Press Releases

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


WASHINGTON, DC, and CHARLOTTESVILLE, VA – (September 2, 2020) The 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.

About MITA
The Medical Imaging & Technology Alliance (MITA), a division of NEMA, is the collective voice of medical imaging equipment manufacturers, innovators, and product developers. It represents companies whose sales comprise more than 90 percent of the global market for advanced medical imaging technology. For more information, visit Follow MITA on Twitter @MITAToday.

About the Focused Ultrasound Foundation
The Focused Ultrasound Foundation was created to improve the lives of millions of people worldwide by accelerating the development of this noninvasive technology. The Foundation works to clear the path to global adoption by organizing and funding research, fostering collaboration, and building awareness among patients and professionals. Since its establishment in 2006, the Foundation has become the largest non-governmental source of funding for focused ultrasound research. For more information, visit