CMS officially kills 'breakthrough' medical device program

By staff writers

November 15, 2021 -- It's official. The U.S. Centers for Medicare and Medicaid Services (CMS) has killed a Trump administration-era program to promote the development of "breakthrough" medical devices.

The agency has rescinded the Medicare Coverage of Innovative Technology and Definition of "Reasonable and Necessary" (MCIT/R&N) rule due to concerns that it would not effectively protect Medicare patients from flaws in new technologies. The CMS first signaled that the MCIT program was on the chopping block in September.

The program would have facilitated expedited Medicare coverage for up to four years for devices categorized as "breakthrough" by the U.S. Food and Drug Administration (FDA). Now, the agency plans to "explore coverage process improvements that will enhance access to innovative and beneficial medical devices in a way that will better suit the health care needs of people with Medicare," it said in a statement.

"Although we continue to be in favor of enhancing access to new technologies, we are mindful that they may have unknown or unexpected risks and must first ensure such technologies improve health outcomes for Medicare beneficiaries," said CMS Administrator Chiquita Brooks-LaSure. "The Medicare program needs to implement policies that balance access and appropriate safeguards."

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