Medical Foods Coverage

Medical foods are regulated by the FDA and must be used under physician supervision according to federal statutes and regulations.

Medical foods are intended to manage many different chronic diseases. Some of these include inborn errors in inflammatory conditions such as osteoarthritis , osteopenia, chronic venous disease, amino acid metabolism, hyperhomocysteinemia, pancreatic exocrine insufficiency, cancer cachexia, gastrointestinal disorders, neurological disorders, microcirculation conditions and other diseases.

Medical foods and supplements are defined as separate regulatory categories by federal statutes. Each category’s regulations are enforced separately by the FDA, the Federal Trade Commission (FTC) and state laws. A medical food is for a specific disease, prescribed and supervised by a physician, whereas a supplement is a consumer product for healthy populations that can be purchased by anyone without medical supervision.

• Medical foods require physician supervision, whereas supplements are intended for use by the general public without medical supervision.
• Medical foods make disease claims (i.e., to manage the disease), but supplements are forbidden to make disease claims.
• Medical foods are intended for the dietary management of a specific disease at a specific dose. Supplements are intended to maintain structure and/or function.
• Medical food ingredients require a higher standard of safety (GRAS – Generally Recognized As Safe per FDA standards). Supplements only need to have a “presumption of safety.”

Similar to drugs, medical foods are used to manage diseases and require physician supervision [By law in the Orphan Drug Act]. Prescription medical foods generally do not cause severe adverse events or dangerous drug-on-drug interactions.

Both medical foods and prescription drugs are for people with disease, require physician supervision, and are regulated by the FDA. Whereas medical foods contain highly purified nutritional ingredients not achievable by dietary change, prescription drugs are composed mostly of synthetic chemical ingredients. Medical foods have achieved GRAS affirmation (Generally Recognized As Safe) status, the highest standard of safety at the FDA. Most prescription drugs do not have GRAS status.

Medical foods are generally recognized as safe by the FDA with no significant side effects.

As with any other prescription product, you should discuss the benefits versus the potential for side effects or allergies with your physician before using a medical food.

Unfortunately, Medicare Part D does not cover medical foods. Some people with diabetes or kidney disease receive coverage under Part B for some medical nutrition therapy services.

CoverMyMedicalFoods.com is your resource to help make your voice heard with legislators and demand coverage under Medicare Part D for safe and effective medical foods. Click here to email your elected officials…

Insurance coverage for medical foods varies by state and by health plan.

If your medical food is not covered by your health plan, you can ask for a formulary exception. Check with your health plan to find out how its exception process works. Your healthcare provider may need to provide a letter of medical necessity. Unfortunately, there is no guarantee that a health plan will grant the exception and cover the medical food.