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医疗器械授权和报销格局的变化:在4个国家对2种心血管器械的案例研究

Marta M Williams¹, Nathan R Smith², Carin A Uyl-de Groot³

¹Department of Health Care Policy, Harvard Medical School, Boston, MA (M.A.W., B.L.).

Circulation. Cardiovascular quality and outcomes

|February 21, 2025

概括

监管部门的批准和补偿对医疗器械的采用有重大影响. 与加拿大和欧洲相比,美国对新型心血管设备的授权较早,利用率更高,突出显示了国际过程变化.

科学领域:

卫生政策卫生政策
医疗器械规则医疗器械规则
卫生经济学卫生经济学

背景情况:

医疗器械采用受到授权和报销流程的影响.
这些机制的国际变化,特别是数据透明度和报销效应,尚不清楚.

研究的目的:

为了比较美国,加拿大,英国和荷兰两种心血管器械的监管批准和报销机制.
分析这些过程对设备采用和利用的影响.

主要方法:

检查了Watchman和Impella设备的公开数据库,政府政策和新闻稿.
在四个国家比较了监管审查时间表,批准要求和退款决定.

主要成果:

授权数据在美国和加拿大比在英国和荷兰更容易获得.
设备在欧洲比北美早大约10年获得许可.
美国是唯一为这两种设备明确提供公共补偿的国家,导致与加拿大和欧洲相比,采用率和使用率显著更高.

结论:

授权和报销政策的差异影响医疗器械的采用和使用.
调查结果可以为未来的医疗器械监管和报销政策制定提供信息.

关键词:

医疗保健经济学和组织心房动是心房动的一种.生物医学技术生物医学技术设备和用品以及供应.心脏衰竭是因为心脏衰竭.这是心脏辅助器件.左心房附属体的关闭闭关闭

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