CMS Fields Many Suggestions And Criticisms On Proposed VAD Policy
Several stakeholders are still pushing CMS to recognize “bridge-to-decision” heart failure patients who may eventually be suitable for a heart transplant but are not so at the time they receive a ventricular assist device.
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The current two-indication system for approving and covering left-ventricular assist devices does not reflect the reality of heart failure patients receiving these devices, according to transplant surgeons.
With only two companies, Thoratec and HeartWare International, selling LVADs in the US, clinical data along with sales and product pipeline strategies have become paramount for capturing market share – and expanding the market to treat a wide range of class III heart failure patients.
CMS does not currently have a national coverage determination process open on ventricular assist devices for heart failure, though the agency may open a new one, an agency official said.