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CMS Proposes Quick Path to Medicare Coverage for FDA Breakthrough Devices

NEW YORK – The US Centers for Medicare and Medicaid Services on Monday issued a proposed rule that would provide more immediate federal payor coverage of medical devices given the US Food and Drug Administration's breakthrough designation.

The rule would create what CMS is calling the Medicare Coverage of Innovative Technology (MCIT) pathway, under which medical devices given FDA's breakthrough designation would, upon receiving FDA market authorization, be covered by Medicare, with that coverage continuing for four years.

At the end of the four year period, devices could receive an affirmative national coverage decision from CMS, a negative NCD from CMS, or have coverage left to the discretion of Medicare Administrative Contractors, either through local coverage determinations or on a claim-by-claim basis.

The proposed pathway would be voluntary, with manufacturers having to notify CMS that they are opting into the process.

CMS said that it was proposing the rule to address delays in instituting device coverage caused by the current national and local coverage determination processes, which the agency noted take on average nine to 12 months to finalize.

It is also intended to address inconsistencies in coverage across geographies due to, for instance, differences in local coverage determinations by MACs. CMS noted that of the 16 breakthrough devices to have received market authorization from FDA, 10 have variabilities in coverage.

The rule would cover breakthrough devices that received FDA market authorization more than two years before the proposed rule is finalized, with the four year coverage period beginning on the date the device received FDA market authorization.

The proposed rule will be submitted to the Federal Register on September 1, 2020, after which CMS will collect comments on the rule for 60 days.