What's Happening?
The Centers for Medicare and Medicaid Services (CMS) is set to reconsider its national coverage decision for transcatheter aortic valve replacement (TAVR) following a request from Edwards Lifesciences.
The company has presented new evidence indicating improved outcomes for asymptomatic patients undergoing TAVR, which are currently not covered under Medicare. Edwards' request, submitted in July, aims to expand Medicare coverage to include these patients, potentially increasing the adoption of TAVR procedures. Analysts, including William Blair's Brandon Vazquez, suggest that broader reimbursement could lead to more hospitals establishing TAVR centers, as approximately one-third of severe aortic stenosis patients are asymptomatic. Edwards has already received an expanded label indication from the FDA for its Sapien 3 TAVR devices for asymptomatic patients and approval in Europe.
Why It's Important?
The reconsideration of TAVR coverage by CMS could significantly impact the healthcare landscape for patients with severe aortic stenosis. If approved, the expanded coverage would allow more patients to access TAVR procedures, potentially improving patient outcomes and reducing the need for more invasive surgeries. This move could also drive the establishment of new TAVR centers, enhancing access to care across the U.S. For Edwards Lifesciences, the expanded coverage could lead to increased sales and market penetration of their TAVR devices. Additionally, the decision could set a precedent for future coverage expansions based on emerging clinical evidence, influencing how medical innovations are integrated into standard care practices.
What's Next?
CMS plans to issue a proposed decision memo on the request by June 15, 2026, with a final national coverage analysis expected by September 13, 2026. During this period, CMS will evaluate the clinical evidence to determine which patient characteristics are most likely to benefit from TAVR and whether specific treatment conditions are necessary. Public comments on the proposal will be accepted until January 14, 2026. The outcome of this analysis could lead to changes in coverage criteria, potentially removing outdated requirements that currently limit access to TAVR for asymptomatic patients.
