EW: Proposed NCD Positive for EW/TAVR

Research evidence excerpt

EW: Proposed NCD Positive for EW/TAVR

1,412.7A 1,532.2A 1,553.1A 1,569.6A

so the change is about day-of-procedure presence, not institutional 2026 1,648.6A 1,699.9E 1,688.5E 1,719.7E

composition. 2027 1,772.1E 1,871.3E 1,905.5E 1,929.9E

EPS, Adj Diluted

CED is terminated for symptomatic severe aortic stenosis (AS), which 2025 0.64A 0.67A 0.67A 0.58A

removes administrative burden for the majority of current TAVR volume. 2026 0.78A 0.73E 0.75E 0.76E 2027 0.81E 0.85E 0.86E 0.87E

CMS found evidence "sufficient to conclude that TAVR meaningfully

improves health outcomes" for symptomatic patients, supported by 17 All values in USD unless otherwise noted. Priced as of prior trading day's market close, EST (unless otherwise noted).

RCTs with >10,000 patients and >450,000 real-world TVT registry patients

across 860+ sites.

Asymptomatic coverage under CED vs. full coverage represents partial

success, but creates a pathway for formal coverage in the future. This is

operationally manageable for established centers, but strategically limiting

for market expansion. CMS cited some evidence gap (e.g. EARLY TAVR as

the sole large RCT, valve durability concerns for younger patients, and

the ongoing EASY-AS trial with results in 2030–31), requiring CED studies

with active comparator. Given centers are already treating asymptomatic

patients post-FDA approval without reimbursement issues, this likely

limits formalization more than practice and creates a pathway for formal

coverage in the future.

Hospital volume requirements are eliminated and operator-level

thresholds streamlined, which should aid TAVR procedures. The proposal

states that operators must perform ≥20 transcatheter cardiac valve

procedures/year (≥15 TAVR), or ≥40/two years (≥30 TAVR). CMS explicitly