Oral Anticancer Drugs - Policy Article

Medicare covers oral anticancer drugs only when all statutory and CMS criteria are met: FDA approval, same active ingredient or prodrug relationship to a covered non-self-administerable form, use for the same anticancer indications, and prescription by a licensed practitioner with a written signed and dated order received prior to claim submission. Coverage is limited to a 30-day supply, antiemetics billed with J8498/J8597 are covered only if given within two hours before the oral anticancer drug to allow absorption, supply fees Q0511/Q0512 have defined per-drug and per-pharmacy limits, and strict documentation and billing rules (ICD-10 on claim, NDC matching product, narrative details for J8498/J8597) must be followed.

"An oral anticancer drug is covered only if it is an FDA-approved drug or biological and meets all other Medicare statutory/regulatory requirements."