CMS Releases Proposed Rule Eliminating Gap between FDA Approval and Medicare Coverage: Comments Welcome


CMS logoOn August 31, the Centers for Medicare and Medicaid Services (CMS) released a draft rule 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.

The Foundation and our partner, the Medical Imaging & Technology Alliance (MITA), enthusiastically support the implementation of this rule because it would create a more efficient adoption path for noninvasive technologies, such as focused ultrasound, and improve the health and well-being of countless people in the US.

This new rule also presents a great incentive for focused ultrasound manufacturers to apply for breakthrough designation by the FDA for their future or ongoing applications. Sponsors can submit a breakthrough designation request for a device at any time prior to sending their marketing submission.

Public comments on the proposed rule will be accepted until November 2, 2020. The Foundation plans to submit comments, and we encourage manufacturers to do so as well. Please contact Jessica Foley, PhD, with any thoughts on the rule that you would like the Foundation to include in our comments.