CMS panel votes on volume requirements for TAVR centers

The Center for Medicare and Medicaid Services’ Medicare Evidence Development and Coverage Advisory Committee this week opened itself to comments and voted on volume requirements for new and existing transcatheter aortic valve replacement programs and operators.
Panelists heard data from individuals across the healthcare spectrum, and ended up voting in the middle on most of the issues, according to a Medscape report.
Voting was done on a one-to-five scale of confidence, with five showing high confidence in the resolution, according to the report.
On considering hospitals with no TAVR experience opening new programs, panelists voted an average 3.78 in support of there being sufficient evidence that a specific threshold of SAVR procedural volumes should be required, 3.44 that there is sufficient evidence that a specific threshold of PCI procedural volume should be required and 3.11 that benefits of meeting SAVR or PCI volume to start a new program outweighed the harms of limiting such programs, according to Medscape.
On considering hospital requirements for maintaining existing TAVR programs, panelists voted on average of 3.56 that there is sufficient evidence for SAVR procedural volume requirements and 3.33 that there’s sufficient evidence for PCI procedural volume requirements. Panelists also voted an average of 3.67 that benefits of those requirements outweighed the harms of limiting TAVR access, according to the report.
On the topic of operator requirements to begin new...

Source: Mass Device - July 27, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Regulatory/Compliance Replacement Heart Valves Centers for Medicare and Medicaid Services (CMS) Source Type: news