THE SOCIETY FOR INHERITED METABOLIC DISORDERS
Policy Statement: Coverage for Medical Foods
18 April, 2016
In support of 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
specialized diets, including medical foods, for treatment of inborn errors of
metabolism found by newborn screening or clinically diagnosed. This statement
reiterates our concerns presented in 2007. Little or no progress has occurred in
that interval.
Inborn errors of metabolism result from genetic
alterations in biochemical pathways that, if left untreated, can lead to brain
damage, physical disability and death. Some of these conditions, for example,
phenylalanine hydroxylase (PAH) deficiency (also known as phenylketonuria or
PKU), are treated with specialized diets using medical foods, and in some cases
specific amino acids or cofactors, to normalize biochemistry and improve health
and developmental outcomes. In fact, the success of newborn screening to prevent
cognitive impairment from PAH deficiency was entirely founded on the use of
medically prescribed diets using medical foods.
The 1988 Orphan Drug Act
defined "Medical Food" 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 products marketed to the general population, such as those designed
to supplement a normal diet, and unlike a variety of foods for special dietary
use, medical foods are an essential, medically necessary treatment for many
inherited metabolic disorders, including PAH deficiency. However, many health
care payers deny coverage for medical foods, citing provisions in their local or
national policies that exclude coverage for "nutritional supplements" or foods.
Many state legislatures have required that private insurance companies cover
medical foods; however, these mandates are not consistent across states, they
vary as to the disorders and ages covered, and they do not apply to individuals
covered by Federal insurance or the Employee Retirement Income Security Act
(ERISA). Thus, the complex pattern of health care coverage in the United States
means that many individuals 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.
While the Affordable Care Act
mandates coverage of newborn screening without co-pay to families, it is silent
on coverage of the medical food treatments for individuals identified with
inborn errors of metabolism. The lack of uniform and consistent coverage of
medical foods throughout the United States threatens individuals and families.
Because medical foods are essential treatments for many of the conditions
detected by expanded newborn screening, failure to provide lifelong access to
these treatment modalities also threatens the success of public health policy.