CurrentAmbetter NevadaPolicy CP.MP.127

Total Artificial Heart (TAH) Coverage Criteria

Defines medical necessity criteria for use of the SynCardia temporary Total Artificial Heart as a bridge to heart transplantation for eligible members; also states stance on destination therapy. Affects providers requesting coverage for implantation/replacement of a total artificial heart for Ambetter Nevada members.

Policy Summary

PayerAmbetter Nevada

PolicyTotal Artificial Heart (TAH) Coverage Criteria

Policy CodePolicy CP.MP.127

Change TypeClarification & terminology update

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization for implantation (33927) or replacement/repair (33928) and document transplant approval, active transplant listing, NYHA Class IV status, and failure or ineligibility of other ventricular support devices.

SourceLink

POLICY UPDATE CHANGES

Under I.F. added 'due to irreversible biventricular heart failure'.

Replaced investigational/experimental language in sections II & III with 'insufficient evidence to support the use of …'.

fewer than 100TAH implantations per year in the United States

50Children supported with TAH (Dec 1985–Oct 2019)

33927, 33928Referenced CPT codes

Coverage Criteria

inv-01: COVERAGE CRITERIA

Covered when ALL of the following are met:

Bridge to Transplant Criteria

A: Member/enrollee is approved for cardiac transplant and is currently on transplant list
B: New York Heart Association (NYHA) Functional Class IV
C: Presence of non-reversible biventricular failure unresponsive to all other treatments
D: Ineligible for other ventricular support devices

Policy Summary

PayerAmbetter Nevada

PolicyTotal Artificial Heart (TAH) Coverage Criteria

Policy CodePolicy CP.MP.127

Change TypeClarification & terminology update

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coding and Device Sizing

Referenced CPT CodesCPT

33927	Implantation of a total replacement heart system (artificial heart) with recipient cardiectomy.
33928	Replacement or repair of thoracic unit of a total replacement heart system (artificial heart)

Body surface area / T10 measurement for device sizing

Sizing guidance50cc intended for patients with body surface area (BSA) ≤ 1.85 m² and adequate T10 (posterior sternum to anterior spine at T10) or adequate chest room by 3D imaging/clinical assessment; patients with T10 ≥ 10 cm should be considered for the 70cc device.

Device comparison50cc is a smaller version of the SynCardia 70cc TAH intended for smaller-stature patients; 70cc used when T10 ≥ 10 cm.

FDA indication for 50cc50cc TAH received U.S. FDA approval as a bridge to transplantation in cardiac transplant–eligible patients at risk of imminent death from biventricular failure.

Sizing assessment methodsAdequacy for 50cc may be determined by T10 measurement or by 3D imaging assessment or other standard clinical assessments of chest room.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for implantation or repair of the Total Artificial Heart. Requests must be submitted and approved before scheduling the procedure.

Affected codes: CPT codes for implantation/repair (e.g., 33927, 33928) — prior authorization required
Include expected device model (e.g., SynCardia 50cc or 70cc) and intended use (bridge-to-transplant)

Documentation Required

Requirement to Document Prior/Alternative Therapies

Provide documentation demonstrating failure or ineligibility of alternative ventricular support devices before approval of a Total Artificial Heart.

Document trials of other therapies and mechanical circulatory support devices and clinical reasons for ineligibility (e.g., anatomy, BSA, T10 measurement, prior device failure)
If member is ineligible for other devices, include specific clinical rationale and supporting imaging or specialist consult notes

Documentation Required

Required Documentation

Submit complete clinical documentation to support medical necessity: evidence of transplant approval/active listing, NYHA Class IV status, irreversible biventricular failure, imminent risk of death, FDA-approved device use, and ability to maintain anticoagulation.

Proof of cardiac transplant approval and current listing status
NYHA Functional Class IV documentation
Clinical evidence of non-reversible biventricular failure unresponsive to other treatments
Documentation confirming ineligibility for other ventricular support devices
Statement that a compatible donor heart is currently unavailable and imminent risk of death exists
Device details showing FDA approval and intended use per labeling (e.g., SynCardia 50cc/70cc with BSA/T10 suitability)
Anticoagulation plan demonstrating member can receive adequate anticoagulation while on the device
Relevant imaging (3D chest assessment, T10 measurement), specialist consults, and hospital course notes

Denial Risk

Triggers for Denial

Requests may be denied if documentation does not meet the bridge-to-transplant criteria or if clinical exclusions apply.

Member not approved for transplant or not actively listed
NYHA Functional Class less than IV
Biventricular failure is reversible or responsive to other treatments
Member eligible for other ventricular support devices and no justification for ineligibility
Device proposed for destination therapy (permanent replacement) — considered insufficient evidence and not supported
No evidence that a compatible donor heart is currently unavailable or no imminent risk of death documented
Inability to tolerate/receive adequate anticoagulation

Background

The SynCardia temporary Total Artificial Heart (TAH) is a biventricular pulsatile pump that replaces the native ventricles and valves and is intended to provide circulatory support as a bridge to cardiac transplantation for transplant‑eligible patients. Policy criteria require that patients be approved for transplant and currently listed, have NYHA Functional Class IV symptoms, have non‑reversible biventricular failure unresponsive to other treatments, be ineligible for other ventricular support devices, have no compatible donor heart available, be at imminent risk of death due to irreversible biventricular failure, have a device that is FDA‑approved and used per labeled indications, and be able to receive adequate anticoagulation while supported by the TAH.

Definitions

SynCardia temporary Total Artificial Heart (TAH)

DefinitionSynCardia temporary Total Artificial Heart (TAH) is a biventricular pulsatile pump that replaces the patient’s native ventricles and valves and is used as a bridge to cardiac transplantation in eligible patients.

Indication in policyMedically necessary as a bridge to transplant for transplant‑eligible patients at imminent risk of death from irreversible biventricular heart failure when all coverage criteria are met.

Device modelsIncludes SynCardia 70cc TAH and the smaller SynCardia 50cc TAH for patients of smaller stature.

Freedom Driver (portable driver)

DefinitionThe SynCardia Freedom portable driver is an FDA‑approved external driver that enables clinically stable patients implanted with the TAH to be discharged from the hospital while awaiting donor heart transplantation.

Approval date/contextFDA approved the SynCardia Freedom portable driver (June 26, 2014) for use in implanted, clinically stable TAH patients to allow outpatient support.

Clinical roleAllows outpatient discharge of clinically stable patients supported on the TAH while they await transplant.