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 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-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Patient Access to Med-
ical Foods Act’’. 
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SEC. 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 ad-
ministered enterally, including tube feeding and 
oral intake, and dispensed upon a written pre-
scription 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 estab-
lished by medical evaluation; or 
‘‘(ii) in the case of an individual for whom 
the prescribing physician determines the indi-
vidual has failed on traditional therapies or de-
termines continuing the traditional therapy is 
inappropriate 
for 
the 
patient 
due 
to 
comorbidities or severe side effects that endan-
ger the health of the individual— 
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‘‘(I) has been shown to provide clin-
ical 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 sub-
section (d); and 
(2) by inserting after subsection (b) the fol-
lowing: 
‘‘(c) NATIONAL DRUG CODE NUMBER.—Medical 
foods shall be eligible for a National Drug Code number.’’. 
SEC. 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— 
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fined in section 1861(kkk)), the amount 
paid shall be an amount equal to 80 per-
cent 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 re-
spect to plan years beginning on or after Janu-
ary 1, 2021. 
(b) COVERAGE UNDER MEDICAID PROGRAM.— 
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(1) IN GENERAL.—Section 1905(a) of the So-
cial Security Act (42 U.S.C. 1396d(a)) is amend-
ed— 
(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 in-
serting ‘‘(29), and (30)’’. 
(3) EFFECTIVE DATE.— 
(A) IN
GENERAL.—Subject to subpara-
graph (B), the amendments made by this sub-
section shall apply with respect to medical as-
sistance 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 
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Human Services determines requires State leg-
islation (other than legislation appropriating 
funds) in order for the plan to meet the addi-
tional 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 pur-
poses 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 So-
cial 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-in-
come child shall include coverage of medically nec-
essary food (as defined in section 1861(kkk)).’’. 
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(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 subpara-
graph (B), the amendments made by this sub-
section 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 re-
quires 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 fail-
ing 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 
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legislature that begins after the date of the en-
actment of this Act. For purposes of the pre-
vious 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 INSUR-
ANCE.— 
(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: 
‘‘SEC. 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 de-
fined in section 1861(kkk) of the Social Security Act).’’. 
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(2) EFFECTIVE DATE.—The amendment made 
by paragraph (1) shall apply to plan years beginning 
on or after January 1, 2021. 
Æ 
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