A Faster Path to Medicare Coverage for Devices May Get Slower. Or Vanish Altogether

The Biden administration put a hold on the new and pending rule changes that the outgoing Trump administration made, so whether the Medicare Coverage of Innovative Technology pathway will ever take effect is uncertain. But many providers and payers — and presumably most device makers — are keeping a close watch on the fate of the pathway.

Supporters see it as speeding the adoption of new devices and cutting through a cumbersome CMS coverage process. Detractors, including the authors of an opinion piece published in the New England Journal of Medicine last in March, say the pathway would increase Medicare spending by billions of dollars on devices of uncertain value.

The authors of the NEJM piece, which include Joseph S. Ross, M.D., the vice chair of CMS’ Medicare Evidence Development and Advisory Committee, propose instead more FDA and CMS collaboration and a greater emphasis on premarket and postmarketing studies.

CMS covers a device if it deems it “reasonable or necessary” for treating or diagnosing a disease. Some coverage decisions are made at the national level. Others are left to Medicare Administrative Contractors, the private insurers who process claims for CMS. If implemented, the pathway would guarantee up to four years of Medicare coverage of devices approved under the FDA’s Breakthrough Devices Program. Ross and his colleagues leveled some of the same criticisms against the Breakthrough Device Program that critics have of the agency’s breakthrough programs for drugs: the studies are short; the endpoints, surrogates; and the postmarking studies, not completed for years if at all.

More than 400 devices have been awarded breakthrough status because, say the critics, the bar has been set low. Ross and his co-authors say making Medicare coverage automatic for breakthrough devices under this Medicare coverage pathway could “place tremendous financial strain on the Medicare program.”

The Biden administration has not signaled how it wants to approach drug and device regulation. Even so, a greenlight for the Medicare Coverage of Innovative Technology pathway seems unlikely. Perhaps the administration will make some of the modifications that Ross and his colleagues suggest.