CMS considers Medicare coverage for TAVR in asymptomatic patients
The U.S. Centers for Medicare and Medicaid Services (CMS) announced it is reconsidering Medicare coverage for the use of transcatheter aortic valve replacement (TAVR) to treat severe aortic stenosis (AS) in asymptomatic patients.
TAVR has been approved for the treatment of severe AS for many years, but previous approvals only covered patients who presented with symptoms. CMS is now rethinking its current National Coverage Determination (NCD) for TAVR after receiving a request from Edwards Lifesciences.
Edwards Lifesciences requested the change after EARLY TAVR and a key FDA approval
Edwards Lifesciences, one of the world’s largest TAVR vendors, made its request official with a letter that pointed to the EARLY TAVR data presented at TCT 2024 and then published in The New England Journal of Medicine.[1]
According to EARLY TAVR, which Edwards Lifesciences funded, TAVR with one of the company’s balloon-expandable valves was associated with significant benefits for patients with asymptomatic AS compared to clinical surveillance. The study’s primary endpoint—a composite of all-cause mortality, stroke or unplanned cardiovascular hospitalizations—was seen in 26.8% of TAVR patients and 45.3% of clinical surveillance patients. This was primarily driven by a significant reduction in unplanned hospitalizations for the TAVR group, though early treatment was also associated with lower rates of all-cause mortality and stroke.
EARLY TAVR lead investigator Philippe Généreux, MD, announces his team’s findings in front of a packed audience at TCT 2024. Attendees cheered and roared with excitement as he revealed the study’s primary outcomes, an early sign that interventional cardiologists have been anticipating these results for quite some time.
Another significant moment came in May, when the U.S. Food and Drug Administration (FDA) approved the Sapien 3 TAVR platform from Edwards Lifesciences for treating asymptomatic severe AS. This was the first time the agency had ever approved TAVR devices to be used to treat asymptomatic patients. Once the FDA’s approval was announced, it became clear Edwards Lifesciences would be pushing CMS to rethink its current coverage policies.
“Today, outdated TAVR coverage requirements exacerbate barriers to patient access, leading to delayed patient care and poor outcomes,” according to the letter from Edwards Lifesciences. “Increased patient need and widespread AS undertreatment, as well as a growing demand for structural heart procedures overall, delay timely treatment under existing NCD requirements. Flexibilities to outdated TAVR coverage criteria are needed to empower hospitals and heart teams to make appropriate care decisions that will enable patient access to treatment locally.”
CMS seeks public comments on asymptomatic AS TAVR coverage
Many cardiologists and cardiac surgeons have come out publicly against the treatment of asymptomatic patients with TAVR. It can create unnecessary risks for patients who may not even require treatment, they argue. With these concerns in mind, it is worth noting that CMS is now seeking public comments on this potential change to its coverage policies. Public comments will be accepted until Jan. 14, and then a proposed decision is expected later in 2026.
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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.