Coverage Decisions for Drugs

Medical Foods

Coverage Decision

Medical food products are not covered for state fund and self-insured workers’ compensation claims in Washington due to lack of good quality scientific evidence of effectiveness. This policy includes medical food products and their convenience packs. In addition, the Food and Drug Administration (FDA) considers convenience packs or “co-packs” to be unapproved drugs at this time.

Medical food products are formulated for specific dietary management of patients with diseases or conditions that have nutritional needs. These products are required to comply with the provisions of medical foods and food manufacturing.  In addition, individual ingredients must be generally recognized as safe. However, medical food products are not approved or registered with FDA. Therefore, there is no requirement that these products demonstrate efficacy for the intended disease or condition.

Examples of medical food products:

  • Deplin® (L-methylfolate) is promoted for depression. 
  • Theramine® (arginine, glutamine, 5-hydroxytryptophan and choline) is promoted to relieve discomfort associated with acute and chronic pain, fibromyalgia, neuropathic pain and pain due to inflammation.
  • Gabadone® (5-hydroxytryptophan, gamma aminobutyric acid and choline) is promoted to improve sleep associated with anxiety.

Examples of “co-packs”:

  • Theraproxen® (Theramine and naproxen) is promoted to relieve discomfort associated with acute and chronic pain, fibromyalgia, neuropathic pain and pain due to inflammation.
  • Gaboxetine® (Gabadone and fluoxetine) is promoted to improve sleep and depression.

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