Off-Label Use of Chemotherapeutic Drugs and Biologicals for Non-Cancer Indications

Off-label use of chemotherapeutic drugs and biologics for non-cancer indications may be considered for coverage on a case-by-case basis under CMS IOM 100-02 Ch.15 50.4.2, primarily when supported by compendia, peer-reviewed articles, societal recommendations, and documented clinical rationale. Uses identified as not indicated by CMS or FDA, or those lacking support in peer‑reviewed literature per NGS review, are not covered; billing and documentation must follow specified HCPCS/NOC code and claim-field requirements and include required drug, dose, route, NDC, and pricing information.

"Off-label (unlabeled) use of chemotherapeutic drugs and biologicals for non-cancer indications may be considered for coverage on a case-by-case basis per CMS IOM 100-02, Chapter 15, 50."

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