Oral Anti-Cancer Drugs

50.5.3 - Oral Anti-Cancer Drugs (Rev. 1, 10-01-03) A3-3112.4.B.5, HO-230.4.B.5 Effective January 1, 1994, Medicare Part B coverage is extended to include oral anti-cancer drugs that are prescribed as anti-cancer chemotherapeutic agents providing they have the same active ingredients and are used for the same indications as anti-cancer chemotherapeutic agents which would be covered if they were not self-administered and they were furnished incident to a physician’s service as drugs and biologicals. For an oral anti-cancer drug to be covered under Part B, it must: • Be prescribed by a physician or other practitioner licensed under State law to prescribe such drugs as anti-cancer chemotherapeutic agents; • Be 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; • Be 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.