TAVR Review Sets Stage for Future Device Approval and Coverage

STS News, Summer 2012 -- One day after the Centers for Medicare and Medicaid Services released its final National Coverage Determination (NCD) for transcatheter aortic valve replacement (TAVR), STS hosted a session about how the pilot program that allowed parallel review of TAVR reduced the time between FDA approval and Medicare coverage decisions. The session, TAVR: Lessons Learned, was held during the American Association for Thoracic Surgery 92nd Annual Meeting in San Francisco.

STS President Jeffrey B. Rich, MD moderated a panel of experts that included representatives from STS, AATS, the American College of Cardiology, government, and industry. Louis Jacques, MD, Director of the Coverage and Analysis Group in the Office of Clinical Standards and Quality at CMS, kicked off the panel discussion by outlining several CMS policy goals and explaining how the TAVR approval process helped refine these goals and pose new questions. Dr. Jacques asked, “Is there a way that CMS and FDA can align on the outstanding evidentiary questions?”

Speaking further to alignment, Bram Zuckerman, MD, Director of the Division of Cardiovascular Devices at the FDA’s Center for Devices and Radiological Health, noted: “We can do things more efficiently and better if we get all of the relevant stakeholders to the plate early and try to see where the common interests are. This NCD is an excellent example of this paradigm being set into motion.”

ACC Immediate Past President David R. Holmes, MD praised the collaboration that occurred among the organizations and government entities. He said: “The process has been unbelievably exciting for the [ACC] to be involved so closely with the [FDA and CMS]. It’s been a wonderful journey for us, and we hope it’s the first of many such journeys.”

Dr. Zuckerman cited the role that professional societies played as a central reason TAVR approval and implementation went so smoothly, noting that he wanted to continue this type of approach to improve the system of product approval. Dr. Rich concurred, “It clearly has been a phenomenal process.”

To listen to the audio recording of TAVR: Lessons Learned, please visit www.sts.org/news/tavr-lessons-learned-podcast-available.