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    v1.0.28
    OpenPayerPolicy UpdatesCardiologyBlue Cross Blue Shield WI VAD Policy Update | Open…
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    CurrentBlue Cross Blue Shield - WisconsinPolicy N/A

    Ventricular Assist Device (VAD) Facility Participation Criteria

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    Defines facility, team, quality, volume, certification, and outcome requirements for Anthem Centers of Medical Excellence designation for adult Ventricular Assist Device (VAD) programs; applies to facilities providing covered VAD services to Anthem commercial members.

    Policy Summary
    PayerBlue Cross Blue Shield - Wisconsin
    PolicyVentricular Assist Device (VAD) Facility Participation Criteria
    Policy CodePolicy N/A
    Change TypeNo material changes
    Effective DateN/A
    Next Review DateN/A
    Key ActionEnsure facility, medical group, and hospital-based physicians are participating providers in Anthem's commercial networks and maintain CMS VAD certification with required documentation and registry reporting.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    20minimum average VAD implants (3 yrs)
    12

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    primary surgeon implants (36 mo)
    3 yrsactive program period
    24/72hnotification requirement
    ≤10%allowed survival deviation
    ≤2%allowed adverse event deviation

    Facility Designation & Coverage Criteria

    Facility CME Designation Criteria

    Designation (and thus inclusion in Anthem's VAD network) is granted when ALL of the following are met:

    Core facility and program requirements: Facility, medical group, and all hospital-based physicians providing covered VAD services must be participating providers in Anthem's commercial networks with corresponding agreements in place (including reimbursement rates); facility and medical group must meet biannual quality criteria and provide formal program approval/notification to Anthem; facility must maintain CMS VAD certification; facility must have been actively performing VAD implantation over the most recent 3 years and have a minimum average of 20 VAD implants over the most recent consecutive 3 years.facility: >= 20 VAD implants average over most recent consecutive 3 years; active implantation in most recent 3 years

    Operational: timely notification to Anthem required for material changes (24 hours working day / 72 hours weekend).

    Transplant relationship: Facility must either be a UNOS-certified heart transplant center meeting applicable UNOS membership criteria OR have a relationship with a UNOS-certified heart transplant center that provides heart transplant evaluation and/or emergency transplant support.either/or
    Multidisciplinary team composition and services: Program must have an explicitly identified multidisciplinary VAD team based at the facility including: (1) one or more cardiologists board certified or board-eligible in advanced heart failure/transplant cardiology or with equivalent contemporary device/transplant experience; (2) one or more cardiothoracic surgeons with privileges and individual experience as primary surgeon implanting >= 12 durable intracorporeal VADs (BTT or DT) over the previous 36 months with activity in the last year; (3) a VAD program coordinator; (4) a VAD-experienced registered nurse; (5) a social worker; (6) a palliative care representative; (7) a nutrition services representative; (8) a psychological services representative; (9) a rehabilitative services representative; and (10) a financial support representative; the program must provide 24/7 support for VAD recipients/families, ensure advanced care planning and informed shared decision-making, coordinate care prior to discharge including community practitioner education, and verify CMS or Joint Commission approval if primary physician/surgeon changed within the most recent 36 months.primary surgeon: >= 12 VADs as primary surgeon over previous 36 months
    Data reporting and quality measures: Patient data for every FDA-approved device must be entered into a nationally audited registry; program overall survival at 1 month, 3 months, 6 months, 1 year, 2 years and 3 years must not be lower than 10% from the corresponding national INTERMACS mean; subsequent device counts and adverse event rates (bleeding, device malfunction, infection, stroke, readmission) must not exceed a 2% deviation compared to national INTERMACS data.<=10% survival deviation; <=2% adverse event/subsequent device deviation

    Satisfaction of the program quality criteria is not a guarantee of designation. Programs should note that meeting all listed structural, process, volume, certification, and outcome requirements supports consideration for Anthem Centers of Medical Excellence (CME) VAD designation but does not automatically confer it.

    Volume & Coding Requirements

    Primary surgeon implant volume — threshold
    Requirement>= 12 durable intracorporeal VADs as primary surgeon over the previous 36 months
    ApplicabilityCounts apply to individual surgeons serving as the primary implanting surgeon for bridge-to-transplant (BTT) or destination therapy (DT) procedures
    RecencyImplant activity must include the most recent year within the 36-month measurement period
    VerificationWhen the primary physician and/or surgeon has changed during the most recent 36 months, program must provide verification of CMS or Joint Commission approval
    Facility implant volume — threshold
    Requirement>= 20 VAD implants average over the most recent consecutive 3 years

    Provider Participation, Documentation & Risk Conditions

    Prior Authorization

    Network participation, certification, and agreements required

    Facility, medical group, and all hospital-based physicians who provide covered VAD services must be participating providers in Anthem's commercial provider networks and have corresponding agreements (including reimbursement rates) in place with Anthem; the facility must maintain CMS VAD certification and meet the program and network participation requirements described in this policy.

    • Participating provider status required for facility, medical group, and all hospital-based physicians providing covered VAD services.
    • Corresponding agreements with Anthem (including reimbursement rates) must be in place.
    • Facility must have and maintain CMS VAD certification.
    Step Therapy

    Step therapy

    No step therapy requirements are specified in this policy.

    Clinical Background

    Durable ventricular assist devices (VADs) are implanted to provide circulatory support as bridge-to-transplant or destination therapy for advanced heart failure. Successful VAD programs require multidisciplinary infrastructure, continuous collection and reporting of patient data, and quality improvement activities. Program evaluation includes tracking patient outcomes, a formal quality improvement plan, quality of life and functional capacity measures, and patient safety initiatives to support program performance monitoring and improvement.

    Definitions & Program Terms

    CME (Anthem Centers of Medical Excellence) — definition and obligations
    DefinitionDesignation awarded by Anthem to programs meeting participation requirements for the VAD network, based on evaluation of structures, processes, and outcomes of care.
    Basis for awardingEvaluation of program structures, processes, participation, and outcomes, including registry reporting and biannual quality criteria
    Program obligationsPrograms must enter patient data for every FDA-approved device into a nationally audited registry and meet survival/adverse-event thresholds relative to national reports
    Actionable notePrograms meeting these CME criteria are eligible for inclusion in Anthem's VAD network but designation is granted only after Anthem review and formal approval.
    UNOS relationship requirement
    Requirement
    Policy Summary
    PayerBlue Cross Blue Shield - Wisconsin
    PolicyVentricular Assist Device (VAD) Facility Participation Criteria
    Policy CodePolicy N/A
    Change TypeNo material changes
    Effective DateN/A
    Next Review DateN/A
    Key ActionEnsure facility, medical group, and hospital-based physicians are participating providers in Anthem's commercial networks and maintain CMS VAD certification with required documentation and registry reporting.
    SourceLink
    On This Page
    Facility Designation & Coverage CriteriaVolume & Coding RequirementsProvider Participation, Documentation & Risk ConditionsClinical BackgroundDefinitions & Program Terms
    Active program periodFacility must have been actively performing VAD implantation over the course of the most recent 3 years
    CertificationFacility must have and maintain CMS VAD certification to meet this requirement
    NotificationFacility must notify Anthem within 24 hours of a working day or 72 hours of a weekend day of material changes that could affect participation
    Documentation Required

    Program documentation and registry reporting

    Programs must maintain and provide program documentation and enter patient data for every FDA‑approved device into a nationally audited registry; they must also maintain a quality improvement plan and track quality-of-life, functional capacity, patient safety initiatives, and related program materials.

    • Maintain multidisciplinary team composition documentation (roles listed in policy).
    • Provide a quality improvement plan and evidence of patient outcome tracking.
    • Enter patient data for every FDA‑approved device into a nationally audited registry.
    • Maintain records of quality of life indicators, functional capacity data, and patient safety initiatives.
    Denial Risk

    Network participation requirement — denial risk

    Failure of the facility, medical group, or hospital-based physicians to be participating providers in Anthem's commercial networks and to maintain corresponding agreements may lead to denial of network designation and affect coverage.

    • Loss of participating provider status or missing agreements can jeopardize CME designation and associated coverage pathways.
    Denial Risk

    Volume, certification, and outcomes risk

    Programs that do not meet minimum facility and surgeon volumes, maintain required certification, satisfy biannual quality criteria, or meet specified survival and adverse-event thresholds relative to INTERMACS/ST S data risk losing CME designation, which can affect coverage pathways.

    • Facility must have averaged ≥20 VAD implants over the most recent consecutive 3 years and been actively performing VAD implantation over the most recent 3 years.
    • Primary surgeon must have implanted ≥12 durable intracorporeal VADs as primary surgeon over the previous 36 months.
    • Facility must maintain CMS VAD certification and meet biannual quality criteria and timely notification requirements.
    • Program overall survival at each timepoint must not be lower than 10% from the national INTERMACS mean; subsequent device count and adverse event rates must not exceed 2% deviation from INTERMACS data.
    Facility must either be a UNOS-certified heart transplant center OR have a relationship with a UNOS-certified heart transplant center that provides heart transplant evaluation and/or emergency support.
    ContinuityFacility must meet all applicable UNOS membership criteria at all times if it is a UNOS-certified center
    PurposeRelationship ensures availability of transplant evaluation and emergency transplant support for VAD recipients