Medical Foods Reclassified as Over-the-Counter Medicines
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Medical foods are processed nutritional products formulated specifically to manage a disease or condition. They are specially formulated, defined, and regulated by the U.S. Food and Drug Administration (FDA). Medical foods are not drugs and so patients don’t need a prescription to obtain them.
Specifically, the FDA defines a medical food as “a food which is formulated to be consumed or administered enterally [via the digestive system through the mouth or a feeding tube] under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.”
Medical foods are created for children and adults and are available in a variety of forms. They may be used for chronic conditions such as diabetes, cardiovascular disease, osteoporosis, inborn errors of metabolism (such as amino acid and protein metabolism disorders), mitochondrial disease, wound healing, pain management, gastrointestinal disorders, and neurological and psychological disorders such as Alzheimer’s disease and depression.
In May 2016, the FDA reclassified medical foods as over-the-counter/non-prescription medicines. The FDA determined they can be used safely and effectively without a doctor’s supervision. This may help lower health care costs as prescription costs, doctor visits, lost time from work, insurance costs, and travel are no longer needed. Additionally, consumers can manage their own health care by buying medicines over the counter.
Health plan coverage for medical foods varies widely. WHA, for example, covers prescription medicines, but excludes coverage for most over-the-counter medications, supplies or equipment. Members who take medical foods are therefore responsible for the cost of those foods.
There are several possible sources of assistance if you cannot pay for your medical food.
- Visit the websites of medical food manufacturers, which sometimes provide information about the availability of discounted or free medical foods.
- Advocacy groups, such as the National Organization for Rare Disorders (NORD) (rarediseases.org), work with patients to obtain coverage for medical foods.
- Ask your doctor if there is an alternative covered product or prescription drug that can be used instead of the medical food for your treatment.
- Some pharmaceutical companies have established programs to provide medical foods for free to people who cannot afford them. For example:
- Medicare, the federally-funded health insurance program, offers some medical food benefits for qualified applicants.
- Medicaid, the federal health care program managed by each state, is a possible source of payment for elemental formulas for children and adults with health care needs.
- The WIC program provides pediatric medical foods to qualified participants. WIC is a federal program that provides nutrition assistance to pregnant women, infants and children to age five.
- The Federal School Lunch Program is for students with developmental and special health care needs, including nutrition needs. A child may qualify for federally subsidized specialized formula given during school hours.
- Some non-profit organizations offer donated medical foods.
- SNAP, the Supplemental Nutrition Assistance Program, a federal nutrition program, offers benefits to anyone who is eligible. SNAP benefits can be used to purchase medical foods in many cases.
- More generally, the federal government has a website that offers eligibility searches.
