01/10/17. Replaces Effective Policy Dated: Amino Acid Based Elemental Formula (AABF) 09/28/15 Reference #: MP/A003 Page: 1 of 3

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1 Reference #: MP/A003 Page: 1 of 3 PRODUCT APPLICATION: PreferredOne Administrative Services, Inc. (PAS) ERISA PreferredOne Administrative Services, Inc. (PAS) Non-ERISA PreferredOne Community Health Plan (PCHP) PreferredOne Insurance Company (PIC) Individual PreferredOne Insurance Company (PIC) Large Group PreferredOne Insurance Company (PIC) Small Group Please refer to the member s benefit document for specific information. To the extent there is any inconsistency between this policy and the terms of the member s benefit plan or certificate of coverage, the terms of the member s benefit plan document will govern. Benefits must be available for health care services. Health care services must be ordered by a physician, physician assistant, or nurse practitioner. Health care services must be medically necessary, applicable conservative treatments must have been tried, and the most cost-effective alternative must be requested for coverage consideration. This policy applies to PAS members only when the employer group has elected to provide benefits for the service/procedure/device. Check benefits in SPD/COC. If benefits not specifically addressed in the SPD/COC verify with the appropriate account manager the availability of benefits. PURPOSE: The intent of this policy is to provide guidelines for coverage of amino acid based elemental formulas required to sustain life. POLICY: Coverage of amino-acid based elemental formula is subject to the benefits, limitations, and exclusions in the member s benefit plan and the guidelines below. GUIDELINES: Must meet: all of I-III, and any of IV VI, as applicable I. The amino acid based elemental formula must be ordered or prescribed by a physician, physician assistant, or nurse practitioner; and II. The formula must contain 100% free amino acids as the protein source; and III. The formula is requested for one of the following metabolic or malabsorption conditions that has been diagnosed by a specialist (allergist, gastroenterologist, or pediatrician): A-G A. Amino acid, organic acid, or fatty acid metabolic and malabsorption disorders; or B. Cystic fibrosis; or C. Eosinophilic esophagitis (EE); or D. Eosinophilic gastroenteritis (EG); or E. Eosinophilic colitis; or F. Food Protein induced enterocolitis syndrome (FPIES); or G. IgE mediated allergies to food proteins documented by allergy testing.

2 Reference #: MP/A003 Page: 2 of 3 IV. PAS: Check coverage under the DME schedule of benefits V. PCHP A. Limited coverage is provided for amino-acid-based elemental formula (AABF) that are consumed orally, for members age 5 (five) years or younger. If diagnosis has not been formally made, and the child is under 1 (one) year old, but a physician is actively seeking the diagnosis, coverage may be provided for the formula for up to 90 days. B. Limited coverage is provided for amino-acid-based elemental formula, that are consumed orally, for members age 6 (six) years and older when documentation supports that such formula is medically necessary and is required to sustain good health without such formula. VI. PIC A. Individual: Limited coverage for amino-acid based elemental formulas that are consumed orally. If diagnosis has not been formally made, and the child is under 1 (one) year old, but a physician is actively seeking the diagnosis, coverage may be provided for the formula for up to 90 days. B. Large: Limited coverage is provided for orally consumed amino-acid-based elemental formula (AABF) for members age 5 (five) years or younger. If diagnosis has not been formally made, and the child is under 1 (one) year old, but a physician is actively seeking the diagnosis, coverage may be provided for the formula for up to 90 days. C. Small: Limited coverage for amino-acid based elemental formulas that are consumed orally. If diagnosis has not been formally made, and the child is under 1 (one) year old, but a physician is actively seeking the diagnosis, coverage may be provided for the formula for up to 90 days. EXCLUSION: Products purchased on the internet or OTC without a prescription DEFINITIONS: Amino-acid based elemental formulas: An amino acid-based formula, also known as an elemental formula, is a type of hypoallergenic infant formula made from individual amino acids. Amino acids are the building blocks of protein and together they form the protein requirements in formula needed for growth and development. The amino acids are in the simplest form, making it easy for the body to process and digest. EleCare, E028 Splash, Neocate, Pur Amino, Nutramigen AA LIPIL, Tolerex, and Vivonex are examples of 100% free amino acid based elemental formulas. IgE mediated gastrointestinal food allergy: An adverse reaction by the body's immune system to food that is driven by IgE. IgE antibodies specific to food molecules bind with the circulating food allergen and cause the release of immune response molecules such as cytokines. Symptoms usually occur soon after exposure to the allergen and usually cause skin symptoms. Severe cases may result in anaphylaxis. It is associated with allergic conditions such as pollen-food allergy and other oral allergies and immediate gastrointestinal hypersensitivity.

3 Reference #: MP/A003 Page: 3 of 3 FOR INTERNAL USE ONLY COVERAGE: Prior Authorization: Yes when administered orally Coverage is subject to the member s contract benefits. CODING: HCPCS B4153 Enteral formula, nutritionally complete, hydrolyzed proteins (amino acids and peptide chain), includes fats, carbohydrates, vitamins and minerals, may include fiber, administered through an enteral feeding tube, 100 calories=1 unit B4161 Enteral formula, for pediatrics, hydrolyzed/amino acids and peptide chain proteins, includes fats, carbohydrates, vitamins and minerals, may include fiber, administered through an enteral feeding tube, 100 calories=1 unit RELATED CRITERIA/POLICIES: Process Manual UR015 Use of Medical Policy and Criteria Medical Policy MP/C009 Coverage Determination Guidelines Medical Policy MP/D005 Dietary Formulas, Electrolyte Substances, or Food Products for PKU or Other Inborn Errors of Metabolism REFERENCES: 1. Minnesota Council of Health Plans 2007 Health Plan Agreement regarding Amino Acid Based Formula coverage 2. Sicherer SH. Manifestations of Food Allergy: Evaluation and Management. American Family Physician. Vol.59/No.2 (January 15, 1999). DOCUMENT HISTORY: Created Date: 09/14/10 (previously addressed under MP/E004) Reviewed Date: 08/31/11, 09/07/12, 09/06/13, 09/05/14, 09/04/15, 09/02/16 Revised Date: 09/07/11, 11/13/13, 04/20/15, 12/09/16

4 PreferredOne Community Health Plan Nondiscrimination Notice PreferredOne Community Health Plan ( PCHP ) complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. PCHP does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. PCHP: Provides free aids and services to people with disabilities to communicate effectively with us, such as: Qualified sign language interpreters Written information in other formats (large print, audio, accessible electronic formats, other formats) Provides free language services to people whose primary language is not English, such as: Qualified interpreters Information written in other languages If you need these services, contact a Grievance Specialist. If you believe that PCHP has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Grievance Specialist PreferredOne Community Health Plan PO Box Minneapolis, MN Phone: (TTY: ) Fax: customerservice@preferredone.com You can file a grievance in person or by mail, fax, or . If you need help filing a grievance, a Grievance Specialist is available to help you. You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights, electronically through the Office for Civil Rights Complaint Portal, available at or by mail or phone at: U.S. Department of Health and Human Services 200 Independence Avenue, SW Room 509F, HHH Building Washington, D.C , (TDD) Complaint forms are available at Language Assistance Services NDR PCHP LV (10/16)

5 PreferredOne Insurance Company Nondiscrimination Notice PreferredOne Insurance Company ( PIC ) complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. PIC does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. PIC: Provides free aids and services to people with disabilities to communicate effectively with us, such as: Qualified sign language interpreters Written information in other formats (large print, audio, accessible electronic formats, other formats) Provides free language services to people whose primary language is not English, such as: Qualified interpreters Information written in other languages If you need these services, contact a Grievance Specialist. If you believe that PIC has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Grievance Specialist PreferredOne Insurance Company PO Box Minneapolis, MN Phone: (TTY: ) Fax: customerservice@preferredone.com You can file a grievance in person or by mail, fax, or . If you need help filing a grievance, a Grievance Specialist is available to help you. You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights, electronically through the Office for Civil Rights Complaint Portal, available at or by mail or phone at: U.S. Department of Health and Human Services 200 Independence Avenue, SW Room 509F, HHH Building Washington, D.C , (TDD) Complaint forms are available at Language Assistance Services NDR PIC LV (10/16)