PolicyBrief
S. 3304
119th CongressDec 2nd 2025
Medical Foods and Formulas Access Act of 2025
IN COMMITTEE

This bill mandates federal health programs like Medicare, Medicaid, and CHIP to cover medically necessary specialized foods and formulas required for managing specific digestive and inherited metabolic disorders.

Roger Wicker
R

Roger Wicker

Senator

MS

LEGISLATION

Federal Health Programs Must Cover Medically Necessary Formulas and Foods Starting in 2026

The newly proposed Medical Foods and Formulas Access Act of 2025 is designed to close a critical gap in health coverage for thousands of Americans who rely on specialized nutrition just to survive. Essentially, this legislation mandates that major federal health programs—Medicare, Medicaid, CHIP, and the Federal Employees Health Benefits Program (FEHBP)—must cover “medically necessary food” and related supplies for patients dealing with severe digestive or inherited metabolic disorders.

The Formula: What Exactly is Covered?

Think of this as a fix for a problem where medicine is food, but insurance treats it like groceries. The bill defines “medically necessary food” as specially formulated products—including low protein foods, amino acid preparations, and nutritional formulas—that are prescribed by a doctor for someone who simply cannot digest, absorb, or metabolize normal food. This isn't for general health; it's for conditions like short bowel syndrome, severe inflammatory bowel disease (Crohn's), or inherited metabolic disorders that require highly specific, often expensive, oral formulas to prevent malnutrition, developmental delays, or death. The law specifically addresses the need for oral consumption, clarifying that patients shouldn't be forced to get a surgical feeding tube just to secure coverage.

The motivation here is clear: the 2022 formula shortage showed how devastating it is when access to these life-sustaining products is cut off. For a parent of a child with a metabolic disorder, running out of formula isn't a dietary inconvenience; it's a medical emergency that can lead to brain damage or hospitalization. This bill aims to make that life-saving nutrition a guaranteed medical benefit under federal programs.

Who Gets the Lifeline and Who Doesn’t?

The bill is very specific about who benefits. Coverage is mandatory for severe inherited metabolic conditions and specific immune/inflammatory digestive disorders. This standardization is a huge win for patients who currently live in states with poor or non-existent coverage mandates. However, the bill also draws very clear lines around what isn't covered. It explicitly excludes gluten-free foods for celiac disease, foods marketed for diabetes management, and products for general weight loss or disease risk reduction.

For someone with celiac disease, this means their specialized diet is still considered a dietary choice by federal programs, even though it’s medically required. The distinction the bill makes is between a condition managed by diet modification (like celiac) and a condition where the body fundamentally cannot process normal nutrients (like certain metabolic disorders). This distinction, while medically sound, will likely be a source of frustration and potential coverage disputes for other patients who rely on specialized diets.

The Rollout and the Fine Print

Because this involves massive federal programs, implementation will be staggered. The changes will roll out over the next one to three years, depending on the program: CHIP and FEHBP coverage starts in one year, Medicaid in two years, and Medicare in three years. This delay gives state legislatures and federal agencies time to adapt their systems.

For Medicare beneficiaries, there's a key detail: the payment is set at 80% of the cost, meaning patients will still face a 20% co-pay for these items. While this is a huge improvement over 100% out-of-pocket costs, it means that even with the new mandate, access to these expensive formulas won't be entirely free. Finally, the Secretary of Health and Human Services is given the power to add or subtract conditions from the covered list. This administrative discretion is necessary for adapting to new medical knowledge, but it also creates a point of medium vagueness, meaning future access could depend on bureaucratic decisions rather than just the law itself.