CurrentEmpire BluecrossPolicy N/A

Ventricular Assist Device (VAD) Facility Participation Criteria

Defines Anthem's Centers of Medical Excellence criteria and requirements for hospitals and programs to be designated in the VAD (adult) network; affects facilities, medical groups, and hospital-based physicians that provide VAD services to Anthem covered members.

Policy Summary

PayerEmpire Bluecross

PolicyVentricular Assist Device (VAD) Facility Participation Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionEnsure facility, medical group, and hospital-based physicians are participating providers in Anthem's commercial networks with agreements in place.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

20minimum average VAD implants (3 yrs)

3 yearsactive performance period

12surgeon implant minimum (36 mo)

24/72hnotification timeframe

≤10%allowed survival deviation

≤2%allowed adverse event deviation

Facility Participation & Quality Criteria

inv-01: Core/Absolute Participation Requirements

Facilities must meet ALL of the following Core/Absolute Criteria:

Core/Absolute Criteria: Facility, Medical Group and all hospital-based physicians providing covered VAD services must be participating providers in Anthem's commercial provider networks with corresponding agreements and reimbursement rates in place; Facility and Medical Group must meet biannual quality criteria and maintain formal program approval and notification from Anthem; Facility and Medical Group must meet and continue to meet network participation requirements, including providing notice to Anthem within 24 working hours or 72 weekend hours of any material changes in team or program structure, changes in federal rating status (e.g., loss of Medicare certification), or any adverse event that could affect participation eligibility; Facility must have and maintain CMS VAD certification; Facility must either be a UNOS-certified heart transplant center or have a relationship with a UNOS-certified heart transplant center that provides transplant evaluation and/or emergency transplant support; Facility must have been actively performing VAD implantation during the most recent 3 years; Facility must have performed a minimum average of 20 VAD implants over the most recent consecutive 3 years.Program volume: average ≥20 VAD implants over most recent consecutive 3 years; Facility active VAD implantation period: most recent 3 years

From Core/Absolute Criteria Requirements

inv-02: General Review Criteria

Policy Summary

PayerEmpire Bluecross

PolicyVentricular Assist Device (VAD) Facility Participation Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionEnsure facility, medical group, and hospital-based physicians are participating providers in Anthem's commercial networks with agreements in place.

SourceLink

On This Page

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Team composition and program functions: A multidisciplinary VAD team based at the facility must manage VAD recipients and include: one or more cardiologists board-certified or board-eligible in advanced heart failure and transplant cardiology (or documented equivalent experience); one or more cardiothoracic surgeons with individual experience as the primary surgeon implanting at least 12 durable intracorporeal VADs (BTT or DT) in the previous 36 months with activity in the last year; a VAD program coordinator experienced in the full VAD care course; a registered nurse experienced with VAD care; a social worker; a palliative care representative; a nutrition services representative; a psychological services representative; a rehabilitative services representative; and a financial support representative. When there has been a change in the VAD primary physician and/or surgeon within the most recent 36 months, the program must provide verification of CMS or Joint Commission approval; the team must ensure patient and caregiver education, informed consent, and advanced care planning; the program must provide 24/7 support for emergency and urgent post-discharge care; care coordination prior to discharge must include contact information for the community practitioner who will provide ongoing VAD care; the program must provide education/resources to community practitioners as needed; and patient data for every FDA-approved device must be entered into a nationally audited registry to evaluate outcomes.Surgeon implant experience: primary surgeon ≥12 durable intracorporeal VAD implants in prior 36 months

From General Review Criteria Requirements

inv-03: Outcome and Adverse Event Criteria

Program performance must meet outcome benchmarks relative to national registry data:

Outcome benchmarks: Overall patient survival at 1 month, 3 months, 6 months, 1 year, 2 years and 3 years should not be lower than 10% from the corresponding national INTERMACS mean; the program's subsequent device count deviation must not exceed 2% compared with corresponding national INTERMACS data; adverse event rates (bleeding, device malfunction, infection, stroke, readmission) must not exceed 2% deviation compared with corresponding INTERMACS data.Survival deviation ≤10% from INTERMACS mean; Adverse event and subsequent device count deviation ≤2% from INTERMACS

From Adult Overall Survival Rates and Adverse Outcomes Measures

Key Volume, Surgeon Experience & Performance Thresholds

inv-05: Surgeon implant experience

RequirementPrimary surgeon must have implanted ≥12 durable intracorporeal VADs (bridge-to-transplant or destination therapy) in the previous 36 months, with activity in the last year.

ScopeApplies to the individual identified as the primary surgeon performing VAD implantation at the facility.

EvidenceVerification required when there has been a change in the VAD primary physician and/or surgeon within the most recent 36-month period (CMS or Joint Commission approval).

inv-06: Program volume

Minimum average volumeProgram must have performed an average of ≥20 VAD implants over the most recent consecutive 3 years.

Active practice periodFacility must have been actively performing VAD implantation over the course of the most recent 3 years.

Program-level requirementApplies to the facility/program as a condition for participation and CME designation consideration.

inv-07: Survival performance threshold

Survival benchmarkProgram overall patient survival at 1 month, 3 months, 6 months, 1 year, 2 years and 3 years should not be lower than 10% from the corresponding national INTERMACS mean.

Data sourceBenchmarks use the latest STS/INTERMACS center-specific report (national INTERMACS data).

Time points assessed1 month, 3 months, 6 months, 1 year, 2 years, and 3 years.

inv-08: Adverse outcome deviation

Adverse event deviation limitProgram adverse event rates for bleeding, device malfunction, infection, stroke, and readmission must not exceed a 2% deviation compared to INTERMACS data.

Subsequent device countProgram's subsequent device count must not exceed a 2% deviation compared to corresponding national INTERMACS data.

Data sourceMeasures use the latest STS/INTERMACS center-specific report for comparisons.

Network Participation, Data Submission, and Notification Requirements

Prior Authorization

Network participation and agreements

Facility, Medical Group, and all hospital-based physicians providing covered VAD services to Covered Members must be participating providers in Anthem's commercial networks and have corresponding agreements (including reimbursement rates) in place with Anthem. Failure to maintain network participation for the facility, medical group, or hospital-based physicians may jeopardize program approval and member coverage for services provided at that site.

Facility, Medical Group and all hospital-based physicians must be participating providers in Anthem's commercial networks with signed agreements in place.
Facility and Medical Group must meet biannual quality criteria and maintain formal program approval and notification from Anthem.
Facility must maintain CMS VAD certification and either be a UNOS-certified heart transplant center or have a formal relationship with a UNOS-certified center for transplant support.

Documentation Required

Data submission and quality documentation

Programs must track and submit patient-level data for every FDA-approved device into a nationally audited registry (e.g., INTERMACS/STS registry) to evaluate outcomes. The program must maintain documentation of registry submissions, quality improvement plans, quality of life and functional capacity measures, patient safety initiatives, and any other materials used to evaluate VAD program outcomes. These records must be available for Anthem review as requested.

All patient data for every FDA-approved device entered into a nationally audited registry.
Maintain documentation: registry submissions, Quality Improvement Plan, Quality of Life indicators, Functional Capacity data, Patient Safety initiatives.
Program must provide registry-derived reports (survival, adverse events, device counts) as requested for Anthem review.

Denial Risk

Quality and outcome benchmarks

Programs that do not meet established volume, survival, or adverse outcome benchmarks may be subject to remedial action or loss of approved status. Specifically, the program must meet minimum volume thresholds and outcome deviations as defined by national INTERMACS/ST S benchmarks.

Minimum volume: Facility must have performed an average of at least 20 VAD implants over the most recent consecutive 3 years and be actively performing VAD implantation during that period.
Survival benchmark: At 1 month, 3 months, 6 months, 1 year, 2 years and 3 years, overall patient survival should not be lower than 10% below the corresponding national INTERMACS mean.
Adverse outcomes benchmark: Subsequent device count deviation and adverse event rates (bleeding, device malfunction, infection, stroke, readmission) must not exceed 2% deviation from corresponding INTERMACS data.
Failure to meet volume or outcome thresholds may result in loss of program approval or other network participation consequences.

Note

Change notification

Provide notice to Anthem within twenty-four (24) hours of a Working Day or seventy-two (72) hours of a weekend day of any material changes in team or program structure, changes in federal rating status (such as loss of Medicare certification), any adverse event that could affect continued compliance with participation criteria, or other material changes that could impact member care or program qualification.

Notify Anthem within 24 working hours or 72 weekend hours of: material team/program structure changes; loss or change of CMS/Medicare certification; significant adverse events affecting program eligibility.
When there has been a change in the VAD primary physician and/or surgeon within the most recent 36 months, provide verification of CMS or Joint Commission approval.

Key Definitions

inv-16: CME (Anthem Centers of Medical Excellence)

DefinitionDesignation awarded by Anthem to programs meeting participation requirements for the VAD network following evaluation of clinical data, structures, processes, and outcomes.

Evaluation basisAward based on program participation, clinical data, structures, processes, and outcomes as assessed by Anthem.

Notification requirementPrograms must notify Anthem within 24 working hours or 72 weekend hours of material changes in team or program structure, federal rating changes, or adverse events that could affect participation.

inv-17: Multidisciplinary VAD team

Core membersAdvanced heart failure cardiologist(s); cardiothoracic surgeon(s) meeting implant experience thresholds; VAD program coordinator; VAD-experienced registered nurse; social worker; palliative care representative; nutrition services; psychological services; rehabilitative services; financial support representative.

LocationMultidisciplinary VAD team must be based at the facility.

Program responsibilitiesEnsure patient/caregiver education, informed consent, advanced care planning, 24/7 urgent support, discharge coordination with community practitioner contact, and entry of patient data for every FDA-approved device into a nationally audited registry.

OpenPayer

Ventricular Assist Device (VAD) Facility Participation Criteria

Facility Participation & Quality Criteria

Key Volume, Surgeon Experience & Performance Thresholds

Network Participation, Data Submission, and Notification Requirements

Clinical Background

Key Definitions