On August 7, the Centers for Medicare & Medicaid Services (CMS) released the finalized National Coverage Determination for FDA-approved Chimeric Antigen Receptor T-cell (CAR T-cell) Therapy. FDA-approved CAR T-cell therapies are approved to treat some people with specific types of cancer – certain types of non-Hodgkin lymphoma and B-cell precursor acute lymphoblastic leukemia.
Medicare will cover CAR T-cell therapies when they are provided in healthcare facilities enrolled in the FDA risk evaluation and mitigation strategies (REMS) for FDA-approved indications (according to the FDA-approved label). In addition, Medicare will cover FDA-approved CAR T-cell therapies for off-label uses that are recommended by CMS-approved compendia.
The NCD continues coverage for routine costs in clinical trials that use CAR T-cell therapy as an investigational agent that meet the requirements listed in NCD 310.1.
In announcing the NCD, CMS notes that outcomes data for CAR T-cell therapy in the Medicare population are "relatively limited," and states that "CMS will leverage information obtained from the FDA’s required post-approval safety studies for CAR T-cell therapies to the fullest extent possible."
Read the CMS Decision Memo.
Download CMS Decision Memo.