Medicare proposes ending expedited payment pathway for breakthrough medical devices

The Centers for Medicare & Medicaid Services (CMS) has proposed to eliminate a streamlined pathway for new medical technologies seeking supplemental Medicare payments. This alternative pathway, established in 2021, allowed devices with FDA Breakthrough Device designation to bypass a full substantial clinical improvement review. CMS now argues that many devices approved through this expedited route have not proven to offer significant clinical advantages in practice, leading to a reconsideration of the process. AI

RANK_REASON The cluster discusses a proposed regulatory change by a major government agency impacting the healthcare industry. [lever_c_demoted from significant: ic=1 ai=0.1]

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• Centers for Medicare & Medicaid Services
• FDA Breakthrough Device designation
• Medicare
• Food and Drug Administration

• policy
• other

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