H.R. 5684 — Medical Foods and Formulas Access Act of 2025

This section states congressional findings concerning medically necessary food (i.e., often administered as orally consumed formulas) as standard-of-care treatment for patients with certain digestive or inherited metabolic disorders, including health risks such as malnutrition, intellectual disability, and death without it; insurance coverage limitations and feeding tube requirements; the role of vitamins and amino acids; newborn screening identifying approximately 2,000 cases annually; state policy variations; and medical consequences of the 2022 formula shortage.

This section requires Medicare Part B to cover medically necessary food (i.e., specially formulated low-protein products, amino acid preparations, nutritional formulas, vitamins, or individual amino acids prescribed for the dietary management of specified inherited metabolic disorders, malabsorption conditions, food protein allergies, inflammatory bowel disease, or other Secretary-determined conditions), along with necessary medical equipment and supplies to administer it (excluding items otherwise covered under Part B), with payment equal to 80% of the lesser of the actual charge or a fee schedule amount established by the Secretary; and requires Medicaid to cover such medically necessary food. (As background, Medicare Part B covers outpatient services at 80% of approved amounts after the annual deductible, while Medicaid provides health coverage to low-income individuals.) The amendments apply to items and services furnished on or after the date that is 3 years after enactment.