Member Article

On Sept. 15, 2021, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule to repeal the Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” final rule, which was published on Jan. 14, 2021, and would be effective on Dec. 15, 2021. 

In June 2021, we reported on CMS’ decision to delay the MCIT Program Final Rule (The Rule). At that time, the agency said it could revise, further postpone, or even repeal The Rule.  According to the Sept. 15 Federal Register Notice, CMS decision to repeal The Rule was based on a finding that it is not in the best interest of Medicare beneficiaries, because the change could result in coverage for FDA-designated breakthrough devices without adequate evidence the treatment would be “reasonable and necessary.”

Although the MCIT Program had broad support from the medical device industry, CMS has proposed to rescind the rule amid continued controversy and objections from some physician, insurance, and patient organization groups. Critics of The Rule warn that it risks taking away the incentive to conduct further clinical studies related to the Medicare patient population, which is often not included in the data weighed by the FDA in making clearance and approval determinations.

In keeping with President Joe Biden’s pledge to “marshal the forces of science” in his administration, it appears likely that The Rule will be repealed. Another version of it may be implemented in some form in the future in a manner that is consistent with the legislative intent of the 21st Century Cures Act in order to help accelerate medical product development and make new innovations available faster. CMS has indicated the agency is considering future policies and potential rulemaking to provide improved access to innovative and beneficial technologies.

CMS must finalize or repeal the proposed rule no later than Dec. 15, 2021. CMS is requiring a 30-day public comment period. Afterwards, the agency will have an additional 30 days to review the comments, draft, and post the repeal notice. Once the repeal is posted, it will become effective in 30 days. To be assured consideration, all comments must be received by Oct. 15, 2021.

If you or your organization are interested in learning more about the FDA Breakthrough Devices Program principles and features or actions that you can take during the comment period for the proposed rule to repeal the MCIT and Definition of “Reasonable and Necessary” final rule, please contact one of Dinsmore’s Life Sciences attorneys.