CMS is proposing that Medicare cover all medical devices designated by the Food and Drug Administration as a “breakthrough” technology. The proposed rule, released Monday, is in response to an executive order by President Donald Trump in late 2019 that tasked CMS with streamlining coverage for breakthrough medical devices. Manufacturers can voluntarily participate in FDA’s Breakthrough Devices Program to secure quicker review of their devices. The program is only open to devices that provide effective treatment or diagnosis of a life-threatening or debilitating condition and they must use a breakthrough technology, offer significant advantages compared to existing alternatives or have no approved clearance currently in existence.
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Source: https://www.modernhealthcare.com/medical-devices/medicare-proposes-coverage-breakthough-medical-devices