CMS rule granting speedy coverage to FDA-designated breakthrough devices delayed again medcitynews.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from medcitynews.com Daily Mail and Mail on Sunday newspapers.
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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 lobby America s Health Insurance Plans, 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.
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Unlike drugs, which are typically covered by CMS immediately upon FDA approval, seniors can t access many FDA approved or cleared medical diagnostics and devices unless they can participate in a clinical study sanctioned by CMS. Those studies can take years requiring additional data and a lengthy regulatory process to determine coverage criteria and keep potentially lifesaving medical interventions from Medicare beneficiaries in the meantime.
A new policy that was set to take effect in mid-March would have allowed seniors and their doctors decide whether or not they need those devices, but it was put on hold along with other pending regulations when the Biden administration took office. The proposed Medicare Coverage of Innovative Technology policy, which was delayed until May 15 pending regulatory review, leverages existing FDA legal authority through the Breakthrough Devices Program to identify a limited number of promising medical technologies and offers those products a shor