15 February 2019 - Proposed decision would provide nationwide consistency in CMS’s coverage of the innovative new cancer therapy, to improve patient access and ensure appropriate evidence generation

Today the Centers for Medicare & Medicaid Services (CMS) proposed to cover FDA-approved CAR T-cell therapy, which is a new form of cancer therapy that uses a patient’s own immune system to fight the disease, under “Coverage with Evidence Development” (CED). Currently, there is no national Medicare policy for covering CAR T-cell therapy, so local Medicare Administrative Contractors have 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. Evidence from the registries and studies would help CMS identify the types of patients that benefit from CAR T-cell therapy, informing a future decision by the agency regarding the types of cases in which Medicare would cover the treatment with no registry or trial requirement.

Read CMS press release