CMS aborts launch of MCIT payment program for breakthrough devices – Medical Design and Outsourcing – Medical Design & Outsourcing

CMSCMS intends to kill the Medicare Coverage of Innovative Technology (MCIT) program that would have accelerated government payments for medical devices designated by the FDA as breakthroughs.

CMS (the U.S. Centers for Medicare & Medicaid Services) disclosed its proposal in the Federal Registrar yesterday — three months before the rule was set to take effect on Dec. 15 — saying the rule “is not in the best interest of Medicare beneficiaries.”

CMS created the MCIT pathway in the last days of the Trump Administration. It was among a host of regulations the Biden Administration immediately put on hold for further consideration.

“While the rule tried to address stakeholder concerns about accelerating coverage of new devices, significant concerns persist about the availability of clinical evidence on Breakthrough Devices when used in the Medicare population as well as the benefit or risks of these devices with respect to use in the Medicare population upon receipt of coverage,” the agency said in its notice.

Medicare patients generally have more comorbidities than patients typically enrolled in early clinical trials, and they often require additional and higher acuity clinical treatments. CMS said these considerations are often not addressed in the early device development process.

CMS also said it did not want to appear to promote the use of MCIT-covered devices over more appropriate alternatives, warning that “early and unrestricted adoption of devices may have consequences that may
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