CurrentBlue Cross Blue Shield - WisconsinPolicy N/A

Anthem Centers of Medical Excellence Ventricular Assist Device (VAD) Facility Participation Criteria

Policy Summary

PayerBlue Cross Blue Shield - Wisconsin

PolicyAnthem Centers of Medical Excellence Ventricular Assist Device (VAD) Facility Participation Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

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

POLICY UPDATE CHANGES

No material changes to clinical criteria or coverage in this update.

20Minimum 3-year average VAD implants required

12Minimum surgeon implants in prior 36 months

10%Allowed survival deviation vs INTERMACS mean

2%Allowed adverse outcome deviation vs INTERMACS

Coverage Summary

Defines facility, program, team, volume, certification, quality and outcome criteria for Anthem Centers of Medical Excellence designation for adult VAD programs and requirements for participation in the Anthem VAD network. The policy requires facilities to maintain CMS VAD certification, meet program volume and surgeon experience thresholds, maintain a multidisciplinary VAD team, participate in nationally audited registries, and meet outcome benchmarks compared to national INTERMACS data.

Anthem awards CME designation to VAD programs that meet participation requirements and quality/outcome benchmarks. Key numeric thresholds include a minimum 3-year average of 20 VAD implants, surgeons with at least 12 durable intracorporeal VAD implants in the prior 36 months, program survival no more than 10% lower than the INTERMACS national mean at specified time points, and adverse outcome deviations within 2% of INTERMACS for specified events.

Minimum VAD implants (3-year average)>= 20 VAD implants over the most recent consecutive 3 years

Surgeon experience>= 12 durable intracorporeal VAD implants as primary surgeon over previous 36 months with activity in the last year

Survival deviation thresholdProgram survival not lower than 10% below national INTERMACS mean at 1 month, 3 months, 6 months, 1 year, 2 years, 3 years

Adverse event deviation threshold<= 2% deviation from national INTERMACS data for subsequent device count and adverse event rates (bleeding, device malfunction, infection, stroke, readmission)

Program Participation and Quality Criteria

Core/Absolute Criteria Requirements

Facility, medical group, and hospital-based physicians must meet ALL of the following:

ALL of the following

Facility, Medical Group and all hospital-based physicians located at the facility who provide covered VAD services to Covered Members must be participating providers in Anthem's commercial provider networks and have corresponding agreements, including reimbursement rates, in place with Anthem.
Facility and Medical Group must meet biannual quality criteria, as stated within this document, with formal program approval and notification from Anthem.
Facility and Medical Group must meet/continue to meet Network participation requirements including providing notice to Anthem within 24 hours of a Working Day or 72 hours of a weekend day of any material changes in its team or program structure, changes in federal rating status (such as loss of Medicare certification) or any adverse event that could result in failure to continue to satisfy any of the criteria for participation in the network.
Facility must have and maintain CMS VAD certification.
One of
- Facility is a United Network for Organ Sharing (UNOS) certified heart transplant center, meeting all applicable UNOS membership criteria at all times during the term of this agreement.
- Facility has a relationship with a UNOS certified heart transplant center that provides heart transplant evaluation and/or support in case of emergency heart transplant.
Facility must have been actively performing VAD implantation over the course of the most recent 3 years.
Facility must have performed a minimum volume average of 20 VAD implants over the most recent consecutive 3 years.Minimum 3-year average = 20 VAD implants

General Review Criteria Requirements (Program Team and Operations)

The VAD multidisciplinary team must be based at the facility and ALL of the following roles/requirements apply:

ALL of the following

One or more cardiologists is board certified or board-eligible in advanced heart failure and transplant cardiology or with documented equivalent contemporary experience in the care of device-based management or heart transplants.
One or more physicians with cardiothoracic surgery privileges and individual experience as the primary surgeon implanting at least 12 durable, intracorporeal, VADs as bridge to transplant (BTT) or destination therapy (DT) over the course of the previous 36 months with activity in the last year.Surgeon experience >= 12 implants in prior 36 months
A VAD program coordinator with experience and expertise in the complete treatment course of a VAD recipient.
A registered nurse with experience and expertise providing care for a VAD recipient and family.

Adult Overall Survival Rates

Program survival must meet ALL of the following comparisons vs national INTERMACS data:

At each time point (1 month, 3 months, 6 months, 1 year, 2 years and 3 years), the program's overall patient survival should not be lower than 10% from the corresponding standard (mean) reported survival based on the national INTERMACS data.Not more than 10% lower than INTERMACS mean at 1 month, 3 months, 6 months, 1 year, 2 years, 3 years

Comparison uses latest STS/INTERMACS center-specific report

Adverse Outcomes Measures

Using the latest STS/INTERMACS center-specific report, the program must meet ALL of the following deviation thresholds:

The program's subsequent device count (exhibit 'Primary and Subsequent Device Counts') does not exceed 2% deviation when compared to the corresponding national INTERMACS data.<= 2% deviation

The program's adverse event rates do not exceed 2% deviation when compared to the corresponding INTERMACS data for Bleeding.<= 2% deviation

The program's adverse event rates do not exceed 2% deviation when compared to the corresponding INTERMACS data for Device Malfunction.<= 2% deviation

The program's adverse event rates do not exceed 2% deviation when compared to the corresponding INTERMACS data for Infection.

Additional Program Evaluation Information

Programs are evaluated additionally on the following items (all considered in review):

Patient data are tracked to evaluate outcomes.

Quality Improvement Plan for the VAD program.

Quality of Life Indicators.

Functional Capacity data.

Patient Safety initiatives.

NOTE: Satisfaction of the program quality criteria is not a guarantee of designation.

Provider Actions & Requirements

Documentation Required

Network participation and agreements

Facility, medical group and hospital-based physicians must be participating providers in Anthem's commercial provider networks and have corresponding agreements, including reimbursement rates, in place with Anthem.

Documentation Required

Timely notification of material changes

Facility must notify Anthem of any material changes in its team or program structure, changes in federal rating status, or any adverse event that could affect continued compliance with network participation requirements.

Notify within 24 hours of a Working Day
Notify within 72 hours of a weekend day

Documentation Required

CMS VAD certification maintenance

Facility must have and maintain CMS VAD certification and provide verification when requested.

Documentation Required

Registry reporting

Patient data for every FDA-approved device must be entered into a nationally audited registry to evaluate outcomes.

Documentation Required

Verification of approvals after staffing changes

When there has been a change in the VAD primary physician and/or surgeon during the most recent 36-month period, the program must provide verification of CMS or Joint Commission approval.

Denial Risk

Designation denial or removal risk

Failure to meet certification, volume, team composition, outcome or quality thresholds may result in failure to receive or continue CME designation.

Background

Anthem's Centers of Medical Excellence (CME) designation is awarded to programs that meet the participation requirements for Anthem's VAD network after rigorous evaluation of clinical data, including structures, processes and outcomes. Designation depends on network participation (participating providers and agreements), biannual quality criteria, and timely notification to Anthem of material program changes or adverse events.

The designation process requires facilities to maintain CMS VAD certification and either be a UNOS-certified heart transplant center or have an established relationship with a UNOS-certified center for transplant evaluation/support. Outcome and benchmark comparisons use nationally audited registry data — specifically the STS/INTERMACS center-specific reports — to evaluate survival at multiple time points and adverse event rates for program review.

Evidence for outcome and adverse event benchmarking is drawn from The Society of Thoracic Surgeons (STS) Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) center-specific reports, which are used to compare program device counts, adverse event rates (bleeding, device malfunction, infection, stroke, readmission) and survival against national INTERMACS standards.

OpenPayer

Anthem Centers of Medical Excellence Ventricular Assist Device (VAD) Facility Participation Criteria

Coverage Summary

Program Participation and Quality Criteria

Provider Actions & Requirements

Coding / Facility Listing

Background

Definitions

Revision History

Term	Definition
CME
Anthem Centers of Medical Excellence designation
VAD
Ventricular Assist Device
UNOS
United Network for Organ Sharing
INTERMACS
Interagency Registry for Mechanically Assisted Circulatory Support (national registry)