MITA and Focused Ultrasound Foundation Support Proposed Rule Eliminating Gap Between FDA Approval and Medicare Coverage

Sep 2, 2020, 14:52 PM

Washington, DC, & Charlottesville, VAThe Medical Imaging & Technology Alliance (MITA) and the Focused Ultrasound Foundation today voiced support for changes proposed that would establish a Medicare coverage pathway for innovative medical devices. If finalized, Medicare’s proposed rule, the Medicare Coverage of Innovative Technologies Pathway (MCIT), would allow four years of Medicare coverage upon FDA authorization of breakthrough devices.

The proposed rule outlines policies that will eliminate the lag time between FDA approval of a device or drug and the subsequent provision of Medicare coverage following approval of FDA designated breakthrough devices. If finalized, the rule would pair FDA breakthrough and CMS coverage and grant immediate, four-year Medicare coverage for new, innovative devices.

“We enthusiastically support the implementation of this rule,” said Jessica Foley, PhD, Chief Scientific Officer at the Focused Ultrasound Foundation. “This would create a more efficient adoption path for noninvasive technologies, such as focused ultrasound, improving the health and well-being of countless people in the U.S.”

“MITA strongly supports this pro-innovation rule that will improve patient care by giving seniors faster access to breakthrough technologies that otherwise perish in the ‘valley of death,” said Patrick Hope, Executive Director, MITA.  “Too often, innovative devices are approved by the FDA but aren’t covered by Medicare until sufficient evidence has been collected. This creates a ‘Catch-22’ scenario in which, without adequate coverage or reimbursement, access to an FDA approved treatment or therapy is limited to only those who can afford to pay out-of-pocket. This results in a reduced ability to collect the same data needed to support reimbursement.”

Public comments on the proposed rule will be accepted until November 2, 2020.