Comments Split on Edwards Bid to Widen Medicare TAVR Coverage and Drop Evidence Rules

Public comments on Edwards Lifesciences' request to broaden Medicare's national coverage policy for transcatheter aortic valve replacement (TAVR) show support for covering patients without symptoms, alongside resistance to Edwards' call to drop the policy's evidence-collection requirements. MedTech Dive reported on January 28 that several medical groups backed extending coverage to asymptomatic patients with severe aortic stenosis, while some physicians and rival valve maker Medtronic said more data are needed.

The Centers for Medicare & Medicaid Services began the reconsideration on December 15, opening a 30-day comment period, according to the Society for Cardiovascular Angiography and Interventions. CMS has said its proposed decision memo should be released by June 15, 2026, the society said.

What Edwards asked for

In its comment letter dated January 14, posted on the CMS website, Edwards listed three priorities: aligning TAVR coverage with FDA-approved indications, including asymptomatic aortic stenosis; recognising that TAVR "has satisfied its Coverage with Evidence Development (CED) requirements" while continuing to support engagement with national registries; and preserving the multidisciplinary Heart Team while allowing flexibility in care models.

"Edwards believes updating this NCD will not only advance care, but will also improve patient outcomes, provide equitable access for all patients with AS, and reduce long-term Medicare costs," wrote Daniel Lippis, the company's corporate vice president for TAVR. The letter says Edwards' Sapien transcatheter valves have been implanted in more than 500,000 patients in the US.

According to MedTech Dive, Edwards received FDA approval in May 2025 for an expanded indication for its Sapien 3 valve in asymptomatic patients, based on its Early TAVR trial, which showed asymptomatic patients had better outcomes after the procedure than those kept under clinical surveillance.

Societies want CED kept

The Society of Thoracic Surgeons and four other groups, the American Association for Thoracic Surgery, American College of Cardiology, Heart Failure Society of America and SCAI, recommended that CMS update the coverage determination to include FDA-approved indications such as asymptomatic aortic stenosis, and anticipate future indications such as aortic regurgitation, MedTech Dive reported.

But STS president Joseph Sabik urged CMS to maintain CED for TAVR. "Removing CED now could compromise the ability to monitor outcomes, address emerging risks, and ensure equitable access to high-quality care," he wrote, according to the outlet.

Calls for more data

Medtronic vice president Jeff Farkas noted that long-term data are not yet available for asymptomatic patients. "The ability to diagnose asymptomatic aortic stenosis and existing clinical guidelines are not yet mature enough for CMS to use for coverage without additional evidence development," he wrote, MedTech Dive reported.

Diana Zuckerman, president of the National Center for Health Research, argued that Early TAVR data cannot be generalised to most Medicare beneficiaries because study participants were predominantly at low surgical risk, and raised concerns about valve durability and repeat procedures, according to the outlet. Steven Woloshin of the Dartmouth Institute for Health Policy and Clinical Practice wrote: "TAVR may ultimately have a role for asymptomatic patients — but we just don't know yet."