[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5684 Introduced in House (IH)]
<DOC>
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 consideration
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 coverage, and for other purposes.
Be it enacted by the Senate and House of Representatives 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''.
SEC. 2. FINDINGS.
Congress finds the following:
(1) Each year, thousands of children and adults in the
United States are diagnosed with certain digestive 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 patients risk
malnutrition, surgery, and repeated hospitalizations. They may
suffer intellectual disability or even death. Risks in
pediatric populations are particularly profound and often
severe and also include inadequate growth, abnormal
development, cognitive impairment, and behavioral disorders.
Specialized medically necessary food is standard-of-care
therapy for these patients and is essential to preventing such
outcomes.
(3) While not every person diagnosed with these conditions
needs to be treated with medically necessary 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.
(4) Insurance 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 certain
cancers or suppression of the immune system, 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 surgically 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 require careful assessment and monitoring in
patients with GI and metabolic disorders, as their absorption,
metabolism, and utilization may be significantly impacted by
the underlying disease processes.
(7) Testing for select inherited metabolic disorders 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 nutrition for
their affected children which can lead to delayed 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 formulas are inaccessible. During the
shortage, patients lacking access to their formulas faced
medical consequences such as feeding intolerance, weight loss,
rectal bleeding, rapid gastric emptying, acute kidney injury,
and electrolyte disturbances, all of which resulted in
increased physician and emergency department visits. Children
with metabolic disorders who were hospitalized due to lack of
formula faced similar challenges due to lack of formula supply
and had to be placed on IV nutrition.
SEC. 3. COVERAGE OF MEDICALLY NECESSARY FOOD, VITAMINS, AND INDIVIDUAL
AMINO ACIDS FOR DIGESTIVE AND INHERITED METABOLIC
DISORDERS UNDER FEDERAL HEALTH PROGRAMS.
(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
application of this subparagraph;''.
(2) Definition.--Section 1861 of the Social Security Act
(42 U.S.C. 1395x) is amended by adding at the end the following
new subsection:
``Medically Necessary Food
``(nnn)(1) Subject to paragraph (2), the term `medically 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 practitioner, or other
health care practitioner acting within the practitioner's scope
of practice, for the dietary management of a covered disease or
condition;
``(B) a specially formulated and processed product (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
management of which cannot be achieved by the modification of
the normal diet alone;
``(D) intended to be used under medical direction, 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 practitioner.
``(2) For purposes of paragraph (1), the term `medically necessary
food' does not include the following:
``(A) Foods, including vitamins and amino acids, taken as
part of an overall diet designed to reduce 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:
``(A) Inherited metabolic disorders, including the
following:
``(i) Conditions included on the Recommended
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 malabsorption,
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-obstruction.
``(ii) Malabsorption due to liver or pancreatic
disease.
``(C) Immunoglobulin E and non-Immunoglobulin E-mediated
allergies to food proteins, 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 conditions of the
alimentary tract, including the following:
``(i) Inflammatory bowel disease, including Crohn's
disease, ulcerative colitis, and indeterminate 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.
``(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 naturally low in
protein, such as some fruits or vegetables.''.
(3) Payment.--Section 1833(a)(1) of the Social Security Act
(42 U.S.C. 1395l(a)(1)) is amended--
(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 determined under a fee schedule established by
the Secretary for purposes of this subparagraph.''.
(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.--
(1) In general.--Section 1905(a) of the Social Security Act
(42 U.S.C. 1396d(a)) is amended--
(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 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; 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.--Section
1903(i)(27) of the Social Security Act (42 U.S.C.
1396b(i)(27)) is amended--
(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.--Notwithstanding 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 subparagraph (B), the
amendments made by this subsection 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 Secretary of Health and Human
Services determines requires State legislation (other
than legislation appropriating funds) in order for the
plan to meet the additional requirements 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 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.
(c) Coverage Under CHIP.--
(1) In general.--Section 2103(c) of the Social 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-income 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 purposes of section 1861(nnn)) and the medical
equipment 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 subparagraph (B), the
amendments made by this subsection 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 assistance under title XXI
of the Social Security Act 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
requirements 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 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
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 necessary food (as defined in
section 1861(nnn) of the Social Security Act) and the medical equipment
and supplies necessary 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 subsection
(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 necessary food (as so defined) for
individuals with certain digestive and metabolic disorders and
conditions, 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
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 Provide 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 provisions 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
defined in subsection (nnn) of section 1861 of the Social Security 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.
<all>