Formula and Enteral Nutrition-eff112513

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.

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 nutrition1 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_ADULT%20FORMULA_061511.PDF)

For infants and pediatric patients, weight for age, weight for height growth charts3, 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 formulas4) 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




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-Specific Criteria

Condition Criteria Additional Information

Prematurity 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

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.





(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 compromise6; and

2. Trials of both cow-milk based and soy-based formulas and thickened feeds have not been successful in resolving symptoms.

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 on-going 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.

Special medical formulas are typically not authorized solely for treatment of gastroesophageal reflux (GER).7 Medical therapies, such as H2-

blockers or proton-pump inhibitors may be ordered at the discretion

of the attending physician.

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

5 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.





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.

enteropathy, and food protein-induced 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.

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 on-

going need for the requested special medical formula.

Subsequent requests for children age 1 and older must include:

Consideration of a retrial of both cow-milk-based and soy-based foods/formula; and

A nutritionist consult including calorie counts; and

A gastroenterologist evaluation.

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.

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, nutritionist9, and

These conditions rarely occur in infants. In children, the

condition is typically characterized by symptoms

including intermittent vomiting, food refusal,

8 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.





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.

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.

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.

For infants with food protein-

induced enteropathy or enterocolitis, soy formula trial is

not required because of the high

cross intolerance to soy-based formula in children with this

condition.

Subsequent requests for children age 1 and older must include

evidence of:

Consideration of a retrial of both cow-milk-based and soy-

based 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.





For formula fed infants and children, there must

be documentation confirming that cow milk-

based 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.

Failure to Thrive

(FTT)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 5th percentile.

For adults: Involuntary loss of more than 10% of

usual body weight over 3-6 months; or

BMI less than the 5th percentile, or 18.5 kg/m2.

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 nd percentile.





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.

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).

IgE Mediated Food Allergy

Special medical formula is authorized for eligible 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.

When cow milk-based formula is clearly implicated in the highly

likely IgE mediated reaction, a soy-

based 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%.)

Subsequent requests for children

over age 1 year must include documentation of ALL the

following: Consideration of re-trial of

both cow milk-based and soy-

based foods/formula; and

Results of nutritionist

consultation (including calorie counts); and

Results of allergist evaluation

to further document the food allergy.

Atopic Dermatitis (AD)12

Special medical formula is authorized for eligible

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

Subsequent requests for children

over age 1 year must include documentation of ALL the

following: Consideration of re-trial of

both cow milk-based and soy-

based 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%.





elimination diet); and Allergist evaluation confirms the

presence of formula induced atopic dermatitis.

Results of nutritionist consult

including calorie counts; Results of allergist evaluation

to further document to food

allergy.

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.

Trial of cow milk-based or soy-based formula/foods is not required.

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.

The requested formula is not expected to provide more than 50% of the members nutritional intake. Trial of cow milk-based or soy-based 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;




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 non-prescription 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.

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)

New Hampshire 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




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.

Low protein foods are limited to $1,800 per member per year. (NH R.S.A. 420-A:17)

Maine

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) .]




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).]

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. 695, Pt. C, 15 (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. 695, Pt. C, 15 (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: 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).]

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. 695, Pt. C, 16 (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. 695, Pt. C, 16




(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:

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) .]

Connecticut 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.

Formula and Enteral Nutrition-eff112513

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