Medicare panel meeting highlights concerns about gaps in LVAD research

November 30, 2012 by MassDevice staff

A November panel meeting at the Centers for Medicare & Medicaid Services highlights the agency's concerns about gap in evidentiary research supporting ventricular assist devices.

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At a meeting of the Centers for Medicare & Medicaid Services surveyed members agreed almost universally that there are clinically significant gaps in research regarding ventricular assist devices.

The panelists gathered earlier this month to review coverage decision for VADs, which is currently provided for heart failure patients after open-heart surgery, as a bridge to heart transplant and as a destination therapy.

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The panel was tasked with discussing and answering 4 questions:

  1. How confident are you that there is adequate evidence that specific patient criteria can be used to prospectively identify clinically meaningful changes in the health outcomes listed above (improved, equivalent or worsened) that are likely to be experienced by patients who receive a VAD in addition to optimal medical therapy compared with optimal medical therapy alone?
  2. How confident are you that there is adequate evidence that one or more facility and/or operator characteristics predict clinically meaningful improvements in the health outcomes listed above for patients who receive a VAD in addition to optimal medical therapy compared with optimal medical therapy alone?
  3. How confident are you that these conclusions are generalizable to the Medicare beneficiary population?
  4. How confident are you that clinically significant evidentiary gaps remain regarding the use of VADs?

The element panelists agreed with most was the lack of sufficient evidence regarding use of VADs, which the members gave an average of 4.85 out of 5 points of confidence.

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