Position Statement on Medical Foods

Genetic Metabolic Dietitians International
Statement Of Support for Coverage of Medical Foods

Newborn Screening was built on the premise that early detection and treatment of inborn errors of metabolism can prevent the devastating outcome of untreated disease. Prevention of cognitive and/or physical impairment is completely dependent on the availability of and the adherence to a recommended course of treatment throughout the life of the individual. Medical foods are the most basic and essential treatment for many of the genetic metabolic disorders. They are defined as follows by the Orphan Drug Act (http://www.fda.gov/orphan/oda.htm)

The term "medical food" means "a food which is formulated to be consumed or administered enterally 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 on the basis of recognized scientific principles are established by medical evaluation".

Despite their proven efficacy many insurance companies continue to deny coverage for medical food declaring that they are not a covered benefit or the policy does not provide coverage for "nutritional supplements". Medical foods are not supplements. They are as critical to the prevention of the health complications associated with untreated genetic metabolic disease as antibiotics are for the treatment of infections.

In response to this contradiction in public healthcare policy, a number of states have passed legislative mandates requiring coverage of medical foods. However there are differences in the number of disorders covered, the types of medical foods allowed as well as age and cost restrictions. Disparities in access to treatment among states must be addressed to ensure that newborn screening systems throughout the country offer the same chance at the best possible outcome for affected individuals and their families. The call for expanded newborn screening at the national level magnifies the present inconsistencies and multiplies the number of infants and children denied coverage for their conditions.

Genetic Metabolic Dietitians International (GMDI) recommends the development of a national policy that supports healthcare coverage by both private and public health plan providers. A review of effective state based systems would provide important information as to how a national policy could be successfully implemented. National policy supporting treatment coverage of genetic metabolic disease would resolve the current newborn screening paradox --- screening in order to identify individuals with genetic metabolic disorders without then providing coverage for the medically necessary treatment. GMDI recognizes that without access to and coverage of medical food treatment for these conditions, many children will not benefit from early diagnosis, diminishing the returns of newborn screening not only for those individuals and their families but also for society as a whole.

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