Medicare’s Device Coverage Pathway Reveals Breakthrough Device Designation Flaws, Experts Say

Researchers from three prominent medical institutions have urged the FDA to refine its processes for Breakthrough Device designation to better reflect device risks and benefits.

The researchers claim in a New England Journal of Medicine article that flaws in the FDA’s breakthrough devices program came to light when the Centers for Medicare and Medicaid Services passed a rule in the final days of the Trump administration establishing the Medicare Coverage of Innovative Technology (MCIT) pathway, which provides immediate Medicare coverage for four years for any new device or diagnostic designated as a breakthrough technology.

The co-authors from the Massachusetts Eye and Ear Infirmary, the Yale School of Medicine and the University of California, San Francisco, School of Medicine contend that high-risk breakthrough devices were approved by the FDA largely on the basis of studies that used “short-term, surrogate endpoints for effectiveness, which may not translate into clinical benefits.”