Chimeric Antigen Receptor (CAR) T-cell Therapy

CMS nationally covers autologous CAR T-cell therapy for cancer when administered at healthcare facilities enrolled in the FDA REMS and used for medically accepted indications (FDA‑approved label or CMS‑compendia supported uses) for services on or after August 7, 2019. Routine costs of qualifying clinical trials (per NCD 310.1) are covered. Non‑FDA‑approved autologous CAR T-cell products and any uses not meeting the policy's requirements are non‑covered.

"CMS covers autologous CAR T-cell therapy for cancer when administered at healthcare facilities enrolled in the FDA REMS."

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