be provided by the in-
(iii) Government mandated replen- dividual or entity to the health center.
ishing. The replenishing arrangement is (ii) The amount of goods, items, serv-
undertaken in accordance with a State ices, donations, or loans specified in
or local statute, ordinance, regulation the agreement in accordance with
or binding protocol that requires hos- paragraph (w)(1)(i)(C) of this section
pitals or receiving facilities in the area may be a fixed sum, fixed percentage,
subject to such requirement to replen- or set forth by a fixed methodology.
ish ambulances that deliver patients to The amount may not be conditioned on
the hospital with drugs or medical sup- the volume or value of Federal health
plies (including linens) that are used care program business generated be-
during the transport of that patient. tween the parties. The written agree-
(4) For purposes of paragraph (v) of ment will be deemed to cover all goods,
this section— items, services, donations, or loans
(i) A receiving facility is a hospital or provided by the individual or entity to
other facility that provides emergency the health center as required by para-
medical services. graph (w)(1)(i)(C) of this section if all
(ii) An ambulance provider is a pro- separate agreements between the indi-
vider or supplier of ambulance trans- vidual or entity and the health center
port services that provides emergency incorporate each other by reference or
ambulance services. The term does not if they cross-reference a master list of
1155
§ 1001.952 42 CFR Ch. V (10–1–24 Edition)
agreements that is maintained cen- (6) Individuals and entities that offer
trally, is kept up to date, and is avail- to furnish goods, items, or services
able for review by the Secretary upon without charge or at a reduced charge
request. The master list should be to the health center must furnish such
maintained in a manner that preserves goods, items, or services to all patients
the historical record of arrangements. from the health center who clinically
(2) The goods, items, services, dona- qualify for the goods, items, or serv-
tions, or loans are medical or clinical ices, regardless of the patient’s payor
in nature or relate directly to services status or ability to pay. The individual
provided by the health center as part of or entity may impose reasonable limits
the scope of the health center’s section on the aggregate volume or value of
330 grant (including, by way of exam- the goods, items, or services furnished
ple, billing services, administrative under the arrangement with the health
support services, technology support, center, provided such limits do not
and enabling services, such as case take into account a patient’s payor
management, transportation, and status or ability to pay.
translation services, that are within (7) The agreement must not restrict
the health center’s ability, if it choos-
the scope of the grant).
es, to enter into agreements with other
(3) The health center reasonably ex- providers or suppliers of comparable
pects the arrangement to contribute goods, items, or services, or with other
meaningfully to the health center’s lenders or donors. Where a health cen-
ability to maintain or increase the ter has multiple individuals or entities
availability, or enhance the quality, of willing to offer comparable remunera-
services provided to a medically under- tion, the health center must employ a
served population served by the health reasonable methodology to determine
center, and the health center docu- which individuals or entities to select
ments the basis for the reasonable ex- and must document its determination.
pectation prior to entering the ar- In making these determinations,
rangement. The documentation must health centers should look to the pro-
be made available to the Secretary curement standards for beneficiaries of
upon request. Federal grants set forth in 45 CFR
(4) At reasonable intervals, but at 75.326 through 75.340.
least annually, the health center must (8) The health center must provide ef-
re-evaluate the arrangement to ensure fective notification to patients of their
that the arrangement is expected to freedom to choose any willing provider
continue to satisfy the standard set or supplier. In addition, the health cen-
forth in paragraph (w)(3) of this sec- ter must disclose the existence and na-
tion, and must document the re-evalua- ture of an agreement under paragraph
tion contemporaneously. The docu- (w)(1) of this section to any patient
mentation must be made available to who inquires. The health center must
the Secretary upon request. Arrange- provide such notification or disclosure
ments must not be renewed or renego- in a timely fashion and in a manner
tiated unless the health center reason- reasonably calculated to be effective
ably expects the standard set forth in and understood by the patient.
paragraph (w)(3) of this section to be (9) The health center may, at its op-
satisfied in the next agreement term. tion, elect to require that an individual
Renewed or renegotiated agreements or entity charge a referred health cen-
must comply with the requirements of ter patient the same rate it charges
paragraph (w)(3) of this section. other similarly situated patients not
(5) The individual or entity does not referred by the health center or that
(i) Require the health center (or its af- the individual or entity charge a re-
filiated health care professionals) to ferred health center patient a reduced
refer patients to a particular individual rate (where the discount applies to the
or entity, or total charge and not just to the cost-
(ii) restrict the health center (or its sharing portion owed by an insured pa-
affiliated health care professionals) tient).
from referring patients to any indi- NOTE TO PARAGRAPH (w): For purposes of
vidual or entity. this paragraph, the term ‘‘health center’’
1156
means a Federally Qualified Health Center value of referrals or other business gen-
under section 1905(l)(2)(B)(i) or erated between the parties.
1905(l)(2)(B)(ii) of the Act, and ‘‘medically
underserved population’’ means a medically
(7) The arrangement is set forth in a
underserved population as defined in regula- written agreement that—
tions at 42 CFR 51c.102(e). (i) Is signed by the parties;
(ii) Specifies the items and services
(x) Electronic prescribing items and
services. As used in section 1128B of the being provided and the donor’s cost of
Act, ‘‘remuneration’’ does not include the items and services; and
nonmonetary remuneration (consisting (iii) Covers all of the electronic pre-
of items and services in the form of scribing items and services to be pro-
hardware, software, or information vided by the donor (or affiliated par-
technology and training services) nec- ties). This requirement will be met if
essary and used solely to receive and all separate agreements between the
transmit electronic prescription infor- donor (and affiliated parties) and the
mation, if all of the following condi- beneficiary incorporate each other by
tions are met: reference or if they cross-reference a
(1) The items and services are pro- master list of agreements that is main-
vided by a— tained and updated centrally and is
(i) Hospital to a physician who is a available for review by the Secretary
member of its medical staff; upon request. The master list should be
(ii) Group practice to a prescribing maintained in a manner that preserves
health care professional who is a mem- the historical record of agreements.
ber of the group practice; and (8) The donor does not have actual
(iii) A PDP sponsor or MA organiza- knowledge of, and does not act in reck-
tion to pharmacists and pharmacies less disregard or deliberate ignorance
participating in the network of such of, the fact that the beneficiary pos-
sponsor or organization and to pre- sesses or has obtained items or services
scribing health care professionals. equivalent to those provided by the
(2) The items and services are pro- donor.
vided as part of, or are used to access,
NOTE TO PARAGRAPH (x): For purposes of
an electronic prescription drug pro- paragraph (x) of this section, group practice
gram that meets the applicable stand- shall have the meaning set forth at 42 CFR
ards under Medicare Part D at the time 411.352; member of the group practice shall
the items and services are provided. mean all persons covered by the definition of
(3) The donor (or any person on the ‘‘member of the group or member of a group
donor’s behalf) does not take any ac- practice’’ at 42 CFR 411.351, as well as other
tion to limit or restrict the use or com- prescribing health care professionals who are
patibility of the items or services with owners or employees of the group practice;
other electronic prescribing or elec- prescribing health care professional shall mean
a physician or other health care professional
tronic health records systems.
licensed to prescribe drugs in the State in
(4) For items or services that are of which the drugs are dispensed; PDP sponsor
the type that can be used for any pa- or MA organization shall have the meanings
tient without regard to payor status, set forth at 42 CFR 423.4 and 422.2, respec-
the donor does not restrict, or take any tively; prescription information shall mean in-
action to limit, the recipient’s right or formation about prescriptions for drugs or
ability to use the items or services for for any other item or service normally ac-
any patient. complished through a written prescription;
(5) Neither the recipient nor the re- and electronic health record shall mean a re-
cipient’s practice (or any affiliated in- pository of consumer health status informa-
tion in computer processable form used for
dividual or entity) makes the receipt of
clinical diagnosis and treatment for a broad
items or services, or the amount or na- array of clinical conditions.
ture of the items or services, a condi-
tion of doing business with the donor. (y) Electronic health records items and
(6) Neither the eligibility of a bene- services. As used in section 1128B of the
ficiary for the items or services, nor Act, ‘‘remuneration’’ does not include
the amount or nature of the items or nonmonetary remuneration (consisting
services, is determined in a manner of items and services in the form of
that takes into account the volume or software or information technology
1157
§ 1001.952 42 CFR Ch. V (10–1–24 Edition)
and training services, including cyber- (ii) The determination is based on the
security software and services) nec- size of the recipient’s medical practice
essary and used predominantly to cre- (for example, total patients, total pa-
ate, maintain, transmit, receive, or tient encounters, or total relative
protect electronic health records, if all value units);
of the conditions in paragraphs (y)(1) (iii) The determination is based on
through (13) of this section are met: the total number of hours that the re-
(1) The items and services are pro- cipient practices medicine;
vided to an individual or entity en- (iv) The determination is based on
gaged in the delivery of health care by: the recipient’s overall use of auto-
(i) An individual or entity, other mated technology in his or her medical
than a laboratory company, that: practice (without specific reference to
(A) Provides services covered by a the use of technology in connection
Federal health care program and sub- with referrals made to the donor);
mits claims or requests for payment, (v) The determination is based on
either directly or through reassign- whether the recipient is a member of
ment, to the Federal health care pro- the donor’s medical staff, if the donor
gram; or has a formal medical staff;
(B) Is comprised of the types of indi- (vi) The determination is based on
viduals or entities in paragraph the level of uncompensated care pro-
(y)(1)(i)(A) of this section; or vided by the recipient; or
(ii) A health plan. (vii) The determination is made in
(2) The software is interoperable at any reasonable and verifiable manner
the time it is provided to the recipient. that does not directly take into ac-
For purposes of this paragraph (y)(2) of count the volume or value of referrals
this section, software is deemed to be or other business generated between
interoperable if, on the date it is pro- the parties.
vided to the recipient, it is certified by (6) The arrangement is set forth in a
a certifying body authorized by the Na- written agreement that —
tional Coordinator for Health Informa- (i) Is signed by the parties;
tion Technology to certification cri- (ii) Specifies the items and services
teria identified in the then-applicable being provided, the donor’s cost of
version of 45 CFR part 170. those items and services, and the
(3) [Reserved] amount of the recipient’s contribution;
(4) Neither the recipient nor the re- and
cipient’s practice (or any affiliated in- (iii) Covers all of the electronic
dividual or entity) makes the receipt of health records items and services to be
items or services, or the amount or na- provided by the donor (or any affiliate).
ture of the items or services, a condi- This requirement will be met if all sep-
tion of doing business with the donor. arate agreements between the donor
(5) Neither the eligibility of a recipi- (and affiliated parties) and the bene-
ent for the items or services, nor the ficiary incorporate each other by ref-
amount or nature of the items or serv- erence or if they cross-reference a mas-
ices, is determined in a manner that di- ter list of agreements that is main-
rectly takes into account the volume tained and updated centrally and is
or value of referrals or other business available for review by the Secretary
generated between the parties. For the upon request. The master list should be
purposes of this paragraph (y)(5), the maintained in a manner that preserves
determination is deemed not to di- the historical record of agreements.
rectly take into account the volume or (7) [Reserved]
value of referrals or other business gen- (8) For items or services that are of
erated between the parties if any one of the type that can be used for any pa-
the following conditions is met: tient without regard to payor status,
(i) The determination is based on the the donor does not restrict, or take any
total number of prescriptions written action to limit, the recipient’s right or
by the beneficiary (but not the volume ability to use the items or services for
or value of prescriptions dispensed or any patient.
paid by the donor or billed to a Federal (9) The items and services do not in-
health care program); clude staffing of the recipient’s office
1158
and are not used primarily to conduct pursuant to a written agreement de-
personal business or business unrelated scribed in section 1853(a)(4) of the Act.
to the recipient’s clinical practice or (aa) Medicare Coverage Gap Discount
clinical operations. Program. As used in section 1128B of the
(10) [Reserved] Act, ‘‘remuneration’’ does not include
(11) The recipient pays 15 percent of a discount in the price of a drug when
the donor’s cost for the items and serv- the discount is furnished to a bene-
ices. The following conditions apply to ficiary under the Medicare Coverage
such contribution: Gap Discount Program established in
(i) If the donation is the initial dona- section 1860D–14A of the Act, as long as
tion of EHR items and services, or the all the following requirements are met:
replacement of part or all of an exist- (1) The discounted drug meets the
ing system of EHR items and services, definition of ‘‘applicable drug’’ set
the recipient must pay 15 percent of forth in section 1860D–14A(g) of the
the donor’s cost before receiving the Act;
items and services. The contribution (2) The beneficiary receiving the dis-
for updates to previously donated EHR count meets the definition of ‘‘applica-
items and services need not be paid in ble beneficiary’’ set forth in section
advance of receiving the update; and 1860D–14A(g) of the Act; and
(ii) The donor (or any affiliated indi- (3) The manufacturer of the drug par-
vidual or entity) does not finance the ticipates in, and is in compliance with
recipient’s payment or loan funds to be the requirements of, the Medicare Cov-
used by the recipient to pay for the erage Gap Discount Program.
items and services. (bb) Local Transportation. As used in
(12) The donor does not shift the section 1128B of the Act, ‘‘remunera-
costs of the items or services to any tion’’ does not include free or dis-
Federal health care program. counted local transportation made
(13) [Reserved] available by an eligible entity (as de-
(14) For purposes of this paragraph fined in this paragraph (bb)):
(y), the following definitions apply: (1) To Federal health care program
(i) Cybersecurity means the process of beneficiaries if all the following condi-
protecting information by preventing, tions are met:
detecting, and responding to (i) The availability of the free or dis-
cyberattacks. counted local transportation services—
(ii) Health plan shall have the mean- (A) Is set forth in a policy, which the
ing set forth at § 1001.952(l)(2). eligible entity applies uniformly and
(iii) Interoperable shall mean able to: consistently; and
(A) Securely exchange data with and (B) Is not determined in a manner re-
use data from other health information lated to the past or anticipated volume
technology; and or value of Federal health care pro-
(B) Allow for complete access, ex- gram business;
change, and use of all electronically (ii) The free or discounted local
accessible health information for au- transportation services are not air,
thorized use under applicable State or luxury, or ambulance-level transpor-
Federal law. tation;
(iv) Electronic health record shall (iii) The eligible entity does not pub-
mean a repository of consumer health licly market or advertise the free or
status information in computer discounted local transportation serv-
processable form used for clinical diag- ices, no marketing of health care items
nosis and treatment for a broad array and services occurs during the course
of clinical conditions. of the transportation or at any time by
(z) Federally Qualified Health Centers drivers who provide the transportation,
and Medicare Advantage Organizations. and drivers or others arranging for the
As used in section 1128B of the Act, transportation are not paid on a per-
‘‘remuneration’’ does not include any beneficiary-transported basis;
remuneration between a federally (iv) The eligible entity makes the
qualified health center (or an entity free or discounted transportation avail-
controlled by such a health center) and able only:
a Medicare Advantage organization (A) To an individual who is:
1159
§ 1001.952 42 CFR Ch. V (10–1–24 Edition)
(1) An established patient (as defined tween that stop and any providers or
in this paragraph (bb)) of the eligible suppliers on the route;
entity that is providing the free or dis- (iv) The eligible entity that makes
counted transportation, if the eligible the shuttle service available bears the
entity is a provider or supplier of costs of the free or discounted shuttle
health care services; and services and does not shift the burden
(2) An established patient of the proof these costs onto any Federal health
vider or supplier to or from which the care program, other payers, or individ-
individual is being transported; uals.
(B) Within 25 miles of the health care (3) For purposes of this paragraph
provider or supplier to or from which (bb), the following definitions apply:
the patient would be transported, or
(i) An eligible entity is any individual
within 75 miles if the patient resides in
or entity, except for individuals or en-
a rural area, as defined in this para-
graph (bb) except that, if the patient is tities (or family members or others
discharged from an inpatient facility acting on their behalf) that primarily
following inpatient admission or re- supply health care items.
leased from a hospital after being (ii) An established patient is a person
placed in observation status for at who has selected and initiated contact
least 24 hours and transported to the to schedule an appointment with a pro-
patient’s residence, or another resi- vider or supplier, or who previously has
dence of the patient’s choice, the mile- attended an appointment with the pro-
age limits in this paragraph vider or supplier.
(bb)(1)(iv)(B) shall not apply; and (iii) A shuttle service is a vehicle that
(C) For the purpose of obtaining runs on a set route, on a set schedule.
medically necessary items and serv- (iv) A rural area is an area that is not
ices. an urban area, as defined in paragraph
(v) The eligible entity that makes (bb)(3)(v) of this section.
the transportation available bears the (v) An urban area is:
costs of the free or discounted local (A) A Metropolitan Statistical Area
transportation services and does not (MSA) or New England County Metro-
shift the burden of these costs onto any politan Area (NECMA), as defined by
Federal health care program, other the Executive Office of Management
payers, or individuals; and and Budget; or
(2) In the form of a ‘‘shuttle service’’ (B) The following New England coun-
(as defined in this paragraph (bb)) if all ties, which are deemed to be parts of
of the following conditions are met:
urban areas under section 601(g) of the
(i) The shuttle service is not air, lux-
Social Security Amendments of 1983
ury, or ambulance-level transpor-
(Pub. L. 98–21, 42 U.S.C. 1395ww (note)):
tation;
Litchfield County, Connecticut; York
(ii) The shuttle service is not mar-
County, Maine; Sagadahoc County,
keted or advertised (other than posting
necessary route and schedule details), Maine; Merrimack County, New Hamp-
no marketing of health care items and shire; and Newport County, Rhode Is-
services occurs during the course of the land.
transportation or at any time by driv- (cc) Point-of-sale reductions in price for
ers who provide the transportation, prescription pharmaceutical products. (1)
and drivers or others arranging for the As used in section 1128B of the Act,
transportation are not paid on a per- ‘‘remuneration’’ does not include a re-
beneficiary-transported basis; duction in price from a manufacturer
(iii) The eligible entity makes the to a plan sponsor under Medicare Part
shuttle service available only within D or a Medicaid Managed Care Organi-
the eligible entity’s local area, mean- zation for a prescription pharma-
ing there are no more than 25 miles ceutical product that is payable, in
from any stop on the route to any stop whole or in part, by a plan sponsor
at a location where health care items under Medicare Part D or a Medicaid
or services are provided, except that if Managed Care Organization, provided
a stop on the route is in a rural area, the following conditions are met with
the distance may be up to 75 miles be- regard to that reduction in price:
1160
(i) The manufacturer and the plan the services the PBM provides to the
sponsor under Medicare Part D, a Med- manufacturer in connection with the
icaid MCO, or the PBM acting under PBM’s arrangements with health plans
contract with either, set the reduction for the term of the agreement and
in price in advance, in writing, by the specifies each of the services to be pro-
time of the first purchase of the prod- vided by the PBM and the compensa-
uct at that reduced price by the plan tion associated with such services.
sponsor or Medicaid MCO on behalf of (ii) The services performed under the
an enrollee; agreement do not involve the coun-
(ii) The reduction in price does not seling or promotion of a business ar-
involve a rebate unless the full value of rangement or other activity that vio-
the reduction in price is provided to lates any State or Federal law.
the dispensing pharmacy by the manu- (iii) The compensation paid to the
facturer, directly or indirectly, PBM is:
through a point-of-sale chargeback or (A) Is consistent with fair market
series of point-of-sale chargebacks, or value in an arm’s-length transaction;
is required by law; and
(B) Is a fixed payment, not based on
(iii) The reduction in price must be
a percentage of sales; and
completely reflected in the price of the
prescription pharmaceutical product at (C) Is not determined in a manner
the time the pharmacy dispenses it to that takes into account the volume or
the beneficiary. value of any referrals or business oth-
(2)(i) For purposes of this paragraph erwise generated between the parties,
(cc), the terms manufacturer, phar- or between the manufacturer and the
macy benefit manager or PBM, pre- PBM’s health plans, for which payment
scription pharmaceutical product, and may be made in whole or in part under
rebate have the meanings ascribed to Medicare, Medicaid, or other Federal
them in paragraph (h) of this section. health care programs.
(ii) For purposes of this paragraph (iv) The PBM discloses in writing to
(cc), a point-of-sale chargeback is a each health plan with which it con-
payment by a manufacturer made di- tracts at least annually the services
rectly or indirectly (through a PBM or rendered to each pharmaceutical man-
other entity) to a dispensing pharmacy ufacturer related to the PBM’s ar-
equal to the reduction in price agreed rangements to furnish pharmacy ben-
upon in writing between the Plan efit management services to the health
Sponsor under Part D, the Medicaid plan, and to the Secretary upon re-
MCO, or a PBM acting under contract quest, the services rendered to each
with either, and the manufacturer of pharmaceutical manufacturer related
the prescription pharmaceutical prod- to the PBM’s arrangements to furnish
uct. pharmacy benefit management services
(iii) For purposes of this paragraph to the health plan and the fees paid for
(cc), the term Medicaid Managed Care such services.
Organization or Medicaid MCO carries (2) For purposes of safe harbor in this
the meaning ascribed to it in section paragraph (dd), the terms manufac-
1903(m) of the Social Security Act. turer, pharmacy benefit manager or
(dd) PBM service fees. (1) As used in PBM, and prescription pharmaceutical
section 1128B of the Act, ‘‘remunera- product have the meanings ascribed to
tion’’ does not include any payment by them in paragraph (h) of this section,
a pharmaceutical manufacturer to a and health plan has the meaning as-
pharmacy benefit manager (PBM) for cribed to it in paragraph (l) of this sec-
services the PBM provides to the phar- tion.
maceutical manufacturer related to (ee) Care coordination arrangements to
the pharmacy benefit management improve quality, health outcomes, and ef-
services that the PBM furnishes to one ficiency. As used in section 1128B of the
or more health plans as long as the fol- Act, ‘‘remuneration’’ does not include
lowing conditions are met: the exchange of anything of value be-
(i) The PBM has a written agreement tween a VBE and VBE participant or
with the pharmaceutical manufacturer, between VBE participants pursuant to
signed by the parties, that covers all of a value-based arrangement if all of the
1161
§ 1001.952 42 CFR Ch. V (10–1–24 Edition)
standards in paragraphs (ee)(1) through gitimate outcome or process measures

(13) of this section are met: that:
(1) The remuneration exchanged: (i) The parties reasonably anticipate
(i) Is in-kind; will advance the coordination and man-
(ii) Is used predominantly to engage agement of care for the target patient
in value-based activities that are di- population based on clinical evidence
rectly connected to the coordination or credible medical or health sciences
and management of care for the target support;
patient population and does not result (ii) Include one or more benchmarks
in more than incidental benefits to per- that are related to improving or main-
sons outside of the target patient popu- taining improvements in the coordina-
lation; and tion and management of care for the
(iii) Is not exchanged or used: target patient population;
(A) More than incidentally for the re- (iii) Are monitored, periodically as-
cipient’s billing or financial manage- sessed, and prospectively revised as
ment services; or necessary to ensure that the measure
(B) For the purpose of marketing and its benchmark continue to advance
items or services furnished by the VBE the coordination and management of
or a VBE participant to patients or for care of the target patient population;
patient recruitment activities. (iv) Relate to the remuneration ex-
(2) The value-based arrangement is changed under the value-based arrange-
commercially reasonable, considering ment; and
both the arrangement itself and all (v) Are not based solely on patient
value-based arrangements within the satisfaction or patient convenience.
VBE.
(5) The offeror of the remuneration
(3) The terms of the value-based ar-
does not take into account the volume
rangement are set forth in writing and
or value of, or condition the remunera-
signed by the parties in advance of, or
tion on:
contemporaneous with, the commence-
(i) Referrals of patients who are not
ment of the value-based arrangement
part of the target patient population;
and any material change to the value-
or
based arrangement. The writing states
at a minimum: (ii) Business not covered under the
(i) The value-based purpose(s) of the value-based arrangement.
value-based activities provided for in (6) The recipient pays at least 15 per-
the value-based arrangement; cent of the offeror’s cost for the remu-
(ii) The value-based activities to be neration, using any reasonable ac-
undertaken by the parties to the value- counting methodology, or the fair mar-
based arrangement; ket value of the in-kind remuneration.
(iii) The term of the value-based ar- If it is a one-time cost, the recipient
rangement; makes such contribution in advance of
(iv) The target patient population; receiving the in-kind remuneration. If
(v) A description of the remunera- it is an ongoing cost, the recipient
tion; makes such contribution at reasonable,
(vi) Either the offeror’s cost for the regular intervals.
remuneration and the reasonable ac- (7) The value-based arrangement does
counting methodology used by the of- not:
feror to determine its cost, or the fair (i) Limit the VBE participant’s abil-
market value of the remuneration; ity to make decisions in the best inter-
(vii) The percentage and amount con- ests of its patients;
tributed by the recipient; (ii) Direct or restrict referrals to a
(viii) If applicable, the frequency of particular provider, practitioner, or
the recipient’s contribution payments supplier if:
for ongoing costs; and (A) A patient expresses a preference
(ix) The outcome or process meas- for a different practitioner, provider, or
ure(s) against which the recipient will supplier;
be measured. (B) The patient’s payor determines
(4) The parties to the value-based ar- the provider, practitioner, or supplier;
rangement establish one or more le- or
1162
(C) Such direction or restriction is likely to be diverted, resold, or used by

contrary to applicable law under titles the recipient for an unlawful purpose.
XVIII and XIX of the Act; or (12) For a period of at least 6 years,
(iii) Induce parties to furnish medi- the VBE or VBE participant makes
cally unnecessary items or services, or available to the Secretary, upon re-
reduce or limit medically necessary quest, all materials and records suffi-
items or services furnished to any pa- cient to establish compliance with the
tient. conditions of this paragraph (ee).
(8) The exchange of remuneration by (13) The remuneration is not ex-
a limited technology participant and changed by:
another VBE participant or the VBE (i) A pharmaceutical manufacturer,
must not be conditioned on any recipi- distributor, or wholesaler;
ent’s exclusive use or minimum pur- (ii) A pharmacy benefit manager;
chase of any item or service manufac- (iii) A laboratory company;
tured, distributed, or sold by the lim- (iv) A pharmacy that primarily com-
ited technology participant. pounds drugs or primarily dispenses
(9) The VBE, a VBE participant in compounded drugs;
the value-based arrangement acting on (v) Except to the extent the entity is
the VBE’s behalf, or the VBE’s ac- a limited technology participant, a
countable body or responsible person manufacturer of a device or medical
reasonably monitors and assesses the supply;
following and reports the monitoring (vi) Except to the extent the entity
and assessment of the following to the or individual is a limited technology
VBE’s accountable body or responsible participant, an entity or individual
person, as applicable, no less fre- that sells or rents durable medical
quently than annually or at least once equipment, prosthetics, orthotics, or
during the term of the value-based ar- supplies covered by a Federal health
rangement for arrangements with care program (other than a pharmacy
terms of less than 1 year: or a physician, provider, or other enti-
ty that primarily furnishes services);
(i) The coordination and management
or
of care for the target patient popu-
(vii) A medical device distributor or
lation in the value-based arrangement;
wholesaler that is not otherwise a
(ii) Any deficiencies in the delivery manufacturer of a device or medical
of quality care under the value-based supplies.
arrangement; and (14) For purposes of this paragraph
(iii) Progress toward achieving the (ee), the following definitions apply:
legitimate outcome or process meas- (i) Coordination and management of
ure(s) in the value-based arrangement. care (or coordinating and managing care)
(10) If the VBE’s accountable body or means the deliberate organization of
responsible person determines, based patient care activities and sharing of
on the monitoring and assessment con- information between two or more VBE
ducted pursuant to paragraph (ee)(9) of participants, one or more VBE partici-
this section, that the value-based ar- pants and the VBE, or one or more
rangement has resulted in material de- VBE participants and patients, that is
ficiencies in quality of care or is un- designed to achieve safer, more effec-
likely to further the coordination and tive, or more efficient care to improve
management of care for the target pa- the health outcomes of the target pa-
tient population, the parties must tient population.
within 60 days either: (ii) Digital health technology means
(i) Terminate the arrangement; or hardware, software, or services that
(ii) Develop and implement a correc- electronically capture, transmit, ag-
tive action plan designed to remedy the gregate, or analyze data and that are
deficiencies within 120 days, and if the used for the purpose of coordinating
corrective action plan fails to remedy and managing care; such term includes
the deficiencies within 120 days, termi- any internet or other connectivity
nate the value-based arrangement. service that is necessary and used to
(11) The offeror does not and should enable the operation of the item or
not know that the remuneration is service for that purpose.
1163
§ 1001.952 42 CFR Ch. V (10–1–24 Edition)
(iii) Limited technology participant (1) The provision of an item or serv-

means a VBE participant that ex- ice;
changes digital health technology with (2) The taking of an action; or
another VBE participant or a VBE and (3) The refraining from taking an ac-
that is: tion; and
(A) A manufacturer of a device or (B) Does not include the making of a
medical supply, but not including a referral.
manufacturer of a device or medical (vii) Value-based arrangement means
supply that was obligated under 42 CFR an arrangement for the provision of at
403.906 to report one or more ownership least one value-based activity for a tar-
or investment interests held by a phy- get patient population to which the
sician or an immediate family member only parties are:
during the preceding calendar year, or (A) The value-based enterprise and
that reasonably anticipates that it will one or more of its VBE participants; or
be obligated to report one or more own- (B) VBE participants in the same
ership or investment interests held by value-based enterprise.
a physician or an immediate family (viii) Value-based enterprise or VBE
member during the present calendar means two or more VBE participants:
year (for purposes of this paragraph, (A) Collaborating to achieve at least
the terms ‘‘ownership or investment one value-based purpose;
interest,’’ ‘‘physician,’’ and ‘‘imme- (B) Each of which is a party to a
diate family member’’ have the same value-based arrangement with the
meaning as set forth in 42 CFR 403.902); other or at least one other VBE partic-
or ipant in the value-based enterprise;
(B) An entity or individual that sells (C) That have an accountable body or
or rents durable medical equipment, person responsible for financial and
prosthetics, orthotics, or supplies cov- operational oversight of the value-
ered by a Federal health care program based enterprise; and
(other than a pharmacy or a physician, (D) That have a governing document
provider, or other entity that pri- that describes the value-based enter-
marily furnishes services). prise and how the VBE participants in-
(iv) Manufacturer of a device or med- tend to achieve its value-based pur-
ical supply means an entity that meets pose(s).
the definition of applicable manufac- (ix) Value-based enterprise participant
turer in 42 CFR 403.902 because it is en- or VBE participant means an individual
gaged in the production, preparation, or entity that engages in at least one
propagation, compounding, or conver- value-based activity as part of a value-
sion of a device or medical supply that based enterprise, other than a patient
meets the definition of covered drug, acting in their capacity as a patient.
device, biological, or medical supply in (x) Value-based purpose means:
42 CFR 403.902, but not including enti- (A) Coordinating and managing the
ties under common ownership with care of a target patient population;
such entity. (B) Improving the quality of care for
(v) Target patient population means an a target patient population;
identified patient population selected (C) Appropriately reducing the costs
by the VBE or its VBE participants to or growth in expenditures of payors
using legitimate and verifiable criteria without reducing the quality of care
that: for a target patient population; or
(A) Are set out in writing in advance (D) Transitioning from health care
of the commencement of the value- delivery and payment mechanisms
based arrangement; and based on the volume of items and serv-
(B) Further the value-based enter- ices provided to mechanisms based on
prise’s value-based purpose(s). the quality of care and control of costs
(vi) Value-based activity. (A) Means of care for a target patient population.
any of the following activities, pro- (ff) Value-based arrangements with sub-
vided that the activity is reasonably stantial downside financial risk. As used
designed to achieve at least one value- in section 1128B of the Act, ‘‘remu-
based purpose of the value-based enter- neration’’ does not include the ex-
prise: change of payments or anything of
1164
value between a VBE and a VBE partic- which the VBE has assumed (or has en-
ipant pursuant to a value-based ar- tered into a written contract or value-
rangement if all of the following stand- based arrangement to assume in the
ards in paragraphs (ff)(1) through (8) of next 6 months) substantial downside fi-
this section are met: nancial risk;
(1) The remuneration is not ex- (iii) Does not include the offer or re-
changed by: ceipt of an ownership or investment in-
(i) A pharmaceutical manufacturer, terest in an entity or any distributions
distributor, or wholesaler; related to such ownership or invest-
(ii) A pharmacy benefit manager; ment interest; and
(iii) A laboratory company; (iv) Is not exchanged or used for the
(iv) A pharmacy that primarily com- purpose of marketing items or services
pounds drugs or primarily dispenses furnished by the VBE or a VBE partici-
compounded drugs; pant to patients or for patient recruit-
(v) A manufacturer of a device or ment activities.
medical supply;
(5) The value-based arrangement is
(vi) An entity or individual that sells
set forth in writing, is signed by the
or rents durable medical equipment,
prosthetics, orthotics, or supplies cov- parties in advance of, or contempora-
ered by a Federal health care program neous with, the commencement of the
(other than a pharmacy or a physician, value-based arrangement and any ma-
provider, or other entity that pri- terial change to the value-based ar-
marily furnishes services); or rangement, and specifies all material
(vii) A medical device distributor or terms including:
wholesaler that is not otherwise a (i) Terms evidencing that the VBE is
manufacturer of a device or medical at substantial downside financial risk
supplies. or will assume such risk in the next 6
(2) The VBE (directly or through a months for the target patient popu-
VBE participant, other than a payor, lation;
acting on the VBE’s behalf) has as- (ii) A description of the manner in
sumed through a written contract or a which the VBE participant (unless the
value-based arrangement (or has en- VBE participant is the payor from
tered into a written contract or a which the VBE is assuming risk) has a
value-based arrangement to assume in meaningful share of the VBE’s substan-
the next 6 months) substantial down- tial downside financial risk; and
side financial risk from a payor for a (iii) The value-based activities, the
period of at least 1 year. target patient population, and the type
(3) The VBE participant (unless the of remuneration exchanged.
VBE participant is the payor from (6) The VBE or VBE participant of-
which the VBE is assuming risk) is at fering the remuneration does not take
risk for a meaningful share of the into account the volume or value of, or
VBE’s substantial downside financial condition the remuneration on:
risk for providing or arranging for the (i) Referrals of patients who are not
provision of items and services for the
part of the target patient population;
target patient population.
or
(4) The remuneration provided by, or
(ii) Business not covered under the
shared among, the VBE and VBE par-
ticipant: value-based arrangement.
(i) Is directly connected to one or (7) The value-based arrangement does
more of the VBE’s value-based pur- not:
poses, at least one of which must be a (i) Limit the VBE participant’s abil-
value-based purpose defined in ity to make decisions in the best inter-
§ 1001.952(ee)(14)(x)(A), (B), or (C); ests of its patients;
(ii) Unless exchanged pursuant to (ii) Direct or restrict referrals to a
risk methodologies defined in para- particular provider, practitioner, or
graph (ff)(9)(i) or (ii) of this section, is supplier if:
used predominantly to engage in value- (A) A patient expresses a preference
based activities that are directly con- for a different practitioner, provider, or
nected to the items and services for supplier;
1165
§ 1001.952 42 CFR Ch. V (10–1–24 Edition)
(B) The patient’s payor determines (A) Assumes two-sided risk for at
the provider, practitioner, or supplier; least 5 percent of the losses and sav-
or ings, as applicable, realized by the VBE
(C) Such direction or restriction is pursuant to its assumption of substan-
contrary to applicable law under titles tial downside financial risk; or
XVIII and XIX of the Act; or (B) Receives from the VBE a prospec-
(iii) Induce parties to reduce or limit tive, per-patient payment on a month-
medically necessary items or services ly, quarterly, or annual basis for a
furnished to any patient. predefined set of items and services
(8) For a period of at least 6 years, furnished to the target patient popu-
the VBE or VBE participant makes lation, designed to approximate the ex-
available to the Secretary, upon re- pected total cost of expenditures for
quest, all materials and records suffi- the predefined set of items and serv-
cient to establish compliance with the ices, and does not claim payment in
conditions of this paragraph (ff). any form from the payor for the
(9) For purposes of this paragraph predefined items and services.
(ff), the following definitions apply: (iii) Manufacturer of a device or med-
(i) Substantial downside financial risk ical supply, target patient population,
means: value-based activity, value-based arrange-
(A) Financial risk equal to at least 30 ment, value-based enterprise, value-based
percent of any loss, where losses and purpose, and VBE participant shall have
savings are calculated by comparing the meaning set forth in paragraph (ee)
current expenditures for all items and of this section.
services that are covered by the appli- (gg) Value-based arrangements with
cable payor and furnished to the target full financial risk. As used in section
patient population to a bona fide bench- 1128B of the Act, ‘‘remuneration’’ does
mark designed to approximate the ex- not include the exchange of payments
pected total cost of such care; or anything of value between the VBE
(B) Financial risk equal to at least 20 and a VBE participant pursuant to a
percent of any loss, where: value-based arrangement if all of the
(1) Losses and savings are calculated standards in paragraphs (gg)(1) through
by comparing current expenditures for (9) of this section are met:
all items and services furnished to the (1) The remuneration is not ex-
target patient population pursuant to a changed by:
defined clinical episode of care that are (i) A pharmaceutical manufacturer,
covered by the applicable payor to a distributor, or wholesaler;
bona fide benchmark designed to ap- (ii) A pharmacy benefit manager;
proximate the expected total cost of (iii) A laboratory company;
such care for the defined clinical epi- (iv) A pharmacy that primarily com-
sode of care; and pounds drugs or primarily dispenses
(2) The parties design the clinical compounded drugs;
episode of care to cover items and serv- (v) A manufacturer of a device or
ices collectively furnished in more medical supply;
than one care setting; or (vi) An entity or individual that sells
(C) The VBE receives from the payor or rents durable medical equipment,
a prospective, per-patient payment prosthetics, orthotics, or supplies cov-
that is: ered by a Federal health care program
(1) Designed to produce material sav- (other than a pharmacy or a physician,
ings; and provider, or other entity that pri-
(2) Paid on a monthly, quarterly, or marily furnishes services); or
annual basis for a predefined set of (vii) A medical device distributor or
items and services furnished to the tar- wholesaler that is not otherwise a
get patient population, designed to ap- manufacturer of a device or medical
proximate the expected total cost of supplies.
expenditures for the predefined set of (2) The VBE (directly or through a
items and services. VBE participant, other than a payor,
(ii) Meaningful share means the VBE acting on behalf of the VBE) has as-
participant: sumed through a written contract or a
1166
value-based arrangement (or has en- cient to establish compliance with the
tered into a written contract or a conditions of this paragraph (gg).
value-based arrangement to assume in (10) For purposes of this paragraph
the next 1 year) full financial risk from (gg), the following definitions apply:
a payor. (i) Full financial risk means the VBE
(3) The value-based arrangement is is financially responsible on a prospec-
set forth in writing, is signed by the tive basis for the cost of all items and
parties, and specifies all material services covered by the applicable
terms, including the value-based ac- payor for each patient in the target pa-
tivities and the term. tient population for a term of at least
(4) The VBE participant (unless the 1 year.
VBE participant is a payor) does not (ii) Prospective basis means that the
claim payment in any form from the VBE has assumed financial responsi-
payor for items or services covered bility for the cost of all items and serv-
under the contract or value-based ar- ices covered by the applicable payor
rangement between the VBE and the prior to the provision of items and
payor described in paragraph (2). services to patients in the target pa-
(5) The remuneration provided by, or tient population.
shared among, the VBE and VBE par- (iii) Items and services means health
ticipant: care items, devices, supplies, and serv-
(i) Is directly connected to one or ices.
more of the VBE’s value-based pur- (iv) Manufacturer of a device or med-
poses; ical supply, target patient population,
(ii) Does not include the offer or re- value-based activity, value-based arrange-
ceipt of an ownership or investment in- ment, value-based enterprise, value-based
terest in an entity or any distributions purpose, and VBE participant shall have
related to such ownership or invest- the meaning set forth in paragraph (ee)
ment interest; and of this section.
(iii) Is not exchanged or used for the
(hh) Arrangements for patient engage-
purpose of marketing items or services
ment and support to improve quality,
furnished by the VBE or a VBE partici-
health outcomes, and efficiency. As used
pant to patients or for patient recruit-
in section 1128B of the Act, ‘‘remu-
ment activities.
neration’’ does not include a patient
(6) The value-based arrangement does
engagement tool or support furnished
not induce parties to reduce or limit
by a VBE participant to a patient in
medically necessary items or services
the target patient population of a
furnished to any patient.
value-based arrangement to which the
(7) The VBE or VBE participant of-
VBE participant is a party if all of the
fering the remuneration does not take
conditions in paragraphs (hh)(1)
into account the volume or value of, or
through (9) of this section are met:
condition the remuneration on:
(1) The VBE participant is not:
(i) Referrals of patients who are not
part of the target patient population; (i) A pharmaceutical manufacturer,
or distributor, or wholesaler;
(ii) Business not covered under the (ii) A pharmacy benefit manager;
value-based arrangement. (iii) A laboratory company;
(8) The VBE provides or arranges for (iv) A pharmacy that primarily com-
a quality assurance program for serv- pounds drugs or primarily dispenses
ices furnished to the target patient compounded drugs;
population that: (v) A manufacturer of a device or
(i) Protects against underutilization; medical supply, unless the patient en-
and gagement tool or support is digital
(ii) Assesses the quality of care fur- health technology;
nished to the target patient popu- (vi) An entity or individual that sells
lation. or rents durable medical equipment,
(9) For a period of at least 6 years, prosthetics, orthotics, or supplies cov-
the VBE or VBE participant makes ered by a Federal health care program
available to the Secretary, upon re- (other than a pharmacy, a manufac-
quest, all materials and records suffi- turer of a device or medical supply, or
1167
§ 1001.952 42 CFR Ch. V (10–1–24 Edition)
a physician, provider, or other entity (D) Prevention or management of a

that primarily furnishes services); disease or condition as directed by the
(vii) A medical device distributor or patient’s licensed health care profes-
wholesaler that is not otherwise a sional.
manufacturer of a device or medical (E) Ensure patient safety.
supply; or (4) The patient engagement tool or
(viii) A manufacturer of a device or support is not funded or contributed
medical supply that was obligated by:
under 42 CFR 403.906 to report one or (i) A VBE participant that is not a
more ownership or investment inter- party to the applicable value-based ar-
ests held by a physician or an imme- rangement; or
diate family member during the pre- (ii) An entity listed in paragraph
ceding calendar year, or that reason- (hh)(1) of this section.
ably anticipates that it will be obli- (5) The aggregate retail value of pa-
gated to report one or more ownership tient engagement tools and supports
or investment interests held by a phy- furnished to a patient by a VBE partic-
sician or an immediate family member ipant on an annual basis does not ex-
during the present calendar year, even ceed $500. The monetary cap set forth
if the patient engagement tool or sup- in this paragraph (hh)(5) is adjusted
port is digital health technology (for each calendar year to the nearest
purposes of this paragraph, the terms whole dollar by the increase in the
‘‘ownership or investment interest,’’ Consumer Price Index—Urban All
‘‘physician,’’ and ‘‘immediate family Items (CPI–U) for the 12-month period
member’’ have the same meaning as set ending the preceding September 30.
forth in 42 CFR 403.902). OIG will publish guidance after Sep-
(2) The patient engagement tool or tember 30 of each year reflecting the
support is furnished directly to the pa- increase in the CPI–U for the 12-month
tient (or the patient’s caregiver, family period ending September 30 and the
member, or other individual acting on new monetary cap applicable for the
the patient’s behalf) by a VBE partici- following calendar year.
pant that is a party to the value-based (6) The VBE participant or any eligi-
arrangement or its eligible agent. ble agent does not exchange or use the
(3) The patient engagement tool or patient engagement tools or supports
support: to market other reimbursable items or
(i) Is an in-kind item, good, or serv- services or for patient recruitment pur-
ice; poses.
(ii) That has a direct connection to (7) For a period of at least 6 years,
the coordination and management of the VBE participant makes available
care of the target patient population; to the Secretary, upon request, all ma-
(iii) Does not include any cash or terials and records sufficient to estab-
cash equivalent; lish that the patient engagement tool
(iv) Does not result in medically un- or support was distributed in a manner
necessary or inappropriate items or that meets the conditions of this para-
services reimbursed in whole or in part graph (hh).
by a Federal health care program; (8) The availability of a tool or sup-
(v) Is recommended by the patient’s port is not determined in a manner
licensed health care professional; and that takes into account the type of in-
(vi) Advances one or more of the fol- surance coverage of the patient.
lowing goals: (9) For purposes of this paragraph
(A) Adherence to a treatment regi- (hh), the following definitions apply:
men determined by the patient’s li- (i) Eligible agent means any person or
censed health care professional. entity that is not identified in para-
(B) Adherence to a drug regimen de- graphs (hh)(1)(i) through (viii) of this
termined by the patient’s licensed section as ineligible to furnish pro-
health care professional. tected tools and supports under this
(C) Adherence to a followup care plan paragraph.
established by the patient’s licensed (ii) Coordination and management of
health care professional. care, target patient population, value-
1168
based arrangement, VBE, VBE partici- connection with the use of this safe
pant, manufacturer of a device or medical harbor.
supply, and digital health technology (2) As used in section 1128B of the
shall have the meaning set forth in Act, ‘‘remuneration’’ does not include
paragraph (ee) of this section. a CMS-sponsored model patient incen-
(ii) CMS-sponsored model arrangements tive for which CMS has determined
and CMS-sponsored model patient incen- that this safe harbor is available if all
tives. of the following conditions are met:
(1) As used in section 1128B of the (i) The CMS-sponsored model partici-
Act, ‘‘remuneration’’ does not include pant reasonably determines that the
an exchange of anything of value be- CMS-sponsored model patient incen-
tween or among CMS-sponsored model tive will advance one or more goals of
parties under a CMS-sponsored model the CMS-sponsored model;
arrangement for which CMS has deter- (ii) The CMS-sponsored model pa-
mined that this safe harbor is available tient incentive has a direct connection
if all of the following conditions are to the patient’s health care unless the
met: participation documentation expressly
(i) The CMS-sponsored model parties specifies a different standard;
reasonably determine that the CMS- (iii) The CMS-sponsored model pa-
sponsored model arrangement will ad- tient incentive is furnished by a CMS-
vance one or more goals of the CMS- sponsored model participant (or by an
sponsored model; agent of the CMS-sponsored model par-
(ii) The exchange of value does not ticipant under the CMS-sponsored
induce CMS-sponsored model parties or model participant’s direction and con-
other providers or suppliers to furnish trol), unless otherwise specified by the
medically unnecessary items or serv- participation documentation;
ices, or reduce or limit medically nec- (iv) The CMS-sponsored model partic-
essary items or services furnished to ipant makes available to the Sec-
any patient; retary, upon request, all materials and
(iii) The CMS-sponsored model par- records sufficient to establish whether
ties do not offer, pay, solicit, or receive the CMS-sponsored model patient in-
remuneration in return for, or to incentive was distributed in a manner
duce or reward, any Federal health that meets the conditions of this safe
care program referrals or other Federal harbor; and
health care program business gen- (v) The CMS-sponsored model patient
erated outside of the CMS-sponsored incentive is furnished consistent with
model; the CMS-sponsored model and satisfies
(iv) The CMS-sponsored model par- such programmatic requirements as
ties in advance of or contemporaneous may be imposed by CMS in connection
with the commencement of the CMS- with the use of this safe harbor.
sponsored model arrangement set forth (3) For purposes of this paragraph
the terms of the CMS-sponsored model (ii), the following definitions apply:
arrangement in a signed writing. The (i) CMS-sponsored model means:
writing must specify at a minimum the (A) A model being tested under sec-
activities to be undertaken by the tion 1115A(b) of the Act or a model ex-
CMS-sponsored model parties and the panded under section 1115A(c) of the
nature of the remuneration to be ex- Act; or
changed under the CMS-sponsored (B) The Medicare shared savings pro-
model arrangement; gram under section 1899 of the Act.
(v) The parties to the CMS-sponsored (ii) CMS-sponsored model arrangement
model arrangement make available to means a financial arrangement be-
the Secretary, upon request, all mate- tween or among CMS-sponsored model
rials and records sufficient to establish parties to engage in activities under
whether the remuneration was ex- the CMS-sponsored model that is con-
changed in a manner that meets the sistent with, and is not a type of ar-
conditions of this safe harbor; and rangement prohibited by, the partici-
(vi) The CMS-sponsored model par- pation documentation.
ties satisfy such programmatic require- (iii) CMS-sponsored model participant
ments as may be imposed by CMS in means an individual or entity that is
1169
§ 1001.952 42 CFR Ch. V (10–1–24 Edition)
subject to and is operating under par- day on which patient care services may
ticipation documentation with CMS to be furnished under the CMS-sponsored
participate in a CMS-sponsored model. model, unless a different timeframe is
(iv) CMS-sponsored model party means: established in the participation docu-
(A) A CMS-sponsored model partici- mentation. A patient may retain any
pant; or incentives furnished in compliance
(B) Another individual or entity with paragraph (ii)(2) of this section.
whom the participation documentation (jj) Cybersecurity technology and re-
specifies may enter into a CMS-spon- lated services. As used in section 1128B
sored model arrangement. of the Act, ‘‘remuneration’’ does not
(v) CMS-sponsored model patient incen- include nonmonetary remuneration
tive means remuneration not of a type (consisting of cybersecurity technology
prohibited by the participation docu- and services) that is necessary and
mentation that is furnished to a pa- used predominantly to implement,
tient under the terms of a CMS-spon- maintain, or reestablish effective cy-
sored model. bersecurity if all of the conditions in
(vi) Participation documentation paragraphs (jj)(1) through (4) of this
means the participation agreement, section are met.
legal instrument setting forth the (1) The donor does not:
terms and conditions of a grant or co- (i) Directly take into account the
operative agreement, regulations, or volume or value of referrals or other
model-specific addendum to an existing business generated between the parties
contract with CMS that specifies the when determining the eligibility of a
terms of a CMS-sponsored model. potential recipient for the technology
(4) For purposes of remuneration that or services, or the amount or nature of
satisfies this paragraph (ii), the safe the technology or services to be do-
harbor protects: nated; or
(i) For a CMS-sponsored model gov- (ii) Condition the donation of tech-
erned by participation documentation nology or services, or the amount or
other than the legal instrument setting nature of the technology or services to
forth the terms and conditions of a be donated, on future referrals.
grant or a cooperative agreement, the
(2) Neither the recipient nor the re-
exchange of remuneration between
cipient’s practice (or any affiliated in-
CMS-sponsored model parties that oc-
dividual or entity) makes the receipt of
curs on or after the first day on which
technology or services, or the amount
services under the CMS-sponsored
or nature of the technology or services,
model begin and no later than 6
a condition of doing business with the
months after the final payment deter-
donor.
mination made by CMS under the
(3) A general description of the tech-
model;
nology and services being provided and
(ii) For a CMS-sponsored model gov-
the amount of the recipient’s contribu-
erned by the legal instrument setting
tion, if any, are set forth in writing and
forth the terms and conditions of a
signed by the parties.
grant or cooperative agreement, the
exchange of remuneration between (4) The donor does not shift the costs
CMS-sponsored model parties that oc- of the technology or services to any
curs on or after the first day of the pe- Federal health care program.
riod of performance (as defined at 45 (5) For purposes of this paragraph (jj)
CFR 75.2) or such other date specified the following definitions apply:
in the participation documentation and (i) Cybersecurity means the process of
no later than 6 months after closeout protecting information by preventing,
occurs pursuant to 45 CFR 75.381; and detecting, and responding to
(iii) For a CMS-sponsored model pa- cyberattacks.
tient incentive, an incentive given on (ii) Technology means any software or
or after the first day on which patient other types of information technology.
care services may be furnished under (kk) ACO Beneficiary Incentive Pro-
the CMS-sponsored model as specified gram. As used in section 1128B of the
by CMS in the participation docu- Act, ‘‘remuneration’’ does not include
mentation and no later than the last an incentive payment made by an ACO
1170
to an assigned beneficiary under a ben- (3) An entity excluded under this sec-
eficiary incentive program established tion may apply for reinstatement at
under section 1899(m) of the Act, as any time in accordance with the proce-
amended by Congress from time to dures set forth in § 1001.3001(a)(2).
time, if the incentive payment is made [57 FR 3330, Jan. 29, 1992, as amended at 64
in accordance with the requirements FR 39427, July 22, 1999; 82 FR 4114, Jan. 12,
found in such subsection. 2017]
[57 FR 3330, Jan. 29, 1992]
§ 1001.1101 Failure to disclose certain
EDITORIAL NOTE: For FEDERAL REGISTER ci- information.
tations affecting § 1001.952, see the List of
CFR Sections Affected, which appears in the
(a) Circumstance for exclusion. The
Finding Aids section of the printed volume OIG may exclude any entity that did
and at www.govinfo.gov. not fully and accurately, or com-
pletely, make disclosures as required
by section 1124, 1124A or 1126 of the Act,
29, 2023, § 1001.952(h)(5)(viii), (h)(6) through
(9), (cc), and (dd) were stayed, effective Dec. and by part 455, subpart B and part 420,
29, 2023, until Jan. 1, 2032. subpart C of this title.
(b) Length of exclusion. The following
§ 1001.1001 Exclusion of entities factors will be considered in deter-
owned or controlled by a sanc- mining the length of an exclusion
tioned person. under this section—
(a) Circumstance for exclusion. The (1) The number of instances where
OIG may exclude an entity: full and accurate, or complete, disclo-
(1) If a person with a relationship sure was not made;
with such entity— (2) The significance of the undis-
(i) Has been convicted of a criminal closed information;
offense as described in sections 1128(a) (3) Whether the individual or entity
and 1128(b)(1), (2), or (3) of the Act; has a documented history of criminal,
(ii) Has had civil money penalties or civil or administrative wrongdoing
assessments imposed under section (The lack of any prior record is to be
1128A of the Act; or considered neutral);
(iii) Has been excluded from partici- (4) Any other facts that bear on the
pation in Medicare or any State health nature or seriousness of the conduct;
care program, and and
(2) Such a person has a direct or indi- (5) The extent to which the entity
rect ownership or control interest in knew that the disclosures made were
the entity, or formerly held an owner- not full or accurate.
ship or control interest in the entity [57 FR 3330, Jan. 29, 1992, as amended at 63
but no longer holds an ownership or FR 46689, Sept. 2, 1998; 82 FR 4115, Jan. 12,
control interest because of a transfer of 2017]
the interest to an immediate family
member or a member of the person’s § 1001.1201 Failure to provide payment
household in anticipation of or fol- information.
lowing a conviction, imposition of a (a) Circumstance for exclusion. The
civil money penalty or assessment OIG may exclude any individual or en-
under section 1128A of the Act, or im- tity that furnishes, orders, refers for
position of an exclusion. furnishing, or certifies the need for
(b) Length of exclusion. (1) Except as items or services for which payment
provided in § 1001.3002(c), exclusions may be made under Medicare or any of
under this section will be for the same the State health care programs and
period as that of the individual whose that—
relationship with the entity is the (1) Fails to provide such information
basis for this exclusion, if the indi- as is necessary to determine whether
vidual has been or is being excluded. such payments are or were due and the
(2) If the individual was not excluded, amounts thereof, or
the length of the entity’s exclusion will (2) Has refused to permit such exam-
be determined by considering the fac- ination and duplication of its records
tors that would have been considered if as may be necessary to verify such in-
the individual had been excluded. formation.
1171
§ 1001.1301 42 CFR Ch. V (10–1–24 Edition)
(b) Length of exclusion. The following (J) An end-stage renal disease facil-
factors will be considered in deter- ity is meeting the requirements of sec-
mining the length of an exclusion tion 1881(b) of the Act;
under this section— (K) A physical therapist in inde-
(1) The number of instances where in- pendent practice is meeting the re-
formation was not provided; quirements of section 1861(p) of the
(2) The circumstances under which Act;
such information was not provided; (L) An occupational therapist in
(3) The amount of the payments at independent practice is meeting the re-
issue; and quirements of section 1861(g) of the
(4) Whether the individual or entity Act;
has a documented history of criminal, (M) An organ procurement organiza-
civil, or administrative wrongdoing. tion meets the requirements of section
1138(b) of the Act; or.
(The lack of any prior record is to be
(N) A rural primary care hospital
considered neutral).
meets the requirements of section
[57 FR 3330, Jan. 29, 1992, as amended at 63 1820(i)(2) of the Act;
FR 46689, Sept. 2, 1998; 82 FR 4115, Jan. 12, (ii) The Secretary, a State survey
2017] agency or other authorized entity to
perform the reviews and surveys re-
§ 1001.1301 Failure to grant immediate quired under State plans in accordance
access. with sections 1902(a)(26) (relating to in-
(a) Circumstance for exclusion. (1) The patient mental hospital services),
OIG may exclude any individual or en- 1902(a)(31) (relating to intermediate
tity that fails to grant immediate ac- care facilities for individuals with in-
cess upon reasonable request to— tellectual disabilities), 1919(g) (relating
(i) The Secretary, a State survey to nursing facilities), 1929(i) (relating
agency or other authorized entity for to providers of home and community
the purpose of determining, in accord- care and community care settings),
ance with section 1864(a) of the Act, 1902(a)(33) and 1903(g) of the Act;
whether— (iii) The OIG for reviewing records,
(A) An institution is a hospital or documents, and other material or data
skilled nursing facility; in any medium (including electroni-
(B) An agency is a home health agen- cally stored information and any tan-
cy; gible thing) necessary to the OIG’s
(C) An agency is a hospice program; statutory functions; or
(iv) A State Medicaid fraud control
(D) A facility is a rural health clinic
unit for the purpose of conducting its
as defined in section 1861(aa)(2) of the
activities.
Act, or a comprehensive outpatient re- (2) For purposes of paragraphs
habilitation facility as defined in sec- (a)(1)(i) and (a)(1)(ii) of this section, the
tion 1861(cc)(2) of the Act; term—
(E) A laboratory is meeting the re- Failure to grant immediate access
quirements of section 1861(s) (15) and means the failure to grant access at
(16) of the Act, and section 353(f) of the the time of a reasonable request or to
Public Health Service Act; provide a compelling reason why access
(F) A clinic, rehabilitation agency or may not be granted.
public health agency is meeting the re- Reasonable request means a written
quirements of section 1861(p)(4) (A) or request made by a properly identified
(B) of the Act; agent of the Secretary, of a State sur-
(G) An ambulatory surgical center is vey agency or of another authorized
meeting the standards specified under entity, during hours that the facility,
section 1832(a)(2)(F)(i) of the Act; agency or institution is open for busi-
(H) A portable x-ray unit is meeting ness.
the requirements of section 1861(s)(3) of The request will include a statement
the Act; of the authority for the request, the
(I) A screening mammography serv- rights of the entity in responding to
ice is meeting the requirements of sec- the request, the definition of reasonable
tion 1834(c)(3) of the Act; request and immediate access, and the
1172
penalties for failure to comply, included based on consideration of the fol-

ing when the exclusion will take effect. lowing factors—
(3) For purposes of paragraphs (i) The impact of the failure to grant
(a)(1)(iii) and (a)(1)(iv) of this section, the requested immediate access on
the term— Medicare or any of the State health
Failure to grant immediate access care programs, beneficiaries or the
means— public;
(i) The failure to produce or make (ii) The circumstances under which
available for inspection and copying such access was refused;
the requested material upon reasonable (iii) The impact of the exclusion on
request, or to provide a compelling rea- Medicare, Medicaid or any of the other
son why they cannot be produced, with- Federal health care programs, bene-
in 24 hours of such request, except ficiaries or the public; and
when the OIG or State Medicaid Fraud (iv) Whether the entity has a docu-
Control Unit (MFCU) reasonably be- mented history of criminal, civil or ad-
lieves that the requested material is ministrative wrongdoing (The lack of
about to be altered or destroyed, or any prior record is to be considered
(ii) When the OIG or MFCU has rea- neutral).
son to believe that the requested mate- (3) For purposes of paragraphs (b)(1)
rial is about to be altered or destroyed, and (b)(2) of this section, the length of
the failure to provide access to the re- the period in which immediate access
quested material at the time the re- was not granted will be measured from
quest is made. the time the request is made, or from
Reasonable request means a written the time by which access was required
request, signed by a designated rep- to be granted, whichever is later.
resentative of the OIG or MFCU and (c) The exclusion will be effective as
made by a properly identified agent of of the date immediate access was not
the OIG or an MFCU during reasonable granted.
business hours, where there is informa-
tion to suggest that the person has vio- [57 FR 3330, Jan. 29, 1992, as amended at 58
lated statutory or regulatory require- FR 40753, July 30, 1993; 63 FR 46689, Sept. 2,
ments under Titles V, XI, XVIII, XIX, 1998; 64 FR 39427, July 22, 1999; 82 FR 4115,
Jan. 12, 2017]
or XX of the Act. The request will in-
clude a statement of the authority for § 1001.1401 Violations of PPS correc-
the request, the person’s rights in re- tive action.
sponding to the request, the definition
of ‘‘reasonable request’’ and ‘‘failure to (a) Circumstance for exclusion. The
grant immediate access’’ under part OIG may exclude any hospital that
1001, and the effective date, length, and CMS determines has failed substan-
scope and effect of the exclusion that tially to comply with a corrective ac-
would be imposed for failure to comply tion plan required by CMS under sec-
with the request, and the earliest date tion 1886(f)(2)(B) of the Act.
that a request for reinstatement would (b) Length of exclusion. The following
be considered. factors will be considered in deter-
(4) Nothing in this section shall in mining the length of exclusion under
any way limit access otherwise author- this section—
ized under State or Federal law. (1) The impact of the hospital’s fail-
(b) Length of exclusion. (1) An exclu- ure to comply on Medicare, Medicaid
sion of an individual under this section or any of the other Federal health care
may be for a period equal to the sum programs, program beneficiaries or
of: other individuals;
(i) The length of the period during (2) The circumstances under which
which the immediate access was not the failure occurred;
granted, and (3) The nature of the failure to com-
(ii) An additional period of up to 90 ply;
days. (4) The impact of the exclusion on
(2) The exclusion of an entity may be Medicare, Medicaid or any of the other
for a longer period than the period in Federal health care programs, bene-
which immediate access was not grant- ficiaries or the public; and
1173
§ 1001.1501 42 CFR Ch. V (10–1–24 Edition)
(5) Whether the individual or entity vidual of his or her right to apply for
has a documented history of criminal, reinstatement.
civil or administrative wrongdoing [57 FR 3330, Jan. 29, 1992, as amended at 64
(The lack of any prior record is to be FR 39427, July 22, 1999; 67 FR 11935, Mar. 18,
considered neutral). 2002; 82 FR 4115, Jan. 12, 2017]
[57 FR 3330, Jan. 29, 1992, as amended at 63 § 1001.1551 Exclusion of individuals
FR 46689, Sept. 2, 1998; 64 FR 39427, July 22, with ownership or control interest
1999] in sanctioned entities.
§ 1001.1501 Default of health education (a) Circumstance for exclusion. The
loan or scholarship obligations. OIG may exclude any individual who—
(1) Has a direct or indirect ownership
(a) Circumstance for exclusion. (1) Ex- or control interest in a sanctioned en-
cept as provided in paragraph (a)(4) of tity, and who knows or should know (as
this section, the OIG may exclude any defined in section 1128A(i)(6) of the Act)
individual that the administrator of of the action constituting the basis for
the health education loan, scholarship, the conviction or exclusion set forth in
or loan repayment program determines paragraph (b) of this section; or
is in default on repayments of scholar- (2) Is an officer or managing em-
ship obligations or loans, or the obliga- ployee (as defined in section 1126(b) of
tions of any loan repayment program, the Act) of such an entity.
in connection with health professions (b) For purposes of paragraph (a) of
education made or secured in whole or this section, the term ‘‘sanctioned en-
in part by the Secretary. tity’’ means an entity that—
(2) Before imposing an exclusion in (1) Has been convicted of any offense
accordance with paragraph (a)(1) of described in §§ 1001.101 through 1001.401
this section, the OIG must determine of this part; or
that the administrator of the health (2) Has been terminated or excluded
education loan, scholarship, or loan re- from participation in Medicare, Med-
payment program has taken all reason- icaid and all other Federal health care
able administrative steps to secure re- programs.
payment of the loans or obligations. (c) Length of exclusion. (1) If the enti-
ty has been excluded, the length of the
When an individual has been offered a
individual’s exclusion will be for the
Medicare offset arrangement as re-
same period as that of the sanctioned
quired by section 1892 of the Act, the
entity.
OIG will find that all reasonable steps
(2) If the entity was not excluded, the
have been taken. length of the individual’s exclusion
(3) The OIG will take into account will be determined by considering the
access of beneficiaries to physicians’ factors that would have been consid-
services for which payment may be ered if the entity had been excluded.
made under Medicare, Medicaid or (3) An individual excluded under this
other Federal health care programs in section may apply for reinstatement in
determining whether to impose an ex- accordance with the procedures set
clusion. forth in § 1001.3001.
(4) The OIG will not exclude a physi-
[63 FR 46689, Sept. 2, 1998. Redesignated and
cian who is the sole community physi- amended at 82 FR 4115, Jan. 12, 2017]
cian or the sole source of essential spe-
cialized services in a community if a § 1001.1552 Making false statements or
State requests that the physician not misrepresentation of material facts.
be excluded. (a) Circumstance for exclusion. The
(b) Length of exclusion. The individual OIG may exclude any individual or en-
will be excluded until the adminis- tity that it determines has knowingly
trator of the health education loan, made or caused to be made any false
scholarship, or loan repayment pro- statement, omission, or misrepresenta-
gram notifies the OIG that the default tion of a material fact in any applica-
has been cured or that there is no tion, agreement, bid, or contract to
longer an outstanding debt. Upon such participate or enroll as a provider of
notice, the OIG will inform the indi- services or supplier under a Federal
1174
health care program, including Medi- (ii) Furnished services to a bene-

care Advantage organizations under ficiary;
Part C of Medicare, prescription drug (iii) Knowingly and willfully billed—
plan sponsors under Part D of Medi- (A) On a repeated basis for such serv-
care, Medicaid managed care organiza- ices actual charges in excess of the
tions, and entities that apply to par- maximum allowable actual charge de-
ticipate as providers of services or sup- termined in accordance with section
pliers in such managed care organiza- 1842(j)(1)(C) of the Act for the period
tions and such plans. January 1, 1987 through December 31,
(b) Definition of ‘‘Material’’. For pur- 1990, or
poses of this section, the term ‘‘mate- (B) Individuals enrolled under part B
rial’’ means having a natural tendency of title XVIII of the Act during the
to influence or be capable of influ- statutory freeze for actual charges in
encing the decision to approve or deny excess of such physician’s actual
the request to participate or enroll as a charges determined in accordance with
provider of services or supplier under a section 1842(j)(1)(A) of the Act for the
Federal health care program. period July 1, 1984 to December 31, 1986;
(c) Sources. The OIG’s determination and’’
under paragraph (a) of this section will (iv) Is not the sole community physi-
be made on the basis of information cian or sole source of essential special-
from the following sources: ized services in the community.
(1) CMS; (2) The OIG will take into account
(2) Medicaid State agencies; access of beneficiaries to physicians’
(3) Fiscal agents or contractors or services for which Medicare payment
private insurance companies; may be made in determining whether
(4) Law enforcement agencies; to impose an exclusion.
(5) State or local licensing or certifi- (b) Length of exclusion. (1) In deter-
cation authorities; mining the length of an exclusion in
(6) State or local professional soci- accordance with this section, the OIG
eties; or will consider the following factors—
(7) Any other sources deemed appro- (i) The number of services for which
priate by the OIG. the physician billed in excess of the
(d) Length of exclusion. In deter- maximum allowable charges;
mining the length of an exclusion im- (ii) The number of beneficiaries for
posed in accordance with this section, whom services were billed in excess of
the OIG will consider the following fac- the maximum allowable charges;
tors: (iii) The amount of the charges that
were in excess of the maximum allow-
(1) The nature and circumstances
able charges; and
surrounding the false statement;
(iv) Whether the physician has a doc-
(2) Whether and to what extent pay-
umented history of criminal, civil, or
ments were requested or received from
administrative wrongdoing (the lack of
the Federal health care program under
any prior record is to be considered
the application, agreement, bid, or con-
neutral).
tract on which the false statement,
(2) The period of exclusion may not
omission, or misrepresentation was
exceed 5 years.
made; and
(3) Whether the individual or entity [57 FR 3329, Jan. 29, 1992; 57 FR 9669, Mar. 20,
has a documented history of criminal, 1992, as amended at 63 FR 46689, Sept. 2, 1998;
civil, or administrative wrongdoing. 82 FR 4116, Jan. 12, 2017]
[82 FR 4115, Jan. 12, 2017] § 1001.1701 Billing for services of as-
sistant at surgery during cataract
§ 1001.1601 Violations of the limita- operations.
tions on physician charges. (a) Circumstance for exclusion. The
(a) Circumstance for exclusion. (1) The OIG may exclude a physician whom it
OIG may exclude a physician whom it determines—
determines— (1) Has knowingly and willfully pre-
(i) Is a non-participating physician sented or caused to be presented a
under section 1842(j) of the Act; claim, or billed an individual enrolled
1175
Pt. 1001, Subpt. C, App. A 42 CFR Ch. V (10–1–24 Edition)
under Part B of the Medicare program 1. We will restock all ambulance providers
(or his or her representative) for: (other than ambulance providers that do not
(i) Services of an assistant at surgery provide emergency services) that bring pa-
tients to Hospital X [or to a subpart of Hos-
during a cataract operation, or
pital X, such as the emergency room] in the
(ii) Charges that include a charge for following category or categories: [insert de-
an assistant at surgery during a cata- scription of category of ambulances to be re-
ract operation; stocked, i.e., all ambulance providers, all
(2) Has not obtained prior approval ambulance providers that do not charge pa-
for the use of such assistant from the tients or insurers for their services, or all
appropriate Utilization and Quality nonprofit and Government ambulance pro-
Control Quality Improvement Organi- viders]. [Optional: We only offer restocking
zation (QIO) or Medicare carrier; and of emergency transports.]
(3) Is not the sole community physi- 2. The restocking will include the following
cian or sole source of essential special- drugs and medical supplies, and linens, used
for patient prior to delivery of the patient to
ized services in the community.
Hospital X: [insert description of drugs and
(b) The OIG will take into account medical supplies, and linens to be restocked].
access of beneficiaries to physicians’ 3. The ambulance providers [will/will not]
services for which Medicare payment be required to pay for the restocked drugs
may be made in determining whether and medical supplies, and linens.
to impose an exclusion. 4. The restocked drugs and medical sup-
(c) Length of exclusion. (1) In deter- plies, and linens, must be documented as fol-
mining the length of an exclusion in lows: [insert description consistent with the
accordance with this section, the OIG documentation requirements described in
will consider the following factors— § 1001.952(v). By way of example only, docu-
(i) The number of instances for which mentation may be by a patient care report
filed with the receiving facility within 24
claims were submitted or beneficiaries
hours of delivery of the patient that records
were billed for unapproved use of as- the name of the patient, the date of the
sistants during cataract operations; transport, and the relevant drugs and med-
(ii) The amount of the claims or bills ical supplies.]
presented; 5. This restocking program does not apply
(iii) The circumstances under which to the restocking of ambulances that only
the claims or bills were made, includ- provide non-emergency services or to the
ing whether the services were medi- general stocking of an ambulance provider’s
cally necessary; inventory.
(iv) Whether approval for the use of 6. To ensure that Hospital X does not bill
an assistant was requested from the any Federal health care program for re-
stocked drugs or supplies for which a partici-
QIO or carrier; and
pating ambulance provider bills or is eligible
(v) Whether the physician has a docu- to bill, all participating ambulance providers
mented history of criminal, civil, or must notify Hospital X if they intend to sub-
administrative wrongdoing (the lack of mit claims for restocked drugs or supplies to
any prior record is to be considered any Federal health care program. Partici-
neutral). pating ambulance providers must agree to
(2) The period of exclusion may not work with Hospital X to ensure that only
exceed 5 years. one party bills for a particular restocked
drug or supply.
[57 FR 3330, Jan. 29, 1992, as amended at 63 7. All participants in this ambulance re-
FR 46690, Sept. 2, 1998; 82 FR 4116, Jan. 12, stocking arrangement that bill Federal
2017] health care programs for restocked drugs or
supplies must comply with all applicable
APPENDIX A TO SUBPART C OF PART 1001 Federal program billing and claims filing
The following is a sample written disclo- rules and regulations.
sure for purposes of satisfying the require- 8. For further information about our re-
ments of § 1001.952(v)(3)(i)(B)(1)(i) of this part. stocking program or to obtain a copy of this
This form is for illustrative purposes only; notice, please contact [name] at [telephone
parties may, but are not required to, adapt number].
this sample written disclosure form. Dated:____
NOTICE OF AMBULANCE RESTOCKING PROGRAM /s/____
Appropriate officer or official
Hospital X offers the following ambulance
restocking program: [66 FR 62991, Dec. 4, 2001]
1176
Subpart D—Waivers and Effect of § 1001.1901 Scope and effect of exclu-

Exclusion sion.
(a) Scope of exclusion. Exclusions of
§ 1001.1801 Waivers of exclusions. individuals and entities under this title
(a) The OIG has the authority to will be from Medicare, Medicaid and
grant or deny a request from the ad- any of the other Federal health care
ministrator of a Federal health care programs, as defined in § 1001.2.
program (as defined in section 1128B(f) (b) Effect of exclusion on excluded indi-
of the Act) that an exclusion from that viduals and entities. (1) Unless and until
program be waived with respect to an an individual or entity is reinstated
individual or entity, except that no into the Medicare, Medicaid, and other
waiver may be granted with respect to Federal health care programs in ac-
an exclusion under § 1001.101(b). The re- cordance with subpart F of this part,
quest must be in writing and from an no payment will be made by Medicare,
individual directly responsible for ad- including Medicare Advantage and Pre-
ministering the Federal health care scription Drug Plans, Medicaid, or any
program. other Federal health care program for
(b) With respect to exclusions under any item or service furnished, on or
§ 1001.101(a), (c), or (d), a request from a after the effective date specified in the
Federal health care program for a notice—
waiver of the exclusion will be consid- (i) By an excluded individual or enti-
ered only if the Federal health care ty; or
program administrator determines (ii) At the medical direction or on
that— the prescription of a physician or an
(1) The individual or entity is the authorized individual who is excluded
sole community physician or the sole when the person furnishing such item
source of essential specialized services or service knew, or had reason to
in a community; and know, of the exclusion.
(2) The exclusion would impose a (2) This section applies regardless of
hardship on beneficiaries (as defined in whether an individual or entity has ob-
section 1128A(i)(5) of the Act) of that tained a program provider number or
program. equivalent, either as an individual or
(c) With respect to exclusions im- as a member of a group, prior to being
posed under subpart C of this part, a reinstated.
request for waiver will only be granted (3) An excluded individual or entity
if the OIG determines that imposition may not take assignment of an enroll-
of the exclusion would not be in the ee’s claim on or after the effective date
public interest. of exclusion.
(d) If the basis for the waiver ceases (4) An excluded individual or entity
to exist, the waiver will be rescinded, that submits, or causes to be sub-
and the individual or entity will be ex- mitted, claims for items or services
cluded for the period remaining on the furnished during the exclusion period is
exclusion, measured from the time the subject to civil money penalty liability
exclusion would have been imposed if under section 1128A(a)(1)(D) of the Act
the waiver had not been granted. and criminal liability under section
(e) In the event a waiver is granted, 1128B(a)(3) of the Act and other provi-
it is applicable only to the program(s) sions. In addition, submitting claims,
for which waiver is requested. or causing claims to be submitted or
(f) The decision to grant, deny or repayments to be made, for items or
scind a request for a waiver is not sub- services furnished, ordered, or pre-
ject to administrative or judicial re- scribed, including administrative and
view. management services or salary, may
serve as the basis for denying rein-
[57 FR 3330, Jan. 29, 1992, as amended at 82 statement to the programs.
FR 4116, Jan. 12, 2017]
(c) Exceptions to paragraph (b)(1) of
this section. (1) If an enrollee of Part B
1177
§ 1001.2001 42 CFR Ch. V (10–1–24 Edition)
of Medicare submits an otherwise pay- (5)(i) Notwithstanding the other pro-

able claim for items or services fur- visions of this section, payment may be
nished by an excluded individual or en- made under Medicare, Medicaid or
tity, or under the medical direction or other Federal health care programs for
on the prescription of an excluded phy- certain emergency items or services
sician or other authorized individual furnished by an excluded individual or
after the effective date of exclusion, entity, or at the medical direction or
CMS will pay the first claim submitted on the prescription of an excluded phy-
by the enrollee and immediately notify sician or other authorized individual
the enrollee of the exclusion. during the period of exclusion. To be
(2) CMS will not pay an enrollee for payable, a claim for such emergency
items or services furnished by an ex- items or services must be accompanied
cluded individual or entity, or under by a sworn statement of the person fur-
the medical direction or on the pre- nishing the items or services specifying
scription of an excluded physician or the nature of the emergency and why
other authorized individual more than the items or services could not have
15 days after the date on the notice to been furnished by an individual or enti-
the enrollee, or after the effective date ty eligible to furnish or order such
of the exclusion, whichever is later. items or services.
(3) Unless the Secretary determines (ii) Notwithstanding paragraph
that the health and safety of bene- (c)(5)(i) of this section, no claim for
ficiaries receiving services under Medi- emergency items or services will be
care, Medicaid or any of the other Fed- payable if such items or services were
eral health care programs warrants the provided by an excluded individual
exclusion taking effect earlier, pay- who, through an employment, contrac-
ment may be made under such program tual or any other arrangement, rou-
for up to 30 days after the effective tinely provides emergency health care
date of the exclusion for— items or services.
(i) Inpatient institutional services
furnished to an individual who was ad- [57 FR 3330, Jan. 29, 1992, as amended at 60
FR 32917, June 26, 1995; 63 FR 46690, Sept. 2,
mitted to an excluded institution be- 1998; 64 FR 39427, July 22, 1999; 82 FR 4116,
fore the date of the exclusion, Jan. 12, 2017]
(ii) Home health services and hospice
care furnished to an individual under a
plan of care established before the ef- Subpart E—Notice and Appeals
fective date of the exclusion, and
§ 1001.2001 Notice of intent to exclude.
(iii) Any health care items that are
ordered by a practitioner, provider or (a) Except as provided in paragraph
supplier from an excluded manufac- (c) of this section, if the OIG proposes
turer before the effective date of the to exclude an individual or entity in
exclusion and delivered within 30 days accordance with subpart C of this part,
of the effective date of such exclusion. or in accordance with subpart B of this
(For the period October 2, 1998, to Octo- part where the exclusion is for a period
ber 4, 1999, payment may be made exceeding 5 years, it will send written
under Medicare or a State health care notice of its intent, the basis for the
program for up to 60 days after the ef- proposed exclusion and the potential
fective date of the exclusion for any effect of an exclusion. Within 30 days of
health care items that are ordered by a receipt of notice, which will be deemed
practitioner, provider or supplier from to be 5 days after the date on the no-
an excluded manufacturer before the tice, the individual or entity may sub-
effective date of such exclusion and de- mit documentary evidence and written
livered within 60 days of the effect of argument concerning whether the ex-
the exclusion.) clusion is warranted and any related
(4) CMS will not pay any claims sub- issues.
mitted by, or for items or services or- (b) If the OIG intends to exclude an
dered or prescribed by, an excluded pro- individual or entity under the provi-
vider for dates of service 15 days or sions of § 1001.701, § 1001.801, or
more after the notice of the provider’s § 1001.1552, in conjunction with the sub-
exclusion was mailed to the supplier. mission of documentary evidence and
1178
written argument, an individual or en- § 1001.2003 Notice of proposal to ex-

tity may request an opportunity to clude.
present oral argument to an OIG offi- (a) Except as provided in paragraph
cial. (c) of this section, if the OIG proposes
(c) Exception. If the OIG intends to to exclude an individual or entity in
exclude an individual or entity under accordance with § 1001.901, § 1001.951,
the provisions of § 1001.901, § 1001.951, § 1001.1601, or § 1001.1701, it will send a
§ 1001.1301, § 1001.1401, § 1001.1601, or written notice of proposal to exclude to
§ 1001.1701, paragraph (a) of this section the affected individual or entity. The
will not apply. written notice will provide the same
(d) If an entity has a provider agree- information set forth in § 1001.2002(c). If
ment under section 1866 of the Act, and an entity has a provider agreement
the OIG proposes to terminate that under section 1866 of the Act, and the
agreement in accordance with section OIG also proposes to terminate that
1866(b)(2)(C) of the Act, the notice pro- agreement in accordance with section
vided for in paragraph (a) of this sec- 1866(b)(2)(C) of the Act, the notice will
tion will so state. so indicate. The exclusion will be effec-
tive 60 days after the receipt of the no-
[63 FR 46690, Sept. 2, 1998, as amended at 63 tice (as defined in § 1005.2 of this chap-
FR 57918, Oct. 29, 1998; 82 FR 4116, Jan. 12, ter) unless, within that period, the in-
2017] dividual or entity files a written re-
quest for a hearing in accordance with
§ 1001.2002 Notice of exclusion. part 1005 of this chapter. Such request
(a) Except as provided in § 1001.2003, if must set forth—
the OIG determines that exclusion is (1) The specific issues or statements
warranted, it will send a written notice in the notice with which the individual
of this decision to the affected indi- or entity disagrees;
vidual or entity. (2) The basis for that disagreement;
(b) The exclusion will be effective 20 (3) The defenses on which reliance is
days from the date of the notice. intended;
(c) The written notice will state— (4) Any reasons why the proposed
(1) The basis for the exclusion; length of exclusion should be modified;
(2) The length of the exclusion and, and
where applicable, the factors consid- (5) Reasons why the health or safety
ered in setting the length; of individuals receiving services under
(3) The effect of the exclusion; Medicare or any of the State health
care programs does not warrant the ex-
(4) The earliest date on which the
clusion going into effect prior to the
OIG will consider a request for rein-
completion of an administrative law
statement; judge (ALJ) proceeding in accordance
(5) The requirements and procedures with part 1005 of this chapter.
for reinstatement; and (b) If the individual or entity makes
(6) The appeal rights available to the a timely written request for a hearing
excluded individual or entity. and the OIG has determined that the
(d) Paragraph (b) of this section does health or safety of individuals receiv-
not apply to exclusions imposed in ac- ing services under Medicare or any of
cordance with § 1001.1301. the State health care programs does
(e) No later than 15 days prior to the not warrant immediate exclusion, an
final exhibit exchanges required under exclusion will only go into effect as of
§ 1005.8 of this chapter, the OIG may the date of the ALJ’s decision, if the
amend its notice letter if information ALJ upholds the decision to exclude.
comes to light that justifies the impo- (c) If, prior to issuing a notice of pro-
sition of a different period of exclusion posal to exclude under paragraph (a) of
other than the one proposed in the this section, the OIG determines that
original notice letter. the health or safety of individuals re-
ceiving services under Medicare or any
[57 FR 3330, Jan. 29, 1992, as amended at 63 of the State health care programs war-
FR 46690, Sept. 2, 1998] rants the exclusion taking place prior
1179
§ 1001.2004 42 CFR Ch. V (10–1–24 Edition)
to the completion of an ALJ pro- (4) Hospitals, skilled nursing facili-

ceeding in accordance with part 1005 of ties, home health agencies and health
this chapter, the OIG will proceed maintenance organizations;
under §§ 1001.2001 and 1001.2002. (5) Medical societies and other pro-
fessional organizations;
(6) Contractors, health care prepay-
FR 46690, Sept. 2, 1998; 65 FR 24414, Apr. 26,
2000; 82 FR 4116, Jan. 12, 2017] ment plans, private insurance compa-
nies and other affected agencies and or-
§ 1001.2004 Notice to State agencies. ganizations;
(7) The State and Area Agencies on
HHS will promptly notify each appro- Aging established under title III of the
priate State agency administering or Older Americans Act;
supervising the administration of each (8) The National Practitioner Data
State health care program of: Bank.
(a) The facts and circumstances of (9) Other Departmental operating di-
each exclusion, and visions, Federal agencies, and other
(b) The period for which the State agencies or organizations, as appro-
agency is being directed to exclude the priate.
individual or entity. (b) In the case of an exclusion under
§ 1001.101 of this chapter, if section
§ 1001.2005 Notice to State licensing 304(a)(5) of the Controlled Substances
agencies. Act (21 U.S.C. 824(a)(5)) applies, HHS
(a) HHS will promptly notify the ap- will give notice to the Attorney Gen-
propriate State(s) or local agencies or eral of the United States of the facts
authorities having responsibility for and circumstances of the exclusion and
the licensing or certification of an in- the length of the exclusion.
dividual or entity excluded (or directed
to be excluded) from participation of FR 46690, Sept. 2, 1998]
the facts and circumstances of the ex-
clusion. § 1001.2007 Appeal of exclusions.
(b) HHS will request that appropriate (a)(1) Except as provided in § 1001.2003,
investigations be made and sanctions an individual or entity excluded under
invoked in accordance with applicable this part may file a request for a hear-
State law and policy, and will request ing before an ALJ only on the issues of
that the State or local agency or au- whether:
thority keep the Secretary and the OIG (i) The basis for the imposition of the
fully and currently informed with re- sanction exists, and
spect to any actions taken in response (ii) The length of exclusion is unrea-
to the request. sonable.
(2) When the OIG imposes an exclu-
§ 1001.2006 Notice to others regarding
exclusion. sion under subpart B of this part for a
period of 5 years, paragraph (a)(1)(ii) of
(a) HHS will give notice of the exclu- this section will not apply.
sion and the effective date to the pub- (3) The request for a hearing should
lic, to beneficiaries (in accordance with contain the information set forth in
§ 1001.1901(c)), and, as appropriate, to— § 1005.2(d) of this chapter.
(1) Any entity in which the excluded (b) The excluded individual or entity
individual is known to be serving as an has 60 days from the receipt of notice
employee, administrator, operator, or of exclusion provided for in § 1001.2002
in which the individual is serving in to file a request for such a hearing.
any other capacity and is receiving (c) The standard of proof at a hearing
payment for providing services (The is preponderance of the evidence.
lack of this notice will not affect (d) When the exclusion is based on
CMS’s ability to deny payment for the existence of a criminal conviction
services); or a civil judgment imposing liability
(2) State Medicaid Fraud Control by Federal, State or local court, a de-
Units; termination by another Government
(3) Utilization and Quality Control agency, or any other prior determina-
Quality Improvement Organizations; tion where the facts were adjudicated
1180
and a final decision was made, the once the reduced exclusion period ex-
basis for the underlying conviction, pires.
civil judgment or determination is not [57 FR 3330, Jan. 29, 1992, as amended at 63
reviewable and the individual or entity FR 46691, Sept. 2, 1998; 82 FR 4117, Jan. 12,
may not collaterally attack it either 2017]
on substantive or procedural grounds
in this appeal. § 1001.3002 Basis for reinstatement.
(e) The procedures in part 1005 of this (a) The OIG will authorize reinstate-
chapter will apply to the appeal. ment if it determines that—
[57 FR 3330, Jan. 29, 1992, as amended at 67 (1) The period of exclusion has ex-
FR 11935, Mar. 18, 2002] pired;
(2) There are reasonable assurances
that the types of actions that formed
Subpart F—Reinstatement into the the basis for the original exclusion
Programs have not recurred and will not recur;
and
§ 1001.3001 Timing and method of re-
(3) There is no additional basis under
quest for reinstatement.
sections 1128(a) or (b) or 1128A of the
(a)(1) Except as provided in para- Act for continuation of the exclusion.
graph (a)(2) of this section or in (b) In making the reinstatement de-
§ 1001.501(b)(2), § 1001.501(c), or termination described in paragraph (a)
§ 1001.601(b)(4), an excluded individual of this section, the OIG will consider—
or entity (other than those excluded in (1) Conduct of the individual or enti-
accordance with §§ 1001.1001 and ty occurring prior to the date of the
1001.1501) may submit a written request notice of exclusion, if not known to the
for reinstatement to the OIG only after OIG at the time of the exclusion;
the date specified in the notice of ex- (2) Conduct of the individual or enti-
clusion. Obtaining a program provider ty after the date of the notice of exclu-
number or equivalent does not rein- sion;
state eligibility. (3) Whether all fines and all debts due
(2) An entity excluded under and owing (including overpayments) to
§ 1001.1001 may apply for reinstatement any Federal, State, or local govern-
prior to the date specified in the notice ment that relate to Medicare, Med-
of exclusion by submitting a written icaid, and all other Federal health care
request for reinstatement that includes programs have been paid or satisfac-
tory arrangements have been made to
documentation demonstrating that the
fulfill obligations;
standards set forth in § 1001.3002(c) have
(4) Whether CMS has determined that
been met.
the individual or entity complies with,
(b) Upon receipt of a written request, or has made satisfactory arrangements
the OIG will require the requestor to to fulfill, all the applicable conditions
furnish specific information and au- of participation or supplier conditions
thorization to obtain information from for coverage under the statutes and
private health insurers, peer review regulations;
bodies, probation officers, professional (5) Whether the individual or entity
associates, investigative agencies and has, during the period of exclusion,
such others as may be necessary to de- submitted claims, or caused claims to
termine whether reinstatement should be submitted or payment to be made by
be granted. any Federal health care program, for
(c) Failure to furnish the required in- items or services the excluded party
formation or authorization will result furnished, ordered, or prescribed, in-
in the continuation of the exclusion. cluding health care administrative
(d) If a period of exclusion is reduced services. This section applies regard-
on appeal (regardless of whether fur- less of whether an individual or entity
ther appeal is pending), the individual has obtained a program provider num-
or entity may request reinstatement ber or equivalent, either as an indi-
vidual or as a member of a group, prior
to being reinstated; and
1181
§ 1001.3003 42 CFR Ch. V (10–1–24 Edition)
(c) If the OIG determines that the § 1001.3004 Denial of request for rein-
criteria in paragraphs (a)(2) and (3) of statement.
this section have been met, an entity (a) If a request for reinstatement is
excluded in accordance with § 1001.1001 denied, OIG will give written notice to
will be reinstated upon a determina- the requesting individual or entity.
tion by the OIG that the individual Within 30 days of the date on the no-
whose conviction, exclusion, or civil tice, the excluded individual or entity
money penalty was the basis for the may submit:
entity’s exclusion— (1) Documentary evidence and writ-
(1) Has properly reduced his or her ten argument against the continued ex-
ownership or control interest in the en- clusion,
tity below 5 percent; (2) A written request to present writ-
(2) Is no longer an officer, director, ten evidence and oral argument to an
agent or managing employee of the en- OIG official, or
tity; or (3) Both documentary evidence and a
(3) Has been reinstated in accordance written request.
with paragraph (a) of this section or (b) After evaluating any additional
§ 1001.3005. evidence submitted by the excluded in-
(d) Reinstatement will not be effec- dividual or entity (or at the end of the
tive until the OIG grants the request 30-day period, if none is submitted), the
and provides notice under § 1001.3003(a) OIG will send written notice either
of this part. Reinstatement will be ef- confirming the denial, and indicating
fective as provided in the notice. that a subsequent request for rein-
(e) A determination with respect to statement will not be considered until
reinstatement is not appealable or re- at least one year after the date of de-
viewable except as provided in nial, or approving the request con-
§ 1001.3004. sistent with the procedures set forth in
(f) An ALJ may not require rein- § 1001.3003(a).
statement of an individual or entity in (c) The decision to deny reinstate-
accordance with this chapter. ment will not be subject to administra-
tive or judicial review.
FR 46691, Sept. 2, 1998; 64 FR 39427, July 22, § 1001.3005 Withdrawal of exclusion
1999; 82 FR 4117, Jan. 12, 2017] for reversed or vacated decisions.
(a) An exclusion will be withdrawn
§ 1001.3003 Approval of request for re- and an individual or entity will be rein-
instatement.
stated into Medicare, Medicaid, and
(a) If the OIG grants a request for re- other Federal health care programs
instatement, the OIG will— retroactive to the effective date of the
(1) Give written notice to the ex- exclusion when such exclusion is based
cluded individual or entity specifying on—
the date of reinstatement; (1) A conviction that is reversed or
(2) Notify CMS of the date of the in- vacated on appeal;
dividual’s or entity’s reinstatement; (2) An action by another agency, such
(3) Notify appropriate Federal and as a State agency or licensing board,
State agencies that administer health that is reversed or vacated on appeal;
care programs that the individual or or
entity has been reinstated into all Fed- (3) An OIG exclusion action that is
eral health care programs; and reversed or vacated at any stage of an
(4) To the extent applicable, give no- individual’s or entity’s administrative
tice to others that were originally no- appeal process.
tified of the exclusion. (b) If an individual or entity is rein-
stated in accordance with paragraph
(b) A determination by the OIG to re-
(a) of this section, CMS and other Fed-
instate an individual or entity has no
eral health care programs will make
effect if a Federal health care program
payment for services covered under
has imposed a longer period of exclu-
such program that were furnished or
sion under its own authorities.
performed during the period of exclu-
[64 FR 39428, July 22, 1999] sion.
1182
(c) The OIG will give notice of a rein- SOURCE: 57 FR 3343, Jan. 29, 1992, unless
statement under this section in accord- otherwise noted.
ance with § 1001.3003(a).
(d) An action taken by the OIG under Subpart A—General Provisions
this section will not require any other
Federal health care program to rein- § 1002.1 Basis and scope.
state the individual or entity if such (a) Statutory basis. This part imple-
program has imposed an exclusion ments sections 1902(a)(4), 1902(a)(39),
under its own authority. 1902(a)(41), 1902(p), 1903(i)(2), 1124, 1126,
(e) If an action which results in the and 1128 of the Act.
retroactive reinstatement of an indi- (1) Under authority of section
vidual or entity is subsequently over- 1902(a)(4) of the Act, this part sets
turned, the OIG may reimpose the ex- forth methods of administration and
clusion for the initial period of time, procedures the State agency must fol-
less the period of time that was served low to exclude a provider from partici-
prior to the reinstatement of the indi- pation in the State Medicaid program.
vidual or entity. State-initiated exclusion from Med-
[57 FR 3330, Jan. 29, 1992, as amended at 64 icaid may lead to OIG exclusion from
FR 39428, July 22, 1999; 67 FR 11935, Mar. 18, all Federal health care programs.
2002; 82 FR 4117, Jan. 12, 2017] (2) Under authority of sections 1124
and 1126 of the Act, this part requires
PART 1002—PROGRAM INTEG- the Medicaid agency to obtain and dis-
RITY—STATE-INITIATED EXCLU- close to the OIG certain provider own-
ership and control information, along
SIONS FROM MEDICAID with actions taken on a provider’s ap-
plication to participate in the program.
(3) Under authority of sections
Sec. 1902(a)(41) and 1128 of the Act, this part
1002.1 Basis and scope. requires the State agency to notify the
1002.2 Other applicable regulations. OIG of sanctions and other actions the
1002.3 General authority. State takes to limit a provider’s par-
1002.4 Disclosure by providers and State
Medicaid agencies.
ticipation in Medicaid.
1002.5 State plan requirement. (4) Section 1902(p) of the Act permits
1002.6 Payment prohibitions. the State to exclude an individual or
entity from Medicaid for any reason
Subpart B—State Exclusion of Certain the Secretary can exclude and requires
Managed Care Entities the State to exclude certain managed
1002.203 State exclusion of certain managed
care entities that could be excluded by
care entities. the OIG.
(5) Sections 1902(a)(39) and 1903(i)(2)
Subpart C—Procedures for State-Initiated of the Act prohibit State payments to
Exclusions providers and deny Federal financial
participation (FFP) in State expendi-
1002.210 General authority.
tures for items or services furnished by
1002.211 [Reserved]
1002.212 State agency notifications. an individual or entity that has been
1002.213 Appeals of exclusions. excluded by the OIG from participation
1002.214 Basis for reinstatement after State in Federal health care programs.
agency-initiated exclusion. (b) Scope. This part specifies certain
1002.215 Action on request for reinstate- bases upon which the State may or, in
ment. some cases, must exclude an individual
or entity from participation in the
Subpart D—Notification to OIG of State or
Medicaid program and the administra-
Local Convictions of Crimes Against
tive procedures the State must follow
Medicaid
to do so. These regulations specifically
1002.230 Notification of State or local con- address the authority of State agencies
victions of crimes against Medicaid. to exclude on their own initiative, re-
AUTHORITY: 42 U.S.C. 1302, 1320a–3, 1320a–5, gardless of whether the OIG has ex-
1320a–7, 1396(a)(4)(A), 1396a(p), 1396a(a)(39), cluded an individual or entity under
1396a(a)(41), and 1396b(i)(2). part 1001 of this chapter. In addition,
1183
§ 1002.2 42 CFR Ch. V (10–1–24 Edition)
this part delineates the States’ obliga- (3) The agency must also promptly
tion to obtain certain information notify the Inspector General of any ac-
from Medicaid providers and to inform tion it takes to limit the ability of an
the OIG of information received and ac- individual or entity to participate in
tions taken. its program, regardless of what such an
[82 FR 4117, Jan. 12, 2017] action is called. This includes, but is
not limited to, suspension actions, set-
§ 1002.2 Other applicable regulations. tlement agreements and situations
where an individual or entity volun-
(a) Part 455, subpart B, of this title
tarily withdraws from the program to
sets forth requirements for disclosure
avoid a formal sanction.
of ownership and control information
to the State Medicaid agency by pro- (c) Denial or termination of provider
viders and fiscal agents. participation. (1) The Medicaid agency
(b) Part 438, subpart J, of this title may refuse to enter into or renew an
sets forth payment and exclusion re- agreement with a provider if any per-
quirements specific to Medicaid man- son who has an ownership or control
aged care organizations. interest, or who is an agent or man-
aging employee of the provider, in the
[82 FR 4118, Jan. 12, 2017] provider has been convicted of a crimi-
nal offense related to that person’s in-
§ 1002.3 General authority. volvement in any program established
(a) In addition to any other authority under Medicare, Medicaid, Title V,
it may have, a State may exclude an Title XX, or Title XXI of the Act.
individual or entity from participation (2) The Medicaid agency may refuse
in the Medicaid program for any reason to enter into, or terminate, a provider
for which the Secretary could exclude agreement if it determines that the
that individual or entity from partici- provider did not fully and accurately
pation in Federal health care programs make any disclosure required under
under sections 1128, 1128A, or 1866(b)(2) paragraph (a) of this section.
of the Act.
(b) Nothing contained in this part [57 FR 3343, Jan. 29, 1992, as amended at 63
FR 46691, Sept. 2, 1998. Redesignated and
should be construed to limit a State’s amended at 82 FR 4118, Jan. 12, 2017]
own authority to exclude an individual
or entity from Medicaid for any reason § 1002.5 State plan requirement.
or period authorized by State law.
The plan must provide that the re-
[57 FR 3343, Jan. 29, 1992, as amended at 64 quirements of this subpart are met.
FR 39428, July 22, 1999. Redesignated and However, the provisions of these regu-
amended at 82 FR 4118, Jan. 12, 2017] lations are minimum requirements.
§ 1002.4 Disclosure by providers and The agency may impose broader sanc-
State Medicaid agencies. tions if it has the authority to do so
under State law.
(a) Information that must be disclosed.
Before the Medicaid agency enters into [57 FR 3343, Jan. 29, 1992. Redesignated at 82
or renews a provider agreement, or at FR 4118, Jan. 12, 2017]
any time upon written request by the
Medicaid agency, the provider must § 1002.6 Payment prohibitions.
disclose to the Medicaid agency the (a) Denial of payment by State agen-
identity of any person described in cies. Except as provided for in
§ 1001.1001(a)(1) of this chapter. § 1001.1901(c)(3), (4) and (5)(i) of this
(b) Notification to Inspector General. (1) chapter, no payment may be made by
The Medicaid agency must notify the the State agency for any item or serv-
Inspector General of any disclosures ice furnished on or after the effective
made under paragraph (a) of this sec- date specified in the notice:
tion within 20 working days from the (1) By an individual or entity ex-
date it receives the information. cluded by the OIG or
(2) The agency must promptly notify (2) At the medical direction or on the
the Inspector General of any action it prescription of a physician or other au-
takes on the provider’s application for thorized individual who is excluded by
participation in the program. the OIG when a person furnishing such
1184
item or service knew, or had reason to ices, supplies, equipment, space or sal-
know, of the exclusion. aried employment.
(b) Denial of Federal financial partici- [57 FR 3343, Jan. 29, 1992, as amended at 63
pation (FFP). FFP is not available for FR 46691, Sept. 2, 1998; 82 FR 4118, Jan. 12,
any item or service for which the State 2017]
agency is required to deny payment
under paragraph (a) of this section. Subpart C—Procedures for State-
FFP will be available for items and Initiated Exclusions
services furnished after the excluded
individual or entity is reinstated in the § 1002.210 General authority.
Medicaid program. The State agency must have adminis-
[82 FR 4118, Jan. 12, 2017] trative procedures in place that enable
it to exclude an individual or entity for
any reason for which the Secretary
Subpart B—State Exclusion of could exclude such individual or entity
Certain Managed Care Entities under parts 1001 or 1003 of this chapter.
The period of such exclusion is at the
§ 1002.203 State exclusion of certain
managed care entities. discretion of the State agency.
(a) The State agency, in order to re- § 1002.211 [Reserved]

ceive FFP, must provide that it will
exclude from participation any man- § 1002.212 State agency notifications.
aged care organization (as defined in When the State agency initiates an
section 1903(m) of the Act) or entity exclusion under § 1002.210, it must pro-
furnishing services under a waiver ap- vide to the individual or entity subject
proved under section 1915(b)(1) of the to the exclusion notification consistent
Act, if such organization or entity— with that required in subpart E of part
(1) Has a prohibited ownership or 1001 of this chapter, and must notify
control relationship with any indi- other State agencies, the State med-
vidual or entity that could subject the ical licensing board (where applicable),
managed care organization or entity to the public, beneficiaries, and others as
provided in §§ 1001.2005 and 1001.2006 of
exclusion under § 1001.1001 or § 1001.1551
this chapter.
of this chapter or
(2) Has, directly or indirectly, a sub- § 1002.213 Appeals of exclusions.
stantial contractual relationship with
Before imposing an exclusion under
an individual or entity that could be
§ 1002.210, the State agency must give
excluded under § 1001.1001 or § 1001.1551
the individual or entity the oppor-
of this chapter. tunity to submit documents and writ-
(b) As used in this section, the term— ten argument against the exclusion.
Exclude includes the refusal to enter The individual or entity must also be
into or renew a participation agree- given any additional appeals rights
ment or the termination of such an that would otherwise be available
agreement. under procedures established by the
Substantial contractual relationship is State.
one in which the sanctioned individual
described in § 1001.1001 of this chapter § 1002.214 Basis for reinstatement
has direct or indirect business trans- after State agency-initiated exclu-
sion.
actions with the organization or entity
that, in any fiscal year, amount to (a) The provisions of this section and
more than $25,000 or 5 percent of the or- § 1002.215 apply to the reinstatement in
ganization’s or entity’s total operating the Medicaid program of all individuals
expenses, whichever is less. Business or entities excluded in accordance with
transactions include, but are not lim- § 1002.210, if a State affords reinstate-
ment opportunity to those excluded
ited to, contracts, agreements, pur-
parties.
chase orders, or leases to obtain serv-
(b) An individual or entity who has
been excluded from Medicaid may be
1185
§ 1002.215 42 CFR Ch. V (10–1–24 Edition)
reinstated only by the Medicaid agency Subpart D—Notification to OIG of

that imposed the exclusion. State or Local Convictions of
(c) An individual or entity may sub- Crimes Against Medicaid
mit to the State agency a request for
reinstatement at any time after the § 1002.230 Notification of State or local
date specified in the notice of exclu- convictions of crimes against Med-
sion. icaid.
(a) The State agency must notify the
§ 1002.215 Action on request for rein- OIG whenever a State or local court
statement. has convicted an individual who is re-
(a) The State agency may grant rein- ceiving reimbursement under Medicaid
statement only if it is reasonably cer- of a criminal offense related to partici-
tain that the types of actions that pation in the delivery of health care
formed the basis for the original exclu- items or services under the Medicaid
sion have not recurred and will not program, except where the State Med-
recur. In making this determination, icaid Fraud Control Unit (MFCU) has
the agency will consider, in addition to so notified the OIG.
any factors set forth in State law— (b) If the State agency was involved
in the investigation or prosecution of
(1) The conduct of the individual or
the case, it must send notice within 15
entity occurring prior to the date of
days after the conviction.
the notice of exclusion, if not known to
(c) If the State agency was not so in-
the agency at the time of the exclu- volved, it must give notice within 15
sion; days after it learns of the conviction.
(2) The conduct of the individual or
entity after the date of the notice of
exclusion; and
PART 1003—CIVIL MONEY PEN-
(3) Whether all fines, and all debts
ALTIES, ASSESSMENTS AND EX-
due and owing (including overpay- CLUSIONS
ments) to any Federal, State or local
government that relate to Medicare or
any of the State health care programs, Sec.
have been paid, or satisfactory ar- 1003.100 Basis and purpose.
rangements have been made, that ful- 1003.110 Definitions.
fill these obligations. 1003.120 Liability for penalties and assess-
ments.
(b) Notice of action on request for re-
1003.130 Assessments.
instatement. (1) If the State agency ap- 1003.140 Determinations regarding the
proves the request for reinstatement, it amount of penalties and assessments and
must give written notice to the ex- the period of exclusion.
cluded party, and to all others who 1003.150 Delegation of authority.
were informed of the exclusion in ac- 1003.160 Waiver of exclusion.
cordance with § 1002.212, specifying the
date on which Medicaid program par- Subpart B—CMPs, Assessments, and Exclu-
sions for False or Fraudulent Claims
ticipation may resume.
and Other Similar Misconduct
(2) If the State agency does not ap-
prove the request for reinstatement, it 1003.200 Basis for civil money penalties, as-
will notify the excluded party of its de- sessments, and exclusions.
cision. Any appeal of a denial of rein- 1003.210 Amount of penalties and assess-
ments.
statement will be in accordance with
1003.220 Determinations regarding the
State procedures and need not be sub- amount of penalties and assessments and
ject to administrative or judicial re- the period of exclusion.
view, unless required by State law.
Subpart C—CMPs, Assessments, and Ex-
clusions for Anti-Kickback and Physi-
cian Self-Referral Violations
1003.300 Basis for civil money penalties, as-
sessments, and exclusions.
1186
Office of Inspector General—Health Care, HHS Pt. 1003
1003.310 Amount of penalties and assess- 1003.920 Determinations regarding the
ments. amount of penalties.
amount of penalties and assessments and Subpart J—CMPs, Assessments, and Exclu-
the period of exclusion. sions for Beneficiary Inducement Vio-
lations
Subpart D—CMPs and Assessments for
1003.1000 Basis for civil money penalties, as-
Contracting Organization Misconduct sessments, and exclusions.
1003.400 Basis for civil money penalties and 1003.1010 Amount of penalties and assess-
ments.
assessments.
1003.410 Amount of penalties and assess- amount of penalties and assessments and
ments for Contracting Organizations. the period of exclusion.
amount of penalties and assessments. Subpart K—CMPs for the Sale of Medicare
Supplemental Policies
Subpart E—CMPs and Exclusions for
EMTALA Violations 1003.1100 Basis for civil money penalties.
1003.1110 Amount of penalties.
1003.500 Basis for civil money penalties and 1003.1120 Determinations regarding the
exclusions. amount of penalties.
1003.510 Amount of penalties.
1003.520 Determinations regarding the Subpart L—CMPs for Drug Price Reporting
amount of penalties and the period of ex- 1003.1200 Basis for civil money penalties.
clusion. 1003.1210 Amount of penalties.
Subpart F—CMPs for Section 1140 amount of penalties.
Violations
Subpart M—CMPs for Notifying a Skilled
1003.600 Basis for civil money penalties. Nursing Facility, Nursing Facility, Home
1003.610 Amount of penalties. Health Agency, or Community Care
1003.620 Determinations regarding the Setting of a Survey
amount of penalties.
1003.1300 Basis for civil money penalties.
Subpart G—CMPs, Assessments, and Ex- 1003.1310 Amount of penalties.
clusions for Fraud or False Claims or 1003.1320 Determinations regarding the
Similar Conduct Related to Grants, amount of penalties.
Contracts, and Other Agreements
Subpart N—CMPs for Information Blocking
1003.700 Basis for civil money penalties, as- 1003.1400 Basis for civil money penalties.
sessments, and exclusions. 1003.1410 Amount of penalties.
1003.710 Amount of penalties and assess- 1003.1420 Determinations regarding the
ments. amount of penalties.
amount of penalties and assessments and Subpart O—Procedures for the Imposition
period of exclusion. of CMPs, Assessments, and Exclusions
Subpart H—CMPs for Adverse Action 1003.1500 Notice of proposed determination.
Reporting and Disclosure Violations 1003.1510 Failure to request a hearing.
1003.1520 Collateral estoppel.
1003.800 Basis for civil money penalties. 1003.1530 Settlement.
1003.810 Amount of penalties. 1003.1540 Judicial review.
1003.1550 Collection of penalties and assess-
ments.
amount of penalties.
1003.1560 Notice to other agencies.
1003.1570 Limitations.
Subpart I—CMPs for Select Agent Program 1003.1580 Statistical sampling.
Violations 1003.1590 Effect of exclusion.
1003.1600 Reinstatement.
1003.900 Basis for civil money penalties.
1003.910 Amount of penalties. AUTHORITY: 42 U.S.C. 262a, 300jj–52, 1302,
1320a–7, 1320a–7a, 1320b–10, 1395u(j), 1395u(k),
1395cc(j), 1395w–141(i)(3), 1395dd(d)(1), 1395mm,
1395nn(g), 1395ss(d), 1396b(m), 11131(c), and
11137(b)(2).
1187
§ 1003.100 42 CFR Ch. V (10–1–24 Edition)
SOURCE: 51 FR 34777, Sept. 30, 1986, unless suant to sections 1857, 1860D–12, 1876(b),
otherwise noted. or 1903(m) of the Act.
Department means the Department of
Subpart A—General Provisions Health and Human Services.
Enrollee means an individual who is
§ 1003.100 Basis and purpose. eligible for Medicare or Medicaid and
(a) Basis. This part implements sec- who enters into an agreement to re-
tions 1128(c), 1128A, 1140, 1819(b)(3)(B), ceive services from a contracting orga-
1819(g)(2)(A), 1857(g)(2)(A), 1860D– nization.
12(b)(3)(E), 1860D–31(i)(3), 1862(b)(3)(C), Items and services or items or services
1867(d)(1), 1876(i)(6), 1877(g), 1882(d), includes without limitation, any item,
1891(c)(1); 1903(m)(5), 1919(b)(3)(B), device, drug, biological, supply, or
1919(g)(2)(A), 1927(b)(3)(B), 1927(b)(3)(C), service (including management or ad-
and 1929(i)(3) of the Social Security ministrative services), including, but
Act; sections 421(c) and 427(b)(2) of Pub- not limited to, those that are listed in
lic Law 99–660; section 201(i) of Public an itemized claim for program pay-
Law 107–188 (42 U.S.C. 1320a–7(c), 1320a– ment or a request for payment; for
7a, 1320b–10, 1395i–3(b)(3)(B), 1395i– which payment is included in any Fed-
3(g)(2)(A), 1395w–27(g)(2)(A), 1395w– eral or State health care program re-
112(b)(3)(E), 1395w–141(i)(3), imbursement method, such as a pro-
1395y(b)(3)(B), 1395dd(d)(1), spective payment system or managed
1395mm(i)(6), 1395nn(g), 1395ss(d), care system; or that are, in the case of
1395bbb(c)(1), 1396b(m)(5), 1396r(b)(3)(B), a claim based on costs, required to be
1396r(g)(2)(A), 1396r–8(b)(3)(B), 1396r– entered in a cost report, books of ac-
8(b)(3)(C), 1396t(i)(3), 11131(c), count, or other documents supporting
11137(b)(2), and 262a(i)); and section 3022 the claim (whether or not actually en-
of the Public Health Service Act (42 tered).
U.S.C. 300jj–52). Knowingly means that a person, with
(b) Purpose. This part— respect to an act, has actual knowledge
(1) Provides for the imposition of of the act, acts in deliberate ignorance
civil money penalties (CMPs) and, as of the act, or acts in reckless disregard
applicable, assessments and exclusions of the act, and no proof of specific in-
against persons who have committed tent to defraud is required.
an act or omission that violates one or Material means having a natural
more provisions of this part; and tendency to influence, or be capable of
(2) Sets forth the appeal rights of per- influencing, the payment or receipt of
sons subject to a penalty, assessment, money or property.
and exclusion. Maternal and Child Health Services
Block Grant program means the program
[81 FR 88354, Dec. 7, 2016, as amended at 88 authorized under Title V of the Act.
FR 42839, July 3, 2023] Medical malpractice claim or action
means a written complaint or claim de-
manding payment based on a physi-
For purposes of this part: cian’s, dentist’s, or other health care
Assessment means the amounts de- practitioner’s provision of, or failure to
scribed in this part and includes the provide, health care services and in-
plural of that term. cludes the filing of a cause of action
Claim means an application for pay- based on the law of tort brought in any
ment for an item or service under a State or Federal court or other adju-
Federal health care program. dicative body.
Contracting organization means a pub- Non-separately-billable item or service
lic or private entity, including a health means an item or service that is a com-
maintenance organization, Medicare ponent of, or otherwise contributes to
Advantage organization, Prescription the provision of, an item or a service,
Drug Plan sponsor, or other organiza- but is not itself a separately billable
tion that has contracted with the De- item or service.
partment or a State to furnish, or oth- Obligation for the purposes of
erwise pay for, items and services to § 1003.700 means an established duty,
Medicare or Medicaid beneficiaries pur- whether or not fixed, arising from an
1188
express or implied contractual, grant- nishing benefits or assistance to indi-

or-grantee, or licensor-licensee rela- viduals and for which the Secretary
tionship for a fee-based or similar rela- provides funding—an individual who
tionship, from statute or regulation, or applies for or who receives such bene-
from the retention of any overpay- fits or assistance from such grant, con-
ment. tract, or other agreement. Such term
Other agreement for the purposes of does not include—with respect to such
§ 1003.700 includes a cooperative agree- grant, contract, or other agreement—
ment, scholarship, fellowship, loan, an officer, employee, or agent of a per-
subsidy, payment for a specified use, son or entity that receives such grant
donation agreement, award, or or that enters into such contract or
subaward (regardless of whether one or other agreement.
more of the persons entering into the Reasonable request with respect to
agreement is a contractor or subcon- §§ 1003.200(b)(10) and 1003.700(a)(5) means
tractor). a written request signed by a des-
Overpayment means any funds that a ignated representative of the OIG and
person receives or retains under Medi- made by a properly identified agent of
care or Medicaid to which the person, the OIG during reasonable business
after applicable reconciliation, is not hours. The request will include:
entitled under such program. (1) A statement of the authority for
Participating hospital means either a the request;
hospital or a critical access hospital, as (2) The person’s rights in responding
defined in section 1861(mm)(1) of the to the request;
Act, that has entered into a Medicare (3) The definition of ‘‘reasonable re-
provider agreement under section 1866 quest’’ and ‘‘failure to grant timely ac-
of the Act. cess’’ under this part;
Penalty means the amount described (4) The deadline by which the OIG re-
in this part and includes the plural of quests access; and
that term. (5) The amount of the civil money
Person means an individual, trust or penalty or assessment that could be
estate, partnership, corporation, pro- imposed and the effective date, length,
fessional association or corporation, or and scope and effect of the exclusion
other entity, public or private. that would be imposed for failure to
Physician incentive plan means any comply with the request, and the ear-
compensation arrangement between a liest date that a request for reinstate-
contracting organization and a physi- ment would be considered.
cian or physician group that may di- Recipient for the purposes of § 1003.700
rectly or indirectly have the effect of means any person (excluding a program
reducing or limiting services provided beneficiary as defined in this section)
with respect to enrollees in the organi- directly or indirectly receiving money
zation. or property under a grant, contract, or
Preventive care, for purposes of the other agreement funded in whole or in
definition of the term Remuneration as part by the Secretary, including a sub-
set forth in this section and the pre- recipient or subcontractor.
ventive care exception to section 231(h) Remuneration, for the purposes of
of HIPAA, means any service that— § 1003.1000(a) of this part, is consistent
(1) Is a prenatal service or a post- with the definition in section
natal well-baby visit or is a specific 1128A(i)(6) of the Act and includes the
clinical service described in the cur- waiver of copayment, coinsurance and
rent U.S. Preventive Services Task deductible amounts (or any part there-
Force’s Guide to Clinical Preventive Serv- of) and transfers of items or services
ices, and for free or for other than fair market
(2) Is reimbursable in whole or in value. The term ‘‘remuneration’’ does
part by Medicare or an applicable not include:
State health care program. (1) The waiver of coinsurance and de-
Program beneficiary means—in the ductible amounts by a person, if the
case of a grant, contract, or other waiver is not offered as part of any ad-
agreement designed to accomplish the vertisement or solicitation; the person
objective of awarding or otherwise fur- does not routinely waive coinsurance
1189
§ 1003.110 42 CFR Ch. V (10–1–24 Edition)
or deductible amounts; and the person (i) The items or services consist of
waives coinsurance and deductible coupons, rebates, or other rewards
amounts after determining in good from a retailer;
faith that the individual is in financial (ii) The items or services are offered
need or failure by the person to collect or transferred on equal terms available
coinsurance or deductible amounts to the general public, regardless of
after making reasonable collection ef- health insurance status; and
forts; (iii) The offer or transfer of the items
(2) Any permissible practice as speci- or services is not tied to the provision
fied in section 1128B(b)(3) of the Act or of other items or services reimbursed
in regulations issued by the Secretary; in whole or in part by the program
(3) Differentials in coinsurance and under Title XVIII or a State health
deductible amounts as part of a benefit care program (as defined in section
plan design (as long as the differentials 1128(h) of the Act);
have been disclosed in writing to all (8) The offer or transfer of items or
beneficiaries, third party payers and
services for free or less than fair mar-
providers), to whom claims are pre-
ket value by a person, if—
sented;
(i) The items or services are not of-
(4) Incentives given to individuals to
fered as part of any advertisement or
promote the delivery of preventive care
services where the delivery of such solicitation;
services is not tied (directly or indi- (ii) The offer or transfer of the items
rectly) to the provision of other serv- or services is not tied to the provision
ices reimbursed in whole or in part by of other items or services reimbursed
Medicare or an applicable State health in whole or in part by the program
care program. Such incentives may in- under Title XVIII or a State health
clude the provision of preventive care, care program (as defined in section
but may not include— 1128(h) of the Act);
(i) Cash or instruments convertible (iii) There is a reasonable connection
to cash; or between the items or services and the
(ii) An incentive the value of which is medical care of the individual; and
disproportionally large in relationship (iv) The person provides the items or
to the value of the preventive care services after determining in good
service (i.e., either the value of the faith that the individual is in financial
service itself or the future health care need;
costs reasonably expected to be avoided (9) Waivers by a Part D Plan sponsor
as a result of the preventive care). (as that term is defined in 42 CFR 423.4)
(5) A reduction in the copayment of any copayment for the first fill of a
amount for covered OPD services under covered Part D drug (as defined in sec-
section 1833(t)(8)(B) of the Act; tion 1860D–2(e)) that is a generic drug
(6) Items or services that improve a (as defined in 42 CFR 423.4) or an au-
beneficiary’s ability to obtain items thorized generic drug (as defined in 21
and services payable by Medicare or CFR 314.3) for individuals enrolled in
Medicaid, and pose a low risk of harm the Part D plan (as that term is defined
to Medicare and Medicaid beneficiaries in 42 CFR 423.4), as long as such waiv-
and the Medicare and Medicaid pro- ers are included in the benefit design
grams by— package submitted to CMS. This excep-
(i) Being unlikely to interfere with, tion is applicable to coverage years be-
or skew, clinical decision making; ginning on or after January 1, 2018.
(ii) Being unlikely to increase costs (10) The provision of telehealth tech-
to Federal health care programs or nologies by a provider of services, phy-
beneficiaries through overutilization sician, or a renal dialysis facility (as
or inappropriate utilization; and such terms are defined for purposes of
(iii) Not raising patient safety or title XVIII of the Act) to an individual
quality-of-care concerns; with end-stage renal disease who is re-
(7) The offer or transfer of items or ceiving home dialysis for which pay-
services for free or less than fair mar- ment is being made under part B of
ket value by a person if— such title, if:
1190
(i) The telehealth technologies are agent and/or toxin’’ as set forth in 42
furnished to the individual by the pro- CFR part 73.
vider of services, physician, or the Separately billable item or service
renal dialysis facility that is currently means an item or service for which an
providing the in-home dialysis, tele- identifiable payment may be made
health services, or other end-stage under a Federal health care program,
renal disease care to the individual, or e.g., an itemized claim or a payment
has been selected or contacted by the under a prospective payment system or
individual to schedule an appointment other reimbursement methodology.
or provide services; Should know, or should have known,
(ii) The telehealth technologies are means that a person, with respect to
not offered as part of any advertise- information, either acts in deliberate
ment or solicitation; and ignorance of the truth or falsity of the
(iii) The telehealth technologies are information or acts in reckless dis-
provided for the purpose of furnishing regard of the truth or falsity of the in-
telehealth services related to the indi- formation. For purposes of this defini-
vidual’s end-stage renal disease. tion, no proof of specific intent to de-
Request for payment means an applica- fraud is required.
tion submitted by a person to any per- Social Services Block Grant Program
son for payment for an item or service. means the program authorized under
Title XX of the Act.
Respondent means the person upon
Specified claim means any application,
whom the Department has imposed, or
request, or demand under a grant, con-
proposes to impose, a penalty, assess-
tract, or other agreement for money or
ment or exclusion. property, whether or not the United
Responsible Official means the indi- States or a specified State agency has
vidual designated pursuant to 42 CFR title to the money or property, that is
part 73 to serve as the Responsible Offi- not a claim (as defined in this section)
cial for the person holding a certificate and that:
of registration to possess, use, or trans- (1) Is presented or caused to be pre-
fer select agents or toxins. sented to an officer, employee, or agent
Responsible physician means a physi- of the Department or agency thereof,
cian who is responsible for the exam- or of any specified State agency; or
ination, treatment, or transfer of an (2) Is made to a contractor, grantee,
individual who comes to a partici- or other recipient if the money or prop-
pating hospital’s emergency depart- erty is to be spent or used on the De-
ment requesting examination or treat- partment’s behalf or to advance a De-
ment, including any physician who is partment program or interest, and if
on-call for the care of such individual the Department:
and fails or refuses to appear within a (i) Provides or has provided any por-
reasonable time at such hospital to tion of the money or property re-
provide services relating to the exam- quested or demanded; or
ination, treatment, or transfer of such (ii) Will reimburse such contractor,
individual. Responsible physician also grantee, or other recipient for any por-
includes a physician who is responsible tion of the money or property which is
for the examination or treatment of in- requested or demanded.
dividuals at hospitals with specialized Specified State agency means an agen-
capabilities or facilities, as provided cy of a State government established
under section 1867(g) of the Act, includ- or designated to administer or super-
ing any physician who is on-call for the vise the administration of a grant, con-
care of such individuals and refuses to tract, or other agreement funded in
accept an appropriate transfer or fails whole or in part by the Secretary.
or refuses to appear within a reason- Telehealth technologies, for purposes
able time to provide services related to of paragraph (10) of the definition of
the examination or treatment of such the term ‘‘remuneration’’ as set forth
individuals. in this section, means hardware, soft-
Select agents and toxins is defined con- ware, and services that support distant
sistent with the definition of ‘‘select or remote communication between the
agent and/or toxin’’ and ‘‘overlap select patient and provider, physician, or
1191
§ 1003.120 42 CFR Ch. V (10–1–24 Edition)
renal dialysis facility for diagnosis, this part, the OIG will consider the fol-
intervention, or ongoing care manage- lowing factors—
ment. (1) The nature and circumstances of
Timely basis means, in accordance the violation;
with § 1003.300(a) of this part, the 60-day (2) The degree of culpability of the
period from the time the prohibited person against whom a civil money
amounts are collected by the indi- penalty, assessment, or exclusion is
vidual or the entity. proposed. It should be considered an
[51 FR 34777, Sept. 30, 1986. Redesignated at aggravating circumstance if the re-
81 FR 88355, Dec. 7, 2016] spondent had actual knowledge where a
lower level of knowledge was required
to establish liability (e.g., for a provi-
tations affecting § 1003.110, see the List of
CFR Sections Affected, which appears in the sion that establishes liability if the re-
Finding Aids section of the printed volume spondent ‘‘knew or should have
and at www.govinfo.gov. known’’ a claim was false or fraudu-
lent, it will be an aggravating cir-
§ 1003.120 Liability for penalties and cumstance if the respondent knew the
assessments. claim was false or fraudulent). It
(a) In any case in which it is deter- should be a mitigating circumstance if
mined that more than one person was the person took appropriate and timely
responsible for a violation described in corrective action in response to the
this part, each such person may be held violation. For purposes of this part,
liable for the penalty prescribed by this corrective action must include dis-
part. closing the violation to the OIG
(b) In any case in which it is deter- through the Self-Disclosure Protocol
mined that more than one person was and fully cooperating with the OIG’s
responsible for a violation described in review and resolution of such disclo-
this part, an assessment may be im- sure, or in cases of physician self-refer-
posed, when authorized, against any ral law violations, disclosing the viola-
one such person or jointly and sever- tion to CMS through the Self-Referral
ally against two or more such persons, Disclosure Protocol;
but the aggregate amount of the as- (3) The history of prior offenses. Ag-
sessments collected may not exceed gravating circumstances include, if at
the amount that could be assessed if any time prior to the violation, the in-
only one person was responsible. dividual—or in the case of an entity,
(c) Under this part, a principal is lia- the entity itself; any individual who
ble for penalties and assessments for had a direct or indirect ownership or
the actions of his or her agent acting control interest (as defined in section
within the scope of his or her agency. 1124(a)(3) of the Act) in a sanctioned
This provision does not limit the un- entity at the time the violation oc-
derlying liability of the agent. curred and who knew, or should have
known, of the violation; or any indi-
[81 FR 88356, Dec. 7, 2016]
vidual who was an officer or a man-
§ 1003.130 Assessments. aging employee (as defined in section
1126(b) of the Act) of such an entity at
The assessment in this part is in lieu the time the violation occurred—was
of damages sustained by the Depart- held liable for criminal, civil, or ad-
ment, a State agency, or a specified ministrative sanctions in connection
State agency because of the violation. with a program covered by this part or
[88 FR 42839, July 3, 2023] in connection with the delivery of a
health care item or service;
§ 1003.140 Determinations regarding (4) Other wrongful conduct. Aggra-
the amount of penalties and assess- vating circumstances include proof
ments and the period of exclusion. that the individual—or in the case of
(a) Except as otherwise provided in an entity, the entity itself; any indi-
this part, in determining the amount of vidual who had a direct or indirect
any penalty or assessment or the pe- ownership or control interest (as de-
riod of exclusion in accordance with fined in section 1124(a)(3) of the Act) in
1192
a sanctioned entity at the time the vio- ciently below the maximum permitted
lation occurred and who knew, or by this part to reflect that fact.
should have known, of the violation; or (2) If there are substantial or several
any individual who was an officer or a aggravating circumstances, the aggre-
managing employee (as defined in sec- gate amount of the penalty and assess-
tion 1126(b) of the Act) of such an enti- ment should be set at an amount suffi-
ty at the time the violation occurred— ciently close to or at the maximum
engaged in wrongful conduct, other permitted by this part to reflect that
than the specific conduct upon which fact.
liability is based, relating to a govern- (3) Unless there are extraordinary
ment program or in connection with mitigating circumstances, the aggre-
the delivery of a health care item or gate amount of the penalty and assess-
service. The statute of limitations gov- ment should not be less than double
erning civil money penalty proceedings the approximate amount of damages
does not apply to proof of other wrong- and costs (as defined by paragraph
ful conduct as an aggravating cir-
(d)(2) of this section) sustained by the
cumstance; and
United States, or any State, as a result
(5) Such other matters as justice may of the violation.
require. Other circumstances of an ag-
(4) The presence of any single aggra-
gravating or mitigating nature should
vating circumstance may justify im-
be considered if, in the interests of jus-
posing a penalty and assessment at or
tice, they require either a reduction or
close to the maximum even when one
an increase in the penalty, assessment,
or period of exclusion to achieve the or more mitigating factors is present.
purposes of this part. (d)(1) The standards set forth in this
(b)(1) After determining the amount section are binding, except to the ex-
of any penalty and assessment in ac- tent that their application would re-
cordance with this part, the OIG consult in imposition of an amount that
siders the ability of the person to pay would exceed limits imposed by the
the proposed civil money penalty or as- United States Constitution.
sessment. The person shall provide, in (2) The amount imposed will not be
a time and manner requested by the less than the approximate amount re-
OIG, sufficient financial documenta- quired to fully compensate the United
tion, including, but not limited to, au- States, or any State, for its damages
dited financial statements, tax returns, and costs, tangible and intangible, in-
and financial disclosure statements, cluding, but not limited to, the costs
deemed necessary by the OIG to deter- attributable to the investigation, pros-
mine the person’s ability to pay the ecution, and administrative review of
penalty or assessment. the case.
(2) If the person requests a hearing in (3) Nothing in this part limits the au-
accordance with 42 CFR 1005.2, the only thority of the Department or the OIG
financial documentation subject to re- to settle any issue or case as provided
view is that which the person provided by § 1003.1530 or to compromise any ex-
to the OIG during the administrative clusion and any penalty and assess-
process, unless the ALJ finds that ex- ment as provided by § 1003.1550.
traordinary circumstances prevented (4) Penalties, assessments, and exclu-
the person from providing the financial sions imposed under this part are in ad-
documentation to the OIG in the time dition to any other penalties, assess-
and manner requested by the OIG prior ments, or other sanctions prescribed by
to the hearing request. law.
(c) In determining the amount of any (5) The penalty amounts in this part
penalty and assessment to be imposed are updated annually, as adjusted in
under this part the following cir- accordance with the Federal Civil Pen-
cumstances are also to be considered— alties Inflation Adjustment Act of 1990,
(1) If there are substantial or several as amended by the Federal Civil Pen-
mitigating circumstances, the aggre- alties Inflation Adjustment Act Im-
gate amount of the penalty and assess- provements Act of 2015 (section 701 of
ment should be set at an amount suffi- Pub. L. 114–74). Annually adjusted
1193
§ 1003.150 42 CFR Ch. V (10–1–24 Edition)
amounts are published at 45 CFR part § 1003.200 Basis for civil money pen-
102. alties, assessments, and exclusions.
[81 FR 88356, Dec. 7, 2016, as amended at 88 (a) The OIG may impose a penalty,
FR 42839, July 3, 2023] assessment, and an exclusion against
any person who it determines has
§ 1003.150 Delegation of authority. knowingly presented, or caused to be
The OIG is delegated authority from presented, a claim that was for—
the Secretary to impose civil money (1) An item or service that the person
penalties and, as applicable, assess- knew, or should have known, was not
ments and exclusions against any per- provided as claimed, including a claim
son who has violated one or more pro- that was part of a pattern or practice
visions of this part. The delegation of of claims based on codes that the per-
authority includes all powers to impose son knew, or should have known, would
and compromise civil monetary pen- result in greater payment to the person
alties, assessments, and exclusion than the code applicable to the item or
under section 1128A of the Act. service actually provided;
(2) An item or service for which the
[81 FR 88356, Dec. 7, 2016] person knew, or should have known,
that the claim was false or fraudulent;
§ 1003.160 Waiver of exclusion. (3) An item or service furnished dur-
(a) The OIG will consider a request ing a period in which the person was
from the administrator of a Federal excluded from participation in the Fed-
health care program for a waiver of an eral health care program to which the
exclusion imposed under this part as claim was presented;
set forth in paragraph (b) of this sec- (4) A physician’s services (or an item
tion. The request must be in writing or service) for which the person knew,
and from an individual directly respon- or should have known, that the indi-
sible for administering the Federal vidual who furnished (or supervised the
health care program. furnishing of) the service—
(b) If the OIG subsequently obtains (i) Was not licensed as a physician;
information that the basis for a waiver (ii) Was licensed as a physician, but
no longer exists, the waiver will cease such license had been obtained through
and the person will be fully excluded a misrepresentation of material fact
from the Federal health care programs (including cheating on an examination
for the remainder of the exclusion pe- required for licensing); or
riod, measured from the time the full (iii) Represented to the patient at the
exclusion would have been imposed if time the service was furnished that the
the waiver had not been granted. physician was certified by a medical
specialty board when he or she was not
(c) The OIG will notify the adminis-
so certified; or
trator of the Federal health care pro-
(5) An item or service that a person
gram whether his or her request for a
knew, or should have known was not
waiver has been granted or denied.
medically necessary, and which is part
(d) If a waiver is granted, it applies
of a pattern of such claims.
only to the program(s) for which waiv-
(b) The OIG may impose a penalty;
er is requested.
an exclusion; and, where authorized, an
(e) The decision to grant, deny, or reassessment against any person who it
scind a waiver is not subject to admin- determines—
istrative or judicial review. (1) Has knowingly presented, or
[81 FR 88356, Dec. 7, 2016] caused to be presented, a request for
payment in violation of the terms of—
(i) An agreement to accept payments
Subpart B—CMPs, Assessments, on the basis of an assignment under
and Exclusions for False or section 1842(b)(3)(B)(ii) of the Act;
Fraudulent Claims and Other (ii) An agreement with a State agen-
Similar Misconduct cy or other requirement of a State
Medicaid plan not to charge a person
SOURCE: 81 FR 88357, Dec. 7, 2016, unless for an item or service in excess of the
otherwise noted. amount permitted to be charged;
1194
(iii) An agreement to be a partici- (7) Knowingly makes, or causes to be

pating physician or supplier under sec- made, any false statement, omission,
tion 1842(h)(1) of the Act; or or misrepresentation of a material fact
(iv) An agreement in accordance with in any application, bid, or contract to
section 1866(a)(1)(G) of the Act not to participate or enroll as a provider of
charge any person for inpatient hos- services or a supplier under a Federal
pital services for which payment had health care program, including con-
been denied or reduced under section tracting organizations, and entities
1886(f)(2) of the Act; that apply to participate as providers
(2) Has knowingly given, or caused to of services or suppliers in such con-
be given, to any person, in the case of tracting organizations;
inpatient hospital services subject to (8) Knows of an overpayment and
section 1886 of the Act, information does not report and return the overpay-
that he or she knew, or should have ment in accordance with section
known, was false or misleading and 1128J(d) of the Act;
that could reasonably have been ex- (9) Knowingly makes, uses, or causes
pected to influence the decision when to be made or used, a false record or
to discharge such person or another statement material to a false or fraud-
person from the hospital; ulent claim for payment for items and
(3) Is an individual who is excluded services furnished under a Federal
from participating in a Federal health health care program; or
care program under section 1128 or (10) Fails to grant timely access to
1128A of the Act, and who— records, documents, and other material
(i) Knows, or should know, of the ac- or data in any medium (including elec-
tion constituting the basis for the ex- tronically stored information and any
clusion and retains a direct or indirect tangible thing), upon reasonable re-
ownership or control interest of 5 per- quest, to the OIG, for the purpose of
cent or more in an entity that partici- audits, investigations, evaluations, or
pates in a Federal health care program other OIG statutory functions. Such
or failure to grant timely access means:
(ii) Is an officer or a managing em- (i) Except when the OIG reasonably
ployee (as defined in section 1126(b) of believes that the requested material is
the Act) of such entity; about to be altered or destroyed, the
(4) Arranges or contracts (by employ- failure to produce or make available
ment or otherwise) with an individual for inspection and copying the re-
or entity that the person knows, or quested material upon reasonable re-
should know, is excluded from partici- quest or to provide a compelling reason
pation in Federal health care programs why they cannot be produced, by the
for the provision of items or services deadline specified in the OIG’s written
for which payment may be made under request, and
such a program; (ii) When the OIG has reason to be-
(5) Has knowingly and willfully pre- lieve that the requested material is
sented, or caused to be presented, a bill about to be altered or destroyed, the
or request for payment for items and failure to provide access to the re-
services furnished to a hospital patient quested material at the time the re-
for which payment may be made under quest is made.
a Federal health care program if that (c) The OIG may impose a penalty
bill or request is inconsistent with an against any person who it determines,
arrangement under section 1866(a)(1)(H) in accordance with this part, is a phy-
of the Act or violates the requirements sician and who executes a document
for such an arrangement; falsely by certifying that a Medicare
(6) Orders or prescribes a medical or beneficiary requires home health serv-
other item or service during a period in ices when the physician knows that the
which the person was excluded from a beneficiary does not meet the eligi-
Federal health care program, in the bility requirements in section
case when the person knows, or should 1814(a)(2)(C) or 1835(a)(2)(A) of the Act.
know, that a claim for such medical or (d) The OIG may impose a penalty
other item or service will be made against any person who it determines
under such a program; knowingly certifies, or causes another
1195
§ 1003.210 42 CFR Ch. V (10–1–24 Edition)
individual to certify, a material and occurred on or before February 9, 2018,

false statement in a resident assess- and not more than $100,000 for conduct
ment pursuant to sections 1819(b)(3)(B) that occurred after February 9, 2018, for
and 1919(b)(3)(B). each false record or statement in viola-
tion of § 1003.200(b)(9).
§ 1003.210 Amount of penalties and as- (8) The OIG may impose a penalty of
sessments.
not more than $10,000 for conduct that
(a) Penalties. (1) Except as provided in occurred on or before February 9, 2018,
this section, the OIG may impose a and not more than $20,000 for conduct
penalty of not more than $10,000 for that occurred after February 9, 2018, for
conduct that occurred on or before each item or service related to an over-
February 9, 2018, and not more than payment that is not reported and re-
$20,000 for conduct that occurred after turned in accordance with section
February 9, 2018, for each individual 1128J(d) of the Act in violation of
violation that is subject to a deter- § 1003.200(b)(8).
mination under this subpart. (9) The OIG may impose a penalty of
(2) The OIG may impose a penalty of not more than $15,000 for conduct that
not more than $15,000 for conduct that occurred on or before February 9, 2018,
occurred on or before February 9, 2018, and not more than $30,000 for conduct
and not more than $30,000 for conduct that occurred after February 9, 2018, for
that occurred after February 9, 2018, for each day of failure to grant timely ac-
each person with respect to whom a de- cess in violation of § 1003.200(b)(10).
termination was made that false or (10) For each false certification in
misleading information was given violation of § 1003.200(c), the OIG may
under § 1003.200(b)(2). impose a penalty of not more than the
(3) The OIG may impose a penalty of greater of:
not more than $10,000 for conduct that
(i) $5,000 for conduct that occurred on
occurred on or before February 9, 2018,
or before February 9, 2018, and $10,000
and not more than $20,000 for conduct
for conduct that occurred after Feb-
that occurred after February 9, 2018,
ruary 9, 2018; or
per day for each day that the prohib-
(ii) Three times the amount of Medi-
ited relationship described in
care payments for home health services
§ 1003.200(b)(3) occurs.
that are made with regard to the false
(4) For each individual violation of
certification of eligibility by a physi-
§ 1003.200(b)(4), the OIG may impose a
cian, as prohibited by section
penalty of not more than $10,000 for
1814(a)(2)(C) or 1835(a)(2)(A) of the Act.
conduct that occurred on or before
February 9, 2018, and not more than (11) For each false certification in
$20,000 for conduct that occurred after violation of § 1003.200(d), the OIG may
February 9, 2018, for each separately impose a penalty of not more than—
billable or non-separately-billable item (i) $1,000 with respect to an individual
or service provided, furnished, ordered, who willfully and knowingly falsely
or prescribed by an excluded individual certifies a material and false state-
or entity. ment in a resident assessment; and
(5) The OIG may impose a penalty of (ii) $5,000 with respect to an indi-
not more than $2,000 for each bill or re- vidual who willfully and knowingly
quest for payment for items and serv- causes another individual to falsely
ices furnished to a hospital patient in certify a material and false statement
violation of § 1003.200(b)(5). in a resident assessment.
(6) The OIG may impose a penalty of (b) Assessments. (1) Except for viola-
not more than $50,000 for conduct that tions of § 1003.200(b)(4), (5), and (7), and
occurred on or before February 9, 2018, § 1003.200(c) and (d), the OIG may im-
and not more than $100,000 for conduct pose an assessment for each individual
that occurred after February 9, 2018, for violation of § 1003.200, of not more than
each false statement, omission, or mis- 3 times the amount claimed for each
representation of a material fact in item or service.
violation of § 1003.200(b)(7). (2) For violations of § 1003.200(b)(4),
(7) The OIG may impose a penalty of the OIG may impose an assessment of
not more than $50,000 for conduct that not more than 3 times—
1196
(i) The amount claimed for each sep- (5) The amount or type of financial,
arately billable item or service pro- ownership, or control interest or the
vided, furnished, ordered, or prescribed degree of responsibility a person has in
by an excluded individual or entity or an entity was substantial with respect
(ii) The total costs (including salary, to an action brought under
benefits, taxes, and other money or § 1003.200(b)(3).
items of value) related to the excluded
individual or entity incurred by the Subpart C—CMPs, Assessments,
person that employs, contracts with, or and Exclusions for Anti-Kick-
otherwise arranges for an excluded in-
dividual or entity to provide, furnish,
back and Physician Self-Re-
order, or prescribe a non-separately- ferral Violations
billable item or service.
(3) For violations of § 1003.200(b)(7), SOURCE: 81 FR 88357, Dec. 7, 2016, unless
the OIG may impose an assessment of otherwise noted.
not more than 3 times the total
amount claimed for each item or serv- § 1003.300 Basis for civil money pen-
alties, assessments, and exclusions.
ice for which payment was made based
upon the application containing the The OIG may impose a penalty, an
false statement, omission, or misrepre- assessment, and an exclusion against
sentation of material fact. any person who it determines in ac-
cordance with this part—
[81 FR 88357, Dec. 7, 2016, as amended at 88
FR 42839, 42841, July 3, 2023]
(a) Has not refunded on a timely
basis, as defined in § 1003.110, amounts
§ 1003.220 Determinations regarding collected as a result of billing an indi-
the amount of penalties and assess- vidual, third party payer, or other enti-
ments and the period of exclusion. ty for a designated health service fur-
In considering the factors listed in nished pursuant to a prohibited refer-
§ 1003.140— ral as described in 42 CFR 411.353.
(a) It should be considered a miti- (b) Is a physician or other person who
gating circumstance if all the items or enters into any arrangement or scheme
services or violations included in the (such as a cross-referral arrangement)
action brought under this part were of that the physician or other person
the same type and occurred within a knows, or should know, has a principal
short period of time, there were few purpose of ensuring referrals by the
such items or services or violations, physician to a particular person that,
and the total amount claimed or re- if the physician directly made referrals
quested for such items or services was to such person, would be in violation of
less than $5,000. the prohibitions of 42 CFR 411.353.
(b) Aggravating circumstances in- (c) Has knowingly presented, or
clude— caused to be presented, a claim that is
(1) The violations were of several for a payment that such person knows,
types or occurred over a lengthy period or should know, may not be made
of time; under 42 CFR 411.353;
(2) There were many such items or (d) Has violated section 1128B(b) of
services or violations (or the nature the Act by unlawfully offering, paying,
and circumstances indicate a pattern soliciting, or receiving remuneration
of claims or requests for payment for to induce or in return for the referral
such items or services or a pattern of of business paid for, in whole or in
violations); part, by Medicare, Medicaid, or other
(3) The amount claimed or requested Federal health care programs.
for such items or services, or the
amount of the overpayment was $50,000 § 1003.310 Amount of penalties and as-
or more; sessments.
(4) The violation resulted, or could (a) Penalties. The OIG may impose a
have resulted, in patient harm, pre- penalty of not more than—
mature discharge, or a need for addi- (1) $15,000 for each claim or bill for a
tional services or subsequent hospital designated health service, as defined in
admission; or § 411.351 of this title, that is subject to
1197
§ 1003.320 42 CFR Ch. V (10–1–24 Edition)
a determination under § 1003.300(a) or amount of the remuneration was

(c); $50,000 or more; or
(2) $100,000 for each arrangement or (4) The violation resulted, or could
scheme that is subject to a determina- have resulted, in harm to the patient, a
tion under § 1003.300(b); and premature discharge, or a need for ad-
(3) $50,000 for conduct that occurred ditional services or subsequent hospital
on or before February 9, 2018, and admission.
$100,000 for conduct that occurred after
February 9, 2018, for each offer, pay- Subpart D—CMPs and Assess-
ment, solicitation, or receipt of remu-
neration that is subject to a deter-
ments for Contracting Organi-
mination under § 1003.300(d). zation Misconduct
(b) Assessments. The OIG may impose
an assessment of not more than 3 SOURCE: 81 FR 88357, Dec. 7, 2016, unless
times— otherwise noted.
(1) The amount claimed for each des-
ignated health service that is subject § 1003.400 Basis for civil money pen-
alties and assessments.
to a determination under § 1003.300(a),
(b), or (c). (a) All contracting organizations. The
(2) The total remuneration offered, OIG may impose a penalty against any
paid, solicited, or received that is sub- contracting organization that—
ject to a determination under (1) Fails substantially to provide an
§ 1003.300(d). Calculation of the total re- enrollee with medically necessary
muneration for purposes of an assess- items and services that are required
ment shall be without regard to wheth- (under the Act, applicable regulations,
er a portion of such remuneration was or contract with the Department or a
offered, paid, solicited, or received for State) to be provided to such enrollee
a lawful purpose. and the failure adversely affects (or has
the substantial likelihood of adversely
FR 42840, 42841, July 3, 2023]
affecting) the enrollee;
(2) Imposes a premium on an enrollee
§ 1003.320 Determinations regarding in excess of the amounts permitted
the amount of penalties and assess- under the Act;
ments and the period of exclusion. (3) Engages in any practice that
In considering the factors listed in would reasonably be expected to have
§ 1003.140: the effect of denying or discouraging
(a) It should be considered a miti- enrollment by beneficiaries whose med-
gating circumstance if all the items, ical condition or history indicates a
services, or violations included in the need for substantial future medical
action brought under this part were of services, except as permitted by the
the same type and occurred within a Act;
short period of time; there were few (4) Misrepresents or falsifies informa-
such items, services, or violations; and tion furnished to a person under sec-
the total amount claimed or requested tions 1857, 1860D–12, 1876, or 1903(m) of
for such items or services was less than the Act;
$5,000. (5) Misrepresents or falsifies informa-
(b) Aggravating circumstances in- tion furnished to the Secretary or a
clude— State, as applicable, under sections
(1) The violations were of several 1857, 1860D–12, 1876, or 1903(m) of the
types or occurred over a lengthy period Act;
of time; (6) Fails to comply with the require-
(2) There were many such items, ments of 42 CFR 417.479(d) through (i)
services, or violations (or the nature for Medicare and 42 CFR 417.479(d)
and circumstances indicate a pattern through (g) and (i) for Medicaid regard-
of claims or requests for payment for ing certain prohibited incentive pay-
such items or services or a pattern of ments to physicians; or
violations); (7) Fails to comply with applicable
(3) The amount claimed or requested requirements of the Act regarding
for such items or services or the prompt payment of claims.
1198
(b) All Medicare contracting organiza- an individual or engaging in any prac-

tions. The OIG may impose a penalty tice that would reasonably be expected
against any contracting organization to have the effect of denying or dis-
with a contract under section 1857, couraging enrollment by eligible indi-
1860D–12, or 1876 of the Act that— viduals with the contracting organiza-
(1) Acts to expel or to refuse to re- tion whose medical condition or his-
enroll a beneficiary in violation of the tory indicates a need for substantial
Act; or future medical services.
(2) Employs or contracts with a per-
son excluded, under section 1128 or § 1003.410 Amount of penalties and as-
1128A of the Act, from participation in sessments for Contracting Organi-
zation.
Medicare for the provision of health
care, utilization review, medical social (a) Penalties. (1) The OIG may impose
work, or administrative services, or a penalty of up to $25,000 for each indi-
employs or contracts with any entity vidual violation under § 1001.400, except
for the provision of such services (di- as provided in this section.
rectly or indirectly) through an ex- (2) The OIG may impose a penalty of
cluded person. up to $100,000 for each individual viola-
(c) Medicare Advantage and Part D tion under § 1003.400(a)(3), (a)(5), or (e).
contracting organizations. The OIG may (b) Additional penalties. In addition to
impose a penalty, and for § 1003.400(c)(4) the penalties described in paragraph (a)
or (5), an assessment, against a con- of this section, the OIG may impose—
tracting organization with a contract (1) An additional penalty equal to
under section 1857 or 1860D–12 of the double the amount of excess premium
Act that: charged by the contracting organiza-
(1) Enrolls an individual without the tion for each individual violation of
individual’s (or his or her designee’s) § 1003.400(a)(2). The excess premium
prior consent, except as provided under amount will be deducted from the pen-
subparagraph (C) or (D) of section alty and returned to the enrollee.
1860D–1(b)(1) of the Act; (2) An additional $15,000 penalty for
(2) Transfers an enrollee from one each individual expelled or not enrolled
plan to another without the individ- in violation of § 1003.400(a)(3) or (e).
ual’s (or his or her designee’s) prior (c) Assessments. The OIG may impose
consent; an assessment against a contracting
(3) Transfers an enrollee solely for organization with a contract under sec-
the purpose of earning a commission; tion 1857 or 1860D–12 of the Act (Medi-
(4) Fails to comply with marketing care Advantage or Part D) of not more
restrictions described in subsection (h) than the amount claimed in violation
or (j) of section 1851 of the Act or appli- of § 1003.400(a)(4) or (a)(5) on the basis of
cable implementing regulations or the misrepresentation or falsified in-
guidance; or formation involved.
(5) Employs or contracts with any (d) The OIG may impose a penalty or,
person who engages in the conduct de- when applicable, an assessment,
scribed in paragraphs (a) through (c) of against a contracting organization
this section. with a contract under section 1857 or
(d) Medicare Advantage contracting or- 1860D–12 of the Act (Medicare Advan-
ganizations. The OIG may impose a pen- tage or Part D) if any of its employees,
alty against a contracting organization agents, or contracting providers or sup-
with a contract under section 1857 of pliers engages in any of the conduct de-
the Act that fails to comply with the scribed in § 1003.400(a) through (d).
requirements of section 1852(j)(3) or [81 FR 88357, Dec. 7, 2016, as amended at 88
1852(k)(2)(A)(ii) of the Act. FR 42841, July 3, 2023]
(e) Medicaid contracting organizations.
The OIG may impose a penalty against § 1003.420 Determinations regarding
any contracting organization with a the amount of penalties and assess-
contract under section 1903(m) of the ments.
Act that acts to discriminate among In considering the factors listed in
individuals in violation of the Act, in- § 1003.140, aggravating circumstances
cluding expulsion or refusal to reenroll include—
1199
§ 1003.500 42 CFR Ch. V (10–1–24 Edition)
(a) Such violations were of several subpart from participation in Federal

types or occurred over a lengthy period health care programs.
of time; (d) For purposes of this subpart, a
(b) There were many such violations ‘‘gross and flagrant violation’’ is a vio-
(or the nature and circumstances indi- lation that presents an imminent dan-
cate a pattern of incidents); ger to the health, safety, or well-being
(c) The amount of money, remunera- of the individual who seeks examina-
tion, damages, or tainted claims in- tion and treatment or places that indi-
volved in the violation was $15,000 or vidual unnecessarily in a high-risk sit-
more; or uation.
(d) Patient harm, premature dis-
charge, or a need for additional serv- § 1003.510 Amount of penalties.
ices or subsequent hospital admission The OIG may impose—
resulted, or could have resulted, from
(a) Against each participating hos-
the incident; and
pital, a penalty of not more than
(e) The contracting organization
$50,000 for each individual violation, ex-
knowingly or routinely engaged in any
prohibited practice that acted as an in- cept that if the participating hospital
ducement to reduce or limit medically has fewer than 100 State-licensed,
necessary services provided with re- Medicare-certified beds on the date the
spect to a specific enrollee in the orga- penalty is imposed, the penalty will
nization. not exceed $25,000 for each violation,
and
(b) Against each responsible physi-
Subpart E—CMPs and Exclusions cian, a penalty of not more than $50,000
for EMTALA Violations for each individual violation.
SOURCE: 81 FR 88357, Dec. 7, 2016, unless [81 FR 88357, Dec. 7, 2016, as amended at 88
otherwise noted. FR 42841, July 3, 2023]
§ 1003.500 Basis for civil money pen- § 1003.520 Determinations regarding

alties and exclusions. the amount of penalties and the pe-
riod of exclusion.
(a) The OIG may impose a penalty
against any participating hospital with In considering the factors listed in
an emergency department or special- § 1003.140,
ized capabilities or facilities for each (a) It should be considered a miti-
negligent violation of section 1867 of gating circumstance if a hospital took
the Act or § 489.24 (other than § 489.24(j)) appropriate and timely corrective ac-
of this title. tion in response to the violation. For
(b) The OIG may impose a penalty purposes of this subpart, corrective ac-
against any responsible physician for tion must be completed prior to CMS
each— initiating an investigation of the hos-
(1) Negligent violation of section 1867 pital for violations of section 1867 of
of the Act; the Act and must include disclosing
(2) Certification signed under section the violation to CMS prior to CMS re-
1867(c)(l)(A) of the Act if the physician ceiving a complaint regarding the vio-
knew, or should have known, that the lation from another source or other-
benefits of transfer to another facility wise learning of the violation.
did not outweigh the risks of such a (b) Aggravating circumstances in-
transfer; or clude:
(3) Misrepresentation made con- (1) Requesting proof of insurance,
cerning an individual’s condition or prior authorization, or a monetary
other information, including a hos- payment prior to appropriately screen-
pital’s obligations under section 1867 of ing or initiating stabilizing treatment
the Act. for an emergency medical condition, or
(c) The OIG may, in lieu of or in addi- requesting a monetary payment prior
tion to any penalty available under to stabilizing an emergency medical
this subpart, exclude any responsible condition;
physician who commits a gross and fla- (2) Patient harm, or risk of patient
grant, or repeated, violation of this harm, resulted from the incident; or
1200
(3) The individual presented to the symbol or emblem or any words or let-
hospital with a request for examina- ters that specifically identify that
tion or treatment of a medical condi- agency or instrumentality of the State
tion that was an emergency medical or political subdivision.
condition, as defined by § 489.24(b) of
this title. § 1003.610 Amount of penalties.
(a) The OIG may impose a penalty of
Subpart F—CMPs for Section 1140 not more than—
Violations (1) $5,000 for each individual violation
resulting from the misuse of Depart-
SOURCE: 81 FR 88357, Dec. 7, 2016, unless mental, CMS, or Medicare or Medicaid
otherwise noted. program words, letters, symbols, or
§ 1003.600 Basis for civil money pen- emblems as described in § 1003.600(a) re-
alties. lating to printed media;
(a) The OIG may impose a penalty (2) $5,000 for each individual violation
against any person who it determines in the case of such misuse related to an
in accordance with this part has used electronic communication, Web page,
the words, letters, symbols, or em- or telemarketing solicitation;
blems as defined in paragraph (b) of (3) $25,000 for each individual viola-
this section in such a manner that such tion in the case of such misuse related
person knew, or should have known, to a broadcast or telecast.
would convey, or in a manner that rea- (b) For purposes of this paragraph, a
sonably could be interpreted or con- violation is defined as—
strued as conveying, the false impres- (1) In the case of a direct mailing so-
sion that an advertisement, a solicita- licitation or advertisement, each sepa-
tion, or other item was authorized, ap- rate piece of mail that contains one or
proved, or endorsed by the Department more words, letters, symbols, or em-
or CMS or that such person or organi-
blems related to a determination under
zation has some connection with or au-
§ 1003.600(a);
thorization from the Department or
CMS. (2) In the case of a printed solicita-
(b) Civil money penalties may be im- tion or advertisement, each reproduc-
posed, regardless of the use of a dis- tion, reprinting, or distribution of such
claimer of affiliation with the United item related to a determination under
States Government, the Department, § 1003.600(a);
or its programs, for misuse of— (3) In the case of a broadcast or tele-
(1) The words ‘‘Department of Health cast, each airing of a single commer-
and Human Services,’’ ‘‘Health and cial or solicitation related to a deter-
Human Services,’’ ‘‘Centers for Medi- mination under § 1003.600(a);
care & Medicaid Services,’’ ‘‘Medi- (4) In the case of an electronic com-
care,’’ or ‘‘Medicaid’’ or any other communication, each dissemination, view-
bination or variations of such words; ing, or accessing of the electronic com-
(2) The letters ‘‘DHHS,’’ ‘‘HHS,’’ or munication that contains one or more
‘‘CMS,’’ or any other combination or words, letters, symbols, or emblems re-
variation of such letters; or lated to a determination under
(3) A symbol or an emblem of the De- § 1003.600(a);
partment or CMS (including the design
(5) In the case of a Web page accessed
of, or a reasonable facsimile of the de-
sign of, the Medicare card, the check by a computer or other electronic
used for payment of benefits under means, each instance in which the Web
Title II, or envelopes or other sta- page was viewed or accessed and that
tionery used by the Department or Web page contains one or more words,
CMS) or any other combination or var- letters, symbols, or emblems related to
iation of such symbols or emblems. a determination under § 1003.600(a); and
(c) Civil money penalties will not be (6) In the case of a telemarketing so-
imposed against any agency or instru- licitation, each individual unsolicited
mentality of a State, or political sub- telephone call regarding an item or
division of the State, that uses any
1201
§ 1003.620 42 CFR Ch. V (10–1–24 Edition)
service under Medicare or Medicaid re- (b) Knowingly makes, uses, or causes
lated to a determination under to be made or used, any false state-
§ 1003.600(a). ment, omission, or misrepresentation
of a material fact in any application,
FR 42841, July 3, 2023] proposal, bid, progress report, or other
document that is required to be sub-
§ 1003.620 Determinations regarding mitted in order to directly or indi-
the amount of penalties. rectly receive or retain funds provided
(a) In considering the factors listed in whole or in part by such Secretary
in § 1003.140, the following cir- pursuant to such grant, contract, or
cumstances are to be considered— other agreement;
(1) The nature and objective of the (c) Knowingly makes, uses, or causes
advertisement, solicitation, or other to be made or used, a false record or
communication and the degree to statement material to a false or fraud-
which it had the capacity to deceive ulent specified claim under such grant,
members of the public; contract, or other agreement;
(2) The frequency and scope of the (d) Knowingly makes, uses, or causes
violation and whether a specific seg- to be made or used, a false record or
ment of the population was targeted; statement material to an obligation (as
and defined in § 1003.110) to pay or transmit
(3) The prior history of the indi- funds or property to such Secretary
vidual, organization, or entity in its with respect to such grant, contract, or
willingness or refusal to comply with a other agreement, or knowingly con-
formal or informal request to correct ceals or knowingly and improperly
violations. avoids or decreases an obligation to
(b) The use of a disclaimer of affili- pay or transmit funds or property to
ation with the United States Govern- such Secretary with respect to such
ment, the Department, or its programs grant, contract, or other agreement; or
will not be considered as a mitigating (e) Fails to grant timely access (as
factor in determining the amount of defined in § 1003.200(b)(10)), upon reason-
penalty in accordance with § 1003.600(a). able request (as defined in § 1003.110), to
the Inspector General of the Depart-
Subpart G—CMPs, Assessments, ment, for the purpose of audits, inves-
tigations, evaluations, or other statu-
and Exclusions for Fraud or tory functions of such Inspector Gen-
False Claims or Similar Con- eral in matters involving such grants,
duct Related to Grants, Con- contracts, or other agreements.
tracts, and Other Agree-
ments § 1003.710 Amount of penalties and as-
sessments.
SOURCE: 88 FR 42840, July 3, 2023, unless (a) Penalties. (1) In cases under
otherwise noted. § 1003.700(a)(1), the OIG may impose a
penalty of not more than $10,000 for
§ 1003.700 Basis for civil money pen- each specified claim.
alties, assessments, and exclusions. (2) In cases under § 1003.700(a)(2), the
The OIG may impose a penalty, as- OIG may impose a penalty of not more
sessment, and an exclusion against any than $50,000 for each false statement,
person including an organization, agen- omission, or misrepresentation of a
cy, or other entity, but excluding a material fact.
program beneficiary (as defined in (3) In cases under § 1003.700(a)(3), the
§ 1003.110), that, with respect to a grant, OIG may impose a penalty of not more
contract, or other agreement for which than $50,000 for each false record or
the Secretary provides funding: statement.
(a) Knowingly presents or causes to (4) In cases under § 1003.700(a)(4), the
be presented a specified claim (as de- OIG may impose a penalty of not more
fined in § 1003.110) under such grant, than $50,000 for each false record or
contract, or other agreement that the statement or not more than $10,000 for
person knows or should know is false each day that the person knowingly
or fraudulent; conceals or knowingly and improperly
1202
avoids or decreases an obligation to Subpart H—CMPs for Adverse Ac-

pay. tion Reporting and Disclosure
(5) In cases under § 1003.700(a)(5), the Violations
OIG may impose a penalty of not more
than $15,000 for each day of the failure
described in § 1003.700(a)(5).
otherwise noted.
(b) Assessments. (1) In cases under
§ 1003.700(a)(1) and (3), such a person § 1003.800 Basis for civil money pen-
shall be subject to an assessment of not alties.
more than three times the amount The OIG may impose a penalty
claimed in the specified claim de- against any person (including an insur-
scribed in § 1003.700(a)(1) and (3) in lieu ance company) who it determines—
of damages sustained by the United (a) Fails to report information con-
States or a specified State agency be- cerning—
cause of such specified claim. (1) A payment made under an insur-
(2) In cases under § 1003.700(a)(2) and ance policy, self-insurance, or other-
(4), such a person shall be subject to an wise for the benefit of a physician, den-
assessment of not more than three tist, or other health care practitioner
times the total amount of the funds de- in settlement of, or in satisfaction in
scribed in § 1003.700(a)(2) and (4), respec- whole or in part of, a medical mal-
tively (or, in the case of an obligation practice claim or action or a judgment
to transmit property to the Secretary against such a physician, dentist, or
described in § 1003.700(a)(4), of the value other practitioner in accordance with
of the property described in section 421 of Public Law 99–660 (42
§ 1003.700(a)(4)) in lieu of damages sus- U.S.C. 11131) and as required by regula-
tained by the United States or a speci- tions at 45 CFR part 60 or
fied State agency because of such case. (2) An adverse action required to be
reported under section 1128E, as estab-
§ 1003.720 Determinations regarding
the amount of penalties and assess- lished by section 221 of Public Law 104–
ments and period of exclusion. 191.
(b) Improperly discloses, uses, or per-
In considering the factors listed in mits access to information reported in
§ 1003.140: accordance with Part B of Title IV of
(a) It should be considered a miti- Public Law 99–660 (42 U.S.C. 11137) or
gating circumstance if all the viola- regulations at 45 CFR part 60. (The dis-
tions included in the action brought closure of information reported in ac-
under this part were of the same type cordance with Part B of Title IV in re-
and occurred within a short period of sponse to a subpoena or a discovery re-
time, there were few such violations, quest is considered an improper disclo-
and the total amount claimed or re- sure in violation of section 427 of Pub-
quested related to the violations was lic Law 99–660. However, disclosure or
less than $5,000. release by an entity of original docu-
(b) Aggravating circumstances in- ments or underlying records from
clude but are not limited to: which the reported information is ob-
(1) The violations were of several tained or derived is not considered an
types or occurred over a lengthy period improper disclosure in violation of sec-
of time; tion 427 of Public Law 99–660.)
(2) There were many such violations
(or the nature and circumstances indi- § 1003.810 Amount of penalties.
cate a pattern of false or fraudulent The OIG may impose a penalty of not
specified claims, requests for payment, more than—
or a pattern of violations); (a) $11,000 for each payment for which
(3) The amount requested or claimed there was a failure to report required
or related to the violations was $50,000 information in accordance with
or more; or § 1003.800(a)(1) or for each improper dis-
(4) The violation resulted, or could closure, use, or access to information
have resulted, in physical harm to any in accordance with a determination
individual. under § 1003.800(b); and
1203
§ 1003.820 42 CFR Ch. V (10–1–24 Edition)
(b) $25,000 against a health plan for ized removal of a select agent or toxin
each failure to report information on from the person’s physical location as
an adverse action required to be re- identified on the person’s certificate of
ported in accordance with section 1128E registration; or
of the Act and § 1003.800(a)(2). (c) The person previously received an
[81 FR 88362, Dec. 7, 2016, as amended at 88 observation, finding, or other state-
FR 42841, July 3, 2023] ment of deficiency from the Depart-
ment or the Department of Agriculture
§ 1003.820 Determinations regarding for the same or substantially similar
the amount of penalties. conduct.
In determining the amount of any
penalty in accordance with this sub- Subpart J—CMPs, Assessments,
part, the OIG will consider the factors and Exclusions for Beneficiary
listed in § 1003.140.
Inducement Violations
Subpart I—CMPs for Select Agent
Program Violations otherwise noted.
SOURCE: 81 FR 88362, Dec. 7, 2016, unless § 1003.1000 Basis for civil money pen-
otherwise noted. alties, assessments, and exclusions.
§ 1003.900 Basis for civil money pen- (a) The OIG may impose a penalty,
alties. an assessment, and an exclusion
The OIG may impose a penalty against any person who it determines
against any person who it determines offers or transfers remuneration (as de-
in accordance with this part is involved fined in § 1003.110) to any individual eli-
in the possession or use in the United gible for benefits under Medicare or a
States, receipt from outside the United State health care program that such
States or transfer within the United person knows, or should know, is likely
States, of select agents and toxins in to influence such individual to order or
violation of sections 351A(b) or (c) of to receive from a particular provider,
the Public Health Service Act or 42 practitioner, or supplier, any item or
CFR part 73. service for which payment may be
made, in whole or in part, under Medi-
§ 1003.910 Amount of penalties. care or a State health care program.
For each individual violation of sec- (b) The OIG may impose a penalty
tion 351A(b) or (c) of the Public Health against any person who it determines
Service Act or 42 CFR part 73, the OIG offered any financial or other incentive
may impose a penalty of not more than for an individual entitled to benefits
$250,000 in the case of an individual, under Medicare not to enroll, or to ter-
and not more than $500,000 in the case minate enrollment, under a group
of any other person. health plan or a large group health
plan that would, in the case of such en-
FR 42841, July 3, 2023]
rollment, be a primary plan as defined
in section 1862(b)(2)(A) of the Act.
the amount of penalties. § 1003.1010 Amount of penalties and
assessments.
In considering the factors listed in
§ 1003.140, aggravating circumstances The OIG may impose a penalty of not
include: more than—
(a) The Responsible Official partici- (a) $10,000 for conduct that occurred
pated in or knew, or should have on or before February 9, 2018, and
known, of the violation; $20,000 for conduct that occurred after
(b) The violation was a contributing February 9, 2018, for each item or serv-
factor to an unauthorized individual’s ice for which payment may be made, in
access to or possession of a select agent whole or in part, under Medicare or a
or toxin, an individual’s exposure to a State health care program, ordered by
select agent or toxin, or the unauthor- or received from a particular provider,
1204
practitioner, or supplier for a bene- paper, documents, or anything of

ficiary who was offered or received re- value;
muneration in violation of § 1003.1000(a) (c) Knowingly, directly, or through
that was likely to influence the bene- his or her agent, mails or causes to be
ficiary to order or receive the item or mailed any matter for the advertising,
service from the provider, practitioner, solicitation, or offer for sale of a Medi-
or supplier, and an assessment of not care supplemental policy, or the deliv-
more than 3 times the amount claimed ery of such a policy, in or into any
for each such item or service and State in which such policy has not
(b) $5,000 for each individual violation been approved by the State commis-
of § 1003.1000(b). sioner or superintendent of insurance;
[81 FR 88362, Dec. 7, 2016, as amended at 88 (d) Issues or sells to any individual
FR 42841, July 3, 2023] entitled to benefits under Part A or en-
rolled under Part B of Medicare—
§ 1003.1020 Determinations regarding (1) A health insurance policy with
the amount of penalties and assess-
ments and the period of exclusion. knowledge that the policy duplicates
health benefits to which the individual
In determining the amount of any is otherwise entitled under Medicare or
penalty or assessment or the period of Medicaid,
exclusion under this subpart, the OIG
(2) A health insurance policy (other
will consider the factors listed in
than a Medicare supplemental policy)
§ 1003.140, as well as the amount of re-
muneration or the amount or nature of with knowledge that the policy dupli-
any other incentive. cates health benefits to which the indi-
vidual is otherwise entitled, other than
benefits to which the individual is enti-
Subpart K—CMPs for the Sale of tled under a requirement of State or
Medicare Supplemental Policies Federal law,
(3) In the case of an individual not
SOURCE: 81 FR 88362, Dec. 7, 2016, unless electing a Part C plan, a Medicare sup-
otherwise noted. plemental policy with knowledge that
§ 1003.1100 Basis for civil money pen- the individual is entitled to benefits
alties. under another Medicare supplemental
policy, or
The OIG may impose a penalty
(4) In the case of an individual elect-
against any person who—
ing a Part C plan, a Medicare supple-
(a) Knowingly and willfully makes or
mental policy with knowledge that the
causes to be made or induces or seeks
policy duplicates health benefits to
to induce the making of any false
which the individual is otherwise enti-
statement or representation of a mate-
tled under the Part C plan or under an-
rial fact with respect to—
other Medicare supplemental policy;
(1) The compliance of any policy with
the standards and requirements for (e) Issues or sells a health insurance
Medicare supplemental policies set policy (other than a policy described in
forth in section 1882(c) of the Act or in section 1882(d)(3)(A)(vi)(III)) to any in-
promulgating regulations, or dividual entitled to benefits under
(2) The use of the emblem designed Medicare Part A or enrolled under
by the Secretary under section 1882(a) Medicare Part B who is applying for a
of the Act for use as an indication that health insurance policy and fails to
a policy has received the Secretary’s furnish the appropriate disclosure
certification; statement described in section
(b) Falsely assumes or pretends to be 1882(d)(3)(A)(vii); or
acting, or misrepresents in any way (f) Issues or sells a Medicare supple-
that he or she is acting, under the au- mental policy to any individual eligi-
thority of or in association with Medi- ble for benefits under Part A or en-
care or any Federal agency, for the rolled under Medicare Part B without
purpose of selling or attempting to sell obtaining the written statement or the
insurance, or in such pretended char- written acknowledgment described in
acter demands, or obtains money, section 1882(d)(3)(B) of the Act.
1205
§ 1003.1110 42 CFR Ch. V (10–1–24 Edition)
§ 1003.1110 Amount of penalties. (a) $100,000 for each individual viola-

tion of § 1003.1200(a) or § 1003.1200(b)(2);
The OIG may impose a penalty of not
and
more than—
(b) $10,000 for each day that such in-
(a) $5,000 for each individual violation
formation has not been provided in vio-
of § 1003.1100(a), (b), or (c).
lation of § 1003.1200(b)(1).
(b) $25,000 for each individual viola-
tion of § 1003.1100(d), (e), or (f) by a sell- [81 FR 88362, Dec. 7, 2016, as amended at 88
er who is also the issuer of the policy; FR 42841, July 3, 2023]
and
(c) $15,000 for each individual viola- § 1003.1220 Determinations regarding
tion of § 1003.1100(d), (e), or (f) by a sell- the amount of penalties.
er who is not the issuer of the policy. In determining the amount of the
penalty in accordance with this sub-
FR 42841, July 3, 2023] part, the OIG will consider the factors
listed in § 1003.140.
the amount of penalties. Subpart M—CMPs for Notifying a
In determining the amount of the Skilled Nursing Facility, Nurs-
penalty in accordance with this sub- ing Facility, Home Health
part, the OIG will consider the factors Agency, or Community Care
listed in § 1003.140. Setting of a Survey
Subpart L—CMPs for Drug Price SOURCE: 81 FR 88362, Dec. 7, 2016, unless
Reporting otherwise noted.
SOURCE: 81 FR 88362, Dec. 7, 2016, unless § 1003.1300 Basis for civil money pen-
otherwise noted. alties.
The OIG may impose a penalty
§ 1003.1200 Basis for civil money pen- against any individual who notifies, or
alties. causes to be notified, a skilled nursing
The OIG may impose a penalty facility, nursing facility, home health
against— agency, a community care setting, of
(a) Any wholesaler, manufacturer, or the time or date on which a survey pur-
direct seller of a covered outpatient suant to sections 1819(g)(2)(A),
drug that— 1919(g)(2)(A), 1891(c)(1), or 1929(i) of the
(1) Refuses a request for information Act is scheduled to be conducted.
by, or
(2) Knowingly provides false informa- § 1003.1310 Amount of penalties.
tion to, the Secretary about charges or The OIG may impose a penalty of not
prices in connection with a survey more than $2,000 for each individual
being conducted pursuant to section violation of § 1003.1300.
1927(b)(3)(B) of the Act; and
(b) Any manufacturer with an agree- [81 FR 88362, Dec. 7, 2016, as amended at 88
FR 42841, July 3, 2023]
ment under section 1927 of the Act
that— § 1003.1320 Determinations regarding
(1) Fails to provide any information the amount of penalties.
required by section 1927(b)(3)(A) of the
Act by the deadlines specified therein, In determining the amount of the
or penalty in accordance with this sub-
(2) Knowingly provides any item in- part, the OIG will consider the factors
formation required by section listed in § 1003.140.
1927(b)(3)(A) or (B) of the Act that is
false. Subpart N—CMPs for Information
Blocking
§ 1003.1210 Amount of penalties.
The OIG may impose a penalty of not SOURCE: 88 FR 42841, July 3, 2023, unless
more than— otherwise noted.
1206
§ 1003.1400 Basis for civil money pen- assessment, and an exclusion, as appli-
alties. cable. The notice will include—
The OIG may impose a civil money (1) Reference to the statutory basis
penalty against any individual or enti- for the penalty, assessment, and exclu-
ty described in 45 CFR 171.103(a)(2) that sion;
commits information blocking, as set (2) A description of the violation for
forth in 45 CFR part 171. which the penalty, assessment, and ex-
clusion are proposed (except in cases in
§ 1003.1410 Amount of penalties. which the OIG is relying upon statis-
tical sampling in accordance with
The OIG may impose a penalty of not
§ 1003.1580, in which case the notice
more than $1,000,000 per violation.
shall describe those claims and re-
(a) For this subpart, violation means
quests for payment constituting the
a practice, as defined in 45 CFR 171.102,
sample upon which the OIG is relying
that constitutes information blocking,
and will briefly describe the statistical
as set forth in 45 CFR part 171.
sampling technique used by the OIG);
(b) [Reserved]
(3) The reason why such violation
§ 1003.1420 Determinations regarding subjects the respondent to a penalty,
the amount of penalties. an assessment, and an exclusion,
(4) The amount of the proposed pen-
In considering the factors listed in
alty and assessment, and the length of
§ 1003.140, the OIG shall take into ac-
the period of proposed exclusion (where
count:
applicable);
(a) The nature and extent of the in-
(5) Any factors and circumstances de-
formation blocking including where ap-
scribed in this part that were consid-
plicable:
ered when determining the amount of
(1) The number of patients affected;
the proposed penalty and assessment
(2) The number of providers affected;
and the length of the period of exclu-
and
sion;
(3) The number of days the informa-
(6) Instructions for responding to the
tion blocking persisted; and
notice, including—
(b) The harm resulting from such in-
(i) A specific statement of the re-
formation blocking including where ap-
spondent’s right to a hearing and
plicable:
(ii) A statement that failure to re-
(1) The number of patients affected;
quest a hearing within 60 days permits
(2) The number of providers affected;
the imposition of the proposed penalty,
and
assessment, and exclusion without
(3) The number of days the informa-
right of appeal; and
tion blocking persisted.
(7) In the case of a notice sent to a
respondent who has an agreement
Subpart O—Procedures for the Im- under section 1866 of the Act, the no-
position of CMPs, Assess- tice also indicates that the imposition
ments, and Exclusions of an exclusion may result in the ter-
mination of the respondent’s provider
SOURCE: 81 FR 88364, Dec. 7, 2016, unless agreement in accordance with section
otherwise noted. 1866(b)(2)(C) of the Act.
(b) Any person upon whom the OIG
§ 1003.1500 Notice of proposed deter- has proposed the imposition of a pen-
mination. alty, an assessment, or an exclusion
(a) If the OIG proposes a penalty and, may appeal such proposed penalty, as-
when applicable, an assessment, or pro- sessment, or exclusion to the Depart-
poses to exclude a respondent from par- mental Appeals Board in accordance
ticipation in all Federal health care with 42 CFR 1005.2. The provisions of 42
programs, as applicable, in accordance CFR part 1005 govern such appeals.
with this part, the OIG must serve on (c) If the respondent fails, within the
the respondent, in any manner author- time period permitted, to exercise his
ized by Rule 4 of the Federal Rules of or her right to a hearing under this
Civil Procedure, written notice of the section, any exclusion, penalty, or as-
OIG’s intent to impose a penalty, an sessment becomes final.
1207
§ 1003.1510 42 CFR Ch. V (10–1–24 Edition)
§ 1003.1510 Failure to request a hear- the issue in the underlying administra-

ing. tive appeal.
If the respondent does not request a (b) A respondent must exhaust all ad-
hearing within 60 days after the notice ministrative appeal procedures estab-
prescribed by § 1003.1500(a) is received, lished by the Secretary or required by
as determined by 42 CFR 1005.2(c), by law before a respondent may bring an
the respondent, the OIG may impose action in Federal court, as provided in
the proposed penalty, assessment, and section 1128A(e) of the Act, concerning
exclusion, or any less severe penalty, any penalty, assessment, or exclusion
assessment, or exclusion. The OIG shall imposed pursuant to this part.
notify the respondent in any manner (c) Administrative remedies are ex-
authorized by Rule 4 of the Federal hausted when a decision becomes final
Rules of Civil Procedure of any pen- in accordance with 42 CFR 1005.21(j).
alty, assessment, and exclusion that
have been imposed and of the means by § 1003.1550 Collection of penalties and
which the respondent may satisfy the assessments.
judgment. The respondent has no right (a) Once a determination by the Sec-
to appeal a penalty, an assessment, or retary has become final, collection of
an exclusion with respect to which he any penalty and assessment will be the
or she has not made a timely request responsibility of CMS, except in the
for a hearing under 42 CFR 1005.2. case of the Maternal and Child Health
Services Block Grant Program, in
§ 1003.1520 Collateral estoppel.
which the collection will be the respon-
(a) Where a final determination per- sibility of the Public Health Service
taining to the respondent’s liability for (PHS); in the case of the Social Serv-
acts that violate this part has been ices Block Grant program, in which the
rendered in any proceeding in which collection will be the responsibility of
the respondent was a party and had an the Administration for Children and
opportunity to be heard, the respond- Families; and in the case of violations
ent shall be bound by such determina- of subpart I, collection will be the re-
tion in any proceeding under this part. sponsibility of the Program Support
(b) In a proceeding under this part, a Center (PSC).
person is estopped from denying the es- (b) A penalty or an assessment im-
sential elements of the criminal of-
posed under this part may be com-
fense if the proceeding—
promised by the OIG and may be recov-
(1) Is against a person who has been
ered in a civil action brought in the
convicted (whether upon a verdict after
United States district court for the dis-
trial or upon a plea of guilty or nolo
trict where the claim or specified claim
contendere) of a Federal crime charg-
was presented or where the respondent
ing fraud or false statements, and
resides.
(2) Involves the same transactions as
in the criminal action. (c) The amount of penalty or assess-
ment, when finally determined, or the
§ 1003.1530 Settlement. amount agreed upon in compromise,
may be deducted from any sum then or
The OIG has exclusive authority to
later owing by the United States Gov-
settle any issues or case without con-
ernment or a State agency to the per-
sent of the ALJ.
son against whom the penalty or as-
§ 1003.1540 Judicial review. sessment has been assessed.
(d) Matters that were raised, or that
(a) Section 1128A(e) of the Act au-
could have been raised, in a hearing be-
thorizes judicial review of a penalty, an
fore an ALJ or in an appeal under sec-
assessment, or an exclusion that has
tion 1128A(e) of the Act may not be
become final. The only matters subject
raised as a defense in a civil action by
to judicial review are those that the re-
the United States to collect a penalty
spondent raised pursuant to 42 CFR
1005.21, unless the court finds that ex- under this part.
traordinary circumstances existed that [81 FR 88364, Dec. 7, 2016, as amended at 88
prevented the respondent from raising FR 42841, July 3, 2023]
1208
Office of Inspector General—Health Care, HHS Pt. 1004
§ 1003.1560 Notice to other agencies. to rebut the findings of the statistical

(a) Whenever a penalty, an assess- sampling study. The OIG will then be
ment, or an exclusion becomes final, given the opportunity to rebut this evi-
the following organizations and enti- dence.
ties will be notified about such action [81 FR 88364, Dec. 7, 2016, as amended at 88
and the reasons for it: The appropriate FR 42841, July 3, 2023]
State or local medical or professional
association; the appropriate quality § 1003.1590 Effect of exclusion.
improvement organization; as appro- The effect of an exclusion will be as
priate, the State agency that admin- set forth in 42 CFR 1001.1901.
isters each State health care program;
the appropriate Medicare carrier or § 1003.1600 Reinstatement.
intermediary; the appropriate State or A person who has been excluded in
local licensing agency or organization accordance with this part may apply
(including the Medicare and Medicaid for reinstatement at the end of the pe-
State survey agencies); and the long- riod of exclusion. The OIG will consider
term-care ombudsman. In cases involv- any request for reinstatement in ac-
ing exclusions, notice will also be given cordance with the provisions of 42 CFR
to the public of the exclusion and its 1001.3001 through 1001.3004.
effective date.
(b) When the OIG proposes to exclude PART 1004—IMPOSITION OF SANC-
a nursing facility under this part, the
OIG will, at the same time the facility TIONS ON HEALTH CARE PRACTI-
is notified, notify the appropriate TIONERS AND PROVIDERS OF
State licensing authority, the State Of- HEALTH CARE SERVICES BY A
fice of Aging, the long-term-care om- QUALITY IMPROVEMENT ORGA-
budsman, and the State Medicaid agen- NIZATION
cy of the OIG’s intention to exclude the
facility. Subpart A—General Provisions
§ 1003.1570 Limitations. Sec.
1004.1 Scope and definitions.
No action under this part will be en-
tertained unless commenced, in accord- Subpart B—Sanctions Under the QIO
ance with § 1003.1500(a), within 6 years Program; General Provisions
from the date on which the violation
occurred. 1004.10 Statutory obligations of practi-
tioners and other persons.
§ 1003.1580 Statistical sampling. 1004.20 Sanctions.
(a) In meeting the burden of proof in Subpart C—QIO Responsibilities

§ 1005.15 of this chapter, the OIG may
introduce the results of a statistical 1004.30 Basic responsibilities.
sampling study as evidence of the num- 1004.40 Action on identification of a viola-
tion.
ber and amount of claims, specified 1004.50 Meeting with a practitioner or other
claims, and/or requests for payment, as person.
described in this part, that were pre- 1004.60 QIO finding of a violation.
sented, or caused to be presented, by 1004.70 QIO action on final finding of a vio-
the respondent. Such a statistical sam- lation.
pling study, if based upon an appro- 1004.80 QIO report to the OIG.
priate sampling and computed by valid 1004.90 Basis for recommended sanction.
statistical methods, shall constitute
Subpart D—OIG Responsibilities
prima facie evidence of the number and
amount of claims, specified claims, or 1004.100 Acknowledgement and review of re-
requests for payment, as described in port.
this part. 1004.110 Notice of sanction.
(b) Once the OIG has made a prima
facie case, as described in paragraph (a) Subpart E—Effect and Duration of Exclusion
of this section, the burden of produc- 1004.120 Effect of an exclusion on program
tion shall shift to the respondent to payments and services.
produce evidence reasonably calculated 1004.130 Reinstatement after exclusion.
1209
§ 1004.1 42 CFR Ch. V (10–1–24 Edition)
Subpart F—Appeals Health professional shortage area

(HPSA) means an area designated by
1004.140 Appeal rights.
the Secretary and defined in 42 CFR
AUTHORITY: 42 U.S.C. 1302 and 1320c–5. 5.2.
SOURCE: 60 FR 63640, Dec. 12, 1995, unless Metropolitan Statistical Area means an
otherwise noted. area as defined by the Executive Office
of Management and Budget.
Obligation means any of the obliga-
Subpart A—General Provisions tions specified at section 1156(a) of the
§ 1004.1 Scope and definitions. Act.
Other person means a hospital or
(a) Scope. This part implements sec- other health care facility, an organiza-
tion 1156 of the Act by— tion or an agency that provides health
(1) Setting forth certain obligations care services or which payment may be
imposed on practitioners and providers made (in whole or in part) under the
of services under Medicare; Medicare or State health care pro-
(2) Establishing criteria and proce- grams.
dures for the reports required from Pattern or care means that the care
quality improvement organizations under question has been demonstrated
(QIOs) when there is failure to meet in more than three instances, each of
those obligations; which involved different admissions.
(3) Specifying the policies and proce- Pharmacy professional is a term lim-
dures for making determinations on ited to individuals who are licensed or
violations and imposing sanctions; and registered to provide pharmaceutical
(4) Defining the procedures for ap- services.
peals by the affected party and the pro- Podiatric professional is a term lim-
cedures for reinstatements. ited to licensed doctors of podiatric
(b) Definitions. As used in this part, medicine.
unless the context indicates other- Practice area means the location
wise— where over 50 percent of the practi-
Dentist is limited to licensed doctors tioner’s or other person’s patients are
of dental surgery or dental medicine. seen.
Economically means the services are Practitioner means a physician or
provided at the least expensive, medi- other health care professional licensed
cally appropriate type of setting or under State law to practice his or her
level of care available. profession.
Exclusion means that items and serv- Primary medical care professional is a
ices furnished or ordered (or at the term limited to:
medical direction or on the prescrip- (i) Licensed doctors of medicine and
tion of a physician) by a specified doctors of osteopathy providing direct
health care practitioner, provider or patient care who practice in the fields
other person during a specified period of general or family practice, general
are not reimbursed under titles V, internal medicine, pediatrics, obstet-
XVIII, XIX, or XX of the Social Secu- rics and gynecology, surgery, and any
rity Act and all other Federal non-pro- other specialty that is not accommo-
curement programs. dated by the remaining specialty HPSA
Gross and flagrant violation means a designator, or
violation of an obligation has occurred (ii) Those facilities where care and
in one or more instances which pre- treatment is provided to patients with
sents an imminent danger to the health problems other than mental dis-
health, safety, or well-being of a pro- orders.
gram patient or places the program pa- Pro area means the geographic area
tient unnecessarily in high-risk situa- subject to review by a particular QIO.
tions. Provider means a hospital or other
Health care service or services means health care facility, agency, or organi-
services or items for which payment zation.
may be made (in whole or in part) Psychiatric professional is a term lim-
under the Medicare or State health ited to licensed doctors of medicine
care programs. who limit their practice to psychiatry
1210
or to those facilities where care and (a) Provided economically and only
treatment is limited to patients with when, and to the extent, medically nec-
mental disorders. essary;
Rural means any area outside an (b) Of a quality that meets profes-
urban area. sionally recognized standards of health
Rural health professional shortage area care; and
means any health professional shortage (c) Supported by evidence of medical
area located outside a Metropolitan necessity and quality in the form and
Statistical Area. fashion and at such time that the re-
Sanction means an exclusion or mone- viewing QIO may reasonably require
tary penalty that the Secretary may (including copies of the necessary doc-
impose on a practitioner or other per- umentation and evidence of compliance
with pre-admission or pre-procedure re-
son as a result of a recommendation
view requirements) to ensure that the
from a QIO.
practitioner or other person is meeting
Serious risk includes situations that the obligations imposed by section
may involve the risk of unnecessary 1156(a) of the Act.
treatment, prolonged treatment, lack
of treatment, incorrect treatment, § 1004.20 Sanctions.
medical complication, premature dis-
In addition to any other sanction
charge, physiological or anatomical
provided under the law, a practitioner
impairment, disability, or death. or other person may be—
State health care program means a (a) Excluded from participating in
State plan approved under title XIX, programs under titles V, XVIII, XIX,
any program receiving funds under and XX of the Social Security Act for
title V or from an allotment to a State a period of no less than 1 year; or
under such title, or any program re- (b) In lieu of exclusion and as a con-
ceiving funds under title XX or from an dition for continued participation in ti-
allotment to a State under such title. tles V, XVIII, XIX, and XX of the Act,
Substantial violation in a substantial if the violation involved the provision
number of cases means a pattern of pro- or ordering of health care services (or
viding care, as defined in this section, services furnished at the medical direc-
that is inappropriate, unnecessary, or tion or on the prescription of a physi-
does not meet recognized professional cian) that were medically improper or
standards of care, or is not supported unnecessary, required to pay an
by the necessary documentation of amount of up to $10,000 for each in-
care as required by the QIO. stance in which improper or unneces-
Urban means a Metropolitan Statis- sary services were furnished or ordered
tical Area as defined by the Executive (or prescribed, if appropriate). The
Office of Management and Budget. practitioner or other person will be re-
Vision care professional is a term lim- quired either to pay the monetary as-
ited to licensed doctors of medicine sessment within 6 months of the date
who limit their practice to ophthal- of notice or have it deducted from any
mology and to doctors of optometry. sums the Federal Government owes the
practitioner or other person.
Subpart B—Sanctions Under the [62 FR 23143, Apr. 29, 1997]
QIO Program; General Provisions
Subpart C—QIO Responsibilities
§ 1004.10 Statutory obligations of prac-
titioners and other persons. § 1004.30 Basic responsibilities.
It is the obligation of any health care (a) The QIO must use its authority or
practitioner or other person who fur- influence to enlist the support of other
nishes or orders health care services professional or government agencies to
that may be reimbursed under the ensure that each practitioner or other
Medicare or State health care pro- person complies with the obligations
grams to ensure, to the extent of his or specified in § 1004.10.
her or its authority, that those serv- (b) When the QIO identifies situa-
ices are— tions where an obligation specified in
1211
§ 1004.40 42 CFR Ch. V (10–1–24 Edition)
§ 1004.10 is violated, it will afford the tion of a violation containing the fol-
practitioner or other person reasonable lowing information—
notice and opportunity for discussion (1) The obligation(s) involved;
and, if appropriate, a suggested method (2) The situation, circumstances or
for correcting the situation and a time activity that resulted in a violation;
period for a corrective action in ac- (3) The authority and responsibility
cordance with §§ 1004.40 and 1004.60. of the QIO to report violations of any
(c) The QIO must submit a report to obligation under section 1156(a) of the
the OIG after the notice and oppor- Act;
tunity provided under paragraph (b) of (4) A suggested method for correcting
this section and, if appropriate, the op- the situation and a time period for cor-
portunity to enter into and complete a rective action, if appropriate;
corrective action plan (CAP) if the QIO (5) The sanction that the QIO could
finds that the practitioner or other recomment to the OIG;
person has— (6) The right of the practitioner or
(1) Failed substantially to comply other person to submit to the QIO
with any obligation in a substantial within 30 days of receipt of the notice
number of admissions; or additional information or a written re-
(2) Grossly and flagrantly violated quest for a meeting with the QIO to re-
any obligation in one or more in- view and discuss the finding, or both.
stances. The date of receipt is presumed to be 5
days after the date on the notice, un-
(d) The QIO report to the OIG must
less there is a reasonable showing to
comply with the provisions of § 1004.80.
the contrary. The notice will also state
(e) If a practitioner or other person that if a meeting is requested—
relocates to another QIO area prior to (i) It will be held within 30 days of re-
a finding of a violation or sanction rec- ceipt by the QIO of the request, but
ommendation, and the originating may be extended for good cause;
QIO— (ii) The practitioner or other person
(1) Is able to make a finding, the may have an attorney present; and
originating QIO must, as appropriate, (iii) The attorney, if present, will be
close the case or forward a sanction permitted to make opening and closing
recommendation to the OIG; or remarks, ask clarifying questions at
(2) Cannot make a finding, the origi- the meeting and assist the practitioner
nating QIO must forward all docu- or other person in presenting the testi-
mentation regarding the case to the mony of expert witnesses who may ap-
QIO with jurisdiction, and notify the pear on the practitioner’s or other per-
practitioner or other person of this ac- son’s behalf; and
tion. (7) A copy of the material used by the
(f) The QIO must deny payment for QIO in arriving at its finding except for
services or items furnished or ordered QIO deliberations, as set forth in
(or at the medical direction or on the § 480.139 of this part.
prescription of an excluded physician)
by an excluded practitioner or other FR 72910, Nov. 16, 2020]
person when the QIO identifies the
services or items. It must report the § 1004.50 Meeting with a practitioner
findings to the Centers for Medicare & or other person.
Medicaid Services. If the practitioner or other person re-
quests a meeting with the QIO—
§ 1004.40 Action on identification of a
violation. (a) The QIO panel that meets with
the practitioner or other person must
When a QIO identifies a violation, it consist of a minimum of 3 physicians;
must— (b) No physician member of the QIO
(a) Indicate whether the violation is panel may be in direct economic com-
a gross and flagrant violation or is a petition with the practitioner or other
substantial violation in a substantial person being considered for sanction;
number of cases; and (c) The QIO must ensure that no phy-
(b) Send the practitioner or other sician member of the QIO panel has a
person written notice of the identifica- substantial bias for or against the
1212
practitioner or other person being con- and at least one member of the panel
sidered for sanction; must be in the same medical specialty.
(d) At least one member of the QIO Both requirements can be met by a sin-
panel meeting with the practitioner or gle individual. In addition, no one at
other person should practice in a simi- the QIO who is a participant in such a
lar area, e.g., urban or rural, and at finding may be in direct economic com-
least one member of the panel must be petition with, or have a substantial
in the same specialty (both require- bias for or against, that practitioner or
ments could be met by a single indi- other person being recommended for
vidual); sanction.
(e) If the practitioner or other person
has an attorney present, that attorney § 1004.70 QIO action on final finding of
will be permitted to make opening and a violation.
closing remarks, ask clarifying ques- If the finding is not resolved to the
tions and assist the practitioner or QIO’s satisfaction as specified in
other person in presenting the testi- § 1004.60(a), the QIO must—
mony of expert witnesses who may ap- (a) Submit its report and rec-
pear on the practitioner’s or other per- ommendation to the OIG;
son behalf; (b) Send the affected practitioner or
(f) The physician who recommends to other person a concurrent final notice,
the QIO that a practitioner or other with a copy of all the material that is
person be sanctioned may not vote on being forwarded to the OIG, advising
that recommendation at the meeting; that—
(g) The QIO may allow the practi-
(1) The QIO recommendation has
tioner or other person 5 working days
been submitted to the OIG;
after the meeting to provide the QIO
(2) The practitioner or other person
additional relevant information that
has 30 days from receipt of this final
may affect its finding; and
(h) A verbatim record must be made notice to submit any additional writ-
of the meeting and must be made avail- ten material or documentary evidence
able to the practitioner or other person to the OIG at its headquarters loca-
promptly. tion. The date of receipt is presumed to
be 5 days after the date on the notice,
§ 1004.60 QIO finding of a violation. unless there is a reasonable showing to
the contrary; and
(a) On the basis of any additional in-
(3) Due to the 120-day statutory re-
formation received, the QIO will affirm
quirement specified in § 1004.100(e), the
or modify its finding. If the QIO affirms
period for submitting additional infor-
its finding, it may suggest in writing a
mation will not be extended and any
method for correcting the situation
material received by the OIG after the
and a time period for corrective action.
30-day period will not be considered;
This CAP could correspond with, or be
and
a continuation of, a prior CAP or be a
new proposal based on additional infor- (c) Provide notice to the State med-
mation received by the QIO. If the find- ical board or to other appropriate li-
ing has been resolved to the QIO’s sat- censing boards for other practitioner
isfaction, the QIO may modify its ini- types when it submits a report and rec-
tial finding or recommendation or ommendations to the OIG with respect
close the case. to a physician or other person whom
(b) The QIO must give written notice the board is responsible for licensing.
to the practitioner or other person of
§ 1004.80 QIO report to the OIG.
any action it takes as a result of the
additional information received, as (a) Manner of reporting. If the viola-
specified in § 1004.70. tion(s) identified by the QIO have not
(c) At least one member of the QIO been resolved, it must submit a report
participating in the process which re- and recommendation to the OIG at the
sulted in a recommendation to the OIG field office with jurisdiction.
that a practitioner or other person be (b) Content of report. The QIO report
sanctioned should practice in a similar must include the following informa-
geographic area, e.g. urban or rural, tion—
1213
§ 1004.90 42 CFR Ch. V (10–1–24 Edition)
(1) Identification of the practitioner § 1004.90 Basis for recommended sanc-

or other person and, when applicable, tion.
the name of the director, administrator The QIO’s specific recommendation
or owner of the entity involved; must be based on documentation pro-
(2) The type of health care services vided to the OIG showing its consider-
involved; ation of—
(3) A description of each failure to (a) The type of offense involved;
comply with an obligation, including (b) The severity of the offense;
specific dates, places, circumstances (c) The deterrent value;
and other relevant facts; (d) The practitioner’s or other per-
(4) Pertinent documentary evidence; son’s previous sanction record;
(e) The availability of alternative
(5) Copies of written correspondence,
sources of services in the community;
including reports of conversations with and
the practitioner or other person re- (f) Any other factors that the QIO
garding the violation and, if applicable, considers relevant, such as the dura-
a copy of the verbatim transcript of tion of the problem.
the meeting with the practitioner or
other person; Subpart D—OIG Responsibilities
(6) The QIO’s finding that an obliga-
tion under section 1156(a) of the Act § 1004.100 Acknowledgement and re-
has been violated and that the viola- view of report.
tion is substantial and has occurred in (a) Acknowledgement. The OIG will in-
a substantial number of cases or is form the QIO of the date it received the
gross and flagrant; QIO’s report and recommendation.
(7) A case-by-case analysis and eval- (b) Review. The OIG will review the
uation of any additional information QIO report and recommendation to de-
provided by the practitioner or other termine whether—
person in response to the QIO’s initial (1) The QIO has followed the regu-
finding; latory requirements of this part; and
(8) A copy of the CAP that was devel- (2) A violation has occurred.
(c) Rejection of the QIO recommenda-
oped and documentation of the results
tion. If the OIG decides that a sanction
of such plan;
is not warranted, it will notify the QIO
(9) The number of admissions by the that recommended the sanction, the af-
practitioner or other person reviewed fected practitioner or other person, and
by the QIO during the period in which the licensing board informed by the
the violation(s) were identified; QIO of the sanction recommendation
(10) The professional qualifications of that the recommendation is rejected.
the QIO’s reviewers; and (d) Decision to sanction. If the OIG de-
(11) The QIO’s sanction recommenda- cides that a violation of obligations
tion. has occurred, it will determine the ap-
(c) QIO recommendation. The QIO propriate sanction by considering—
must specify in its report— (1) The recommendation of the QIO;
(1) The sanction recommended; (2) The type of offense;
(2) The amount of the monetary pen- (3) The severity of the offense;
alty recommended, if applicable; (4) The previous sanction record of
the practitioner or other person;
(3) The period of exclusion rec-
(5) The availability of alternative
ommended, if applicable; sources of services in the community;
(4) The availability of alternative (6) Any prior problems the Medicare
sources of services in the community, or State health care programs have had
with supporting information; and with the practitioner or other person;
(5) The county or counties in which and
the practitioner or other person fur- (7) Any other matters relevant to the
nishes services. particular case.
(e) Exclusion sanction. If the QIO sub-
mits a recommendation for exclusion
FR 23143, Apr. 29, 1997]
to the OIG, and a determination is not
1214
made by the 120th day after actual re- the notice. For purposes of this sec-
ceipt by the OIG, the exclusion sanction, the term ‘‘all existing patients’’
tion recommended will become effec- includes all patients currently under
tive and the OIG will provide notice in active treatment with the practitioner
accordance with § 1004.110(f). or other person, as well as all patients
(f) Monetary penalty. If the QIO rec- who have been treated by the practi-
ommendation is to assess a monetary tioner or other person within the last 3
penalty, the 120-day provision does not years. In addition, the practitioner or
apply and the OIG will provide notice other person must notify all prospec-
in accordance with § 1004.110 (a)–(e). tive patients orally at the time such
[60 FR 63640, Dec. 12, 1995, as amended at 62 persons request an appointment. If the
FR 23143, Apr. 29, 1997] sanctioned party is a hospital, it must
notify all physicians who have privi-
§ 1004.110 Notice of sanction. leges at the hospital, and must post a
(a) The OIG must notify the practi- notice in its emergency room, business
tioner or other person of the adverse office and in all affiliated entities re-
determination and of the sanction to garding the exclusion. In addition, for
be imposed. purposes of this section, the term ‘‘in
(b) The sanction is effective 20 days all affiliated entities’’ encompasses all
from the date of the notice. Receipt is entities and properties in which the
presumed to be 5 days after the date on hospital has a direct or indirect owner-
the notice, unless there is a reasonable ship interest of 5 percent or more and
showing to the contrary. any management, partnership or con-
(c) The notice must specify— trol of the entity.
(1) The legal and factual basis for the (ii) The certification will provide
determination; that the practitioner or other person—
(2) The sanction to be imposed; (A) Has informed each of his, her or
(3) The effective date and, if appro- its patients in writing that the practi-
priate, the duration of the exclusion; tioner or other person has been sanc-
(4) The appeal rights of the practi- tioned, or if a hospital, has informed
tioner or other person; all physicians having privileges at the
(5) The opportunity and the process hospital that it has been sanctioned;
necessary to provide alternative notifi- (B) If excluded from Medicare and the
cation as set forth in paragraphs (d) State health care programs, has in-
and (e) of this section; and formed his, her or its existing patients
(6) In the case of exclusion, the ear- in writing that the programs will not
liest date on which the OIG will accept pay for items and services furnished or
a request for reinstatement. ordered (or at the medical direction or
(d) Patient notification. (1)(i) The OIG on the prescription of an excluded phy-
will provide a sanctioned practitioner sician) by the practitioner or other per-
or other person an opportunity to elect son until they are reinstated, or if a
to inform each of their patients of the hospital, has provided this information
sanction action. In order to elect this to all physicians having privileges at
option, the sanctioned practitioner or that hospital;
other person must, within 30 calendar (C) If excluded from Medicare and
days from receipt of the OIG notice, in- State health care programs, will pro-
form both new and existing patients vide prospective patients—or if a hos-
through written notice—based on a pital, physicians requesting privileges
suggested (non-mandatory) model pro- at that hospital prior to furnishing or
vided to the sanctioned individual by ordering (or in the case of an excluded
the OIG—of the sanction and, in the physician, medically directing or pre-
case of an exclusion, its effective date. scribing) services—oral information of
Receipt of the OIG notice is presumed both the sanction and that the pro-
to be 5 days after the date of the no- grams will not pay for services pro-
tice, unless there is a reasonable show- vided and written notification of the
ing to the contrary. Within this same same at the time of the provision of
period, the practitioner or other person services;
must also sign and return the certifi- (D) If excluded from Medicare and
cation that the OIG will provide with State health care programs and is an
1215
§ 1004.120 42 CFR Ch. V (10–1–24 Edition)
entity such as a hospital, has posted a originated and where the individual
notice in its emergency room, business currently has privileges, if known;
office and in all affiliated entities that skilled nursing facilities, home health
the programs will not pay for services agencies, and health maintenance or-
provided; and ganizations and Federally-funded com-
(E) Certifies to the truthfulness and munity health centers where the prac-
accuracy of the notification and the titioner or other person works;
statements in the certification. (6) Medical societies and other pro-
(2) If the sanctioned practitioner or fessional organizations; and
other person does not inform his, her (7) Medicare carriers and fiscal inter-
or its patients and does not return the mediaries, health care prepayment
required certification within the 30-day
plans and other affected agencies and
period, or if the sanctioned practi-
organizations.
tioner or other person returns the cer-
tification within the 30-day period but (f) If an exclusion sanction is effec-
the OIG obtains reliable evidence that tuated because a decision was not made
such person nevertheless has not ade- within 120 days after receipt of the QIO
quately informed new and existing pa- recommendation, notification is as fol-
tients of the sanction, the OIG— lows—
(i) Will see that the public is notified (1) As soon as possible after the 120th
directly of the identity of the sanc- day, the OIG will issue a notice to the
tioned practitioner or other person, the practitioner or other person, in compli-
finding that the obligation has been ance with the requirements of para-
violated, and the effective date of any graph (c) of this section, affirming the
exclusion; and QIO recommendation based on the
(ii) May consider this failure to ad- OIG’s review of the case, and that the
here to the certification obligation as exclusion is effective 20 days from the
an adverse factor at the time the sanc- date of the notice; and
tioned practitioner or other person re- (2) Notice of sanction is also provided
quests reinstatement. as specified in paragraph (e) of this sec-
(3) If the sanctioned practitioner or tion.
other person is entitled to a prelimi-
nary hearing in accordance with [60 FR 63640, Dec. 12, 1995; 61 FR 1841, Jan. 24,
§ 1004.140(a) and requests such a pre- 1996, as amended at 62 FR 23143, Apr. 29, 1997]
liminary hearing, and if the adminis-
trative law judge (ALJ) decides that Subpart E—Effect and Duration of
he, she or it poses a risk to program Exclusion
beneficiaries, the sanctioned practi-
tioner or other person would have 30 § 1004.120 Effect of an exclusion on
days from the date of receipt of the program payments and services.
ALJ’s decision to provide certification The effect of an exclusion is set forth
to the OIG in accordance with in § 1001.1901 of this chapter.
§ 1004.110(d)(1). The date of receipt is
presumed to be 5 days after the date of § 1004.130 Reinstatement after exclu-
the ALJ’s decision, unless there is a sion.
reasonable showing to the contrary.
(e) Notice of the sanction is also pro- (a) A practitioner or other person
vided to the following entities as ap- who has been excluded in accordance
propriate— with this part may apply for reinstate-
(1) The QIO that originated the sanc- ment at the end of the period of exclu-
tion report; sion. The OIG will consider any request
(2) QIOs in adjacent areas; for reinstatement in accordance with
(3) State Medicaid fraud control units provisions of §§ 1001.3001 through
and State licensing and accreditation 1001.3005 of this chapter.
bodies; (b) The OIG may also consider a prac-
(4) Appropriate program contractors titioner’s or other person’s compliance
and State agencies; with the certification obligation in
(5) Hospitals, including the hospital § 1004.110(d) at the time of reinstate-
where the sanctioned individual’s case ment.
1216
Subpart F—Appeals unless the OIG waives it in accordance

with paragraph (a)(6)(i) of this section.
§ 1004.140 Appeal rights. (v) The ALJ cannot consolidate the
(a) Right to preliminary hearing. (1)(i) preliminary hearing with a full hearing
A practitioner or other person excluded without the approval of all parties to
from participation in Medicare and any the hearing.
State health care programs under sec- (3)(i) The preliminary hearing will be
tion 1156 of the Act may request a pre- conducted by an ALJ of the DAB in a
liminary hearing if the location where city that the ALJ deems equitable to
services are rendered to over 50 percent all parties. The ALJ will conduct the
of the practitioner’s or other person’s preliminary hearing and render a deci-
patients at the time of the exclusion sion no later than 45 days after receipt
notice is in a rural HPSA or in a coun- of the request for such a hearing by the
ty with a population of less than 70,000. DAB. Unless there is a reasonable
(ii) Unless the practitioner’s or other showing to the contrary, date of re-
person’s practice meets the definition ceipt by the DAB is presumed to be 5
for psychiatric professional, vision care days after the date on the request for a
professional, dental professional, preliminary hearing or, if undated, the
podiatric professional or pharmacy date of receipt will be the date the
professional, the HPSA used by the DAB actually received the request. A
OIG for determination of entitlement reasonable extension to the 45-day pe-
to a preliminary hearing will be the riod of up to 15 days may be requested
HPSA list for primary medical care by any party to the preliminary hear-
professional. ing and such a request may be granted
(iii) Information on the population upon concurrence by all parties to the
size of a county in order to determine preliminary hearing. Such request
entitlement to a preliminary hearing must be received no later than 15 days
will be obtained by the OIG from the prior to the scheduled date of the pre-
responsible officials of that county. liminary hearing.
(2)(i) A request for a preliminary (ii) The only issue to be heard and de-
hearing must be made in writing and cided on by the ALJ at the preliminary
received by the Departmental Appeals hearing, based on the preponderance of
Board (DAB) no later than the 15th day the evidence, is whether the practi-
after the notice of exclusion is received tioner’s or other person’s continued
by a practitioner or other person. The participation in the Medicare and
date of receipt of the notice of exclu- State health care programs during the
sion by the practitioner or other per- appeal of the exclusion before an ALJ
son is presumed to be 5 days after the would place program beneficiaries at
date appearing on the notice, unless serious risk. The ALJ’s decision is to
there is a reasonable showing to the be based on the preponderance of the
contrary. evidence.
(ii) A request for a preliminary hear- (iii) In the interest of time, the ALJ
ing will stay the effective date of the may issue an oral decision to be fol-
exclusion pending a decision of the lowed by a written decision.
ALJ at the preliminary hearing, and (iv) In those cases where the ALJ has
all the parties informed by the OIG of stayed an exclusion after a preliminary
the exclusion will be notified of the hearing, a full hearing must be held
stay. and a decision rendered by the ALJ
(iii) A request for a preliminary hear- within 6 months. If, for any reason, the
ing received after the 15-day period has request for a full hearing before the
expired will be treated as a request for ALJ is withdrawn or dismissed, the
a hearing before an ALJ in accordance practitioner or other person will be ex-
with paragraph (b) of this section. cluded effective 5 days after the notice
(iv) If the practitioner or other per- of the withdrawal or dismissal is re-
son exercises his, her or its right to a ceived in the OIG headquarters.
preliminary hearing, such a hearing (4) The preliminary hearing decision
must be held by the ALJ in accordance is not appealable or subject to further
with paragraph (a)(3)(i) of this section administrative or judicial review.
1217
Pt. 1005 42 CFR Ch. V (10–1–24 Edition)
(5) A practitioner or other person PART 1005—APPEALS OF EXCLU-

found at the preliminary hearing not SIONS, CIVIL MONEY PENALTIES
to place program beneficiaries at seri- AND ASSESSMENTS
ous risk, but later determined to have
been properly excluded from program Sec.
participation after a full hearing before 1005.1 Definitions.
an ALJ, is not entitled to have the ex- 1005.2 Hearing before an administrative law
clusion stayed further during an appeal judge.
to the DAB. Exclusions in such in- 1005.3 Rights of parties.
stances will be effective 5 days after re- 1005.4 Authority of the ALJ.
1005.5 Ex parte contacts.
ceipt of the ALJ decision in the OIG
1005.6 Prehearing conferences.
headquarters. 1005.7 Discovery.
(6)(i) After notice of a timely request 1005.8 Exchange of witness lists, witness
for a preliminary hearing, the OIG may statements and exhibits.
determine that the practitioner’s or 1005.9 Subpoenas for attendance at hearing.
other person’s continued program par- 1005.10 Fees.
ticipation during the appeal before the 1005.11 Form, filing and service of papers.
1005.12 Computation of time.
ALJ will not place program bene-
1005.13 Motions.
ficiaries at serious risk and waive the 1005.14 Sanctions.
preliminary hearing. Under these cir- 1005.15 The hearing and burden of proof.
cumstances, the exclusion will be 1005.16 Witnesses.
stayed pending the decision of the ALJ 1005.17 Evidence.
after a full hearing. the hearing must 1005.18 The record.
be held, and a decision reached, within 1005.19 Post-hearing briefs.
1005.20 Initial decision.
6 months.
1005.21 Appeal to DAB.
(ii) If the OIG decides to waive the 1005.22 Stay of initial decision.
preliminary hearing, the request for 1005.23 Harmless error.
the preliminary hearing will be consid-
AUTHORITY: 42 U.S.C. 405(a), 405(b), 1302,
ered a request for a hearing before the 1320a–7, 1320a–7a and 1320c–5.
ALJ in accordance with paragraph (b)
of this section. SOURCE: 57 FR 3350, Jan. 29, 1992, unless
otherwise noted.
(b) Right to administrative review. (1) A
practitioner or other person dissatis- § 1005.1 Definitions.
fied with an OIG determination, or an
Civil money penalty cases refers to all
exclusion that results from a deter-
proceedings arising under any of the
mination not being made within 120
statutory bases for which the OIG has
days, is entitled to appeal such sanc-
been delegated authority to impose
tion in accordance with part 1005 of
civil money penalties (CMPs).
this chapter.
DAB refers to the Departmental Ap-
(2) Due to the 120-day statutory re- peals Board or its delegatee.
quirement specified in § 1004.100(e), the Exclusion cases refers to all pro-
following limitations apply— ceedings arising under any of the stat-
(i) The period of time for submitting utory bases for which the OIG has been
additional information will not be ex- delegated authority to impose exclu-
tended. sions.
(ii) Any material received by the OIG Inspector General (IG) means the In-
after the 30-day period allowed will not spector General of the Department of
be considered by the ALJ or the DAB. Health and Human Services or his or
(3) The OIG’s determination con- her designees.
tinues in effect unless reversed by a [57 FR 3350, Jan. 29, 1992, as amended at 65
hearing. FR 24418, Apr. 26, 2000; 88 FR 42841, July 3,
(c) Rights to judicial review. Any prac- 2023]
titioner or other person dissatisfied
with a final decision of the Secretary § 1005.2 Hearing before an administra-
may file a civil action in accordance tive law judge.
with the provisions of section 205(g) of (a) A party sanctioned under any cri-
the Act. teria specified in parts 1001, 1003 and
1218
1004 of this chapter may request a hear- (5) Present evidence relevant to the
ing before an ALJ. issues at the hearing;
(b) In exclusion cases, the parties to (6) Present and cross-examine wit-
the proceeding will consist of the peti- nesses;
tioner and the IG. In civil money pen- (7) Present oral arguments at the
alty cases, the parties to the pro- hearing as permitted by the ALJ; and
ceeding will consist of the respondent (8) Submit written briefs and pro-
and the IG. posed findings of fact and conclusions
(c) The request for a hearing will be of law after the hearing.
made in writing to the DAB; signed by (b) Fees for any services performed
the petitioner or respondent, or by his on behalf of a party by an attorney are
or her attorney; and sent by certified not subject to the provisions of section
mail. The request must be filed within 206 of title II of the Act, which author-
60 days after the notice, provided in ac- izes the Secretary to specify or limit
cordance with § 1001.2002, § 1001.203 or these fees.
§ 1003.109, is received by the petitioner
or respondent. For purposes of this sec- § 1005.4 Authority of the ALJ.
tion, the date of receipt of the notice
(a) The ALJ will conduct a fair and
letter will be presumed to be 5 days
impartial hearing, avoid delay, main-
after the date of such notice unless
tain order and assure that a record of
there is a reasonable showing to the
the proceeding is made.
contrary.
(d) The request for a hearing will (b) The ALJ has the authority to—
contain a statement as to the specific (1) Set and change the date, time and
issues or findings of fact and conclu- place of the hearing upon reasonable
sions of law in the notice letter with notice to the parties;
which the petitioner or respondent dis- (2) Continue or recess the hearing in
agrees, and the basis for his or her con- whole or in part for a reasonable period
tention that the specific issues or find- of time;
ings and conclusions were incorrect. (3) Hold conferences to identify or
(e) The ALJ will dismiss a hearing re- simplify the issues, or to consider
quest where— other matters that may aid in the ex-
(1) The petitioner’s or the respond- peditious disposition of the proceeding;
ent’s hearing request is not filed in a (4) Administer oaths and affirma-
timely manner; tions;
(2) The petitioner or respondent with- (5) Issue subpoenas requiring the at-
draws his or her request for a hearing; tendance of witnesses at hearings and
(3) The petitioner or respondent the production of documents at or in
abandons his or her request for a hear- relation to hearings;
ing; or (6) Rule on motions and other proce-
(4) The petitioner’s or respondent’s dural matters;
hearing request fails to raise any issue (7) Regulate the scope and timing of
which may properly be addressed in a documentary discovery as permitted by
hearing. this part;
[57 FR 3350, Jan. 29, 1992, as amended at 65 (8) Regulate the course of the hearing
FR 24418, Apr. 26, 2000] and the conduct of representatives,
parties, and witnesses;
§ 1005.3 Rights of parties. (9) Examine witnesses;
(a) Except as otherwise limited by (10) Receive, rule on, exclude or limit
this part, all parties may— evidence;
(1) Be accompanied, represented and (11) Upon motion of a party, take of-
advised by an attorney; ficial notice of facts;
(2) Participate in any conference held (12) Upon motion of a party, decide
by the ALJ; cases, in whole or in part, by summary
(3) Conduct discovery of documents judgment where there is no disputed
as permitted by this part; issue of material fact; and
(4) Agree to stipulations of fact or (13) Conduct any conference, argu-
law which will be made part of the ment or hearing in person or, upon
record; agreement of the parties, by telephone.
1219
§ 1005.5 42 CFR Ch. V (10–1–24 Edition)
(c) The ALJ does not have the au- (4) Whether the parties can agree to
thority to— submission of the case on a stipulated
(1) Find invalid or refuse to follow record;
Federal statutes or regulations or sec- (5) Whether a party chooses to waive
retarial delegations of authority; appearance at an oral hearing and to
(2) Enter an order in the nature of a submit only documentary evidence
directed verdict; (subject to the objection of other par-
(3) Compel settlement negotiations; ties) and written argument;
(4) Enjoin any act of the Secretary; (6) Limitation of the number of wit-
(5) Review the exercise of discretion nesses;
by the OIG to exclude an individual or (7) Scheduling dates for the exchange
entity under section 1128(b) of the Act of witness lists and of proposed exhib-
or under part 1003 of this chapter, or its;
determine the scope or effect of the ex- (8) Discovery of documents as per-
clusion; mitted by this part;
(6) Set a period of exclusion at zero, (9) The time and place for the hear-
or reduce a period of exclusion to zero, ing;
in any case in which the ALJ finds that (10) Such other matters as may tend
an individual or entity committed an to encourage the fair, just and expedi-
act described in section 1128(b) of the tious disposition of the proceedings;
Act or under part 1003 of this chapter; and
or (11) Potential settlement of the case.
(7) Review the exercise of discretion (c) The ALJ will issue an order con-
by the OIG to impose a CMP, assess- taining the matters agreed upon by the
ment or exclusion under part 1003 of parties or ordered by the ALJ at a pre-
this chapter. hearing conference.
FR 5618, Jan. 22, 1993; 81 FR 88365, Dec. 7, § 1005.7 Discovery.
2016] (a) A party may make a request to
another party for production of docu-
§ 1005.5 Ex parte contacts.
ments for inspection and copying
No party or person (except employees which are relevant and material to the
of the ALJ’s office) will communicate issues before the ALJ.
in any way with the ALJ on any mat- (b) For the purpose of this section,
ter at issue in a case, unless on notice the term documents includes informa-
and opportunity for all parties to par- tion, reports, answers, records, ac-
ticipate. This provision does not pro- counts, papers and other data and doc-
hibit a person or party from inquiring umentary evidence. Nothing contained
about the status of a case or asking in this section will be interpreted to re-
routine questions concerning adminis- quire the creation of a document, ex-
trative functions or procedures. cept that requested data stored in an
electronic data storage system will be
§ 1005.6 Prehearing conferences. produced in a form accessible to the re-
(a) The ALJ will schedule at least questing party.
one prehearing conference, and may (c) Requests for documents, requests
schedule additional prehearing con- for admissions, written interrogatories,
ferences as appropriate, upon reason- depositions and any forms of discovery,
able notice to the parties. other than those permitted under para-
(b) The ALJ may use prehearing con- graph (a) of this section, are not au-
ferences to discuss the following— thorized.
(1) Simplification of the issues; (d) This section will not be construed
(2) The necessity or desirability of to require the disclosure of interview
amendments to the pleadings, includ- reports or statements obtained by any
ing the need for a more definite state- party, or on behalf of any party, of per-
ment; sons who will not be called as witnesses
(3) Stipulations and admissions of by that party, or analyses and sum-
fact or as to the contents and authen- maries prepared in conjunction with
ticity of documents; the investigation or litigation of the
1220
case, or any otherwise privileged docu- (2) Unless the ALJ finds that extraor-
ments. dinary circumstances justified the fail-
(e)(1) When a request for production ure to timely exchange the information
of documents has been received, within listed under paragraph (a) of this sec-
30 days the party receiving that re- tion, the ALJ must exclude from the
quest will either fully respond to the party’s case-in-chief:
request, or state that the request is (i) The testimony of any witness
being objected to and the reasons for whose name does not appear on the
that objection. If objection is made to witness list, and
part of an item or category, the part (ii) Any exhibit not provided to the
will be specified. Upon receiving any opposing party as specified in para-
objections, the party seeking produc- graph (a) of this section.
tion may then, within 30 days or any (3) If the ALJ finds that extraor-
other time frame set by the ALJ, file a dinary circumstances existed, the ALJ
motion for an order compelling dis- must then determine whether the ad-
covery. (The party receiving a request mission of such evidence would cause
for production may also file a motion substantial prejudice to the objecting
for protective order any time prior to party. If the ALJ finds that there is no
the date the production is due.) substantial prejudice, the evidence
(2) The ALJ may grant a motion for may be admitted. If the ALJ finds that
protective order or deny a motion for there is substantial prejudice, the ALJ
an order compelling discovery if the may exclude the evidence, or at his or
ALJ finds that the discovery sought— her discretion, may postpone the hear-
(i) Is irrelevant, ing for such time as is necessary for
(ii) Is unduly costly or burdensome, the objecting party to prepare and re-
(iii) Will unduly delay the pro- spond to the evidence.
ceeding, or (c) Unless another party objects
within a reasonable period of time
(iv) Seeks privileged information.
prior to the hearing, documents ex-
(3) The ALJ may extend any of the
changed in accordance with paragraph
time frames set forth in paragraph
(a) of this section will be deemed to be
(e)(1) of this section.
authentic for the purpose of admissi-
(4) The burden of showing that dis- bility at the hearing.
covery should be allowed is on the
party seeking discovery. § 1005.9 Subpoenas for attendance at
hearing.
FR 5618, Jan. 22, 1993; 65 FR 24418, Apr. 26, (a) A party wishing to procure the
2000; 65 FR 35584, June 5, 2000; 67 FR 11936, appearance and testimony of any indi-
Mar. 18, 2002] vidual at the hearing may make a mo-
tion requesting the ALJ to issue a sub-
§ 1005.8 Exchange of witness lists, wit- poena if the appearance and testimony
ness statements and exhibits.
are reasonably necessary for the pres-
(a) At least 15 days before the hear- entation of a party’s case.
ing, the ALJ will order the parties to (b) A subpoena requiring the attend-
exchange witness lists, copies of prior ance of an individual in accordance
written statements of proposed wit- with paragraph (a) of this section may
nesses and copies of proposed hearing also require the individual (whether or
exhibits, including copies of any writ- not the individual is a party) to
ten statements that the party intends produce evidence authorized under
to offer in lieu of live testimony in ac- § 1005.7 of this part at or prior to the
cordance with § 1005.16. hearing.
(b)(1) If at any time a party objects (c) When a subpoena is served by a re-
to the proposed admission of evidence spondent or petitioner on a particular
not exchanged in accordance with para- individual or particular office of the
graph (a) of this section, the ALJ will OIG, the OIG may comply by desig-
determine whether the failure to com- nating any of its representatives to ap-
ply with paragraph (a) of this section pear and testify.
should result in the exclusion of such (d) A party seeking a subpoena will
evidence. file a written motion not less than 30
1221
§ 1005.10 42 CFR Ch. V (10–1–24 Edition)
days before the date fixed for the hear- case number, and a designation of the
ing, unless otherwise allowed by the paper, such as motion to quash sub-
ALJ for good cause shown. Such re- poena.
quest will: (3) Every pleading and paper will be
(1) Specify any evidence to be pro- signed by, and will contain the address
duced, and telephone number of the party or
(2) Designate the witnesses, and the person on whose behalf the paper
(3) Describe the address and location was filed, or his or her representative.
with sufficient particularity to permit (4) Papers are considered filed when
such witnesses to be found. they are mailed.
(e) The subpoena will specify the (b) Service. A party filing a document
time and place at which the witness is with the ALJ or the Secretary will, at
to appear and any evidence the witness the time of filing, serve a copy of such
is to produce. document on every other party. Serv-
(f) Within 15 days after the written ice upon any party of any document
motion requesting issuance of a sub-
will be made by delivering a copy, or
poena is served, any party may file an
placing a copy of the document in the
opposition or other response.
United States mail, postage prepaid
(g) If the motion requesting issuance
and addressed, or with a private deliv-
of a subpoena is granted, the party
ery service, to the party’s last known
seeking the subpoena will serve it by
address. When a party is represented by
delivery to the individual named, or by
an attorney, service will be made upon
certified mail addressed to such indi-
such attorney in lieu of the party.
vidual at his or her last dwelling place
or principal place of business. (c) Proof of service. A certificate of
(h) The individual to whom the sub- the individual serving the document by
poena is directed may file with the personal delivery or by mail, setting
ALJ a motion to quash the subpoena forth the manner of service, will be
within 10 days after service. proof of service.
(i) The exclusive remedy for contu-
§ 1005.12 Computation of time.
macy by, or refusal to obey a subpoena
duly served upon, any person is speci- (a) In computing any period of time
fied in section 205(e) of the Social Secu- under this part or in an order issued
rity Act (42 U.S.C. 405(e)). thereunder, the time begins with the
day following the act, event or default,
FR 24418, Apr. 26, 2000]
and includes the last day of the period
unless it is a Saturday, Sunday or legal
§ 1005.10 Fees. holiday observed by the Federal Gov-
ernment, in which event it includes the
The party requesting a subpoena will
next business day.
pay the cost of the fees and mileage of
any witness subpoenaed in the amounts (b) When the period of time allowed
that would be payable to a witness in a is less than 7 days, intermediate Satur-
proceeding in United States District days, Sundays and legal holidays ob-
Court. A check for witness fees and served by the Federal Government will
mileage will accompany the subpoena be excluded from the computation.
when served, except that when a sub- (c) Where a document has been served
poena is issued on behalf of the IG, a or issued by placing it in the mail, an
check for witness fees and mileage additional 5 days will be added to the
need not accompany the subpoena. time permitted for any response. This
paragraph does not apply to requests
§ 1005.11 Form, filing and service of for hearing under § 1005.2.
papers.
(a) Forms. (1) Unless the ALJ directs § 1005.13 Motions.
the parties to do otherwise, documents (a) An application to the ALJ for an
filed with the ALJ will include an order or ruling will be by motion. Mo-
original and two copies. tions will state the relief sought, the
(2) Every pleading and paper filed in authority relied upon and the facts al-
the proceeding will contain a caption leged, and will be filed with the ALJ
setting forth the title of the action, the and served on all other parties.
1222
(b) Except for motions made during a other costs caused by the failure or
prehearing conference or at the hear- misconduct.
ing, all motions will be in writing. The
ALJ may require that oral motions be § 1005.15 The hearing and burden of
reduced to writing. proof.
(c) Within 10 days after a written mo- (a) The ALJ will conduct a hearing
tion is served, or such other time as on the record in order to determine
may be fixed by the ALJ, any party whether the petitioner or respondent
may file a response to such motion. should be found liable under this part.
(d) The ALJ may not grant a written
(b) With regard to the burden of proof
motion before the time for filing re-
in civil money penalty cases under part
sponses has expired, except upon con-
sent of the parties or following a hear- 1003, in Quality Improvement Organiza-
ing on the motion, but may overrule or tion exclusion cases under part 1004,
deny such motion without awaiting a and in exclusion cases under §§ 1001.701,
response. 1001.901 and 1001.951 of this chapter—
(e) The ALJ will make a reasonable (1) The respondent or petitioner, as
effort to dispose of all outstanding mo- applicable, bears the burden of going
tions prior to the beginning of the forward and the burden of persuasion
hearing. with respect to affirmative defenses
and any mitigating circumstances; and
§ 1005.14 Sanctions. (2) The IG bears the burden of going
(a) The ALJ may sanction a person, forward and the burden of persuasion
including any party or attorney, for with respect to all other issues.
failing to comply with an order or pro- (c) Burden of proof in all other exclu-
cedure, for failing to defend an action sion cases. In all exclusion cases except
or for other misconduct that interferes those governed by paragraph (b) of this
with the speedy, orderly or fair con- section, the ALJ will allocate the bur-
duct of the hearing. Such sanctions den of proof as the ALJ deems appro-
will reasonably relate to the severity priate.
and nature of the failure or mis-
(d) The burden of persuasion will be
conduct. Such sanction may include—
judged by a preponderance of the evi-
(1) In the case of refusal to provide or
permit discovery under the terms of dence.
this part, drawing negative factual in- (e) The hearing will be open to the
ferences or treating such refusal as an public unless otherwise ordered by the
admission by deeming the matter, or ALJ for good cause shown.
certain facts, to be established; (f)(1) A hearing under this part is not
(2) Prohibiting a party from intro- limited to specific items and informa-
ducing certain evidence or otherwise tion set forth in the notice letter to
supporting a particular claim or de- the petitioner or respondent. Subject
fense; to the 15-day requirement under
(3) Striking pleadings, in whole or in § 1005.8, additional items and informa-
part; tion, including aggravating or miti-
(4) Staying the proceedings; gating circumstances that arose or be-
(5) Dismissal of the action; came known subsequent to the
(6) Entering a decision by default; issuance of the notice letter, may be
and introduced by either party during its
(7) Refusing to consider any motion case-in-chief unless such information
or other action that is not filed in a or items are—
timely manner.
(i) Privileged;
(b) In civil money penalty cases com-
menced under section 1128A of the Act (ii) Disqualified from consideration
or under any provision which incor- due to untimeliness in accordance with
porates section 1128A(c)(4) of the Act, § 1004.130(a)(2)(ii); or
the ALJ may also order the party or (iii) Deemed otherwise inadmissible
attorney who has engaged in any of the under § 1005.17.
acts described in paragraph (a) of this (2) After both parties have presented
section to pay attorney’s fees and their cases, evidence may be admitted
1223
§ 1005.16 42 CFR Ch. V (10–1–24 Edition)
on rebuttal even if not previously ex- individual engaged in assisting the at-
changed in accordance with § 1005.8. torney for the IG.
[57 FR 3350, Jan. 29, 1992, as amended at 63 [57 FR 3350, Jan. 29, 1992, as amended at 67
FR 46691, Sept. 2, 1998; 65 FR 24418, Apr. 26, FR 11936, Mar. 18, 2002]
2000]
§ 1005.17 Evidence.
§ 1005.16 Witnesses. (a) The ALJ will determine the ad-
(a) Except as provided in paragraph missibility of evidence.
(b) Except as provided in this part,
(b) of this section, testimony at the
the ALJ will not be bound by the Fed-
hearing will be given orally by wit-
eral Rules of Evidence. However, the
nesses under oath or affirmation. ALJ may apply the Federal Rules of
(b) At the discretion of the ALJ, tes- Evidence where appropriate, for exam-
timony (other than expert testimony) ple, to exclude unreliable evidence.
may be admitted in the form of a writ- (c) The ALJ must exclude irrelevant
ten statement. The ALJ may, at his or or immaterial evidence.
her discretion, admit prior sworn testi- (d) Although relevant, evidence may
mony of experts which has been subject be excluded if its probative value is
to adverse examination, such as a depo- substantially outweighed by the danger
sition or trial testimony. Any such of unfair prejudice, confusion of the
written statement must be provided to issues, or by considerations of undue
all other parties along with the last delay or needless presentation of cumu-
known address of such witnesses, in a lative evidence.
manner that allows sufficient time for (e) Although relevant, evidence must
other parties to subpoena such witness be excluded if it is privileged under
for cross-examination at the hearing. Federal law.
Prior written statements of witnesses (f) Evidence concerning offers of com-
promise or settlement made in this ac-
proposed to testify at the hearing will
tion will be inadmissible to the extent
be exchanged as provided in § 1005.8.
provided in Rule 408 of the Federal
(c) The ALJ will exercise reasonable Rules of Evidence.
control over the mode and order of in- (g) Evidence of crimes, wrongs or
terrogating witnesses and presenting acts other than those at issue in the in-
evidence so as to: stant case is admissible in order to
(1) Make the interrogation and pres- show motive, opportunity, intent,
entation effective for the ascertain- knowledge, preparation, identity, lack
ment of the truth, of mistake, or existence of a scheme.
(2) Avoid repetition or needless con- Such evidence is admissible regardless
sumption of time, and of whether the crimes, wrongs or acts
(3) Protect witnesses from harass- occurred during the statute of limita-
ment or undue embarrassment. tions period applicable to the acts
(d) The ALJ will permit the parties which constitute the basis for liability
to conduct such cross-examination of in the case, and regardless of whether
witnesses as may be required for a full they were referenced in the IG’s notice
and true disclosure of the facts. sent in accordance with § 1001.2002,
(e) The ALJ may order witnesses ex- § 1001.2003 or § 1003.109.
cluded so that they cannot hear the (h) The ALJ will permit the parties
to introduce rebuttal witnesses and
testimony of other witnesses. This does
evidence.
not authorize exclusion of—
(i) All documents and other evidence
(1) A party who is an individual; offered or taken for the record will be
(2) In the case of a party that is not open to examination by all parties, un-
an individual, an officer or employee of less otherwise ordered by the ALJ for
the party appearing for the entity pro good cause shown.
se or designated as the party’s rep- (j) The ALJ may not consider evi-
resentative; or dence regarding the issue of willingness
(3) An individual whose presence is and ability to enter into and success-
shown by a party to be essential to the fully complete a corrective action plan
presentation of its case, including an when such evidence pertains to matters
1224
occurring after the submittal of the be accompanied by a statement de-

case to the Secretary. The determina- scribing the right of any party to file a
tion regarding the appropriateness of notice of appeal with the DAB and in-
any corrective action plan is not re- structions for how to file such appeal.
viewable. If the ALJ fails to meet the deadline
contained in this paragraph, he or she
§ 1005.18 The record. will notify the parties of the reason for
(a) The hearing will be recorded and the delay and will set a new deadline.
transcribed. Transcripts may be ob- (d) Except for exclusion actions
tained following the hearing from the taken in accordance with § 1001.2003 of
ALJ. this chapter and as provided in para-
(b) The transcript of testimony, ex- graph (e) of this section, unless the ini-
hibits and other evidence admitted at tial decision is appealed to the DAB, it
the hearing, and all papers and re- will be final and binding on the parties
quests filed in the proceeding con- 30 days after the ALJ serves the parties
stitute the record for the decision by with a copy of the decision. If service is
the ALJ and the Secretary. by mail, the date of service will be
(c) The record may be inspected and deemed to be 5 days from the date of
copied (upon payment of a reasonable mailing.
fee) by any person, unless otherwise or- (e) If an extension of time within
dered by the ALJ for good cause shown. which to appeal the initial decision is
(d) For good cause, the ALJ may granted under § 1005.21(a), except as
order appropriate redactions made to provided in § 1005.22(a), the initial deci-
the record. sion will become final and binding on
the day following the end of the exten-
§ 1005.19 Post-hearing briefs.
sion period.
The ALJ may require the parties to
file post-hearing briefs. In any event, [57 FR 3350, Jan. 29, 1992, as amended at 65
FR 24418, Apr. 26, 2000]
any party may file a post-hearing brief.
The ALJ will fix the time for filing § 1005.21 Appeal to DAB.
such briefs which are not to exceed 60
days from the date the parties receive (a) Any party may appeal the initial
the transcript of the hearing or, if ap- decision of the ALJ to the DAB by fil-
plicable, the stipulated record. Such ing a notice of appeal with the DAB
briefs may be accompanied by proposed within 30 days of the date of service of
findings of fact and conclusions of law. the initial decision. The DAB may ex-
The ALJ may permit the parties to file tend the initial 30 day period for a pe-
reply briefs. riod of time not to exceed 30 days if a
party files with the DAB a request for
§ 1005.20 Initial decision. an extension within the initial 30 day
(a) The ALJ will issue an initial deci- period and shows good cause.
sion, based only on the record, which (b) If a party files a timely notice of
will contain findings of fact and con- appeal with the DAB, the ALJ will for-
clusions of law. ward the record of the proceeding to
(b) The ALJ may affirm, increase or the DAB.
reduce the penalties, assessment or ex- (c) A notice of appeal will be accom-
clusion proposed or imposed by the IG, panied by a written brief specifying ex-
or reverse the imposition of the exclu- ceptions to the initial decision and rea-
sion. In exclusion cases where the pe- sons supporting the exceptions. Any
riod of exclusion commenced prior to party may file a brief in opposition to
the hearing, any period of exclusion exceptions, which may raise any rel-
imposed by the ALJ will be deemed to evant issue not addressed in the excep-
commence on the date such exclusion tions, within 30 days of receiving the
originally went into effect. notice of appeal and accompanying
(c) The ALJ will issue the initial de- brief. The DAB may permit the parties
cision to all parties within 60 days to file reply briefs.
after the time for submission of post- (d) There is no right to appear per-
hearing briefs and reply briefs, if personally before the DAB or to appeal to
mitted, has expired. The decision will the DAB any interlocutory ruling by
1225
§ 1005.22 42 CFR Ch. V (10–1–24 Edition)
the ALJ, except on the timeliness of a will be time-stamped by the clerk of

filing of the hearing request. the court when the original is filed
(e) The DAB will not consider any with the court.
issue not raised in the parties’ briefs, (3) If the Chief Counsel to the IG re-
nor any issue in the briefs that could ceives two or more petitions within 10
have been raised before the ALJ but days after the DAB issues its decision,
was not. the Chief Counsel to the IG will notify
(f) If any party demonstrates to the the U.S. Judicial Panel on Multidis-
satisfaction of the DAB that additional trict Litigation of any petitions that
evidence not presented at such hearing were received within the 10-day period.
is relevant and material and that there
were reasonable grounds for the failure
FR 46691, Sept. 2, 1998; 65 FR 24419, Apr. 26,
to adduce such evidence at such hear- 2000]
ing, the DAB may remand the matter
to the ALJ for consideration of such § 1005.22 Stay of initial decision.
additional evidence.
(g) The DAB may decline to review (a) In a CMP case under section 1128A
the case, or may affirm, increase, re- of the Act, the filing of a respondent’s
duce, reverse or remand any penalty, request for review by the DAB will
assessment or exclusion determined by automatically stay the effective date
the ALJ. of the ALJ’s decision.
(h) The standard of review on a dis- (b) (1) After the DAB renders a deci-
puted issue of fact is whether the ini- sion in a CMP case, pending judicial re-
tial decision is supported by substan- view, the respondent may file a request
tial evidence on the whole record. The for stay of the effective date of any
standard of review on a disputed issue penalty or assessment with the ALJ.
of law is whether the initial decision is The request must be accompanied by a
erroneous. copy of the notice of appeal filed with
(i) Within 60 days after the time for the Federal court. The filing of such a
submission of briefs and reply briefs, if request will automatically act to stay
permitted, has expired, the DAB will the effective date of the penalty or as-
issue to each party to the appeal a sessment until such time as the ALJ
copy of the DAB’s decision and a state- rules upon the request.
ment describing the right of any peti- (2) The ALJ may not grant a respond-
tioner or respondent who is found lia- ent’s request for stay of any penalty or
ble to seek judicial review. assessment unless the respondent posts
(j) Except with respect to any pen- a bond or provides other adequate secu-
alty, assessment or exclusion remanded rity.
by the ALJ, the DAB’s decision, includ- (3) The ALJ will rule upon a respond-
ing a decision to decline review of the ent’s request for stay within 10 days of
initial decision, becomes final and receipt.
binding 60 days after the date on which
the DAB serves the parties with a copy § 1005.23 Harmless error.
of the decision. If service is by mail, No error in either the admission or
the date of service will be deemed to be the exclusion of evidence, and no error
5 days from the date of mailing. or defect in any ruling or order or in
(k) (1) Any petition for judicial re- any act done or omitted by the ALJ or
view must be filed within 60 days after by any of the parties, including Federal
the DAB serves the parties with a copy representatives such as Medicare car-
of the decision. If service is by mail, riers and intermediaries and Quality
the date of service will be deemed to be Improvement Organizations, is ground
5 days from the date of mailing. for vacating, modifying or otherwise
(2) In compliance with 28 U.S.C. disturbing an otherwise appropriate
2112(a), a copy of any petition for judi- ruling or order or act, unless refusal to
cial review filed in any U.S. Court of take such action appears to the ALJ or
Appeals challenging a final action of the DAB inconsistent with substantial
the DAB will be sent by certified mail, justice. The ALJ and the DAB at every
return receipt requested, to the Chief stage of the proceeding will disregard
Counsel to the IG. The petition copy any error or defect in the proceeding
1226
that does not affect the substantial ticularity the subject matter on which
rights of the parties. testimony is required. In such event,
the named entity will designate one or
PART 1006—INVESTIGATIONAL more individuals who will testify on its
INQUIRIES behalf, and will state as to each indi-
vidual so designated that individual’s
Sec. name and address and the matters on
1006.1 Scope. which he or she will testify. The indi-
1006.2 Contents of subpoena. vidual so designated will testify as to
1006.3 Service and fees. matters known or reasonably available
1006.4 Procedures for investigational inquir- to the entity.
ies.
1006.5 Enforcement of a subpoena. § 1006.3 Service and fees.
AUTHORITY: 42 U.S.C. 405(d), 405(e), 1302, (a) A subpoena under this part will be
1320a–7, and 1320a–7a.
served by—
SOURCE: 57 FR 3354, Jan. 29, 1992, unless (1) Delivering a copy to the indi-
otherwise noted. vidual named in the subpoena;
(2) Delivering a copy to the entity
§ 1006.1 Scope.
named in the subpoena at its last prin-
(a) The provisions in this part govern cipal place of business; or
subpoenas issued by the Inspector Gen- (3) Registered or certified mail ad-
eral, or his or her delegates, in accord- dressed to such individual or entity at
ance with sections 205(d), 1128A(j), and its last known dwelling place or prin-
1128(f)(4) of the Act and require the at- cipal place of business.
tendance and testimony of witnesses (b) A verified return by the indi-
and the production of any other evi- vidual serving the subpoena setting
dence at an investigational inquiry. forth the manner of service or, in the
(b) Such subpoenas may be issued in case of service by registered or cer-
investigations under section 1128 or tified mail, the signed return post of-
1128A of the Act or under any other fice receipt, will be proof of service.
section of the Act that incorporates (c) Witnesses will be entitled to the
the provisions of sections 1128(f)(4) or same fees and mileage as witnesses in
1128A(j). the district courts of the United States
(c) Nothing in this part is intended to (28 U.S.C. 1821 and 1825). Such fees need
apply to or limit the authority of the not be paid at the time the subpoena is
Inspector General, or his or her dele- served.
gates, to issue subpoenas for the pro-
duction of documents in accordance § 1006.4 Procedures for investigational
with 5 U.S.C. 6(a)(4), App. 3. inquiries.
[57 FR 3354, Jan. 29, 1992, as amended at 82 (a) Testimony at investigational in-
FR 4118, Jan. 12, 2017] quiries will be taken under oath or af-
firmation.
§ 1006.2 Contents of subpoena. (b) Investigational inquiries are non-
A subpoena issued under this part public investigatory proceedings. At-
will— tendance of non-witnesses is within the
(a) State the name of the individual discretion of the OIG, except that—
or entity to whom the subpoena is ad- (1) A witness is entitled to be accom-
dressed; panied, represented and advised by an
(b) State the statutory authority for attorney; and
the subpoena; (2) Representatives of the OIG are en-
(c) Indicate the date, time and place titled to attend and ask questions.
that the investigational inquiry at (c) A witness will have an oppor-
which the witness is to testify will tunity to clarify his or her answers on
take place; the record following the questions by
(d) Include a reasonably specific de- the OIG.
scription of any documents or items re- (d) Any claim of privilege must be as-
quired to be produced; and serted by the witness on the record.
(e) If the subpoena is addressed to an (e) Objections must be asserted on
entity, describe with reasonable par- the record. Errors of any kind that
1227
§ 1006.5 42 CFR Ch. V (10–1–24 Edition)
might be corrected if promptly pre- may be used by the OIG or DHHS in

sented will be deemed to be waived un- any of its activities, and may be used
less reasonable objection is made at or offered into evidence in any admin-
the investigational inquiry. Except istrative or judicial proceeding.
where the objection is on the grounds [57 FR 3354, Jan. 29, 1992, as amended at 65
of privilege, the question will be an- FR 24419, Apr. 26, 2000]
swered on the record, subject to the ob-
jection. § 1006.5 Enforcement of a subpoena.
(f) If a witness refuses to answer any A subpoena to appear at an investiga-
question not privileged or to produce tional inquiry is enforceable through
requested documents or items, or en- the District Court of the United States
gages in conduct likely to delay or ob- and the district where the subpoenaed
struct the investigational inquiry, the person is found, resides or transacts
OIG may seek enforcement of the sub- business.
poena under § 1006.5.
(g)(1) The proceedings will be re-
corded and transcribed. PART 1007—STATE MEDICAID
(2) The witness is entitled to a copy FRAUD CONTROL UNITS
of the transcript, upon payment of pre-
scribed costs, except that, for good Subpart A—General Provisions and
cause, the witness may be limited to Definitions
inspection of the official transcript of Sec.
his or her testimony. 1007.1 Definitions.
(3)(i) The transcript will be sub- 1007.3 Statutory basis and organization of
mitted to the witness for signature. rule.
(ii) Where the witness will be pro-
vided a copy of the transcript, the Subpart B—Requirements for Certification
transcript will be submitted to the wit- 1007.5 Single, identifiable entity require-
ness for signature. The witness may ments of Unit.
submit to the OIG written proposed 1007.7 Prosecutorial authority requirements
corrections to the transcript, with such of Unit.
corrections attached to the transcript. 1007.9 Relationship and agreement between
Unit and Medicaid agency.
If the witness does not return a signed 1007.11 Duties and responsibilities of Unit.
copy of the transcript or proposed cor- 1007.13 Staffing requirements of Unit.
rections within 30 days of its being sub- 1007.15 Establishment and certification of
mitted to him or her for signature, the Unit.
witness will be deemed to have agreed 1007.17 Annual recertification of Unit.
that the transcript is true and accu-
rate. Subpart C—Federal Financial Participation
(iii) Where, as provided in paragraph (FFP)
(g)(2) of this section, the witness is lim- 1007.19 FFP rate and eligible FFP costs.
ited to inspecting the transcript, the 1007.20 Circumstances of permissible data
witness will have the opportunity at mining.
the time of inspection to propose cor- 1007.21 Disallowance of claims for FFP.
rections to the transcript, with correc-
tions attached to the transcript. The Subpart D—Other Provisions
witness will also have the opportunity 1007.23 Other applicable HHS regulations.
to sign the transcript. If the witness
AUTHORITY: 42 U.S.C. 1302, 1396a(a)(61),
does not sign the transcript or offer 1396b(a)(6), 1396b(b)(3), and 1396b(q).
corrections within 30 days of receipt of
notice of the opportunity to inspect SOURCE: 84 FR 10713, Mar. 22, 2019, unless
otherwise noted.
the transcript, the witness will be
deemed to have agreed that the tran-
script is true and accurate. Subpart A—General Provisions
(iv) The OIG’s proposed corrections and Definitions
the record of transcript will be at-
tached to the transcript. § 1007.1 Definitions.
(h) Testimony and other evidence ob- As used in this part, unless otherwise
tained in an investigational inquiry indicated by the context:
1228
Abuse of patients or residents means State law. Such conduct may include
any act that constitutes abuse of a pa- deception, concealment of material
tient or resident of a health care facil- fact, or misrepresentation made inten-
ity or board and care facility under ap- tionally, in deliberate ignorance of the
plicable State law. Such conduct may truth, or in reckless disregard of the
include the infliction of injury, unrea- truth.
sonable confinement, intimidation, or Full-time employee means an employee
punishment with resulting physical or of the Unit who has full-time status as
financial harm, pain, or mental an- defined by the State.
guish. Health care facility means a provider
Board and care facility means a resi- that receives payments under Medicaid
dential setting that receives payment and furnishes food, shelter, and some
(regardless of whether such payment is treatment or services to four or more
made under Title XIX of the Social Se- persons unrelated to the proprietor in
curity Act) from or on behalf of two or an inpatient setting.
more unrelated adults who reside in
Misappropriation of patient or resident
such facility, and for whom one or both
funds means the wrongful taking or
of the following is provided:
(1) Nursing care services provided by, use, as defined under applicable State
or under the supervision of, a reg- law, of funds or property of a patient or
istered nurse, licensed practical nurse, resident of a health care facility or
or licensed nursing assistant. board and care facility.
(2) A substantial amount of personal Neglect of patients or residents means
care services that assist residents with any act that constitutes neglect of a
the activities of daily living, including patient or resident of a health care fa-
personal hygiene, dressing, bathing, cility or board and care facility under
eating, toileting, ambulation, transfer, applicable State law. Such conduct
positioning, self-medication, body care, may include the failure to provide
travel to medical services, essential goods and services necessary to avoid
shopping, meal preparation, laundry, physical harm, mental anguish, or
and housework. mental illness.
Data mining means the practice of Part-time employee means an em-
electronically sorting Medicaid or ployee of the Unit who has part-time
other relevant data, including, but not status as defined by the State.
limited to, the use of statistical models Professional employee means an inves-
and intelligent technologies, to un- tigator, attorney, or auditor.
cover patterns and relationships within Program abuse means provider prac-
that data to identify aberrant utiliza- tices that do not meet the definition of
tion, billing, or other practices that civil or criminal fraud under applicable
are potentially fraudulent. State law, but nonetheless are incon-
Director means a professional em- sistent with sound fiscal, business, or
ployee of the Unit who supervises all medical practices.
Unit employees, either directly or Provider means:
through other Unit managers.
(1) An individual or entity that fur-
Exclusive effort means that a Unit’s
nishes or arranges for the furnishing of
professional employees, except as oth-
erwise permitted in § 1007.13, dedicate items or services for which payment is
their efforts ‘‘exclusively’’ to the func- claimed under Medicaid, including an
tions and responsibilities of a Unit as individual or entity in a managed care
described in this part. Exclusive effort network;
requires that duty with the Unit be in- (2) An individual or entity that is re-
tended to last for at least one (1) year quired to enroll in a State Medicaid
and includes an arrangement in which program, such as an ordering, pre-
an employee is on detail or assignment scribing, or referring physician; or
from another government agency, but (3) Any individual or entity that may
only if the detail or arrangement is in- operate as a health care provider under
tended to last for at least one (1) year. applicable State law.
Fraud means any act that constitutes Unit means State Medicaid Fraud
criminal or civil fraud under applicable Control Unit.
1229
§ 1007.3 42 CFR Ch. V (10–1–24 Edition)
§ 1007.3 Statutory basis and organiza- (b) To be considered a single, identifi-

tion of rule. able entity of the State government,
(a) Statutory basis. This part codifies the Unit must:
sections 1903(a)(6) and 1903(b)(3) of the (1) Be a single organization reporting
Social Security Act (the Act), which to the Unit director;
establish the amounts and conditions (2) Operate under a budget that is
of Federal matching payments for ex- separate from that of its parent agen-
penditures incurred in establishing and cy; and
operating a State MFCU. This part also (3) Have the headquarters office and
implements section 1903(q) of the Act, any field offices each in their own con-
which establishes the basic require- tiguous space, unless the Unit dem-
ments and standards that Units must onstrates to OIG that circumstances
meet to demonstrate that they are ef- warrant a different arrangement for
fectively carrying out the functions of certain employees.
the Unit in order to be certified by OIG § 1007.7 Prosecutorial authority re-
as eligible for FFP under Title XIX of quirements of Unit.
the Act. Section 1902(a)(61) of the Act
requires a State to provide in its Med- A Unit must be organized according
icaid State plan that it operates a Unit to one of the following three options
that effectively carries out the func- related to a Unit’s prosecutorial au-
tions and requirements described in thority:
this part, as determined in accordance (a) The Unit is in the office of the
with standards established by OIG, un- State Attorney General or another de-
less the State demonstrates that a partment of State government that has
Unit would not be cost effective be- statewide authority to prosecute indi-
cause of minimal Medicaid fraud in the viduals for violations of criminal laws
covered services under the plan and with respect to fraud and patient or
that beneficiaries under the plan will resident abuse or neglect in the provi-
be protected from abuse and neglect in sion or administration of medical as-
connection with the provision of med- sistance under a State plan imple-
ical assistance under the plan without menting Title XIX of the Act.
the existence of such a Unit. CMS re- (b) If there is no State agency with
tains the authority to determine a statewide authority and capability for
State’s compliance with Medicaid criminal fraud or patient or resident
State plan requirements in accordance abuse or neglect prosecutions, the Unit
with section 1902(a) of the Act. has established formal written proce-
dures ensuring that the Unit refers sus-
(b) Organization of this part. Subpart
pected cases of criminal fraud in the
A of this part defines terms used in
State Medicaid program or of patient
this part and sets forth the statutory
or resident abuse and neglect to the ap-
basis and organization of this part.
propriate prosecuting authority or au-
Subpart B specifies the certification
thorities, and coordinates with and as-
requirements that a Unit must meet to
sists such authority or authorities in
be eligible for FFP, including require-
the prosecution of such cases.
ments for applying and reapplying for
(c) The Unit has a formal working re-
certification. Subpart C specifies FFP
lationship with the office of the State
rates, costs eligible and not eligible for
Attorney General, or another office
FFP, and FFP disallowance proce-
with statewide prosecutorial authority,
dures. Subpart D specifies other HHS
and has formal written procedures for
regulations applicable to the MFCU
referring to the State Attorney Gen-
grants.
eral or other office suspected criminal
violations and for effective coordina-
Subpart B—Requirements for tion of the activities of both entities
Certification relating to the detection, investiga-
tion, and prosecution of those viola-
§ 1007.5 Single, identifiable entity re- tions relating to the State Medicaid
quirements of Unit. program. Under this working relation-
(a) A Unit must be a single, identifi- ship, the office of the State Attorney
able entity of the State government. General, or other office, must agree to
1230
assume responsibility for prosecuting (e)(1) The Unit may refer any pro-
alleged criminal violations referred to vider with respect to which there is
it by the Unit. However, if the State pending an investigation of a credible
Attorney General finds that another allegation of fraud under the Medicaid
prosecuting authority has the dem- program to the Medicaid agency for
onstrated capacity, experience, and payment suspension in whole or part
willingness to prosecute an alleged vio- under § 455.23 of this title.
lation, he or she may refer a case to (2) Referrals may be brief but must
that prosecuting authority, as long as be in writing and include sufficient in-
the office of the State Attorney Gen- formation to allow the Medicaid agen-
eral maintains oversight responsibility cy to identify the provider and to ex-
for the prosecution and for coordina- plain the credible allegations forming
tion between the Unit and the pros- the grounds for the payment suspen-
ecuting authority. sion.
(f) Any request by the Unit to the
§ 1007.9 Relationship and agreement
between Unit and Medicaid agency. Medicaid agency to delay notification
to the provider of a payment suspen-
(a) The Unit must be separate and sion under § 455.23 of this title must be
distinct from the Medicaid agency. made promptly in writing.
(b) No official of the Medicaid agency (g) The Unit should reach a decision
will have authority to review the ac- on whether to accept a case referred by
tivities of the Unit or to review or the Medicaid agency in a timely fash-
overrule the referral of a suspected ion. When the Unit accepts or declines
criminal violation to an appropriate a case referred by the Medicaid agency,
prosecuting authority. the Unit promptly notifies the Med-
(c) The Unit will not receive funds icaid agency in writing of the accept-
paid under this part either from or ance or declination of the case.
through the Medicaid agency. (h) Upon request from the Medicaid
(d) The Unit must enter into a writ- agency on a quarterly basis under
ten agreement with the Medicaid agen- § 455.23(d)(3)(ii), the Unit will certify
cy under which: that any matter accepted on the basis
(1) The Medicaid agency will agree to of a referral continues to be under in-
comply with all requirements of vestigation, thus warranting continu-
§ 455.21(a) of this title; ation of the payment suspension.
(2) The Unit will agree to comply
with the requirements of § 1007.11(c) of § 1007.11 Duties and responsibilities of
this title; and Unit.
(3) The Medicaid agency and the Unit (a) The Unit will conduct a statewide
will agree to: program for investigating and pros-
(i) Establish a practice of regular ecuting (or referring for prosecution)
meetings or communication between violations of all applicable State laws,
the two entities; including criminal statutes as well as
(ii) Establish procedures for how they civil false claims statutes or other civil
will coordinate their efforts; authorities, pertaining to the fol-
(iii) Establish procedures for lowing:
§§ 1007.9(e) through 1007.9(h) of this (1) Fraud in the administration of the
title; Medicaid program, the provision of
(iv) Establish procedures by which medical assistance, or the activities of
the Unit will receive referrals of poten- providers.
tial fraud from managed care organiza- (2) Fraud in any aspect of the provi-
tions, if applicable, either directly or sion of health care services and activi-
through the Medicaid agency, as re- ties of providers of such services under
quired at § 438.608(a)(7) of this title; and any Federal health care program (as
(v) Review and, as necessary, update defined in section 1128B(f)(1)of the Act),
the agreement no less frequently than if the Unit obtains the written ap-
every five (5) years to ensure that the proval of the Inspector General of the
agreement reflects current law and relevant agency and the suspected
practice. fraud or violation of law in such case
1231
§ 1007.13 42 CFR Ch. V (10–1–24 Edition)
or investigation is primarily related to (2) The Unit will coordinate with OIG
the State Medicaid program. investigators and attorneys, or with
(b)(1) The Unit will also review com- other Federal investigators and pros-
plaints alleging abuse or neglect of pa- ecutors, on any Unit cases involving
tients or residents in health care facili- the same suspects or allegations that
ties receiving payments under Med- are also under investigation or pros-
icaid and may review complaints of the ecution by OIG or other Federal inves-
misappropriation of funds or property tigators or prosecutors.
of patients or residents of such facili- (3) The Unit will establish a practice
ties. of regular Unit meetings or commu-
(2) At the option of the Unit, it may nication with OIG investigators and
review complaints of abuse or neglect, Federal prosecutors.
including misappropriation of funds or (4) When the Unit lacks the authority
property, of patients or residents of or resources to pursue a case, including
board and care facilities, regardless of for allegations of Medicare fraud and
whether payment to such facilities is for civil false claims actions in a State
made under Medicaid. without a civil false claims act or
(3) If the initial review of the com- other State authority, the Unit will
plaint indicates substantial potential make appropriate referrals to OIG in-
for criminal prosecution, the Unit will vestigators and attorneys or other Fed-
eral investigators or prosecutors.
investigate the complaint or refer it to
(5) The Unit will establish written
an appropriate criminal investigative
policy consistent with paragraphs (e)(1)
or prosecutorial authority.
through (4) of this section.
(4) If the initial review does not indi- (f) The Unit will guard the privacy
cate a substantial potential for crimi- rights of all beneficiaries and other in-
nal prosecution, the Unit will, if appro- dividuals whose data is under the
priate, refer the complaint to the prop- Unit’s control and will provide ade-
er Federal, State, or local agency. quate safeguards to protect sensitive
(c) If the Unit, in carrying out its du- information and data under the Unit’s
ties and responsibilities under para- control.
graphs (a) and (b) of this section, dis- (g)(1) The Unit will transmit to OIG
covers that overpayments have been pertinent information on all convic-
made to a health care facility or other tions, including charging documents,
provider, the Unit will either recover plea agreements, and sentencing or-
such overpayment as part of its resolu- ders, for purposes of program exclusion
tion of a fraud case or refer the matter under section 1128 of the Act.
to the appropriate State agency for (2) Convictions include those ob-
collection. tained either by Unit prosecutors or
(d) Where a prosecuting authority non-Unit prosecutors in any case inves-
other than the Unit is to assume re- tigated by the Unit.
sponsibility for the prosecution of a (3) Such information will be trans-
case investigated by the Unit, the Unit mitted to OIG within 30 days of sen-
will ensure that those responsible for tencing, or as soon as practicable if the
the prosecutorial decision and the Unit encounters delays in receiving the
preparation of the case for trial have necessary information from the court.
the fullest possible opportunity to par-
ticipate in the investigation from its § 1007.13 Staffing requirements of
inception and will provide all nec- Unit.
essary assistance to the prosecuting (a) The Unit will employ sufficient
authority throughout all resulting professional, administrative, and sup-
prosecutions. port staff to carry out its duties and
(e)(1) The Unit, if requested, will responsibilities in an effective and effi-
make available to OIG investigators cient manner.
and attorneys, or to other Federal in- (b) The Unit will employ individuals
vestigators and prosecutors, all infor- from each of the following categories
mation in the Unit’s possession con- of professional employees, whose exclu-
cerning investigations or prosecutions sive effort, as defined in § 1007.1, is de-
conducted by the Unit. voted to the work of the Unit:
1232
(1) One or more attorneys capable of ments, individuals who have forensic or
prosecuting the Unit’s health care other specialized skills that support
fraud or criminal cases and capable of the investigation and prosecution of
giving informed advice on applicable cases.
law and procedures and providing effec- (2) The Unit may not, through con-
tive prosecution or liaison with other sultant agreements or other contrac-
prosecutors; tual arrangements, rely on individuals
(2) One or more experienced auditors not employed directly by the Unit for
capable of reviewing financial records the investigation or prosecution of
and advising or assisting in the inves- cases.
tigation of alleged health care fraud (h) The Unit will provide training for
and patient or resident abuse and ne- its professional employees for the pur-
glect; and pose of establishing and maintaining
(3) One or more investigators capable proficiency in Medicaid fraud and pa-
of conducting investigations of health tient or resident abuse and neglect
care fraud and patient or resident matters.
abuse and neglect matters, including a
senior investigator who is capable of § 1007.15 Establishment and certifi-
supervising and directing the inves- cation of Unit.
tigative activities of the Unit. (a) Initial application. In order to
(c) The Unit will employ a director, demonstrate that it meets the require-
as defined in § 1007.1, who supervises all ments for certification, the State or
Unit employees. territory must submit to OIG an appli-
(d) Professional employees: cation approved by the Governor or
(1) Will devote their exclusive effort chief executive, containing the fol-
to the work of the Unit, as defined in lowing:
§ 1007.1 and except as provided in para- (1) A description of the applicant’s
graphs (d)(2) and (3) of this section; organization, structure, and location
(2) May be employed outside the Unit within State government, and a state-
during nonduty hours, only if the em- ment of whether it seeks certification
ployee is not: under § 1007.7(a), (b), or (c);
(i) Employed with a State agency (2) A statement from the State At-
(other than the Unit itself) or its con- torney General that the applicant has
tractors; or authority to carry out the functions
(ii) Employed with an entity whose and responsibilities set forth in Sub-
mission poses a conflict of interest part B. If the applicant seeks certifi-
with Unit function and duties; cation under § 1007.7(b), the statement
(3) May perform non-Unit assign- must also specify either that:
ments for the State government only (i) There is no State agency with the
to the extent that such duties are lim- authority to exercise statewide pros-
ited in duration; and ecuting authority for the violations
(4) Will be under the direction and su- with which the Unit is concerned, or
pervision of the Unit director. (ii) Although the State Attorney
(e) The Unit may employ administra- General may have common law author-
tive and support staff, such as para- ity for statewide criminal prosecu-
legals, information technology per- tions, he or she has not exercised that
sonnel, interns, and secretaries, who authority;
may be full-time or part-time employ- (3) A copy of whatever memorandum
ees and must report to the Unit direc- of agreement, regulation, or other doc-
tor or other Unit supervisor. ument sets forth the formal procedures
(f) The Unit will employ, or have required under § 1007.7(b), or the formal
available to it, individuals who are working relationship and procedures
knowledgeable about the provision of required under § 1007.7(c);
medical assistance under Title XIX of (4) A copy of the agreement with the
the Act and about the operations of Medicaid agency required under
health care providers. §§ 1007.9 and 455.21(c);
(g)(1) The Unit may employ, or have (5) A statement of the procedures to
available through consultant agree- be followed in carrying out the func-
ments or other contractual arrange- tions and responsibilities of this part;
1233
§ 1007.17 42 CFR Ch. V (10–1–24 Edition)
(6) A proposed budget for the 12- ing the expected and actual monetary
month period for which certification is recoveries (both Federal and non-Fed-
sought; and eral share); and any other relevant in-
(7) Current and projected staffing, in- dicia of return on investment from
cluding the names, education, and ex- such activities.
perience of all senior professional em- (iii) Information requested by OIG to
ployees already employed and job de- assess compliance with this part and
scriptions, with minimum qualifica- adherence to MFCU performance stand-
tions, for all professional positions. ards, including any significant changes
(b) Basis for, and notification of, certifi- in the information or documentation
cation. (1) OIG will make a determina- provided to OIG in the previous report-
tion as to whether the initial applica- ing period.
tion under paragraph (a) of this section (2) Statistical reporting. By November
meets the requirements of §§ 1007.5 30 of each year, the Unit will submit
through 1007.13 and whether a Unit will statistical reporting for the Federal
be effective in using its resources in in- fiscal year that ended on the prior Sep-
vestigating Medicaid fraud and patient tember 30 containing the following sta-
or resident abuse and neglect. tistics:
(2) OIG will certify a Unit only if OIG (i) Unit staffing. The number of Unit
specifically approves the applicant’s employees, categorized by attorneys,
formal written procedures under investigators, auditors, and other em-
§ 1007.7(b) or (c), if either of those provi- ployees, on board, and total number of
sions is applicable. approved Unit positions;
(3) If the application is not approved, (ii) Caseload. The number of open,
the applicant may submit a revised ap- new, and closed cases categorized by
plication at any time. type of case and the number of open
(4) OIG will certify a Unit that meets criminal and civil cases categorized by
the requirements of this Subpart B for type of provider;
12 months. (iii) Criminal case outcomes. The num-
ber of criminal convictions and indict-
§ 1007.17 Annual recertification of ments categorized by type of case and
Unit. by type of provider; the number of ac-
(a) Information required annually for quittals, dismissals, referrals for pros-
recertification. To continue receiving ecution, sentences, and other nonmone-
payments under this part, a Unit must tary penalties categorized by type of
submit to OIG: case; and the amount of total ordered
(1) Reapplication for recertification. Re- criminal recoveries categorized by type
application is due at least 60 days prior of provider; the amount of ordered
to the expiration of the 12-month cer- Medicaid restitution, fines ordered, in-
tification period. A reapplication must vestigative costs ordered, and other
include: monetary payment ordered categorized
(i) A brief narrative that evaluates by type of case;
the Unit’s performance, describes any (iv) Civil case outcomes. The number of
specific problems it has had in connec- civil settlements and judgments and
tion with the procedures and agree- recoveries categorized by type of pro-
ments required under this part, and vider; the number of global (coordi-
discusses any other matters that have nated among a group of States) civil
impaired its effectiveness. The nar- settlements and successful judgments;
rative should include any extended in- the amount of global civil recoveries to
vestigative authority approvals ob- the Medicaid program; the amount of
tained pursuant to § 1007.11(a)(2). other global civil monetary recoveries;
(ii) For those Units approved to con- the number of other civil cases opened,
duct data mining under § 1007.20, all filed, or referred for filing; the number
costs expended by the Unit attributed of other civil case settlements and suc-
to data mining activities; the amount cessful judgments; the amount of other
of staff time devoted to data mining civil case recoveries to the Medicaid
activities; the number of cases gen- program; the amount of other mone-
erated from those activities; the out- tary recoveries; and the number of
come and status of those cases, includ- other civil cases declined or closed
1234
without successful settlement or judg- (d) Notification. OIG will notify the
ment; Unit by the Unit’s recertification date
(v) Collections. The monies actually of approval or denial of the recertifi-
collected on criminal and civil cases cation reapplication.
categorized by type of case; and (1) Approval subject to conditions. OIG
(vi) Referrals. The number of referrals may impose special conditions or re-
received categorized by source of refer- strictions and may require corrective
ral and type of case; the number of action, as provided in 45 CFR 75.207, be-
cases opened categorized by source of fore approving a reapplication for re-
referral and type of case; and the num- certification.
ber of referrals made to other agencies (2) Written explanation for denials. If
categorized by type of case. the reapplication is denied, OIG will
(b) Other information reviewed for re- provide a written explanation of the
certification. In addition to reviewing findings on which the denial was based.
information required at § 1007.17(a), OIG (e) Reconsideration of denial of recer-
will review, as appropriate, the fol- tification. (1) A Unit may request that
lowing information when considering OIG reconsider a decision to deny re-
recertification of a Unit: certification by providing written in-
(1) Information obtained through on- formation contesting the findings on
site reviews and which the denial was based.
(2) Other information OIG deems nec- (2) Within 30 days of receipt of the re-
essary or warranted. quest for reconsideration, OIG will pro-
(c) Basis for recertification. In review- vide a final decision in writing, ex-
ing the information described at plaining its basis for approving or de-
§ 1007.17(a) and (b), OIG will evaluate nying the reconsideration of recertifi-
whether the Unit has demonstrated cation.
that it effectively carries out the func-
tions and requirements described in Subpart C—Federal Financial
section 1903(q) of the Act as imple- Participation (FFP)
mented by this part. In making that
determination, OIG will take into con- § 1007.19 FFP rate and eligible FFP
sideration the following factors: costs.
(1) Unit’s compliance with this part (a) Rate of FFP. (1) Subject to the
and other Federal regulations, includ- limitation of this section, the Sec-
ing those specified in § 1007.23; retary of Health and Human Services
(2) Unit’s compliance with OIG policy must reimburse each State by an
transmittals; amount equal to 90 percent of the al-
(3) Unit’s adherence to MFCU per- lowable costs incurred by a certified
formance standards as published in the Unit during the first 12 quarters of op-
FEDERAL REGISTER; eration that are attributable to car-
(4) Unit’s effectiveness in using its rying out its functions and responsibil-
resources in investigating cases of pos- ities under this part. Each quarter of
sible fraud in the administration of the operation must be counted in deter-
Medicaid program, the provision of mining when the Unit has accumulated
medical assistance, or the activities of 12 quarters of operation and is, there-
providers of medical assistance under fore, no longer eligible for a 90-percent
the State Medicaid plan, and in pros- matching rate. Quarters of operation
ecuting cases or cooperating with the do not have to be consecutive to accu-
prosecuting authorities; and mulate.
(5) Unit’s effectiveness in using its (2) Beginning with the 13th quarter of
resources in reviewing and inves- operation, the Secretary must reim-
tigating, referring for investigation or burse 75 percent of allowable costs in-
prosecution, or criminally prosecuting curred by a certified Unit.
complaints alleging abuse or neglect of (b) Retroactive certification. OIG may
patients or residents in health care fa- grant certification retroactive to the
cilities receiving payments under the date on which the Unit first met all the
State Medicaid plan and, at the Unit’s requirements of section 1903(q) of the
option, in board and care facilities. Act and of this part. For any quarter
1235
§ 1007.20 42 CFR Ch. V (10–1–24 Edition)
with respect to which the Unit is cer- pected fraud cases also involve con-
tified, the Secretary will provide reim- spiracy with a provider;
bursement for the entire quarter. (6) Any payment, direct or indirect,
(c) Total amount of FFP. FFP for any from the Unit to the Medicaid agency,
quarter must not exceed the higher of other than payments for the salaries of
$125,000 or one-quarter of 1 percent of employees on detail to the Unit; or
the sums expended by the Federal, (7) Temporary duties performed by
State, and local governments during professional employees that are not re-
the previous quarter in carrying out quired functions and responsibilities of
the State Medicaid program.
the Unit, as described at § 1007.13(d)(3).
(d) Costs eligible for FFP. (1) FFP is al-
lowable under this part for the expendi- § 1007.20 Circumstances of permissible
tures attributable to the establishment data mining.
and operation of the Unit, including
the cost of training personnel em- (a) Notwithstanding § 1007.19(e)(2), a
ployed by the Unit and efforts to in- Unit may engage in data mining as de-
crease referrals to the Unit through fined in this part and receive FFP only
program outreach. Reimbursement is under the following conditions:
allowable only for costs attributable to (1) The Unit identifies the methods of
the specific responsibilities and func- coordination between the Unit and the
tions set forth in this part and if the Medicaid agency, the individuals serv-
Unit has been certified and recertified ing as primary points of contact for
by OIG. data mining, as well as the contact in-
(2) Establishment costs are limited to formation, title, and office of such in-
clearly identifiable costs of personnel dividuals;
that meet the requirements of § 1007.13 (2) Unit employees engaged in data
of this part. mining receive specialized training in
(e) Costs not eligible for FFP. FFP is data mining techniques;
not allowable under this part for ex-
(3) The Unit describes how it will
penditures attributable to:
comply with paragraphs (a)(1) and (2) of
(1) The investigation of cases involv-
ing program abuse or other failures to this section as part of the agreement
comply with applicable laws and regu- required by § 1007.9(d); and
lations, if these cases do not involve (4) OIG, in consultation with CMS,
substantial allegations or other indica- approves in advance the provisions of
tions of fraud, as described in the agreement as defined in paragraph
§ 1007.11(a) of this part; (a)(3) of this section.
(2) Routine verification with bene- (i) OIG will act on a request from a
ficiaries of whether services billed by Unit for review and approval of the
providers were actually received, or, agreement within 90 days after receipt
except as provided in § 1007.20, efforts to of a written request, or the request
identify situations in which a question shall be considered approved if OIG
of fraud may exist by the screening of fails to respond within 90 days after re-
claims and analysis of patterns and ceipt of the written request.
practice that involve data mining as (ii) If OIG requests additional infor-
defined in § 1007.1. mation in writing, the 90-day period for
(3) The routine notification of pro- OIG action on the request begins on
viders that fraudulent claims may be the day OIG receives the information
punished under Federal or State law; from the Unit.
(4) The performance of any audit or
(iii) The approval is for 3 years.
investigation, any professional legal
function, or any criminal, civil or ad- (iv) A Unit may request renewal of
ministrative prosecution of suspected its data-mining approval for additional
providers by a person who does not 3-year periods by submitting a written
meet the professional employee re- request for renewal to OIG, along with
quirements in § 1007.13(d); an updated agreement with the Med-
(5) The investigation or prosecution icaid agency.
of fraud cases involving a beneficiary’s
eligibility for benefits, unless the sus-
1236
§ 1007.21 Disallowance of claims for from the Unit any additional informa-
FFP. tion or documents necessary to make a
(a) Notice of disallowance and of right decision. The request for additional in-
to reconsideration. When OIG deter- formation must be sent via registered
mines that a Unit’s claim or portion of or certified mail to establish the date
a claim for FFP is not allowable, OIG the request was sent by OIG and re-
shall promptly send to the Unit notifi- ceived by the Unit.
cation that meets the requirements (4) Within 30 days after receipt of the
listed at 42 CFR 430.42(a). request for additional information, the
(b) Reconsideration of disallowance. (1) Unit must submit to the Principal Dep-
The Principal Deputy Inspector Gen- uty Inspector General all requested
eral will reconsider Unit disallowance documents and materials.
determinations made by OIG. (i) If the Principal Deputy Inspector
(2) To request a reconsideration from General finds that the materials are
the Principal Deputy Inspector Gen- not in readily reviewable form or that
eral, the Unit must follow the require- additional information is needed, he or
ments in 42 CFR 430.42(b)(2) and submit she shall notify the Unit via registered
all required information to the Prin- or certified mail that it has 15 business
cipal Deputy Inspector General. Copies days from the date of receipt of the no-
should be sent via registered or cer- tice to submit the readily reviewable
tified mail to the Principal Deputy In- or additional materials.
spector General. (ii) If the Unit does not provide the
(3) The Unit may request to retain necessary materials within 15 business
FFP during the reconsideration of the days from the date of receipt of such
disallowance under section 1116(e) of notice, the Principal Deputy Inspector
the Act, in accordance with 42 CFR General shall affirm the disallowance
433.38. in a final reconsideration decision
(4) The Unit is not required to reissued within 15 days from the due date
quest reconsideration before seeking of additional information from the
review from the Departmental Appeals Unit.
Board.
(5) If additional documentation is
(5) The Unit may also seek reconsid-
provided in readily reviewable form
eration, and following the reconsider-
under paragraph (c)(4) of this section,
ation decision, request a review from
the Principal Deputy Inspector General
the Departmental Appeals Board.
(6) If the Unit elects reconsideration, shall issue a written decision within 60
the reconsideration process must be days from the due date of such infor-
completed or withdrawn before re- mation.
questing review by the Departmental (6) The final written decision shall
Appeals Board. constitute final OIG administrative ac-
(c) Procedures for reconsideration of a tion on the reconsideration and shall
disallowance. (1) Within 60 days after be (within 15 business days of the deci-
receipt of the disallowance letter, the sion) mailed to the Unit via registered
Unit shall, in accordance with para- or certified mail to establish the date
graph (b)(2) of this section, submit in the reconsideration decision was re-
writing to the Principal Deputy Inspec- ceived by the Unit.
tor General any relevant evidence, doc- (7) If the Principal Deputy Inspector
umentation, or explanation. General does not issue a decision with-
(2) After consideration of the policies in 60 days from the date of receipt of
and factual matters pertinent to the the request for reconsideration or the
issues in question, the Principal Dep- date of receipt of the requested addi-
uty Inspector General shall, within 60 tional information, the disallowance
days from the date of receipt of the re- shall be deemed to be affirmed.
quest for reconsideration, issue a writ- (8) No section of this regulation shall
ten decision or a request for additional be interpreted as waiving OIG’s right
information as described in paragraph to assert any provision or exemption
(c)(3) of this section. under the Freedom of Information Act.
(3) At the Principal Deputy Inspector (d) Withdrawal of a request for recon-
General’s option, OIG may request sideration of a disallowance. (1) A Unit
1237
§ 1007.23 42 CFR Ch. V (10–1–24 Edition)
may withdraw the request for reconsid- (6) If the appeal decision requires an
eration at any time before the notice of adjustment of FFP, either upward or
the reconsideration decision is received downward, a subsequent grant action
by the Unit without affecting its right will be made in the amount of such in-
to submit a notice of appeal to the De- crease or decrease.
partmental Appeals Board. The request
for withdrawal must be in writing and Subpart D—Other Provisions
sent to the Principal Deputy Inspector
General via registered or certified § 1007.23 Other applicable HHS regula-
mail. tions.
(2) Within 60 days after OIG’s receipt The following regulations from 45
of a Unit’s withdrawal request, a Unit CFR, subtitle A, apply to grants under
may, in accordance with (f)(2) of this this part:
section, submit a notice of appeal to (a) Part 16—Procedures of the De-
the Departmental Appeals Board. partmental Grant Appeals Board.
(e) Implementation of decisions for re- (b) Part 75—Uniform Administrative
consideration of a disallowance. (1) After Requirements, Cost Principles, and
undertaking a reconsideration, the Audit Requirements for HHS Awards.
Principal Deputy Inspector General (c) Part 80—Nondiscrimination under
may affirm, reverse, or revise the dis- Programs Receiving Federal Assist-
allowance and shall issue a final writ- ance through HHS, Effectuation of
ten reconsideration decision to the Title VI of the Civil Rights Act of 1964.
Unit in accordance with paragraphs (d) Part 81—Practice and Procedure
(c)(4) and (5) of this section. for Hearings under 45 CFR part 80.
(2) If the reconsideration decision re- (e) Part 84—Nondiscrimination on
quires an adjustment of FFP, either the Basis of Handicap in Programs and
upward or downward, a subsequent Activities Receiving Federal Financial
grant action will be made in the Assistance.
amount of such increase or decrease. (f) Part 91—Nondiscrimination on the
(3) Within 60 days after receipt of a Basis of Age in Programs or Activities
reconsideration decision from OIG, a Receiving Federal Financial Assistance
Unit may, in accordance with para- from HHS.
graph (f) of this section, submit a no-
tice of appeal to the Departmental Ap- PART 1008—ADVISORY OPINIONS
peals Board. BY THE OIG
(f) Appeal of disallowance. (1) The De-
partmental Appeals Board reviews dis- Subpart A—General Provisions
allowances of FFP under Title XIX of Sec.
the Act, including disallowances issued 1008.1 Basis and purpose.
by OIG to the Units. 1008.3 Effective period.
(2) A Unit that wishes to appeal a dis- 1008.5 Matters subject to advisory opinions.
allowance to the Departmental Appeals
Board must follow the requirements in Subpart B—Preliminary Obligations and
42 CFR 430.42(f)(2). Responsibilities of the Requesting Party
(3) The appeals procedures are those 1008.11 Who may submit a request.
set forth in 45 CFR part 16 for Medicaid 1008.15 Facts subject to advisory opinions.
and for many other programs, includ- 1008.18 Preliminary questions suggested for
ing the Units, administered by the De- the requesting party.
partment.
Subpart C—Advisory Opinion Fees
(4) The Departmental Appeals Board
may affirm the disallowance, reverse 1008.31 OIG fees for the cost of advisory
the disallowance, modify the disallow- opinions.
ance, or remand the disallowance to 1008.33 Expert opinions from outside
OIG for further consideration. sources.
(5) The Departmental Appeals Board
Subpart D—Submission of a Formal
will issue a final written decision to
Request for an Advisory Opinion
the Unit consistent with 45 CFR part
16. 1008.36 Submission of a request.
1238
1008.37 Disclosure of ownership and related essing the request for an advisory opin-
information. ion as set forth in subpart C of this
1008.38 Signed certifications by the re- part.
questor. (d) Nothing in this part limits the in-
1008.39 Additional information.
1008.40 Withdrawal.
vestigatory or prosecutorial authority
of the OIG, DoJ or any other agency of
Subpart E—Obligations and Responsibilities the Government.
of the OIG [62 FR 7357, Feb. 19, 1997, as amended at 63
FR 38324, July 16, 1998]
1008.41 OIG acceptance of the request.
1008.43 Issuance of a formal advisory opin- § 1008.3 Effective period.
ion.
1008.45 Rescission, termination or modifica- The provisions in this part are appli-
tion. cable to requests for advisory opinions
1008.47 Disclosure. submitted on or after February 21, 1997,
and before August 21, 2000, and to any
Subpart F—Scope and Effect of OIG requests submitted during any other
Advisory Opinions time period for which the OIG is re-
1008.51 Exclusivity of OIG advisory opin- quired by law to issue advisory opin-
ions. ions.
1008.53 Affected parties.
1008.55 Admissibility of evidence. § 1008.5 Matters subject to advisory
1008.59 Range of the advisory opinion. opinions.
AUTHORITY: 42 U.S.C. 1320a-7d(b). (a) An individual or entity may re-
quest an advisory opinion from the OIG
SOURCE: 62 FR 7357, Feb. 19, 1997, unless regarding—
otherwise noted.
(1) What constitutes prohibited remu-
neration within the meaning of section
Subpart A—General Provisions 1128B(b) of the Act;
(2) Whether an arrangement, or pro-
§ 1008.1 Basis and purpose. posed arrangement, satisfies the cri-
(a) This part contains the specific teria set forth in section 1128B(b)(3) of
procedures for the submission of re- the Act for activities that do not result
quests by an individual or entity for in prohibited remuneration;
advisory opinions to, and the issuance (3) Whether an arrangement, or pro-
of advisory opinions by, the OIG, in posed arrangement, satisfies the cri-
consultation with the Department of teria set forth in § 1001.952 of this chap-
Justice (DoJ), in accordance with sec- ter for activities that do not result in
tion 1128D(b) of the Social Security Act prohibited remuneration;
(Act), 42 U.S.C. 1320a–7d(b). The OIG (4) What constitutes an inducement
will issue such advisory opinions based to reduce or limit services under sec-
on actual or proposed factual cir- tion 1128A(b) of the Act to Medicare or
cumstances submitted by the request- Medicaid program beneficiaries; and
ing individual or entity, or by counsel (5) Whether any activity, or proposed
on behalf of the requesting individual activity, constitutes grounds for the
or entity, provided all other require- imposition of a sanction under sections
ments of this part are satisfied (includ- 1128, 1128A or 1128B of the Act.
ing the requirement that the request- (b) Exceptions. The OIG will not ad-
ing individual or entity provide the dress through the advisory opinion
certifications required in accordance process—
with § 1008.38 of this part). (1) What the fair market value will
(b) An individual or entity may re- be, or whether fair market value was
quest an advisory opinion from the OIG paid or received, for any goods, services
regarding any of five specific subject or property; or
matters described in § 1008.5 of this (2) Whether an individual is a bona
part. fide employee within the requirements
(c) The requesting party must proof section 3121(d)(2) of the Internal Rev-
vide a complete description of the facts enue Code of 1986.
as set forth in subpart B of this part, [62 FR 7357, Feb. 19, 1997, as amended at 63
and pay the costs to the OIG of proc- FR 38324, July 16, 1998]
1239
§ 1008.11 42 CFR Ch. V (10–1–24 Edition)
Subpart B—Preliminary Obliga- sought; however, answering the ques-

tions and Responsibilities of tions is voluntary.
(b) Questions the OIG suggests that
the Requesting Party the requestor address may be obtained
§ 1008.11 Who may submit a request. from the OIG. Requests should be made
in writing, specify the subject matter,
Any individual or entity may submit and be sent to the headquarter offices
a request to the OIG for an advisory of the OIG.
opinion regarding an existing arrange- (c) When submitting a request for an
ment or one which the requestor in advisory opinion, a requestor may an-
good faith specifically plans to under- swer the questions corresponding to
take. The requestor must be a party to the subject matter for which the opin-
the arrangement, or proposed arrange- ion is requested. The extent to which
ment, that is the subject of the re- any of the questions is not fully an-
quest. swered may effect the content of the
advisory opinion.
§ 1008.15 Facts subject to advisory
opinions. [62 FR 7357, Feb. 19, 1997, as amended at 63
FR 38324, July 16, 1998]
(a) The OIG will consider requests
from a requesting party for advisory
opinions regarding the application of Subpart C—Advisory Opinion Fees
specific facts to the subject matters set § 1008.31 OIG fees for the cost of advi-
forth in § 1008.5(a) of this part. The sory opinions.
facts must relate to an existing ar-
rangement, or one which the requestor (a) Responsibility for fees. The re-
in good faith plans to undertake. The questor is responsible for paying a fee
plans may be contingent upon receiv- equal to the costs incurred by the De-
ing a favorable advisory opinion. The partment in responding to the request
advisory opinion request should con- for an advisory opinion.
(b) Payment Method. Payment for a
tain a complete description of the ar-
request for an advisory opinion must
rangement that the requestor is under-
be made to the Treasury of the United
taking, or plans to undertake.
States, as directed by OIG.
(b) Requests presenting a general
(c) Calculation of costs: Prior to the
question of interpretation, posing a hy-
issuance of the advisory opinion, the
pothetical situation, or regarding the OIG will calculate the costs incurred
activities of third parties do not qual- by the Department in responding to
ify as advisory opinion requests. the request. The calculation will in-
(c) An advisory opinion request will clude the costs of salaries and benefits
not be accepted, and/or an opinion will payable to attorneys and others who
not be issued when— have worked on the request in ques-
(1) The request is not related to a tion, as well as administrative and su-
named individual or entity; or pervisory support for such person. The
(2) An informed opinion cannot be OIG has the exclusive authority to de-
made, or could be made only after ex- termine the cost of responding to a re-
tensive investigation, clinical study, quest for an advisory opinion and such
testing, or collateral inquiry. determination is not reviewable or
[62 FR 7357, Feb. 19, 1997, as amended at 63 waiveable.
FR 38324, July 16, 1998; 87 FR 1369, Jan. 11, (d) Agreement to pay all costs. (1) By
2022] submitting the request for an advisory
opinion, the requestor agrees, except as
§ 1008.18 Preliminary questions sug- indicated in paragraph (d)(4) of this
gested for the requesting party. section, to pay all costs incurred by
(a) The OIG may establish and main- the OIG in responding to the request
tain a set of questions corresponding to for an advisory opinion.
the categories of opinion subject mat- (2) In its request for an advisory
ter as set forth in § 1008.5(a) of this part opinion, the requestor may request a
as appropriate. The questions will be written estimate of the cost involved
designed to elicit specific information in processing the advisory opinion.
relevant to the advisory opinion being Within 10 business days of receipt of
1240
the request, the OIG will notify in requestor has paid the OIG the total
writing of such estimate. Such esti- amount due for the costs of processing
mate will not be binding on the Depart- the request, the OIG will issue the ad-
ment, and the actual cost to be paid visory opinion. The time period for
may be higher or lower than estimated. issuing advisory opinions will be tolled
The time period for issuing the advi- from the time the OIG notifies the re-
sory opinion will be tolled from the questor of the amount owed until the
time the OIG notifies the requestor of time full payment is received.
the estimate until the OIG receives (e) Fees for outside experts. (1) In addi-
written confirmation from the re- tion to the fees identified in this sec-
questor that the requestor wants the
tion, the requestor also must pay any
OIG to continue processing the request.
required fees for expert opinions, if
Such notice may include a new or re-
vised triggering dollar amount, as set any, from outside sources, as described
forth in paragraph (d)(3) of this section. in § 1008.33.
(3) In its request for an advisory (2) If the OIG determines that it is
opinion, the requestor may designate a necessary to obtain expert advice to
triggering dollar amount. If the OIG es- issue a requested advisory opinion, the
timates that the costs of processing OIG will notify the requestor of that
the advisory opinion request have fact and provide the identity of the ap-
reached, or are likely to exceed, the propriate expert and an estimate of the
designated triggering dollar amount, costs of the expert advice.
the OIG will notify the requestor. The
requestor may revise its designated FR 38324, July 16, 1998; 73 FR 15939, Mar. 26,
triggering dollar amount in writing in 2008]
its response to notification of a cost es-
timate in accordance with paragraph § 1008.33 Expert opinions from outside
(d)(2) of this section. sources.
(4) If the OIG notifies the requestor
that the estimated cost of processing (a) The OIG may request expert ad-
the request has reached or is likely to vice from qualified sources on non-
exceed the triggering dollar amount, legal issues if necessary to respond to
the OIG will stop processing the re- the advisory opinion request. For ex-
quest until such time as the requestor ample, the OIG may require the use of
makes a written request for the OIG to appropriate medical reviewers, such as
continue processing the request. Any quality improvement organizations, to
delay in the processing of the request obtain medical opinions on specific
for an advisory opinion attributable to issues.
these procedures will toll the time for (b) The time period for issuing an ad-
issuance of an advisory opinion until visory opinion will be tolled from the
the requestor asks the OIG to continue time that the OIG notifies the re-
working on the request. questor of the need for an outside ex-
(5) If the requestor chooses not to pert opinion until the time the OIG re-
pay for completion of an advisory opin- ceives the necessary expert opinion.
ion, or withdraws the request, the re- (c) Once payment is made for the cost
questor is still obligated to pay for all of the expert opinion, as set forth in
costs incurred and identified by the § 1008.31(e) of this part, either directly
OIG attributable to processing the re-
to the expert or otherwise, the OIG will
quest for an advisory opinion up to
arrange for a prompt expert review of
that point.
(6) If the costs incurred by the OIG in the issue or issues in question. Regard-
responding to the request are greater less of the manner of payment, the ex-
than the amount paid by the requestor, pert’s work and opinion will be subject
the OIG will, prior to the issuance of to the sole direction of the OIG.
the advisory opinion, notify the re- [62 FR 7357, Feb. 19, 1997, as amended at 63
questor of any additional amount due. FR 38325, July 16, 1998]
The OIG will not issue an advisory
opinion until the full amount owed by
the requestor has been paid. Once the
1241
§ 1008.36 42 CFR Ch. V (10–1–24 Edition)
Subpart D—Submission of a For- (iv) Detailed statements of all collat-

mal Request for an Advisory eral or oral understandings, if any, and
Opinion (v) If applicable, a designation of
trade secrets or confidential commer-
§ 1008.36 Submission of a request. cial or financial information in the
manner described in 45 CFR 5.41;
(a) A request for a formal advisory
(5) Signed certifications by the re-
opinion must be submitted in writing.
questor(s), as described in § 1008.37 of
An original and 2 copies of the request
this part;
should be addressed to the headquarter
(6) A declaration regarding whether
offices of the OIG.
an advisory opinion in accordance with
(b) Each request for an advisory opin-
part 411 of this title has been or will be
ion must include—
(1) To the extent known to the re- requested from CMS about the arrange-
questor, the identities, including the ment that is the subject of the advi-
names and addresses, of the requestor sory opinion request; and
and of all other actual and potential (7) Each requesting party’s Taxpayer
parties to the arrangement, that are Identification Number.
the subject of the request for an advi- (Approved by the Office of Management and
sory opinion; Budget under control number 0990–0213)
(2) The name, title, address, and day- [62 FR 7357, Feb. 19, 1997, as amended at 63
time telephone number of a contact FR 38325, July 16, 1998; 73 FR 15939, Mar. 26,
person who will be available to discuss 2008; 85 FR 72910, Nov. 16, 2020]
the request for an advisory opinion
with the OIG on behalf of the re- § 1008.37 Disclosure of ownership and
questor; related information.
(3) A declaration of the subject cat- Each individual or entity requesting
egory or categories as described in an advisory opinion must supply full
§ 1008.5 of this part for which the advi- and complete information as to the
sory opinion is requested. To the ex- identity of each entity owned or con-
tent an individual or entity requests an trolled by the individual or entity, and
advisory opinion in accordance with of each person with an ownership or
§ 1008.5(a)(3) or (a)(5) of this part, the control interest in the entity, as de-
requesting individual or entity should fined in section 1124(a)(1) of the Social
identify the specific subsections of sec- Security Act (42 U.S.C. 1320a–3(a)(1))
tions 1128, 1128A or 1128B of the Act or and part 420 of this chapter.
the specific provision of § 1001.952 of
(Approved by the Office of Management and
this chapter about which an advisory Budget under control number 0990–0213)
opinion is sought:
(4) A complete and specific descrip- [67 FR 11936, Mar. 18, 2002]
tion of all relevant information bear-
§ 1008.38 Signed certifications by the
ing on the arrangement for which an requestor.
advisory opinion is requested and on
the circumstances of the conduct, 1 in- (a) Every request must include the
cluding— following signed certification from all
(i) Background information, requestors: ‘‘With knowledge of the
(ii) For existing arrangements, com- penalties for false statements provided
plete copies of all operative documents, by 18 U.S.C. 1001 and with knowledge
(iii) For proposed arrangements, that this request for an advisory opin-
complete copies of all operative docu- ion is being submitted to the Depart-
ments, if possible, and otherwise de- ment of Health and Human Services, I
scriptions of proposed terms, drafts, or certify that all of the information pro-
models of documents sufficient to per- vided is true and correct, and con-
mit the OIG to render an informed stitutes a complete description of the
opinion, facts regarding which an advisory opin-
ion is sought, to the best of my knowl-
1 The requestor is under an affirmative ob- edge and belief.’’
ligation to make full and true disclosure (b) If the advisory opinion relates to
with respect to the facts regarding the advi- a proposed arrangement, the request
sory opinion being requested. must also include the following signed
1242
certification from all requestors: ‘‘The 411 of this title from CMS about the ar-
arrangement described in this request rangement that is the subject of their
for an advisory opinion is one that [the advisory opinion request.
requestor(s)] in good faith plan(s) to (f) Where appropriate, after receipt of
undertake.’’ This statement may be an advisory opinion request, the OIG
made contingent on a favorable OIG may consult with the requesting par-
advisory opinion, in which case, the ties to the extent the OIG deems nec-
phrase ‘‘if the OIG issues a favorable essary.
advisory opinion’’ should be added to
the certification.
FR 38325, July 16, 1998]
(c) The certification(s) must be
signed by— § 1008.40 Withdrawal.
(1) The requestor, if the requestor is
an individual; The requestor of an advisory opinion
(2) The chief executive officer, or may withdraw the request prior to the
comparable officer, of the requestor, if issuance of a formal advisory opinion
the requestor is a corporation; by the OIG. The withdrawal must be
(3) The managing partner of the re- written and must be submitted to the
questor, if the requestor is a partner- same address as the submitted request,
ship; or as indicated in §§ 1008.18(b) and
(4) The managing member, or com- 1008.36(a) of this part. Regardless of
parable person, if the requestor is a whether the request is withdrawn, the
limited liability company. requestor must pay the costs expended
by the OIG in processing the opinion,
as discussed in § 1008.31(d) of this part.
FR 38325, July 16, 1998]
The OIG reserves the right to retain
§ 1008.39 Additional information. any request for an advisory opinion,
documents and information submitted
(a) If the request for an advisory
to it under these procedures, and to use
opinion does not contain all of the in-
them for any governmental purposes.
formation required by § 1008.36 of this
part, or the OIG believes it needs more
information prior to rendering an advi- Subpart E—Obligations and
sory opinion, the OIG may, at any Responsibilities of the OIG
time, request whatever additional in-
formation or documents it deems nec- § 1008.41 OIG acceptance of the re-
quest.
essary. The time period for the
issuance of an advisory opinion will be (a) Upon receipt of a request for an
tolled from the time the OIG requests advisory opinion, the OIG will prompt-
the additional information from the rely make an initial determination
questor until such time as the OIG de- whether the submission includes all of
termines that it has received the re- the information the OIG will require to
quested information. process the request.
(b) The OIG may request additional (b) Within 10 working days of receipt
information before or after the request of the request, the OIG will—
for an advisory opinion has been ac- (1) Formally accept the request for
cepted. an advisory opinion,
(c) Additional information should be (2) Notify the requestor of what addi-
provided in writing and certified to be tional information is needed, or
a true, correct and complete disclosure (3) Formally decline to accept the re-
of the requested information in a man- quest.
ner equivalent to that described in (c) If the requestor provides the addi-
§ 1008.38 of this part. tional information requested, or other-
(d) In connection with any request wise resubmits the request, the OIG
for an advisory opinion, the OIG or DoJ will process the resubmission in ac-
may conduct whatever independent in- cordance with paragraphs (a) and (b) of
vestigation they believe appropriate. this section as if it was an initial re-
(e) Requesting parties are required to quest for an advisory opinion.
notify the OIG if they request an advi- (d) Upon acceptance of the request,
sory opinion in accordance with part the OIG will notify the requestor by
1243
§ 1008.43 42 CFR Ch. V (10–1–24 Edition)
regular U.S. mail of the date that the ceives payment of the full amount
request for the advisory opinion was owed; and
formally accepted. (iv) Notifies the requestor of the need
(e) The 60-day period for issuance of for expert advice until the time the
an advisory opinion set forth in OIG receives the expert advice.
§ 1008.43(c) of this part will not com- (d) After OIG has notified the re-
mence until the OIG has formally ac- questor of the full amount owed and
cepted the request for an advisory OIG has determined that the full pay-
opinion. ment of that amount has been properly
paid by the requestor, OIG will issue
[62 FR 7357, Feb. 19, 1997, as amended at 63 the advisory opinion and promptly
FR 38326, July 16, 1998]
mail it to the requestor by regular first
§ 1008.43 Issuance of a formal advisory class U.S. mail.
opinion. [62 FR 7357, Feb. 19, 1997, as amended at 63
(a) An advisory opinion will be con- FR 38326, July 16, 1998; 73 FR 15939, Mar. 26,
2008]
sidered issued once payment is received
and it is dated, numbered, and signed § 1008.45 Rescission, termination or
by an authorized official of the OIG. modification.
(b) An advisory opinion will contain (a) Any advisory opinion given by the
a description of the material facts pro- OIG is without prejudice to the right of
vided to the OIG with regard to the ar- the OIG to reconsider the questions in-
rangement for which an advisory opin- volved and, where the public interest
ion has been requested. The advisory requires, to rescind, terminate or mod-
opinion will state the OIG’s opinion re- ify the advisory opinion. Requestors
garding the subject matter of the re- will be given a preliminary notice of
quest based on the facts provided to the OIG’s intent to rescind, terminate
the OIG. If necessary, to fully describe or modify the opinion, and will be pro-
the arrangement, the OIG is authorized vided a reasonable opportunity to re-
to include in the advisory opinion the spond. A final notice of rescission, ter-
material facts of the arrangement, not- mination or modification will be given
withstanding that some of these facts to the requestor so that the individual
could be considered confidential infor- or entity may discontinue or modify,
mation or trade secrets within the as the case may be, the course of ac-
meaning of 18 U.S.C. 1905. tion taken in accordance with the OIG
(c)(1) The OIG will issue an advisory advisory opinion.
opinion, in accordance with the provi- (b) For purposes of this part—
sions of this part, within 60 days after (1) To rescind an advisory opinion
the request for an advisory opinion has means that the advisory opinion is re-
been formally accepted; voked retroactively to the original
(2) If the 60th day falls on a Saturday, date of issuance with the result that
Sunday, or Federal holiday, the time the advisory opinion will be deemed to
period will end at the close of the next have been without force and effect
business day following the weekend or from the original date of issuance.
holiday; Recission may occur only where rel-
(3) The 60 day period will be tolled evant and material facts were not
from the time the OIG— fully, completely and accurately dis-
(i) Notifies the requestor that the closed to the OIG.
costs have reached, or are likely to ex- (2) To terminate an advisory opinion
ceed, the triggering amount until the means that the advisory opinion is re-
time when the OIG receives written no- voked as of the termination date and is
tice from the requestor to continue no longer in force and effect after the
processing the request; termination date. The OIG will not
(ii) Requests additional information proceed against the requestor under
from the requestor until the time the this part if such action was promptly,
OIG receives the requested informa- diligently, and in good faith discon-
tion; tinued in accordance with reasonable
(iii) Notifies the requestor of the full time frames established by the OIG
amount due until the time the OIG re- after consultation with the requestor.
1244
(3) To modify an advisory opinion Subpart F—Scope and Effect of

means that the advisory opinion is OIG Advisory Opinions
amended, altered, or limited, and that
the advisory opinion continues in full § 1008.51 Exclusivity of OIG advisory
force and effect in modified form there- opinions.
after. The OIG will not proceed against The only method for obtaining a
the requestor under this part if such binding advisory opinion regarding any
action was promptly, diligently, and in of the subject matters set forth in
good faith modified in accordance with § 1008.5(a) is through the procedures de-
reasonable time frames established by scribed in this part. No binding advi-
the OIG after consultation with the re- sory opinion, oral or written, has or
questor. may be issued by the OIG regarding the
[63 FR 38326, July 16, 1998]
specific matters set forth in § 1008.5(a)
except through written opinions issued
§ 1008.47 Disclosure. in accordance with this part.
(a) Advisory opinions issued and re- § 1008.53 Affected parties.
leased in accordance with the provi-
An advisory opinion issued by the
sions set forth in this part will be
OIG will have no application to any in-
available to the public.
dividual or entity that does not join in
(b) Promptly after the issuance and the request for the opinion. No indi-
release of an advisory opinion to the vidual or entity other than the re-
requestor, a copy of the advisory opin- questor(s) may rely on an advisory
ion will be available for public inspec- opinion.
tion between the hours of 10:00 a.m. and
3:00 p.m. on normal business days at § 1008.55 Admissibility of evidence.
the headquarter offices of the OIG and
(a) The failure of a party to seek an
on the DHHS/OIG web site. advisory opinion may not be intro-
(c) Any pre-decisional document, or duced into evidence to prove that the
part of such pre-decisional document, party intended to violate the provi-
that is prepared by the OIG, DoJ, or sions of sections 1128, 1128A or 1128B of
any other Department or agency of the the Act.
United States in connection with an (b) An advisory opinion may not be
advisory opinion request under the pro- introduced into evidence by a person or
cedures set forth in this part generally entity that was not the requestor of
will be exempt from disclosure under 5 the advisory opinion to prove that the
U.S.C. 552, and will not be made pub- person or entity did not violate the
licly available. provisions of sections 1128, 1128A or
(d) Documents submitted by the re- 1128B of the Act or any other law.
questor to the OIG in connection with
a request for an advisory opinion may FR 38326, July 16, 1998]
be available to the public in accord-
ance with 5 U.S.C. 552 through proce- § 1008.59 Range of the advisory opin-
dures set forth in 45 CFR part 5. ion.
(e) Nothing in this section will limit (a) An advisory opinion will state
the OIG’s right, in its discretion, to only the OIG’s opinion regarding the
issue a press release or otherwise pub- subject matter of the request. If the ar-
licly disclose the identity of the re- rangement for which an advisory opin-
questing party or parties, and the na- ion is requested is subject to approval
ture of the action taken by the OIG or regulation by any other Federal,
upon the request. State or local government agency, such
advisory opinion may not be taken to
indicate the OIG’s views on the legal or
FR 38326, July 16, 1998]
factual issues that may be raised be-
fore that agency. The OIG will not pro-
vide any legal opinion on questions or
issues regarding an authority which is
1245
§ 1008.59 42 CFR Ch. V (10–1–24 Edition)
vested in other Federal, State or local latory provision other than that which
government agencies. is the specific subject matter of the ad-
(b) An advisory opinion issued under visory opinion.
this part will not bind or obligate any
agency other than the Department. It [62 FR 7357, Feb. 19, 1997, as amended at 63
FR 38326, July 16, 1998]
will not affect the requestor’s, or any-
one else’s, obligations to any other
agency, or under any statutory or regu- PARTS 1009–1099 [RESERVED]
1246
FINDING AIDS
A list of CFR titles, subtitles, chapters, subchapters and parts and an alphabet-
ical list of agencies publishing in the CFR are included in the CFR Index and
Finding Aids volume to the Code of Federal Regulations which is published sepa-
rately and revised annually.
Table of CFR Titles and Chapters
Alphabetical List of Agencies Appearing in the CFR
List of CFR Sections Affected
1247
Table of CFR Titles and Chapters
(Revised as of October 1, 2024)
Title 1—General Provisions
I Administrative Committee of the Federal Register (Parts 1—49)

II Office of the Federal Register (Parts 50—299)
III Administrative Conference of the United States (Parts 300—399)
IV Miscellaneous Agencies (Parts 400—599)
VI National Capital Planning Commission (Parts 600—699)
Title 2—Grants and Agreements
SUBTITLE A—OFFICE OF MANAGEMENT AND BUDGET GUIDANCE FOR

GRANTS AND AGREEMENTS
I Office of Management and Budget Governmentwide Guidance for
Grants and Agreements (Parts 2—199)
II Office of Management and Budget Guidance (Parts 200—299)
SUBTITLE B—FEDERAL AGENCY REGULATIONS FOR GRANTS AND
AGREEMENTS
III Department of Health and Human Services (Parts 300—399)
IV Department of Agriculture (Parts 400—499)
VI Department of State (Parts 600—699)
VII Agency for International Development (Parts 700—799)
VIII Department of Veterans Affairs (Parts 800—899)
IX Department of Energy (Parts 900—999)
X Department of the Treasury (Parts 1000—1099)
XI Department of Defense (Parts 1100—1199)
XII Department of Transportation (Parts 1200—1299)
XIII Department of Commerce (Parts 1300—1399)
XIV Department of the Interior (Parts 1400—1499)
XV Environmental Protection Agency (Parts 1500—1599)
XVI U.S. International Development Finance Corporation (Parts
1600—1699)
XVIII National Aeronautics and Space Administration (Parts 1800—
1899)
XX United States Nuclear Regulatory Commission (Parts 2000—2099)
XXII Corporation for National and Community Service (Parts 2200—
2299)
XXIII Social Security Administration (Parts 2300—2399)
XXIV Department of Housing and Urban Development (Parts 2400—
2499)
1249
Title 2—Grants and Agreements—Continued
Chap.
XXV National Science Foundation (Parts 2500—2599)

XXVI National Archives and Records Administration (Parts 2600—2699)
XXVII Small Business Administration (Parts 2700—2799)
XXVIII Department of Justice (Parts 2800—2899)
XXIX Department of Labor (Parts 2900—2999)
XXX Department of Homeland Security (Parts 3000—3099)
XXXI Institute of Museum and Library Services (Parts 3100—3199)
XXXII National Endowment for the Arts (Parts 3200—3299)
XXXIII National Endowment for the Humanities (Parts 3300—3399)
XXXIV Department of Education (Parts 3400—3499)
XXXV Export-Import Bank of the United States (Parts 3500—3599)
XXXVI Office of National Drug Control Policy, Executive Office of the
President (Parts 3600—3699)
XXXVII Peace Corps (Parts 3700—3799)
LVIII Election Assistance Commission (Parts 5800—5899)
LIX Gulf Coast Ecosystem Restoration Council (Parts 5900—5999)
LX Federal Communications Commission (Parts 6000—6099)
Title 3—The President
I Executive Office of the President (Parts 100—199)
Title 4—Accounts
I Government Accountability Office (Parts 1—199)
Title 5—Administrative Personnel
I Office of Personnel Management (Parts 1—1199)

II Merit Systems Protection Board (Parts 1200—1299)
III Office of Management and Budget (Parts 1300—1399)
IV Office of Personnel Management and Office of the Director of
National Intelligence (Parts 1400—1499)
V The International Organizations Employees Loyalty Board
(Parts 1500—1599)
VI Federal Retirement Thrift Investment Board (Parts 1600—1699)
VIII Office of Special Counsel (Parts 1800—1899)
IX Appalachian Regional Commission (Parts 1900—1999)
XI Armed Forces Retirement Home (Parts 2100—2199)
XIV Federal Labor Relations Authority, General Counsel of the Fed-
eral Labor Relations Authority and Federal Service Impasses
Panel (Parts 2400—2499)
XVI Office of Government Ethics (Parts 2600—2699)
XXI Department of the Treasury (Parts 3100—3199)
XXII Federal Deposit Insurance Corporation (Parts 3200—3299)
XXIII Department of Energy (Parts 3300—3399)
1250
Title 5—Administrative Personnel—Continued
Chap.
XXIV Federal Energy Regulatory Commission (Parts 3400—3499)

XXV Department of the Interior (Parts 3500—3599)
XXVI Department of Defense (Parts 3600—3699)
XXVIII Department of Justice (Parts 3800—3899)
XXIX Federal Communications Commission (Parts 3900—3999)
XXX Farm Credit System Insurance Corporation (Parts 4000—4099)
XXXI Farm Credit Administration (Parts 4100—4199)
XXXIII U.S. International Development Finance Corporation (Parts
4300—4399)
XXXIV Securities and Exchange Commission (Parts 4400—4499)
XXXV Office of Personnel Management (Parts 4500—4599)
XXXVI Department of Homeland Security (Parts 4600—4699)
XXXVII Federal Election Commission (Parts 4700—4799)
XL Interstate Commerce Commission (Parts 5000—5099)
XLI Commodity Futures Trading Commission (Parts 5100—5199)
XLII Department of Labor (Parts 5200—5299)
XLIII National Science Foundation (Parts 5300—5399)
XLV Department of Health and Human Services (Parts 5500—5599)
XLVI Postal Rate Commission (Parts 5600—5699)
XLVII Federal Trade Commission (Parts 5700—5799)
XLVIII Nuclear Regulatory Commission (Parts 5800—5899)
XLIX Federal Labor Relations Authority (Parts 5900—5999)
L Department of Transportation (Parts 6000—6099)
LII Export-Import Bank of the United States (Parts 6200—6299)
LIII Department of Education (Parts 6300—6399)
LIV Environmental Protection Agency (Parts 6400—6499)
LV National Endowment for the Arts (Parts 6500—6599)
LVI National Endowment for the Humanities (Parts 6600—6699)
LVII General Services Administration (Parts 6700—6799)
LVIII Board of Governors of the Federal Reserve System (Parts 6800—
6899)
LIX National Aeronautics and Space Administration (Parts 6900—
6999)
LX United States Postal Service (Parts 7000—7099)
LXI National Labor Relations Board (Parts 7100—7199)
LXII Equal Employment Opportunity Commission (Parts 7200—7299)
LXIII Inter-American Foundation (Parts 7300—7399)
LXIV Merit Systems Protection Board (Parts 7400—7499)
LXV Department of Housing and Urban Development (Parts 7500—
7599)
LXVI National Archives and Records Administration (Parts 7600—7699)
LXVII Institute of Museum and Library Services (Parts 7700—7799)
LXVIII Commission on Civil Rights (Parts 7800—7899)
LXIX Tennessee Valley Authority (Parts 7900—7999)
1251
Title 5—Administrative Personnel—Continued
Chap.
LXX Court Services and Offender Supervision Agency for the District
of Columbia (Parts 8000—8099)
LXXI Consumer Product Safety Commission (Parts 8100—8199)
LXXIII Department of Agriculture (Parts 8300—8399)
LXXIV Federal Mine Safety and Health Review Commission (Parts
8400—8499)
LXXVI Federal Retirement Thrift Investment Board (Parts 8600—8699)
LXXVII Office of Management and Budget (Parts 8700—8799)
LXXX Federal Housing Finance Agency (Parts 9000—9099)
LXXXIII Special Inspector General for Afghanistan Reconstruction (Parts
9300—9399)
LXXXIV Bureau of Consumer Financial Protection (Parts 9400—9499)
LXXXVI National Credit Union Administration (Parts 9600—9699)
XCVII Department of Homeland Security Human Resources Manage-
ment System (Department of Homeland Security—Office of
Personnel Management) (Parts 9700—9799)
XCVIII Council of the Inspectors General on Integrity and Efficiency
(Parts 9800—9899)
XCIX Military Compensation and Retirement Modernization Commis-
sion (Parts 9900—9999)
C National Council on Disability (Parts 10000—10049)
CI National Mediation Board (Parts 10100—10199)
CII U.S. Office of Special Counsel (Parts 10200—10299)
CIII U.S. Office of Federal Mediation and Conciliation Service (Parts
10300—10399)
CIV Office of the Intellectual Property Enforcement Coordinator
(Part 10400—10499)
Title 6—Domestic Security
I Department of Homeland Security, Office of the Secretary

(Parts 1—199)
X Privacy and Civil Liberties Oversight Board (Parts 1000—1099)
Title 7—Agriculture
SUBTITLE A—OFFICE OF THE SECRETARY OF AGRICULTURE (PARTS

0—26)
SUBTITLE B—REGULATIONS OF THE DEPARTMENT OF AGRICULTURE
I Agricultural Marketing Service (Standards, Inspections, Mar-
keting Practices), Department of Agriculture (Parts 27—209)
II Food and Nutrition Service, Department of Agriculture (Parts
210—299)
III Animal and Plant Health Inspection Service, Department of Ag-
riculture (Parts 300—399)
IV Federal Crop Insurance Corporation, Department of Agriculture
(Parts 400—499)
V Agricultural Research Service, Department of Agriculture
(Parts 500—599)
1252
Title 7—Agriculture—Continued
Chap.
VI Natural Resources Conservation Service, Department of Agri-

culture (Parts 600—699)
VII Farm Service Agency, Department of Agriculture (Parts 700—
799)
VIII Agricultural Marketing Service (Federal Grain Inspection Serv-
ice, Fair Trade Practices Program), Department of Agri-
IX Agricultural Marketing Service (Marketing Agreements and Or-
ders; Fruits, Vegetables, Nuts), Department of Agriculture
(Parts 900—999)
X Agricultural Marketing Service (Marketing Agreements and Or-
ders; Milk), Department of Agriculture (Parts 1000—1199)
XI Agricultural Marketing Service (Marketing Agreements and Or-
ders; Miscellaneous Commodities), Department of Agriculture
(Parts 1200—1299)
XIV Commodity Credit Corporation, Department of Agriculture
(Parts 1400—1499)
XV Foreign Agricultural Service, Department of Agriculture (Parts
1500—1599)
XVI [Reserved]
XVII Rural Utilities Service, Department of Agriculture (Parts 1700—
1799)
XVIII Rural Housing Service, Rural Business-Cooperative Service,
Rural Utilities Service, and Farm Service Agency, Depart-
ment of Agriculture (Parts 1800—2099)
XX [Reserved]
XXV Office of Advocacy and Outreach, Department of Agriculture
(Parts 2500—2599)
XXVI Office of Inspector General, Department of Agriculture (Parts
2600—2699)
XXVII Office of Information Resources Management, Department of
Agriculture (Parts 2700—2799)
XXVIII Office of Operations, Department of Agriculture (Parts 2800—
2899)
XXIX Office of Energy Policy and New Uses, Department of Agri-
XXX Office of the Chief Financial Officer, Department of Agriculture
(Parts 3000—3099)
XXXI Office of Environmental Quality, Department of Agriculture
(Parts 3100—3199)
XXXII Office of Procurement and Property Management, Department
of Agriculture (Parts 3200—3299)
XXXIII Office of Transportation, Department of Agriculture (Parts
3300—3399)
XXXIV National Institute of Food and Agriculture (Parts 3400—3499)
XXXV Rural Housing Service, Department of Agriculture (Parts 3500—
3599)
XXXVI National Agricultural Statistics Service, Department of Agri-
1253
Title 7—Agriculture—Continued
Chap.
XXXVII Economic Research Service, Department of Agriculture (Parts

3700—3799)
XXXVIII World Agricultural Outlook Board, Department of Agriculture
(Parts 3800—3899)
XLI [Reserved]
XLII Rural Business-Cooperative Service, Department of Agriculture
(Parts 4200—4299)
L Rural Business-Cooperative Service, Rural Housing Service, and
Rural Utilities Service, Department of Agriculture (Parts
5000—5099)
Title 8—Aliens and Nationality
I Department of Homeland Security (Parts 1—499)

V Executive Office for Immigration Review, Department of Justice
(Parts 1000—1399)
Title 9—Animals and Animal Products
I Animal and Plant Health Inspection Service, Department of Ag-

riculture (Parts 1—199)
II Agricultural Marketing Service (Fair Trade Practices Program),
Department of Agriculture (Parts 200—299)
III Food Safety and Inspection Service, Department of Agriculture
(Parts 300—599)
Title 10—Energy
I Nuclear Regulatory Commission (Parts 0—199)

II Department of Energy (Parts 200—699)
III Department of Energy (Parts 700—999)
X Department of Energy (General Provisions) (Parts 1000—1099)
XIII Nuclear Waste Technical Review Board (Parts 1300—1399)
XVII Defense Nuclear Facilities Safety Board (Parts 1700—1799)
XVIII Northeast Interstate Low-Level Radioactive Waste Commission
(Parts 1800—1899)
Title 11—Federal Elections
I Federal Election Commission (Parts 1—9099)

II Election Assistance Commission (Parts 9400—9499)
Title 12—Banks and Banking
I Comptroller of the Currency, Department of the Treasury (Parts

1—199)
II Federal Reserve System (Parts 200—299)
III Federal Deposit Insurance Corporation (Parts 300—399)
1254
Title 12—Banks and Banking—Continued
Chap.
IV Export-Import Bank of the United States (Parts 400—499)

V (Parts 500—599) [Reserved]
VI Farm Credit Administration (Parts 600—699)
VII National Credit Union Administration (Parts 700—799)
VIII Federal Financing Bank (Parts 800—899)
IX (Parts 900—999)[Reserved]
X Consumer Financial Protection Bureau (Parts 1000—1099)
XI Federal Financial Institutions Examination Council (Parts
1100—1199)
XII Federal Housing Finance Agency (Parts 1200—1299)
XIII Financial Stability Oversight Council (Parts 1300—1399)
XIV Farm Credit System Insurance Corporation (Parts 1400—1499)
XV Department of the Treasury (Parts 1500—1599)
XVI Office of Financial Research, Department of the Treasury (Parts
1600—1699)
XVII Office of Federal Housing Enterprise Oversight, Department of
Housing and Urban Development (Parts 1700—1799)
XVIII Community Development Financial Institutions Fund, Depart-
ment of the Treasury (Parts 1800—1899)
Title 13—Business Credit and Assistance
I Small Business Administration (Parts 1—199)

III Economic Development Administration, Department of Com-
merce (Parts 300—399)
IV Emergency Steel Guarantee Loan Board (Parts 400—499)
V Emergency Oil and Gas Guaranteed Loan Board (Parts 500—599)
Title 14—Aeronautics and Space
I Federal Aviation Administration, Department of Transportation

(Parts 1—199)
II Office of the Secretary, Department of Transportation (Aviation
Proceedings) (Parts 200—399)
III Commercial Space Transportation, Federal Aviation Adminis-
tration, Department of Transportation (Parts 400—1199)
V National Aeronautics and Space Administration (Parts 1200—
1299)
VI Air Transportation System Stabilization (Parts 1300—1399)
Title 15—Commerce and Foreign Trade
SUBTITLE A—OFFICE OF THE SECRETARY OF COMMERCE (PARTS 0—

29)
SUBTITLE B—REGULATIONS RELATING TO COMMERCE AND FOREIGN
TRADE
I Bureau of the Census, Department of Commerce (Parts 30—199)
1255
Title 15—Commerce and Foreign Trade—Continued
Chap.
II National Institute of Standards and Technology, Department of

Commerce (Parts 200—299)
III International Trade Administration, Department of Commerce
(Parts 300—399)
IV Foreign-Trade Zones Board, Department of Commerce (Parts
400—499)
VII Bureau of Industry and Security, Department of Commerce
(Parts 700—799)
VIII Bureau of Economic Analysis, Department of Commerce (Parts
800—899)
IX National Oceanic and Atmospheric Administration, Department
of Commerce (Parts 900—999)
XI National Technical Information Service, Department of Com-
merce (Parts 1100—1199)
XIII East-West Foreign Trade Board (Parts 1300—1399)
XIV Minority Business Development Agency (Parts 1400—1499)
XV Office of the Under-Secretary for Economic Affairs, Department
of Commerce (Parts 1500—1599)
SUBTITLE C—REGULATIONS RELATING TO FOREIGN TRADE AGREE-
MENTS
XX Office of the United States Trade Representative (Parts 2000—
2099)
SUBTITLE D—REGULATIONS RELATING TO TELECOMMUNICATIONS
AND INFORMATION
XXIII National Telecommunications and Information Administration,
Department of Commerce (Parts 2300—2399) [Reserved]
Title 16—Commercial Practices
I Federal Trade Commission (Parts 0—999)

II Consumer Product Safety Commission (Parts 1000—1799)
Title 17—Commodity and Securities Exchanges
I Commodity Futures Trading Commission (Parts 1—199)

II Securities and Exchange Commission (Parts 200—399)
IV Department of the Treasury (Parts 400—499)
Title 18—Conservation of Power and Water Resources
I Federal Energy Regulatory Commission, Department of Energy

(Parts 1—399)
III Delaware River Basin Commission (Parts 400—499)
VI Water Resources Council (Parts 700—799)
VIII Susquehanna River Basin Commission (Parts 800—899)
XIII Tennessee Valley Authority (Parts 1300—1399)
1256
Title 19—Customs Duties
Chap.
I U.S. Customs and Border Protection, Department of Homeland

Security; Department of the Treasury (Parts 0—199)
II United States International Trade Commission (Parts 200—299)
III International Trade Administration, Department of Commerce
(Parts 300—399)
IV U.S. Immigration and Customs Enforcement, Department of
Homeland Security (Parts 400—599) [Reserved]
Title 20—Employees’ Benefits
I Office of Workers’ Compensation Programs, Department of

Labor (Parts 1—199)
II Railroad Retirement Board (Parts 200—399)
III Social Security Administration (Parts 400—499)
IV Employees’ Compensation Appeals Board, Department of Labor
(Parts 500—599)
V Employment and Training Administration, Department of Labor
(Parts 600—699)
VI Office of Workers’ Compensation Programs, Department of
VII Benefits Review Board, Department of Labor (Parts 800—899)
VIII Joint Board for the Enrollment of Actuaries (Parts 900—999)
IX Office of the Assistant Secretary for Veterans’ Employment and
Training Service, Department of Labor (Parts 1000—1099)
Title 21—Food and Drugs
I Food and Drug Administration, Department of Health and

Human Services (Parts 1—1299)
II Drug Enforcement Administration, Department of Justice (Parts
1300—1399)
III Office of National Drug Control Policy (Parts 1400—1499)
Title 22—Foreign Relations
I Department of State (Parts 1—199)

II Agency for International Development (Parts 200—299)
III Peace Corps (Parts 300—399)
IV International Joint Commission, United States and Canada
(Parts 400—499)
V United States Agency for Global Media (Parts 500—599)
VII U.S. International Development Finance Corporation (Parts
700—799)
IX Foreign Service Grievance Board (Parts 900—999)
X Inter-American Foundation (Parts 1000—1099)
XI International Boundary and Water Commission, United States
and Mexico, United States Section (Parts 1100—1199)
1257
Title 22—Foreign Relations—Continued
Chap.
XII United States International Development Cooperation Agency

(Parts 1200—1299)
XIII Millennium Challenge Corporation (Parts 1300—1399)
XIV Foreign Service Labor Relations Board; Federal Labor Relations
Authority; General Counsel of the Federal Labor Relations
Authority; and the Foreign Service Impasse Disputes Panel
(Parts 1400—1499)
XV African Development Foundation (Parts 1500—1599)
XVI Japan-United States Friendship Commission (Parts 1600—1699)
XVII United States Institute of Peace (Parts 1700—1799)
Title 23—Highways
I Federal Highway Administration, Department of Transportation

(Parts 1—999)
II National Highway Traffic Safety Administration and Federal
Highway Administration, Department of Transportation
(Parts 1200—1299)
III National Highway Traffic Safety Administration, Department of
Transportation (Parts 1300—1399)
Title 24—Housing and Urban Development
SUBTITLE A—OFFICE OF THE SECRETARY, DEPARTMENT OF HOUSING

AND URBAN DEVELOPMENT (PARTS 0—99)
SUBTITLE B—REGULATIONS RELATING TO HOUSING AND URBAN DE-
VELOPMENT
I Office of Assistant Secretary for Equal Opportunity, Department
of Housing and Urban Development (Parts 100—199)
II Office of Assistant Secretary for Housing-Federal Housing Com-
missioner, Department of Housing and Urban Development
(Parts 200—299)
III Government National Mortgage Association, Department of
Housing and Urban Development (Parts 300—399)
IV Office of Housing and Office of Multifamily Housing Assistance
Restructuring, Department of Housing and Urban Develop-
ment (Parts 400—499)
V Office of Assistant Secretary for Community Planning and De-
velopment, Department of Housing and Urban Development
(Parts 500—599)
VI Office of Assistant Secretary for Community Planning and De-
velopment, Department of Housing and Urban Development
(Parts 600—699) [Reserved]
VII Office of the Secretary, Department of Housing and Urban Devel-
opment (Housing Assistance Programs and Public and Indian
Housing Programs) (Parts 700—799)
1258
Title 24—Housing and Urban Development—Continued
Chap.
VIII Office of the Assistant Secretary for Housing—Federal Housing

Commissioner, Department of Housing and Urban Develop-
ment (Section 8 Housing Assistance Programs, Section 202 Di-
rect Loan Program, Section 202 Supportive Housing for the El-
derly Program and Section 811 Supportive Housing for Persons
With Disabilities Program) (Parts 800—899)
IX Office of Assistant Secretary for Public and Indian Housing, De-
partment of Housing and Urban Development (Parts 900—1699)
X Office of Assistant Secretary for Housing—Federal Housing
ment (Interstate Land Sales Registration Program) (Parts
1700—1799) [Reserved]
XII Office of Inspector General, Department of Housing and Urban
Development (Parts 2000—2099)
XV Emergency Mortgage Insurance and Loan Programs, Depart-
ment of Housing and Urban Development (Parts 2700—2799)
[Reserved]
XX Office of Assistant Secretary for Housing—Federal Housing
ment (Parts 3200—3899)
XXIV Board of Directors of the HOPE for Homeowners Program (Parts
4000—4099) [Reserved]
XXV Neighborhood Reinvestment Corporation (Parts 4100—4199)
Title 25—Indians
I Bureau of Indian Affairs, Department of the Interior (Parts 1—

299)
II Indian Arts and Crafts Board, Department of the Interior (Parts
300—399)
III National Indian Gaming Commission, Department of the Inte-
rior (Parts 500—599)
IV Office of Navajo and Hopi Indian Relocation (Parts 700—899)
V Bureau of Indian Affairs, Department of the Interior, and Indian
Health Service, Department of Health and Human Services
(Part 900—999)
VI Office of the Assistant Secretary, Indian Affairs, Department of
the Interior (Parts 1000—1199)
VII Office of the Special Trustee for American Indians, Department
of the Interior (Parts 1200—1299)
Title 26—Internal Revenue
I Internal Revenue Service, Department of the Treasury (Parts 1—

End)
Title 27—Alcohol, Tobacco Products and Firearms
I Alcohol and Tobacco Tax and Trade Bureau, Department of the

Treasury (Parts 1—399)
1259
Title 27—Alcohol, Tobacco Products and Firearms—Continued
Chap.
II Bureau of Alcohol, Tobacco, Firearms, and Explosives, Depart-

ment of Justice (Parts 400—799)
Title 28—Judicial Administration
I Department of Justice (Parts 0—299)

III Federal Prison Industries, Inc., Department of Justice (Parts
300—399)
V Bureau of Prisons, Department of Justice (Parts 500—599)
VI Offices of Independent Counsel, Department of Justice (Parts
600—699)
VII Office of Independent Counsel (Parts 700—799)
VIII Court Services and Offender Supervision Agency for the District
of Columbia (Parts 800—899)
IX National Crime Prevention and Privacy Compact Council (Parts
900—999)
XI Department of Justice and Department of State (Parts 1100—
1199)
Title 29—Labor
SUBTITLE A—OFFICE OF THE SECRETARY OF LABOR (PARTS 0—99)

SUBTITLE B—REGULATIONS RELATING TO LABOR
I National Labor Relations Board (Parts 100—199)
II Office of Labor-Management Standards, Department of Labor
(Parts 200—299)
III National Railroad Adjustment Board (Parts 300—399)
IV Office of Labor-Management Standards, Department of Labor
(Parts 400—499)
V Wage and Hour Division, Department of Labor (Parts 500—899)
IX Construction Industry Collective Bargaining Commission (Parts
900—999)
X National Mediation Board (Parts 1200—1299)
XII Federal Mediation and Conciliation Service (Parts 1400—1499)
XIV Equal Employment Opportunity Commission (Parts 1600—1699)
XVII Occupational Safety and Health Administration, Department of
XX Occupational Safety and Health Review Commission (Parts
2200—2499)
XXV Employee Benefits Security Administration, Department of
XXVII Federal Mine Safety and Health Review Commission (Parts
2700—2799)
XL Pension Benefit Guaranty Corporation (Parts 4000—4999)
1260
Title 30—Mineral Resources
Chap.
I Mine Safety and Health Administration, Department of Labor

(Parts 1—199)
II Bureau of Safety and Environmental Enforcement, Department
of the Interior (Parts 200—299)
IV Geological Survey, Department of the Interior (Parts 400—499)
V Bureau of Ocean Energy Management, Department of the Inte-
VII Office of Surface Mining Reclamation and Enforcement, Depart-
ment of the Interior (Parts 700—999)
XII Office of Natural Resources Revenue, Department of the Interior
(Parts 1200—1299)
Title 31—Money and Finance: Treasury
SUBTITLE A—OFFICE OF THE SECRETARY OF THE TREASURY (PARTS

0—50)
SUBTITLE B—REGULATIONS RELATING TO MONEY AND FINANCE
I Monetary Offices, Department of the Treasury (Parts 51—199)
II Fiscal Service, Department of the Treasury (Parts 200—399)
IV Secret Service, Department of the Treasury (Parts 400—499)
V Office of Foreign Assets Control, Department of the Treasury
(Parts 500—599)
VI Bureau of Engraving and Printing, Department of the Treasury
(Parts 600—699)
VII Federal Law Enforcement Training Center, Department of the
VIII Office of Investment Security, Department of the Treasury
(Parts 800—899)
IX Federal Claims Collection Standards (Department of the Treas-
ury—Department of Justice) (Parts 900—999)
X Financial Crimes Enforcement Network, Department of the
Title 32—National Defense
SUBTITLE A—DEPARTMENT OF DEFENSE

I Office of the Secretary of Defense (Parts 1—399)
V Department of the Army (Parts 400—699)
VI Department of the Navy (Parts 700—799)
VII Department of the Air Force (Parts 800—1099)
SUBTITLE B—OTHER REGULATIONS RELATING TO NATIONAL DE-
FENSE
XII Department of Defense, Defense Logistics Agency (Parts 1200—
1299)
XVI Selective Service System (Parts 1600—1699)
XVII Office of the Director of National Intelligence (Parts 1700—1799)
XVIII National Counterintelligence Center (Parts 1800—1899)
XIX Central Intelligence Agency (Parts 1900—1999)
1261
Title 32—National Defense—Continued
Chap.
XX Information Security Oversight Office, National Archives and

Records Administration (Parts 2000—2099)
XXI National Security Council (Parts 2100—2199)
XXIV Office of Science and Technology Policy (Parts 2400—2499)
XXVII Office for Micronesian Status Negotiations (Parts 2700—2799)
XXVIII Office of the Vice President of the United States (Parts 2800—
2899)
Title 33—Navigation and Navigable Waters
I Coast Guard, Department of Homeland Security (Parts 1—199)

II Corps of Engineers, Department of the Army, Department of De-
fense (Parts 200—399)
IV Great Lakes St. Lawrence Seaway Development Corporation,
Department of Transportation (Parts 400—499)
Title 34—Education
SUBTITLE A—OFFICE OF THE SECRETARY, DEPARTMENT OF EDU-

CATION (PARTS 1—99)
SUBTITLE B—REGULATIONS OF THE OFFICES OF THE DEPARTMENT
OF EDUCATION
I Office for Civil Rights, Department of Education (Parts 100—199)
II Office of Elementary and Secondary Education, Department of
Education (Parts 200—299)
III Office of Special Education and Rehabilitative Services, Depart-
ment of Education (Parts 300—399)
IV Office of Career, Technical, and Adult Education, Department of
Education (Parts 400—499)
V Office of Bilingual Education and Minority [Reserved]
VI Office of Postsecondary Education, Department of Education
(Parts 600—699)
VII Office of Educational Research and Improvement, Department of
Education (Parts 700—799) [Reserved]
SUBTITLE C—REGULATIONS RELATING TO EDUCATION
XI [Reserved]
XII National Council on Disability (Parts 1200—1299)
Title 35 [Reserved]
Title 36—Parks, Forests, and Public Property
I National Park Service, Department of the Interior (Parts 1—199)

II Forest Service, Department of Agriculture (Parts 200—299)
III Corps of Engineers, Department of the Army (Parts 300—399)
IV American Battle Monuments Commission (Parts 400—499)
V Smithsonian Institution (Parts 500—599)
VI [Reserved]
1262
Title 36—Parks, Forests, and Public Property—Continued
Chap.
VII Library of Congress (Parts 700—799)

VIII Advisory Council on Historic Preservation (Parts 800—899)
IX Pennsylvania Avenue Development Corporation (Parts 900—999)
X Presidio Trust (Parts 1000—1099)
XI Architectural and Transportation Barriers Compliance Board
(Parts 1100—1199)
XII National Archives and Records Administration (Parts 1200—1299)
XV Oklahoma City National Memorial Trust (Parts 1500—1599)
XVI Morris K. Udall Scholarship and Excellence in National Environ-
mental Policy Foundation (Parts 1600—1699)
Title 37—Patents, Trademarks, and Copyrights
I United States Patent and Trademark Office, Department of

II U.S. Copyright Office, Library of Congress (Parts 200—299)
III Copyright Royalty Board, Library of Congress (Parts 300—399)
IV National Institute of Standards and Technology, Department of
Title 38—Pensions, Bonuses, and Veterans’ Relief
I Department of Veterans Affairs (Parts 0—199)

II Armed Forces Retirement Home (Parts 200—299)
Title 39—Postal Service
I United States Postal Service (Parts 1—999)

III Postal Regulatory Commission (Parts 3000—3099)
Title 40—Protection of Environment
I Environmental Protection Agency (Parts 1—1099)

IV Environmental Protection Agency and Department of Justice
(Parts 1400—1499)
V Council on Environmental Quality (Parts 1500—1599)
VI Chemical Safety and Hazard Investigation Board (Parts 1600—
1699)
VII Environmental Protection Agency and Department of Defense;
Uniform National Discharge Standards for Vessels of the
Armed Forces (Parts 1700—1799)
VIII Gulf Coast Ecosystem Restoration Council (Parts 1800—1899)
IX Federal Permitting Improvement Steering Council (Part 1900)
Title 41—Public Contracts and Property Management
SUBTITLE A—FEDERAL PROCUREMENT REGULATIONS SYSTEM

[NOTE]
1263
Title 41—Public Contracts and Property Management—Continued
Chap.
SUBTITLE B—OTHER PROVISIONS RELATING TO PUBLIC CONTRACTS

50 Public Contracts, Department of Labor (Parts 50–1—50–999)
51 Committee for Purchase From People Who Are Blind or Severely
Disabled (Parts 51–1—51–99)
60 Office of Federal Contract Compliance Programs, Equal Employ-
ment Opportunity, Department of Labor (Parts 60–1—60–999)
61 Office of the Assistant Secretary for Veterans’ Employment and
Training Service, Department of Labor (Parts 61–1—61–999)
Chapters 62— [Reserved]
100
SUBTITLE C—FEDERAL PROPERTY MANAGEMENT REGULATIONS
SYSTEM
101 Federal Property Management Regulations (Parts 101–1—101–99)
102 Federal Management Regulation (Parts 102–1—102–299)
Chapters (Parts 103–001—104–099)[Reserved]
103—104
105 General Services Administration (Parts 105–1—105–999)
109 Department of Energy Property Management Regulations (Parts
109–1—109–99)
114 Department of the Interior (Parts 114–1—114–99)
115 Environmental Protection Agency (Parts 115–1—115–99)
128 Department of Justice (Parts 128–1—128–99)
Chapters [Reserved]
129—200
SUBTITLE D—FEDERAL ACQUISITION SUPPLY CHAIN SECURITY
201 Federal Acquisition Security Council (Parts 201–1—201–99)
SUBTITLE E [RESERVED]
SUBTITLE F—FEDERAL TRAVEL REGULATION SYSTEM
300 General (Parts 300–1—300–99)
301 Temporary Duty (TDY) Travel Allowances (Parts 301–1—301–99)
302 Relocation Allowances (Parts 302–1—302–99)
303 Payment of Expenses Connected with the Death of Certain Em-
ployees (Part 303–1—303–99)
304 Payment of Travel Expenses from a Non-Federal Source (Parts
304–1—304–99)
Title 42—Public Health
I Public Health Service, Department of Health and Human Serv-

ices (Parts 1—199)
Chapters II— [Reserved]
III
IV Centers for Medicare & Medicaid Services, Department of Health
and Human Services (Parts 400—699)
V Office of Inspector General-Health Care, Department of Health
1264
Title 43—Public Lands: Interior
Chap.
SUBTITLE A—OFFICE OF THE SECRETARY OF THE INTERIOR (PARTS

1—199)
SUBTITLE B—REGULATIONS RELATING TO PUBLIC LANDS
I Bureau of Reclamation, Department of the Interior (Parts 400—
999)
II Bureau of Land Management, Department of the Interior (Parts
1000—9999)
III Utah Reclamation Mitigation and Conservation Commission
(Parts 10000—10099)
Title 44—Emergency Management and Assistance
I Federal Emergency Management Agency, Department of Home-

land Security (Parts 0—399)
IV Department of Commerce and Department of Transportation
(Parts 400—499)
Title 45—Public Welfare
SUBTITLE A—DEPARTMENT OF HEALTH AND HUMAN SERVICES

(PARTS 1—199)
SUBTITLE B—REGULATIONS RELATING TO PUBLIC WELFARE
II Office of Family Assistance (Assistance Programs), Administra-
tion for Children and Families, Department of Health and
Human Services (Parts 200—299)
III Office of Child Support Services, Administration of Families and
Services, Department of Health and Human Services (Parts
300—399)
IV Office of Refugee Resettlement, Administration for Children and
Families, Department of Health and Human Services (Parts
400—499)
V Foreign Claims Settlement Commission of the United States,
Department of Justice (Parts 500—599)
VI National Science Foundation (Parts 600—699)
VII Commission on Civil Rights (Parts 700—799)
VIII Office of Personnel Management (Parts 800—899)
IX Denali Commission (Parts 900—999)
X Office of Community Services, Administration for Children and
Families, Department of Health and Human Services (Parts
1000—1099)
XI National Foundation on the Arts and the Humanities (Parts
1100—1199)
XII Corporation for National and Community Service (Parts 1200—
1299)
XIII Administration for Children and Families, Department of Health
XVI Legal Services Corporation (Parts 1600—1699)
XVII National Commission on Libraries and Information Science
(Parts 1700—1799)
XVIII Harry S. Truman Scholarship Foundation (Parts 1800—1899)
1265
Title 45—Public Welfare—Continued
Chap.
XXI Commission of Fine Arts (Parts 2100—2199)

XXIII Arctic Research Commission (Parts 2300—2399)
XXIV James Madison Memorial Fellowship Foundation (Parts 2400—
2499)
XXV Corporation for National and Community Service (Parts 2500—
2599)
Title 46—Shipping
I Coast Guard, Department of Homeland Security (Parts 1—199)

II Maritime Administration, Department of Transportation (Parts
200—399)
III Coast Guard (Great Lakes Pilotage), Department of Homeland
Security (Parts 400—499)
IV Federal Maritime Commission (Parts 500—599)
Title 47—Telecommunication
I Federal Communications Commission (Parts 0—199)

II Office of Science and Technology Policy and National Security
Council (Parts 200—299)
III National Telecommunications and Information Administration,
Department of Commerce (Parts 300—399)
IV National Telecommunications and Information Administration,
Department of Commerce, and National Highway Traffic Safe-
ty Administration, Department of Transportation (Parts 400—
499)
V The First Responder Network Authority (Parts 500—599)
Title 48—Federal Acquisition Regulations System
1 Federal Acquisition Regulation (Parts 1—99)

2 Defense Acquisition Regulations System, Department of Defense
(Parts 200—299)
3 Health and Human Services (Parts 300—399)
4 Department of Agriculture (Parts 400—499)
5 General Services Administration (Parts 500—599)
6 Department of State (Parts 600—699)
7 Agency for International Development (Parts 700—799)
8 Department of Veterans Affairs (Parts 800—899)
9 Department of Energy (Parts 900—999)
10 Department of the Treasury (Parts 1000—1099)
12 Department of Transportation (Parts 1200—1299)
13 Department of Commerce (Parts 1300—1399)
14 Department of the Interior (Parts 1400—1499)
15 Environmental Protection Agency (Parts 1500—1599)
16 Office of Personnel Management, Federal Employees Health
Benefits Acquisition Regulation (Parts 1600—1699)
1266
Title 48—Federal Acquisition Regulations System—Continued
Chap.
17 Office of Personnel Management (Parts 1700—1799)

18 National Aeronautics and Space Administration (Parts 1800—
1899)
19 Broadcasting Board of Governors (Parts 1900—1999)
20 Nuclear Regulatory Commission (Parts 2000—2099)
21 Office of Personnel Management, Federal Employees Group Life
Insurance Federal Acquisition Regulation (Parts 2100—2199)
23 Social Security Administration (Parts 2300—2399)
24 Department of Housing and Urban Development (Parts 2400—
2499)
25 National Science Foundation (Parts 2500—2599)
28 Department of Justice (Parts 2800—2899)
29 Department of Labor (Parts 2900—2999)
30 Department of Homeland Security, Homeland Security Acquisi-
tion Regulation (HSAR) (Parts 3000—3099)
34 Department of Education Acquisition Regulation (Parts 3400—
3499)
51 Department of the Army Acquisition Regulations (Parts 5100—
5199) [Reserved]
52 Department of the Navy Acquisition Regulations (Parts 5200—
5299)
53 Department of the Air Force Federal Acquisition Regulation
Supplement (Parts 5300—5399) [Reserved]
54 Defense Logistics Agency, Department of Defense (Parts 5400—
5499)
57 African Development Foundation (Parts 5700—5799)
61 Civilian Board of Contract Appeals, General Services Adminis-
tration (Parts 6100—6199)
99 Cost Accounting Standards Board, Office of Federal Procure-
ment Policy, Office of Management and Budget (Parts 9900—
9999)
Title 49—Transportation
SUBTITLE A—OFFICE OF THE SECRETARY OF TRANSPORTATION

(PARTS 1—99)
SUBTITLE B—OTHER REGULATIONS RELATING TO TRANSPORTATION
I Pipeline and Hazardous Materials Safety Administration, De-
partment of Transportation (Parts 100—199)
II Federal Railroad Administration, Department of Transportation
(Parts 200—299)
III Federal Motor Carrier Safety Administration, Department of
IV Coast Guard, Department of Homeland Security (Parts 400—499)
V National Highway Traffic Safety Administration, Department of
VI Federal Transit Administration, Department of Transportation
(Parts 600—699)
1267
Title 49—Transportation—Continued
Chap.
VII National Railroad Passenger Corporation (AMTRAK) (Parts

700—799)
VIII National Transportation Safety Board (Parts 800—999)
X Surface Transportation Board (Parts 1000—1399)
XI Research and Innovative Technology Administration, Depart-
ment of Transportation (Parts 1400—1499) [Reserved]
XII Transportation Security Administration, Department of Home-
land Security (Parts 1500—1699)
Title 50—Wildlife and Fisheries
I United States Fish and Wildlife Service, Department of the Inte-

II National Marine Fisheries Service, National Oceanic and Atmos-
pheric Administration, Department of Commerce (Parts 200—
299)
III International Fishing and Related Activities (Parts 300—399)
IV Joint Regulations (United States Fish and Wildlife Service, De-
partment of the Interior and National Marine Fisheries Serv-
ice, National Oceanic and Atmospheric Administration, De-
partment of Commerce); Endangered Species Committee Reg-
ulations (Parts 400—499)
V Marine Mammal Commission (Parts 500—599)
VI Fishery Conservation and Management, National Oceanic and
Atmospheric Administration, Department of Commerce (Parts
600—699)
1268
Alphabetical List of Agencies Appearing in the CFR
(Revised as of October 1, 2024)
CFR Title, Subtitle or

Agency Chapter
Administrative Conference of the United States 1, III
Advisory Council on Historic Preservation 36, VIII
Advocacy and Outreach, Office of 7, XXV
Afghanistan Reconstruction, Special Inspector General for 5, LXXXIII
African Development Foundation 22, XV
Federal Acquisition Regulation 48, 57
Agency for International Development 2, VII; 22, II
Agricultural Marketing Service 7, I, VIII, IX, X, XI; 9, II
Agricultural Research Service 7, V
Agriculture, Department of 2, IV; 5, LXXIII
Advocacy and Outreach, Office of 7, XXV
Agricultural Marketing Service 7, I, VIII, IX, X, XI; 9, II
Agricultural Research Service 7, V
Animal and Plant Health Inspection Service 7, III; 9, I
Chief Financial Officer, Office of 7, XXX
Commodity Credit Corporation 7, XIV
Economic Research Service 7, XXXVII
Energy Policy and New Uses, Office of 2, IX; 7, XXIX
Environmental Quality, Office of 7, XXXI
Farm Service Agency 7, VII, XVIII
Federal Crop Insurance Corporation 7, IV
Food and Nutrition Service 7, II
Food Safety and Inspection Service 9, III
Foreign Agricultural Service 7, XV
Forest Service 36, II
Information Resources Management, Office of 7, XXVII
Inspector General, Office of 7, XXVI
National Agricultural Library 7, XLI
National Agricultural Statistics Service 7, XXXVI
National Institute of Food and Agriculture 7, XXXIV
Natural Resources Conservation Service 7, VI
Operations, Office of 7, XXVIII
Procurement and Property Management, Office of 7, XXXII
Rural Business-Cooperative Service 7, XVIII, XLII
Rural Development Administration 7, XLII
Rural Housing Service 7, XVIII, XXXV
Rural Utilities Service 7, XVII, XVIII, XLII
Secretary of Agriculture, Office of 7, Subtitle A
Transportation, Office of 7, XXXIII
World Agricultural Outlook Board 7, XXXVIII
Air Force, Department of 32, VII
Federal Acquisition Regulation Supplement 48, 53
Air Transportation Stabilization Board 14, VI
Alcohol and Tobacco Tax and Trade Bureau 27, I
Alcohol, Tobacco, Firearms, and Explosives, Bureau of 27, II
AMTRAK 49, VII
American Battle Monuments Commission 36, IV
American Indians, Office of the Special Trustee 25, VII
Animal and Plant Health Inspection Service 7, III; 9, I
Appalachian Regional Commission 5, IX
Architectural and Transportation Barriers Compliance Board 36, XI
1269
Agency Chapter
Arctic Research Commission 45, XXIII
Armed Forces Retirement Home 5, XI; 38, II
Army, Department of 32, V
Engineers, Corps of 33, II; 36, III
Benefits Review Board 20, VII
Bilingual Education and Minority Languages Affairs, Office of 34, V
Blind or Severely Disabled, Committee for Purchase from 41, 51
People Who Are
Career, Technical, and Adult Education, Office of 34, IV
Census Bureau 15, I
Centers for Medicare & Medicaid Services 42, IV
Central Intelligence Agency 32, XIX
Chemical Safety and Hazard Investigation Board 40, VI
Chief Financial Officer, Office of 7, XXX
Child Support Services, Office of 45, III
Children and Families, Administration for 45, II, IV, X, XIII
Civil Rights, Commission on 5, LXVIII; 45, VII
Civil Rights, Office for 34, I
Coast Guard 33, I; 46, I; 49, IV
Coast Guard (Great Lakes Pilotage) 46, III
Commerce, Department of 2, XIII; 44, IV; 50, VI
Census Bureau 15, I
Economic Affairs, Office of the Under-Secretary for 15, XV
Economic Analysis, Bureau of 15, VIII
Economic Development Administration 13, III
Emergency Management and Assistance 44, IV
Foreign-Trade Zones Board 15, IV
Industry and Security, Bureau of 15, VII
International Trade Administration 15, III; 19, III
National Institute of Standards and Technology 15, II; 37, IV
National Marine Fisheries Service 50, II, IV
National Oceanic and Atmospheric Administration 15, IX; 50, II, III, IV, VI
National Technical Information Service 15, XI
National Telecommunications and Information 15, XXIII; 47, III, IV
Administration
National Weather Service 15, IX
Patent and Trademark Office, United States 37, I
Secretary of Commerce, Office of 15, Subtitle A
Commercial Space Transportation 14, III
Commodity Credit Corporation 7, XIV
Commodity Futures Trading Commission 5, XLI; 17, I
Community Planning and Development, Office of Assistant 24, V, VI
Secretary for
Community Services, Office of 45, X
Comptroller of the Currency 12, I
Construction Industry Collective Bargaining Commission 29, IX
Consumer Financial Protection Bureau 5, LXXXIV; 12, X
Consumer Product Safety Commission 5, LXXI; 16, II
Copyright Royalty Board 37, III
Corporation for National and Community Service 2, XXII; 45, XII, XXV
Cost Accounting Standards Board 48, 99
Council on Environmental Quality 40, V
Council of the Inspectors General on Integrity and Efficiency 5, XCVIII
Court Services and Offender Supervision Agency for the 5, LXX; 28, VIII
District of Columbia
Customs and Border Protection 19, I
Defense, Department of 2, XI; 5, XXVI; 32,
Subtitle A; 40, VII
Advanced Research Projects Agency 32, I
Air Force Department 32, VII
Army Department 32, V; 33, II; 36, III; 48,
51
Defense Acquisition Regulations System 48, 2
Defense Intelligence Agency 32, I
1270
Agency Chapter
Defense Logistics Agency 32, I, XII; 48, 54
National Imagery and Mapping Agency 32, I
Navy, Department of 32, VI; 48, 52
Secretary of Defense, Office of 2, XI; 32, I
Defense Contract Audit Agency 32, I
Defense Intelligence Agency 32, I
Defense Logistics Agency 32, XII; 48, 54
Defense Nuclear Facilities Safety Board 10, XVII
Delaware River Basin Commission 18, III
Denali Commission 45, IX
Disability, National Council on 5, C; 34, XII
District of Columbia, Court Services and Offender Supervision 5, LXX; 28, VIII
Agency for the
Drug Enforcement Administration 21, II
East-West Foreign Trade Board 15, XIII
Economic Affairs, Office of the Under-Secretary for 15, XV
Economic Analysis, Bureau of 15, VIII
Economic Development Administration 13, III
Economic Research Service 7, XXXVII
Education, Department of 2, XXXIV; 5, LIII
Bilingual Education and Minority Languages Affairs, Office 34, V
of
Career, Technical, and Adult Education, Office of 34, IV
Civil Rights, Office for 34, I
Educational Research and Improvement, Office of 34, VII
Elementary and Secondary Education, Office of 34, II
Postsecondary Education, Office of 34, VI
Secretary of Education, Office of 34, Subtitle A
Special Education and Rehabilitative Services, Office of 34, III
Educational Research and Improvement, Office of 34, VII
Election Assistance Commission 2, LVIII; 11, II
Elementary and Secondary Education, Office of 34, II
Emergency Oil and Gas Guaranteed Loan Board 13, V
Emergency Steel Guarantee Loan Board 13, IV
Employee Benefits Security Administration 29, XXV
Employees’ Compensation Appeals Board 20, IV
Employees Loyalty Board 5, V
Employment and Training Administration 20, V
Employment Policy, National Commission for 1, IV
Employment Standards Administration 20, VI
Endangered Species Committee 50, IV
Energy, Department of 2, IX; 5, XXIII; 10, II,
III, X
Federal Energy Regulatory Commission 5, XXIV; 18, I
Property Management Regulations 41, 109
Energy, Office of 7, XXIX
Engraving and Printing, Bureau of 31, VI
Environmental Protection Agency 2, XV; 5, LIV; 40, I, IV,
VII
Environmental Quality, Office of 7, XXXI
Equal Employment Opportunity Commission 5, LXII; 29, XIV
Equal Opportunity, Office of Assistant Secretary for 24, I
Executive Office of the President 3, I
Environmental Quality, Council on 40, V
Management and Budget, Office of 2, Subtitle A; 5, III,
LXXVII; 14, VI; 48, 99
National Drug Control Policy, Office of 2, XXXVI; 21, III
National Security Council 32, XXI; 47, II
Presidential Documents 3
Science and Technology Policy, Office of 32, XXIV; 47, II
Trade Representative, Office of the United States 15, XX
1271
Agency Chapter
Export-Import Bank of the United States 2, XXXV; 5, LII; 12, IV
Families and Services, Administration of 45, III
Family Assistance, Office of 45, II
Farm Credit Administration 5, XXXI; 12, VI
Farm Credit System Insurance Corporation 5, XXX; 12, XIV
Farm Service Agency 7, VII, XVIII
Federal Acquisition Security Council 41, 201
Federal Aviation Administration 14, I
Federal Claims Collection Standards 31, IX
Federal Communications Commission 2, LX; 5, XXIX; 47, I
Federal Contract Compliance Programs, Office of 41, 60
Federal Crop Insurance Corporation 7, IV
Federal Deposit Insurance Corporation 5, XXII; 12, III
Federal Election Commission 5, XXXVII; 11, I
Federal Emergency Management Agency 44, I
Federal Employees Group Life Insurance Federal Acquisition 48, 21
Regulation
Federal Employees Health Benefits Acquisition Regulation 48, 16
Federal Energy Regulatory Commission 5, XXIV; 18, I
Federal Financial Institutions Examination Council 12, XI
Federal Financing Bank 12, VIII
Federal Highway Administration 23, I, II
Federal Home Loan Mortgage Corporation 1, IV
Federal Housing Enterprise Oversight Office 12, XVII
Federal Housing Finance Agency 5, LXXX; 12, XII
Federal Labor Relations Authority 5, XIV, XLIX; 22, XIV
Federal Law Enforcement Training Center 31, VII
Federal Management Regulation 41, 102
Federal Maritime Commission 46, IV
Federal Mediation and Conciliation Service 5, CIII; 29, XII
Federal Mine Safety and Health Review Commission 5, LXXIV; 29, XXVII
Federal Motor Carrier Safety Administration 49, III
Federal Permitting Improvement Steering Council 40, IX
Federal Prison Industries, Inc. 28, III
Federal Procurement Policy Office 48, 99
Federal Property Management Regulations 41, 101
Federal Railroad Administration 49, II
Federal Register, Administrative Committee of 1, I
Federal Register, Office of 1, II
Federal Reserve System 12, II
Board of Governors 5, LVIII
Federal Retirement Thrift Investment Board 5, VI, LXXVI
Federal Service Impasses Panel 5, XIV
Federal Trade Commission 5, XLVII; 16, I
Federal Transit Administration 49, VI
Federal Travel Regulation System 41, Subtitle F
Financial Crimes Enforcement Network 31, X
Financial Research Office 12, XVI
Financial Stability Oversight Council 12, XIII
Fine Arts, Commission of 45, XXI
Fiscal Service 31, II
Fish and Wildlife Service, United States 50, I, IV
Food and Drug Administration 21, I
Food and Nutrition Service 7, II
Food Safety and Inspection Service 9, III
Foreign Agricultural Service 7, XV
Foreign Assets Control, Office of 31, V
Foreign Claims Settlement Commission of the United States 45, V
Foreign Service Grievance Board 22, IX
Foreign Service Impasse Disputes Panel 22, XIV
Foreign Service Labor Relations Board 22, XIV
Foreign-Trade Zones Board 15, IV
Forest Service 36, II
General Services Administration 5, LVII; 41, 105
Contract Appeals, Board of 48, 61
1272
Agency Chapter
Federal Management Regulation 41, 102
Federal Property Management Regulations 41, 101
Federal Travel Regulation System 41, Subtitle F
General 41, 300
Payment From a Non-Federal Source for Travel Expenses 41, 304
Payment of Expenses Connected With the Death of Certain 41, 303
Employees
Relocation Allowances 41, 302
Temporary Duty (TDY) Travel Allowances 41, 301
Geological Survey 30, IV
Government Accountability Office 4, I
Government Ethics, Office of 5, XVI
Government National Mortgage Association 24, III
Grain Inspection, Packers and Stockyards Administration 7, VIII; 9, II
Great Lakes St. Lawrence Seaway Development Corporation 33, IV
Gulf Coast Ecosystem Restoration Council 2, LIX; 40, VIII
Harry S. Truman Scholarship Foundation 45, XVIII
Health and Human Services, Department of 2, III; 5, XLV; 45,
Subtitle A
Centers for Medicare & Medicaid Services 42, IV
Child Support Services, Office of 45, III
Children and Families, Administration for 45, II, IV, X, XIII
Community Services, Office of 45, X
Families and Services, Administration of 45, III
Family Assistance, Office of 45, II
Food and Drug Administration 21, I
Indian Health Service 25, V
Inspector General (Health Care), Office of 42, V
Public Health Service 42, I
Refugee Resettlement, Office of 45, IV
Homeland Security, Department of 2, XXX; 5, XXXVI; 6, I;
8, I
Coast Guard 33, I; 46, I; 49, IV
Coast Guard (Great Lakes Pilotage) 46, III
Federal Emergency Management Agency 44, I
Human Resources Management and Labor Relations 5, XCVII
Systems
Immigration and Customs Enforcement Bureau 19, IV
Transportation Security Administration 49, XII
HOPE for Homeowners Program, Board of Directors of 24, XXIV
Housing and Urban Development, Department of 2, XXIV; 5, LXV; 24,
Subtitle B
Community Planning and Development, Office of Assistant 24, V, VI
Secretary for
Equal Opportunity, Office of Assistant Secretary for 24, I
Federal Housing Enterprise Oversight, Office of 12, XVII
Government National Mortgage Association 24, III
Housing—Federal Housing Commissioner, Office of 24, II, VIII, X, XX
Assistant Secretary for
Housing, Office of, and Multifamily Housing Assistance 24, IV
Restructuring, Office of
Inspector General, Office of 24, XII
Public and Indian Housing, Office of Assistant Secretary for 24, IX
Secretary, Office of 24, Subtitle A, VII
Housing—Federal Housing Commissioner, Office of Assistant 24, II, VIII, X, XX
Secretary for
Housing, Office of, and Multifamily Housing Assistance 24, IV
Restructuring, Office of
Immigration and Customs Enforcement Bureau 19, IV
Immigration Review, Executive Office for 8, V
Independent Counsel, Office of 28, VII
Independent Counsel, Offices of 28, VI
Indian Affairs, Bureau of 25, I, V
1273
Agency Chapter
Indian Affairs, Office of the Assistant Secretary 25, VI
Indian Arts and Crafts Board 25, II
Indian Health Service 25, V
Industry and Security, Bureau of 15, VII
Information Resources Management, Office of 7, XXVII
Information Security Oversight Office, National Archives and 32, XX
Records Administration
Inspector General
Agriculture Department 7, XXVI
Health and Human Services Department 42, V
Housing and Urban Development Department 24, XII, XV
Institute of Peace, United States 22, XVII
Intellectual Property Enforcement Coordinator, Office of 5, CIV
Inter-American Foundation 5, LXIII; 22, X
Interior, Department of 2, XIV
American Indians, Office of the Special Trustee 25, VII
Endangered Species Committee 50, IV
Federal Property Management Regulations System 41, 114
Fish and Wildlife Service, United States 50, I, IV
Geological Survey 30, IV
Indian Affairs, Bureau of 25, I, V
Indian Affairs, Office of the Assistant Secretary 25, VI
Indian Arts and Crafts Board 25, II
Land Management, Bureau of 43, II
National Indian Gaming Commission 25, III
National Park Service 36, I
Natural Resource Revenue, Office of 30, XII
Ocean Energy Management, Bureau of 30, V
Reclamation, Bureau of 43, I
Safety and Environmental Enforcement, Bureau of 30, II
Secretary of the Interior, Office of 2, XIV; 43, Subtitle A
Surface Mining Reclamation and Enforcement, Office of 30, VII
Internal Revenue Service 26, I
International Boundary and Water Commission, United States 22, XI
and Mexico, United States Section
International Development, United States Agency for 22, II
International Development Cooperation Agency, United 22, XII
States
International Development Finance Corporation, U.S. 2, XVI; 5, XXXIII; 22,
VII
International Joint Commission, United States and Canada 22, IV
International Organizations Employees Loyalty Board 5, V
International Trade Administration 15, III; 19, III
International Trade Commission, United States 19, II
Interstate Commerce Commission 5, XL
Investment Security, Office of 31, VIII
James Madison Memorial Fellowship Foundation 45, XXIV
Japan–United States Friendship Commission 22, XVI
Joint Board for the Enrollment of Actuaries 20, VIII
Justice, Department of 2, XXVIII; 5, XXVIII;
28, I, XI; 40, IV
Alcohol, Tobacco, Firearms, and Explosives, Bureau of 27, II
Drug Enforcement Administration 21, II
Federal Prison Industries, Inc. 28, III
Foreign Claims Settlement Commission of the United 45, V
States
Immigration Review, Executive Office for 8, V
Independent Counsel, Offices of 28, VI
Prisons, Bureau of 28, V
Labor, Department of 2, XXIX; 5, XLII
Benefits Review Board 20, VII
Employee Benefits Security Administration 29, XXV
1274
Agency Chapter
Employees’ Compensation Appeals Board 20, IV
Employment and Training Administration 20, V
Federal Contract Compliance Programs, Office of 41, 60
Federal Procurement Regulations System 41, 50
Labor-Management Standards, Office of 29, II, IV
Mine Safety and Health Administration 30, I
Occupational Safety and Health Administration 29, XVII
Public Contracts 41, 50
Secretary of Labor, Office of 29, Subtitle A
Veterans’ Employment and Training Service, Office of the 41, 61; 20, IX
Wage and Hour Division 29, V
Workers’ Compensation Programs, Office of 20, I, VI
Labor-Management Standards, Office of 29, II, IV
Land Management, Bureau of 43, II
Legal Services Corporation 45, XVI
Libraries and Information Science, National Commission on 45, XVII
Library of Congress 36, VII
Copyright Royalty Board 37, III
U.S. Copyright Office 37, II
Management and Budget, Office of 2, Subpart A; 5, III,
LXXVII; 14, VI; 48, 99
Marine Mammal Commission 50, V
Maritime Administration 46, II
Merit Systems Protection Board 5, II, LXIV
Micronesian Status Negotiations, Office for 32, XXVII
Military Compensation and Retirement Modernization 5, XCIX
Commission
Millennium Challenge Corporation 22, XIII
Mine Safety and Health Administration 30, I
Minority Business Development Agency 15, XIV
Miscellaneous Agencies 1, IV
Monetary Offices 31, I
Morris K. Udall Scholarship and Excellence in National 36, XVI
Environmental Policy Foundation
Museum and Library Services, Institute of 2, XXXI
National Aeronautics and Space Administration 2, XVIII; 5, LIX; 14, V
National Agricultural Library 7, XLI
National Agricultural Statistics Service 7, XXXVI
National and Community Service, Corporation for 2, XXII; 45, XII, XXV
National Archives and Records Administration 2, XXVI; 5, LXVI; 36,
XII
Information Security Oversight Office 32, XX
National Capital Planning Commission 1, IV, VI
National Counterintelligence Center 32, XVIII
National Credit Union Administration 5, LXXXVI; 12, VII
National Crime Prevention and Privacy Compact Council 28, IX
National Drug Control Policy, Office of 2, XXXVI; 21, III
National Endowment for the Arts 2, XXXII
National Endowment for the Humanities 2, XXXIII
National Foundation on the Arts and the Humanities 45, XI
National Geospatial-Intelligence Agency 32, I
National Highway Traffic Safety Administration 23, II, III; 47, VI; 49, V
National Imagery and Mapping Agency 32, I
National Indian Gaming Commission 25, III
National Institute of Food and Agriculture 7, XXXIV
National Institute of Standards and Technology 15, II; 37, IV
National Intelligence, Office of Director of 5, IV; 32, XVII
National Labor Relations Board 5, LXI; 29, I
National Marine Fisheries Service 50, II, IV
National Mediation Board 5, CI; 29, X
National Oceanic and Atmospheric Administration 15, IX; 50, II, III, IV, VI
National Park Service 36, I
National Railroad Adjustment Board 29, III
National Railroad Passenger Corporation (AMTRAK) 49, VII
1275
Agency Chapter
National Science Foundation 2, XXV; 5, XLIII; 45, VI
National Security Council 32, XXI; 47, II
National Technical Information Service 15, XI
National Telecommunications and Information 15, XXIII; 47, III, IV, V
Administration
National Transportation Safety Board 49, VIII
Natural Resource Revenue, Office of 30, XII
Natural Resources Conservation Service 7, VI
Navajo and Hopi Indian Relocation, Office of 25, IV
Navy, Department of 32, VI
Neighborhood Reinvestment Corporation 24, XXV
Northeast Interstate Low-Level Radioactive Waste 10, XVIII
Commission
Nuclear Regulatory Commission 2, XX; 5, XLVIII; 10, I
Occupational Safety and Health Administration 29, XVII
Occupational Safety and Health Review Commission 29, XX
Ocean Energy Management, Bureau of 30, V
Oklahoma City National Memorial Trust 36, XV
Operations Office 7, XXVIII
Patent and Trademark Office, United States 37, I
Payment From a Non-Federal Source for Travel Expenses 41, 304
Payment of Expenses Connected With the Death of Certain 41, 303
Employees
Peace Corps 2, XXXVII; 22, III
Pennsylvania Avenue Development Corporation 36, IX
Pension Benefit Guaranty Corporation 29, XL
Personnel Management, Office of 5, I, IV, XXXV; 45, VIII
Federal Employees Group Life Insurance Federal 48, 21
Acquisition Regulation
Federal Employees Health Benefits Acquisition Regulation 48, 16
Human Resources Management and Labor Relations 5, XCVII
Systems, Department of Homeland Security
Pipeline and Hazardous Materials Safety Administration 49, I
Postal Regulatory Commission 5, XLVI; 39, III
Postal Service, United States 5, LX; 39, I
Postsecondary Education, Office of 34, VI
President’s Commission on White House Fellowships 1, IV
Presidential Documents 3
Presidio Trust 36, X
Prisons, Bureau of 28, V
Privacy and Civil Liberties Oversight Board 6, X
Procurement and Property Management, Office of 7, XXXII
Public and Indian Housing, Office of Assistant Secretary for 24, IX
Public Contracts, Department of Labor 41, 50
Public Health Service 42, I
Railroad Retirement Board 20, II
Reclamation, Bureau of 43, I
Refugee Resettlement, Office of 45, IV
Relocation Allowances 41, 302
Research and Innovative Technology Administration 49, XI
Rural Business-Cooperative Service 7, XVIII, XLII, L
Rural Housing Service 7, XVIII, XXXV, L
Rural Utilities Service 7, XVII, XVIII, XLII, L
Safety and Environmental Enforcement, Bureau of 30, II
Science and Technology Policy, Office of 32, XXIV; 47, II
Secret Service 31, IV
Securities and Exchange Commission 5, XXXIV; 17, II
Selective Service System 32, XVI
Small Business Administration 2, XXVII; 13, I
Smithsonian Institution 36, V
Social Security Administration 2, XXIII; 20, III; 48, 23
Soldiers’ and Airmen’s Home, United States 5, XI
Special Counsel, Office of 5, VIII
1276
Agency Chapter
Special Education and Rehabilitative Services, Office of 34, III
State, Department of 2, VI; 22, I; 28, XI
Surface Mining Reclamation and Enforcement, Office of 30, VII
Surface Transportation Board 49, X
Susquehanna River Basin Commission 18, VIII
Tennessee Valley Authority 5, LXIX; 18, XIII
Trade Representative, United States, Office of 15, XX
Transportation, Department of 2, XII; 5, L
Emergency Management and Assistance 44, IV
Federal Aviation Administration 14, I
Federal Highway Administration 23, I, II
Federal Motor Carrier Safety Administration 49, III
Federal Railroad Administration 49, II
Federal Transit Administration 49, VI
Great Lakes St. Lawrence Seaway Development Corporation 33, IV
Maritime Administration 46, II
National Highway Traffic Safety Administration 23, II, III; 47, IV; 49, V
Pipeline and Hazardous Materials Safety Administration 49, I
Secretary of Transportation, Office of 14, II; 49, Subtitle A
Transportation Statistics Bureau 49, XI
Transportation, Office of 7, XXXIII
Transportation Security Administration 49, XII
Transportation Statistics Bureau 49, XI
Travel Allowances, Temporary Duty (TDY) 41, 301
Treasury, Department of the 2, X; 5, XXI; 12, XV; 17,
IV; 31, IX
Alcohol and Tobacco Tax and Trade Bureau 27, I
Community Development Financial Institutions Fund 12, XVIII
Comptroller of the Currency 12, I
Engraving and Printing, Bureau of 31, VI
Federal Law Enforcement Training Center 31, VII
Financial Crimes Enforcement Network 31, X
Fiscal Service 31, II
Foreign Assets Control, Office of 31, V
Internal Revenue Service 26, I
Investment Security, Office of 31, VIII
Monetary Offices 31, I
Secret Service 31, IV
Secretary of the Treasury, Office of 31, Subtitle A
Truman, Harry S. Scholarship Foundation 45, XVIII
United States Agency for Global Media 22, V
United States and Canada, International Joint Commission 22, IV
United States and Mexico, International Boundary and Water 22, XI
Commission, United States Section
U.S. Copyright Office 37, II
U.S. Office of Special Counsel 5, CII
Utah Reclamation Mitigation and Conservation Commission 43, III
Veterans Affairs, Department of 2, VIII; 38, I
Veterans’ Employment and Training Service, Office of the 41, 61; 20, IX
Vice President of the United States, Office of 32, XXVIII
Wage and Hour Division 29, V
Water Resources Council 18, VI
Workers’ Compensation Programs, Office of 20, I, VI
World Agricultural Outlook Board 7, XXXVIII
1277
List of CFR Sections Affected
All changes in this volume of the Code of Federal Regulations (CFR)
that were made by documents published in the FEDERAL REGISTER since
January 1, 2019 are enumerated in the following list. Entries indicate the
nature of the changes effected. Page numbers refer to FEDERAL REGISTER
pages. The user should consult the entries for chapters, parts and sub-
parts as well as sections for revisions.
For changes to this volume of the CFR prior to this listing, consult
the annual edition of the monthly List of CFR Sections Affected (LSA).
The LSA is available at www.govinfo.gov. For changes to this volume of
the CFR prior to 2001, see the ‘‘List of CFR Sections Affected, 1949–1963,
1964–1972, 1973–1985, and 1986–2000’’ published in 11 separate volumes. The
‘‘List of CFR Sections Affected 1986–2000’’ is available at
www.govinfo.gov.
2019 42 CFR—Continued 84 FR
Page
42 CFR 84 FR Chapter IV—Continued
Page
482.51 (b)(1)(i) and (ii) revised;
Chapter IV (b)(1)(iii) added; eff. 11-29-19....... 51821
482 Authority citation revised; 482.58 (b)(4) removed; (b)(5)
eff. 11-29-19....................... 51817, 51882 through (8) redesignated as
482.13 (e)(5), (8)(ii), (10), (11), new (b)(4) through (7); (b)(1),
(12)(i), (14), and (g)(4)(ii) renew (4), new (5), and new (7) re-
vised; eff. 11-29-19 ...................... 51817 vised; eff. 11-29-19; eff. 11-29-
482.13 (d)(2) revised; eff. 11-29- 19.............................................. 51821
19.............................................. 51882 482.61 (d) revised; eff. 11-29-19......... 51821
482.15 (a) introductory text, (4), 482.68 Heading, introductory
(b) introductory text, (c) intro- text, and (b) amended; eff. 11-
ductory text, (d) introductory 29-19 ......................................... 51821
text, (1)(ii), and (2) revised; 482.70 Amended; eff. 11-29-19 .......... 51821
(d)(1)(v) added; (g) introduc- 482.72 Amended; eff. 11-29-19 .......... 51822
tory text, (1) and (2) amended; 482.74 (a) introductory text, (1),
eff. 11-29-19................................ 51817 (2), (3), and (b) introductory
482.21 (b)(1) revised; (f) added; eff. text amended; eff. 11-29-19 ......... 51822
11-29-19 ..................................... 51818 482.78 Heading, introductory
482.22 (c)(5)(i) and (ii) revised; text, (a), and (b) amended; eff.
(c)(5)(iii), (iv), and (v) added; (d) 11-29-19 ..................................... 51822
removed; eff. 11-29-19................. 51818 482.80 Heading, introductory
482.23 (b) introductory text, (4), text, (a), (b), (c) introductory
(6), (c)(1) introductory text, text, (1), (2), (d)(1), (2), (3), (4),
and (3) revised; (b)(7) added; eff. and (5) amended; eff. 11-29-
11-29-19 ..................................... 51819 19.............................................. 51822
482.24 (c)(4)(i)(A) and (B) revised; 482.82 Removed; eff. 11-29-19 .......... 51822
(c)(4)(i)(C) added; eff. 11-29- 482.90—482.104 Undesignated cen-
19.............................................. 51819 ter heading revised; eff. 11-29-
482.27 (b)(7) revised; (b)(11) re- 19.............................................. 51822
moved;

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Title 42

Revised as of October 1, 2024

Containing a codification of documents

Published by the Office of the Federal Register

Legal Status and Use of Seals and Logos

Use of ISBN Prefix

U.S. GOVERNMENT PUBLISHING OFFICE

U.S. Superintendent of Documents • Washington, DC 20402–0001

Chapter IV—Centers for Medicare & Medicaid Services, Depart-

Chapter V—Office of Inspector General-Health Care, Department

Table of CFR Titles and Chapters ....................................................... 1249

Alphabetical List of Agencies Appearing in the CFR ......................... 1269

List of CFR Sections Affected ............................................................. 1279

To cite the regulations in

CHAPTER IV—Centers for Medicare & Medicaid Services, De-

SUBCHAPTER G—STANDARDS AND CERTIFICATION

505 Establishment of the health care infrastructure

600 Administration, eligibility, essential health bene-

PART 482—CONDITIONS OF 482.55 Condition of participation: Emer-

§ 482.12 Condition of participation: (9) Ensure that when telemedicine

(i) A doctor of medicine or osteop- (C) Limited, under paragraph (c)(1)(v)

(4) A method for sharing information nual individual, facility-based func-

(3) Emergency generator fuel. Hospitals development and maintenance of the

are authorized to do so by hospital pol- (A) Ensure that a practitioner re-

(1) Medical records must be retained tocols is conducted by the medical

comprehensive medical history and (ii) The patient’s admission to the

(c) Standard: Personnel. (1) A qualified roscopic and microscopic examina-

(a) Standard: Infection prevention and (ii) Documents the evidence-based

policies and procedures by hospital per- ferences in patient populations and

when the Secretary specifies an earlier (iii) Confirmed co-morbid influenza

medical staff has chosen to develop and (5) An anesthesiologist’s assistant, as

(ii) All practitioners not appointed to therapy assistants, speech-language pa-

carry out specific procedures must be cility requirements contained in sub-

§ 482.61 Condition of participation: tient’s strengths and disabilities. The

uses it in accordance with all State and § 482.62 Condition of participation:

§ 482.76 Condition of participation: Pe- (d) Instead of meeting all conditions

transplantation activities on a routine § 482.102 Condition of participation:

(2) The evaluation process; (ii) Inform Medicare recipients on the

must have intended to inflict injury or ments for participation independently

harm, pain, mental anguish, or emo- resident, State or Federal law, or a

(G) Gifts purchased on behalf of a ical records pertaining to him or her-

(B) A description of the requirements to resident abuse, neglect, exploi-

or misappropriation of resident prop- or mistreatment, including injuries of

admission or expedited admission, or must specify the policies that apply to

(iv) A statement of the resident’s ap- cation of the residents, as required at

(B) Is eligible for Medicare skilled (xii) Skin condition.

(D) Therapy services. (iv) In consultation with the resident

must indicate where the individual (5) Communication, including

and hearing abilities, the facility must, duction in mobility is demonstrably

endoscopic jejunostomy, and enteral goals and preferences, to wear and be

(i) The facility is located in a rural force that is a minimum of 20 percent

§ 483.40 Behavioral health services. and/or increased withdrawn, angry, or

drugs in sufficient detail to enable an (d) Unnecessary drugs—General. Each

for notification of a practitioner or per (i) In making appointments; and

(3) The notice specified in paragraph admission to, or as a requirement to

resident representatives, and family (3) Address resident population, in-

(g) The standards incorporated by § 483.75 Quality assurance and per-

(5) Corrective actions address gaps in § 483.80 Infection control.

(4) A system for recording incidents to medical contraindications or re-