Department of Origin: Integrated Healthcare Services. Approved by: Chief Medical Officer Department(s) Affected: Date approved: 01/10/17

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1 Reference #: MP/D005 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 dietary formulas, electrolyte substances or food products needed to sustain life for phenylketonuria (PKU) or other inborn errors of metabolism. POLICY: Coverage of dietary formulas, electrolyte substances or food products for PKU or other inborn errors of metabolism is subject to the benefits, limitations, and exclusions in the member s benefit plan and the guidelines below. GUIDELINES: Must meet: I and any of II-IV, as applicable I. The dietary formula, electrolyte substance or food product must be ordered or prescribed by a physician, physician assistant, or nurse practitioner; and II. PAS: Check coverage under the DME schedule of benefits III. PCHP A. For members age 5 (five) years or younger, limited coverage is provided for special dietary formulas, electrolyte substances and other specialty food products that are consumed orally and treat PKU or other inborn errors of metabolism; or B. For members age 6 (six) years or older, limited coverage is provided for special dietary formulas, electrolyte substances and other specialty food products that are consumed orally and treat PKU or other

2 Reference #: MP/D005 Page: 2 of 3 inborn errors of metabolism when medical documentation establishes they are medically necessary and that the member is not able to sustain good with without such dietary item(s). IV. PIC A. Individual - Limited coverage for special dietary formulas and electrolyte substances that are consumed B. Large Group - Limited coverage for special dietary formulas and electrolyte substances that are consumed C. Small Group - Limited coverage for special dietary formulas and electrolyte substances that are consumed EXCLUSIONS: I. Other products that can be purchased without a prescription and other grocery items that can be prepared in a blender including food thickener, supplements, sport shakes, baby food, and related supplies. II. Specialty infant formulas for diagnosis other than inborn errors in metabolism. III. Products purchased on the internet or OTC without a prescription. DEFINITIONS: Inborn Errors of Metabolism: Comprise a large class of genetic diseases involving disorders of metabolism. The majority are due to defects of single genes that code for enzymes that facilitate conversion of various substances (substrates) into others (products). In most of the disorders, problems arise due to accumulation of substances which are toxic or interfere with normal function, or to the effects of reduced ability to synthesize essential compounds. Inborn errors of metabolism are now often referred to as congenital metabolic diseases or inherited metabolic diseases, and these terms are considered synonymous. Traditionally the inherited metabolic diseases were categorized as disorders of carbohydrate metabolism, amino acid metabolism, organic acid metabolism, or lysosomal storage diseases. In recent decades, hundreds of new inherited disorders of metabolism have been discovered and the categories have proliferated.

3 Reference #: MP/D005 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 B4157 Enteral formula, nutritionally complete, for special metabolic needs for inherited disease of metabolism, includes proteins, fats, carbohydrates, vitamins and minerals, may include fiber, administered through an enteral feeding tube, 100 calories=1 unit B4162 Enteral formula, for pediatrics, for special metabolic needs for inherited disease of metabolism, includes proteins, fats, carbohydrates, vitamins and minerals, may include fiber, administered through an enteral feeding tube, 100 calories=1 unit S9434 Modified solid food supplements for inborn errors of metabolism S9435 Medical foods for inborn errors of metabolism RELATED CRITERIA/POLICIES: Process Manual UR015 Use of Medical Policy and Criteria Medical Policy MP/C009 Coverage Determination Guidelines Medical Policy MP/A003 Amino Acid Based Elemental Formulas REFERENCES: 1. State Mandate: Minnesota Statutes 62A.26 Coverage for Phenylketonuria Treatment 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,

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)