The Centers for Medicare and Medicaid Services (CMS) may extend coverage for artificial hearts and ventricular assist devices (VADs).
Currently, Medicare covers artificial hearts for beneficiaries enrolled in a CMS-approved clinical study, a status that hasn’t been updated since 2008. Artificial heart-maker SynCardia wrote a letter last year to CMS asking it to extend coverage beyond clinical-study use.
Medicare has covered VADs for use after open-heart surgery, as a bridge-to-transplant and as destination therapy for patients not eligible for heart transplantation since 2013. Abbott (NYSE:ABT) also wrote to CMS and asked the agency to expand coverage of VADs, including left ventricular assist devices (LVADs), for for bridge-to-transplant and destination therapy based on scientific evidence generated since its last coverage decision.
If CMS decides to extend coverage for these devices, a number of other companies might benefit as well. Medtronic (NYSE:MDT), for instance, won breakthrough device designation from the FDA for its fully implantable LVAD heart pump in October. It acquired the HeartWare LVAD in 2016.
CMS is taking comments on the letters through March 4, 2020. The proposed coverage determination is due August 3, and the final determination is expected November 1.