CMS considers covering TAVR for aortic regurgitation
The U.S. Centers for Medicare and Medicaid Services (CMS) is considering another substantial update to its transcatheter aortic valve replacement (TAVR) policies. If finalized, even more patients would be eligible for the minimally invasive procedure than ever before.
In September, CMS finalized a new national coverage determination (NCD) for TAVR that included significant changes. Medicare now covers TAVR in asymptomatic patients, for example, and fewer reporting requirements are in place symptomatic patients undergo treatment.
Now, the agency has officially started the NCD process again by reconsidering whether or not Medicare should automatically cover TAVR in patients with aortic regurgitation (AR) in addition to those who present with severe aortic stenosis. According to CMS, it made this decision internally and not at the request of an outside vendor. It reached this decision after reviewing public comments from various stakeholders and noting that JenaValve received U.S. Food and Drug Administration (FDA) approval for its Trilogy Transcatheter Heart Valve System to be used for TAVR in patients with symptomatic, severe AR.
CMS now accepting public comments
“Instead of expanding the scope of the prior analysis, we are opening a new reconsideration of the TAVR NCD to address coverage of AR,” CMS explained. “This national coverage analysis will only address indications for TAVR for AR. CMS is soliciting public comment. We are particularly interested in comments that include scientific evidence, specifically any peer-reviewed literature, that describes the role of TAVR for AR.”
The JenaValve Transcatheter Heart System on display at TCT 2023. Photo by Dave Fornell.
The public comment period ends on Oct. 10, 2026. A proposed decision memo is then expected by March 10, 2027. If CMS does officially propose updating the NCD to include coverage for AR, that announcement would then be followed by an additional public comment period.
A small selection of public comments have already been shared with CMS. Additional comments are expected as the deadline of Oct. 10 approaches.
The Society for Cardiovascular Angiography and Interventions (SCAI) shared a message with its members asking for any feedback related to this issue. SCAI President J. Dawn Abbott, MD, emphasized that the group’s feedback has helped shape previous TAVR policy changes.
The continued evolution of TAVR
The FDA’s decision to approve JenaValve’s Trilogy Transcatheter Heart Valve System for symptomatic, severe AR was seen as a major turning point in TAVR’s ongoing evolution. Aortic valve surgery is typically the preferred treatment for patients with severe AR, but the risks associated with these procedures lead some clinicians to use TAVR valves built to treat AS instead. This off-label treatment strategy is far from ideal, and many clinicians have been wondering if TAVR would ever be fully embraced as a go-to treatment strategy for patients with AR. In January, in fact, an analysis in The American Journal of Cardiology called AR “the next frontier” for TAVR care.[1]
Will CMS make another major update to its TAVR coverage policies in 2027? The answer is not yet clear—but it is certainly a conversation the cardiology, interventional cardiology and cardiac surgery communities will be keeping a close eye on in the months ahead.
Click here for more details from CMS.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.