Clinical Policy: Total Artificial Heart
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Medical necessity criteria and coverage stance for SynCardia temporary Total Artificial Heart (TAH) as a bridge to heart transplantation for members of Arizona Complete Health (Centene-affiliated health plans). Applies to providers requesting coverage for implantation and related services.
Under I.F. added 'due to irreversible biventricular heart failure'.
Coverage Criteria
Bridge to Heart Transplant (Medically Necessary)
Covered when ALL of the following are met:
All conditions A–H required per policy.
Destination Therapy (Not Supported)
Not supported as destination therapy per policy.
Use of the Total Artificial Heart as destination therapy (permanent replacement of the failing heart) is not supported by the available evidence. The policy considers destination therapy for the Total Artificial Heart to have insufficient evidence to establish safety and effectiveness for permanent implantation, and therefore it is not an approved indication under this policy.
The Total Artificial Heart for destination therapy is explicitly considered unsupported due to insufficient evidence. Requests for permanent (non-bridge) implantation are not covered under this policy because current evidence does not demonstrate adequate support for use as a permanent replacement.
Coding and Device Sizing
Provider Actions and Requirements
Step therapy / device sequencing — demonstrate other options inappropriate
There is no formal step therapy sequence specified in the policy; before TAH is approved as a bridge to transplant, documentation must demonstrate that other treatments and alternative ventricular assist devices are not appropriate or feasible for the member.
- Policy requires member to be ineligible for other ventricular support devices (criterion D) and to have non-reversible biventricular failure unresponsive to all other treatments (criterion C).
- Use of TAH as destination (permanent) therapy is not supported by the policy and is not an approved sequencing option.
Required documentation and clinical data for authorization
Requests must include clinical documentation that supports transplant listing, NYHA Class IV status, irreversible biventricular failure unresponsive to other treatments, ineligibility for other ventricular support devices, unavailability of a compatible donor heart, imminent risk of death from irreversible biventricular failure, FDA-approved use according to labeled indications, and ability to receive anticoagulation.
- Include evidence the member is approved for cardiac transplant and currently on the transplant list (criterion A).
- Document New York Heart Association (NYHA) Functional Class IV status (criterion B).
- Provide records demonstrating non-reversible biventricular failure unresponsive to all other treatments (criterion C) and ineligibility for other ventricular support devices (criterion D).
- For smaller patients considered for the 50cc TAH, include Body Surface Area (BSA) and T10 or 3D chest imaging assessment as applicable per manufacturer guidance (BSA ≤ 1.85 m² and T10 measurement guidance).
Denial triggers — incomplete medical necessity criteria
Requests that do not meet all listed medical necessity criteria for use as a bridge to transplant may be denied.
- Examples include requests where the member is not approved/listed for transplant, is not NYHA Class IV, has reversible or unilateral failure, is eligible for other VADs, or documentation of ability to anticoagulate is lacking.
Background
The SynCardia temporary Total Artificial Heart (TAH) is a biventricular pulsatile device designed to replace the native ventricles and heart valves in patients with end-stage biventricular heart failure. Under this policy the TAH is recognized as medically necessary as a bridge to heart transplantation when all specified criteria are met, including that the member is approved and listed for transplant, is NYHA Functional Class IV, has irreversible biventricular failure unresponsive to other treatments, is ineligible for other ventricular support devices, a compatible donor heart is unavailable, there is imminent risk of death from irreversible biventricular heart failure, the device is used according to FDA-labeled indications, and the member can receive adequate anticoagulation.
Definitions
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