To improve access to new cancer therapies and provide national consistency in coverage, on February 15, 2019, the Centers for Medicare and Medicaid Services (CMS) announced a proposed plan of coverage with evidence development for CAR T-cell therapy. The public is invited to share comments for the next 30 days.

CAR T-cell therapy is the first gene therapy approved by the U.S. Food and Drug Administration to treat cancer, with current approvals for certain types of leukemias and lymphomas. Because no national Medicare policy exists regarding the therapy’s coverage, local Medicare administrative contractors have had discretion over whether to pay for it.

The proposed national coverage determination would require Medicare to cover the therapy nationwide when it is offered in a CMS-approved registry or clinical study in which patients are monitored for at least two years post-treatment. This is to generate evidence to help CMS identify the patient populations that would best benefit from CAR T-cell therapy so it can expand coverage in those cases with no registry or trial requirement.

The proposal is open for public comment through March 15.