National Coverage Analysis (NCA) Tracking Sheet for Ventricular Assist Devices for Bridge-to-Transplant and Destination Therapy (CAG-00432R)
Ventricular assist devices (VADs) or left ventricular assist devices (LVADs) are mechanical blood pumps that are surgically attached to one or both intact ventricles of a damaged or weakened native heart to assist in pumping blood.
VAD coverage requirements are addressed in section 20.9 of the Medicare National Coverage Determination (NCD) Manual (Pub. 100-03) entitled National Coverage Determination (NCD) for Artificial Hearts and Related Devices. Medicare covers VADs for three indications: postcardiotomy (after open-heart surgery); bridge-to-transplant (while patients await heart transplantation) and destination therapy (for patients not eligible for heart transplantation.)
Det Norske Veritas Healthcare, Inc. (DNV) has formally requested a reconsideration of the NCD to include the DNV Mechanical Circulatory Support Certification Program as an acceptable credential for facilities qualifying under this NCD. On November 14, 2012 we convened a Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) meeting to review available evidence on the management of heart failure with the use of VADs including the role, if any, of facility VAD-specific certification. In response to this reconsideration request and the recommendations of the MEDCAC panel, CMS is opening this reconsideration. The scope of our review does not include non-durable devices that are intended for temporary in-hospital use.
VAD coverage requirements are addressed in section 20.9 of the Medicare National Coverage Determination (NCD) Manual (Pub. 100-03) entitled National Coverage Determination (NCD) for Artificial Hearts and Related Devices. Medicare covers VADs for three indications: postcardiotomy (after open-heart surgery); bridge-to-transplant (while patients await heart transplantation) and destination therapy (for patients not eligible for heart transplantation.)
Det Norske Veritas Healthcare, Inc. (DNV) has formally requested a reconsideration of the NCD to include the DNV Mechanical Circulatory Support Certification Program as an acceptable credential for facilities qualifying under this NCD. On November 14, 2012 we convened a Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) meeting to review available evidence on the management of heart failure with the use of VADs including the role, if any, of facility VAD-specific certification. In response to this reconsideration request and the recommendations of the MEDCAC panel, CMS is opening this reconsideration. The scope of our review does not include non-durable devices that are intended for temporary in-hospital use.
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