I 116th CONGRESS 2d Session H. R. 8138 IN THE HOUSE OF REPRESENTATIVES September 1, 2020 Mr. Biggs introduced the following bill; which was referred to the Committee on Energy and Commerce , and in addition to the Committees on Ways and Means , and Armed Services , for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned A BILL To amend the Orphan Drug Act with respect to the definition of medical food, and for other purposes.

1. Short title This Act may be cited as the Patient Access to Medical Foods Act . 2. Definition of medical food for purposes of Orphan Drug Act (a) In general Section 5(b)(3) of the Orphan Drug Act ( 21 U.S.C. 360ee(b)(3) ) is amended to read as follows: (3) The term medical food means a food which— (A) is formulated to be consumed or administered enterally, including tube feeding and oral intake, and dispensed upon a written prescription of a practitioner licensed under the laws of the State in which such practitioner practices to administer drugs; and (B) (i) is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, including conditions of inborn errors of metabolism, based on recognized scientific principles, are established by medical evaluation; or (ii) in the case of an individual for whom the prescribing physician determines the individual has failed on traditional therapies or determines continuing the traditional therapy is inappropriate for the patient due to comorbidities or severe side effects that endanger the health of the individual— (I) has been shown to provide clinical benefit in well-controlled peer-reviewed clinical trials to patients with a disease or condition specified in clause (i); and (II) is determined by the prescribing physician to be a safer therapeutic option or the only effective clinical option for the individual. . (b) National Drug Code number Section 5 of the Orphan Drug Act ( 21 U.S.C. 360ee ) is amended— (1) by redesignating subsection (c) as subsection (d); and (2) by inserting after subsection (b) the following: (c) National Drug Code number Medical foods shall be eligible for a National Drug Code number. . 3. Coverage of medically necessary food under Federal health programs and private health insurance (a) Coverage under Medicare program (1) Part B coverage (A) In general Section 1861(s)(2) of the Social Security Act ( 42 U.S.C. 1395x(s)(2) ) is amended— (i) in subparagraph (GG), by striking and at the end; (ii) in subparagraph (HH), by striking the period at the end and inserting ; and ; and (iii) by adding at the end the following new subparagraph: (II) medically necessary food (as defined in subsection (kkk)); . (B) Definition Section 1861 of the Social Security Act ( 42 U.S.C. 1395x ) is amended by adding at the end the following new subsection: (kkk) Medically Necessary Food The term medically necessary food has the meaning given the term medical food in section 5(b)(3) of the Orphan Drug Act ( 21 U.S.C. 360ee(b)(3) ). . (C) Payment Section 1833(a)(1) of the Social Security Act ( 42 U.S.C. 1395l(a)(1) ) is amended— (i) by striking and before (DD) ; and (ii) by inserting before the semicolon at the end the following: , and (EE) with respect to medically necessary food (as defined in section 1861(kkk)), the amount paid shall be an amount equal to 80 percent of the actual charge for the services. . (D) Effective date The amendments made by this paragraph shall apply to items and services furnished on or after January 1, 2021. (2) Coverage as covered part D drug (A) In general Section 1860D–2(e)(1) of the Social Security Act ( 42 U.S.C. 1395w–102(e)(1) ) is amended— (i) in subparagraph (A), by striking at the end or ; (ii) in subparagraph (B), by striking at the end the comma and inserting ; or ; and (iii) by inserting after subparagraph (B) the following new subparagraph: (C) a medically necessary food (as defined in section 1861(kkk)), . (B) Effective date The amendments made by subparagraph (A) shall apply with respect to plan years beginning on or after January 1, 2021. (b) Coverage under Medicaid program (1) In general Section 1905(a) of the Social Security Act ( 42 U.S.C. 1396d(a) ) is amended— (A) in paragraph (29), by striking and at the end; (B) by redesignating paragraph (30) as paragraph (31); and (C) by inserting after paragraph (29) the following new paragraph: (30) medically necessary food (as defined in section 1861(kkk)); and . (2) Mandatory benefit Section 1902(a)(10)(A) of the Social Security Act ( 42 U.S.C. 1396a(a)(10)(A) ) is amended, in the matter preceding clause (i), by striking and (29) and inserting (29), and (30) . (3) Effective date (A) In general Subject to subparagraph (B), the amendments made by this subsection shall apply with respect to medical assistance furnished on or after July 1, 2021. (B) Exception if state legislation required In the case of a State plan for medical assistance under title XIX of the Social Security Act which the Secretary of Health and Human Services determines requires State legislation (other than legislation appropriating funds) in order for the plan to meet the additional requirement imposed by the amendments made by this subsection, the State plan shall not be regarded as failing to comply with the requirements of such title solely on the basis of its failure to meet this additional requirement before the first day of the first calendar quarter beginning after the close of the first regular session of the State legislature that begins after the date of the enactment of this Act. For purposes of the previous sentence, in the case of a State that has a 2-year legislative session, each year of such session shall be deemed to be a separate regular session of the State legislature. (c) Coverage under CHIP (1) In general Section 2103(c) of the Social Security Act ( 42 U.S.C. 1397cc(c) ) is amended by adding at the end the following: (11) Medically necessary food The child health assistance provided to a targeted low-income child shall include coverage of medically necessary food (as defined in section 1861(kkk)). . (2) Conforming amendment Section 2103(a) of the Social Security Act ( 42 U.S.C. 1397cc(a) ) is amended, in the matter preceding paragraph (1), by striking and (8) and inserting , (8), and (11) . (3) Effective date (A) In general Subject to subparagraph (B), the amendments made by this subsection shall apply with respect to child health assistance furnished on or after July 1, 2021. (B) Exception if state legislation required In the case of a State child health plan for child health assistance under title XXI of the Social Security Act which the Secretary of Health and Human Services determines requires State legislation (other than legislation appropriating funds) in order for the plan to meet the additional requirement imposed by the amendments made by this subsection, the State child health plan shall not be regarded as failing to comply with the requirements of such title solely on the basis of its failure to meet this additional requirement before the first day of the first calendar quarter beginning after the close of the first regular session of the State legislature that begins after the date of the enactment of this Act. For purposes of the previous sentence, in the case of a State that has a 2-year legislative session, each year of such session shall be deemed to be a separate regular session of the State legislature. (d) Coverage under TRICARE Paragraph (2) of section 1077(h) of title 10, United States Code, is amended to read as follows: (2) In this section, the term medically necessary food has the meaning given the term medical food in section 5(b)(3) of the Orphan Drug Act. . (e) Coverage under private health insurance (1) In general Subpart II of part A of title XXVII of the Public Health Service Act ( 42 U.S.C. 300gg–11 et seq.) is amended by adding at the end the following: 2730. Coverage of medically necessary food A group health plan and group or individual health insurance coverage offered by a health insurance issuer shall provide coverage for medically necessary food (as defined in section 1861(kkk) of the Social Security Act). . (2) Effective date The amendment made by paragraph (1) shall apply to plan years beginning on or after January 1, 2021.