Anti-Cancer Chemotherapy for Colorectal Cancer

This NCD covers FDA‑labeled uses and compendium-supported uses of anti‑cancer chemotherapeutic agents (including oxaliplatin, irinotecan, cetuximab, bevacizumab) and permits coverage of off‑label uses when administered within CMS‑identified, NCI‑sponsored clinical trials (CMS trial list referenced). Off‑label uses outside those listed trials remain subject to existing coverage paths (FDA labeling, authoritative compendia, or MAC determination based on Secretary guidance), and routine clinical trial costs and enrollment requirements continue to follow NCD Manual section 310.1.

"Off-label use of oxaliplatin, irinotecan, cetuximab, or bevacizumab is covered when administered within CMS-identified, NCI‑sponsored clinical trials that study off-label uses in colorectal cancer ..."

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