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 TAVR programs, panelists provided an average 4.33 vote saying there’s evidence that a threshold of SAVR or TAVR procedure volume be required for the principle cardiovascular surgeon, and 4.22 that there’s evidence for procedural volume requirements for structural heart disease procedures for the lead TAVR cardiologist, Medscape reports.

Panelists also considered questions of TAVR heart team requirements to maintain existing programs, and voted 3.33, 4.11 and 3.78 that evidence exists that procedural volumes for the principal cardiovascular surgeon, interventional cardiologist and combined experience of both should be required, according to the report.

Major medtech players Medtronic (NYSE:MDT) and Edwards Lifesciences (NYSE:EW) chimed in on the topic, releasing their own statements.

Medtronic supported the existing framework, but suggested that there isn’t evidence showing a correlation between volume and quantity, while Edwards suggested that measures be more closely tied to quality outcomes than quantity.

“While considering requirements for centers and physicians to deliver quality outcomes, patient access is equally important, and we believe that any coverage policy and patient access decisions need to be supported by high-quality empirical evidence. The evidence that we’ve seen to date does not show a correlation between volume and quality. We do not believe there is sufficient evidence to support significant modifications to the current operator and facility volume requirements in the TAVR NCD at this time. We will continue to collaborate with key stakeholders as the NCD process moves forward, and we are committed to delivering meaningful, evidence-based solutions across the care continuum that provide excellent outcomes for heart valve patients across the globe,” Medtronic structural heart biz chief medical officer Dr. Pieter Kappetein said in a press release.

“Today’s advisory panel meeting provided a review of current and possible future impacts of volume requirements on TAVR centers in the United States.  In the absence of definitive evidence linking high volumes of procedures to high quality outcomes for TAVR patients, we continue to believe the best course of action is to focus on defined quality measures for both new programs and also those continuing to offer this life-saving, less-invasive therapy. Our priority is assuring that all people with heart valve disease have equitable access to all treatment options. The primary risk severe aortic stenosis patients face today does not come from complications during treatment – rather, it comes from not receiving treatment at all.  We believe access to both TAVR and surgical valve replacement procedures should be thoughtfully expanded, based on the needs of the patient community, but restricted to programs that deliver high quality outcomes,” Edwards wrote in a press release.

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