BioUtah Statement on Biden Administration's Proposed Repeal of Medicare Coverage of Innovative Technology Final Rule

BioUtah President and CEO Kelvyn Cullimore issued the following statement today regarding the Centers for Medicare and Medicaid Services' (CMS) proposal to repeal the Medicare Coverage of Innovative Technology (MCIT) final rule.

"While we share the administration's goal to promote innovation and make FDA-designated breakthrough medical devices and diagnostics that have been market authorized widely available to Medicare beneficiaries, we are disappointed in CMS' decision to issue a proposed rule to repeal the MCIT pathway as provided in the January 14, 2021 final rule.

BioUtah has long supported the MCIT pathway to more quickly bring new medical innovations to Medicare patients that need them. We have also expressed concerns about repeated delays in implementing the program.

A number of medical innovations being developed by Utah life sciences companies address some of our most serious healthcare conditions, such as lung cancer, Parkinson's, degenerative disc disease, breast cancer, chronic kidney disease and more. The MCIT final rule provided coverage certainties that are essential to spur continued investment in medical innovation while ensuring that seniors, including those in our most vulnerable communities, can benefit from cutting-edge medical technologies in a timely manner.

Importantly, there is strong bipartisan support for expedited Medicare coverage policies like MCIT. BioUtah appreciates CMS' intent to conduct future rulemaking to explore alternative pathways or utilize existing ones. We look forward to working with the administration, Congress and stakeholders to ultimately expand patient access to beneficial breakthrough technologies.

About BioUtah

BioUtah is an independent 501(c)(6) trade association serving Utah's life sciences industry. Its member companies reflect a broad spectrum of the industry with strengths in medical device manufacturing and services, research and testing, biotechnology, biopharmaceuticals, and advanced diagnostics, and healthIT, amongst others; and are a key driver of Utah's economy. BioHive driven by BioUtah, is an industry initiative, in collaboration with key public partners, to showcase the crucial innovations and contributions of the industry collective that boosts our state's economy and helps patients worldwide.