2026年4月23日 美国东部时间中午12:16 / 路透社
作者：艾哈迈德·阿布勒延（Ahmed Aboulenein）和斯妮哈·S·K（Sneha S K）
2026年4月23日 美国东部时间中午12:16 UTC 更新于1小时前
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华盛顿，4月23日（路透社）——美国卫生监管机构周四宣布一项新计划，将加快联邦医疗保险（Medicare）对特定医疗设备的覆盖审批，称此举可将报销审批时限从一年甚至更久缩短至最多两个月。
医疗设备制造商往往需要在监管机构获批与医保报销之间等待漫长时间，他们一直呼吁，与药品不同，医疗设备缺乏明确的报销路径，这会打击创新与投资积极性。
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美国医疗保险和医疗补助服务中心（CMS）与美国食品药品监督管理局（FDA）表示，这项名为RAPID的快速覆盖通道计划，将协调FDA指定的部分II类和III类突破性医疗器械的监管审查与医保覆盖决策，这类设备通常属于高风险医疗技术。
两机构表示，该方案旨在缩短设备获批与医保报销之间的延误。
“根据这项计划，对于为患者提供有前景的治疗方案的新型设备，CMS将能够在FDA批准后的60至90天内，面向全体医保参保人群提供覆盖，”CMS副署长兼首席政策与监管官约翰·布鲁克斯（John Brooks）在记者电话会上对记者表示。
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CMS将在符合条件的设备获得FDA批准的当天发布拟议的全国覆盖决定，随后开启为期30天的公众意见征询期。
FDA负责政策、立法与国际事务的副专员格蕾丝·格雷厄姆（Grace Graham）表示，监管机构预计最初将有约40款设备符合加速覆盖的资格。
布鲁克斯称，受影响的设备类型包括人工心脏瓣膜、治疗心律不齐的设备，以及用于刺激神经治疗疾病的植入物。
“这将为医疗设备制造商在接触FDA和CMS时提供更高的透明度，”他补充道。
“我们将通过向设备制造商清晰说明，要获得医保覆盖需要达到哪些具体标准，来简化整个审批流程，”布鲁克斯说道。
这项计划对于美敦力（Medtronic MDT.N）和强生（Johnson & Johnson JNJ.N）等大型医疗器械制造商而言是一项利好，这些企业此前一直在游说议员加快医保对新产品的覆盖审批。
2025年，美敦力的营收达335亿美元，强生的医疗技术销售额达338亿美元。
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US health regulators to speed up Medicare device coverage
2026-04-23 12:16 PM UTC / Reuters
By Ahmed Aboulenein and Sneha S K
April 23, 2026 12:16 PM UTC Updated 1 hour ago
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WASHINGTON, April 23 (Reuters) – U.S. health regulators announced a new program to speed up Medicare coverage for certain medical devices on Thursday, saying it would cut reimbursement timelines to as little as two months from a year or more.
Medical device makers often face long delays between regulatory approval and Medicare reimbursement and have argued that the lack of a clear reimbursement pathway, unlike for drugs, discourages innovation and investment.
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The Centers for Medicare & Medicaid Services and the Food and Drug Administration said the new RAPID coverage pathway will align regulatory review and Medicare coverage decisions for some FDA-designated Class II and Class III breakthrough devices, which typically include higher-risk medical technologies.
The agencies said the approach is designed to reduce delays between approval and reimbursement.
“Under this program, CMS will be able to provide coverage within 60 to 90 days of FDA approval across the Medicare population for new devices that offer promising therapies for individuals,” CMS Deputy Administrator and Chief Policy and Regulatory Officer John Brooks told reporters on a press call.
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CMS will issue a proposed national coverage decision on the same day an eligible device receives FDA approval, followed by a 30-day public comment period.
Regulators expect about 40 devices to be initially eligible for accelerated coverage, said FDA Deputy Commissioner for Policy, Legislation, and International Affairs Grace Graham.
The types of devices affected include artificial heart valves, devices that treat heart rhythms, and implants that stimulate nerves to treat diseases, Brooks said.
“There’s just going to be a lot more transparency for device manufacturers as they approach the FDA and CMS,” he added.
“We’re going to demystify the process by providing a clear signal to device manufacturers of exactly what targets they need to hit to get Medicare coverage,” Brooks said.
The program represents a win for large device makers such as Medtronic MDT.N and Johnson & Johnson JNJ.N, which have lobbied lawmakers to speed up Medicare coverage for new products.
In 2025, Medtronic generated $33.5 billion in revenue and J&J generated $33.8 billion in medtech sales.
J&J and Medtronic did not immediately respond to a Reuters request for comment.
Reporting by Siddhi Mahatole, Chandni Shah, and Sneha S K in Bengaluru, Ahmed Aboulenein in Washington; Editing by Sharon Singleton, Sahal Muhammed, Tasim Zahid and Alexander Smith
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