CAR T-Cell Therapy Claims: End of REMS & KX Modifier Requirement

Related CR Release Date: December 9, 2025
MLN Matters Number: MM14204
Effective Date: June 26, 2025 
Related Change Request (CR) Number: CR 14204
Implementation Date: February 6, 2026 
Related CR Transmittal Numbers: R13432CP & R13432CP1

CR 14204 tells you about:

  • Providers to administer Chimeric Antigen Receptor (CAR) T-cell therapy in an FDA Risk Evaluation Mitigation Strategy (REMS) - approved facility
  • The KX modifier on Medicare Part B claims for CAR T-cell therapy

Make sure your billing staff know about these changes no longer required as of June 26. 2025.

View the complete CMS Medicare Learning Network (MLN) Matters (MM)14204.

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