Purpose - The purpose of this paper is to analyze the Parallel Review program that offers simultaneous review of the Food and Drug Administration premarket approval submissions and the Centers for Medicare and Medicaid Services (CMS) national coverage determinations (NCDs) of medical devices. Design/methodology/approach - The paper analyzes the impact of Parallel Review on medical device innovation, focusing in particular on the causes for low popularity of the program among medical device manufacturers. Program outcomes are evaluated in the light of its intended goals. Findings - The paper identifies four reasons for the program’s limited impact. First, few devices are eligible to participate. Second, most manufacturers prefer to seek Medicare reimbursement at the local level as less risky than the CMS NCDs. Third, participation in the Parallel Review might actually delay the marketing of the device. Fourth, the program does not address numerous obstacles that device sponsors currently encounter. While giving the appearance of support for the medical device innovation, the policy falls short on its intended goals. Originality/value - This paper elucidates the challenges to internal reform and serves as a reminder to political economists and health care researchers that to make disruptive innovation possible, we must continue to illuminate the otherwise unseen cost of marketing delays and document the ability of emergent market mechanisms to protect consumer safety.

中文翻译：

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FDA-CMS平行审查–激发创新的失败尝试

目的-本文的目的是分析并行审查程序，该程序可以同时审查食品和药物管理局的上市前批准书以及医疗设备的医疗保险和医疗补助服务中心（CMS）的国家覆盖范围确定（NCD）。设计/方法/方法-本文分析了Parallel Review对医疗器械创新的影响，尤其关注了该计划在医疗器械制造商中普及率低的原因。计划结果将根据其预期目标进行评估。调查结果-本文确定了该计划影响有限的四个原因。首先，很少有设备有资格参加。其次，大多数制造商更愿意在当地寻求医疗保险报销，因为其风险要比CMS NCD小。第三，参与平行审查实际上可能会延迟该设备的上市。第四，该程序无法解决设备赞助商当前遇到的众多障碍。该政策虽然为医疗器械创新提供了支持，但仍未达到其预期目标。独创性/价值-本文阐明了内部改革的挑战，并提醒政治经济学家和卫生保健研究人员，要使破坏性创新成为可能，我们必须继续阐明原本看不见的营销延误成本，并记录新兴市场的能力保护消费者安全的机制。该政策虽然为医疗器械创新提供了支持，但仍未达到其预期目标。独创性/价值-本文阐明了内部改革的挑战，并提醒政治经济学家和卫生保健研究人员，要使破坏性创新成为可能，我们必须继续阐明原本看不见的营销延误成本，并记录新兴市场的能力保护消费者安全的机制。该政策虽然为医疗器械创新提供了支持，但仍未达到其预期目标。独创性/价值-本文阐明了内部改革的挑战，并提醒政治经济学家和卫生保健研究人员，要使破坏性创新成为可能，我们必须继续阐明原本看不见的营销延误成本，并记录新兴市场的能力保护消费者安全的机制。