Formula and Enteral Nutrition-Eff112513

Medical Review Criteria
Formulas and Enteral Nutrition

Effective Date: November 25, 2013
Subject: Formulas and Enteral Nutrition
Overview:
This document describes the criteria used to facilitate fair, impartial, and consistent decisions regarding the coverage for formulas and
enteral nutrition.
Policy:
HPHC covers formulas and enteral nutrition 1 that are prescribed by a licensed health care provider, and
medically necessary to prevent clinical deterioration in members at nutritional risk2 when:
The requested formula/enteral nutrition is expected to provide more than 50% of the members daily
caloric intake; and
Clinical documentation confirms the member meets relevant criteria (listed below).
NOTE: For members with inherited diseases of amino acids or organic acids, low protein foods
ordered by a provider are covered in accordance with applicable state mandates.
Coverage requests must include pertinent clinical notes, and be submitted on the appropriate HPHC Request form
(available in HPHCs Provider Manual).
Infant Formula Review Request:
(https://www.harvardpilgrim.org/pls/portal/docs/PAGE/PROVIDERS/MANUALS/
REFERRAL/D%20INFANT%20FORMULA%20AUTH_061511.PDF)
Pedi/Adult Formula Review Request
(https://www.harvardpilgrim.org/pls/portal/docs/PAGE/PROVIDERS/MANUALS/REFERRAL/D%20PEDI_AD
ULT%20FORMULA_061511.PDF)
For infants and pediatric patients, weight for age, weight for height growth charts 3, and Body Mass
Index (BMI) charts (if applicable) must be submitted.
For adults, documentation of BMI and/or weight measured over time must be submitted.
Growth charts can be found at: http://www.cdc.gov/growthcharts/
Body mass index (BMI) calculators for children over the age of 2 years and for adults can be found at:
http://www.cdc.gov/healthyweight/assessing/bmi/
Authorization:
Prior authorization is required for formulas and enteral nutrition (including special medical infant formulas 4) requested for
1
Enteral Nutrition: Liquid feeding provided orally, or through a tube, catheter, or stoma, and used as a therapeutic regimen to prevent to prevent clinical
deterioration in patients at with medical conditions that preclude the full use of regular food including typical infant formulas (e.g., Similac, Nutramigen,
Enfamil).
2
A patient is considered to be at nutritional risk if he/she is malnourished, or at risk for developing malnutrition, due to a medical condition, chronic disease, or
increased metabolic requirements resulting from the inability to ingest or adequately absorb food.
3
HPHC uses age adjusted for gestational age when using growth charts. HPHC uses CDC-recommended WHO growth standards to monitor growth for
U.S. children up to 24 months, and CDC growth charts for U.S. children age 2 years and older.
4
Special medical infant formulas include, but are not limited to, transitional formulas for premature infants, extensively hydrolyzed formulas, amino
Page 1 of 12
HPHC Medical Review Criteria
Formulas and Other Enteral Nutrition
Coverage described in this policy is standard under most HPHC plans. Specific benefits may vary by product and/or employer group. Please reference
appropriate member materials (e.g., Benefit Handbook, Certificate of Coverage) for member-specific benefit information.
members enrolled in Core (HMO, POS, and PPO) products.

When formula/enteral nutrition is authorized, the authorization period for the subsequent requests may vary depending on
the members clinical condition and timing of follow up physician or nutritionist visits.
Prior authorization is not required for low protein foods covered under state mandates and ordered for members
with inherited diseases of amino acids or organic acids,
General Eligibility Criteria
Formulas/enteral nutrition are authorized when clinical notes and supportive testing confirm ALL applicable criteria are met:
1. The member has been diagnosed with a Covered Condition, and relevant Condition-Specific Criteria (listed below) are
met;
2. The requested formula/enteral nutrition is expected to provide more than 50% of the members daily nutritional
intake, and themembers age and/or medical condition precludes the use of regular food or supplementation
with commercially available food products (e.g., Carnation Instant Breakfast, thickeners, butter or cream
added to prepared foods) in sufficient caloric density to provide more than 50% of his/her daily caloric
needs.
For members over age 1 year, documented calorie counts and findings from a nutritionist evaluation are
required to confirm that the 50% threshold is met.
3. Requests for special medical formula for infants and children must include additional documentation:
For formula fed infants and children: Required documentation must confirm that, unless contra-indicated, at least 2
different commercial formulas (including at least one cow-milk based, and one soy based formula) have been tried for
a reasonable period of time (4-5 days per formula in most cases) and were not tolerated.
If trial of commercial formulas is contra-indicated or unsuccessful, documentation confirming the
contraindication(s) and/or failure of commercial formula trial(s) is required.
For infants and children transitioning from breast milk to formula: Required documentation must
include evidence of an appropriate maternal elimination diet.
If symptoms/clinical condition resolved with the maternal elimination of cow-milk or, and one soy
protein a trial of the same protein formula is not required.
If symptoms/clinical condition did not resolve after the elimination diet, a reasonable trial of both
cow-milk based and soy based formulas (typically 4-5 days per formula) is required.
For members over 1 year old: Relevant documentation including findings of nutritionist evaluation, calorie counts,
gastroenterologist and/or allergist evaluation (as appropriate) is required.
Specific documentation requirements may vary depending on Condition-Specific Criteria listed below.
Condition
Prematurity
Condition-Specific Criteria
Criteria
Premature transition formulas (e.g., Neosure,
Enfacare) are authorized for up to 3 months of life for:
Premature infants with birth weight of 1500g or
less, and a hospital discharge weight less than
the 10th percentile (for age corrected for
prematurity); or
Premature infants younger than 3 months of life
who are unable to tolerate cow milk-based
formula due to ANY of the Covered Conditions
Additional Information
Subsequent requests for
premature infants over 3 months
of life are re-evaluated against
General Eligibility Criteria, and
relevant Covered Condition Criteria
(listed below).
acid based formulas, ketogenic formulas, and specific metabolic formulas.

Page 2 of 12
Condition
Criteria
(listed below).
A trial of soy-based formula is not required for
premature infants younger than 3 months of life with
documented intolerance of cow milk-based formula.
Gastroesophageal Reflux
Disease (GERD)5
Special medical formulas are authorized for eligible

infants up to 9 months of life when ALL the
following are met:
1. Clinical history and physical exam document a
high probability of GERD characterized by
regurgitation associated with complications
and nutritional compromise 6; and
2. Trials of both cow-milk based and soy-based
formulas and thickened feeds have not been
successful in resolving symptoms.
Special medical formulas are typically

not authorized solely for treatment of
gastroesophageal reflux (GER). 7
Medical therapies, such as H2blockers or proton-pump inhibitors
may be ordered at the discretion
of the attending physician.
Subsequent requests for infants up to age 1 year

must include documentation confirming that
symptoms were significantly improved with the use
of the requested special medical formula; and
1. Retrials of both cow milk-based and soy-based
foods/formula were unsuccessful; or
2. Gastroenterologist evaluation confirms the ongoing need for the requested special medical
formula.
Subsequent requests for children over 1 year old
must include documentation of both nutritionist
consultation (including calorie counts), and
gastroenterologist evaluation.
Retrial of both cow milk-based foods/formula
and soy-based formula must be considered
unless contraindicated.
Bloody Stools With or
Without Weight Loss or
Other GI Symptoms
Special medical formulas are authorized for eligible

infants up to 1 year old when ALL the following are
met:
1. Guaiac card testing confirms the presence of
Potential formula-related
diagnoses include non-IgE
mediated food protein-induced
proctocolitis, food protein-induced
Additional information on the treatment of GERD in children is available at the NIH Information Clearinghouse, and in NASPGHAN Pediatric GE Reflux Clinical
Practice Guidelines 2009
http://digestive.niddk.nih.gov/ddiseases/pubs/gerdinfant/index.htm http://digestive.niddk.nih.gov/ddiseases/pubs/gerinchildren/index.htm
http://www.naspghan.org/user-assets/Documents/pdf/PositionPapers/FINAL%20-%20JPGN%20GERD%20guideline.pdf
6
Evidence of nutritional compromise includes weight loss/lack of weight gain due to insufficient caloric intake or formula refusal, blood in regurgitated foods,
or severe vomiting.
7
GER (the regurgitation of gastric contents) is common in infants, usually peaks at 4-6 months of life, and generally does not need medical treatment or a
change in formula. Parental reassurance, restriction of volume in overfed infants, and a trial of thickened formula are usually sufficient in these cases.
Page 3 of 12
Condition
Criteria
bloody stools; and
2. Other etiologies (e.g., anorectal fissure,
infectious/inflammatory colitis) have been
excluded by history and exam, and/or further
testing and serial guaiacs (when appropriate);
and
3. Bloody stools occurred while the infant was:
a. Being fed a cow milk-based formula; or
b. Breastfeeding, and a dairy elimination diet
resolved the problem.
Note: Trial of soy formula trial is not
required due to the high cross intolerance
to soy-based formula for these conditions.
GI Irritability
Special medical formula is authorized for infants up

to age 6 months of life with severe and persistent
symptoms, when General Eligibility Criteria (above)
are met.
Subsequent requests for infants age 6 months to 1
year old must include documentation confirming
that symptoms were significantly improved with the
use of the requested special medical formula; and
Retrials of both cow milk-based and soy-based
foods/formula were unsuccessful; or
Gastroenterologist evaluation confirms the ongoing need for the requested special medical
formula.
enteropathy, and food proteininduced enterocolitis. 8
Subsequent requests for children
over 1 year old must include
documentation of both nutritionist
consultation (including calorie
counts), and gastroenterologist
evaluation. Unless contraindicated,
retrial of both cow milk-based
foods/formula and soy-based
formula must be considered.
Mild to moderate symptoms in

the absence of weight loss, lack
of weight gain, significant
vomiting or gastrointestinal
bleeding, generally do not require
a formula change.
Mild to moderate symptoms
include spitting, fussiness and
gassiness or loose/mucous
containing stools.
Subsequent requests for children age 1 and older

must include:
Consideration of a retrial of both cow-milkbased and soy-based foods/formula; and
A nutritionist consult including calorie counts;
and
A gastroenterologist evaluation.
Eosinophilic
Esophagitis (EE)
Eosinophilic
Gastroenteritis
Enteral nutrition is authorized for eligible infants and

children when ALL the following are met:
Condition is documented by endoscopy and
biopsy; and
Documentation confirms the member is closely
followed by gastroenterologist, nutritionist 9, and
These conditions rarely occur

in infants. In children, the
condition is typically
characterized by symptoms
including intermittent
vomiting, food refusal,
Food protein-induced proctocolitis is associated with blood streaked stools in a generally healthy member. Food protein-induced enteropathy is
associated with malabsorption, failure to thrive, diarrhea and vomiting. Food protein -induced enterocolitis is associated with malabsorption and failure to
thrive; acute reactions include recurrent vomiting, diarrhea, and dehydration. Common non-food related etiologies are rectal fissures and
infectious/inflammatory colitis.
9
Nutritionist documentation of diet and calorie needs is required.
Page 4 of 12
Condition
Criteria
allergist (if clinically indicated); and
Either of the following:
For formula fed infants, there must be high
suspicion (by elimination diet or supportive
IgE specific antibody testing) that symptoms
are caused by milk and soy exposure; or
For children, the condition is caused by an
multiple food groups, and multi-food
elimination diet (including elimination of
milk and soy) is planned.
When criteria are met, the requested special medical

formula/enteral nutrition need not constitute more
than 50% of the members daily caloric intake as
treatment goal is to provide calories and nutrients
that cannot be obtained through regular
foods/allergy-free-vitamins in these highly allergic
members.
Malabsorption10
Special medical formula is authorized for eligible

infants up to 1 year old when ALL the following are
met:
Diagnosis of food protein-induced enteropathy
or enterocolitis is confirmed by a pediatric
gastroenterology evaluation; and
Malabsorption symptoms occurred while the
infant was being fed either:
Cow milk-based formula; or
Breast milk, and symptoms resolved with a
dairy elimination diet.
For eligible children and adults with malabsorption
and nutritional compromise (i.e., weight loss, lack of
weight gain, other nutritional deficiencies), enteral
nutrition is authorized for up to 6 months when ALL
the following are met:
1. Clinical documentation and supportive testing
confirm ANY of the following diagnoses:
Crohn's Disease
Ulcerative Colitis
Gastrointestinal Motility Disorders
Chronic Intestinal Pseudo-Obstruction
Cystic Fibrosis
2. The member is being closely followed by a
gastroenterologist and a nutritionist.
dysphagia, abdominal pain,
and/or weight loss.
Subsequent requests must include
documentation of intervening
medical and nutritional
reassessments (including calorie
counts) and follow up endoscopy
to determine if the clinical
condition has improved enough to
allow intake of other nutrients.
For infants with food proteininduced enteropathy or

enterocolitis, soy formula trial is
not required because of the high
cross intolerance to soy-based
formula in children with this
condition.
age 1 and older must include
evidence of:
Consideration of a retrial of
both cow-milk-based and soybased foods/formula; and
A nutritionist consult including
calorie counts; and
A gastroenterologist
evaluation.
10
Malabsorption in infants and children can be associated with chronic diarrhea and weight loss, and may be secondary to food protein-induced enteropathy or
enterocolitis (acute enterocolitis reactions are associated with recurrent vomiting, diarrhea, and dehydration), or to non-food related etiologies as well.
Page 5 of 12
Condition
Criteria
For formula fed infants and children, there must

be documentation confirming that cow milkbased and soy-based formula trials have failed.
When clinically appropriate, there must be
documentation confirming that the member has
attempted to supplement diet with commercially
available foods or nutritional supplements (e.g.,
Carnation Instant Breakfast, food thickeners,
butter or cream added to prepared foods, etc.).
Subsequent requests for authorization must include
documentation of intervening clinical and nutritional
reassessments (including documented calorie
counts) to determine if the members clinical
condition has improved sufficiently to allow intake of
adequate calories and nutrients.
Fai l ur e to Th ri v e
(FT T) 11
Special medical formula/enteral nutrition is

authorized for up to 6 months at a time when an
eligible member at nutritional risk meets ANY of
the following:
For infants and children up to 24 months of
age:
Decrease of 2 or more major weight for
age percentile lines over time; or
Weight less than the 5th percentile for age
(corrected for prematurity); or
Weight for length less than the 10th
percentile.
For children and adolescents (aged 2-18

years):
BMI for age less than the 5 th
percentile.
For adults:
Involuntary loss of more than 10% of
usual body weight over 3-6 months; or
BMI less than the 5 th percentile, or
18.5 kg/m 2 .
For members with cystic fibrosis and weight
Required documentation
includes:
Clinical history, and results of
physical exam and supportive
testing to evaluate potential
treatable causes of growth
failure;
Evidence that the member
has attempted, or is unable to
tolerate, supplementation
with commercially available
foods and nutritional
supplements (e.g., Carnation
Instant Breakfast, food
thickeners, butter or cream
added to prepared foods,
etc.), if appropriate;
A written plan of care for
regular monitoring of signs and
symptoms to detect
improvement in the members
condition.
For members over age 1 year,
additional requirements include:
11
The diagnosis of FTT is based on growth failure due to inadequate nutrient intake or absorption, increased nutritional losses , or
ineffective nutrient utilization. This diagnosis does not automatically apply to infants or children with medical conditions such as
intrauterine growth restriction, prematurity, or genetic short stature if the childs growth velocity is tracking along a wei ght for
length growth curve, even if the curve is less than the 2 n d percentile.
Page 6 of 12
Condition
Criteria
loss:
Weight for length/height or BMI less than
the 25th percentile.
For members on renal dialysis:

Weight loss with BMI less than 22; or
Falling serum albumin to less than 4 g/dl.
Subsequent requests for authorization require
documentation of intervening clinical and
nutritional reassessments (including calorie
counts) to determine if the members clinical
condition has improved sufficiently to allow
adequate intake of other nutrients.
IgE Mediated
Food Allergy

infants up to 1 year of age when there is
documentation confirming the presence of ANY of
the following symptoms:
Severe vomiting and abdominal pain within
minutes to hours of food ingestion; or
Severe diarrhea within 6 hours of food
ingestion; or,
Pruritis (localized or generalized); or
Angioedema and urticaria; or
Stridor, wheezing, or anaphylaxis.
NOTE: GI symptomotology generally
does not occur in isolation, and most
often is associated with involvement in
other organ systems.
For members with a non-urticarial rash, or a rash
and a negative IgE to soy, documentation of failed
cow milk-based and soy-based formula trials is
required.
Atopic
Dermatitis
(AD)12

infants up to age 1 year when ALL the following are
met:
Documentation confirms the role of both cow
milk-based and soy-based formulas in causing
the atopic dermatitis (e.g., an immediate
reaction after ingestion, or a well-defined
Detailed dietary/feeding
history including calorie
counts, and evidence of
referral to a nutritionist;
and
Documentation/results of
appropriate specialist
evaluation (e.g.,
gastroenterologist,
feeding/swallowing
specialist).
When cow milk-based formula is

clearly implicated in the highly
likely IgE mediated reaction, a soybased formula trial is not required.
(Although soy cross reactivity for
an IgE mediated response is low at
10-15%, and the cross occurrence
of anaphylaxis less than 1%.)
over age 1 year must include
documentation of ALL the
following:
Consideration of re-trial of
both cow milk-based and soybased foods/formula; and
Results of nutritionist
consultation (including calorie
counts); and
Results of allergist evaluation
to further document the food
allergy.
over age 1 year must include
documentation of ALL the
following:
Consideration of re-trial of
both cow milk-based and soybased food/formula;
12
Mild to moderate AD is generally not related to formula allergy even in the presence of food specific IgE antibodies. Food allergy may cause
1-3% of mild AD, and 5-10% of moderate AD. For severe AD, defined as widespread skin involvement which impairs quality of life that persists
despite first line medical therapy (moisturizers, wraps,topical steroids, and antihistamines), and occurring in very young infants, causal food
allergy may be present in 20-30%.
Page 7 of 12
Condition
Criteria
elimination diet); and
Allergist evaluation confirms the
presence of formula induced atopic
dermatitis.
Inborn Errors of
Metabolism including:
Phenylketonuria (PKU)
Tyrosinemia
Homocystinuria
Maple Syrup Urine
Disease
Propionic Acidemia
Methylmalonic
Acidemia
Other Organic
Acidemias
Urea Cycle Disorders
Special formulas/enteral nutrition is authorized when

a letter of medical necessity documenting relevant
clinical history, supportive evaluation and testing is
submitted.
Ketogenic
Formula for
Uncontrolled
Seizures
Ketogenic formulas are authorized for up to 6

months at a time when clinical documentation
confirms the member:
1. Has seizures that are refractory to standard
anti-seizure medications; and
2. Requires a formula/liquid diet to maintain
weight for age growth because of inability to
tolerate solid foods due to developmental or
other issues.
Results of nutritionist consult
including calorie counts;
Results of allergist evaluation
to further document to food
allergy.
Trial of cow milk-based or soybased formula/foods is not
required.
The requested formula is not

expected to provide more than 50%
of the members nutritional intake.
Trial of cow milk-based or soybased formula/foods is not
required.
Subsequent requests for
authorization require
documentation of intervening
clinical and nutritional
reassessments to document calorie
counts and determine if the
members clinical condition has
improved sufficiently to allow
adequate intake of other nutrients.
Exclusions:
HPHC does not authorize:
Enteral nutrition including infant formulas for indications not listed above.
Enteral nutrition including infant formulas when a medical history or physical examination has not been completed,
and/or there is no documentation that supports the need for enteral nutrition products.
Enteral nutrition including infant formulas when a medical history and physical examination have been performed and other
possible alternatives have been identified to minimize the members nutritional risk.
Enteral nutrition including infant formulas when the member is underweight but has the ability to meet nutritional needs
through the use of regular food consumption.
Enteral nutrition including infant formulas when the member has food allergies or dental problems, but has the ability to
meet his or her nutritional requirements through an alternative store-bought food source.
Standard infant milk or soy formulas;
Formula or food products used for dieting, or a weight-loss program;
Banked breast milk;
Page 8 of 12
Food for a ketogenic diet when dietary needs can be met with regular, store-bought food;
Dietary or food supplements;
Food thickeners,
Supplemental high protein powders and mixes;
Lactose free foods, or products that aid in lactose digestion;
Gluten-free products;
Baby foods;
Oral vitamins and minerals;
Medical foods (e.g., Foltx, Metanx, Cerefolin, probiotics such as VSL#3) including FDA-approved medical foods
obtained via prescription.
Approved by UMCPC: 11/13/13

Revised: 5/02, 6/02, 5/03, 7/04, 9/04, 10/05, 12/06, 10/07, 7/08, 9/09, 9/10, 10/11, 9/10, 10/11, 10/12,
11/13
Initiated: 4/01
State Mandates:
Massachusetts M.G.L. 175 47C and 47I, M.G.L. 176G 4D
New Hampshire NH R.S.A. 420-A:17
Maine 1995, c. 369, 4
Connecticut: Conn. Gen. Stat. 38a-518c
Summary of State Mandated Benefit Requirements
State
Benefit Requirements
Massachusetts
Special infant formulas

Members enrolled through non-group or employer groups must be covered for special
medical formulas to treat infants or children with phenylketonuria (PKU), tyrosinemia,
homocystinuria, maple syrup urine disease, propionic acidemia, or methylmalonic
acidemia, or when medically necessary to protect the fetuses of pregnant women with
PKU.
(M.G.L. 175 47C)
Non-prescription enteral formulas and low protein foods:
Members enrolled through employer groups or with individual coverage must be covered for nonprescription enteral formulas for home use to treat malabsorption caused by Crohn's disease,
ulcerative colitis, gastroesophageal reflux, gastrointestinal motility disorders, chronic intestinal
pseudo-obstruction, and inherited diseases of amino acids and organic acids when medically
necessary and a written order has been issued by a physician. Coverage required for group
policies.
New Hampshire
Low protein foods are covered up to $5,000 per member per year for inherited diseases of amino
acids and organic acids. (M.G.L. 176G 4D)
Special infant formulas: Not Applicable
Non-prescription enteral formulas and low protein foods:
Members enrolled through employer groups must be covered for non-prescription enteral
formulas to treat impaired absorption of nutrients caused by disorders affecting the absorptive
surface, functional length, gastrointestinal tract motility, and inherited diseases of amino acids
and organic acids. A written order must be issued by a physician stating that the enteral formula
Page 9 of 12

is medically necessary, needed to sustain life, and is the least restrictive and most cost effective
treatment.
Additionally, members must be covered for non-prescription enteral formulas and food products
required for persons with inherited diseases of amino and organic acids. Physician must provide a
written order, stating that enteral formula or food product is medically necessary and is the least
restrictive and most cost effective approach to meet patient needs. There is no dollar limit on
enteral formulas.
Maine
Low protein foods are limited to $1,800 per member per year. (NH R.S.A. 420-A:17)
24 2320-D. MEDICAL FOOD COVERAGE FOR INBORN ERROR OF
METABOLISM
All individual and group nonprofit medical services plan policies and contracts and all nonprofit
health care plan policies and contracts must provide coverage for metabolic formula and special
modified low-protein food products that have been prescribed by a licensed physician for a
person with an inborn error of metabolism. The policies and contracts must reimburse:
A. For metabolic formula; and [1995, c. 369, 1 (NEW).]
B. Up to $3,000 per year for special modified low-protein food products. [1995, c. 369, 1
(NEW).] [ 1995, c. 369, 1 (NEW) .]
24-A 2764. COVERAGE FOR MEDICALLY NECESSARY INFANT FORMULA
(REALLOCATED FROM TITLE 24-A, SECTION 2763)
All individual health insurance policies, contracts and certificates must provide coverage for amino
acid-based elemental infant formula for children 2 years of age and under in accordance with this
section.
[2007, c. 2, 11 (RAL).]
Determination of medical necessity. Coverage for amino acid-based elemental infant
formula must be provided when a licensed physician has submitted documentation that the
amino acid-based elemental infant formula is medically necessary health care as defined in
section 4301-A, subsection 10-A, that the amino acid-based elemental infant formula is the
predominant source of nutritional intake at a rate of 50% or greater and that other
commercial infant formulas, including cow milk-based and soy milk-based formulas have been
tried and have failed or are contraindicated. A licensed physician may be required to confirm
and document ongoing medical necessity at least annually. [2007, c. 2, 11 (RAL) .]
Method of delivery. Coverage for amino acid-based elemental infant formula must be
provided without regard to the method of delivery of the formula. [2007, c. 2, 11 (RAL) .]
Required diagnosis. Coverage for amino acid-based elemental infant formula must be
provided when a licensed physician has diagnosed and through medical evaluation has
documented one of the following conditions:
Symptomatic allergic colitis or proctitis; [2007, c. 2, 11 (RAL).]
Laboratory- or biopsy-proven allergic or eosinophilic gastroenteritis; [2007, c. 2, 11 (RAL).]
A history of anaphylaxis; [2007, c. 2, 11 (RAL).]
Gastroesophageal reflux disease that is nonresponsive to standard medical therapies; [2007,
c. 2, 11 (RAL).]
Severe vomiting or diarrhea resulting in clinically significant dehydration requiring treatment
by a medical provider; [2007, c. 2, 11 (RAL).]
Cystic fibrosis; or [2007, c. 2, 11 (RAL).]
Malabsorption of cow milk-based or soy milk-based infant formula. [2007, c. 2, 11 (RAL).]
[2007, c. 2, 11 (RAL) .]
Page 10 of 12
24-A 2847-P. COVERAGE FOR MEDICALLY NECESSARY INFANT FORMULA
(REALLOCATED FROM TITLE 24-A, SECTION 2847-N)
All group health insurance policies, contracts and certificates must provide coverage for amino
acidbased elemental infant formula for children 2 years of age and under in accordance with this
section. [2007, c. 695, Pt. C, 15 (RAL).]
and document ongoing medical necessity at least annually. [ 2007, c. 695, Pt. C, 15 (RAL) .]
provided without regard to the method of delivery of the formula.[ 2007, c. 695, Pt. C, 15
(RAL) .]
1. Symptomatic allergic colitis or proctitis; [2007, c. 695, Pt. C, 15 (RAL).]
2. Laboratory- or biopsy-proven allergic or eosinophilic gastroenteritis; [2007, c. 695, Pt.
C,15 (RAL).]
3. A history of anaphylaxis; [2007, c. 695, Pt. C, 15 (RAL).]
4. Gastroesophageal reflux disease that is nonresponsive to standard medical therapies;
[2007, c. 695, Pt. C, 15 (RAL).]
5. Severe vomiting or diarrhea resulting in clinically significant dehydration requiring
treatment by a medical provider; [2007, c. 695, Pt. C, 15 (RAL).]
6. Cystic fibrosis; or [2007, c. 695, Pt. C, 15 (RAL).]
7. Malabsorption of cow milk-based or soy milk-based infant formula. [2007, c. 695, Pt. C,
15 (RAL).] [2007, c. 695, Pt. C, 15 (RAL) .]
SECTION HISTORY
2007, c. 695, Pt. C, 15 (RAL).
24-A 4256. COVERAGE FOR MEDICALLY NECESSARY INFANT FORMULA
(REALLOCATED FROM TITLE 24-A, SECTION 4254)
All individual and group health maintenance organization policies, contracts and certificates must
provide coverage for amino acid-based elemental infant formula for children 2 years of age and
under in accordance with this section. [2007, c. 695, Pt. C, 16 (RAL).]
and document ongoing medical necessity at least annually. [ 2007, c. 695, Pt. C, 16 (RAL) .]
provided without regard to the method of delivery of the formula. [ 2007, c. 695, Pt. C, 16
Page 11 of 12
Connecticut
(RAL) .]
1. Symptomatic allergic colitis or proctitis; [2007, c. 695, Pt. C, 16 (RAL).]
2. Laboratory- or biopsy-proven allergic or eosinophilic gastroenteritis; [2007, c. 695, Pt. C,
16 (RAL).]
3. A history of anaphylaxis; [2007, c. 695, Pt. C, 16 (RAL).]
4. Gastroesophageal reflux disease that is nonresponsive to standard medical therapies;
[2007, c. 695, Pt. C, 16 (RAL).]
5. Severe vomiting or diarrhea resulting in clinically significant dehydration requiring
treatment by a medical provider; [2007, c. 695, Pt. C, 16 (RAL).]
6. Cystic fibrosis; or [2007, c. 695, Pt. C, 16 (RAL).]
7. Malabsorption of cow milk-based or soy milk-based infant formula. [2007, c. 695, Pt. C,
16 (RAL).] [ 2007, c. 695, Pt. C, 16 (RAL) .]
Coverage for low protein modified food products, amino acid modified preparations
and specialized formulas. For purposes of this section:
1. Inherited metabolic disease includes (A) a disease for which newborn screening is required
under section 19a-55; and (B) cystic fibrosis.
2. Low protein modified food product means a product formulated to have less than one gram
of protein per serving and intended for the dietary treatment of an inherited metabolic
disease under the direction of a physician.
3. Amino acid modified preparation means a product intended for the dietary treatment of an
inherited metabolic disease under the direction of a physician.
4. Specialized formula means a nutritional formula for children up to age twelve that is exempt
from the general requirements for nutritional labeling under the statutory and regulatory
guidelines of the federal Food and Drug Administration and is intended for use solely under
medical supervision in the dietary management of specific diseases.
Each group health insurance policy providing coverage of the type specified in subdivisions (1),
(2), (4), (11) and (12) of section 38a-469 delivered, issued for delivery, renewed, amended or
continued in this state shall provide coverage for amino acid modified preparations and low
protein modified food products for the treatment of inherited metabolic diseases if the amino acid
modified preparations or low protein modified food products are prescribed for the therapeutic
treatment of inherited metabolic diseases and are administered under the direction of a physician.
Each group health insurance policy providing coverage of the type specified in subdivisions (1),
(2), (4), (11) and (12) of section 38a-469 delivered, issued for delivery, renewed, amended or
continued in this state shall provide coverage for specialized formulas when such specialized
formulas are medically necessary for the treatment of a disease or condition and are administered
under the direction of a physician.
Such policy shall provide coverage for such preparations, food products and formulas on the
same basis as outpatient prescription drugs.
Page 12 of 12

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Medical Review Criteria

Formulas and Enteral Nutrition

members enrolled in Core (HMO, POS, and PPO) products.

acid based formulas, ketogenic formulas, and specific metabolic formulas.

Special medical formulas are authorized for eligible

Special medical formulas are typically

Subsequent requests for infants up to age 1 year

Special medical formulas are authorized for eligible

Special medical formula is authorized for infants up

Mild to moderate symptoms in

Subsequent requests for children age 1 and older

Enteral nutrition is authorized for eligible infants and

These conditions rarely occur

When criteria are met, the requested special medical

Special medical formula is authorized for eligible

For infants with food proteininduced enteropathy or

For formula fed infants and children, there must

Special medical formula/enteral nutrition is

For children and adolescents (aged 2-18

For members with cystic fibrosis and weight

For members on renal dialysis:

Special medical formula is authorized for eligible

Special medical formula is authorized for eligible

When cow milk-based formula is

Special formulas/enteral nutrition is authorized when

Ketogenic formulas are authorized for up to 6

The requested formula is not

Approved by UMCPC: 11/13/13

Special infant formulas

HPHC Medical Review Criteria

(REALLOCATED FROM TITLE 24-A, SECTION 2763)

24-A 2847-P. COVERAGE FOR MEDICALLY NECESSARY INFANT FORMULA

(REALLOCATED FROM TITLE 24-A, SECTION 2847-N)

(REALLOCATED FROM TITLE 24-A, SECTION 4254)

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