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Artificial Hearts and Ventricular Assist Devices

Section: Surgery
Effective Date: March 01, 2020
Last Reviewed: January 22, 2020

Description

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 method of supporting heart functions.

Criteria

VADs


VADs, that are approved by the United States Food and Drug Administration (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.

FDA approved VADs 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) greater than or equal to 0.7 m2 and less than 1.5 m2and
  • 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.

FDA approved VADs for children based on ages are:

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

Pediatric VADs are contraindicated and are 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 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
  • 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 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 are considered experimental/investigational for ANY ONE of the following conditions and therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature:

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

Procedure Codes

33975 33976 33977 33978 33979 33980 33981
33982 33983 93750

Percutaneous Ventricular Assist Devices (pVAD)

FDA approved pVADs are intended for partial circulatory support (The Impella® circulatory support system devices or the TandemHeart® (cardiac assist device may be considered medically necessary for short-term stabilization of individuals 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 individuals undergoing invasive cardiac/electrophysiological procedures who need circulatory support; or
  • Ongoing acute myocardial infarction (MI) in individuals at risk for hemodynamic compromise from un-vascularized severe Coronary Artery Disease (CAD)

pVADs are considered experimental/investigational for all other indications and therefore, non-covered because the safety and and/or effectiveness of this service cannot be established by the available published peer-reviewed literature:

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

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

pVADs are contraindicated for the above exclusion criteria.

The use of non-FDA approved or cleared pVADs 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.

Procedure Codes

33990 33991 33992 33993 33999

Total Artificial Hearts (TAHs)

TAHs replace 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.

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

  • For individuals 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.

TAHs that do not meet the above coverage criteria will be 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.

The use of TAHs as destination therapy 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.

The use of non-FDA approved or cleared implantable TAHs 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.

Procedure Codes

33927 33928 33929 L8698

Note: The following are contraindications for bridge-to-transplant VADs and TAHs:

  • Conditions that may exclude individuals for heart transplant:
  • chronic irreversible hepatic, renal, or respiratory failure; or
  • systemic infection; or
  • coagulation disorders; or
  • inadequate psychosocial support
  • uncorrected valvular disease

New York Heart Association (NYHA) Classification System:

  • Class I. Individuals 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. Individuals 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. Individuals 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. Individuals 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.

Diagnosis Codes

I09.81 I11.0 I13.0 I13.2 I20.0 I21.3 I21.4
I21.01 I21.02 I21.09 I21.11 I21.19 I21.21 I21.29
I21.9 I21.A1 I21.A9 I22.0 I22.1 I22.2 I22.8
I22.9 I24.0 I24.1 I24.8 I24.9 I25.10 I25.110
I25.111 I25.118 I25.119 I25.5 I25.6 I25.89 I25.9
I25.700 I25.701 I25.708 I25.709 I25.710 I25.711 I25.718
I25.719 I25.720 I25.721 I25.728 I25.729 I25.730 I25.731
I25.738 I25.739 I25.750 I25.751 I25.758 I25.759 I25.760
I25.761 I25.768 I25.769 I25.790 I25.791 I25.798 I25.799
I25.810 I25.811 I25.812 I34.0 I34.1 I34.2 I34.8
I34.9 I35.0 I35.1 I35.2 I35.8 I35.9 I36.0
I36.1 I36.2 I36.8 I36.9 I37.0 I37.1 I37.2
I37.8 I37.9 I42.0 I42.1 I42.2 I42.5 I42.7
I42.8 I42.9 I43 I46.2 I46.8 I46.9 I47.0
I47.1 I47.2 I47.9 I48.0 I49.01 I49.02 I49.1
I49.2 I49.3 I49.40 I49.49 I49.5 I49.8 I49.9
I50.1 I50.9 I50.20 I50.21 I50.22 I50.23 I50.30
I50.31 I50.32 I50.33 I50.40 I50.41 I50.42 I50.43
I50.810 I50.811 I50.812 I50.813 I50.814 I50.82 I50.83
I50.84 I50.89 I51.4 I97.0 I97.110 I97.111 I97.120
I97.121 I97.130 I97.131 I97.190 I97.191 I97.710 I97.711
I97.790 I97.791 M32.11 Q20.0 Q20.1 Q20.2 Q20.3
Q20.4 Q20.5 Q20.6 Q20.8 Q20.9 Q21.0 Q21.1
Q21.2 Q21.3 Q21.4 Q21.8 Q21.9 Q22.0 Q22.1
Q22.2 Q22.3 Q22.4 Q22.5 Q22.6 Q22.8 Q22.9
Q23.0 Q23.1 Q23.2 Q23.3 Q23.4 Q23.8 Q23.9
Q24.0 Q24.1 Q24.2 Q24.3 Q24.4 Q24.5 Q24.6
Q24.8 Q24.9 R00.1 R57.0 T82.817A T82.827A T82.837A
T82.847A T82.857A T82.867A T82.897A T82.9XXA T86.20 T86.21
T86.22 T86.23 T86.290 T86.298 T86.30 T86.31 T86.32
T86.33 T86.39 Z48.21 Z48.280 Z76.82 Z94.1 Z94.3
Z95.811 Z95.812 Z95.818

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