14204 13432 Removal of Chimeric Antigen Receptor (CAR) T-cell Therapy and Risk Evaluation Mitigation Strategy (REMS) – NCD 110.24 and the “KX’ Modifier for CAR-T Cell Therapy Claims The purpose of this Change Request (CR) is to amend the claims processing instructions (Claims Processing Manual 100-04, Chapter 32, Section 400) for Chimeric Antigen Receptor (CAR) T-cell therapy and clarify that the Risk Evaluation and Mitigation Strategy (REMS) requirement in the National Coverage Determination (
The purpose of this Change Request (CR) is to amend the claims processing instructions (Claims Processing Manual 100-04, Chapter 32, Section 400) for Chimeric Antigen Receptor (CAR) T-cell therapy and clarify that the Risk Evaluation and Mitigation Strategy (REMS) requirement in the National Coverage Determination (NCD) 110.24 for Chimeric Antigen Receptor (CAR) T-cell Part A and Part B requirements have been updated.
Issued by: Centers for Medicare & Medicaid Services (CMS)
Issue Date: December 09, 2025
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