BIO Statement on CMS Proposed Decision Memo for the CAR-T National Coverage Determination

Washington, DC (February 15, 2019) – Today, Biotechnology Innovation Organization (BIO) Executive Vice President for Health Policy, Dan Durham, issued the following statement regarding the CMS proposed decision memo for the CAR-T National Coverage Determination:

“We are further analyzing CMS’ released proposed decision memo for the National Coverage Determination for CAR T-cell therapy and look forward to providing the Agency with detailed comments in the coming weeks. It is critical that CMS coverage policies balance timely access to FDA-approved therapies across all potential appropriate settings of care, particularly when making determinations around innovations that represent significant advances in the delivery of treatment, such as CAR T. Further, such policy requirements should not be overly burdensome for providers, should be well aligned with FDA REMS requirements, and should provide enough flexibility as the class of medicines evolves.”

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