CMS updates coverage policies for artificial hearts and ventricular assist devices

Dec. 3, 2020

The Centers for Medicare & Medicaid Services (CMS) finalized updates to Medicare coverage policies for artificial hearts and ventricular assist devices (VADs), both of which are used to treat patients with life-threatening advanced heart failure.

While Medicare generally does not cover experimental or investigational items and services, the program has historically allowed for coverage of certain interventions when they are provided in the context of an approved clinical study or with the collection of additional clinical data. This process can allow for earlier beneficiary access to innovative treatments and technology while additional data is collected.

Prior to this update, Medicare covered artificial hearts under this “coverage with evidence development” standard. The updated coverage policy CMS is announcing will end this requirement for artificial hearts and instead allow for the more standard coverage determination process where coverage decisions are made by local Medicare Administrative Contractors (MACs). The agency believes this final decision is in the best interest of Medicare beneficiaries since careful patient selection is important, and the MACs are structured to take into account a beneficiary’s particular clinical circumstances to determine which patients will benefit from receiving an artificial heart.

Although a small number of Medicare beneficiaries receive artificial hearts, the technology can save the lives of certain end-stage heart failure patients awaiting heart transplantation.    

The final national coverage determination also provides updated coverage criteria for VADs that better aligns with current medical practice and that we believe will expand coverage to a greater number of candidates who are likely to benefit from this technology. Specifically, the updated patient criteria in the NCD aligns with the inclusion criteria derived from recent large randomized controlled trials, which demonstrated improved patient outcomes.

CMS has the release.