BrainCool AB (publ) – CMS repeals MCIT breakthrough device final rule, leaves open other coverage pathways
Today, November 12, 2021, the Centers for Medicare and Medicare Services (CMS) is rescinding the Medicare Coverage of Innovative Technology and Definition of “Reasonable and Necessary” (MCIT/R&N) final rule because of concerns that the provisions in the final rule may not have been sufficient to protect Medicare patients. However CMS said it plans to work with FDA, medical device manufacturers and other stakeholders to "develop an expeditious process" to cover new technologies that benefit Medicare patients. Please see the press release from CMS below[1]. Previously, BrainCool commented the