Clinical Policy: Total Artificial Heart Form

# Clinical Policy: Total Artificial Heart

Reference Number: CP.MP.127  
Date of Last Revision: 06/24  

[Coding Implications](Coding Implications)  
[Revision Log](Revision Log)  

See [Important Reminder](Important Reminder) at the end of this policy for important regulatory and legal information.  

## Description  
The SynCardia temporary Total Artificial Heart (TAH) (SynCardia Systems Inc.), formerly known as the CardioWest Total Artificial Heart, is a biventricular pulsatile pump that replaces the patient’s native ventricles and valves. This policy describes the medical necessity requirements for the total artificial heart.  

## Policy/Criteria  
I. It is the policy of health plans affiliated with Centene Corporation® that the Total Artificial Heart is **medically necessary** as a bridge to heart transplantation when all of the following criteria are met:  
A. Member/enrollee is approved for cardiac transplant and is currently on transplant list;  
B. New York Heart Association (NYHA) Functional Class IV;  
C. Presence of non-reversible biventricular failure unresponsive to all other treatments;  
D. Ineligible for other ventricular support devices;  
E. Compatible donor heart is currently unavailable;  
F. Imminent risk of death;  
G. The device is approved by the United States Food and Drug Administration (FDA) and used according to the FDA-labeled indications, contraindications, warnings and precautions;  
H. Member/enrollee is able to receive adequate anti-coagulation while on the total artificial heart.  

II. It is the policy of health plans affiliated with Centene Corporation that there is insufficient evidence to support the use of the Total Artificial Heart as destination therapy (permanent replacement of the failing heart).