Medicare Innovation At Risk? Patients And NTAP Breakthrough Technology
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
