CMS opens door to broader TAVR use as Edwards wins national coverage review
U.S. regulators have formally reopened the door to expanded Medicare coverage for transcatheter aortic valve replacement (TAVR), accepting Edwards Lifesciences’ request for a new national coverage determination (NCD) that could significantly broaden patient access and ease procedural barriers.
On December 15, the Centers for Medicare & Medicaid Services (CMS) published an updated tracking sheet confirming it has accepted Edwards’ request and launched a national coverage analysis. The move triggers a public comment period running through Jan. 14, 2026, marking the first major step toward potential changes in TAVR reimbursement policy.
CMS is expected to issue a proposed decision memo by June 15, 2026, with a final NCD anticipated by Sept. 13, 2026, slightly ahead of prior expectations that placed a final decision in the fourth quarter of 2026. The timeline aligns closely with Edwards’ stated goal of reopening the NCD by year-end 2025.
At the center of the request is Edwards’ push to expand Medicare coverage to include asymptomatic patients with aortic stenosis, a population currently excluded under existing policy. The company has also asked CMS to eliminate coverage with evidence development (CED) requirements and to remove what it views as unnecessary procedural and infrastructure constraints tied to pre- and peri-procedural care.
CMS’ reopened review will examine TAVR coverage for both symptomatic and asymptomatic aortic stenosis patients, assessing whether the clinical evidence supports broader use across patient subgroups and whether existing site-of-care and treatment conditions are still necessary to replicate outcomes seen in clinical trials.
Analysts believe updated coverage could have immediate operational benefits. Easing billing complexity and procedural requirements may improve throughput at existing TAVR centers, while also lowering the barrier for new centers to enter the market, a dynamic that could accelerate adoption beyond today’s high-volume hospitals.
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The dominant player in TAVR, a favorable outcome would reinforce long-term procedure growth and further entrench its Sapien platform as the standard of care as the field moves upstream into earlier disease stages.
More broadly, CMS’ decision to reopen the NCD signals a willingness to revisit legacy coverage frameworks as structural heart therapies mature, setting the stage for a high-stakes policy decision that could reshape the U.S. TAVR landscape heading into 2027.
