CMS Proposes Coverage with Evidence Development

February 2019 ~

On February 15, CMS proposed to cover U.S. Food and Drug Administration (FDA)-approved Chimeric Antigen Receptor (CAR) T-cell therapy under “Coverage with Evidence Development.” This is a new form of cancer therapy that uses a patient’s own immune system to fight the disease.

CMS notes in the announcement that, currently, there is no national Medicare policy for covering CAR T-cell therapy, allowing local Medicare Administrative Contractors to have discretion over whether to pay for it.

The proposed National Coverage Determination, according to CMS, would require Medicare to cover the therapy nationwide when it is offered in an agency-approved registry or clinical study, in which patients are monitored for at least two years post-treatment. The agency states that evidence from the registries and studies would help 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.

CMS is proposing to “leverage the FDA’s requirements for post-approval studies for CAR-T to the fullest extent possible in reviewing studies for CMS approval,” according to the release.

“CAR T-cell therapy was the first FDA-approved gene therapy, marking the beginning of an entirely new approach to treating serious and even life-threatening diseases,” said CMS Administrator Seema Verma. “Today’s proposed coverage decision would improve access to this therapy while deepening CMS’s understanding of how patients in Medicare respond to it, so the agency can ensure that it is paying for CAR T-cell therapy for cases in which the benefits outweigh the risks.”

CMS is accepting comments on the proposal through March 17. A final decision will be issued no later than 60 days after the conclusion of the comment period.

For more information, refer to CMS Proposes Coverage with Evidence Development for Chimeric Antigen Receptor (CAR) T-cell Therapy Press Release.



Source(s): CMS Proposes Coverage with Evidence Development for Chimeric Antigen Receptor (CAR) T-cell Therapy Press Release; MLN Connects for February 21, 2019; National Coverage Analysis (NCA) Tracking Sheet for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers (CAG-00451N) Proposed Decision Memo; Healthcare DIVE;