CMS approves nationwide coverage of CAR-T

Chimeric antigen receptor T-cell (CAR-T) therapy will be covered for Medicare beneficiaries nationally, according to an August 7 CMS press release. The therapy will be covered when performed in facilities enrolled in the FDA’s risk evaluation and mitigation strategies program for FDA-approved indications, as well as for off-label uses that are recommended by CMS-approved compendia.

CAR-T, a cancer treatment that uses a patient’s own genetically modified immune cells to treat non-Hodgkin lymphoma and B-cell precursor acute lymphoblastic leukemia, has been inching toward national coverage. In February, CMS proposed a coverage with evidence development (CED) for CAR-T. Although the CED offered greater access to the therapy, it did not address the high cost of the treatment and Medicare’s relatively low reimbursement for it. CMS ultimately chose not to move forward with the CED.

The 2019 Inpatient Prospective Payment System (IPPS) final rule assigned CAR-T to MS-DRG 016 (Autologous Bone Marrow Transplant with CC/MCC or T-cell Immunotherapy) without adjusting the payment rate for that MS-DRG.

The 2019 IPPS final rule also approved a new technology add-on payment (NTAP) for the therapy but did not adjust the NTAP formula. The NTAP formula takes hospital charges on the inpatient account, multiplies the charges by the hospital’s cost-to-charge ratio, then subtracts the MS-DRG payment. Hospitals are then paid 50% of the amount up to the CMS cap, which is half the cost of the new technology. For CAR-T, the cost is $373,000 and the maximum payment a hospital could receive for it was $186,500.

The 2020 IPPS final rule increased the NTAP, including payments for CAR-T, to 65% of the service cost.