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CMS Delays Rule on Breakthrough Devices …Again.

Recently, the Centers for Medicare & Medicaid Services (CMS) announced another delay of the implementation of the new rule for Medicare Coverage of Innovative Technology (MCIT) and discussed several concerns it had with the new rule, raising doubts that CMS would ever implement the new rule without significant changes.

The new rule, as currently written, provides for four years of national Medicare coverage of innovative medical devices starting on the date of FDA market authorization or a manufacturer chosen date within two years thereafter. The rule was initially published by CMS on January 14, 2021 and was set to take effect in March 2021. However, shortly after the transition to the Biden Administration, CMS delayed the effective date until May 2021 as part of its general freeze of new regulations pending review. On May 14, 2021, CMS announced it would further delay the implementation of the new rule until December 15, 2021.

In the May 2021 announcement of the delay, CMS expressed its concerns with the new rule. Specially, CMS expressed concern that the rule establishes a four-year commitment to Medicare coverage for all breakthrough devices that have a benefit category without a specific requirement that the device demonstrates a health benefit in the Medicare population or that the benefits outweigh harms. CMS expressed a desire for more evidence of benefits to Medicare beneficiaries prior to Medicare coverage of a device.

Similarly, CMS also expressed concern that FDA grants breakthrough designation early in a device’s product lifecycle. CMS indicated that, in general, Medicare patients have more comorbidities and often require additional and higher acuity clinical treatments which may impact the outcomes differently than the usual patients enrolled in early studies. Medicare has also focused on real world data or implementation studies to understand how items and services perform when more broadly used in general practice in the Medicare population. CMS stressed that these considerations are not addressed at the early stage of the device development process at which FDA grants breakthrough designation.

Additionally, CMS worried 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 indicated that if rule goes into effect, the agency believes there could be confusion and disruption stemming from devices receiving approval without a clear path for appropriate coding and payment. Therefore, the delay will allow CMS time to develop a clear understanding of the pathways to coverage, coding, and payment.

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 new developments in healthcare law and regulation. 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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