MM14204 - Chimeric Antigen Receptor T-Cell Therapy Claims: End of Risk Evaluation Mitigation Strategy & KX Modifier Requirement
On August 7, 2019, CMS started covering CAR T-cell therapy through National Coverage Determination 110.24. Among other criteria, we required you to administer CAR T-cell therapy at a health care facility enrolled in the FDA REMS. For many years, REMS was part of the FDA-approved indications for these therapies. We also required the use of the KX modifier on claims to acknowledge that you performed the service in an FDA REMS-participating facility.
On June 26, 2025, FDA announced the elimination of REMS and updated product labeling for CAR T-cell therapies.
Issued by: Centers for Medicare & Medicaid Services (CMS)
Issue Date: December 12, 2025
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.