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    v1.0.28
    OpenPayerPolicy UpdatesCardiologyAmbetter Nevada Total Artificial Heart Coverage | …
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    CurrentAmbetter NevadaPolicy CP.MP.127

    Total Artificial Heart (TAH) Coverage Criteria

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    Defines medical necessity criteria for use of the SynCardia temporary Total Artificial Heart as a bridge to heart transplantation for eligible members; also states stance on destination therapy. Affects providers requesting coverage for implantation/replacement of a total artificial heart for Ambetter Nevada members.

    Policy Summary
    PayerAmbetter Nevada
    PolicyTotal Artificial Heart (TAH) Coverage Criteria
    Policy CodePolicy CP.MP.127
    Change TypeClarification & terminology update
    Effective DateN/A
    Last ReviewMay 25, 2025
    Next Review DateN/A
    Key ActionObtain prior authorization for implantation (33927) or replacement/repair (33928) and document transplant approval, active transplant listing, NYHA Class IV status, and failure or ineligibility of other ventricular support devices.
    SourceLink
    POLICY UPDATE CHANGES

    Under I.F. added 'due to irreversible biventricular heart failure'.

    Replaced investigational/experimental language in sections II & III with 'insufficient evidence to support the use of …'.

    fewer than 100TAH implantations per year in the United States

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    50Children supported with TAH (Dec 1985–Oct 2019)
    33927, 33928Referenced CPT codes

    Coverage Criteria

    inv-01: COVERAGE CRITERIA

    Covered when ALL of the following are met:

    Bridge to Transplant Criteria

    • 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 due to irreversible biventricular heart failure
    • 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

    inv-02: Not supported: Destination therapy

    Destination Therapy: There is insufficient evidence to support use of the Total Artificial Heart as destination therapy (permanent replacement)

    Not covered as destination therapy due to insufficient evidence

    Use of the Total Artificial Heart as destination therapy (permanent replacement) is not supported due to insufficient evidence. The policy states explicitly that there is insufficient evidence to support the use of the Total Artificial Heart as destination therapy and therefore it is not an endorsed permanent treatment option.

    The Total Artificial Heart is considered not medically necessary as destination therapy because current evidence is insufficient to support its use as a permanent replacement for the failing heart. Requests for TAH as destination therapy should be considered unsupported given the policy position that long‑term/permanent use lacks adequate clinical evidence.

    Coding and Device Sizing

    Referenced CPT CodesCPT
    33927Implantation of a total replacement heart system (artificial heart) with recipient cardiectomy.
    33928Replacement or repair of thoracic unit of a total replacement heart system (artificial heart)
    Body surface area / T10 measurement for device sizing
    Sizing guidance50cc intended for patients with body surface area (BSA) ≤ 1.85 m² and adequate T10 (posterior sternum to anterior spine at T10) or adequate chest room by 3D imaging/clinical assessment; patients with T10 ≥ 10 cm should be considered for the 70cc device.
    Device comparison50cc is a smaller version of the SynCardia 70cc TAH intended for smaller-stature patients; 70cc used when T10 ≥ 10 cm.
    FDA indication for 50cc50cc TAH received U.S. FDA approval as a bridge to transplantation in cardiac transplant–eligible patients at risk of imminent death from biventricular failure.
    Sizing assessment methodsAdequacy for 50cc may be determined by T10 measurement or by 3D imaging assessment or other standard clinical assessments of chest room.

    Provider Actions and Requirements

    Prior Authorization

    Prior Authorization Required

    Prior authorization is required for implantation or repair of the Total Artificial Heart. Requests must be submitted and approved before scheduling the procedure.

    • Affected codes: CPT codes for implantation/repair (e.g., 33927, 33928) — prior authorization required
    • Include expected device model (e.g., SynCardia 50cc or 70cc) and intended use (bridge-to-transplant)
    Documentation Required

    Requirement to Document Prior/Alternative Therapies

    Provide documentation demonstrating failure or ineligibility of alternative ventricular support devices before approval of a Total Artificial Heart.

    • Document trials of other therapies and mechanical circulatory support devices and clinical reasons for ineligibility (e.g., anatomy, BSA, T10 measurement, prior device failure)
    • If member is ineligible for other devices, include specific clinical rationale and supporting imaging or specialist consult notes

    Background

    The SynCardia temporary Total Artificial Heart (TAH) is a biventricular pulsatile pump that replaces the native ventricles and valves and is intended to provide circulatory support as a bridge to cardiac transplantation for transplant‑eligible patients. Policy criteria require that patients be approved for transplant and currently listed, have NYHA Functional Class IV symptoms, have non‑reversible biventricular failure unresponsive to other treatments, be ineligible for other ventricular support devices, have no compatible donor heart available, be at imminent risk of death due to irreversible biventricular failure, have a device that is FDA‑approved and used per labeled indications, and be able to receive adequate anticoagulation while supported by the TAH.

    Definitions

    SynCardia temporary Total Artificial Heart (TAH)
    DefinitionSynCardia temporary Total Artificial Heart (TAH) is a biventricular pulsatile pump that replaces the patient’s native ventricles and valves and is used as a bridge to cardiac transplantation in eligible patients.
    Indication in policyMedically necessary as a bridge to transplant for transplant‑eligible patients at imminent risk of death from irreversible biventricular heart failure when all coverage criteria are met.
    Device modelsIncludes SynCardia 70cc TAH and the smaller SynCardia 50cc TAH for patients of smaller stature.
    Freedom Driver (portable driver)
    DefinitionThe SynCardia Freedom portable driver is an FDA‑approved external driver that enables clinically stable patients implanted with the TAH to be discharged from the hospital while awaiting donor heart transplantation.
    Approval date/context
    Policy Summary
    PayerAmbetter Nevada
    PolicyTotal Artificial Heart (TAH) Coverage Criteria
    Policy CodePolicy CP.MP.127
    Change TypeClarification & terminology update
    Effective DateN/A
    Last ReviewMay 25, 2025
    Next Review DateN/A
    Key ActionObtain prior authorization for implantation (33927) or replacement/repair (33928) and document transplant approval, active transplant listing, NYHA Class IV status, and failure or ineligibility of other ventricular support devices.
    SourceLink
    On This Page
    Coverage CriteriaCoding and Device SizingProvider Actions and RequirementsBackgroundDefinitions
    Documentation Required

    Required Documentation

    Submit complete clinical documentation to support medical necessity: evidence of transplant approval/active listing, NYHA Class IV status, irreversible biventricular failure, imminent risk of death, FDA-approved device use, and ability to maintain anticoagulation.

    • Proof of cardiac transplant approval and current listing status
    • NYHA Functional Class IV documentation
    • Clinical evidence of non-reversible biventricular failure unresponsive to other treatments
    • Documentation confirming ineligibility for other ventricular support devices
    • Statement that a compatible donor heart is currently unavailable and imminent risk of death exists
    • Device details showing FDA approval and intended use per labeling (e.g., SynCardia 50cc/70cc with BSA/T10 suitability)
    • Anticoagulation plan demonstrating member can receive adequate anticoagulation while on the device
    • Relevant imaging (3D chest assessment, T10 measurement), specialist consults, and hospital course notes
    Denial Risk

    Triggers for Denial

    Requests may be denied if documentation does not meet the bridge-to-transplant criteria or if clinical exclusions apply.

    • Member not approved for transplant or not actively listed
    • NYHA Functional Class less than IV
    • Biventricular failure is reversible or responsive to other treatments
    • Member eligible for other ventricular support devices and no justification for ineligibility
    • Device proposed for destination therapy (permanent replacement) — considered insufficient evidence and not supported
    • No evidence that a compatible donor heart is currently unavailable or no imminent risk of death documented
    • Inability to tolerate/receive adequate anticoagulation
    FDA approved the SynCardia Freedom portable driver (June 26, 2014) for use in implanted, clinically stable TAH patients to allow outpatient support.
    Clinical roleAllows outpatient discharge of clinically stable patients supported on the TAH while they await transplant.