Posted by Michael Wonder on 05 Oct 2021
Medicare reverses course on decision to universally cover breakthrough medical devices for 4 years
4 October 2021 - In January 2021, in the waning days of the Trump Administration, the CMS finalised a rule on coverage of breakthrough medical devices. Specifically, the rule would create a new pathway, “Medicare Coverage of Innovative Technology,” for medical devices designated as breakthrough by the FDA, allowing national coverage for on-label uses of devices for four years, after which CMS would determine further coverage status.
Last month, CMS reversed course, by proposing to rescind the rule due primarily to clinical evidence concerns.
