CMS Comment Deadline: Proposed Decision Memo for Chimeric Antigen Receptor T-cell Therapy for Cancers

Friday, March 15, 2019 - 5:00pm

The Centers for Medicare & Medicaid Services (CMS) is seeking public comments in order to fulfill a national coverage determination to consider coverage under the Medicare Program for chimeric antigen receptor (CAR) T-cell therapy, a rapidly emerging adoptive cell transfer immunotherapy for select patients with relapsed or refractory cancers. The existing CAR T-cell therapies on the market were approved as biologics and, therefore, provisions of the Medicare statute for biologicals apply. To date, two CAR T-cell products have been approved by the FDA. 

CMS proposes to cover autologous treatment with T-cells expressing at least one CAR through coverage with evidence development (CED) when prescribed by the treating oncologist, performed in a hospital, and meeting a variety of requirements laid out in the proposal.

Members of the public may submit comments online. More information is available at the CMS's website