Cardiologists Push Back On Proposed Transcatheter Valve Credentialing Proposals

Clinicians say some of the procedural experience requirements proposed by CMS and societies as prerequisites for conducting transcatheter aortic valve replacements might overly limit access to the technology. ACC has made some revisions to its proposal in response.

The minimum experience that interventional cardiologists and surgeons would need to have to participate in a Medicare-covered transcatheter aortic valve replacement program under a proposal issued last month has many physicians worried that access to the promising new procedure could be overly restricted.

But the credentialing requirements in CMS’ national coverage proposal, released Feb. 2, are based on guidance from the main professional medical societies representing practitioners who will be performing the procedure, recently available in the U.S. via the November 2011 FDA-approval of Edwards Lifesciences’ Sapien valve. And those groups, the American College of Cardiology, the Society of Thoracic Surgeons, the American Association of Thoracic Surgery and the Society for Cardiovascular Angiography and Interventions, issued a

More from Policy & Regulation

More from Medtech Insight

Mirvie Launches Predictive Blood Test For Preeclampsia

 
• By 

Mirvie launched Encompass, a blood test to help identify women over age 35 who are at moderate risk for preeclampsia, and will conduct additional studies to support reimbursements from payers.

Bringing Israeli Medical Device Candidates To The Right Partners In The US

 
• By 

Despite regional unrest, it is business as usual for medtech innovators and investors in Israel as evidenced by continued high-value M&A of locally developed technologies. Irit Yaniv, co-chair of the medtech session at the upcoming BioMed Israel 2025, explained the unique dynamics of Israeli medtech innovation.

How Structured Patient Engagement Gives Medtech Companies A Competitive Edge

 

Communication with patients has become a particularly crucial factor for investors, payers, and other healthcare decision-makers in a hostile market environment.