CMS Will Reconsider Its Stance on TAVR

Centers for Medicare & Medicaid Services (CMS) took an unprecedented stance in 2012 when it decided to cover transcatheter aortic valve replacement (TAVR) with strict restrictions regarding its use in patients with symptomatic aortic stenosis. One of the key issues regarding that CMS decision is that it included specific procedural volume restrictions, limiting the use of TAVR to high-volume hospitals and medical centers. Some doctors have argued that procedural volume is an outdated metric. To understand just how unprecedented the agency's decision on TAVR was six years ago, we look back at this MD+DI story quoting Scott Gottlieb, MD. FDA Commissioner Gottlieb was a resident fellow at the American Enterprise Institute and a senior policy adviser at CMS at that time. "It shows CMS becoming, I think, far more aggressive than it has been in the past,” Gottlieb said. “And in a lot of respects, CMS is behaving in this context like a traditional insurer.” But CMS is not, nor has it ever been, a traditional private insurer and the impact of the agency's decisions tend to run wide and deep. “If you are an institution and Aetna says you have done something to get coverage, you can make a decision if you want to get coverage from them or not,” Gottlieb said. “But if you are an institution and CMS puts in place certain requirements, you have no choice. So it ends up setting up the standard for the entire marketplace.” Fast forward six years to today, when CMS has o...
Source: MDDI - Category: Medical Devices Authors: Tags: Cardiovascular Source Type: news