CMS Should Create New Roadmap For Breakthrough Technologies, Trade Group Urges
The Medical Device Manufacturers Association wants the US Medicare agency to come up with a new rule for implementing a coverage pathway for breakthrough devices by June 2022.
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Despite industry efforts to save what it viewed as a boon to breakthrough medical technology, US Medicare has repealed the Medical Coverage for Innovative Technologies (MCIT) rule. In a more favorable move for industry, the agency scrapped a controversial qualifying definition for coverage eligibility.
In a letter to CMS Administrator Chiquita Brooks-LaSure, the industry association argues that repealing MCIT would deny many Americans access to “transformational” medical technologies.
The US FDA has updated its final guidance to clarify use of the Breakthrough Devices Program in advancing health equity. The voluntary program was created to speed up the process of getting innovative medical devices to patients that treat life-threatening or debilitating diseases.