CMS Proposes More Flexible Requirements For Centers Performing TAVR
A proposed update to the 2012 National Coverage Policy for transcatheter aortic valve replacement (TAVR) would make it easier for hospitals to begin a TAVR program while slightly raising the procedure-volume requirements for maintaining a continuing TAVR program. The agency believes the new rules would balance the need to expand patient access to TAVR while ensuring the quality and safety of TAVR procedures covered by Medicare.
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Manufacturers Support CMS’ New TAVR National Coverage Decision
CMS has completed its new national Medicare Coverage with Evidence Development policy for transcatheter aortic valve replacement. The final decision memo largely maintains the recommendations from the draft version released in March, including more flexible criteria for centers establishing TAVR programs, while emphasizing the importance of the interdisciplinary heart team for decision-making about valve replacement.
TAVR Registry Data Shows Procedure Volume-Safety Relationship
Data from 113,662 procedures at 555 hospitals from 2015 to 2017 shows an inverse relationship between the number of transfemoral transcatheter aortic valve replacement (TAVR) procedures a center or operator performs and the mortality rate for those patients. These results, published in The New England Journal of Medicine, lend support for CMS’ proposal to maintain center-volume requirements in the conditions for Medicare coverage for TAVR.
ACC Results Recap Part I: Low-Risk TAVR Trials Bring Good News For Edwards And Medtronic; Apple Watch Detects AFib In Apple Heart Study
Medtech Insight's Results Recap is a regular feature covering the major device trial results compiled by MedDeviceTracker. This is the first of three special Results Recaps covering trial data presented at the American College of Cardiology Scientific Sessions in New Orleans, March 16-18, including presentations on Medtronic and Edwards Lifesciences’ transcatheter aortic valves and Apple’s Apple Watch, which now has electrocardiography capabilities.