Medicare Advisors Mostly Favor TAVR Center Volume Thresholds
The Medicare Evidence Development & Coverage Advisory Committee looked at the evidence for procedural volume requirements that hospitals and heart-team members currently must meet to perform transcatheter aortic valve replacements versus the prospect of quality measures as a condition of coverage. The discussion at a meeting held this week will inform the US Medicare agency's ongoing reconsideration of its TAVR coverage policy.
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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.
The US Medicare agency opened a national coverage determination for transcatheter aortic valve replacement at the request of three California physicians who argue that the current limitations on which centers can perform TAVR unnecessarily prevent lower-volume hospitals from providing the procedure as a less invasive option to open surgery.
The two-year results from the PARTNER 3 trial showed transcatheter aortic valve replacement with Edwards Lifesciences' Sapien 3 system was statistically non-inferior to surgical valve replacement in low-risk patients. The one-year results from the trial had shown TAVR was superior to surgery in low-risk patients.