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Public Policy Newsletter Article

Biocom Welcomes Feedback on CMS Proposed Pathway for Breakthrough Devices

  • 2020-09-24T14:30:00.000+0000
  • Author: Brittany Blocker

On August 31, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule that would establish a Medicare coverage pathway for innovative medical devices designated as breakthrough by the Food and Drug Administration (FDA). The new pathway, the Medicare Coverage of Innovative Technology (MCIT), would allow for Medicare coverage breakthrough devices the same day they are given FDA market authorization.

Devices participating in FDA’s Breakthrough Device Program would be eligible for MCIT, and any MCIT-participating device must fit within a statutory Medicare benefit category. After notification, CMS would coordinate with the FDA and the manufacturer to work out details before the start of coverage.

During the four-year MCIT period, breakthrough devices would be covered nationally to allow them to build evidence of their value. After those four years, manufacturers would have the option of seeking local coverage determinations (LCD) or a national coverage determination (NCD) for qualifying devices.

Comments are due to CMS by November 2, 2020. Biocom is seeking member feedback on this proposed rule. Please submit comments to Brittany Blocker, Manager of Regulatory Affairs, at [email protected] by October 5, 2020.