Genetic Metabolic Dietitians International

Affordable Care Act

August 19, 2011

Ms. Sherry Glied
Assistant Secretary for Planning and Evaluation
U.S. Department of Health and Human Services
200 Independence Ave SW, 415-F
Washington, DC  20201

Dear Ms. Glied:

Genetic Metabolic Dietitians International (GMDI) is a professional organization whose focus is to provide support and leadership in nutrition therapy for genetic metabolic disorders through clinical practice, education, advocacy, and research.   Our reason for contacting you is to add our voice of support for the inclusion of medical foods for the treatment of inborn errors of metabolism as an essential health benefit once the Affordable Care Act is implemented.
The majority of inborn errors of metabolism that require medical food treatment are identified through Newborn Screening (NBS)  – one of the most effective public health programs in our country.   NBS was built on the premise that early detection and treatment can prevent the devastating outcome of untreated disease.  Prevention of cognitive and/or physical impairment is completely dependent on the availability of treatment and the adherence to therapy recommendations 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 by the Orphan Drug Act (  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".

At this time 38 states have passed legislative mandates requiring health plan coverage of medical foods for the treatment of phenylketonuria and other genetic metabolic conditions.   It is an unfortunate reality that many families with children and adults diagnosed with inborn errors of metabolism struggle with insurance companies over coverage for medical food treatment.   Self-insured policies under the jurisdiction of ERISA can circumvent state mandates, automatic denials practiced by the insurance industry undermine access to treatment, and differences in state mandates create inequities in treatment access.   The cost of medical food treatment, considered standard of care, is not trivial for the average family but is regarded as low impact by the Counsel for Affordable Health Insurance (CAHI) in terms of total healthcare dollars.   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".   However, medical foods are not supplements. They are as critical to the prevention of the health complications associated with untreated genetic metabolic disease as insulin is for the treatment of type I diabetes.

A national policy supporting treatment of genetic metabolic disease would resolve the current newborn screening paradox --- screening in order to identify individuals with genetic metabolic disorders without providing coverage for the medically necessary treatment. GMDI hopes that you are convinced that without access to coverage of medical food treatment as an essential health benefit, many children affected by IEM will not benefit from early diagnosis.  Included as an essential health benefit, ready access to medical food treatment will amplify the returns of newborn screening not only for affected individuals and their families, but also for society as a whole.


Dianne Frazier, PhD, MPH, RD
GMDI President 2011-12