CMS Kicks Can Down Road By Pushing MCIT Breakthrough Devices Rule To Dec. 15. Here’s Why

In a move that will undoubtedly ruffle industry feathers, the US Medicare agency on 14 May issued a final rule that moves implementation of the Medicare Coverage of Innovative Technology rule to the end of the year.

Kicking a can down the road.

In a move that will undoubtedly ruffle industry feathers, the US Centers for Medicare and Medicaid Services (CMS) on 14 May issued a final rule that punts implementation of the Medicare Coverage of Innovative Technology (MCIT) regulation to 15 December.

“We do not believe that it is in the best interest of Medicare beneficiaries for the [MCIT] final rule to...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Regulation

Environmental Group Questions FDA’s Stance On PFAS In Medical Devices

 

The US FDA says PFAS used in medical devices are safe and that there’s no reason to restrict them in device production. An environmental group finds the agency’s assertion questionable.

EU4Health Boost For Orphan Devices And SMEs

 
• By 

EU4Health, the main funding instrument for EU health initiatives, has put renewed emphasis on orphan devices in its 2025 work program, published in July.

PathAI Talks PCCPs: ‘Accelerated Software Updates, Saves Time And Money’

 

The US FDA has authorized around 107 devices with Predetermined Change Control Plans in place, with PathAI's AISight Dx digital pathology image management system one of the latest. Medtech Insight talks to Eric Walk, chief medical officer, to find out about the process and its benefits.

Scores Of Companies On Board With Medicare Data Interoperability And Digital Health Initiative

 

The Centers for Medicare and Medicaid Services has launched a new program the agency says will allow patients easier access to their health data. More than 60 companies have already signed on.

More from Policy & Regulation

Injuries And Deaths Linked To Boston Scientific Cardiac Devices. Company Responds

 

The US FDA issued a pair of early alerts on Wednesday warning customers about serious adverse events associated with two Boston Scientific cardiac devices. Both alerts include numerous reports of injuries and deaths and are part of the FDA’s ongoing pilot to enhance its recall process.

PathAI Talks PCCPs: ‘Accelerated Software Updates, Saves Time And Money’

 

The US FDA has authorized around 107 devices with Predetermined Change Control Plans in place, with PathAI's AISight Dx digital pathology image management system one of the latest. Medtech Insight talks to Eric Walk, chief medical officer, to find out about the process and its benefits.

Trump Taps Food And Drug Law Outsider For FDA Chief Counsel

 

Sean Keveney is largely unknown in the FDA law space, but likely is familiar and connected to the White House given his work on Trump’s antisemitism taskforce.