Position Statements


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.