Latest Review Date: September 2024

Category: Durable Medical Equipment (DME)                                       

POLICY:

Effective for dates of service December 2, 2024, and after:

NOTE: Coverage may be subject to legislative mandates, including but not limited to the following, which applies prior to the policy statements:

• Minnesota Statute 62Q.531 Amino Acid-Based Formula Coverage.

I. Patients with a Definitive Diagnosis

The use of oral amino acid-based elemental formula may be considered medically necessary when ALL of the following criteria are met:

• The formula contains 100% free amino acids as the protein source; AND

• The patient has a definitive diagnosis, as supported by laboratory and/or diagnostic test results, of ONE of the following conditions:
  • Cystic fibrosis;
  • Amino acid, organic acid, and fatty acid metabolic and malabsorption disorders (e.g., phenylketonuria, maple syrup urine disease, homocystinuria, tyrosinemia, methylmalonic acidemia, and propionic acidemia);
  • IgE-mediated allergies to food proteins;
  • Food protein-induced enterocolitis syndrome;
  • Eosinophilic esophagitis;
  • Eosinophilic gastroenteritis;
  • Eosinophilic colitis;
  • Short gut syndrome;
  • Mast cell activation syndrome;

AND

• The condition was diagnosed by a physician.

II. Patients with a Presumptive Diagnosis

The use of oral amino acid-based elemental formula may be considered medically necessary for up to 90 days when requested by a physician while actively seeking a confirmatory diagnosis and documentation of ALL of the following:

• Presumptive diagnosis of one of the conditions defined in the policy statement in section I; AND
• Patient's symptoms are consistent with a digestive disorder; AND
• Minimum of two prior failed formula alternatives.

Effective for dates of service December 5, 2022 through December 1, 2024:

I. Patients with a Definitive Diagnosis

The use of oral amino acid-based elemental formula may be considered medically necessary in patients five years of age and under when ALL of the following criteria are met:

The formula contains 100% free amino acids as the protein source; AND

The patient has a definitive diagnosis, as supported by laboratory and/or diagnostic test results, of ONE of the following conditions:

• Cystic fibrosis;
• Amino acid, organic acid, and fatty acid metabolic and malabsorption disorders (e.g., phenylketonuria, maple syrup urine disease, homocystinuria, tyrosinemia, methylmalonic acidemia, and propionic acidemia);
• IgE-mediated allergies to food proteins;
• Food protein-induced enterocolitis syndrome;
• Eosinophilic esophagitis;
• Eosinophilic gastroenteritis;
• Eosinophilic colitis;
• Short gut syndrome;

AND

The condition was diagnosed by a physician.

II. Patients with a Presumptive Diagnosis

The use of oral amino acid-based elemental formula may be considered medically necessary in children five years and under for up to 90 days when requested by a physician while actively seeking a confirmatory diagnosis and documentation of ALL of the following:

• Presumptive diagnosis of one of the conditions defined in the policy statement in section I; AND
• Patient's symptoms are consistent with a digestive disorder; AND
• Minimum of two prior failed formula alternatives.

Effective for dates of service prior to December 5, 2022:

I. Patients with a Definitive Diagnosis

The use of oral amino acid-based elemental formula may be considered medically necessary in patients five years of age and under when ALL of the following criteria are met:

The formula contains 100% free amino acids as the protein source; AND

The patient has a definitive diagnosis, as supported by laboratory and/or diagnostic test results, of ONE of the following conditions:

• Cystic fibrosis;
• Amino acid, organic acid, and fatty acid metabolic and malabsorption disorders (e.g., phenylketonuria, maple syrup urine disease, homocystinuria, tyrosinemia, methylmalonic acidemia, and propionic acidemia);
• IgE-mediated allergies to food proteins;
• Food protein-induced enterocolitis syndrome;
• Eosinophilic esophagitis;
• Eosinophilic gastroenteritis;
• Eosinophilic colitis;
• Short gut syndrome;

AND

The condition was diagnosed by a physician.

II. Patients with a Presumptive Diagnosis

The use of oral amino acid-based elemental formula may be considered medically necessary in children five years and under for up to 90 days when requested by a physician while actively seeking a confirmatory diagnosis and documentation of ALL of the following:

• Presumptive diagnosis of one of the conditions defined in the policy statement in section I; AND
• Patient's symptoms are consistent with a digestive disorder; AND
• Minimum of three prior failed formula alternatives.

DESCRIPTION OF PROCEDURE OR SERVICE:

An amino acid-based elemental formula is a type of exempt formula which is regulated by the U.S. Food and Drug Administration (FDA) and is prescribed for infants or children with specific medical or dietary problems. An amino acid-based formula contains proteins which are broken down into their simplest and purest form making it easier for the body to process and digest. An infant or child may be placed on an amino acid-based formula if he/she is unable to digest or tolerate whole proteins found in other formulas, due to certain allergies or gastrointestinal conditions. Examples of amino acid-based elemental formulas are Neocate®, Neocate® Splash, EleCare®, PurAmino™, Vivonex®, Tolerex®, and Alfamino™.

Definitions:

Amino acid-based elemental formula:  A formula made of 100% free (i.e., individual) amino acids as the protein source.

Cystic fibrosis:  An inherited, life-threatening disease that causes thick, sticky mucus to form in the lungs, pancreas, and other organs. In the lungs, this mucus blocks the airways, causing lung damage and making it difficult to breathe. In the pancreas, the mucus clogs the pathways leading to the digestive system and interferes with proper digestion.

Amino acid, organic acid, and fatty acid metabolic and malabsorption disorders:  Metabolic disorders, often congenital, in which the body is unable to process and digest proteins and other metabolites.

IgE mediated allergy to food proteins:  An immune reaction resulting from the interaction between a food protein and a type of antibody known as IgE. Symptoms are generally rapid in onset, primarily involve the skin (e.g., itching, hives) and, in severe cases, may lead to anaphylaxis.

Food protein-induced enterocolitis syndrome:  A non-IgE-mediated immune reaction to one or more specific foods, commonly characterized by profuse vomiting and diarrhea. Poor growth may occur with continual ingestion of the specific food(s).

Eosinophilic esophagitis, eosinophilic gastroenteritis, and eosinophilic colitis:  Conditions in which accumulation of a type of white blood cell, the eosinophil, causes injury and inflammation to the esophagus, stomach, or small or large intestine. Symptoms include vomiting, diarrhea, and poor growth.

Short gut syndrome: Also known as short bowel syndrome, is a malabsorptive condition most often caused by massive resection of the small intestine which results in significant malabsorption of nutrients.

Mast cell activation syndrome: Mast cells are allergy cells responsible for immediate allergic reactions. Repeat triggering of mast cells can cause symptoms of anaphylaxis, such as hives, swelling, low blood pressure, difficulty breathing, and severe diarrhea.

Key Points

A medical food, as defined in section 5(b)(3) of the Orphan Drug Act (21 U.S.C. 360ee(b)(3)), is “a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.” Medical foods are not drugs and, therefore, are not subject to any regulatory requirements that specifically apply to drugs. However, manufacturers of medical foods must comply with all applicable FDA requirements for foods.

In 2007, the Anaphylaxis and Food Allergy Association of Minnesota (AFAA) led an effort to ensure that Minnesota health plans cover the cost of amino acid elemental formula for patients under physician’s care. A bill was drafted for the Minnesota legislature. The draft legislation described coverage for amino-acid-based elemental formulas for patients with cystic fibrosis; amino acid, organic acid, and fatty acid metabolic and malabsorption disorders; IgE mediated allergies to food proteins; food protein-induced enterocolitis syndrome; eosinophilic esophagitis; eosinophilic gastroenteritis; and eosinophilic colitis. Conversations with the various health plans, lobbyists, and the MN Council of Health Plans resulted in an agreement that insurers in Minnesota would voluntarily add coverage for amino acid elemental formulas to their medical insurances policies mirroring the draft legislation. Each insurance company, including Blue Cross Blue Shield of Minnesota, submitted letters to the legislature agreeing to follow the intent of the proposed legislation. The letters of agreement were determined to be sufficient and the draft legislation was subsequently not passed at that time.

Minnesota Mandate

Minn. Stats. §62Q.524 Amino Acid-Based Formula Coverage, effective January 1, 2025, applies to health plans offered, issued, or sold on or after the effective date. Minn. Stat. §62Q.524, subd. 2 and 3 state the following:

Subd. 2. Required coverage.

A health plan company must provide coverage for formula when formula is medically necessary.

Subd. 3. Covered conditions.

Conditions for which formula is medically necessary include but are not limited to:

(1) cystic fibrosis;

(2) amino acid, organic acid, and fatty acid metabolic and malabsorption disorders;

(3) IgE mediated allergies to food proteins;

(4) food protein-induced enterocolitis syndrome;

(5) eosinophilic esophagitis;

(6) eosinophilic gastroenteritis;

(7) eosinophilic colitis; and

(8) mast cell activation syndrome.

Summary of Evidence

A Minnesota state statute Minn. Stats. §62Q.524 Amino Acid-Based Formula Coverage (effective 1/1/2025) requires coverage of formula for certain medically necessary conditions. The criteria within this policy promote compliance with the state mandate.

Practice Guidelines & Position Statements

In 2010, the American Academy of Allergy, Asthma, and Immunology (AAAAI) released guidelines for food allergy based on a report from the National Institute of Allergy and Infectious Disease (NIAID). The guideline states that the young infants who develop food protein-induced enterocolitis syndrome (FPIES) in response to one formula or food are at greater risk of developing allergic reactions to other whole-protein formulas. Therefore, hypoallergenic formulas are recommended. The guideline does not recommend using soy infant formula instead of cow's milk infant formula as a strategy for preventing the development of food allergies or modifying its clinical course in at-risk infants, noting that the literature reports little difference between soy infant formula and cow's milk infant formula for the prevention of food allergies in at-risk infants.

Clinical Input

In August 2012, clinical input was received from our Medical and Behavioral Health Policy Committee. The Committee recommended including short gut syndrome as a medically necessary indication because patients with this condition often require amino acid-based elemental formulas.

BENEFIT APPLICATION

Coverage is subject to member’s specific benefits. Group-specific policy will supersede this policy when applicable.

ITS: Covered if covered by the Participating Home Plan

FEP contracts: Special benefit consideration may apply. Refer to member’s benefit plan.

CURRENT CODING:

References:

1. Anaphylaxis and Food Allergy Association of Minnesota. Advocacy: Amino Acid Elemental Formula. Available at: http://www.minnesotafoodallergy.org/node/181. Last accessed August 2024.
2. American Partnership for Eosinophilic Disorders. State Insurance Mandates for Elemental Formula. Available at: https://apfed.org/advocacy/state-insurance-mandates-for-elemental-formula/.
3. Clinical Input. Medical and Behavioral Health Policy Committee. Received August 8, 2012
4. FDA. Frequently Asked Questions about Medical Foods; Second edition: Guidance for Industry. March 2023. Available at: https://www.fda.gov/media/97726/download. Last accessed August 2024.
5. Levy PA. Inborn errors of metabolism: part 2: specific disorders. Pediatr Rev. 2009;30(4):e22-28. DOI: 10.1542/pir.30-4-e22.
6. Minn Stats. §62Q.524 Amino Acid-Based Formula Coverage.
7. NIAID-Sponsored Expert Panel; Boyce JA, Assa'ad A, Burks AW, et al. Guidelines for the diagnosis and management of food allergy in the United States: report of the NIAID-sponsored expert panel. J Allergy Clin Immunol. 2010;126(6 Suppl):S1-S58. DOI: 10.1016/j.jaci.2010.10.007.

POLICY HISTORY:

Reviewed and posted July 1, 2021

September 2022: Policy statement updated to include “Minimum of two prior failed formula alternatives” criteria point, for patients with a presumptive diagnosis. On draft through December 4, 2022.

September 2023: Annual update completed. No change to policy intent.

October 2024: Updates to Description, Policy statement, Key Points, Practice Guidelines, Current Coding (+B4153, B4155) and References. On draft through December 1, 2024.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.