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BioUtah Submits Comments on Proposed MCIT Repeal

October 15, 2021


October 15, 2021 

The Honorable Chiquita Brooks-LaSure


Centers for Medicare & Medicaid Services

Department of Health and Human Services 

Attention: CMS-3372-P2

P.O. Box 8013

Baltimore, MD 21244–8013 

Re: Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” Proposed Rule: [CMS-3372-P2]

Dear Administrator Brooks-LaSure:

BioUtah appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) proposed rule that would repeal the Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” (R&N) final rule, which was published on January 14, 2021.

The final rule, delayed until December 15, 2021 under previous rulemaking, would grant expedited Medicare coverage for up to four years for U.S. Food & Drug Administration (FDA)-designated breakthrough devices or diagnostics (herein referred to as device(s) or technologies) as early as the same day they are given FDA market authorization.

In general, BioUtah believes CMS should move quickly to establish an expedited coverage pathway that will provide faster beneficiary access to innovative medical technologies, including publicly signaling its intention along with the timeline to propose an updated rule by December 15, 2021.

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, diagnostics, research and testing, biotechnology and biopharmaceuticals and health IT, amongst others.  

Medical innovations being developed by Utah life sciences companies address some of our most serious healthcare conditions, such as lung cancer, breast cancer, chronic kidney disease, neurodegenerative diseases, Parkinson’s, degenerative disc disease, heart disease and more. The MCIT pathway, if implemented, would provide 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.

Our comments, in particular, focus on CMS’ proposal to repeal the January final rule and future rulemaking.

I. Proposed Repeal of MCIT Final Rule

BioUtah urges CMS to address concerns about clinical evidence for the Medicare population and operational challenges utilizing the construct of the MCIT pathway finalized in the January 14, 2021 rule.

While we share the administration’s goal to promote innovation and more quickly bring new medical devices to patients that need them, we are disappointed in CMS’ decision to issue a proposed rule to repeal the MCIT final rule. 

In proposing to repeal the final rule, CMS indicates that many important considerations were raised through the public comment process, including concerns regarding lack of information as to whether the device would be beneficial or harmful to Medicare beneficiaries. In addition, the agency cites operational challenges in implementing the MCIT pathway.

In our April 16, 2021 letter regarding Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary”; Delay of Effective Date; Public Comment Period [CMS–3372–IFC], we acknowledged and provided comments on these specific concerns. 

Operational Challenges

In our April comment letter, we stated that the “MCIT pathway is not a significant departure from CMS’ experience with expediting coding and payment for innovative devices, including devices with breakthrough designation, through the NTAP process and the TPT device designation process. Additional details and instructions concerning MCIT operations could be addressed through sub-regulatory guidance.” BioUtah continues to urge the agency to leverage existing approaches and utilize guidance to address operational concerns, rather than act to repeal the MCIT pathway.

Clinical Evidence

In our April comment letter we also noted that the safety and well-being of Medicare beneficiaries are a top priority for BioUtah and our state’s life sciences industry. We further noted that the final rule gives CMS authority to remove a breakthrough device from the MCIT pathway for safety concerns, including giving “CMS the ability to limit or withdraw MCIT coverage if there are significant questions of safety or clinical benefit that are unresolved after FDA market authorization, even absent FDA action.” 

Further, technologies receiving MCIT status would still undergo the rigorous FDA review process for medical safety and effectiveness to achieve approval – considered the gold standard worldwide. Finally, under the MCIT pathway, physicians would still exercise their discretion in determining what is in the best interest of their patients. Thus, BioUtah continues to believe that clinical evidence development, including “Real World Evidence” could be advanced under the MCIT framework, providing meaningful safeguards, while still ensuring quicker access to innovative and life-saving products for Medicare patients.

II. Future Policies and Rulemaking

In the proposed rule, CMS states that it is considering future policies and potential rulemaking to explore an expedited coverage pathway that provides access to innovative beneficial technologies. The agency suggests that certain operational challenges and questions around what devices should qualify for MCIT, and whether to require mandatory collection of clinical evidence during the initial coverage period, cannot be resolved in implementation of the MCIT pathway. Yet, the agency admittedly developed MCIT in part due to concerns that delays and uncertainty in Medicare coverage impaired beneficiary access to important new and innovative technologies, specifically those designated as breakthrough devices by FDA. 

As a result, should the proposed rule to repeal MCIT be finalized before the December 15, 2021 effective date, BioUtah urges CMS to honor its commitment to ensure that all people on Medicare have faster access to innovative medical technologies for life-threatening or irreversibly debilitating diseases by publicly signaling its intention along with the timeline to propose an updated rule by December 15, 2021.

Significantly, there is long-standing and strong bipartisan support for expedited coverage of important new technologies, reflecting years of collaborative discussion among CMS, FDA, and numerous external constituencies. An overwhelming majority of commenters have supported creation of the MCIT pathway. Many of these comments have also offered suggestions on how to address unresolved concerns raised by CMS and ways that the pathway could be improved. 


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

Without timely and predictable coverage, it can be especially difficult for smaller companies to begin to generate revenue and attract the investor interest and funding needed to commercialize their breakthrough devices. As a result, even after FDA market authorization, commercialization of potentially life-saving treatments could be unnecessarily delayed and unavailable to Medicare patients and providers. 

We appreciate CMS’ intent to conduct future rulemaking and to consider creating alternative pathways or utilizing existing ones. In that spirit, BioUtah looks forward to working with the agency, Congress and stakeholders to ultimately ensure faster patient access to beneficial, innovative medical technologies. 

If you have questions regarding these comments, or if you require additional information, please contact me at kelvyn@bioutah.org or Denise Bell, vice president, government affairs at denise@bioutah.org. 

Respectfully submitted, 


Kelvyn Cullimore 

President and CEO