The Centers for Medicare & Medicaid Services (CMS) has announced a proposed decision to cover transcatheter tricuspid valve replacement (TTVR) for Medicare beneficiaries with severe symptomatic tricuspid regurgitation.
美国联邦医疗保险与医疗补助服务中心（CMS）宣布了一项拟议决定，为患有严重症状性三尖瓣反流的联邦医疗保险受益人提供经导管三尖瓣置换术（TTVR）。
The proposed decision would allow coverage under a Coverage with Evidence Development (CED) framework, requiring the procedure to be part of a CMS-approved clinical study to ensure safety and efficacy data collection.
该拟议决定将允许在 “有证据发展的承保”（CED）框架下进行承保，要求该手术必须是 CMS 批准的临床研究的一部分，以确保安全和疗效数据的收集。
According to CMS, TTVR would be covered for patients whose condition remains severe despite medical therapy. A multidisciplinary heart team would have to confirm the appropriateness of the procedure. This team must include a cardiac surgeon, interventional cardiologist, heart failure cardiologist, electrophysiologist, imaging specialists, and an interventional echocardiographer, all of whom must have experience in treating tricuspid regurgitation.
根据 CMS 的规定，TTVR 适用于在接受药物治疗后病情仍然严重的患者。必须由一个多学科心脏团队来确认手术的适当性。该团队必须包括心脏外科医生、介入心脏病专家、心力衰竭心脏病专家、电生理学家、影像学专家和介入超声心动图专家，他们都必须具有治疗三尖瓣反流的经验。
The proposal requires CED studies to focus on critical outcomes such as all-cause mortality and hospitalizations over at least 24 months. The agency also said studies must conduct subgroup analyses by age, sex, race, and pre-existing conditions.
该提案要求 CED 研究重点关注至少 24 个月内的全因死亡率和住院率等关键结果。该机构还表示，研究必须按年龄、性别、种族和原有病症进行亚组分析。
Outside of CMS-approved studies, TTVR would not be covered for Medicare beneficiaries. However, the procedure could still qualify for coverage under Medicare’s Clinical Trial Policy or the FDA’s Investigational Device Exemption program.
在 CMS 批准的研究之外，TTVR 不在医疗保险受益人的承保范围内。不过，根据医疗保险的临床试验政策或美国食品和药物管理局的研究性设备豁免计划，该手术仍有资格获得承保。
TTVR is a minimally invasive medical procedure that involves replacing a damaged or malfunctioning tricuspid valve in the heart with an artificial valve. A catheter is inserted through a blood vessel in the groin and guided to the heart.
TTVR 是一种微创医疗程序，涉及用人工瓣膜替换受损或功能失常的心脏三尖瓣。导管通过腹股沟的血管插入并引导至心脏。
The FDA has approved Edwards’ Evoque TTVR system through its breakthrough device program.
美国食品和药物管理局通过突破性器械计划批准了 Edwards 的 Evoque TTVR 系统。
“Edwards believes the proposed transcatheter tricuspid valve replacement (TTVR) National Coverage Determination (NCD) provides a pathway for beneficiary access to this innovative technology. We appreciate CMS’ commitment to supporting ongoing evidence generation to enable timely patient access to new therapies. We are continuing to analyze the policy and will be submitting a public comment for consideration,” Edwards said in a statement shared with MassDevice.
“Edwards认为，拟议的经导管三尖瓣置换术（TTVR）国家承保范围确定（NCD）为受益人获得这项创新技术提供了途径。我们感谢 CMS 承诺支持不断生成证据，使患者能够及时获得新疗法。Edwards 在与 MassDevice 分享的一份声明中说："我们正在继续分析这项政策，并将提交一份公开意见供审议。
Abbot has requested similar coverage for its TriClip transcatheter edge-to-edge repair (TEER) system, which the FDA also approved for tricuspid regurgitation through its breakthrough devices program. CMS anticipates a proposed decision memo in April 2025 and completion of its coverage analysis in July.
Abbot 也为其 TriClip 经导管边缘到边缘修复（TEER）系统申请了类似的承保范围，FDA 也通过其突破性器械计划批准了该系统用于三尖瓣反流。CMS 预计将于 2025 年 4 月发布建议决定备忘录，并于 7 月完成承保分析。
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