Prior Authorization Required

Prior authorization is required for VAD procedures and supplies when medical necessity criteria are being claimed. Prior authorization requests should confirm FDA approval for the chosen device and that the member meets the applicable clinical criteria (e.g., destination therapy labeling, NYHA class, prior medical management, LVEF, peak VO2 or documented dependence on balloon pump/IV inotropes). Failure to document FDA approval status and alignment with labeled indications may affect coverage determination.

• Prior authorization required for listed VAD procedure and supply codes when medical necessity is claimed (see CPT/HCPCS code lists).
• Confirm device has FDA approval for the requested indication (bridge to transplant, destination therapy, temporary support, pediatric indication, etc.).

Prior Authorization: Temporary VADs (up to 14 days)

Temporary-use VADs intended for short-term circulatory support (examples: CentriMag, Impella RP) are described for use up to 14 days for indicated acute right ventricular failure or post-operative support. Prior authorization should reflect the temporary nature and the FDA-labeled duration of use.

• CentriMag: FDA HDE approved for temporary support up to 14 days for cardiogenic shock due to acute RV failure.
• Impella RP: intended for temporary support up to 14 days for adults/pediatrics (BSA ≥ 1.5 m2) in specified settings.

Authorization Aligned with FDA Indications

Authorization decisions must align with FDA-approved indications for devices. Use of devices or indications not approved by the FDA or not listed in this policy should be considered experimental/investigational and are not covered.

• Examples: Destination therapy and bridge-to-transplant indications require device-specific FDA labeling (e.g., HeartMate 3, HeartMate II).
• Off-label use of pVADs or pediatric VADs outside specified medically necessary criteria is considered experimental/investigational.

Concomitant Aortic Valve Procedures Require Documented Justification

When a concomitant aortic valve procedure is planned at the time of LVAD implantation, documentation must justify the indication for the valve procedure and include evidence of discussion of increased perioperative risk and alternative approaches. Concurrent aortic valve procedures have been associated with higher short-term mortality and reduced long-term survival compared with isolated LVAD implantation.

• Document the specific indication for the aortic valve procedure (repair, replacement, closure) and pre-procedure aortic insufficiency severity.
• Document that risks and benefits, including higher short-term mortality and longer cardiopulmonary bypass time, were discussed with the patient/caregiver.

Prior Authorization — Not Specified in This Section

This section does not specify additional separate prior authorization pathways beyond the requirement to consult the main policy and applicable plan/program provisions. Providers should consult the main policy, plan disclosures, and program provisions for operational details (submission portals, timelines, and local plan rules).

• If in doubt, submit clinical documentation with the authorization request per the main policy guidance and plan-specific instructions.
• Refer to plan disclosures and program provisions for member-specific coverage rules.

Prior Authorization — See Main Policy

Providers should consult the main VAD policy and plan documents for full prior authorization instructions, submission checklists, and any network- or plan-specific requirements.

• See main policy and plan disclosures for how to initiate prior authorization and for any state- or product-specific exceptions.

Use of a VAD for Indications Other Than FDA‑Approved/Policy‑Listed

Use of a VAD for indications other than FDA‑approved or policy-listed indications is considered experimental and investigational and is not covered due to insufficient evidence.

• Off-label uses lacking peer-reviewed evidence are not covered.
• Provide clinical trial identifiers or strong evidence if pursuing coverage for novel indications; otherwise, expect denial as investigational.

Observational Data Limitations May Trigger Review

Observational and registry data have limitations (residual confounding, limited granular hemodynamic/lab data, device heterogeneity) that may prompt additional review or requests for more detailed documentation to support medical necessity.

• Registry/retrospective studies may not capture the clinical status at decision time (vasopressor use, lactate, right heart cath measurements).
• Be prepared to provide detailed hemodynamics, timing of device placement, and rationale when observational evidence is used to support requests.

HVAD Safety / Market Withdrawal

The HeartWare (HVAD) system distribution and sale were stopped by the manufacturer due to safety concerns (increased neurological adverse events and mortality) and device-specific pump failure risks. Providers must account for this market withdrawal when requesting authorization and should document device availability and safety considerations.

• Medtronic stopped distribution/sale of the HeartWare HVAD System (August 2021) due to increased risk of neurologic events and mortality.
• If HVAD or other withdrawn devices are proposed, include justification and mention alternative FDA‑approved devices.

LVAD in ESRD — Prognostic Consideration

For members with end-stage renal disease (ESRD) being considered for LVAD placement, document the poor prognosis and engage in shared decision-making; the markedly increased early mortality may affect appropriateness and coverage considerations.

• Studies report very high early mortality in ESRD patients after LVAD placement (median time to death often measured in days; significantly higher in-hospital mortality).
• Document counseling regarding prognosis and treatment goals when ESRD is present.

No Denial Triggers Are Specified in This Section

No specific denial triggers are enumerated in this section beyond the general statements that non–FDA‑approved or investigational uses are not covered. Providers should recognize that absence of required documentation or failure to meet stated clinical criteria may result in denial.

• There are no additional explicit provider-level denial triggers listed here; however, lack of required documentation or nonalignment with FDA/policy criteria may prompt denial.
• If coverage is denied, providers can appeal with supplemental clinical evidence aligning to policy criteria.

No Denial Triggers or Authorization Requirements in Additional-Information Sections

Similarly, no separate denial triggers or additional authorization requirements are listed in the Additional Information sections; operational or plan-level requirements should be confirmed with the main policy and plan documents.

• Check plan disclosures and program provisions for any member- or product-specific denial or authorization rules.

Documentation Should Support FDA Approval and Clinical Status

Documentation submitted with authorization requests should explicitly support FDA approval status and demonstrate the member meets clinical criteria: NYHA class, LVEF, duration and failure of optimal medical management, peak VO2 results or objective dependence on inotropes/balloon pump, and device model and indication.

• Document NYHA functional class, LVEF (%) and peak VO2 (ml/kg/min) if available.
• If exercise testing not possible, document inotrope or balloon pump dependence with duration (e.g., 7 days for balloon pump, 14 days for IV inotropes).
• Confirm and document device model and its FDA-labeled indication.

Recommended Clinical Documentation Elements

Recommended clinical documentation elements to include with prior authorization: detailed hemodynamics, vasopressor/inotrope use and duration, lactate, right-heart catheterization measurements, device model, timing of device placement, and peri-procedural details.

• Right heart cath values (RAP, PAP, PCWP, cardiac index), PAPi and other RV failure predictors.
• Timing of events (onset of shock, device insertion date), vasopressor doses and duration, lactate trends, and prior ECMO/renal replacement therapy if applicable.

Device Trial Documentation

When authorization is supported by device trial data, provide trial-supported indications and relevant cohort characteristics (including pediatric cohorts and body-surface-area groups) to demonstrate applicability to the member.

• Include IDE or post-approval study identifiers and outcomes if relying on trial evidence (e.g., Excor pediatric IDE cohorts by BSA).
• Document how the member’s characteristics align with trial cohorts (age, BSA, severity).

Pre-Implant RV Failure Risk Documentation

Pre-implant assessment should document risk factors for post-LVAD right ventricular failure (RVF) — include INTERMACS profiles, need for pre-op ECMO or renal replacement therapy, severe tricuspid regurgitation, prior cardiac surgery, and hemodynamic predictors (elevated RAP, low PAPi, low stroke volume).

• Report INTERMACS profile, pre-op support (ECMO, IABP), renal replacement therapy status, and echocardiographic/tricuspid regurgitation findings.
• Provide calculated PAPi and other RVF risk indices where available.

No Documentation Requirements Are Specified Beyond Those Listed

This section does not specify separate or additional documentation requirements beyond the clinical items listed above; submit those standard elements with authorization requests.

• If specific plan or state rules impose additional documentation requirements, include those per main policy guidance.

Medical Therapy Trial

Prior to LVAD implantation for destination therapy, members 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 alternative dependency criteria (7 days balloon pump, 14 days IV inotropes). Evidence of attempted optimal medical therapy should be provided.

• Document medication trials, doses, and durations (e.g., beta-blocker, ACE inhibitor) covering at least 45 of the last 60 days when applicable.
• Alternatively document documented balloon pump or IV inotrope dependence with duration.

Step Approach Recommendation — Consider IABP Before Micro-Axial LVAD (Evidence Context)

Given comparative evidence suggesting higher in-hospital mortality and bleeding with intra-vascular micro-axial LVADs versus IABP in some AMI/CS cohorts, consider a step approach (e.g., IABP before micro-axial LVAD) where clinically appropriate; document rationale for device selection.

• If bypassing IABP in favor of a micro-axial device (Impella), provide clinical justification and supporting hemodynamics.
• Recognize observational evidence limitations and document why the selected device is optimal for the individual patient.

Step Therapy

There are no formal step-therapy sequencing requirements specified in this policy (no mandatory trials of another device prior to approval), but clinical judgement and documentation supporting device choice are expected.

• Providers should document rationale if an alternative device or escalation was not attempted.
• Authorization reviewers may request additional justification when step choices deviate from common practice.

Pediatric Anti-Thrombotic Plan

For pediatric durable VAD candidates, include a planned anti-thrombotic regimen and monitoring plan in the documentation due to high bleeding and thrombotic event rates and variability in practice.

• Document perioperative and long-term anticoagulation strategy (e.g., unfractionated heparin transitioning to LMWH/warfarin) and antiplatelet plan (aspirin, dipyridamole where applicable).
• Include monitoring plans and laboratory targets given pediatric monitoring challenges.