CMS Formally Ditches Breakthrough Device Coverage

The Centers for Medicare and Medicaid Services (CMS) has formally rescinded a final rule on Medicare coverage of breakthrough devices that went into effect in the final days of the Trump administration but was overturned by the Biden administration earlier this year.

The coverage policy — introduced in the Medicare Coverage of Innovative Technology and Definition of “Reasonable and Necessary” final rule — was canceled “because of concerns that the provisions in the final rule may not have been sufficient to protect Medicare patients,” CMS said, adding that by rescinding the rule, “CMS can take action that will better address those safety concerns in the future.”

In place of the rule, the agency said it “intends to explore coverage process improvements that will enhance access to innovative and beneficial medical devices in a way that will better suit the healthcare needs of people with Medicare … on the basis of scientifically sound clinical evidence, with appropriate health and safety protections in place for the Medicare population.”