Ventricular Assist Devices

Medicare nationally covers FDA-approved VADs for post-cardiotomy support and FDA-approved LVADs for short- or long-term mechanical circulatory support in carefully defined advanced heart failure patients (NYHA Class IV with LVEF ≤25% plus hemodynamic and treatment-failure criteria). Coverage requires documented trials of optimal medical management or specified dependence on temporary mechanical support, management by a credentialed on-site multidisciplinary VAD team (including an implanting surgeon with ≥10 LVAD implants in the prior 36 months), and facility credentialing by a CMS-approved organization; all other uses are non-covered except in certain clinical trial contexts.

"VADs used for post-cardiotomy circulatory support are covered only if the device is FDA-approved for post-cardiotomy use and used according to FDA-approved labeling."

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