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CMS Proposes Repeal of Breakthrough Devices Medicare Coverage Rule

The Centers for Medicare & Medicaid Services (CMS) recently announced a proposal to repeal the Medicare Coverage of Innovative Technology (MCIT) rule that has been delayed several times. The latest news in the MCIT saga comes from a CMS announcement expressing concerns with the final rule, specifically that it will require more time for adequate implementation.

The final rule was implemented to reduce the time it takes for FDA-approved medical technology to become covered under Medicare. The MCIT would reduce these wait times by granting Medicare coverage to breakthrough devices immediately after receiving FDA approval. The FDA designates medical devices as “breakthrough devices” when they are shown to be more effective at diagnosing or treating serious diseases than the currently available devices. This designation allows these devices to have reduced development, assessment, and review timelines.

However, CMS announced reservations about the final rule and has proposed changes. CMS’s primary concern is that the final MCIT is not acting in Medicare recipients’ best interest because it could provide coverage for breakthrough devices that are not reasonable and necessary to treat Medicare recipients’ diseases or conditions. This concern stems from the current guidelines for clinical trials for medical devices. Specifically, the FDA does not require Medicare recipients to be included in clinical trials for medical devices. Since Medicare recipients generally have more comorbidities than the general population, the clinical trials may not accurately reflect Medicare patient outcomes. CMS has also expressed concern that the final rule takes away its tools to deny coverage when it becomes apparent that a particular device can be harmful to the Medicare population. If the rule goes into effect, and a device approved under it is later found to be harmful to Medicare recipients, CMS would be limited in the actions it could take to withdraw or modify coverage. Lastly, CMS believes there could be confusion and disruption stemming from devices receiving approval without a clear path for appropriate coding and payment.

Ultimately, CMS is proposing a complete repeal of the MCIT final rule but has also acknowledged the need to expedite access to breakthrough medical devices and indicated the agency believes that there are other avenues to achieve this through existing regulations. Stakeholders are invited to comment on the proposed repeal and may do so before October 15, 2021.

For over 35 years, Wachler & Associates has represented healthcare providers and suppliers nationwide in a variety of health law matters, and our attorneys can assist providers and suppliers in understanding conditions of Medicare coverage. If you or your healthcare entity has any questions pertaining to healthcare compliance, please contact an experienced healthcare attorney at 248-544-0888 or

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