I 
117TH CONGRESS 
1ST SESSION H. R. 3783 
To provide for the coverage of medically necessary food and vitamins and 
individual amino acids for digestive and inherited metabolic disorders 
under Federal health programs and private health insurance, to ensure 
State and Federal protection for existing coverage, and for other pur-
poses. 
IN THE HOUSE OF REPRESENTATIVES 
JUNE 8, 2021 
Mr. MCGOVERN (for himself and Ms. HERRERA BEUTLER) introduced the fol-
lowing bill; which was referred to the Committee on Energy and Com-
merce, and in addition to the Committees on Ways and Means, Oversight 
and Reform, 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 provide for the coverage of medically necessary food and 
vitamins and individual amino acids for digestive and 
inherited metabolic disorders under Federal health pro-
grams and private health insurance, to ensure State and 
Federal protection for existing coverage, and for other 
purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Medical Nutrition Eq-
uity Act of 2021’’. 
SEC. 2. FINDINGS. 
Congress finds the following: 
(1) Each year, thousands of children and adults 
in the United States are diagnosed with certain di-
gestive or inherited metabolic disorders that prevent 
their bodies from digesting or metabolizing the food 
they need to survive. For them, medically necessary 
food, which can often be administered as an orally 
consumed formula, is their treatment. 
(2) Without medically necessary food, these pa-
tients risk malnutrition, surgery, and repeated hos-
pitalizations. They may suffer intellectual disability 
or even death. Risks in pediatric populations are 
particularly profound and often severe and also in-
clude inadequate growth, abnormal development, 
cognitive impairment, and behavioral disorders. Spe-
cialized medically necessary food is standard-of-care 
therapy for these patients and is essential to pre-
venting such outcomes. 
(3) While not every person diagnosed with these 
conditions needs to be treated with medically nec-
essary food for a prolonged period, it is critical that 
patients and their physicians be able to consider the 
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full range of options and select the treatment that 
will be most effective for each patient. 
(4) Insurance companies will typically cover 
pharmaceuticals or biologics for treatment of many 
of these conditions, if there is a therapy approved by 
the Food and Drug Administration. However, these 
types of treatments may not be the first-line therapy 
a physician would recommend, do not work for all 
patients, and can have undesirable risks, such as 
cancer or suppression of the immune system, which 
can increase a patient’s risk of infection. 
(5) Even when an insurance company does 
cover medically necessary food, it can come with the 
stipulation the formula be administered through a 
feeding tube, placed through the nose into the stom-
ach or surgically placed directly into the stomach or 
jejunum, even if a patient is capable of taking the 
formula orally without these devices. Surgical place-
ment of feeding tubes unnecessarily results in in-
creased risk to the patient and increased cost to the 
health care system. 
(6) Testing for select inherited metabolic dis-
orders is required in all States, and approximately 
2,000 babies per year are diagnosed with one of 
these disorders that requires treatment through 
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medically necessary food. Yet, policies on medically 
necessary food vary significantly and do not always 
make it possible for families to get sufficient nutri-
tion for their affected children which can lead to de-
layed development, brain damage, and even death. 
(7) The worsening of food insecurity during the 
COVID–19 pandemic has had a significant impact 
on patients who rely on medical nutrition, and the 
cost of meeting their dietary needs has been a major 
burden to individuals facing financial challenges as 
a result of the pandemic. 
SEC. 3. COVERAGE OF MEDICALLY NECESSARY FOOD, VITA-
MINS, AND INDIVIDUAL AMINO ACIDS FOR DI-
GESTIVE AND INHERITED METABOLIC DIS-
ORDERS 
UNDER 
FEDERAL 
HEALTH 
PRO-
GRAMS AND PRIVATE HEALTH INSURANCE. 
(a) COVERAGE UNDER THE MEDICARE PROGRAM.— 
(1) MEDICALLY NECESSARY FOOD.— 
(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 insert-
ing ‘‘and’’ at the end; and 
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(iii) by adding at the end the fol-
lowing new subparagraph: 
‘‘(II) medically necessary food (as defined in 
subsection (lll)) and, if required, the medical equip-
ment and supplies necessary to administer such food 
(other than medical equipment and supplies de-
scribed in subsection (n));’’. 
(B) DEFINITION.—Section 1861 of the So-
cial Security Act (42 U.S.C. 1395x) is amended 
by adding at the end the following new sub-
section: 
‘‘Medically Necessary Food 
‘‘(lll)(1) Subject to paragraph (2), the term ‘medi-
cally necessary food’ means food, including a low protein 
modified food product, an amino acid preparation product, 
a modified fat preparation product, or a nutritional for-
mula (including such a formula that does not require a 
prescription), that is— 
‘‘(A) furnished pursuant to the prescription, 
order, or recommendation (as applicable) of a physi-
cian or other health care professional qualified to 
make such prescription, order, or recommendation, 
for the dietary management of a covered disease or 
condition; 
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‘‘(B) a specially formulated and processed prod-
uct (as opposed to a naturally occurring foodstuff 
used in its natural state) for the partial or exclusive 
feeding of an individual by means of oral intake or 
enteral feeding by tube; 
‘‘(C) intended for the dietary management of 
an individual who, because of a specified disease or 
condition, has limited or impaired capacity to ingest, 
digest, absorb, or metabolize ordinary foodstuffs or 
certain nutrients, or who has other special medically 
determined nutrient requirements, the dietary man-
agement of which cannot be achieved by the modi-
fication of the normal diet alone; 
‘‘(D) intended to be used under medical super-
vision, which may include in a home setting; and 
‘‘(E) intended only for an individual receiving 
active and ongoing medical supervision wherein the 
individual requires medical care on a recurring basis 
for, among other things, instructions on the use of 
the food. 
‘‘(2) For purposes of paragraph (1), the term ‘medi-
cally necessary food’ does not include the following: 
‘‘(A) Foods taken as part of an overall diet de-
signed to reduce the risk of a disease or medical con-
dition or as weight loss products, even if they are 
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recommended by a physician or other health profes-
sional. 
‘‘(B) Foods marketed as gluten-free for the 
management of celiac disease or non-celiac gluten 
sensitivity. 
‘‘(C) Foods marketed for the management of 
diabetes. 
‘‘(D) Other products determined appropriate by 
the Secretary. 
‘‘(3) In this subsection, the term ‘covered disease or 
condition’ means the following diseases or conditions: 
‘‘(A) Inherited metabolic disorders, including 
the following: 
‘‘(i) Disorders classified as metabolic dis-
orders on the Recommended Uniform Screening 
Panel Conditions list of the Secretary of Health 
and Human Services’ Advisory Committee on 
Heritable Disorders in Newborns and Children. 
‘‘(ii) N-acetyl glutamate synthase defi-
ciency. 
‘‘(iii) Ornithine transcarbamlyase defi-
ciency. 
‘‘(iv) Carbamoyl phosphate synthestase de-
ficiency. 
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‘‘(v) Inherited disorders of mitochondrial 
functioning. 
‘‘(B) Medical and surgical conditions of mal-
absorption, including the following: 
‘‘(i) Impaired absorption of nutrients 
caused by disorders affecting the absorptive 
surface, functional length, and motility of the 
gastrointestinal tract, including short bowel 
syndrome and chronic intestinal pseudo-obstruc-
tion. 
‘‘(ii) Malabsorption due to liver or pan-
creatic disease. 
‘‘(C) 
Immunoglobulin 
E 
and 
non- 
Immunoglobulin E-mediated allergies to food pro-
teins, including the following: 
‘‘(i) 
Immunoglobulin 
E 
and 
non- 
Immunoglobulin E-mediated allergies to food 
proteins. 
‘‘(ii) Food protein-induced enterocolitis 
syndrome. 
‘‘(iii) 
Eosinophilic 
disorders, 
including 
eosinophilic 
esophagitis, 
eosinophilic 
gastroenteritis, eosinophilic colitis, and post- 
transplant eosinophilic disorders. 
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‘‘(D) Inflammatory or immune mediated condi-
tions of the alimentary tract, including the following: 
‘‘(i) Inflammatory bowel disease, including 
Crohn’s disease, ulcerative colitis, and indeter-
minate colitis. 
‘‘(ii) Gastroesophageal reflux disease that 
is nonresponsive to standard medical therapies. 
‘‘(E) Any other disease or condition determined 
appropriate by the Secretary, in consultation with 
appropriate scientific entities, such as the Agency 
for Healthcare Research and Quality. 
‘‘(4)(A) In this subsection, the term ‘low protein 
modified food product’ means a type of medical food that 
is modified to be low in protein and formulated for oral 
consumption for individuals with inborn errors of protein 
metabolism. 
‘‘(B) Such term does not include foods that are natu-
rally low in protein, such as some fruits or vegetables.’’. 
(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 
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respect to medically necessary food (as de-
fined in section 1861(lll)), the amount paid 
shall be an amount equal to 80 percent of 
the lesser of the actual charge for the serv-
ices or the amount determined under a fee 
schedule established by the Secretary for 
purposes of this subparagraph.’’. 
(D) EFFECTIVE DATE.—The amendments 
made by this subsection shall apply to items 
and services furnished on or after the date that 
is 1 year after the date of the enactment of this 
Act. 
(2) INCLUSION OF MEDICALLY NECESSARY VI-
TAMINS AND INDIVIDUAL AMINO ACIDS AS A COV-
ERED 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 
‘‘or’’ at the end; 
(ii) in subparagraph (B), by striking 
the comma at the end and inserting ‘‘; or’’; 
and 
(iii) by inserting after subparagraph 
(B) the following new subparagraph: 
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‘‘(C) medically necessary vitamins and in-
dividual amino acids used for the management 
of a covered disease or condition (as defined in 
section 1861(lll)(3)) pursuant to the prescrip-
tion, order, or recommendation (as applicable) 
of a physician or other health care professional 
qualified to make such prescription, order, or 
recommendation,’’. 
(B) EFFECTIVE DATE.—The amendments 
made by subparagraph (A) shall apply to plan 
years beginning on or after the date that is 1 
year after the date of the enactment of this Act. 
(b) COVERAGE UNDER THE MEDICAID PROGRAM.— 
(1) IN GENERAL.—Section 1905(a) of the So-
cial Security Act (42 U.S.C. 1396d(a)) is amend-
ed— 
(A) in paragraph (30), by striking ‘‘and’’ 
at the end; 
(B) by redesignating paragraph (31) as 
paragraph (33); and 
(C) by inserting after paragraph (30) the 
following new paragraphs: 
‘‘(31) medically necessary food (as defined in 
section 1861(lll)) and the medical equipment and 
supplies necessary to administer such food; 
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‘‘(32) medically necessary vitamins and indi-
vidual amino acids used for the management of a 
covered disease or condition (as defined in section 
1861(lll)(3)) pursuant to the prescription, order, or 
recommendation (as applicable) of a physician or 
other health care professional qualified to make such 
prescription, order, or recommendation; and’’. 
(2) CONFORMING AMENDMENTS.— 
(A) 
MANDATORY
BENEFITS.—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 
(30)’’ and inserting ‘‘(30), (31), and (32)’’. 
(B) EXCEPTION
TO
COVERAGE
RESTRIC-
TION.—Section 1927(d)(2)(E) of the Social Se-
curity Act (42 U.S.C. 1396r–8(d)(2)(E)) is 
amended by inserting ‘‘and except for medically 
necessary vitamins and individual amino acids 
described in section 1905(a)(32)’’ before the pe-
riod at the end. 
(3) EFFECTIVE DATE.— 
(A) IN
GENERAL.—Subject to subpara-
graph (B), the amendments made by this sub-
section shall take effect on the date that is 1 
year after the date of the enactment of this Act. 
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(B) EXCEPTION TO EFFECTIVE DATE IF 
STATE LEGISLATION REQUIRED.—In the case of 
a State plan for medical assistance under title 
XIX of the Social Security Act which the Sec-
retary of Health and Human Services deter-
mines requires State legislation (other than leg-
islation appropriating funds) in order for the 
plan to meet the additional requirements im-
posed by the amendments made by this sub-
section, 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 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. 
(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: 
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