119-hr5684

[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.
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