Off-Label Use of Drugs and Biologicals for Anti-Cancer Chemotherapeutic Regimen
A58113
Off-label use of anti-cancer drugs and biologicals is covered when used for anti-neoplastic conditions and the indication is supported as acceptable by at least one Medicare-approved compendium (NCCN, Micromedex DrugDEX, Lexi-Drugs, AHFS, or Clinical Pharmacology) and not listed as 'not indicated' or unfavorably evaluated. NCCN Category 2B indications are treated as meeting benefit requirements, and uses not listed in compendia may be considered if supported by clinical research consistent with CMS IOM guidance (full peer-reviewed articles required). Uses identified as 'not indicated' by CMS/FDA or unsupported by peer-reviewed literature are not covered, and specific claims coding and documentation (appropriate HCPCS/J/Q or NOC codes, required claim fields, JW modifier rules) must be followed.
"Off-label anti-cancer drug or biological use is covered when used for anti-neoplastic conditions and the use is listed as acceptable in at least one Medicare-approved compendium (NCCN, Micromedex D..."