CMS Is Taking Another Look At Its TAVR Coverage Rules

The US Medicare agency opened a national coverage determination for transcatheter aortic valve replacement at the request of three California physicians who argue that the current limitations on which centers can perform TAVR unnecessarily prevent lower-volume hospitals from providing the procedure as a less invasive option to open surgery.

Core Valve In Situ
Medtronic's CoreValve Transcatheter Aortic Valve Replacement • Source: Medtronic

The US Centers for Medicare & Medicaid Services opened a Medicare national coverage analysis for transcatheter aortic valve replacement in response to a request from physicians who believe the procedural volume requirements for heart teams and hospitals in the current coverage policy are too restrictive.

The current national coverage determination policy for TAVR (NCD 20.32) has been in place since 2012. It is a coverage-with-evidence-development (CED) policy that provides Medicare coverage for TAVR procedures 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 Policy & Regulation

DeepLook AI Imaging Provides A Deeper Look At Dense Breast

DeepLook Medical recently announced the commercial rollout of DL Precise, an AI-powered imaging platform that enhances breast cancer screening, at major healthcare institutions across the US.

First AI Breast Cancer Prediction Platform Receives FDA Authorization

 

Clairity’s "first-in-class" mammography-based AI screening tool, Clairity Breast, provides "equitable risk assessments," expanding access to lifesaving early detection for breast cancer, said company founder Connie Lehman.

Final Curtain For LDTs? FDA Will Not Appeal District Court Decision To Vacate Final Rule

 

The US FDA has given up on its effort to regulate lab-developed tests as medical devices, at least for now. The agency will not appeal a decision from the Eastern District of Texas that tossed out the FDA’s final rule, leaving the agency with few cards.

Abbott Announces FDA Approval Of Tendyne Transcatheter Mitral Valve Replacement System

 
• By 

Abbott received the US FDA nod for its Tendyne system, offering a minimally invasive alternative to replace the valves of patients with severe mitral valve disease who are at risk for open-heart surgery.

More from Medtech Insight

Abbott Announces FDA Approval Of Tendyne Transcatheter Mitral Valve Replacement System

 
• By 

Abbott received the US FDA nod for its Tendyne system, offering a minimally invasive alternative to replace the valves of patients with severe mitral valve disease who are at risk for open-heart surgery.

SAGA Diagnostics Launches Early Breast Cancer MRD Detection Test In US

 

SAGA Diagnostics has launched its breast cancer residual and recurrence detection test – Pathlight – in the US. The test’s ultrahigh sensitivity and specificity is rare to see in oncology, the company claimed.

Siemens Healthineers Widens FY25 EPS Range By €0.15 To Absorb Up To €300M In Tariff Costs

 
• By 

The imaging, Varian, and advanced therapies segments – which are more reliant on equipment sales – are more heavily affected, with tariffs applying to roughly 55% of their revenue base. In diagnostics, the company expects minimal exposure due to sufficient US value-added manufacturing.