Medicare reimbursement for total artificial hearts and ventricular assist devices (VADs) is now broadened under a final national coverage decision (NCD) issued Tuesday.
The Centers for Medicare and Medicaid Services (CMS) followed through with changes to previous requirements proposed in August with few alterations.
The new rules for artificial hearts removed the “coverage with evidence development” designation that had mandated clinical trial enrollment as a condition for reimbursement. They also shifted the coverage determinations for these biventricular replacement devices to the Medicare administrative contractors (MACs).
Comments submitted during the public comment period in many cases “expressed concerns that removing the NCD for artificial hearts would create inconsistent coverage, and could delay or limit access of a time-sensitive procedure for Medicare beneficiaries,” the decision document noted.
However, it argued that the limited evidence available for such a low volume procedure precluded setting national criteria for coverage of total artificial heart implantation. Rather, MACs can look at an individual’s particular clinical circumstances. This strategy shouldn’t limit or delay implantation but “will lead to greater access to artificial hearts under this expansion of coverage,” CMS projected.
For VADs, the major change to coverage was removal of the distinction in therapeutic intent, building in particular on the MOMENTUM 3 trial showing benefits irrespective of bridge-to-transplant or destination therapy.
The update eliminated the rule that bridge-to-transplant patients have to be on the transplant waitlist maintained by the Organ Procurement and Transplantation Network. It extended the prior destination therapy criteria to all left ventricular assist devices whether for short-term bridging or long-term destination therapy.
Also, implanting sites no longer need written permission from the Medicare-approved transplant center before VAD implantation when the two sites aren’t the same.
The NCD didn’t apply to temporary VADs or extracorporeal membrane oxygenation.
Currently marketed products affected by the NCD include SynCardia Systems’s CardioWest temporary Total Artificial Heart and three VADs: Abbott’s HeartMate II and HeartMate 3 devices and the Medtronic HeartWare HVAD.