I 
119TH CONGRESS 
1ST SESSION H. R. 5684 
To provide for the coverage of medical food and vitamins and individual 
amino acids for digestive and inherited metabolic disorders under Federal 
health programs, to ensure State and Federal protection for existing 
coverage, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
OCTOBER 3, 2025 
Mr. MCGOVERN (for himself, Mr. RUTHERFORD, Mrs. DINGELL, and Mr. 
FITZPATRICK) 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 Oversight and Government Reform, for a period 
to be subsequently determined by the Speaker, in each case for consider-
ation of such provisions as fall within the jurisdiction of the committee 
concerned 
A BILL 
To provide for the coverage of medical food and vitamins 
and individual amino acids for digestive and inherited 
metabolic disorders under Federal health programs, to 
ensure State and Federal protection for existing cov-
erage, 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 ‘‘Medical Foods and 
Formulas Access Act of 2025’’. 
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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 
full range of options and select the treatment that 
will be most effective for each patient. 
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(4) Insurance will typically cover pharma-
ceuticals 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 
certain cancers or suppression of the immune sys-
tem, which can increase a patient’s risk of infection. 
(5) Even when insurance 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 stomach or sur-
gically placed directly into the stomach or jejunum, 
even if a patient is capable of taking the formula 
orally without these devices. Surgical placement of 
feeding tubes unnecessarily results in increased risk 
to the patient and increased cost to the health care 
system. 
(6) Vitamins are essential micronutrients that 
play critical roles in metabolism, cellular function, 
and overall health. Amino acids serve as the building 
blocks of proteins and function as critical metabolic 
intermediates. Both vitamins and amino acids re-
quire careful assessment and monitoring in patients 
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with GI and metabolic disorders, as their absorption, 
metabolism, and utilization may be significantly im-
pacted by the underlying disease processes. 
(7) 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 
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. 
(8) The 2022 formula shortage demonstrated 
the essential nature of specialty formulas for those 
with digestive and metabolic conditions and the dire 
medical consequences that can result when these for-
mulas are inaccessible. During the shortage, patients 
lacking access to their formulas faced medical con-
sequences such as feeding intolerance, weight loss, 
rectal bleeding, rapid gastric emptying, acute kidney 
injury, and electrolyte disturbances, all of which re-
sulted in increased physician and emergency depart-
ment visits. Children with metabolic disorders who 
were hospitalized due to lack of formula faced simi-
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lar challenges due to lack of formula supply and had 
to be placed on IV nutrition. 
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. 
(a) COVERAGE UNDER THE MEDICARE PROGRAM.— 
(1) IN
GENERAL.—Section 1861(s)(2) of the 
Social Security Act (42 U.S.C. 1395x(s)(2)) is 
amended— 
(A) in subparagraph (II), by striking 
‘‘and’’ at the end; 
(B) in subparagraph (JJ), by inserting 
‘‘and’’ at the end; and 
(C) by adding at the end the following new 
subparagraph: 
‘‘(KK) medically necessary food (as defined in 
subsection (nnn)) and, if required, the medical 
equipment and supplies necessary to administer such 
food, other than such food, equipment, and supplies 
furnished to an individual that would otherwise be 
covered for such individual under part B without ap-
plication of this subparagraph;’’. 
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(2) DEFINITION.—Section 1861 of the Social 
Security Act (42 U.S.C. 1395x) is amended by add-
ing at the end the following new subsection: 
‘‘Medically Necessary Food 
‘‘(nnn)(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, a nutritional formula, 
a vitamin, or an individual amino acid, that is— 
‘‘(A) furnished pursuant to the prescription or 
order of a physician, physician assistant, nurse prac-
titioner, or other health care practitioner acting 
within the practitioner’s scope of practice, for the di-
etary management of a covered disease or condition; 
‘‘(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-
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agement of which cannot be achieved by the modi-
fication of the normal diet alone; 
‘‘(D) intended to be used under medical direc-
tion, which may include in a home setting; and 
‘‘(E) intended only for an individual receiving 
active or ongoing medical care under the supervision 
of a physician, physician assistant, or nurse practi-
tioner. 
‘‘(2) For purposes of paragraph (1), the term ‘medi-
cally necessary food’ does not include the following: 
‘‘(A) Foods, including vitamins and amino 
acids, taken as part of an overall diet designed to re-
duce the risk of a disease or medical condition or as 
weight loss products, even if they are recommended 
by a physician or other health professional. 
‘‘(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: 
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‘‘(A) Inherited metabolic disorders, including 
the following: 
‘‘(i) Conditions included on the Rec-
ommended Uniform Screening Panel Conditions 
list of the Department of Health and Human 
Services. 
‘‘(ii) Organic acid conditions. 
‘‘(iii) Fatty acid oxidation disorders. 
‘‘(iv) Amino acid disorders. 
‘‘(v) Urea cycle disorders. 
‘‘(vi) Glycogen storage disorders. 
‘‘(vii) Biotinidase deficiency. 
‘‘(viii) Guanidinoacetate methyltransferase 
deficiency. 
‘‘(ix) 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. 
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‘‘(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. 
‘‘(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. 
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‘‘(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.’’. 
(3) PAYMENT.—Section 1833(a)(1) of the So-
cial Security Act (42 U.S.C. 1395l(a)(1)) is amend-
ed— 
(A) by striking ‘‘and’’ before ‘‘(HH)’’; and 
(B) by inserting before the semicolon at 
the end the following: ‘‘and (II) with respect to 
medically necessary food (as defined in section 
1861(nnn)), the amount paid shall be an 
amount equal to 80 percent of the lesser of the 
actual charge for the services or the amount de-
termined under a fee schedule established by 
the Secretary for purposes of this subpara-
graph.’’. 
(4) EFFECTIVE DATE.—The amendments made 
by this subsection shall apply to items and services 
furnished on or after the date that is 3 years after 
the date of the enactment of this Act. 
(b) COVERAGE UNDER THE 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 (31), by striking ‘‘and’’ 
at the end; 
(B) by redesignating paragraph (32) as 
paragraph (33); and 
(C) by inserting after paragraph (31) the 
following new paragraph: 
‘‘(32) medically necessary food (which shall in-
clude at least the items and services included in such 
term for purposes of section 1861(nnn)) and the 
medical equipment and supplies necessary to admin-
ister such food; 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), and (32)’’. 
(B) APPLICATION OF COST LIMITS.—Sec-
tion 1903(i)(27) of the Social Security Act (42 
U.S.C. 1396b(i)(27)) is amended— 
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(i) by inserting ‘‘or for equipment and 
supplies described in section 1905(a)(32),’’ 
after ‘‘2018,’’; and 
(ii) by striking ‘‘such items’’ each 
place such phrase appears and inserting 
‘‘such items, equipment, or supplies’’. 
(C) APPLICATION
TO
BENCHMARK
AND 
BENCHMARK-EQUIVALENT
COVERAGE.—Section 
1937(b) of the Social Security Act (42 U.S.C. 
1396u–7(b)) is amended by adding at the end 
the following new paragraph: 
‘‘(9) MEDICALLY NECESSARY FOOD.—Notwith-
standing the previous provisions of this section, a 
State may not provide for medical assistance 
through enrollment of an individual with benchmark 
coverage or benchmark-equivalent coverage under 
this section unless such coverage includes coverage 
of medically necessary food (which shall include at 
least the items and services included in such term 
for purposes of section 1861(nnn)) and the medical 
equipment and supplies necessary to administer such 
food.’’. 
(3) EFFECTIVE DATE.— 
(A) IN
GENERAL.—Subject to subpara-
graph (B), the amendments made by this sub-
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section shall take effect on the date that is 2 
years after the date of the enactment of this 
Act. 
(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.— 
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(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 new paragraph: 
‘‘(13) MEDICALLY
NECESSARY
FOOD.—The 
child health assistance provided to a targeted low-in-
come child under the plan shall include coverage of 
medically necessary food (which shall include at least 
the items and services included in such term for pur-
poses of section 1861(nnn)) and the medical equip-
ment and supplies necessary to administer such 
food.’’. 
(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 (13)’’. 
(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. 
(B) EXCEPTION TO EFFECTIVE DATE IF 
STATE LEGISLATION REQUIRED.—In the case of 
a State child health plan for child health assist-
ance under title XXI of the Social Security Act 
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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 re-
quirements 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 re-
quirement before the first day of the first cal-
endar 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 FEHBP.— 
(1) IN
GENERAL.—Section 8902 of title 5, 
United States Code, is amended by adding at the 
end the following: 
‘‘(q) A contract for a plan under this chapter shall 
require the carrier to provide coverage for medically nec-
essary food (as defined in section 1861(nnn) of the Social 
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Security Act) and the medical equipment and supplies nec-
essary to administer such food.’’. 
(2) EFFECTIVE DATE.—The amendment made 
by paragraph (1) shall apply with respect to contract 
years beginning on or after the date that is 1 year 
after the date of enactment of this Act. 
(e) SENSE OF CONGRESS: REGARDING COVERAGE 
UNDER PRIVATE HEALTH INSURANCE.—It is the sense 
of Congress that— 
(1) medically necessary food (as defined in sub-
section (nnn) of section 1861 of the Social Security 
Act (42 U.S.C. 1395x), as added by subsection 
(a)(2)) can be life-sustaining and life-saving; and 
(2) all health plans, including private health 
plans offered by health insurance issuers, should 
provide coverage of, and access to, medically nec-
essary food (as so defined) for individuals with cer-
tain digestive and metabolic disorders and condi-
tions, when prescribed or ordered by a physician, 
physician assistant, nurse practitioner, or other 
health care practitioner, in a manner similar to the 
required coverage of medically necessary food for 
such individuals under the Medicare program under 
title XVIII of the Social Security Act (42 U.S.C. 
1395 et seq.), the Medicaid program under title XIX 
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of the Social Security Act (42 U.S.C. 1396 et seq.), 
the State Children’s Health Insurance Program 
under title XXI of the Social Security Act (42 
U.S.C. 1397aa et seq.), and chapter 89 or title 5, 
United States Code, as amended by subsections (a), 
(b), (c), and (d), respectively. 
(f) NONPREEMPTION OF STATE LAWS THAT PRO-
VIDE GREATER COVERAGE.—Nothing in the provisions of, 
or the amendments made by, this section shall preempt 
a State law that requires coverage of medically necessary 
food (as defined in subsection (nnn) of section 1861 of 
the Social Security Act, as added by subsection (a)) that 
exceeds the requirements for coverage under such provi-
sions and amendments. 
(g) MEDICALLY NECESSARY NUTRITION COVERAGE 
INCLUDES COMBINATIONS AND SUPPLIES.—Nothing in 
the provisions of, or the amendments made by, this section 
shall limit coverage of a medically necessary food (as de-
fined in subsection (nnn) of section 1861 of the Social Se-
curity Act, as added by subsection (a)) or the medical 
equipment and supplies necessary to administer such food 
when prescribed, ordered, or recommended in combination 
with another medically necessary food (as so defined) or 
other necessary medical equipment and supplies. 
Æ 
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