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

Off-label (unlabeled) use of chemotherapeutic drugs and biologicals for non-cancer indications may be considered for coverage on a case-by-case basis under CMS IOM guidance when supported by compendium recommendations, peer-reviewed literature, or societal professional recommendations and when the medical record documents the clinical rationale. Inclusion in a compendium alone does not guarantee coverage; uses identified by CMS/FDA as not indicated or lacking supportive peer-reviewed evidence will not be covered. Specific billing and documentation requirements apply (appropriate HCPCS/NOC codes, required claim fields, and JW modifier for single-dose vial wastage).

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

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