There are some drugs that are excluded from Medicare coverage by law. These include:

  • Drugs for:
    • Anorexia, weight loss or weight gain (except to treat physical wasting caused by AIDS, cancer or other diseases)
    • Fertility
    • Cosmetic purposes or hair growth
    • Relief of the symptoms of colds, like a cough and stuffy nose
    • Erectile dysfunction
  • Prescription vitamins and minerals (except prenatal vitamins and fluoride preparations)
  • Non-prescription drugs (over-the-counter drugs)

Note: Prescription drugs used for the above conditions will not be covered by Medicare Part D. However, they may be covered if they are being prescribed to treat other conditions. For example, prescription medications for the relief of cold symptoms may be covered by Part D if prescribed to treat something other than a cold—such as shortness of breath from severe asthma—as long as they are approved by the United States Food and Drug Administration (FDA) for such treatment.

If your doctor prescribes a non-cancer medication on the formulary for a reason other than the use approved by the United States Food and Drug Administration, your drug will probably not be covered unless the use is listed in one of three Medicare-approved drug compendia (medical encyclopedias of drug uses). For anti-cancer drugs, your drug plan should accept indications of drug use from additional compendia and other peer-review medical literature.

You may also receive a denial from your Part D plan stating that your drug does not meet DESI standards. The FDA’s Drug Efficacy Study Implementation (DESI) evaluates the effectiveness of those drugs that had been previously approved on safety grounds alone. Drugs that are found to be less than effective by DESI evaluation are excluded from coverage by Part D.