THE SOCIETY FOR INHERITED METABOLIC DISORDERS
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.