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Medicare coverage of artificial hearts and ventricular assist devices (VADs) has been granted some greater flexibility.
The Centers for Medicare and Medicaid Services (CMS) finalized updates to artificial heart and VAD Medicare coverage on December 1 and ended a key requirement that was blocking these devices from broader coverage.
Before the December 2020 update from the CMS, Medicare did cover experimental or investigational items or services except when provided in the context of a clinical trial or with the collection of additional clinical data.
The updated policy removes that requirement and will now allow artificial hearts to fall under the more standard coverage determination process in which decisions are made by local Medicare Administrative Contractors (MACs). MACs consider a beneficiary’s clinical circumstances to determine which patients will most benefit from an artificial heart.
VAD Medicare coverage criteria will now better align with current medical practice while allowing patients and providers to choose the best treatment for them.
The updated policy became effective Dec. 2.
“CMS is dedicated to improving cardiovascular health in the Medicare population. 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 potentially life-saving treatments most likely to produce good health outcomes.” – CMS Administrator Seema Verma1
A ventricular assist device, or “mechanical circulatory support device,” is a mechanical pump that helps pump blood from the lower chambers (ventricles) of the heart to the rest of the body. VADs are often used in people who have weakened hearts or heart failure.
Artificial hearts replace the right and left ventricles along with the four heart valves and are used in place of the human heart.
1 CMS. (Dec. 1, 2020). CMS Updates Coverage Policies for Artificial Hearts and Ventricular Assist Devices (VADs) [press release]. Retrieved from www.cms.gov/newsroom/press-releases/cms-updates-coverage-policies-artificial-hearts-and-ventricular-assist-devices-vads.