OMB Reviewing CMS’ Breakthrough Technologies Coverage Rule

The White House Office of Management and Budget on Tuesday (July 30) began reviewing a CMS rule aimed at streamlining Medicare coverage of breakthrough technologies that the agency believes have the potential to improve health outcomes. The review started shortly after CMS proposed as part of the 2020 hospital outpatient pay rule to create an alternative path for FDA breakthrough devices to qualify for device pass-through payment status. Under that pathway, the substantial clinical improvement criterion for the device pass-through...