Medicare mulls broadening heart pump reimbursement

Changes to Medicare reimbursement that could increase sales of artificial hearts and ventricular assist devices are in the offing, and a smaller company could benefit alongside the cardio behemoths Medtronic and Abbott. The CMS, responding to requests made by Abbott and the artificial heart maker Syncardia, has proposed two changes, one of which is to lift the current “coverage with evidence development” requirement for artificial hearts. Currently Syncardia’s artificial heart, the only one approved in the US, is only covered by Medicare when recipients are enrolled in a clinical trial; covering patients who do not meet trial enrolment criteria would allow many more to receive the device. Separately the CMS is considering getting rid of the separate indications for which the implanted heart pumps called ventricular assist devices are approved. Currently they may be used as a bridge to transplant in patients awaiting a donor heart, or as destination therapy – permanent implants – in patients too ill to undergo heart transplant. Removing these distinctions would abrogate the need to assess a patient’s suitability for transplant, a time-consuming process that can act as a barrier to uptake. The final decisions will take effect in November.

Selected artificial hearts and VADs
Company Device Type of device Status
Abbott Heartmate 3 Ventricular assist device  Approved in US for BTT and DT
Medtronic Heartware Ventricular assist device  Approved in US for BTT and DT
Syncardia Total Artificial Heart Artificial heart Approved in US 
Jarvik Heart Jarvik 2000 Ventricular assist device  In pivotal US trial for DT
Carmat Unnamed Artificial heart In pivotal European trial for BTT; no US trials yet
BTT=bridge to transplant; DT=destination therapy. Source: EvaluateMedTech & company websites.

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