BVS 5000

The implantation and removal of the biventricular assist device known as the BVS 5000 is covered when used as a single ventricular (33975, 33977, 33979, 33980) or biventricular device (33976, 33978) in accordance with its FDA-approved uses for:

1. postcardiotomy ventricular dysfunction (429.4)
   
   
2. treatment of right heart failure following insertion of an implantable left ventricular device (428.0, 428.20-428.23, 428.30-428.33, 428.40-428.43, 996.72)
   
   
3. treatment of cardiogenic shock following cardiac transplantation (785.51, 996.83)

The BVS 5000 device is intended for short term use and is not covered when used as a bridge to cardiac transplantation.

THORATEC

The implantation and removal of the device known as the Thoratec Ventricular Assist Device System is covered when used as a single ventricular (33975, 33977, 33979, 33980) or biventricular device (33976, 33978) in accordance with its FDA-approved use as a bridge to cardiac transplantation for patients suffering from end-stage heart failure (428.0, 428.1, 428.20-428.23, 428.30-428.33, 428.40-428.43, 428.9). The Thoratec Ventricular Assist Device System is indicated for patients who meet all of the following criteria:

1. candidate for cardiac transplantation,
   
   
2. imminent risk of dying before donor heart procurement, and
   
   
3. dependence on, or incomplete response to, continued vasopressor support.

The Thoratec Ventricular Assist Device System is indicated for postcardiotomy patients who are unable to be weaned from cardiopulmonary bypass.

The implantation (33975, 33979) and removal (33977, 33980) of the Thoratec HeartMate Vented Electric Left Ventricular Assist System (VAS) is covered as destination therapy in accordance with the FDA-approved usage. Destination therapy is defined as permanently implanting the device for patients who are not considered candidates for a heart transplant. Both of the following criteria must be met:

1. The patient has end-stage failure (428.0, 428.1, 428.20-428.23, 428.30-428.33, 428.40-428.43, 428.9); and,
   
   
2. The patient is not eligible for cardiac transplantation.

In addition to the criteria listed above, the following enrollment criteria (required for the REMATCH trial) must be met:

• At least 18 years of age
• Chronic heart failure (NYHA Class IV or III on inotropes/IABAP)
• Patients ineligible for cardiac transplant due to age, diabetes, kidney failure, or other co-morbidity
• Receiving reasonable doses of: digoxin, diuretics, and ACE Inhibitors (unless intolerant)
• Left Ventricular Ejection Fraction ≤ 25%
• VO2 max ≤ 14 ml/kg/min (unless failed inotrope wean)

The exclusion criteria includes:

• 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

OTHER DEVICES

The implantation (33975, 33979) and removal (33977, 33980) of the following single ventricular assist devices is covered when used in accordance with FDA-approved labeled use for patients with irreversible left ventricular congestive failure (398.91, 428.1, 428.20-428.23, 428.30-428.33, 428.40-428.43) awaiting a donor heart for transplantation. The patient's condition should be deteriorating so rapidly that they are likely to die within 24 to 48 hours. Also, the patients must be on their hospital's transplant list. The devices are:

• The HeartMate Implantable Pneumatic left Ventricular Assist System
• The HeartMate Vented Electric Left Ventricular Assist System
• Novacor Left Ventricular Assist System

In addition, the TandemHeart (CardiacAssist)(codes 0048T, 0049T, 0050T) is a covered device specifically designed for short-term stabilization of patients in the postoperative setting. This device is unique in that it allows for percutaneous access through the femoral vein, permitting rapid deployment. In addition, it is the first ventricular assist device that uses continuous axial flow, as opposed to pulsatile flow.

Total artificial hearts (0051T, 0052T, 0053T), in which the recipient undergoes a cardiectomy, represent a natural extension of ventricular assist devices as destination therapy. The CardioWest Total Artificial Heart is a covered device specifically as a bridge to transplantation. This device is unique in that a pulsatile biventricular device is placed after the native ventricles are excised. The labeled indication states that this device should only be used in an inpatient setting.

Total artificial hearts with FDA-approved devices may be considered medically necessary as a bridge to heart transplantation for patients with biventricular failure who are currently listed as heart transplant candidates.

Other artificial hearts (0051T, 0052T, 0053T) and other ventricular assist devices are still considered experimental/investigational as they do not have FDA approval. Therefore, claims reporting services in connection with the implantation of these devices should be denied.

Description

Artificial hearts and ventricular assist devices 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. Ventricular assist devices are used as a temporary method of supporting heart functions.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

This medical policy may not apply to FEP. Medical policy is not an authorization, certification, explanation of benefits, or a contract. Benefits are determined by the Federal Employee Program.