I 

116TH CONGRESS 

2D SESSION H. R. 8138 

To amend the Orphan Drug Act with respect to the definition of medical 

food, and for other purposes. 

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 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Patient Access to Med5 ical Foods Act’’. 


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1 SEC. 2. DEFINITION OF MEDICAL FOOD FOR PURPOSES OF 

2 ORPHAN DRUG ACT. 

3 (a) IN GENERAL.—Section 5(b)(3) of the Orphan 

4 Drug Act (21 U.S.C. 360ee(b)(3)) is amended to read as 

5 follows: 

6 ‘‘(3) The term ‘medical food’ means a food 

7 which— 

8 ‘‘(A) is formulated to be consumed or ad9 ministered enterally, including tube feeding and 

10 oral intake, and dispensed upon a written pre11 scription of a practitioner licensed under the 

12 laws of the State in which such practitioner 

13 practices to administer drugs; and 

14 ‘‘(B)(i) is intended for the specific dietary 

15 management of a disease or condition for which 

16 distinctive nutritional requirements, including 

17 conditions of inborn errors of metabolism, based 

18 on recognized scientific principles, are estab19 lished by medical evaluation; or 

20 ‘‘(ii) in the case of an individual for whom 

21 the prescribing physician determines the indi22 vidual has failed on traditional therapies or de23 termines continuing the traditional therapy is 

24 inappropriate for the patient due to 

25 comorbidities or severe side effects that endan26 ger the health of the individual— 


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1 ‘‘(I) has been shown to provide clin2 ical benefit in well-controlled peer-reviewed 

3 clinical trials to patients with a disease or 

4 condition specified in clause (i); and 

5 ‘‘(II) is determined by the prescribing 

6 physician to be a safer therapeutic option 

7 or the only effective clinical option for the 

8 individual.’’. 

9 (b) NATIONAL DRUG CODE NUMBER.—Section 5 of 

10 the Orphan Drug Act (21 U.S.C. 360ee) is amended— 

11 (1) by redesignating subsection (c) as sub12 section (d); and 

13 (2) by inserting after subsection (b) the fol14 lowing: 

15 ‘‘(c) NATIONAL DRUG CODE NUMBER.—Medical 

16 foods shall be eligible for a National Drug Code number.’’. 

17 SEC. 3. COVERAGE OF MEDICALLY NECESSARY FOOD 

18 UNDER FEDERAL HEALTH PROGRAMS AND 

19 PRIVATE HEALTH INSURANCE. 

20 (a) COVERAGE UNDER MEDICARE PROGRAM.— 

21 (1) PART B COVERAGE.— 

22 (A) IN GENERAL.—Section 1861(s)(2) of 

23 the Social Security Act (42 U.S.C. 1395x(s)(2)) 

24 is amended— 


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1 (i) in subparagraph (GG), by striking 

2 ‘‘and’’ at the end; 

3 (ii) in subparagraph (HH), by strik4 ing the period at the end and inserting ‘‘; 

5 and’’; and 

6 (iii) by adding at the end the fol7 lowing new subparagraph: 

8 ‘‘(II) medically necessary food (as defined in 

9 subsection (kkk));’’. 

10 (B) DEFINITION.—Section 1861 of the So11 cial Security Act (42 U.S.C. 1395x) is amended 

12 by adding at the end the following new sub13 section: 

14 ‘‘Medically Necessary Food 

15 ‘‘(kkk) The term ‘medically necessary food’ has the 

16 meaning given the term ‘medical food’ in section 5(b)(3) 

17 of the Orphan Drug Act (21 U.S.C. 360ee(b)(3)).’’. 

18 (C) PAYMENT.—Section 1833(a)(1) of the 

19 Social Security Act (42 U.S.C. 1395l(a)(1)) is 

20 amended— 

21 (i) by striking ‘‘and’’ before ‘‘(DD)’’; 

22 and 

23 (ii) by inserting before the semicolon 

24 at the end the following: ‘‘, and (EE) with 

25 respect to medically necessary food (as deVerDate Sep 11 2014 17:00 Sep 05, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H8138.IH H8138

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1 fined in section 1861(kkk)), the amount 

2 paid shall be an amount equal to 80 per3 cent of the actual charge for the services.’’. 

4 (D) EFFECTIVE DATE.—The amendments 

5 made by this paragraph shall apply to items 

6 and services furnished on or after January 1, 

7 2021. 

8 (2) COVERAGE AS COVERED PART D DRUG.— 

9 (A) IN GENERAL.—Section 1860D–2(e)(1) 

10 of the Social Security Act (42 U.S.C. 1395w– 

11 102(e)(1)) is amended— 

12 (i) in subparagraph (A), by striking at 

13 the end ‘‘or’’; 

14 (ii) in subparagraph (B), by striking 

15 at the end the comma and inserting ‘‘; or’’; 

16 and 

17 (iii) by inserting after subparagraph 

18 (B) the following new subparagraph: 

19 ‘‘(C) a medically necessary food (as defined 

20 in section 1861(kkk)),’’. 

21 (B) EFFECTIVE DATE.—The amendments 

22 made by subparagraph (A) shall apply with re23 spect to plan years beginning on or after Janu24 ary 1, 2021. 

25 (b) COVERAGE UNDER MEDICAID PROGRAM.— 


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1 (1) IN GENERAL.—Section 1905(a) of the So2 cial Security Act (42 U.S.C. 1396d(a)) is amend3 ed— 

4 (A) in paragraph (29), by striking ‘‘and’’ 

5 at the end; 

6 (B) by redesignating paragraph (30) as 

7 paragraph (31); and 

8 (C) by inserting after paragraph (29) the 

9 following new paragraph: 

10 ‘‘(30) medically necessary food (as defined in 

11 section 1861(kkk)); and’’. 

12 (2) MANDATORY BENEFIT.—Section 

13 1902(a)(10)(A) of the Social Security Act (42 

14 U.S.C. 1396a(a)(10)(A)) is amended, in the matter 

15 preceding clause (i), by striking ‘‘and (29)’’ and in16 serting ‘‘(29), and (30)’’. 

17 (3) EFFECTIVE DATE.— 

18 (A) IN GENERAL.—Subject to subpara19 graph (B), the amendments made by this sub20 section shall apply with respect to medical as21 sistance furnished on or after July 1, 2021. 

22 (B) EXCEPTION IF STATE LEGISLATION

23 REQUIRED.—In the case of a State plan for 

24 medical assistance under title XIX of the Social 

25 Security Act which the Secretary of Health and 


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1 Human Services determines requires State leg2 islation (other than legislation appropriating 

3 funds) in order for the plan to meet the addi4 tional requirement imposed by the amendments 

5 made by this subsection, the State plan shall 

6 not be regarded as failing to comply with the 

7 requirements of such title solely on the basis of 

8 its failure to meet this additional requirement 

9 before the first day of the first calendar quarter 

10 beginning after the close of the first regular 

11 session of the State legislature that begins after 

12 the date of the enactment of this Act. For pur13 poses of the previous sentence, in the case of a 

14 State that has a 2-year legislative session, each 

15 year of such session shall be deemed to be a 

16 separate regular session of the State legislature. 

17 (c) COVERAGE UNDER CHIP.— 

18 (1) IN GENERAL.—Section 2103(c) of the So19 cial Security Act (42 U.S.C. 1397cc(c)) is amended 

20 by adding at the end the following: 

21 ‘‘(11) MEDICALLY NECESSARY FOOD.—The 

22 child health assistance provided to a targeted low-in23 come child shall include coverage of medically nec24 essary food (as defined in section 1861(kkk)).’’. 


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1 (2) CONFORMING AMENDMENT.—Section 

2 2103(a) of the Social Security Act (42 U.S.C. 

3 1397cc(a)) is amended, in the matter preceding 

4 paragraph (1), by striking ‘‘and (8)’’ and inserting 

5 ‘‘, (8), and (11)’’. 

6 (3) EFFECTIVE DATE.— 

7 (A) IN GENERAL.—Subject to subpara8 graph (B), the amendments made by this sub9 section shall apply with respect to child health 

10 assistance furnished on or after July 1, 2021. 

11 (B) EXCEPTION IF STATE LEGISLATION

12 REQUIRED.—In the case of a State child health 

13 plan for child health assistance under title XXI 

14 of the Social Security Act which the Secretary 

15 of Health and Human Services determines re16 quires State legislation (other than legislation 

17 appropriating funds) in order for the plan to 

18 meet the additional requirement imposed by the 

19 amendments made by this subsection, the State 

20 child health plan shall not be regarded as fail21 ing to comply with the requirements of such 

22 title solely on the basis of its failure to meet 

23 this additional requirement before the first day 

24 of the first calendar quarter beginning after the 

25 close of the first regular session of the State 


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1 legislature that begins after the date of the en2 actment of this Act. For purposes of the pre3 vious sentence, in the case of a State that has 

4 a 2-year legislative session, each year of such 

5 session shall be deemed to be a separate regular 

6 session of the State legislature. 

7 (d) COVERAGE UNDER TRICARE.—Paragraph (2) 

8 of section 1077(h) of title 10, United States Code, is 

9 amended to read as follows: 

10 ‘‘(2) In this section, the term ‘medically necessary 

11 food’ has the meaning given the term ‘medical food’ in 

12 section 5(b)(3) of the Orphan Drug Act.’’. 

13 (e) COVERAGE UNDER PRIVATE HEALTH INSUR14 ANCE.— 

15 (1) IN GENERAL.—Subpart II of part A of title 

16 XXVII of the Public Health Service Act (42 U.S.C. 

17 300gg–11 et seq.) is amended by adding at the end 

18 the following: 

19 ‘‘SEC. 2730. COVERAGE OF MEDICALLY NECESSARY FOOD. 

20 ‘‘A group health plan and group or individual health 

21 insurance coverage offered by a health insurance issuer 

22 shall provide coverage for medically necessary food (as de23 fined in section 1861(kkk) of the Social Security Act).’’. 


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1 (2) EFFECTIVE DATE.—The amendment made 

2 by paragraph (1) shall apply to plan years beginning 

3 on or after January 1, 2021. 

Æ 


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