H.R. 5684

119th CONGRESS 1st Session

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 · Sponsor: Mr. McGovern

Table of contents

• H.R. 5684
  • SEC. 1. Short title
  • SEC. 2. Findings
  • SEC. 3. Coverage of medically necessary food, vitamins, and individual amino acids for digestive and inherited metabolic disorders under Federal health programs

SEC. 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:
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 () is amended— 42 U.S.C. 1395x(s)(2)
      • in subparagraph (II), by striking and at the end;
      • in subparagraph (JJ), by inserting at the end; and
        • 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;
      • by adding at the end the following new subparagraph:
  • (2) Definition
    • Section 1861 of the Social Security Act () is amended by adding at the end the following new subsection: 42 U.S.C. 1395x
      • (nnn) Medically Necessary Food
        • 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—
          • 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;
          • 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;
          • 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;
          • intended to be used under medical direction, which may include in a home setting; and
          • intended only for an individual receiving active or ongoing medical care under the supervision of a physician, physician assistant, or nurse practitioner.
        • For purposes of paragraph (1), the term does not include the following: medically necessary food
          • 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.
          • Foods marketed as gluten-free for the management of celiac disease or non-celiac gluten sensitivity.
          • Foods marketed for the management of diabetes.