My son is now in high school, but when he was in the second grade, I received a call that changed everything: “We think he had a stroke.”
He had developed a facial droop and couldn’t walk on his own. His teacher carried him to the nurse’s office with the entire class following. He was eventually diagnosed with metabolic strokes due to mitochondrial disease, a genetic disorder that prevents your cells from producing enough energy.
The treatment prescribed by his doctors to prevent another metabolic stroke — targeted amino acids, antioxidants, and vitamins — was denied by our insurance. Despite a physician’s prescription, we pay more than $500 out of pocket each month for his treatment.
We are not alone.
Nearly half a million Americans rely on prescribed medical nutrition at home: prescription formulas, modified low-protein foods, targeted amino acids, and vitamins.
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These therapies are essential for patients with inherited metabolic disorders like phenylketonuria and mitochondrial diseases, as well as medical and surgical conditions of malabsorption, including pancreatic insufficiency such as cystic fibrosis, certain food allergies, and inflammatory conditions of the gastrointestinal tract, including Crohn’s disease and ulcerative colitis, among others.
Yet insurance coverage for these treatments is inconsistent and often inadequate. That’s in part because medical foods are regulated differently than drugs, allowing insurers to classify them as optional.
Coverage varies widely. Some states mandate limited coverage, often restricted to certain diagnoses or to children. In many cases, coverage ends abruptly in early adulthood — at ages 18, 21, or 22 — despite the lifelong medical need. Lifelong disorders require lifelong treatments.
When coverage stops, the financial burden can become overwhelming, leading patients to discontinue medically necessary treatment.
Until 1972, the Food and Drug Administration classified medical foods as drugs. Then, it made a regulatory change with good intentions, creating the category of “foods for special dietary use.” The idea behind the new classification was that the formula industry could innovate and make these essential products more widely available.
Because medical foods do not require extensive clinical trials or FDA approval, manufacturers could innovate more rapidly, changing flavors, consistency, and protein sources to improve taste and patient adherence. My son doesn’t need to take a formula, but according to others who do, they often taste terrible. These products could also reach patients faster and at a lower cost.
The Orphan Drug Act of 1988 formally separated medical foods from drugs for regulatory purposes. This classification has allowed insurers to treat these products as optional rather than medically necessary therapies.
The result is fragmented, inconsistent coverage that leaves some of the most medically vulnerable Americans without access to the treatments their doctors deem essential.
Congress has documented that, for many families, out-of-pocket costs for specialized formulas can reach thousands of dollars every month.
The American College of Medical Genetics and Genomics has stated low-protein modified foods are lifelong medically necessary treatments and should be regarded as medications.
The Advisory Committee on Heritable Disorders in Newborns and Children recommended that medical foods be covered as required medical benefits for patients of all ages with inherited errors of metabolism.
The American Academy of Pediatrics has called for federal legislation to mandate consistent coverage.
The science is clear, but coverage remains incomplete.
Congress now has the opportunity to fix this.
The Medical Foods and Formulas Access Act of 2025, introduced in the House on Oct. 3, 2025, would expand access to medically necessary foods and supplies through major federal health programs. It would extend coverage under Medicare, Medicaid, the Children’s Health Insurance Program, and the Federal Employees Health Benefits Program.
It explicitly recognizes medical foods, formulas, and associated equipment and supplies as medically necessary therapies when prescribed or supervised by a clinician, giving these products the status they have long deserved.
The bill would expand coverage to patients with inherited metabolic disorders, medical and surgical conditions of malabsorption, certain food allergies, and inflammatory conditions of the gastrointestinal tract. It would reduce the devastating financial strain on families and formally recognize medical nutrition as part of a patient’s medical treatment regimen.
The Senate has a companion bill introduced on Dec. 2, 2025, and lawmakers are currently seeking additional co-sponsors.
There is no cure for my child’s rare disease, but treatment stopped his metabolic strokes, kept him out of the hospital, and allowed him to be a kid.
Insurance companies should not be able to deny critical medical treatments, especially those prescribed by a doctor to prevent a child from losing the ability to walk.
Heather Gatcombe, M.D., is the mother of a child with mitochondrial disease and is on the Board of Trustees of the United Mitochondrial Disease Foundation. She is an assistant professor at Emory University School of Medicine. The views expressed here are her own and do not represent those of Emory University.
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