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


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.

CPT® copyright 2021 American Medical Association (AMA). All rights reserved.

Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

CPT is a registered trademark of the American Medical Association.