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CMS proposes Coverage with Evidence Development for Chimeric Antigen Receptor (CAR) T-cell Therapy

CMS proposes Coverage with Evidence Development for Chimeric Antigen Receptor (CAR) T-cell Therapy
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.

“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 proposes to leverage the FDA’s requirements for post-approval studies for CAR-T to the fullest extent possible in reviewing studies for CMS approval. The agency is issuing its proposal in response to a formal request, and today’s decision was informed by a meeting of the MEDCAC (Medicare Evidence Development & Coverage Advisory Committee) on August 22nd, 2018. The MEDCAC provides CMS with an external review of medical literature, technology assessments, public testimony, and other data and information on the benefits, harms, and appropriateness of therapies under review. CMS has issued seven National Coverage Determinations for drugs and biologicals over the past seven years.

CMS is seeking comments on our proposed National Coverage Determination. All public comments may be submitted at A final decision will be issued no later than 60 days after the conclusion of the 30-day public comment period.

To read the proposed decision, visit the CMS website at:


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