Medical Foods and Formulas Access Act of 2025
- Bill Number
- H.R. 5684
- Origin Chamber
- House
- Congress
- 119th Congress, Session 1
- Policy Area
- Health
- Status
- Introduced
- Latest Action
- 2025-10-03: 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.
- Last Updated
- 2026-07-07T08:05:42Z
AI-Generated Summary
Purpose of the Legislation
The Medical Foods and Formulas Access Act of 2025 aims to guarantee coverage for "medically necessary food"—including specialized formulas, vitamins, and individual amino acids—for individuals with certain digestive or inherited metabolic disorders under major federal health programs. It seeks to prevent severe health risks like malnutrition, developmental delays, and death by ensuring access to these treatments, while protecting existing state and federal coverage levels.
Key Provisions
- Definition of Medically Necessary Food: Establishes a clear definition under federal law, covering specially formulated products (e.g., low-protein foods, amino acid preparations, nutritional formulas, vitamins, or individual amino acids) prescribed by a qualified healthcare provider for dietary management of specific conditions. These must be used under medical supervision, often for oral or tube feeding, but excludes general diet aids, gluten-free foods for celiac disease, or diabetes management products.
- Covered Conditions: Includes inherited metabolic disorders (e.g., organic acid conditions, urea cycle disorders), malabsorption issues (e.g., short bowel syndrome), food protein allergies (e.g., eosinophilic disorders), and inflammatory bowel diseases (e.g., Crohn's disease). The Secretary of Health and Human Services can add others after consulting experts.
- Required Coverage Across Programs:
- Medicare: Adds coverage for medically necessary food and related equipment/supplies (excluding items already covered under Part B), with payments at 80% of the lesser of the actual charge or a fee schedule set by the Secretary. Effective 3 years after enactment.
- Medicaid: Mandates coverage as a required benefit, including in benchmark plans, with no cost limits applied to these items. Effective 2 years after enactment (or later if state legislation is needed).
- Children's Health Insurance Program (CHIP): Requires coverage for targeted low-income children. Effective 1 year after enactment (or later if state legislation is needed).
- Federal Employees Health Benefits Program (FEHBP): Requires carriers to cover these items in contracts. Effective for contract years starting 1 year after enactment.
- Additional Protections: Allows combinations of these foods with other treatments; does not preempt state laws offering broader coverage; expresses a "sense of Congress" encouraging private insurers to provide similar access.
- Findings Section: Highlights the life-sustaining role of these foods, risks without them (e.g., brain damage, hospitalizations), inconsistencies in current coverage, and lessons from the 2022 formula shortage.
Significant Changes to Existing Law
- Amends the Social Security Act to explicitly include medically necessary food as a covered benefit in Medicare (adding a new subparagraph to Section 1861(s)(2) and a definition in Section 1861(nnn)), Medicaid (inserting a new paragraph in Section 1905(a) and updating related sections), and CHIP (adding to Section 2103(c)).
- Introduces payment mechanisms for Medicare not previously specified for these items.
- Modifies FEHBP under Title 5 of the U.S. Code to mandate coverage, expanding beyond current requirements.
- Ensures uniformity by defining terms consistently across programs and prohibiting restrictions like mandatory feeding tubes for oral-capable patients.
Potential Impacts
- On Citizens: Improves access to essential nutrition for thousands affected annually (e.g., ~2,000 newborns with metabolic disorders), potentially reducing hospitalizations, emergency visits, and long-term complications like cognitive impairment or death. Families may face fewer barriers to oral feeding options, lowering surgical risks and costs.
- On Government Agencies: The Centers for Medicare & Medicaid Services (CMS) and Office of Personnel Management (OPM) must implement new coverage rules, develop fee schedules, and monitor compliance, which could increase administrative workload and program costs (though not quantified in the bill). States may need to adjust Medicaid/CHIP plans, with delayed effective dates to accommodate legislation.
- On International Relations: No direct impacts mentioned or implied.
Main Stakeholders Affected
- Patients and Families: Primarily children and adults with digestive/metabolic disorders, including those identified via mandatory newborn screening, who rely on these foods to avoid severe health outcomes.
- Healthcare Providers: Physicians, physician assistants, nurse practitioners, and others who prescribe these items and benefit from clearer coverage guidelines to recommend optimal treatments.
- Federal and State Governments: CMS for oversight; states for Medicaid/CHIP implementation; federal employees and retirees via FEHBP.
- Insurers and Health Plans: Federal programs directly; private insurers indirectly encouraged to expand coverage.
- Food and Pharmaceutical Manufacturers: Producers of specialized formulas, vitamins, and amino acids may see increased demand.
Notable Legal, Constitutional, or Political Implications
- Legal: Expands mandatory benefits under federal health programs, potentially raising enforcement questions around the definition of "medically necessary" and Secretary determinations. Includes safeguards against preemption of stronger state laws, preserving federalism. Could lead to litigation if coverage denials occur, but provides clear criteria to reduce disputes.
- Constitutional: Relies on Congress's spending power to condition federal funds on coverage requirements; no apparent First Amendment, due process, or equal protection issues, as it targets specific medical needs without discriminating.
- Political: Bipartisan sponsorship (Democrats and Republicans) signals broad support for addressing health disparities in rare disorders. May influence future debates on nutrition as healthcare, especially post-2022 shortage, but could face opposition over added costs to federal budgets without offsetting funding.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Rep. McGovern, James P. [D-MA-2]
Cosponsors (14)
Rep. Rutherford, John H. [R-FL-5], Rep. Dingell, Debbie [D-MI-6], Rep. Fitzpatrick, Brian K. [R-PA-1], Rep. Evans, Dwight [D-PA-3], Rep. Auchincloss, Jake [D-MA-4], Rep. Pingree, Chellie [D-ME-1], Rep. McGarvey, Morgan [D-KY-3], Rep. Moulton, Seth [D-MA-6], Rep. Mannion, John W. [D-NY-22], Rep. Morelle, Joseph D. [D-NY-25], Rep. Walkinshaw, James R. [D-VA-11], Rep. Schrier, Kim [D-WA-8], Rep. Carson, André [D-IN-7], Rep. Tlaib, Rashida [D-MI-12]
Recent Actions
- 2025-10-03: 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.
- 2025-10-03: 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.
- 2025-10-03: 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.
- 2025-10-03: Introduced in House
- 2025-10-03: Introduced in House
Bill Versions
- Medical Foods and Formulas Access Act of 2025 — issued 2025-10-03 — PDF (17 pages)