CMS Updates TAVR Coverage: Symptomatic Severe Aortic Stenosis Covered Without Evidence-Development Requirement
The Centers for Medicare & Medicaid Services (CMS) issued an updated National Coverage Determination (NCD) for transcatheter aortic valve replacement (TAVR) on September 10, revising Medicare coverage conditions for the treatment of aortic stenosis.
Under the updated NCD, TAVR for symptomatic severe aortic stenosis is covered without the Coverage with Evidence Development (CED) requirement. Coverage is expanded to asymptomatic severe aortic stenosis under CED, limited to CMS-approved studies and requiring an FDA-approved indication.
The decision also revises procedural requirements: Heart Team evaluation may be conducted asynchronously but must include input from both an interventional cardiologist and a cardiac surgeon; the former dual-operator requirement is removed, leaving the choice of one or two operators to the Heart Team; and hospital volume thresholds are eliminated in favor of operator-level requirements of at least 20 transcatheter cardiac valve procedures per year, including at least 15 TAVR, or 40 procedures over two years including 30 TAVR.
CMS said the reconsideration of the 2019 NCD followed the FDA’s April 30, 2025 expansion of device indications to asymptomatic patients. TAVR studies approved under the earlier NCD transitioned to the Investigational Device Exemption coverage pathway on September 10 without interruption, CMS said.
(Source: Centers for Medicare & Medicaid Services)
Source: Centers for Medicare & Medicaid Services
Published by GSM · USA (original Chinese edition)
Photo: 心脏与心包解剖图版（1905 年医学图谱，公共领域；Wikimedia Commons）/ Heart and pericardium anatomical plate, 1905 (public domain; via Wikimedia Commons)
