Today, 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 today, Medicare covered artificial hearts under this “coverage with evidence development” standard. The updated coverage policy CMS is announcing today 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). We believe 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.
“CMS is dedicated to improving cardiovascular health in the Medicare population,” said CMS Administrator Seema Verma. “As part of President Trump’s steadfast dedication to strengthening Medicare for our nation’s seniors, CMS is continually updating our policies to ensure that Medicare beneficiaries have access to the latest technology and appropriate evidence-based health care. These coverage changes will give beneficiaries and providers more options as they choose the potentially life-saving treatments most likely to produce good health outcomes.”
The final national coverage determination, which is effective today, 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.
To read the final decision, visit the CMS website at: https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=298
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