S. 3304 — Medical Foods and Formulas Access Act of 2025

This section sets forth congressional findings on the medical necessity of specialized food formulas for patients with certain digestive or inherited metabolic disorders, including risks of malnutrition, developmental delays, intellectual disability, or death without such treatment; insurance coverage limitations and preferences for pharmaceuticals over formulas; barriers to oral administration; the role of vitamins and amino acids; state newborn screening identifying approximately 2,000 cases annually; and consequences of the 2022 formula shortage such as increased hospitalizations and medical complications.

This section establishes coverage under Medicare Part B for medically necessary food (as defined in new subsection 1861(nnn)), including low-protein modified food products, amino acid preparations, modified fat products, nutritional formulas, vitamins, and individual amino acids furnished pursuant to prescription for the dietary management of covered diseases or conditions—such as inherited metabolic disorders (e.g., urea cycle disorders, glycogen storage disorders), malabsorption conditions (e.g., short bowel syndrome), immunoglobulin E-mediated food protein allergies (e.g., eosinophilic esophagitis), and inflammatory bowel disease (e.g., Crohn's disease)—along with required medical equipment and supplies to administer such food (excluding items otherwise covered under Part B). The definition excludes foods for weight loss, gluten-free products for celiac disease, diabetes management foods, and others determined by the Secretary. It provides for payment from the Federal Supplementary Medical Insurance Trust Fund of 80 percent of the lesser of the actual charge or a fee schedule amount established by the Secretary. The section also requires states to cover medically necessary food under Medicaid. The amendments apply to items and services furnished on or after the date that is three years after the date of enactment.