HR 5684119th CongressIn Committee

Medical Foods and Formulas Access Act of 2025

Introduced: Oct 3, 2025

Sponsor: Rep. McGovern, James P. [D-MA-2] (D-Massachusetts)

Healthcare

Standard Summary

Comprehensive overview in 1-2 paragraphs

The Medical Foods and Formulas Access Act of 2025 would require federal health programs to cover medically necessary foods, vitamins, and individual amino acids for people with certain digestive and inherited metabolic disorders. It creates a clear, national standard for what counts as “medically necessary food,” including associated medical equipment and supplies needed to administer these foods. The bill extends coverage across Medicare, Medicaid, CHIP, FEHBP, and seeks a similar approach for private plans. It also preserves existing state coverage rules (nonpreemption) and encourages state laws that provide greater coverage. By design, the measure aims to reduce malnutrition, hospitalizations, and other health risks for affected patients, and to ensure access to specialized formulas even when there are non-medical alternatives or shortages. In short, if enacted, people with qualifying digestive/metabolic disorders would have more consistent access to specialized medical foods and related supplies through major federal programs, with standardized payment terms and timelines for implementation. The bill also emphasizes the role of physicians in prescribing these foods and clarifies that coverage should not be limited to tube-fed administration when oral intake is feasible.

Key Points

1Medically necessary food defined and covered
2- Establishes a formal definition of “medically necessary food,” including formulas, amino acid preparations, low-protein foods, vitamins, and individual amino acids used for dietary management of specific covered diseases or conditions, prescribed by a health professional, and usable via oral intake or enteral feeding when medically indicated.
3- Excludes general diet foods or products marketed for gluten-free management of celiac disease, diabetes management, or other conditions not within the defined covered diseases.
4Coverage and equipment across federal programs (Medicare, Medicaid, CHIP, FEHBP)
5- Medicare: adds medically necessary food and related equipment to the list of covered items; reimbursement would be 80% of the lesser of actual charge or a Secretary-established fee schedule.
6- Medicaid/CHIP: requires Medicaid to cover medically necessary food and related equipment; CHIP coverage for medically necessary food for targeted low-income children; states must align benefits with the federal definitions.
7- FEHBP: requires contracts to cover medically necessary food and the necessary equipment starting one year after enactment.
8- Private insurance: Congress urges private plans to provide similar coverage.
9Implementation timing and state considerations
10- Medicare: effective for items/services furnished 3 years after enactment.
11- Medicaid: effective 2 years after enactment, with potential state legislative delay accommodated if required.
12- CHIP: effective 1 year after enactment, with a similar legislative accommodation if needed.
13- FEHBP and private plans: generally align with the 1-year (FEHBP) and voluntary private plan expectations, respectively.
14- States can exceed federal coverage; nonpreemption ensures states may provide greater coverage where they choose.
15Scope of covered diseases and conditions
16- Covers inherited metabolic disorders (e.g., amino acid disorders, urea cycle disorders, fatty acid oxidation disorders, organic acid disorders, biotinidase deficiency, mitochondrial diseases) and medical/surgical malabsorption conditions, certain food allergies, and inflammatory/immune-mediated GI conditions.
17- Includes combinations of medically necessary foods and the equipment to administer them when prescribed or ordered by a health professional.
18Administrative and policy context
19- Includes a sense of Congress that medically necessary food can be life-sustaining and should be covered similarly to other essential therapies by private plans.
20- Maintains that state laws providing greater coverage are not preempted; recognizes lessons from past formula shortages and emphasizes access and continuity of care.
21- Emphasizes that coverage can extend to combinations of foods and necessary related medical equipment if prescribed as part of a medical plan.

Impact Areas

Primary group/area affected- Individuals with digestive and inherited metabolic disorders who rely on medically necessary food, vitamins, and amino acids, and the healthcare teams that treat them (doctors, dietitians, metabolic specialists).Secondary group/area affected- Families and caregivers who manage daily nutrition for affected patients; healthcare providers who prescribe and monitor specialized foods; hospitals and clinics that stock or administer these products.Additional impacts- Payers and insurers (Medicare, Medicaid, CHIP, FEHBP, and potentially private plans) would face changes in coverage rules and reimbursement structures (e.g., 80% of the lesser of charge or a Secretary-determined fee schedule under Medicare).- State health programs may need to adjust formularies and plan designs; states with stronger existing coverage may experience minimal disruption, while others may need to update policies or state legislation to comply.- The broader healthcare system could see changes in demand for specialized formulas, potential cost shifts, and administrative workload related to coding, coverage determinations, and provider education.- The bill’s alignment with past shortages underscores potential benefits for continuity of care and reduced hospital/ED visits due to access issues.

Generated by gpt-5-nano on Oct 16, 2025