Question:

What are the conditions for an oral anti-cancer drug to be covered under Part B?

Answer:

To be covered under Part B, the drug must:

  • Be prescribed by a physician or other practitioner licensed under State law to prescribe such drugs as anti-cancer chemotherapeutic agents;
  • A drug or biological that has been approved by the Food and Drug Administration (FDA);
  • Have the same active ingredients as a non-self-administrable anti-cancer chemotherapeutic drug or biological that is covered when furnished incident to a physician’s service. The oral anti-cancer drug and the non-self-administrable drug must have the same chemical/generic name as indicated by the FDA’s “Approved Drug Products” (Orange Book), “Physician’s Desk Reference” (PDR), or an authoritative drug compendium;
  • Used for the same indications, including unlabeled uses, as the non-self-administrable version of the drug; and
  • Be reasonable and necessary for the individual patient.
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