1. Medtech Insight
  2. >>Policy & Regulation

Breakthrough Devices To Get Special US Medicare Reimbursement Under CMS Proposal

 
• By Sue Darcey

The US Centers for Medicare and Medicaid Services plans to automatically allow reimbursement and up to 65% new technology add-on payments for US FDA-approved, -cleared or de novo devices in the agency's Breakthrough Devices Program. Industry groups, including the Medical Device Manufacturers Association and AdvaMed, have been pushing CMS for such coverage for several years.

CMS is proposing to provide coverage of FDA breakthrough devices

For the first time, US FDA breakthrough devices would be granted Medicare reimbursement by the Centers for Medicare and Medicaid Services without first meeting CMS' “substantial clinical improvement” requirements when compared to existing devices it already reimburses.

Industry groups have long called for CMS to permit such reimbursements. (Also see "CMS Actively Looking For New Reimbursement...

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

NHS Orders Halt On Unapproved AI Scribes, Vendors Rush To Self-Certify

 
• By Natasha Barrow

The NHS England chief clinical information officer issued a cease and desist on unapproved ambient voice technology and AI scribes. The move caused confusion among AVT vendors and went beyond joint MHRA/NHS guidance. IMed consultant Ben Austin shares his perspective.

EU/US Trade Deal Raises Questions For Medtech

 
• By Amanda Maxwell

There is still no clarity on how life sciences will be treated in the final agreement.

NICE To Consult On UK Late-Stage Healthtech Assessments

 
• By Ashley Yeo

NICE’s three-pronged lifecycle approach to healthtech evaluations includes late-stage assessments (LSA), which will be the focus of a short consultation in August.

FDA ‘Regulatory Accelerator’ Aims To Speed Digital Health Development

 
• By Elizabeth Orr

The US FDA has launched the Regulatory Accelerator to expedite digital health product development. This includes resources like a Resource Index for Innovators, a Medical Device Software Guidance Navigator, and best practices for early meetings.

More from Medtech Insight

EU/US Trade Deal Raises Questions For Medtech

 
• By Amanda Maxwell

There is still no clarity on how life sciences will be treated in the final agreement.

NICE To Consult On UK Late-Stage Healthtech Assessments

 
• By Ashley Yeo

NICE’s three-pronged lifecycle approach to healthtech evaluations includes late-stage assessments (LSA), which will be the focus of a short consultation in August.

Roche Diagnostics Growth Flattens As China Reforms Bite; Bets On US Manufacturing, CGM For Growth

 
• By Shubham Singh

Roche has taken steps to mitigate potential tariff exposure that include shifting inventories and increasing US production of medicines. The company also initiated a tech transfer for one of its most exposed products to a US manufacturing site.