Policy Statement: Coverage for Medical Foods

16 May, 2007


Inborn errors of metabolism are genetic alterations in biochemical pathways that can result in brain damage, physical disability and death. Some of these conditions, such as phenylketonuria (PKU) are treated with artificial foods to normalize biochemistry and improve health and developmental outcomes. In fact, the success of newborn screening to prevent mental retardation from PKU is entirely founded on the use of prescribed medical diets using medical foods.

"Medical Food" is defined by the 1988 Orphan Drug Act as "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."

Unlike ordinary nutritional “supplements” marketed to the general population, Medical Foods are essential and medically necessary treatment for many of the inherited metabolic disorders, including PKU. However, many health care payors deny coverage for Medical Foods, citing provisions in their local or national policies that exclude coverage for "nutritional supplements". Many state legislatures have made efforts to assure a "level playing field" for families and for insurance companies by requiring all insurers to cover medical foods. However, the complex pattern of health care coverage in the United States means that many individuals in the United States with inborn errors of metabolism are at significant risk of disability or death because of lack of access to the medical foods that are a critical part of their medical care.

This problem with coverage of medical foods threatens individuals and families, and since medical foods are essential treatment for many of the conditions detected by expanded newborn screening, it also threatens the success of public health policy.

Therefore, in support of the patients and families in our clinics and of the public health system that serves our communities, the members of the SIMD strongly urge that all private and public systems for health care payment be mandated to cover medical foods for treatment of inborn errors of metabolism. The Medical Foods ordered by the metabolic medical team for an individual with an inborn error of metabolism, such as the artificial foods and the amino acids for treatment of maple syrup urine disease, should be regarded as equal to, and covered to the same extent as, medications critical to life - such as insulin for diabetes - are covered.