Patient Access to Medical Foods Act

I 117TH CONGRESS 1ST SESSION H. R. 56 To amend the Orphan Drug Act with respect to the definition of medical food, and for other purposes. IN THE HOUSE OF REPRESENTATIVES JANUARY 4, 2021 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 deter- mined 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. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Patient Access to Med- 4 ical Foods Act’’. 5 VerDate Sep 11 2014 19:34 Jan 12, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H56.IH H56 pamtmann on DSKBC07HB2PROD with BILLS 2 •HR 56 IH SEC. 2. DEFINITION OF MEDICAL FOOD FOR PURPOSES OF 1 ORPHAN DRUG ACT. 2 (a) IN GENERAL.—Section 5(b)(3) of the Orphan 3 Drug Act (21 U.S.C. 360ee(b)(3)) is amended to read as 4 follows: 5 ‘‘(3) The term ‘medical food’ means a food 6 which— 7 ‘‘(A) is formulated to be consumed or ad- 8 ministered enterally, including tube feeding and 9 oral intake, and dispensed upon a written pre- 10 scription of a practitioner licensed under the 11 laws of the State in which such practitioner 12 practices to administer drugs; and 13 ‘‘(B)(i) is intended for the specific dietary 14 management of a disease or condition for which 15 distinctive nutritional requirements, including 16 conditions of inborn errors of metabolism, based 17 on recognized scientific principles, are estab- 18 lished by medical evaluation; or 19 ‘‘(ii) in the case of an individual for whom 20 the prescribing physician determines the indi- 21 vidual has failed on traditional therapies or de- 22 termines continuing the traditional therapy is 23 inappropriate for the patient due to 24 comorbidities or severe side effects that endan- 25 ger the health of the individual— 26 VerDate Sep 11 2014 19:34 Jan 12, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H56.IH H56 pamtmann on DSKBC07HB2PROD with BILLS 3 •HR 56 IH ‘‘(I) has been shown to provide clin- 1 ical benefit in well-controlled peer-reviewed 2 clinical trials to patients with a disease or 3 condition specified in clause (i); and 4 ‘‘(II) is determined by the prescribing 5 physician to be a safer therapeutic option 6 or the only effective clinical option for the 7 individual.’’. 8 (b) NATIONAL DRUG CODE NUMBER.—Section 5 of 9 the Orphan Drug Act (21 U.S.C. 360ee) is amended— 10 (1) by redesignating subsection (c) as sub- 11 section (d); and 12 (2) by inserting after subsection (b) the fol- 13 lowing: 14 ‘‘(c) NATIONAL DRUG CODE NUMBER.—Medical 15 foods shall be eligible for a National Drug Code number.’’. 16 SEC. 3. COVERAGE OF MEDICALLY NECESSARY FOOD 17 UNDER FEDERAL HEALTH PROGRAMS AND 18 PRIVATE HEALTH INSURANCE. 19 (a) COVERAGE UNDER MEDICARE PROGRAM.— 20 (1) PART B COVERAGE.— 21 (A) IN GENERAL.—Section 1861(s)(2) of 22 the Social Security Act (42 U.S.C. 1395x(s)(2)) 23 is amended— 24 VerDate Sep 11 2014 19:34 Jan 12, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H56.IH H56 pamtmann on DSKBC07HB2PROD with BILLS 4 •HR 56 IH (i) in subparagraph (GG), by striking 1 ‘‘and’’ at the end; 2 (ii) in subparagraph (HH), by strik- 3 ing the period at the end and inserting ‘‘; 4 and’’; and 5 (iii) by adding at the end the fol- 6 lowing new subparagraph: 7 ‘‘(II) medically necessary food (as defined in 8 subsection (kkk));’’. 9 (B) DEFINITION.—Section 1861 of the So- 10 cial Security Act (42 U.S.C. 1395x) is amended 11 by adding at the end the following new sub- 12 section: 13 ‘‘Medically Necessary Food 14 ‘‘(kkk) The term ‘medically necessary food’ has the 15 meaning given the term ‘medical food’ in section 5(b)(3) 16 of the Orphan Drug Act (21 U.S.C. 360ee(b)(3)).’’. 17 (C) PAYMENT.—Section 1833(a)(1) of the 18 Social Security Act (42 U.S.C. 1395l(a)(1)) is 19 amended— 20 (i) by striking ‘‘and’’ before ‘‘(DD)’’; 21 and 22 (ii) by inserting before the semicolon 23 at the end the following: ‘‘, and (EE) with 24 respect to medically necessary food (as de- 25 VerDate Sep 11 2014 19:34 Jan 12, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H56.IH H56 pamtmann on DSKBC07HB2PROD with BILLS 5 •HR 56 IH fined in section 1861(kkk)), the amount 1 paid shall be an amount equal to 80 per- 2 cent of the actual charge for the services.’’. 3 (D) EFFECTIVE DATE.—The amendments 4 made by this paragraph shall apply to items 5 and services furnished on or after January 1, 6 2022. 7 (2) COVERAGE AS COVERED PART D DRUG.— 8 (A) IN GENERAL.—Section 1860D–2(e)(1) 9 of the Social Security Act (42 U.S.C. 1395w– 10 102(e)(1)) is amended— 11 (i) in subparagraph (A), by striking at 12 the end ‘‘or’’; 13 (ii) in subparagraph (B), by striking 14 at the end the comma and inserting ‘‘; or’’; 15 and 16 (iii) by inserting after subparagraph 17 (B) the following new subparagraph: 18 ‘‘(C) a medically necessary food (as defined 19 in section 1861(kkk)),’’. 20 (B) EFFECTIVE DATE.—The amendments 21 made by subparagraph (A) shall apply with re- 22 spect to plan years beginning on or after Janu- 23 ary 1, 2022. 24 (b) COVERAGE UNDER MEDICAID PROGRAM.— 25 VerDate Sep 11 2014 19:34 Jan 12, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H56.IH H56 pamtmann on DSKBC07HB2PROD with BILLS 6 •HR 56 IH (1) IN GENERAL.—Section 1905(a) of the So- 1 cial Security Act (42 U.S.C. 1396d(a)) is amend- 2 ed— 3 (A) in paragraph (29), by striking ‘‘and’’ 4 at the end; 5 (B) by redesignating paragraph (30) as 6 paragraph (31); and 7 (C) by inserting after paragraph (29) the 8 following new paragraph: 9 ‘‘(30) medically necessary food (as defined in 10 section 1861(kkk)); and’’. 11 (2) MANDATORY BENEFIT.—Section 12 1902(a)(10)(A) of the Social Security Act (42 13 U.S.C. 1396a(a)(10)(A)) is amended, in the matter 14 preceding clause (i), by striking ‘‘and (29)’’ and in- 15 serting ‘‘(29), and (30)’’. 16 (3) EFFECTIVE DATE.— 17 (A) IN GENERAL.—Subject to subpara- 18 graph (B), the amendments made by this sub- 19 section shall apply with respect to medical as- 20 sistance furnished on or after July 1, 2022. 21 (B) EXCEPTION IF STATE LEGISLATION 22 REQUIRED.—In the case of a State plan for 23 medical assistance under title XIX of the Social 24 Security Act which the Secretary of Health and 25 VerDate Sep 11 2014 19:34 Jan 12, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H56.IH H56 pamtmann on DSKBC07HB2PROD with BILLS 7 •HR 56 IH Human Services determines requires State leg- 1 islation (other than legislation appropriating 2 funds) in order for the plan to meet the addi- 3 tional requirement imposed by the amendments 4 made by this subsection, the State plan shall 5 not be regarded as failing to comply with the 6 requirements of such title solely on the basis of 7 its failure to meet this additional requirement 8 before the first day of the first calendar quarter 9 beginning after the close of the first regular 10 session of the State legislature that begins after 11 the date of the enactment of this Act. For pur- 12 poses of the previous sentence, in the case of a 13 State that has a 2-year legislative session, each 14 year of such session shall be deemed to be a 15 separate regular session of the State legislature. 16 (c) COVERAGE UNDER CHIP.— 17 (1) IN GENERAL.—Section 2103(c) of the So- 18 cial Security Act (42 U.S.C. 1397cc(c)) is amended 19 by adding at the end the following: 20 ‘‘(11) MEDICALLY NECESSARY FOOD.—The 21 child health assistance provided to a targeted low-in- 22 come child shall include coverage of medically nec- 23 essary food (as defined in section 1861(kkk)).’’. 24 VerDate Sep 11 2014 19:34 Jan 12, 2021 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H56.IH H56 pamtmann on DSKBC07HB2PROD with BILLS 8 •HR 56 IH (2) CONFORMING AMENDMENT.—Section 1 2103(a) of the Social Security Act (42 U.S.C. 2 1397cc(a)) is amended, in the matter preceding 3 paragraph (1), by striking ‘‘and (8)’’ and inserting 4 ‘‘, (8), and (11)’’. 5 (3) EFFECTIVE DATE.— 6 (A) IN GENERAL.—Subject to subpara- 7 graph (B), the amendments made by this sub- 8 section shall apply with respect to child health 9 assistance furnished on or after July 1, 2022. 10 (B) EXCEPTION IF STATE LEGISLATION 11 REQUIRED.—In the case of a State child health 12 plan for child health assistance under title XXI 13 of the Social Security Act which the Secretary 14 of Health and Human Services determines re- 15 quires State legislation (other than legislation 16 appropriating funds) in order for the plan to 17 meet the additional requirement imposed by the 18 amendments made by this subsection, the State 19 child health plan shall not be regarded as fail- 20 ing to comply with the requirements of such 21 title solely on the basis of its failure to meet 22 this additional requirement before the first day 23 of the first calendar quarter beginning after the 24 close of the first regular session of the State 25 VerDate Sep 11 2014 19:34 Jan 12, 2021 Jkt 019200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H56.IH H56 pamtmann on DSKBC07HB2PROD with BILLS 9 •HR 56 IH legislature that begins after the date of the en- 1 actment of this Act. For purposes of the pre- 2 vious sentence, in the case of a State that has 3 a 2-year legislative session, each year of such 4 session shall be deemed to be a separate regular 5 session of the State legislature. 6 (d) COVERAGE UNDER TRICARE.—Paragraph (2) 7 of section 1077(h) of title 10, United States Code, is 8 amended to read as follows: 9 ‘‘(2) In this section, the term ‘medically necessary 10 food’ has the meaning given the term ‘medical food’ in 11 section 5(b)(3) of the Orphan Drug Act.’’. 12 (e) COVERAGE UNDER PRIVATE HEALTH INSUR- 13 ANCE.— 14 (1) IN GENERAL.—Subpart II of part A of title 15 XXVII of the Public Health Service Act (42 U.S.C. 16 300gg–11 et seq.) is amended by adding at the end 17 the following: 18 ‘‘SEC. 2730. COVERAGE OF MEDICALLY NECESSARY FOOD. 19 ‘‘A group health plan and group or individual health 20 insurance coverage offered by a health insurance issuer 21 shall provide coverage for medically necessary food (as de- 22 fined in section 1861(kkk) of the Social Security Act).’’. 23 VerDate Sep 11 2014 19:34 Jan 12, 2021 Jkt 019200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H56.IH H56 pamtmann on DSKBC07HB2PROD with BILLS 10 •HR 56 IH (2) EFFECTIVE DATE.—The amendment made 1 by paragraph (1) shall apply to plan years beginning 2 on or after January 1, 2022. 3 Æ VerDate Sep 11 2014 19:34 Jan 12, 2021 Jkt 019200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6301 E:\BILLS\H56.IH H56 pamtmann on DSKBC07HB2PROD with BILLS