On Monday, the Centers for Medicare & Medicaid Services (CMS) proposed removing the coverage with evidence development (CED) requirement for Transcatheter Aortic Valve Replacement (TAVR) in patients with symptomatic severe aortic stenosis.
William Blair on Tuesday wrote, “…this is a positive outcome for Edwards and largely validates the thesis we laid out following the NCD opening in December.”
CMS Proposes Changes To TAVR Coverage Requirements
Aortic stenosis is a narrowing or stiffening of the heart’s aortic valve. It restricts blood flow from the heart’s main pumping chamber to the rest of the body.
The agency also proposed expanding TAVR coverage to patients with asymptomatic severe aortic stenosis under CED and updating coverage criteria for pre-procedure evaluations, intraoperative standards, and operator and hospital volume requirements.
Analyst Views CMS Proposal As Positive For Edwards Lifesciences
Analyst Brandon Vazquez added that the update is a win for Edwards Lifesciences Corp (NYSE:EW) and one that was largely anticipated following the EARLY TAVR data and the FDA’s April 2025 expansion of the SAPIEN 3 label.
Coverage with CED appears appropriate, given that asymptomatic severe aortic stenosis patients represent an early-stage treatment population, and continued data collection should benefit stakeholders across the healthcare system.
Expanded Coverage Could Support TAVR Adoption
William Blair also noted that Edwards currently has the only FDA-approved TAVR device indicated for asymptomatic severe AS patients.
If coverage is included in the final NCD, it would provide the company with a meaningful competitive advantage.
Implementation of the NCD could catalyze TAVR adoption by simplifying the treatment pathway and enabling patients to access therapy sooner.
William Blair maintains the Outperform rating for the structural heart company.
EW Stock Price Activity: Edwards Lifesciences shares were up 3.74% at $88.65 at the time of publication on Tuesday, according to Benzinga Pro data.
Photo: Shutterstock
Recent Comments