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MLN Matters Article (Revised) MM12177: National Coverage Determination (NCD 110.24): Chimeric Antigen Receptor (CAR) T-cell Therapy

This revised Article comprises Subregulatory Guidance for Chimeric Antigen Receptor (CAR) T-cell Therapy. Effective for claims with dates of service on or after August 7, 2019, CMS covers autologous treatment for cancer with T-cells expressing at least 1 CAR when administered at healthcare facilities: Enrolled in the FDA Risk Evaluation and Mitigation Strategies (REMS) and Meets specified CMS/FDA criteria. MLN Matters (MM) Articles are based on information contained within Change Requests (CRs). In this case, this article is based on content within CR12177 that is posted on the CMS website at https://www.cms.gov/files/document/r10891CP.pdf and https://www.cms.gov/files/document/r10891NCD.pdf.

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Issued by: Centers for Medicare & Medicaid Services (CMS)

Issue Date: May 24, 2021

DISCLAIMER: The contents of this database lack the force and effect of law, except as authorized by law (including Medicare Advantage Rate Announcements and Advance Notices) or as specifically incorporated into a contract. The Department may not cite, use, or rely on any guidance that is not posted on the guidance repository, except to establish historical facts.