United States District Court Southern District of Florida Miami Division

Case 1:18-cv-20394-RNS Document 146 Entered on FLSD Docket 11/07/2019 Page 1 of 24
UNITED STATES DISTRICT COURT

SOUTHERN DISTRICT OF FLORIDA
MIAMI DIVISION
Case No. 18-20394-CIV-Scola/Torres
UNITED STATES OF AMERICA ex rel.)

DEREK LEWIS and JOEY NEIMAN, )
)
Plaintiffs, )
)
v. )
)
COMMUNITY HEALTH SYSTEMS, INC., )
et al., )
)
Defendants. /
DEFENDANT CHSPSC, LLC’S REPLY IN SUPPORT OF ITS

MOTION TO DISMISS RELATORS’ FIRST AMENDED COMPLAINT
LASH & GOLDBERG LLP

Martin B. Goldberg
Florida Bar No. 0827029
Daryl L. Saylor
100 Southeast 2nd Street, Suite 1200
Miami, FL 33131-2158
Telephone: (305) 347-4040
Facsimile: (305) 347-4050
ROBBINS, RUSSELL, ENGLERT,

ORSECK, UNTEREINER & SAUBER LLP
Michael L. Waldman (pro hac vice)
Brandon L. Arnold (pro hac vice)
Lauren M. Cassady (pro hac vice)
2000 K Street NW, 4th Floor
Washington, DC 20006
Telephone: (202) 775-4500
Facsimile: (202) 775-4510
Counsel for Defendant CHSPSC, LLC

TABLE OF CONTENTS
Page
TABLE OF AUTHORITIES ...................................................................................................... ii
PRELIMINARY STATEMENT ................................................................................................. 1
I. RELATORS FAIL TO PLEAD THAT CHSPSC SUBMITTED A FALSE CLAIM ........... 2
A. The hospitals correctly attested to using certified software, and Meaningful

Use required nothing more....................................................................................... 2
B. The hospitals correctly attested to meeting the required measures of EHR use,
not that the EHR software was flawless in every circumstance ................................ 7
C. Each hospital correctly attested that it provided Clinical Decision Support .............. 9
II. RELATORS FAIL TO PLEAD FRAUD WITH PARTICULARITY AGAINST

CHSPSC ........................................................................................................................... 10
III. RELATORS FAIL TO PLAUSIBLY PLEAD WRONGFUL KNOWLEDGE

AGAINST CHSPSC ......................................................................................................... 12
IV. RELATORS FAIL TO STATE AN ANTI-KICKBACK STATUTE VIOLATION ........... 14
V. THE COMPLAINT IS AN IMPROPER SHOTGUN PLEADING .................................... 15
CONCLUSION ......................................................................................................................... 15
i
TABLE OF AUTHORITIES
Page(s)
Cases
Ashcroft v. Iqbal,
556 U.S. 662 (2009) ...................................................................................................... 13, 15
Bright v. Thomas,
754 F. App’x 783 (11th Cir. 2018) ................................................................................ 13, 15
Corsello v. Lincare, Inc.,

428 F.3d 1008 (11th Cir. 2005)............................................................................................ 10
Gore v. Jacobs Eng’g Grp.,

706 F. App’x 981 (11th Cir. 2017) ...................................................................................... 14
Guilfoile v. Shields,
913 F.3d 178 (1st Cir. 2019) ................................................................................................ 14
Hill v. Morehouse Med. Assocs., Inc.,

2003 WL 22019936 (11th Cir. Aug. 15, 2003)..................................................................... 12
Kohli v. Pembroke Lakes Mall, LLC,

2017 WL 4863089 (S.D. Fla. Oct. 26, 2017)........................................................................ 14
Lary v. Trinity Physician Fin. & Ins. Servs.,

780 F.3d 1101 (11th Cir. 2015)............................................................................................ 15
MedPricer.com v. Becton, Dixon & Co.,

240 F. Supp. 3d 263 (D. Conn. 2017) .................................................................................. 14
NACS v. Bd. of Governors of the Fed. Reserve Sys.,

746 F.3d 474 (D.C. Cir. 2014) ............................................................................................... 6
Urquilla-Diaz v. Kaplan Univ.,

780 F.3d 1039 (11th Cir. 2015)............................................................................................ 13
U.S. ex rel. Aquino v. Univ. of Miami,

250 F. Supp. 3d 1319 (S.D. Fla. 2017) ................................................................................. 12
U.S. ex rel. Atkins v. McInteer,

470 F.3d 1350 (11th Cir. 2006)............................................................................................ 12
U.S. ex rel. Barrett v. Beauty Basics, Inc.,

2015 WL 3650960 (N.D. Ala. June 11, 2015) ................................................................ 13, 15
ii
TABLE OF AUTHORITIES—Continued
Page(s)
U.S. ex rel. Clausen v. Lab. Corp. of Am.,

290 F.3d 1301 (11th Cir. 2002)............................................................................................ 12
U.S. ex rel. Fernandez v. Miami Cancer Inst.,

2019 WL 1993513 (S.D. Fla. May 6, 2019) ......................................................................... 10
U.S. ex rel. Headen v. Adams & Assocs., Inc.,

2017 WL 6017775 (N.D. Ala. Dec. 5, 2017)........................................................................ 13
U.S. ex rel. Matheny v. Medco Health Sols., Inc.,

671 F.3d 1217 (11th Cir. 2012)............................................................................................ 12
U.S. ex rel. Osheroff v. Tenet Healthcare,

2012 WL 2871264 (S.D. Fla. July 12, 2012) ........................................................................ 12
U.S. ex rel. Walker v. R&F Properties of Lake Cty., Inc.,

433 F.3d 1349 (11th Cir. 2005)............................................................................................ 12
Whitman v. Am. Trucking Associations, Inc.,

531 U.S. 457 (2001) .............................................................................................................. 6
Statutes, Regulations, and Rules
33 U.S.C. § 1311(b)(2)(A) .......................................................................................................... 2
42 U.S.C. § 300jj(1) .................................................................................................................... 5
42 U.S.C. § 1320a-7b(b) ........................................................................................................... 14
42 U.S.C. § 7412(g)(2) ................................................................................................................ 3
42 C.F.R. § 413.9 ...................................................................................................................... 14
42 C.F.R. § 495.4 (2015) ............................................................................................................. 4
42 C.F.R. § 495.6 (2014) ....................................................................................................... 9, 10
42 C.F.R. § 495.8 (2014) ..................................................................................................... 2, 3, 5
45 C.F.R. § 170.102 (2012) ......................................................................................................... 4
45 C.F.R. § 170.306 (2010) ......................................................................................................... 9
45 C.F.R. § 170.314 (2012) ......................................................................................................... 9
iii
Page(s)
75 Fed. Reg. 2014 (2010) ............................................................................................ 3, 6, 7, 8, 9
75 Fed. Reg. 44,314 (2010) ............................................................................................... 7, 9, 10
76 Fed. Reg. 1262 (2011) ............................................................................................................ 7
77 Fed. Reg. 13,832 (2012) ..................................................................................................... 4, 5
77 Fed. Reg. 53,968 (2012) ................................................................................................... 9, 10
77 Fed. Reg. 54,163 (2012) ..................................................................................................... 4, 5
80 Fed. Reg. 62,762 (2015) ......................................................................................................... 5
Federal Rules of Civil Procedure 9 ..................................................................................... passim
Other Authorities
Clinical Decision Support: More Than Just ‘Alerts’ Tipsheet (July 2014), https://
www.healthit.gov/sites/default/files/clinicaldecisionsupport_tipsheet.pdf ............................ 10
CHPL, Medhost Enterprise Version 2014 R1 (Aug. 28, 2014),

https://tinyurl.com/y4pukch9 ................................................................................................. 6
CMS, Certified EHR Technology FAQ No. 12657, https://tinyurl.com/yyqo8hw9 ...................... 7
Complaint, United States v. Greenway Health, LLC,

No. 2:19-CV-00020 (D. Vt.) .................................................................................................. 5
Complaint, U.S. ex rel. Delaney v. eClinicalWorks LLC.,

No. 2:15-CV-00095 (D. Vt.) .................................................................................................. 5
Kelly P. Erb, TurboTax Glitch Led to $216 Million Tax Bill for Thrift Store
Worker, Forbes, Sept. 17, 2019, https://tinyurl.com/yy879e3b ............................................... 7
Federal Plain Language Guidelines, https://tinyurl.com/yyyed5vk ............................................... 6
Health IT; Implementation Specifications, and Certification Criteria: EHR

Technology, 2014 Edition, No. HHS-OS-2012-004,
https://tinyurl.com/y5ecukco ................................................................................................. 5
Industry News, HMA Announces Restatement of Financial Statements (Nov. 13,

2013), https://www.hitechanswers.net/hma-announces-restatement-financial-
statements/ .......................................................................................................................... 13
iv
Page(s)
Medicare and Medicaid Programs; EHR Incentive Program-Stage 3,

No. CMS-2015-0033, https://tinyurl.com/y3sdjvov ............................................................... 5
Office of the Federal Register, Document Drafting Handbook (Aug. 2019),

https://tinyurl.com/yxcdjnrn .................................................................................................. 6
ONC, Generation of CMS EHR Certification ID, https://tinyurl.com/yyfrnwxj ............................ 3
ONC, Proposed Rule Standards & Certification Criteria 2014 Ed.,

https://tinyurl.com/y44ozm58 ................................................................................................ 4
v
PRELIMINARY STATEMENT1
The Meaningful Use program required hospitals to attest that they used certified software
and that they met certain usage percentage measures. Relators concede that the software used by
the hospitals here was certified. And they do not contest the accuracy of the percentage usage
figures that the hospitals reported. They therefore fail to state a claim against CHSPSC.
Instead, Relators focus on representations that the hospitals did not and were not required
to make. Their principal allegation is that the Medhost software should not have been certified.
But the hospitals never said it should; to the contrary, they could not have said so because the form
used for attestation provided no place for such a representation to be made. Instead, the hospitals
relied on the certifications issued by the Office of the National Coordinator for Health Information
Technology’s (“ONC”) authorized certification body (here, Drummond Group), just as the ONC
said they could. Relators only claim otherwise by distorting the text of the regulation beyond
recognition and adopting an interpretation that was never mentioned by the regulators, the
thousands of pages of rulemaking materials, or the thousands of comments received on those rules.
The Meaningful Use rules only required providers to attest that the software was certified—not to
vouch for the certification, nor to represent that the software was either perfect or top-of-the-line.
Relators do not—and cannot—allege that the software here was uncertified, and so their claims
against CHSPSC should be dismissed.

In any event, the Complaint would still fail because its allegations, while lengthy, are
exceedingly conclusory and general. Relators must plead with particularity under Rule 9(b). But
Relators do not explain how the hodgepodge of software glitches that litter the Complaint caused
even a single hospital to fall below the required measures for Meaningful Use. Nor do they allege
any facts suggesting that anyone at CHSPSC knew that even a single hospital was out of
compliance but chose to attest anyway. To the contrary, their allegations only serve to highlight
that CHSPSC dedicated considerable resources to getting Meaningful Use right and its employees
1
Capitalized terms have the same meaning as in CHSPSC’s motion to dismiss, Doc. No. 132
(“CHSPSC Mot.”). All emphasis is added.
1
worked exceptionally hard to fix any problems that arose during implementation.
Relators’ kickback theory should likewise be dismissed. The incentive payments here were
not made to “purchase” software; they were payments for the use of software. Purchase was
neither a necessary nor sufficient condition for payment. In any event, the kickback allegations
are even more threadbare and conclusory. Relators allege scant facts on the kickback claim and
instead rely on vague rumors and bare assertions of wrongdoing. So that theory must fail too.
I. RELATORS FAIL TO PLEAD THAT CHSPSC SUBMITTED A FALSE CLAIM
A. The hospitals correctly attested to using certified software, and Meaningful

Use required nothing more
Relators do not identify a single false statement that any of the hospitals made about the
software that they used for Meaningful Use. As required by Meaningful Use, each hospital attested
that it “[u]sed certified EHR” software and “specif[ied] the technology used.” 42 C.F.R. § 495.8(b)
(2014). Relators do not—and cannot—allege that either representation was false. To the contrary,
Relators frankly and repeatedly concede that the “software was certified” here. Relators’
Opposition, Doc. No. 137 (“Opp.”) 45; see also, e.g., id. at 3 (“Medhost’s products obtained
certification.”); FAC ¶¶ 107-110, 131, 149-152, 204 (alleging “Medhost received certification” for
various versions of its software). That should be the end of the false certification claims.
Despite the fact that the hospitals truthfully attested to using certified software, Relators
continue to insist that those attestations were false because “Medhost’s EHR should not have been
certified,” citing a laundry list of supposed problems and limitations in the software. Opp. 43.
And they repeatedly stress that, in their view, Medhost’s software was “inferior” and “substandard
to other EHR systems.” Id. at 11, 15, 23, 75. Even if those allegations were true (and for this
motion CHSPSC assumes that they are), Relators’ claims still fail.
First, Relators’ attacks on the quality of Medhost’s software vis-à-vis other vendors are
irrelevant. Unlike some other regulatory regimes, Meaningful Use did not (and does not) require
providers to use the “best available” technology. 2 Instead of mandating that all providers use the
2
Compare 42 C.F.R. § 495.8(b) (requiring “certified” software), with 33 U.S.C. § 1311(b)(2)(A)
2
software it deemed “best,” ONC explained its intention was to create a “competitive marketplace”
that would allow providers “to choose from a variety of offerings” that met its certification criteria.
75 Fed. Reg. 2014, 2023/1 (2010). Providers were therefore able to “choose” whether their
practices needed top-of-the-line software or if more budget friendly options would do just as well.
Second, Relators are flat wrong that the Meaningful Use regulations required hospitals to
represent “that its EHR software met the [certification] requirements.” Opp. 45-47. The
Meaningful Use regulations only required hospitals to attest that they “used certified EHR”
software. 42 C.F.R. § 495.8(b) (2014). It did not require hospitals to look behind the certification
and give an independent assessment of whether the software “should have been certified.” And
the hospitals did not make any such representations in the attestations that they actually submitted
to the government. Indeed, as CHSPSC pointed out in its motion, it would have been impossible
for the hospitals to represent that the software “should have been certified” or that the software
possessed all the functionalities for certification because the CMS web portal used for attestations
only permitted hospitals to provide a unique identifying number 3 identifying the certified software
that they used—nothing more and nothing less. See CHSPSC Mot. 7-8.
Relators offer no serious response. They do not dispute that § 495.8 only required hospitals
to attest that they “used certified EHR” software. And they are entirely silent on the impossibility
point—Relators, tellingly, do not contend that the attestation form allowed hospitals to make the
representations that they now attribute to them. Instead, as a last-ditch effort, they attempt to
shoehorn their “should not have been certified” theory into the definition of “certified EHR
technology.” Opp. 45-46. Starting in 2014, “certified EHR technology” was defined as:
EHR technology . . . certified under the ONC Health IT Certification Program that
meets one of the following: (i) [t]he 2014 Edition Base EHR definition and has
(requiring use of “best available technology” under Clean Water Act), and 42 U.S.C. § 7412(g)(2)
(requiring use of “maximum achievable control technology” under Clean Air Act).
3
Providers generated that number by selecting the certified software they used from the Certified
Health IT Product List (“CHPL”) website. See ONC, Generation of CMS EHR Certification ID at
2, https://tinyurl.com/yyfrnwxj.
3
been certified to the certification criteria that are necessary to be a Meaningful EHR
User . . . , (ii) [certain enumerated certification criteria], [or] (iii) [t]he definition
for 2018 subsequent years.
42 C.F.R. § 495.4 (2015).4 Relying on that definition, Relators argue that when hospitals attested
that they “used certified EHR technology,” they were actually representing (whether they knew it
or not) “both that the software has been certified” and independently vouching that the software
has the functions to “meet[] the requirements of a Base EHR,” Opp. 46, or so the theory goes.
As an initial matter, Relators offer no explanation for how a definitional amendment that
became effective in 2014 could have rendered hundreds of pre-2014 attestations false. In addition,
Relators’ new definitional theory flips the actual regulation on its ear. Far from seeking to impose
a burdensome new verification requirement on providers, this definitional amendment aimed to
reduce the burden on providers by giving them more “flexibility” to pick software that had been
certified to the providers’ particular needs. See 77 Fed. Reg. 54,163, 54,257/2 (2012). The
regulations previously defined “certified EHR technology” as software that was certified to “all
applicable certification criteria.” 45 C.F.R. § 170.102 (2012). That all-or-nothing definition
resulted in many providers paying for features that they would never use—dentists, for example,
had to buy EHR software that could submit immunization records even though they do not
administer vaccines (and therefore are excused from the vaccine-related Meaningful Use
objectives). See 77 Fed. Reg. 13,832, 13,864/2 (2012). The language on which Relators now rely
was intended to curb some of that wasteful spending by setting a baseline that all certified software
must meet (the Base EHR), but otherwise allowing software to be “certified to [the] certification
criteria that [the providers] would need/use to demonstrate [Meaningful Use].” 77 Fed. Reg. at
54,257/1; see also id. at 54,164/2-3.5
Until now, there has never been any indication that anyone read that definition to impose
4
Although Relators purport to cite the January 2014 version of this section, the “Base EHR”
language upon which they rely was not added to § 495.4 until December 2015. However, similar
language in the ONC regulations became effective in 2014. See 45 C.F.R. § 170.102 (2012).
5
See also ONC, Proposed Rule Standards & Certification Criteria 2014 Ed. at 7, 11, 15-16, 20-
22 (illustrations depicting how the new definition changed the required certification criteria from
all to potentially less than all) https://tinyurl.com/y44ozm58.
4
an expansive new burden on providers to independently verify the functionality of certified
software. ONC never even hinted at such a notion in either its proposal announcing the definitional
amendment or the final rule implementing it. See 77 Fed. Reg. 13,832 (proposed rule); 77 Fed.
Reg. 54,163 (final rule). CMS was likewise silent when it adopted that language into the
Meaningful Use regulations. See 80 Fed. Reg. 62,762 (2015). Nor does it appear to have been
mentioned in any of the 450 public comments on the ONC proposed rule or the 1,800 comments
on the CMS proposal.6 There also are no CMS manuals, publications, or guidance discussing this
purported new obligation on providers to second-guess the functionality of certified software.
CHSPSC is not aware of any industry or academic source who maintains that providers are
obligated to independently verify functionality. Nor are there any administrative rulings,
enforcement actions, or False Claims Act lawsuits based on this so-called obligation.7 At least to
CHSPSC’s knowledge, no one other than Relators has ever suggested such a reading of
Meaningful Use. 8 So even if Relators were correct about this strained statutory interpretation (and
they are not), their claims still should be dismissed because they do not allege that anyone at
CHSPSC or the hospitals shared this understanding of the Meaningful Use regulations but attested
anyway.
In any event, Relators give no reason to think that CMS engaged “in a high-stakes game of
hide-and-seek” with hundreds of thousands of doctors and hospitals by writing a substantive

provision (42 C.F.R. § 495.8) that merely required “use[]” of certified software but “embedding a
substantially different and . . . much more costly requirement in the [regulation’s] definitions
6
Health IT; Implementation Specifications, and Certification Criteria: EHR Technology, 2014
Edition, No. HHS-OS-2012-004, https://tinyurl.com/y5ecukco; Medicare and Medicaid Programs;
EHR Incentive Program-Stage 3, No. CMS-2015-0033, https://tinyurl.com/y3sdjvov.
7
Relators trumpet the Government’s intervention and settlements in U.S. ex rel. Delaney v.
eClinicalWorks LLC., No. 2:15-CV-0095 (D. Vt.) and United States v. Greenway Health, LLC, No.
2:19-CV-00020 (D. Vt.). See Opp. 43, 62. Yet, both cases were brought against only the software
vendors. CHSPSC is not aware of any FCA case against a provider relating to Meaningful Use.
8
That should come as no surprise because the statutory language that ONC and CMS interpreted
in these rules defines “certified EHR technology” as software that “is certified pursuant to [the
ONC certification program] as meeting [the ONC’s certification] standards.” 42 U.S.C. § 300jj(1).
5
section.” See NACS v. Bd. of Governors of the Fed. Reserve Sys., 746 F.3d 474, 494 (D.C. Cir.
2014). Regulators generally do not “hide elephants in mouseholes.” Cf. Whitman v. Am. Trucking
Associations, Inc., 531 U.S. 457, 468 (2001). That is doubly true when the “mousehole” is a
definitional section; indeed, the Federal Register’s own drafting rules repeatedly instruct agencies
“not [to] include substantive regulatory provisions in a definition.”9 Accordingly, Relators’
attempt to read its “should not have been certified” theory of liability into the definitions must fail.
In a similar vein, Relators argue that the hospital attestations falsely represented that
Medhost’s “Emergency Room software (EDIS) and inpatient hospital software (Enterprise)
modules10 could seamlessly integrate information.” Opp. 22, 48-50. Relators insist that such
representations are necessary “to attest to Meaningful Use based on multiple Meaningful Use
modules,” id. at 48, but their ipse dixit does not make it so. As CHSPSC’s motion explained, these
integration allegations must fail because CMS clearly stated in the rulemaking that it was “not
requiring the certification of combinations of certified EHR Modules, just that the individual EHR
Modules combined have each been certified to all applicable certification criteria in order for such
a ‘combination’ to meet the definition of Certified EHR Technology.” CHSPSC Mot. 9 (quoting
75 Fed. Reg. at 2023/2). And Relators, again, ignore the fact that the attestation form did not
require any representations regarding the integration of certified modules—in fact, hospitals could
not have made any representations about integration even if they wanted to because the CMS web
portal provided no room for any such commentary. See id. Relators may find those points
inconvenient, but they cannot stave off dismissal by simply pretending they do not exist. 11
9
Office of the Federal Register, Document Drafting Handbook (Aug. 2019) at 2-27, 3-33 to 3-34,
https://tinyurl.com/yxcdjnrn; see also Federal Plain Language Guidelines (“Never include
regulatory or substantive material in definitions.”), https://tinyurl.com/yyyed5vk.
10
Relators’ argument seems to wrongly assume that Enterprise was certified as an EHR Module.
But the ONC plainly certified it as a Complete EHR, not a module. See CHPL, https://tinyurl.com/
y4pukch9. In any event, Relators’ argument fails because, as explained infra, the hospitals did not
make (and CMS did not require) any representations about software integration.
11
Instead of actually addressing CHSPSC’s arguments, Relators dismiss them out of hand
because, according to Relators, CHSPSC “inappropriately focus[ed]” on “interoperability rules”
instead of “integration.” Opp. 50. That argument is passing strange. The interoperability rules
6
Next, Relators chide CHSPSC for arguing that hospitals can conclusively “rely on
certification” when the ONC never “even suggest[ed]” such a notion. Opp. 47. But the ONC’s
regulations repeatedly stressed that hospitals “must be able to rely on the certifications.” 76 Fed.
Reg. 1262, 1282/3 (2011); see also 75 Fed. Reg. at 2022/1 (“[H]ospitals can be assured that once
they adopt and implement Certified EHR Technology, it includes, at a minimum,
the . . . capabilities required to support their achievement of . . . meaningful use . . . .”); CHSPSC
Mot. 8. As CMS made abundantly clear, providers could rely on the certification because “certified
EHR technology will always be able to support achievement of the [Meaningful Use] measure[s]
by including the necessary functionalities.” 75 Fed. Reg. 44,314, 44,331/2 (2010). Indeed, even
if a hospital knows that its software has been decertified, it “can still use that product to attest” for
any “EHR reporting period ended before the decertification occurred.”12 Here, both the Medhost
and Pulse software were and remain fully certified and, accordingly, the hospitals (and CHSPSC)
were entitled to rely on those validly issued certifications in their attestations.
B. The hospitals correctly attested to meeting the required measures of EHR use,
not that the EHR software was flawless in every circumstance
Each of the Hospitals truthfully attested that it met the required percentage-measures
necessary to satisfy Meaningful Use. Relators do not allege otherwise. Instead, Relators argue
that the percentages are irrelevant because “[u]nderlying those percentage requirements was the
need for every certified functionality to work accurately and reliably.” Opp. 10, 51-53.
Analogizing to tax software, Relators argue that users of TurboTax “rely on [it] to correctly
calculate their taxes every time” and “TurboTax must actually be able to do so.”13 Id. at 52.
that Relators reference are discussed nowhere in CHSPSC’s motion and the word
“interoperability” appears only once—in a quotation in a footnote. See CHSPSC Mot. 3 n.3. By
contrast, the relevant page of CHSPSC’s motion (correctly cited in Relator’s opposition) uses the
term “integration” five times. Opp. 50 (citing CHSPSC Mot. 9).
12
CMS, Certified EHR Technology FAQ No. 12657, https://tinyurl.com/yyqo8hw9.
13
While TurboTax surely appreciates the vote of confidence, Relators’ claim that TurboTax gets
it right “every time” is also mistaken. Less than six weeks ago, a thrift store worker, who makes
$10 an hour, received a $216-million tax bill because of a “TurboTax glitch.”
https://tinyurl.com/yy879e3b.
7
According to Relators, the “same principle” applies to EHR software and if the software cannot
record every order correctly then it should be treated as if it recorded no orders at all. Id.
But, again, Relators seek to distract with overheated rhetoric and hyperbolic claims about
patient safety.14 That misdirection seeks to obscure that Relators did not allege that the hospitals
attested that the Medhost software worked perfectly “every time.” No matter how many times
Relators repeat their mantra that the software had to be “accurate and reliable,” e.g., Opp. 47, they
never point to any regulation requiring the hospitals to attest that the software passed any quality
control tests or otherwise met any measure of reliability or accuracy.15 Relators also cannot point
to any CMS manuals, publications, or guidance, nor do they cite to any industry or academic
materials, that place a reliability or accuracy requirement on providers using certified software.
Relators likewise fail to identify a single administrative ruling, enforcement action, or FCA lawsuit
that relies on this “reliability or accuracy” theory against a hospital. And, again, Relators cannot
point to any place on the attestation form where a hospital makes a representation regarding the
reliability or accuracy of certified software. That is because no such requirement exists.
Indeed, Relators cannot even say how “accurate” is accurate enough or how “reliable” is
reliable enough. Other than insisting that the software get it right every time without fail (an
obviously impossible goal that no software or hospital could meet), Relators identify no standard
for the Court to apply. The Court would therefore be left at sea in evaluating Relators’ nebulous
“accuracy and reliability” allegations. See CHSPSC Mot. 11-12. Apart from the fact that such a
line-drawing exercise is inherently regulatory—not judicial—it would also fail to state a false
claim because hospitals cannot knowingly lie about crossing a line that has yet to be drawn.
14
In its Motion to Dismiss, CHSPSC noted that the Relators’ Complaint never alleges any actual
patient harm. CHSPSC Mot. 12 n.11. Notably, the Opposition does not dispute this.
15
That is not to say that Meaningful Use had no guardrails to prevent inaccurate, unreliable, or
unsafe software from coming to market. To the contrary, that was the point of certification. The
ONC stressed to providers that “Certified EHR Technology will possess the capabilities that can
assist any health care provider to improve the quality, safety and efficiency of the care they
deliver.” 75 Fed. Reg. at 2015/2-3. And even Relators admit, albeit reluctantly, that the point of
certification was to give providers assurance “that the product would perform as described by the
vendor and meet quality standards for use in healthcare settings.” Opp. 47.
8
C. Each hospital correctly attested that it provided Clinical Decision Support

Each hospital attested to providing one clinical decision support (“CDS”) intervention in
Stage 1 and five CDS interventions in Stage 2 as required by Meaningful Use. See 42 C.F.R.
§ 495.6(f)(10), (l)(5) (2014). The interventions that the hospitals chose to implement—a fall-risk
assessment in Stage 1 and condition-specific order sets in Stage 2—fit comfortably within the
“significant” leeway that CMS afforded providers to choose interventions that were best suited for
their practices and patients. 75 Fed. Reg. at 44,350/2; see also CHSPSC Mot. 13-16.
Relators nevertheless contend that the hospitals’ CDS attestations were false. First,
Relators argue that the CDS interventions used here fall outside the regulatory definition.
According to Relators, providers do not satisfy the CDS measure unless the CDS “uses person-
specific data from” certain specified sources. Opp. 54. Relators, however, cite to regulations that
govern software certification and not Meaningful Use provider attestations. See id. (citing 45
C.F.R. § 170.306(c) (2010), 45 C.F.R. § 170.314(a)(8) (2012)). Although Relators insist these
requirements must also apply to the attestations because “there is no separate definition of ‘Clinical
Decision Support’ in the Meaningful Use regulations,” Opp. 57, that argument is meritless. The
ONC could not have been plainer in stating that the software certification requirements “do not
establish requirements for health care providers, such as . . . hospitals to follow.” 75 Fed. Reg. at
2024/1. True—that leaves the CDS requirements for Meaningful Use somewhat undefined. But
that is by design. In drafting the CDS requirements, CMS intentionally retained an open-ended
description to “allow a provider significant leeway in determining [appropriate] clinical decision
support.” 75 Fed. Reg. at 44,350/2. While “nearly half of the commenters mentioning clinical
decision support suggested that the term needed additional clarification,” CMS refused to “add[]
a more limiting description” because it “believe[d] that [the selection of CDS] is best left to the
provider taking into account their workflow and patient population.” Id.16
16
Relators contend that a cross-reference imported the “patient-specific data” requirement for
software certification into Meaningful Use. Opp. 57 (quoting 77 Fed. Reg. 53,968, 53,995/3
(2012)). If, as Relators claim, CMS had intended to cull out any CDS that did not use “patient-
specific” data, presumably CMS would have said so explicitly rather than hoping that a coy cross-
9
Second, Relators argue that the hospitals’ CDS attestations were false because Medhost’s
“CDS functionality did not work.” Opp. 55. The Meaningful Use regulations only required
hospitals to “implement [] clinical decision support interventions.” 42 C.F.R. § 495.6(l)(5)(ii)(A)
(2014); id. § 495.6(f)(10)(ii). Consistent with the “significant leeway” afforded to providers, CMS
did not require providers to use the built-in CDS functionality to meet that goal; instead, providers
were free to use other methods including “external system[s]” so long as “such systems [] “interact
with [the] certified EHR technology.” CDS Tipsheet at 3. Relators do not—and cannot—allege
that the CDS interventions here (fall-risk assessment and condition-specific order sets) do not
interact with the Medhost EHR. Their “functionality” argument therefore must fail too.
Finally, Relators halfheartedly argue that Meaningful Use “require[d] hospitals to . . . track
compliance with” the CDS. Op. 55. But, as CHSPSC explained in its motion, CMS specifically
excluded the “track compliance” language from the measure that hospitals were required to meet.17
CHSPSC Mot. 15 (quoting 42 C.F.R. § 495.6(f)(10)(ii) (2014)). And, if that were not clear enough,
CMS also expressly instructed that hospitals are “not required to demonstrate . . . compliance
efforts with [] CDS.” Id. (quoting 75 Fed. Reg. at 44,351/2). Relators offer no response to those
arguments, essentially conceding the point.
II. RELATORS FAIL TO PLEAD FRAUD WITH PARTICULARITY AGAINST

CHSPSC
To satisfy Rule 9(b), Relators cannot just allege various software problems and provide a
list of attestations; instead, they must plead a factual nexus that links the supposed software
problems to particular false attestations. See Corsello v. Lincare, Inc., 428 F.3d 1008, 1012 (11th
Cir. 2005) (per curiam); U.S. ex rel. Fernandez v. Miami Cancer Inst., 2019 WL 1993513, at *3
citation would do the trick. Such a cramped interpretation of CDS also is impossible to square
with the next two pages of the Federal Register in which CMS included a host of non-patient-
specific items in a list of acceptable CDS interventions, including “documentation templates,”
“pre-specified order sets,” and “disease specific order sets.” 77 Fed. Reg. at 53,996/2, 53,997/1.
17
To the extent that Relators argue that “track[ing] compliance” was required by the objective,
that arguments fails too. CMS has repeatedly made clear that “achievement of the measure always
equates to achievement of the objective.” 75 Fed. Reg. at 44,331/2.
10
(S.D. Fla. May 6, 2019). The Complaint alleges that, during the rollout of Stage 2 software in
“2014 and 2015,” the hospitals encountered a hodgepodge of bugs and problems with the Medhost
software, including glitches with the CPOE system “under certain circumstances,”18 claims that
certain hospitals had problems of one sort or another,19 certain supposedly broken bells-and-
whistles,20 an order set mapping issue that supposedly would take a week or two to “clean up,”21
and certain features that Relators claim would have made the software better.22 But, critically,
Relators failed to plead any examples of problems prior to the 2014 rollout and failed to provide
the necessary detail about the problems that they contend began in 2014—e.g., details identifying
the “circumstances” under which the software would malfunction, when the malfunctions
occurred, the frequency of the problems, whether CHSPSC (or the hospitals) were able to remedy
those problems, or how those problems caused any—much less all—of the hospitals’ attestations
to be false. CHSPSC Mot. 17-19.
Relators offer no real explanation for how these supposed software problems caused any
statement on a hospital’s attestation form to be false. Indeed, Relators seem to fall back on their
contention that the software “fail[ed] . . . to meet the certification standards” and therefore “should
not have been certified” in the first place. See Opp. 32, 43; see also id. at 67-68 (“Relators did not
bring a FCA case premised on ‘glitches and bugs’ in Medhost’s software” but instead allege that
“Medhost’s software lacked functionality required for certification.”); id. at 23 (Software “lacked
functionality required . . . to be eligible for certification.”). As explained, supra, such allegations
fail to state a claim against CHSPSC because Meaningful Use only required the hospitals to attest
that they used certified software and not that the software should have been certified.
Relators attempt to end-run that pleading requirement by pointing to the list of attestations
18
See, e.g., FAC ¶¶ 155-159, 180-84 (alleging problems “under certain circumstances” with
weight-based dosing, “medication name mismatch,” and drug verification).
19
See FAC ¶¶ 187-190 (problems with pharmacy orders at two hospitals and IV packs at a third).
20
See FAC ¶¶ 160-164 (“Send Dose Now”), 171-179 (PRN orders and “Physician’s Favorites”).
21
FAC ¶¶ 193-202.
22
See, e.g., FAC ¶¶ 165-170 (software should have used more dynamic weight-based dosing).
11
attached to their complaint. Yet, Exhibit B merely lists “every claim” submitted by a CHSPSC-
affiliated hospital that used Medhost or Pulse software. See Opp. 29-30. Nothing on Exhibit B
identifies what statement was purportedly false in the hospital attestations or explains why it was
false. As to any of the hundreds of attestations, Exhibit B does not put CHSPSC on notice about
“the details of [CHSPSC’s] allegedly fraudulent acts, when they occurred, and who engaged in
them.” U.S. ex rel. Clausen v. Lab. Corp. of Am., 290 F.3d 1301, 1310 (11th Cir. 2002). Relators
have failed to provide the critical link or “nexus” to connect the attestations to the alleged software
problems, and thus their Complaint fails to satisfy their pleading burden under Rule 9(b).23
Finally, Relators argue that the pleading standard should be relaxed because they had
“direct and personal involvement.” Opp. 32-34; see also id. 41-42. While the Eleventh Circuit
will allow a case to proceed where there is “clear indicia of reliability,” it sets a “high bar” for such
a finding that requires “firsthand knowledge of a defendant’s actual submission of false claims.”
U.S. ex rel. Aquino v. Univ. of Miami, 250 F. Supp. 3d 1319, 1332, 1334 (S.D. Fla. 2017)
(concluding “manager and decision-maker” who was not involved with the claim submission
process had insufficient knowledge); see also U.S. ex rel. Atkins v. McInteer, 470 F.3d 1350, 1359
(11th Cir. 2006) (same).24 Here, Relators have specifically pled that they had no involvement with
the attestation process. Opp. 24-25. Therefore, they fall well short of clearing that “high bar.”
III. RELATORS FAIL TO PLAUSIBLY PLEAD WRONGFUL KNOWLEDGE

AGAINST CHSPSC
To state a claim under the FCA, Relators must plead facts that would “show that the
23
Relators rely heavily on U.S. ex rel. Osheroff v. Tenet Healthcare, 2012 WL 2871264 (S.D. Fla.
July 12, 2012), but Osheroff is entirely irrelevant—the issue discussed in the cited portion of that
case is whether the relators had sufficiently alleged the submission of any claim at all. Id. at *5-6.
Here, no one disputes that the hospitals submitted attestations; the question is whether Relators
have alleged the critical link demonstrating the falsity of those attestations. They have not.
24
The cases Relators cite are therefore easily distinguishable. See Hill v. Morehouse Med. Assocs.,
Inc., 2003 WL 22019936, at *5 (11th Cir. Aug. 15, 2003) (per curiam) (relator employed in the
“billing and coding department”); U.S. ex rel. Matheny v. Medco Health Sols., Inc., 671 F.3d 1217,
1220 (11th Cir. 2012) (relators employed by accounting department); U.S. ex rel. Walker v. R&F
Properties of Lake Cty., Inc., 433 F.3d 1349, 1360 (11th Cir. 2005) (nurse relator personally billed
her time using a doctor’s code).
12
defendant acted knowingly” or with “reckless disregard,” rather than as a result of “innocent
mistakes or simple negligence.” Urquilla-Diaz v. Kaplan Univ., 780 F.3d 1039, 1058 (11th Cir.
2015); Ashcroft v. Iqbal, 556 U.S. 662, 680-81 (2009); U.S. ex rel. Headen v. Adams & Assocs.,
Inc., 2017 WL 6017775, at *10 n.17 (N.D. Ala. Dec. 5, 2017).
Relators fail to meet that pleading burden. They do not allege that anyone at CHSPSC
believed that any of the attestations were false, they do not allege any incriminating meetings,
conversations, or emails, and they do not allege any facts supporting a cover up. To the contrary,
Relators’ factual allegations cut against scienter. In their Complaint (and again in their
Opposition), Relators detail how CHSPSC devoted “considerable resources” and staffed a “large
team” including “CHS executive leadership” to “address software and deployment problems.”
FAC ¶¶ 12, 86-87, 91-92; Opp. 25, 71. And the Opposition highlights that the HMA hospitals
voluntarily repaid over $30 million in Meaningful Use incentive payments after an internal review
revealed that certain hospitals did not meet the attestation criteria. Opp. 3 n.3.25 That utter lack of
factual allegations should result in dismissal.
Relator’s “response” only serves to prove CHSPSC’s point.26 The two paragraphs of the
Complaint they cite allege that there were reports of “physician frustration” with the software in
2014. Opp. 68 (citing FAC ¶¶ 90-91). As described in those paragraphs, those “reports” consisted
of two emails from a single Indiana hospital on two days in July 2014 reporting problems with new
Stage 2 software that had just recently been “rolled out” to that hospital. See FAC ¶ 88. That is
woefully insufficient. The FCA requires Relators to plead “facts creating an inference that the
individual(s) who submitted the alleged false [attestations] to the government did so with
knowledge of their falsity.” U.S. ex rel. Barrett v. Beauty Basics, Inc., 2015 WL 3650960, at *5
(N.D. Ala. June 11, 2015). These “reports” of “frustration” with software issues at one hospital do
25
Citing Industry News, HMA Announces Restatement of Financial Statements (Nov. 13, 2013),
https://www.hitechanswers.net/hma-announces-restatement-financial-statements/.
26
To the extent Relators contend that scienter cannot be considered on a motion to dismiss, see
Opp. 65, that argument is frivolous. See Iqbal, 556 U.S. at 680-681; see also Bright v. Thomas,
754 F. App’x 783, 787 (11th Cir. 2018) (per curiam); Barrett, 2015 WL 3650960, at *5.
13
not show knowledge of falsity or fraud. As an initial matter, Relators offer no explanation of how
such “reports” from 2014 could support an inference that hundreds of pre-2014 attestations were
knowingly false. Relators also fail to explain how physician dissatisfaction rendered false any
statement in the hospital attestations. And far from even hinting that “every” attestation was false,
nothing in either report even gestures in the direction of Meaningful Use.27
IV. RELATORS FAIL TO STATE AN ANTI-KICKBACK STATUTE VIOLATION

To argue against dismissal of their kickback theory, Relators resort to badly distorting
CHSPSC’s actual argument. CHSPSC is not arguing that the claim should be dismissed because
“federal funds did not directly pay for the EHR software.” Opp. 71-72. The AKS is inapplicable
because the incentives here were not a payment “to purchase” EHR software; they were payments
for using EHR software.28 42 U.S.C. § 1320a-7b(b). Hospitals could receive those payments even
if they developed their own software (as Relators contend HMA did) in lieu of a “purchase.” And
they are entitled to receive the full payment amount regardless of the software’s actual cost, which
would be an exceedingly strange way to handle “reimbursement.” Cf. 42 C.F.R. § 413.9 (requiring
“[a]ll payments to providers of [Medicare] services [to] be based on the reasonable cost”).
In any event, even if the AKS did apply, Relators’ AKS allegations would still fail because
they are inadequately pled. Relators’ only response to CHSPSC’s Rule 9(b) arguments is to insist
27
CHSPSC moved to dismiss Relators’ allegations related to the HMA hospitals raising two
arguments: (1) the Complaint failed to link supposed problems with medical reconciliation to a
false attestation, and (2) it failed to plead any facts supporting its claim of scienter. CHSPSC Mot.
19-21. Relators responded with silence; indeed, only three paragraphs of Relators’ 80-page
opposition brief even mention HMA, and all three simply parrot the insufficient allegations from
the Complaint without anywhere addressing CHSPSC’s motions for dismissal. Opp. 26, 49, 68.
Relators’ claims related to the HMA hospitals should therefore be deemed abandoned. See Kohli
v. Pembroke Lakes Mall, LLC, 2017 WL 4863089, at *2 (S.D. Fla. Oct. 26, 2017); see also Gore
v. Jacobs Eng’g Grp., 706 F. App’x 981, 985-86 (11th Cir. 2017) (per curiam).
28
The cases Relators cite are not to the contrary. Both concern the purchase of goods that would
likely be eventually repaid using federal funds. MedPricer.com v. Becton, Dixon & Co., 240 F.
Supp. 3d 263, 273 & n.10 (D. Conn. 2017) (purchase of medical equipment, primarily syringes);
Guilfoile v. Shields, 913 F.3d 178, 183-84, 191-93 (1st Cir. 2019) (specialty pharmacy company
paying consultant to secure contracts with hospitals).
14
that merely claiming the existence of some agreement for free software with otherwise unknown
terms involving unnamed hospitals agreed to by unnamed parties at an unknown date29 that may
have been oral or may have been written and that Relators learned about from unnamed sources
and “common knowledge” is good enough. Opp. 74; see also FAC ¶¶ 283-84. And, somehow
Relators believe that the allegations about a supposed equity arrangement pass muster when they
explicitly state they never saw any such agreement and claim to have only heard about it through
office gossip. See FAC ¶¶ 285-86; Opp. 74-75. Such vague claims based on second- or third-hand
rumors fail to satisfy the particularity requirements of Rule 9(b).
The AKS claims should also be dismissed because Relators fail to plead facts supporting
scienter. CHSPSC Mot. 24. In response, Relators make the brazen claim that a bare assertion that
“CHS knew the purpose of the offer of the free software” is enough. Opp. 75. Iqbal says otherwise.
556 U.S. at 680-81; see also Lary v. Trinity Physician Fin. & Ins. Servs., 780 F.3d 1101, 1107 (11th
Cir. 2015); Bright, 754 F. App’x at 787; Barrett, 2015 WL 3650960, at *5.
V. THE COMPLAINT IS AN IMPROPER SHOTGUN PLEADING

Even if Relators could state a claim (and they cannot), the Complaint should still be
dismissed as an improper shotgun pleading because the Complaint both fails to distinguish
between the various defendants and alleges all four substantive FCA claims in a single count. See
CHSPSC Mot. 24-25.

CONCLUSION
For the reasons set forth above and in its opening brief, Defendant CHSPSC’s motion to
dismiss should be granted and Relators’ claims against CHSPSC should be dismissed with
prejudice.
29
Relators’ claim that Medhost “initiated” the “free” software scheme “at the same time it
expanded the Medhost Enterprise software suite,” FAC ¶ 283, but tellingly cannot assign even a
rough date to those events and cannot identify the date of the supposed agreement.
15
Dated: November 7, 2019 Respectfully submitted,
By: /s/ Martin B. Goldberg

Martin B. Goldberg
LASH & GOLDBERG LLP

Martin B. Goldberg
Daryl L. Saylor
100 Southeast 2nd Street, Suite 1200
Miami, FL 33131-2158
Telephone: (305) 347-4040
Facsimile: (305) 347-4050
mgoldberg@lashgoldberg.com
dsaylor@lashgoldberg.com
ROBBINS, RUSSELL, ENGLERT,

ORSECK, UNTEREINER & SAUBER LLP
Michael L. Waldman (pro hac vice)
Brandon L. Arnold (pro hac vice)
Lauren M. Cassady (pro hac vice)
2000 K Street NW, 4th Floor
Washington, DC 20006
Telephone: (202) 775-4500
Facsimile: (202) 775-4510
mwaldman@robbinsrussell.com
barnold@robbinsrussell.com
lcassady@robbinsrussell.com
Counsel for Defendant CHSPSC, LLC
16
CERTIFICATE OF SERVICE
I HEREBY CERTIFY that on November 7, 2019, I electronically filed the foregoing with
the Clerk of the Court by using the CM/ECF system. I also certify that the foregoing document is
being served this day on all counsel of record or pro se parties identified below in the Service List
in the manner specified, either via transmission of Notices of Electronic Filing generated by
CM/ECF or in some other authorized manner for those counsel or parties who are not authorized
to receive electronically Notices of Electronic Filing.
By: /s/ Martin B. Goldberg

Martin B. Goldberg
SERVICE LIST:
Jeffrey W. Dickstein (FL Bar No. 434892)

PHILLIPS & COHEN LLP
Southeast Financial Center
200 S. Biscayne BlVd., Suite 2790
Miami, Florida 33131
Tel: (305) 372-5200
jdickstein@phillipsandcohen.com
Colette G. Matzzie (admitted pro hac vice)

Luke J. Diamond (pro hac vice anticipated)
2000 Massachusetts Avenue,
NW Washington, DC 20036
Tel: (202) 833-4567
cmatzzie@phillipsandcohen.com
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100 The Embarcadero, Suite 300 San Francisco, CA 94105
Tel: (415) 836-9000
earens@phillipsandcohen.com
David J. Chizewer (pro hac vice anticipated)

David E. Morrison (admitted pro hac vice)
Harleen Kaur (pro hac vice anticipated)
Danielle K. Johnson (pro hac vice anticipated)
Juan C. Arguello (pro hac vice anticipated)
GOLDBERG KOHN LTD.
17
55 E. Monroe Street, Suite 3300

Chicago, IL 60603
Tel: (312) 201-4000
Fax: (312) 863-7472
David.Chizewer@goldbergkohn.com
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18

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Case 1:18-cv-20394-RNS Document 146 Entered on FLSD Docket 11/07/2019 Page 1 of 24

UNITED STATES DISTRICT COURT

Case No. 18-20394-CIV-Scola/Torres

UNITED STATES OF AMERICA ex rel.)

DEFENDANT CHSPSC, LLC’S REPLY IN SUPPORT OF ITS

LASH & GOLDBERG LLP

ROBBINS, RUSSELL, ENGLERT,

Counsel for Defendant CHSPSC, LLC

TABLE OF AUTHORITIES ...................................................................................................... ii

PRELIMINARY STATEMENT ................................................................................................. 1

I. RELATORS FAIL TO PLEAD THAT CHSPSC SUBMITTED A FALSE CLAIM ........... 2

A. The hospitals correctly attested to using certified software, and Meaningful

II. RELATORS FAIL TO PLEAD FRAUD WITH PARTICULARITY AGAINST

III. RELATORS FAIL TO PLAUSIBLY PLEAD WRONGFUL KNOWLEDGE

IV. RELATORS FAIL TO STATE AN ANTI-KICKBACK STATUTE VIOLATION ........... 14

V. THE COMPLAINT IS AN IMPROPER SHOTGUN PLEADING .................................... 15

Corsello v. Lincare, Inc.,

Gore v. Jacobs Eng’g Grp.,

Hill v. Morehouse Med. Assocs., Inc.,

Kohli v. Pembroke Lakes Mall, LLC,

Lary v. Trinity Physician Fin. & Ins. Servs.,

MedPricer.com v. Becton, Dixon & Co.,

NACS v. Bd. of Governors of the Fed. Reserve Sys.,

Urquilla-Diaz v. Kaplan Univ.,

U.S. ex rel. Aquino v. Univ. of Miami,

U.S. ex rel. Atkins v. McInteer,

U.S. ex rel. Barrett v. Beauty Basics, Inc.,

U.S. ex rel. Clausen v. Lab. Corp. of Am.,

U.S. ex rel. Fernandez v. Miami Cancer Inst.,

U.S. ex rel. Headen v. Adams & Assocs., Inc.,

U.S. ex rel. Matheny v. Medco Health Sols., Inc.,

U.S. ex rel. Osheroff v. Tenet Healthcare,

U.S. ex rel. Walker v. R&F Properties of Lake Cty., Inc.,

Whitman v. Am. Trucking Associations, Inc.,

Statutes, Regulations, and Rules

33 U.S.C. § 1311(b)(2)(A) .......................................................................................................... 2

42 U.S.C. § 300jj(1) .................................................................................................................... 5

42 U.S.C. § 1320a-7b(b) ........................................................................................................... 14

42 U.S.C. § 7412(g)(2) ................................................................................................................ 3

42 C.F.R. § 413.9 ...................................................................................................................... 14

42 C.F.R. § 495.4 (2015) ............................................................................................................. 4

42 C.F.R. § 495.6 (2014) ....................................................................................................... 9, 10

42 C.F.R. § 495.8 (2014) ..................................................................................................... 2, 3, 5

45 C.F.R. § 170.102 (2012) ......................................................................................................... 4

45 C.F.R. § 170.306 (2010) ......................................................................................................... 9

45 C.F.R. § 170.314 (2012) ......................................................................................................... 9

75 Fed. Reg. 2014 (2010) ............................................................................................ 3, 6, 7, 8, 9

75 Fed. Reg. 44,314 (2010) ............................................................................................... 7, 9, 10

76 Fed. Reg. 1262 (2011) ............................................................................................................ 7

77 Fed. Reg. 13,832 (2012) ..................................................................................................... 4, 5

77 Fed. Reg. 53,968 (2012) ................................................................................................... 9, 10

77 Fed. Reg. 54,163 (2012) ..................................................................................................... 4, 5

80 Fed. Reg. 62,762 (2015) ......................................................................................................... 5

Federal Rules of Civil Procedure 9 ..................................................................................... passim

CHPL, Medhost Enterprise Version 2014 R1 (Aug. 28, 2014),

CMS, Certified EHR Technology FAQ No. 12657, https://tinyurl.com/yyqo8hw9 ...................... 7

Complaint, United States v. Greenway Health, LLC,

Complaint, U.S. ex rel. Delaney v. eClinicalWorks LLC.,

Federal Plain Language Guidelines, https://tinyurl.com/yyyed5vk ............................................... 6