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    v1.0.30
    OpenPayerPolicy UpdatesVascular/Cardiothoracic SurgeryAmbetter Nevada Artificial Heart Coverage | OpenPa…
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    CurrentAmbetter NevadaPolicy CP.MP.127

    Total Artificial Heart

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    This policy governs the medical necessity and coverage criteria for the SynCardia temporary Total Artificial Heart as a bridge to cardiac transplantation for members and enrollees receiving support under health plans affiliated with Centene Corporation.

    Policy Summary
    PayerAmbetter Nevada
    PolicyTotal Artificial Heart
    Policy CodePolicy CP.MP.127
    Change TypeAnnual reviewno material clinical or coverage changes
    Effective DateSeptember 1, 2026
    Last ReviewMay 1, 2026
    Next Review DateNot specified
    Key ActionSubmit bridge-to-transplant requests only when all eight medical necessity criteria are met; destination therapy is not supported.
    SourceLink
    POLICY UPDATE CHANGES

    The May 2026 annual review updated the references and documented external specialist review.

    8Required criteria for bridge-to-transplant use
    NYHA IVRequired heart failure class
    1CPT code listed
    <100/yearU.S. implantations annually

    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.

    Medical Necessity Criteria

    Bridge to heart transplantation

    Covered as medically necessary as a bridge to heart transplantation when all of the following are met:

    All required criteria

    • Transplant status: The member/enrollee is approved for cardiac transplant and is currently on the transplant list.
    • Heart failure severity: The member/enrollee has New York Heart Association (NYHA) Functional Class IV heart failure.NYHA Functional Class IV
    • Biventricular failure: The member/enrollee has non-reversible biventricular failure unresponsive to all other treatments.
    • Other ventricular support devices: The member/enrollee is ineligible for other ventricular support devices.
    • Donor availability: A compatible donor heart is currently unavailable.
    • Risk of death: The member/enrollee is at imminent risk of death due to irreversible biventricular heart failure.
    • FDA-approved use: The device is approved by the United States Food and Drug Administration (FDA) and is used according to the FDA-labeled indications, contraindications, warnings, and precautions.
    • Anticoagulation: The member/enrollee is able to receive adequate anticoagulation while on the Total Artificial Heart.

    Destination therapy

    The policy does not support use as destination therapy:

    Destination therapy: There is insufficient evidence to support use of the Total Artificial Heart as destination therapy, meaning permanent replacement of the failing heart.

    Use of the Total Artificial Heart as destination therapy—meaning permanent replacement of the failing heart rather than temporary support until transplantation—is not supported by the policy because evidence is insufficient.

    Coding and Device Selection

    CPT CodesCPT
    33928recipient cardiectomy Replacement or repair of thoracic unit of a total replacement heart system (artificial heart)
    50cc Device Threshold
    Body surface areaBSA ≤ 1.85 m²
    Patient profileThe 50cc temporary Total Artificial Heart is intended for patients with smaller stature.
    Chest dimensionsAdequate T10 measurement or adequate room in the chest, determined by 3D imaging or other standard clinical assessment, is required.
    70cc Device Consideration
    T10 measurementT10 measurement ≥ 10 cm
    Device considerationPatients with a T10 measurement of at least 10 cm should be considered for the 70cc Total Artificial Heart.
    Measurement definitionT10 is the posterior sternum-to-anterior spine measurement at T10.

    Provider Action and Denial Risks

    Denial Risk

    Do not use for destination therapy

    Use of the Total Artificial Heart as destination therapy—permanent replacement of the failing heart—is not supported because there is insufficient evidence.

    Denial Risk

    Meet all bridge-to-transplant criteria

    Bridge-to-transplant implantation is medically necessary only when all eight required criteria are met; absence of any one criterion means the procedure does not meet medical necessity.

    • Approved for cardiac transplant and currently on the transplant list
    • NYHA Functional Class IV heart failure
    • Non-reversible biventricular failure unresponsive to all other treatments
    • Ineligible for other ventricular support devices
    • Compatible donor heart is currently unavailable
    • Imminent risk of death due to irreversible biventricular heart failure
    • FDA-approved device used according to FDA-labeled indications, contraindications, warnings, and precautions
    • Able to receive adequate anticoagulation while on the Total Artificial Heart

    Device Background

    The SynCardia temporary Total Artificial Heart is a biventricular pulsatile pump that replaces the patient’s native ventricles and valves and supports both pulmonary and systemic circulation. It is used as a bridge to transplantation for transplant-eligible patients with irreversible biventricular heart failure who are at imminent risk of death. The policy finds insufficient evidence for its use as destination therapy. The 50cc system is intended for smaller-stature patients, generally those with a body surface area of 1.85 m² or less and adequate thoracic dimensions.

    Key Terms and Device Definitions

    Total Artificial Heart
    Device typeA biventricular pulsatile pump.
    Structures replacedIt replaces the patient's native ventricles and valves.
    Circulation supportedIt pumps blood to both the pulmonary and systemic circulations.
    Bridge to Transplantation
    PurposeTemporary support for a transplant-eligible patient.
    End pointSupport continues until a compatible donor heart becomes available.
    Clinical settingIt is used for cardiac transplant-eligible candidates with biventricular heart failure who are at imminent risk of death.
    Destination Therapy
    DefinitionPermanent replacement of the failing heart.
    Distinction from bridge therapyIt is used instead of temporary support until transplantation.
    Policy positionThere is insufficient evidence to support use of the Total Artificial Heart as destination therapy.
    50cc Temporary Total Artificial Heart
    Device descriptionA smaller version of the SynCardia 70cc Total Artificial Heart.
    Intended patientsPatients with smaller stature, generally those with BSA ≤ 1.85 m² and adequate thoracic dimensions.
    Intended useAn FDA-approved bridge to transplantation for cardiac transplant-eligible patients at risk of imminent death from biventricular failure.
    Policy Summary
    PayerAmbetter Nevada
    PolicyTotal Artificial Heart
    Policy CodePolicy CP.MP.127
    Change TypeAnnual reviewno material clinical or coverage changes
    Effective DateSeptember 1, 2026
    Last ReviewMay 1, 2026
    Next Review DateNot specified
    Key ActionSubmit bridge-to-transplant requests only when all eight medical necessity criteria are met; destination therapy is not supported.
    SourceLink
    On This Page
    Medical Necessity CriteriaCoding and Device SelectionProvider Action and Denial RisksDevice BackgroundKey Terms and Device Definitions