Placeholder Banner

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

February 15, 2019
Media Contact

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.”


Discover More
Former Congressman Jim Greenwood, President and CEO of the Biotechnology Innovation Organization (BIO), issued the following statement after the U.S. Senate confirmed Dr. Stephen Hahn to serve as the next commissioner of the Food and Drug…
Exclusion of biologics provisions in revised USMCA sets dangerous precedent for future trade talks, including with China Puts American jobs, intellectual property and leadership in medical innovation at risk WASHINGTON – BIO President and CEO Jim…