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 Some doctors have argued that procedural volume is an outdated metric.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 opened a national coverage analysis (NCA) to reconsider its national coverage determination (NCD) for TAVR.
"As we move forward, our priority will be on assuring that the NCD provides all people with heart valve disease with access to all treatment options, enabling patients to choose the right treatment at the right time," Edward Lifesciences said Thursday in a press release. "We look forward to continuing to engage with CMS and other stakeholders in the finalization of this important policy, which will define the future of heart valve patients' access to this life-saving care."
Edwards continues to be considered the market leader in TAVR, although it does share the space with Medtronic and others.
On July 25, CMS will convene a panel of the Medicare Evidence Development & Coverage Advisory Committee (MEDAC), during which the agency will seek the committee's recommendations regarding the evidence on procedural volume requirements for hospitals and heart team members to begin and maintain TAVR programs.
The agency is soliciting relevant public comment and said it is particularly interested in comments that include scientific evidence and that address the breadth of the issue. To comment on this NCA, click here.