It looks like coverage for the breakthrough devices has met its end. On Friday, the U.S. Centers for Medicare and Medicaid Services said it has rescinded coverage of the Medicare Coverage of Innovative Technology and Definition of “Reasonable and Necessary.”
The MCIT/R&N final rule would have granted expedited Medicare coverage for up to four years for FDA-designated “breakthrough” devices once it receives or clears market authorization.
However, the kinds of clinical studies needed for FDA market authorization might not consider the differences in clinical profiles, complexities of medical conditions, or associated treatments of the diverse population of Medicare patients.
CMS said by rescinding this rule, it can take action that will better address those safety concerns in the future.
“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,” CMS Administrator Chiquita Brooks-LaSure said in a release. “The Medicare program needs to implement policies that balance access and appropriate safeguards.”
CMS said in a release that it plans to work with FDA, Agency for Healthcare Research and Quality (AHRQ), medical device manufacturers, and other stakeholders to develop a process to cover innovative devices that benefit Medicare patients. CMs added that it intends to hold at least two stakeholder public meetings in CY 2022 to inform future policy-making in this space.