1. Medtech Insight
  2. >>Policy & Regulation

Game-Changer? CMS Proposes Rule To Cover Breakthrough Devices On Provisional Basis

The long-awaited proposed rule from the US Medicare agency would allow breakthrough products approved by the FDA to get reimbursed, while manufacturers continue to collect clinical and real-world data.

Idea breakthrough and the power to demolish an obstacle with creative thinking and innovative solutions as a light bulb shaped as a wrecking ball with 3D illustration elements.

In a hotly anticipated decision, the US Centers for Medicare and Medicaid Services has proposed a rule that would give four-year conditioned coverage for breakthrough medical devices and diagnostics. The rule could be a game-changer for an industry that has bemoaned the fact that after products are cleared for market, the CMS is unwilling to reimburse health care providers due to lack of supporting data.

Over the past few years the CMS has repeatedly promised it was on the verge of proposing a rule that would provide immediate coverage for products that are cleared by...

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
Start Free Trial

Already a subscriber?

More from Policy & Regulation

Industry Execs Talk Tariff Turbulence During MD&M East

 
• By Brian Bossetta

During MD&M East in Manhattan last week, a panel of experts discussed how the Trump administration’s trade policy is affecting manufacturing and offered some ideas on what manufacturers can do to help mitigate the chaos.

Commission’s Flora Giorgio Says Simplification And Safety Are Key In Evolving EU Regs

 
• By Amanda Maxwell

Predictability, proportionality, stability, harmonization and simplification offer the right way forward to address the challenging unintended effects of the EU medical device regulations, the European Commission’s head of devices tells the EU’s largest annual medtech conference.

Pathogen Sharing System Part Of Global Pandemic Agreement

 
• By Neena Brizmohun

Now that the landmark Pandemic Agreement has finally been adopted, work will start on drafting a pathogen access and benefit sharing system that will be voluntary for use by drug companies.

FDA Halts Acceptance Of Chinese Lab Data Due To Accuracy Issues

 
• By Elizabeth Orr

The FDA has stopped accepting data from two Chinese labs due to accuracy issues. Mid-Link and SDWH have been flagged for potentially falsified results and other misconduct. This decision, which follows months of discussions and warnings, emphasizes the FDA's commitment to ensuring data integrity in medical device submissions.

More from Medtech Insight

Commission’s Flora Giorgio Says Simplification And Safety Are Key In Evolving EU Regs

 
• By Amanda Maxwell

Predictability, proportionality, stability, harmonization and simplification offer the right way forward to address the challenging unintended effects of the EU medical device regulations, the European Commission’s head of devices tells the EU’s largest annual medtech conference.

German Bionic Launches ‘Strongest Exoskeleton To Date’

 
• By Natasha Barrow

German Bionic’s new exoskeleton Exia helps healthcare practitioners, nurses, and other caregivers to lift and move patients by supporting muscle movement and reducing the risk of injury.

Medtronic Eyes Up to $350M Tariff Hit in FY26, Leans On Cost Controls And Pricing Strategy

 
• By Shubham Singh

Medtronic expects operating profit to grow approximately 7% in fiscal 2026, excluding tariff impacts. If tariffs materialize at the upper end of the projected range, operating profit growth could drop by 2.2 to 3.2 percentage points.