Artificial hearts and ventricular assist devices (VADs) are devices which either replace all or part of a human heart or assist the heart in performing its pumping function. Artificial hearts may be used as a permanent replacement for a human heart or as a temporary life-support system until a human heart becomes available for transplant. VADs are used as a temporary method of supporting heart functions.

Ventricular Assist Devices
VADs, when approved by the 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, or incomplete response to, continued vasopressor support.

VADs, with FDA approval, may be considered medically necessary as a bridge to heart transplantation in children when used in accordance with the FDA’s Humanitarian Device Exception (HDE) requirements when all of the following are met:

• Body surface area (BSA) ≥ 0.7 m² and < 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.

Current FDA approved ventricular assist devices for children based on ages are:

• Child under age 5: the Berlin Heart EXCOR® Pediatric Ventricular Assist Device; or
• Child between ages 5 and 16: either the HeartAssist® 5 Pediatric Ventricular Assist Device or the Berlin Heart EXCOR® Pediatric Ventricular Assist Device.

Pediatric VADs are contraindicated and are considered not medically necessary in children who meet any one of the following:

• Have right ventricular failure; or
• Have a blood-clotting (primary coagulopathy) or platelet disorder such as hemophilia or Von Willebrand's disease; or
• Have a known allergy or sensitivity to the blood thinner heparin; 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 FDA approval for a destination therapy indication; and
• Member has New York Heart Association (NYHA) Class III or IV end-stage ventricular heart failure and is not a candidate for heart transplant; and
• Member 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 7 days, or has been IV inotrope dependent for 14 days; and
• Has a left ventricular ejection fraction (LVEF) less than 25%; and
• Has demonstrated functional limitation with a peak oxygen consumption of less than or equal to 14 ml/kg/min, and
• Is at least 18 years of age.

VADs will be considered not medically necessary for any of the following conditions:

• Any medical condition that, if corrected, would improve heart function;
• Any condition that could result in a poor surgical risk;
• Prior cardiac transplant, left ventricular reduction, or cardiomyoplasty;
• Stroke, impaired cognitive function, history of severe cerebral vascular disease;
• Severe end organ damage.

Irreversible left ventricular congestive failure:

• Awaiting a donor heart for transplantation;
• On the hospital's transplant list. 

Percutaneous Ventricular Assist Devices (pVAD)
Percutaneous ventricular assist devices (33990) are intended for partial circulatory support (up to 6 hours for the Impella 2.5 and up to 14 hours for the TandemHeart). The Impella® 2.5 Circulatory Support System or the TandemHeart (CardiacAssist) may be considered medically necessary for short-term stabilization of patients with any of the following indications:

• Cardiogenic shock that is refractory to medications and intra-aortic balloon pump (IABP); or
• Cardiogenic shock, as an alternative to IABP; or
• High-risk patients undergoing invasive cardiac/electrophysiological procedures who need circulatory support; or
• Ongoing acute MI in patients at risk for hemodynamic compromise from un-vascularized severe Coronary Artery Disease (CAD)

Percutaneous ventricular assist devices are considered experimental/investigational for all other indications because of insufficient evidence in the peer-reviewed literature.

The exclusion criteria for the Impella 2.5 and the TandemHeart cardiac assist device are as follows:

• Mechanical aortic valve or heart constrictive device;
• Aortic valve stenosis/calcification (graded as ≥ +2 equivalent to an orifice area of 1.5 cm² or less);
• Moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as ≥ +2);
• Severe peripheral arterial obstructive disease that would preclude device placement

Percutaneous ventricular assist devices are contraindicated for the above exclusion criteria.

The use of non-FDA approved or cleared VAD is considered experimental/investigational and therefore, non-covered.

Total Artificial Hearts
Total artificial heart (TAH) replaces the native ventricles and is attached to the pulmonary artery and aorta; the native heart is typically removed.  TAHs are covered only if they have received approval from the FDA for that purpose, and the TAHs are used in accordance with the following FDA approved usages.

TAHs with FDA-approved devices (e.g., CardioWest Total Artificial Heart) may be considered medically necessary as a bridge to heart transplantation for patients when all of the following are met:

• For patients with biventricular failure who have no other reasonable medical or surgical treatment options; and
• Who are ineligible for other univentricular or biventricular support devices; and
• Currently listed as heart transplantation candidates; and
• Not expected to survive until a donor heart can be obtained.

Any artificial heart and or VADs that do not meet the above coverage criteria will be considered experimental/investigational and therefore non-covered.

The use of total artificial hearts as destination therapy is considered experimental/investigational and therefore non-covered.

The use of non-FDA approved or cleared implantable total artificial hearts is considered experimental/investigational and therefore non-covered.

Contraindications for Bridge-to-Transplant Ventricular Assist Devices and Total Artificial Hearts

• Conditions that would generally exclude patients for heart transplant. Such conditions are chronic irreversible hepatic, renal, or respiratory failure; systemic infection; coagulation disorders, and inadequate psychosocial support. 
• Due to potential problems with adequate function of the VAD or TAH, implantation is also contraindicated in patients with uncorrected valvular disease.

New York Heart Association (NYHA) Classification System:

• Class I. Patients with cardiac disease but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.
• Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
• Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea, or anginal pain.
• Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.