The Centers for Medicare and Medicaid Services (CMS) Aug. 8 released the coverage decision for chimeric antigen receptor (CAR) T-cell therapy. Medicare will cover all Food and Drug Administration (FDA) approved uses for CAR T-cell therapy and off-label uses recommended by CMS-approved compendia.
Medicare will provide coverage for CAR T-cell therapy when administered at health care facilities enrolled in the FDA risk evaluation and mitigation strategies. Hospitals will not be required to participate in a clinical registry or study in order to receive reimbursement. Instead, CMS will use patient information collected by the FDA through post-market surveillance.