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    v1.0.30
    OpenPayerPolicy UpdatesClinical/Medical PolicyHealth New England VAD Coverage Update | OpenPayer
    Ask Trek AI about this page
    ModifiedHealth-New-EnglandPolicy UM986POL

    Ventricular Assist Devices - Medical Policy

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    This policy governs medical necessity, coverage criteria, prior authorization, and coding for ventricular assist devices, percutaneous VADs, pediatric VADs, and Temporary Total Artificial Heart systems across Health New England Commercial, Medicare Advantage, and Medicaid lines of business.

    Policy Summary
    PayerHealth-New-England
    PolicyVentricular Assist Devices - Medical Policy
    Policy CodePolicy UM986POL
    Change TypeModified
    Effective DateFebruary 1, 2027
    Last ReviewDec 1, 2024
    Next Review DateN/A
    Key ActionSubmit clinical evidence supporting the applicable policy criteria with every prior authorization request.
    SourceLink
    POLICY UPDATE CHANGES

    The policy added medical necessity criteria for ventricular assist devices, including destination therapy, bridge-to-transplantation, pediatric use, and total artificial heart systems.

    The policy added coverage criteria for Temporary Total Artificial Heart systems with the Freedom Portable Driver.

    The policy adopted InterQual criteria and the Medicare Ventricular Assist Devices National Coverage Determination pathway for Medicare members.

    The policy added definitions and clinical background for percutaneous ventricular assist devices.

    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.

    3Applicable lines of business
    ≤25%LVEF threshold
    45 of 60 daysOptimal management
    ≤16 yearsPediatric age limit
    Non-FDA-approved VADsExcluded device category
    14 / 7 daysHF / IABP pathway

    Medical Necessity and Coverage Criteria

    Bridge to Transplantation

    Implantable VADs with FDA approval or clearance may be medically necessary as a bridge to heart transplantation when either criterion is met.

    Bridge to transplantation

    • Listed candidate: Currently listed as a heart-transplantation candidate and not expected to survive until a donor heart can be obtained
    • Evaluation candidate: Undergoing evaluation to determine candidacy for heart transplantation

    Facility and Bridge-Purpose Coverage

    Health New England may cover VADs for the following bridge purposes and facility settings.

    Support-purpose and facility pathways

    • Bridge to transplant: Bridge-to-Transplant VAD at a heart transplant center
    • Bridge to decision or recovery: Bridge-to-Decision VAD or Bridge-to-Recovery VAD at a facility that is not a heart transplant center

      Must be performed urgently during a medically necessary hospitalization for stabilization and recovery of a member decompensating from heart failure

    Pediatric VADs

    Pediatric VADs may be covered as a bridge to heart transplantation when all device and age requirements and one transplant criterion are met.

    Pediatric VAD bridge to transplantation

    • Age and device requirements: Child is 16 years old or younger and the proposed device is FDA approved for the child's age and size≤16 years

    • Transplant criterion

      • Listed candidate: Currently listed as a heart-transplantation candidate and not expected to survive until a donor heart can be obtained
      • Evaluation candidate: Undergoing evaluation to determine candidacy for heart transplantation

    Temporary Total Artificial Heart

    The Temporary Total Artificial Heart system with the Freedom Portable Driver may be covered as a bridge to transplant when all criteria are met.

    Temporary Total Artificial Heart bridge to transplant

    • No reasonable alternative: No other reasonable medical or surgical treatment options; ineligible for other univentricular or biventricular support devices

    • Transplant status

      • Listed candidate: Currently listed as a heart-transplantation candidate
      • Evaluation candidate: Undergoing evaluation to determine candidacy for heart transplantation
    • Biventricular failure risk:

    Medicare Coverage Pathway

    Medicare coverage follows Health New England-adopted InterQual criteria and the Medicare Ventricular Assist Devices National Coverage Determination pathway.

    Medicare pathway: Medicare procedures are reviewed under InterQual criteria for Ventricular Assist Devices NCD and Ventricular Assist Device

    The applicable National Coverage Determination is NCD 20.9.1. Medicare destination-therapy procedures must be performed at an approved VAD facility identified by CMS. For a Temporary Total Artificial Heart system, apply the total-artificial-heart criteria above.

    Non-FDA-approved ventricular assist devices (VADs) are not covered. Covered VADs must meet applicable FDA approval or clearance and labeling requirements.

    Coding and Clinical Thresholds

    Coding GuidanceCPT
    33927Implantation of a total replacement heart system (artificial heart) with recipient cardiectomy.
    33928Removal and replacement of total replacement heart system (artificial heart).
    33929Removal of a total replacement heart system (artificial heart) for heart transplantation (List separately in addition to code for primary procedure).
    33975Insertion of ventricular assist device; extracorporeal, single ventricle.
    33979Insertion of ventricular assist device, implantable intracorporeal, single ventricle.
    33981Replacement of extracorporeal ventricular assist device, single or biventricular, pump(s), single or each pump.
    33982Replacement of ventricular assist device pump(s); implantable intracorporeal, single ventricle, without cardiopulmonary bypass.
    33983Replacement of ventricular assist device pump(s); implantable intracorporeal, single ventricle, with cardiopulmonary bypass.
    33990Insertion of ventricular assist device, percutaneous, including radiological supervision and interpretation; left heart, arterial access only.
    33991Insertion of ventricular assist device, percutaneous, including radiological supervision and interpretation; left heart, both arterial and venous access, with transseptal puncture.
    1–10 of 12
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    NYHA Functional Class
    NYHA requirementClass III heart failure with dyspnea upon mild physical activity or Class IV
    Clinical severityEnd-stage heart failure in an adult individual
    Criteria relationshipMust be met together with the left ventricular ejection fraction requirement
    Left Ventricular Ejection Fraction
    Required thresholdLeft ventricular ejection fraction ≤ 25%
    Applicable pathwayDestination therapy for end-stage heart failure
    Criteria relationship

    Authorization and Documentation Requirements

    Prior Authorization

    Prior Authorization Required

    Prior authorization is required before VAD and artificial-heart procedures. Submit the request with the applicable procedure, clinical indication, device information, and documentation supporting the policy criteria.

    • Artificial-heart procedures: CPT 33927, 33928, and 33929.
    • VAD procedures: CPT 33975, 33979, 33981, 33982, 33983, 33990, 33991, 33995, and 33977.
    • All listed procedures require prior authorization (PA).
    Documentation Required

    Submit Clinical Evidence

    The treating physician or primary care provider must submit clinical evidence to Health New England demonstrating that the patient meets the applicable medical-necessity criteria. Without this documentation, Health New England cannot properly review the prior-authorization request.

    • Include relevant clinical records, diagnostic findings, treatment history, and provider attestation supporting the requested VAD or artificial-heart procedure.

    Clinical Background

    A ventricular assist device (VAD) helps pump blood from the heart to the body. Depending on the clinical objective, a VAD may provide temporary support while a patient awaits heart transplantation, support recovery of the heart with the goal of eventual device removal, or serve as permanent destination therapy when transplantation is not being considered.

    Most VADs support the left ventricle. A Temporary Total Artificial Heart replaces the ventricles and valves and supports both pulmonary and systemic circulation. Percutaneous VADs, including TandemHeart and Impella, are generally used for short-term circulatory support and require careful inpatient monitoring.

    Device and Treatment Definitions

    Ventricular Assist Device (VAD)
    Device typeExternal device
    PlacementImplanted
    PurposeSupports heart function
    Destination VAD
    DeviceVentricular assist device
    Treatment intentPlacement when no transplant is being considered
    Use categoryDestination VAD
    Policy Summary
    PayerHealth-New-England
    PolicyVentricular Assist Devices - Medical Policy
    Policy CodePolicy UM986POL
    Change TypeModified
    Effective DateFebruary 1, 2027
    Last ReviewDec 1, 2024
    Next Review DateN/A
    Key ActionSubmit clinical evidence supporting the applicable policy criteria with every prior authorization request.
    SourceLink
    On This Page
    Medical Necessity and Coverage CriteriaCoding and Clinical ThresholdsAuthorization and Documentation RequirementsClinical BackgroundDevice and Treatment Definitions
    At risk for imminent death from biventricular failure
  1. Anticoagulation: Able to receive adequate anticoagulation while on the total artificial heart
  2. Training and competency: Member and caregiver(s) have completed the Device Discharge Manual and competencies
    3. Must be met together with the NYHA functional-class requirement
    Cardiac Index
    Required thresholdCardiac index < 2.2 liters/min/m2
    Measurement conditionMeasured while not on inotropes
    Additional requirementMust also meet a qualifying optimal-medical-management or intra-aortic-balloon-pump pathway
    Optimal Medical Management
    Required durationAt least 45 of the last 60 days
    Treatment standardOptimal medical management based on current heart failure practice guidelines
    Response requirementThe individual must be failing to respond
    Advanced Heart Failure and Intra-Aortic Balloon Pump
    Advanced heart failurePresent for at least 14 days
    Intra-aortic balloon pumpDependence for ≥ 7 days
    Applicable pathwayQualifying pathway for destination therapy when the cardiac index is < 2.2 liters/min/m2 while not on inotropes
  3. Documentation must address the criteria applicable to the requested therapy, including device status, clinical severity, hemodynamics, transplant status, and device-use requirements when applicable.
    4. Documentation Required

    Document Device and Medical-Necessity Criteria

    Document the device and clinical factors supporting medical necessity, including FDA status or clearance, intended labeled use, heart-failure severity, cardiac function, hemodynamics, transplant status, and the required treatment or support history.

    • Destination therapy: adult with end-stage heart failure; NYHA Class III with dyspnea on mild physical activity or NYHA Class IV; left-ventricular ejection fraction ≤25%; and either inotrope dependence or cardiac index <2.2 L/min/m² while not on inotropes, plus the applicable treatment-history pathway.
    • For the cardiac-index pathway, document optimal medical management for at least 45 of the last 60 days with failure to respond, or advanced heart failure for at least 14 days with intra-aortic balloon-pump dependence for at least 7 days.
    • Bridge to transplant: document current transplant listing with inability to survive until a donor heart is available, or an active evaluation for transplant candidacy. Identify the transplant-center setting when required.
    • For bridge-to-decision or bridge-to-recovery VADs, document urgent use during a medically necessary hospitalization for stabilization and recovery from cardiac decompensation.
    • For temporary total artificial heart therapy, document that the device is being used as a bridge to transplant and that all applicable TAH-t criteria are met.
    Denial Risk

    Non-FDA-Approved Device or Off-Label Use

    A VAD that is not FDA approved or cleared, or a requested use that is outside compliant FDA labeling, may be denied. Verify the device’s regulatory status and intended use before submitting authorization.

    • Document FDA approval or clearance for the proposed device and the applicable patient population.
    • Do not assume coverage for a non-FDA-approved VAD or an off-label use; provide evidence of compliant labeled use when requesting authorization.
    Denial Risk

    Destination Therapy Criteria Not Met

    Destination-therapy authorization may be denied when the adult patient does not meet the required heart-failure severity, ejection-fraction, hemodynamic, inotrope, or treatment-duration criteria.

    • Patient must have end-stage heart failure with NYHA Class III symptoms involving dyspnea on mild physical activity or NYHA Class IV heart failure.
    • Left-ventricular ejection fraction must be ≤25%.
    • Patient must be inotrope-dependent, or have a cardiac index <2.2 L/min/m² while not on inotropes and also meet one of the following: optimal medical management for at least 45 of the last 60 days with failure to respond, or advanced heart failure for at least 14 days with intra-aortic balloon-pump dependence for at least 7 days.
    Denial Risk

    Transplant Bridge Criteria Not Met

    Bridge-to-transplant VAD authorization may be denied when transplant-listing or transplant-evaluation requirements are not documented. The request must show either that the patient is listed and unlikely to survive until a donor heart is available, or that the patient is undergoing evaluation for transplant candidacy.

    • For a bridge-to-transplant VAD, identify the heart transplant center and document the patient’s transplant status.
    • A current listing without documentation that the patient is not expected to survive until donor-heart availability may not satisfy the criteria.
    Denial Risk

    Pediatric Criteria Not Met

    Pediatric VAD coverage may be denied when the child is older than 16, the proposed device is not FDA approved for the child’s age and size, or qualifying transplant criteria are not met.

    • Patient must be 16 years old or younger.
    • The proposed device must be FDA approved for the child’s age and size.
    • Document either current listing as a heart-transplant candidate with expected inability to survive until a donor heart is available, or an evaluation to determine transplant candidacy.
    Denial Risk

    Total Artificial Heart Criteria Not Met

    Temporary total artificial heart therapy, such as the SynCardia TAH-t System with the Freedom Portable Driver, may be denied unless every bridge-to-transplant criterion is documented.

    • No other reasonable medical or surgical treatment options are available, and the member is ineligible for other univentricular or biventricular support devices.
    • The member is currently listed as a heart-transplant candidate or is undergoing evaluation to determine transplant candidacy.
    • The member is at risk for imminent death from biventricular failure.
    • The member can receive adequate anticoagulation while supported by the total artificial heart.
    • The member and caregiver(s) have completed the Device Discharge Manual and required competencies.
    Bridge to Transplant VAD
    DeviceVentricular assist device
    PurposeSupports functioning in anticipation of a heart transplant
    Use categoryBridge to Transplant VAD
    Bridge to Decision VAD
    DeviceVentricular assist device
    Immediate purposeStabilizes the member
    Long-term purposeAllows determination of the best long-term treatment option
    Bridge to Recovery VAD
    DeviceVentricular assist device
    Treatment goalAllows heart muscle to recover
    Intended outcomeEventual VAD removal
    Percutaneous VAD
    Device typeCirculatory assist device placed percutaneously rather than implanted
    TerminologyAlso referred to as a percutaneous VAD or pVAD
    ExamplesTandemHeart and Impella