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    v1.0.28
    OpenPayerPolicy UpdatesCardiologymediviewcurative VAD Coverage & Prior Auth | OpenP…
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    CurrentmediviewcurativePolicy MM-PNP-023

    Ventricular Assist Device (VAD) Coverage Policy

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    Defines medical necessity criteria and requirements for coverage of ventricular assist devices (including LVAD, RVAD, pVAD, pediatric VADs, and Impella RP) for use by the Medical Utilization Management department.

    Policy Summary
    Payermediviewcurative
    PolicyVentricular Assist Device (VAD) Coverage Policy
    Policy CodePolicy MM-PNP-023
    Change TypeNo material change
    Effective DateDec 1, 2023
    Next Review Date
    Key ActionObtain prior authorization confirming the device is FDA‑approved for the requested indication and that medical necessity criteria are met.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    FDA‑approved VADsconsidered medically necessary for listed indications
    45/60 daysoptimal medical management failure
    <25%LVEF threshold
    ≤14 ml/kg/minpeak VO2 threshold

    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.

    30 days
    RVAD max duration
    14 daysImpella RP max duration

    Coverage Criteria for VADs and Related Devices

    inv-01: LVAD — Bridge to Transplant

    Covered when ALL of the following are met:

    Bridge to transplant criteria: Member is awaiting heart transplantation and the device has FDA approval for a bridge to transplant indication (e.g., HeartMate 3 LVAS)

    See CPB 0586 - Heart Transplantation

    inv-02: LVAD — Destination Therapy

    Covered when ALL of the following are met:

    Destination therapy criteria: Device has FDA approval for a destination therapy indication; member is New York Heart Association (NYHA) Class IV end-stage ventricular heart failure and is not a candidate for heart transplant; member has failed to respond to optimal medical management (including beta-blockers and ACE inhibitors if tolerated) for at least 45 of the last 60 days, or has been balloon pump dependent for 7 days, or has been IV inotrope dependent for 14 days; left ventricular ejection fraction (LVEF) less than 25%; demonstrated functional limitation with peak VO2 ≤ 14 ml/kg/min (this criterion may be waived for balloon pump or IV inotrope dependence or inability to perform exercise testing)

    inv-03: Percutaneous VAD (pVAD)

    Covered when ANY of the following indications are met:

    pVAD indications: Providing short-term circulatory support in cardiogenic shock; or as an adjunct to percutaneous coronary intervention (PCI) in high-risk members (unprotected left main or last-remaining-conduit PCI with EF <35%; or persons with three-vessel disease and EF <30%). Examples: TandemHeart, Impella.

    inv-04: Pediatric VADs

    Covered when ALL of the following are met:

    Pediatric VAD criteria: Child has documented end-stage left ventricular failure; and an age- and size-appropriate FDA-approved VAD will be used until a donor heart can be obtained (e.g., Berlin Heart EXCOR Pediatric VAD for children ≤16 years; HeartAssist 5 Pediatric VAD for children 5–16 years with BSA ≥0.7 m2 and <1.5 m2)

    Current FDA‑approved pediatric VADs include Berlin Heart EXCOR and HeartAssist 5 with specified age/size limits

    inv-05: RVAD (temporary)

    Covered when ALL of the following are met:

    RVAD criteria: RVAD is used for up to 30 days for members in cardiogenic shock due to acute right ventricular failure; and members are willing and able to be treated with heparin or an appropriate alternative anticoagulantup to 30 days

    Example: CentriMag Right Ventricular Assist System

    inv-06: Impella RP

    Covered when ALL of the following are met:

    Impella RP criteria: Used to provide circulatory assistance for up to 14 days in pediatric or adult persons with body surface area ≥ 1.5 m2 who develop acute right heart failure or decompensation following LVAD implantation, myocardial infarction, heart transplant, or open-heart surgeryup to 14 days

    Ventricular assist devices (VADs), percutaneous VADs (pVADs), pediatric VADs, and right‑sided assist devices are covered only for the specific, FDA‑approved indications and when all applicable policy criteria are met. Uses that do not meet the listed FDA‑approved indications or the policy criteria are considered experimental and investigational due to insufficient peer‑reviewed evidence and are not covered. Examples of procedures and technologies considered experimental include concomitant mitral valve surgery at the time of LVAD implantation, implantable aortic counterpulsation systems (e.g., NuPulseCV iVAS, Symphony), and use of mesenchymal precursor cells as adjunctive therapy.

    Requests for devices or procedures that are not FDA‑approved for the requested indication or that fail to meet the specific coverage criteria in this policy are considered not medically necessary or investigational. This includes VAD, pVAD, pediatric VAD, RVAD, or adjunct procedures outside the enumerated indications (for example, pVAD use outside cardiogenic shock or specified high‑risk PCI indications). Denial of coverage may result when documentation does not demonstrate FDA approval for the device/indication or when required clinical criteria (such as NYHA class, failure of optimal medical management, LVEF thresholds, duration of prior therapies, or age/size appropriateness for pediatric devices) are not met.

    Coding, Clinical Thresholds, and Support Durations

    Covered/Referenced CPT/HCPCS/ICD-10 Codesmixed
    No codes listed
    Optimal medical management duration — destination therapy
    Optimal medical management durationFailure of optimal medical management (including beta-blocker and ACE inhibitor if tolerated) for at least 45 of the last 60 days
    Alternate qualifying support - balloon pumpOr member has been balloon pump dependent for 7 days
    Alternate qualifying support - IV inotropeOr member has been IV inotrope dependent for 14 days
    Balloon pump dependence
    Balloon pump dependence durationBalloon pump dependent for 7 days qualifies as meeting the destination therapy medical-management failure criterion
    ContextCounts as an alternative to 45 of 60 days of failed optimal medical management

    Provider Requirements and Documentation

    Prior Authorization

    Prior authorization required

    Prior authorization is required before VAD placement. The authorization must verify the device is FDA‑approved for the requested indication and that all applicable medical necessity criteria for that indication are met (see criteria for bridge to transplant, destination therapy, pVAD, pediatric VADs, RVAD, and Impella RP).

    Step Therapy

    Medical therapy trial requirement for destination therapy

    For destination therapy, the member must have failed optimal medical management (including beta‑blockers and ACE inhibitors if tolerated) for at least 45 of the last 60 days, or meet alternate thresholds such as balloon pump dependence for 7 days or IV inotrope dependence for 14 days, before VAD placement is considered.

    Background

    Ventricular assist devices provide mechanical circulatory support for patients with advanced heart failure. They are used in several clinical roles: as a bridge to transplant for patients awaiting heart transplantation (using devices with FDA bridge‑to‑transplant approval), as destination therapy for patients who are not transplant candidates but meet strict clinical criteria, and as short‑term support in cardiogenic shock. Percutaneous VADs (for example, TandemHeart and Impella) provide temporary support for cardiogenic shock or as an adjunct during specified high‑risk percutaneous coronary interventions. Pediatric and right‑sided devices have specific age, size, anticoagulation, and duration considerations (for example, FDA‑approved pediatric devices such as the Berlin Heart EXCOR and HeartAssist 5 have defined age/weight or body surface area limits; temporary RVAD support is authorized for up to 30 days).

    Definitions

    Destination therapy — definition
    DefinitionVAD implanted as permanent therapy for patients not eligible for transplant
    Typical devicesExamples include HeartMate II and HeartMate 3 when FDA‑approved for destination therapy
    Coverage contextDestination therapy requires meeting all destination therapy criteria including failed medical management and LVEF/peak VO2 thresholds
    Percutaneous left ventricular assist device (pVAD) — definition
    DefinitionPercutaneous left ventricular assist device (pVAD) — short‑term percutaneous circulatory support devices such as TandemHeart and Impella
    IndicationsUsed for short‑term circulatory support in cardiogenic shock or as adjunct to high‑risk PCI

    Revision History

    2023-12-01policy_effectiveLatest

    Policy original effective date: MM-PNP-023 (Ventricular Assist Device Policy) became effective.

    Policy Summary
    Payermediviewcurative
    PolicyVentricular Assist Device (VAD) Coverage Policy
    Policy CodePolicy MM-PNP-023
    Change TypeNo material change
    Effective DateDec 1, 2023
    Next Review Date
    Key ActionObtain prior authorization confirming the device is FDA‑approved for the requested indication and that medical necessity criteria are met.
    SourceLink
    On This Page
    Coverage Criteria for VADs and Related DevicesCoding, Clinical Thresholds, and Support DurationsProvider Requirements and DocumentationBackgroundDefinitionsRevision History
    DocumentationProvider should document duration of balloon pump dependence in clinical records
    IV inotrope dependence
    IV inotrope dependence durationIV inotrope dependent for 14 days qualifies as meeting the destination therapy medical-management failure criterion
    ContextCounts as an alternative to 45 of 60 days of failed optimal medical management
    DocumentationProvider should document type and duration of IV inotrope therapy
    Left ventricular ejection fraction (LVEF)
    LVEF thresholdLeft ventricular ejection fraction less than 25% is required for destination therapy coverage
    Associated indicationApplies to members with NYHA Class IV end-stage ventricular heart failure who are not transplant candidates
    DocumentationProvide measured LVEF in clinical documentation for prior authorization
    Peak oxygen consumption (peak VO2)
    Peak VO2 thresholdPeak oxygen consumption ≤ 14 ml/kg/min is required to demonstrate functional limitation for destination therapy
    Waiver conditionsCriterion may be waived for persons who are balloon pump or IV inotrope dependent or otherwise unable to perform exercise testing
    DocumentationProvide peak VO2 result or rationale for waiver in prior authorization documentation
    RVAD support duration
    Maximum RVAD durationRVAD may be used for up to 30 days for temporary circulatory support in cardiogenic shock due to acute right ventricular failure
    Anticoagulation requirementMember must be willing and able to be treated with heparin or an appropriate alternative anticoagulant
    Example deviceExample: CentriMag Right Ventricular Assist System
    Impella RP support duration
    Impella RP maximum durationImpella RP provides circulatory assistance for up to 14 days
    BSA requirementApplicable in pediatric or adult persons with body surface area ≥ 1.5 m²
    IndicationsUsed for acute right heart failure or decompensation following LVAD implantation, MI, heart transplant, or open‑heart surgery
    Documentation Required

    Required clinical documentation

    Submit clinical documentation that demonstrates FDA approval for the device and requested indication, the member’s NYHA class, prior medical management and its duration (e.g., 45 of the last 60 days or balloon pump/IV inotrope dependence), LVEF, and peak VO2 (or reason for waiver). Include dependence on balloon pump or IV inotropes, pediatric age/size appropriateness when applicable, and willingness/ability to anticoagulate for RVAD use.

    Denial Risk

    Non‑FDA or non‑indicated uses may be denied

    Requests for VADs that are not FDA‑approved for the requested indication or for indications not listed in the policy are considered experimental/investigational and may be denied as not medically necessary.

    High‑risk PCI examplesUnprotected left main or last‑remaining‑conduit PCI with EF <35%, or three‑vessel disease with EF <30%
    Pediatric VADs — examples and indications
    Pediatric VAD examplesFDA‑approved pediatric VADs include the Berlin Heart EXCOR (children ≤16 years, up to 60 kg) and HeartAssist 5 (children aged 5–16 years; BSA ≥0.7 m² and <1.5 m²)
    IndicationUsed for children with documented end‑stage left ventricular failure until donor heart is obtained
    Size/age considerationsDevice selection must be age‑ and size‑appropriate per FDA labeling