CMS again delays breakthrough device payment rule in nod to skeptics – MedTech Dive

Dive Brief:

  • CMS has delayed implementation of its contentious breakthrough payment rule until December 15 depriving the medtech industry, at least for now, of a policy once hailed as a “significant” tailwind.

  • The Medicare Coverage of Innovative Technology initiative would give breakthrough devices Medicare reimbursement automatically on the day they are approved or cleared by FDA.

  • Medtech manufacturers pushed for MCIT but high-profile detractors such as health insurance trade group AHIP as well as some doctor groups drove CMS to delay implementation. The agency said it shares concerns that MCIT “could be problematic in ensuring these devices are demonstrating value and do not have additional risks for Medicare beneficiaries.”

Dive Insight:

MCIT was part of a batch of changes proposed in the final days of the Trump administration temporarily put on hold when President Joe Biden took office. That initial 60-day delay reset the start date to May 15. However, as the date neared, criticism flared and analysts at Cowen predicted CMS would again delay the rule to address the concerns.

The second, longer delay to the implementation of MCIT comes after CMS reviewed feedback on the draft plans. CMS took the action after concluding it does not believe “it is in the best interest of Medicare beneficiaries” for the rule to take effect on May 15 and citing multiple shortcomings of MCIT to make its case.  

“Under the current rule, there [is] no requirement for evidence that MCIT devices will specifically benefit the Medicare target population. Additionally, the
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