CMS 更新经导管主动脉瓣置换全国覆盖决定 有症状重度主动脉狭窄不再附带证据发展要求
美国联邦医疗保险和医疗补助服务中心（CMS）9 月 10 日发布更新后的经导管主动脉瓣置换（TAVR）全国覆盖决定（NCD），对联邦医保覆盖主动脉狭窄治疗的条件作出多项调整。
按新决定，有症状的重度主动脉瓣狭窄患者接受 TAVR 不再附带“覆盖附证据发展”（CED）要求，直接按常规标准覆盖；无症状重度主动脉狭窄则新纳入覆盖范围，但限于参加 CMS 批准的 CED 研究，并须具有美国食品药品管理局（FDA）批准的适应证。
新决定同时修改术前评估与术中要求：心脏团队评估可采用异步方式进行，但必须包含介入心脏科医生与心脏外科医生的共同意见；原先的双操作者要求取消，是否由一名或两名操作者实施由心脏团队决定；医院层面的手术量门槛取消，改为对操作者个人设年度量要求，即每年至少完成 20 例经导管心脏瓣膜手术、其中至少 15 例为 TAVR，或两年完成 40 例、其中 30 例为 TAVR。
CMS 说，本次调整是对 2019 年 TAVR 覆盖决定的再审查，缘起是 FDA 于 2025 年 4 月 30 日把相关器械适应证扩大到无症状患者。此前在旧决定下批准的 CED 研究自 9 月 10 日起转入研究性器械豁免（IDE）覆盖通道，覆盖不中断。
（来源：联邦医疗保险和医疗补助服务中心）
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)
来源：联邦医疗保险和医疗补助服务中心
发布：GSM·美国（发布链接）
图片来源：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)
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