1. Medtech Insight
  2. >>Policy & Regulation

CMS Is Taking Another Look At Its TAVR Coverage Rules

 
• By Reed Miller

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...

More from Policy & Regulation

More from Medtech Insight

SAGA Diagnostics Launches Early Breast Cancer MRD Detection Test In US

 
• By Natasha Barrow

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 Shubham Singh

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.

FDA Rebukes Four Companies, Including One Overseas, For Procedural Failures

 
• By Brian Bossetta

The US FDA’s device center sent warning letters to three domestic device manufacturers and one German firm for failing to adhere to protocol on several issues.