Benefit verification and FDA indication required

Verify member benefits and plan-specific exclusions/mandates prior to determining eligibility. Coverage requires documentation that the device and indication are FDA‑cleared or approved; non‑FDA approved/cleared implantable VADs or TAHs are considered experimental/investigational and are not covered.

• Benefit verification with BCBSKS Customer Service prior to authorization
• Document FDA approval/clearance and the specific FDA‑cleared clinical indication

Prior authorization and evidence‑based eligibility documentation

Prior authorization is required for implantable VADs, total artificial hearts (TAH), and percutaneous VADs (pVADs). Requests must reference device‑specific regulatory status, pivotal or high‑quality randomized controlled trial evidence where applicable, and patient clinical criteria demonstrating eligibility (eg, NYHA class, LVEF, inotrope dependence, cardiac index).

• Submit device model and FDA approval/PMA/HDE documentation
• Include RCT or pivotal-study citation(s) that support the requested device use and rationale for generalizing trial criteria to the patient
• For VAD/TAH bridge-to-transplant: document transplant listing status or active evaluation and transplant candidacy

TAH prior authorization — bridge‑to‑transplant criteria

For TAH and implantable VADs intended as bridge‑to‑transplant, prior authorization must document meeting pivotal‑study‑like criteria: failure of maximal medical and inotropic therapy, presence of biventricular failure when applicable, and that the patient is a listed transplant candidate or actively being evaluated and not expected to survive to transplant without device support.

• Document prior inotropic therapy and evidence of failure (hemodynamics, duration)
• If LVAD is not suitable, provide rationale why LVAD/univentricular support is not an option
• For pediatric candidates, include HDE or pediatric FDA indication where applicable

TAH destination therapy — limited evidence

TAH as destination therapy has limited evidence and may be denied or considered investigational; prior authorization should highlight the limited data if requested for destination use.

• State clearly if request is for destination therapy and include supporting evidence; expect higher denial risk due to limited efficacy data

pVAD prior authorization for cardiogenic shock and high‑risk procedures

Prior authorization for pVADs in cardiogenic shock should document indication (eg, refractory cardiogenic shock or high‑risk PCI with reduced EF), prior therapies attempted (including IABP and inotropes), hemodynamics, and justification given mixed RCT results and higher complication rates.

• Specify whether indication is refractory cardiogenic shock versus high‑risk PCI
• Document prior use or consideration of IABP and optimal medical therapy
• Include current hemodynamic parameters (cardiac index, blood pressure, vasopressor/inotrope requirements)

pVAD increased adverse events — document risk/benefit

pVADs have been associated with increased risks (major bleeding, limb ischemia, sepsis) in RCTs and meta‑analyses; weigh potential benefits against higher adverse event rates when requesting coverage.

• Include risk‑benefit discussion in the prior authorization submission
• Provide rationale why alternative therapies (IABP, medical management) are insufficient

Procedure codes and coding linkage to coverage

Providers must submit procedure and device codes with authorization requests. Inclusion of codes in this policy is informational only; codes are considered medically necessary only if the procedure meets the policy’s clinical criteria.

• Attach relevant CPT/HCPCS codes (eg, 33927–33929, 33975–33980, 33990–33997)
• Explicitly state that code listing does not guarantee coverage — coverage depends on meeting policy criteria and member benefits

Contraindications that may trigger denial

Certain contraindications generally used to exclude heart transplant candidates also apply to VAD/TAH candidacy and may lead to denial: chronic irreversible hepatic, renal, or respiratory failure; systemic infection; coagulation disorders; inadequate psychosocial support; uncorrected valvular disease.

• List all active contraindications in the chart and authorization request
• If present, explain any mitigating factors or planned management of the contraindication

Indication and evidence‑based denial risks

Indication‑related denial risk: requests for indications not supported by FDA clearance or by adequate RCT/pivotal evidence (eg, non‑FDA devices, TAH as destination therapy, pVADs outside specified short‑term indications) are at high risk for denial.

• Non‑FDA device use must be identified as experimental/investigational
• TAH destination therapy requests should include compelling new evidence to be considered

Required clinical documentation for authorization requests

Required clinical documentation for prior authorization should include device/regulatory documentation, detailed clinical history, prior therapies and responses, hemodynamic data, and study evidence linking the patient’s presentation to populations studied in pivotal trials.

• Clinical narrative with timeline of heart failure progression and treatments
• List of prior therapies: inotropes (duration/doses), IABP (dates and response), other MCS
• Hemodynamic measurements: cardiac index, left atrial pressure, LVEF, blood pressure
• Device manufacturer, model, FDA approval status, and supporting trial references

Suggested clinical documentation

Suggested supporting documents to include with requests: transplant listing documentation or evaluation status for bridge‑to‑transplant; detailed rationale when LVAD is not an option; selection rationale for cited clinical studies; and anticipated duration of support.

• UNOS listing or active evaluation notes for bridge‑to‑transplant candidates
• Narrative justifying why LVAD/univentricular support is unsuitable when proposing TAH
• Selection rationale linking patient severity to included studies (eg, pivotal trial inclusion criteria)

Policy‑concordant performance and CMS NCD guidance

Policy‑concordant performance is required: procedures and device implantation must follow the policy’s clinical criteria and established guidelines (eg, AHA/ACC, CMS NCD 20.9.1). Noncompliance with CMS National Coverage Determination or guideline‑recommended sequencing may affect coverage.

• Follow AHA/ACC and professional society recommendations when applicable
• Document adherence to CMS NCD 20.9.1 where relevant to VAD indications

Comparator, sequencing, and step‑therapy requirements

Comparator and step‑therapy expectations: optimal medical management, including IABP when indicated, is the comparator. Providers should document consideration or trial of optimal medical therapy and IABP prior to requesting pVADs when clinically appropriate. For TAH/TAH considerations, document prior inotropic therapy failure and sequencing regarding LVAD candidacy.

• Document duration and response to guideline‑directed medical therapy (GDMT)
• Document any IABP use (dates, clinical response) or rationale for not attempting IABP
• Explain sequence of therapies considered (medical → IABP → pVAD/LVAD/TAH)

Policy references and liaison committee resources

Policy references, BCBSKS Cardiology Liaison Committee materials, and key guideline citations should be made available to providers on request to support prior authorization decisions.

• Reference CMS NCD 20.9.1 and major society guidelines (AHA/ACC/HFSA, ISHLT) in submissions
• BCBSKS liaison committee reports may inform local practice expectations