On Dec. 15, the Centers for Medicare and Medicaid Services (CMS) published an updated tracking sheet for TAVR national coverage analysis. It accepted Edwards’ formal request for an NCD update and initiated a review. This kicks off a public comment period, running through Jan. 14, 2026.
BTIG analysts Marie Thibault, Sam Eiber and Alexandra Pang say that a proposed decision memo is due on June 15, 2026, followed by the final NCD, expected by Sept. 13, 2026. This lands in line with Edwards’ expectations for reopening the NCD by the end of 2025. The timeline even moved up slightly from an expectation for a finalized NCD in the fourth quarter of 2026.
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Edwards, a leader in the TAVR space, requested that CMS expand the indication to include asymptomatic patients. The company also asked CMS to do away with coverage with evidence development (CED) requirements, and remove barriers to access related to pre-procedural, peri-procedural and infrastructure requirements.
CMS’ reopened NCD focuses on TAVR coverage for both symptomatic and asymptomatic patients with aortic stenosis (AS). It will consider clinical evidence supporting TAVR’s benefits for patients with specific characteristics or comorbidities and whether certain treatment conditions are necessary to achieve outcomes in line with results seen in clinical studies.
The analysts say that updated CMS coverage could help improve efficiency in existing centers. They agree, and also note the potential for adding new TAVR centers as a result.
“We think having an updated NCD in place covering asymptomatic TAVR would also make it easier for current centers to process billing for these procedures,” the analysts said.
