CMS Proposes More Flexible Requirements For Centers Performing TAVR

A proposed update to the 2012 National Coverage Policy for transcatheter aortic valve replacement (TAVR) would make it easier for hospitals to begin a TAVR program while slightly raising the procedure-volume requirements for maintaining a continuing TAVR program. The agency believes the new rules would balance the need to expand patient access to TAVR while ensuring the quality and safety of TAVR procedures covered by Medicare.

Edwards' Sapien TAVR system • Source: Edwards Lifesciences

The US Centers for Medicare & Medicaid Services (CMS)’s proposed update to the national coverage determination (NCD) for transcatheter aortic valve replacement (TAVR) would make the policy's procedure-volume requirements for starting a TAVR program more flexible.

“Our proposed modifications to the hospital and heart team operator volume requirements reflect our intent to strike a balance between...

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 Policy & Regulation

International Reliance Gets UK MHRA OK In Drive For Agile Pre-Market Regulation – CE Marking Next

 
• By 

UK government’s response to MHRA public consultation on risk proportionate device routes to market and physical UKCA markings adds momentum to drive for modern, agile system. Another consultation in late 2025 will propose indefinite recognition of CE-marked devices in Great Britain.

Expert Panels Remain Tough On Manufacturers And Their Notified Bodies

 

The EU’s extra layer of checks on clinical evidence is proving a difficult, and sometimes humiliating process, for many device companies whose products have come under the spotlight.

FDA Document Request Denied As Case Against SurModics Merger Intensifies

 
• By 

A federal court in Illinois ruled against SurModics and BC Holdings' request for FDA documents to support a proposed merger. The FTC has challenged the merger, claiming it threatens competition in hydrophilic device coatings. The ruling may indicate the FTC is likely to succeed.

A Passport To Streamlined Medtech Access Under UK Life Sciences Plan

 
• By 

An “NHS Innovator Passport” that allows quicker uptake of proven technologies across the national healthcare provider is one of the wins the UK government is looking to score from its new Life Sciences Sector plan. The plan majors on prevention. The medtech industry has given it a cautious welcome.

More from Medtech Insight

Rising Oncology Start-ups Recognized For Breakthrough Cancer Research

 

The Cancer Research Horizons Innovation Awards took place on July 10. Medtech Insight spoke to nominees for the women’s entrepreneur of the year award: Mireia Crispin-Ortuzar, CEO of 52 North Health; Anita Grigoriadis, CEO of PharosAI; and Maria Giovanna Lizio, Founder of WILD-Imaging Technology.

HeartFlow Takes Another Crack At Public Markets With $100M IPO Filing

 
• By 

AI heart imaging company HeartFlow filed for a $100m IPO after scrapping its 2022 SPAC plans. It remains unprofitable but is betting on FDA clearances, Medicare coverage and a demand for AI-powered diagnostics to win over investors.

FDA Document Request Denied As Case Against SurModics Merger Intensifies

 
• By 

A federal court in Illinois ruled against SurModics and BC Holdings' request for FDA documents to support a proposed merger. The FTC has challenged the merger, claiming it threatens competition in hydrophilic device coatings. The ruling may indicate the FTC is likely to succeed.