Off-Label Use of Drugs and Biologicals for Anti-Cancer Chemotherapeutic Regimen

Medicare covers off‑label use of anti‑cancer drugs/biologics when used for anti‑neoplastic conditions and listed as acceptable in Medicare‑approved compendia (and not listed as 'not indicated' or unfavorably evaluated). NGS‑identified off‑label uses may be covered if supported by peer‑reviewed clinical research under CMS IOM criteria; drugs deemed 'not indicated' by CMS/FDA/compendia or lacking supporting literature are not covered. Specific billing/documentation rules apply for NOC drugs (use appropriate HCPCS or NOC codes, include drug name/dose/route/NDC/invoice price) and JW modifier reporting for single‑dose vial wastage.

"Off-label use of a cancer chemotherapy drug or biological is covered when used for anti-neoplastic conditions and the use is listed as acceptable in a Medicare‑approved drug compendium and is not l..."

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