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NORD supports comprehensive medical nutrition coverage for any condition where medical nutrition is a medically necessary component of effective treatment for rare disorders.
Medical nutrition is defined under the Federal Food, Drug, and Cosmetic Act (FD&C 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, based on recognized scientific principles, are established by medical evaluation.”1 Many rare disorders require medical nutrition to prevent serious disability, allow for normal growth in children and adults, or provide adequate caloric intake. Examples of disorders that require medical nutrition include maple syrup urine disease, food protein-induced enterocolitis syndrome (FPIES), and short bowel syndrome. Medical nutrition for these and other conditions is the only possible treatment option available in many cases.
State-regulated insurance coverage of medical nutrition
Unfortunately, insurance coverage of medical nutrition is inconsistent and varies widely depending on a patient’s diagnosis, plan type, and state. Many insurers deny coverage of medical nutrition because the U.S. Food and Drug Administration (FDA) does not regulate it as a drug. Additionally, insurers may view medical nutrition as a voluntary choice, instead of the lifesaving treatment that it is. As a result, many patients who need these lifesaving treatments encounter significant financial barriers. For example, the average annual cost for a special diet (formula or low-protein foods) can amount to $6,400 for children, and $9,000 for adults.2
Some states mandate medical nutrition coverage through their Medicaid programs. However, many states that mandate coverage of medical nutrition in Medicaid frequently have arbitrary limits based on cost, age, or gender. A few states have chosen to provide access to medical nutrition through other publicly funded health programs or provide coverage on a case-by-case basis, which can lead to highly inconsistent access to urgently needed treatment. Additionally, some states provide medical nutrition through Medicaid or a publicly funded program in practice, but don’t mandate this coverage through state laws or regulations. Coverage that is not codified into law or regulation can be discontinued abruptly and without warning, leaving patients scrambling to obtain necessary medical nutrition products.
Also, some states require that eligible private plans provide coverage of medical nutrition, but only for inherited metabolic diseases such as phenylketonuria (PKU). Recently, states have begun to expand coverage to other conditions that require specialized nutrition. In states without comprehensive medical nutrition coverage mandates, patients are usually forced to pay for medical nutrition out-of-pocket. For costly forms of medical nutrition this can leave patients without access to necessary and lifesaving treatment for their rare condition.
1. Federal Food, Drug, and Cosmetic Act, Title 21 U.S.C. § 360ee (2015). https://www.govinfo.gov/content/pkg/USCODE-2015-title21/html/USCODE-2015-title21-chap9-subchapV-partB-sec360ee.htm
2. Kumar Dalei S, Adlakha N. Food Regime for Phenylketonuria: Presenting Complications and Possible Solutions. J Multidiscip Healthc. 2022 Jan 18;15:125-136. doi: 10.2147/JMDH.S330845. PMID: 35082498; PMCID: PMC8785131.
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