通过证据开发计划评估医疗保险的覆盖范围
Maryam Mooghali1, Osman Moneer2, Guneet Janda3
1Maryam Mooghali (maryam.mooghali@yale.edu), Yale University, New Haven, Connecticut.
Health affairs (Project Hope)
|January 6, 2025
概括
可以加强医疗保险和医疗补助服务中心 (CMS) 的证据开发 (CED) 计划覆盖范围. 对于覆盖范围的重新考虑,CMS经常依赖于质量较差的研究,错过了利用CED批准的强有力的证据的机会.
科学领域:
- 卫生政策 卫生政策
- 医学经济学医学经济学
- 临床证据评估临床证据评估
背景情况:
- 医疗保险和医疗补助服务中心 (CMS) 覆盖证据开发 (CED) 计划允许医疗保险覆盖缺乏"合理和必要"地位的项目/服务,取决于临床研究参与.
- 根据新出现的证据,CMS定期重新评估CED的决定.
研究的目的:
- 分析CMS在CED重新考虑中引用的研究的特点.
- 评估CED批准的研究与非CED批准的研究的质量和代表性,用于覆盖决策.
主要方法:
- 审查CMS引用的235个出版物,重新考虑自2005年以来CED批准的26个项目/服务中的10个.
- 在CED批准和非CED批准的研究之间比较研究设计稳定性,样本规模和患者人口统计数据.
主要成果:
- CMS重新考虑了38%的CED项目/服务,引用了235个出版物.
- 与未经CED批准的研究 (引用证据的49%) 相比,CED批准的研究 (24%的引用证据) 具有更强大的设计 (67%的RCT与13%相比),更大的入学率 (中位数为1,000与125),以及更大的美国患者纳入 (93%与44%) 和非CED批准的研究 (49%的引用证据).
结论:
- 尽管CMS依赖非CED批准的研究进行重新考虑,尽管它们的质量和代表性较低,但这表明CED计划的潜在增强领域.
- 优先考虑更高质量的,CED批准的证据可以提高医疗保险覆盖决定的严格性和相关性.
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