The Orphan Drug Amendments of 1988 define a medical food as “… a food which is formulated to be consumed or administered entirely 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.”
There are several rare disorders that require medical foods in order to prevent serious disability and allow for normal growth and development to occur in children. The manufacture of these medical foods is highly specialized, making them more expensive for patients.
Newborn screenings have made progress in the last decade with all states screening for the 29 disorders recommended by the American College of Medical Genetics. However, treatments critically lack attention. As of 2010, 28 states had implemented legislation for mandating reimbursement for certain medical foods. In the states that do not have medical food mandates, individuals in need of these particular treatments are faced with a huge burden of access and require assistance in paying for medical food expenses.
Third-party payment for foods for special dietary use is inconsistent, and state statutes regarding reimbursement vary widely. Some states require coverage only for inherited metabolic diseases, such as phenylketonuria, and others include a range of metabolic conditions.
On February 10, 2011, NORD hosted a medical foods conference in Washington, DC, that brought together stakeholders to highlight gaps in access and reimbursement, and to discuss resolutions to this issue. At this time, NORD remains committed to helping resolve this important access issue. View the presentations from the meeting.