VADs, that are approved by the United States Food and Drug Administration (U.S. FDA) for that purpose (e.g., HeartMate III LVAD, HeartWare HVAD), may be considered medically necessary when ANY ONE of the following are met:
- Postcardiotomy ventricular dysfunction; or
- Treatment of right heart failure following insertion of an implantable left ventricular device; or
- Treatment of cardiogenic shock following cardiac transplantation.
VADs used as a bridge to transplant may be considered medically necessary when ALL the following are met:
- Candidate for cardiac transplantation; and
- Imminent risk of dying before donor heart procurement; and
- Dependence on, continued vasopressor support.
U.S. FDA approved VADs may be considered medically necessary as a bridge to heart transplantation in children when used in accordance with the U.S. FDA’s Humanitarian Device Exception (HDE) requirements when ALL of the following are met:
- Body surface area (BSA) greater than or equal to 0.7 m2 and less than 1.5 m2; and
- In NYHA Class IV end-stage (i.e., left ventricular) heart failure refractory to medical therapy; and
- Listed candidate for cardiac transplantation; and
- An age appropriate VAD will be used until a donor heart can be obtained.
Treatment is allowed with any U.S. FDA approved device for children based on ages listed below as follows:
- Child under age five (5): the Berlin Heart EXCOR® Pediatric Ventricular Assist Device; or
- Child between ages five (5) and 16: either the 5 Pediatric Ventricular Assist Device or the Berlin Heart EXCOR® Pediatric Ventricular Assist Device.
U.S. FDA approved VAD’s for children may be considered medically necessary as a bridge to heart transplantation include the following indications but not limited to:
- Acute or chronic cardiac insufficiency due to various medical conditions such as an equivalent to recovery or transplantation for ANY of the following indications:
- Myocarditis; or
- Cardiomyopathy; or
- NYHA class III or IV congenital heart failure that cannot be treated with conservative methods.
Pediatric VADs not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore, non-covered, because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature in children who meet ANY of the following criteria:
- Have a blood-clotting (primary coagulopathy) or platelet disorder such as hemophilia or Von Willebrand's disease; or
- Have anatomical anomalies that would prevent surgical connection of the outflow graft to the ascending aorta.
VADs used as destination therapy may be considered medically necessary when ALL the following are met:
- The device has received U.S. FDA approval for a destination therapy indication; and
- Individual has New York Heart Association (NYHA) Class III or IV end-stage ventricular heart failure and is not a candidate for heart transplant; and
- Individual has failed to respond to optimal medical management (including beta-blockers, and angiotensin-converting enzyme (ACE) inhibitors if tolerated) for at least 45 of the last 60 days, or has been balloon pump dependent for seven (7) days, or has been IV inotrope dependent for 14 days; and
- Has a left ventricular ejection fraction (LVEF) less than 25 percent; and
- Has demonstrated functional limitation with a peak oxygen consumption of less than or equal to 14 ml/kg/min.
VADS not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore, non-covered, because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature for ANY of the following:
- Any medical condition that, if corrected, would improve heart function; or
- Any condition that could result in a poor surgical risk; or
- Stroke, impaired cognitive function, history of severe cerebral vascular disease; or
- Severe end organ damage.