Medical Foods and Formulas Access Act of 2025
Sponsors
Legislative Progress
In CommitteeMr. Wicker (for himself, Ms. Klobuchar, Mr. Grassley, and Mr. …
Summary
What This Bill Does
The Medical Foods and Formulas Access Act of 2025 requires Medicare, Medicaid, CHIP (Children's Health Insurance Program), and Federal Employee Health Benefits to cover medically necessary food, vitamins, and amino acids for patients with digestive and inherited metabolic disorders. These specialized formulas are often life-sustaining treatments for conditions like phenylketonuria (PKU), short bowel syndrome, and inflammatory bowel disease, where patients cannot properly digest or metabolize regular food.
Who Benefits and How
Patients with inherited metabolic disorders and digestive conditions will see reduced out-of-pocket costs as their specialized formulas become covered medical benefits. Families of the approximately 2,000 babies diagnosed annually with metabolic disorders requiring these formulas will gain financial relief, as these products can cost thousands of dollars per month. Medical food manufacturers and specialty pharmacies will see increased revenue as insurance coverage expands the market for their products.
Who Bears the Burden and How
Federal taxpayers will bear the cost of expanded Medicare coverage, with payments set at 80% of the fee schedule. State governments will face increased Medicaid costs to cover these specialized products for low-income residents. Federal Employee Health Benefits carriers must add this coverage to their plans, potentially affecting premiums. The bill takes effect over a phased timeline (1-3 years) to allow programs to adjust.
Key Provisions
- Establishes a detailed definition of "medically necessary food" covering low-protein foods, amino acid formulas, nutritional formulas, vitamins, and related medical equipment
- Covers inherited metabolic disorders (conditions on the HHS Recommended Uniform Screening Panel), malabsorption conditions, food allergies, and inflammatory bowel diseases
- Sets Medicare payment at 80% of fee schedule for covered items
- Explicitly excludes foods for weight loss, gluten-free products for celiac disease, and diabetes management foods
- Preserves state laws requiring broader coverage and does not limit combined use with other medical treatments
Evidence Chain:
This summary is derived from the structured analysis below. See "Detailed Analysis" for per-title beneficiaries/burden bearers with clause-level evidence links.
Primary Purpose
Mandates coverage of medically necessary food, vitamins, and amino acids for digestive and inherited metabolic disorders under Medicare, Medicaid, CHIP, and Federal Employee Health Benefits programs.
Policy Domains
Legislative Strategy
"Establish mandatory coverage of medically necessary food across all major federal health programs to ensure consistent access for patients with metabolic and digestive disorders."
Likely Beneficiaries
- Patients with inherited metabolic disorders (PKU, urea cycle disorders, etc.)
- Patients with digestive conditions (IBD, short bowel syndrome, food allergies)
- Families of children with metabolic disorders requiring specialized formulas
- Medical food and formula manufacturers
- Specialty pharmacies and medical nutrition providers
Likely Burden Bearers
- Medicare program (federal government/taxpayers)
- State Medicaid programs
- CHIP programs
- Federal Employee Health Benefits carriers
- Health insurance carriers participating in federal programs
Bill Structure & Actor Mappings
Who is "The Secretary" in each section?
- "the_secretary"
- → Secretary of Health and Human Services
Key Definitions
Terms defined in this bill
Food, including low protein modified food products, amino acid preparations, modified fat preparations, nutritional formulas, vitamins, or individual amino acids that are: (1) prescribed by a healthcare practitioner for dietary management of a covered disease; (2) specially formulated and processed for feeding via oral intake or enteral tube; (3) intended for individuals with limited capacity to ingest, digest, absorb, or metabolize ordinary foods; (4) used under medical direction; and (5) for individuals receiving active medical care.
Excludes: foods taken for disease prevention or weight loss, gluten-free foods for celiac disease management, foods for diabetes management, and other products determined by the Secretary.
Includes: inherited metabolic disorders (conditions on RUSP list, organic acid conditions, fatty acid oxidation disorders, amino acid disorders, urea cycle disorders, glycogen storage disorders, biotinidase deficiency, GAMT deficiency, mitochondrial disorders); malabsorption conditions (short bowel syndrome, liver/pancreatic disease); IgE and non-IgE allergies to food proteins; inflammatory bowel disease and GERD nonresponsive to standard therapy; and other conditions determined by the Secretary.
A medical food modified to be low in protein and formulated for oral consumption for individuals with inborn errors of protein metabolism. Does not include naturally low-protein foods like fruits or vegetables.
We use a combination of our own taxonomy and classification in addition to large language models to assess meaning and potential beneficiaries. High confidence means strong textual evidence. Always verify with the original bill text.
Learn more about our methodology