Cigna VAD pVAD TAH Coverage Update

Coverage Criteria for Mechanical Circulatory Support

Implantable Ventricular Assist Devices (VADs) — general medical necessity

A U.S. FDA‑approved VAD is medically necessary when used in accordance with device‑specific FDA indications and ANY of the following are met:

VAD medical necessity any-of list: 1) Individual in acute cardiogenic shock when recovery is expected; 2) Individual unable to be weaned from cardiopulmonary bypass following cardiac surgery when recovery is expected; 3) Individual in whom heart transplantation is anticipated and who is otherwise not expected to survive until transplantation; 4) Individual not expected to be considered a candidate for heart transplantation, when ALL of the following are met: NYHA Class IV end-stage left ventricular heart failure; left ventricular ejection fraction (LVEF) < 25%; demonstrated functional limitations with peak oxygen consumption (peak VO2) ≤ 14 mL/kg/min; failure to respond to optimal medical therapy for 45 of the last 60 days, or dependence on intra-aortic balloon pump for 7 days, or inotropes for at least 14 days.

Model AND/OR logic preserved; item 4 is an AND group nested within the ANY operator

CentriMag indications

CentriMag Blood Pump is medically necessary for either of the following temporary uses:

CentriMag allowed uses: 1) Use as a right ventricular assist device (RVAD) for temporary circulatory support per the FDA HDE when BOTH: device is used for up to 30 days for cardiogenic shock due to acute right ventricular failure; AND the individual is willing and able to be treated with heparin or an appropriate alternative anticoagulation. 2) Use for up to six hours to provide hemodynamic stabilization in an individual in need of cardiopulmonary support.up to 30 days (RVAD) or up to 6 hours

Both/any logic preserved

Pediatric VADs (HeartAssist 5, Berlin Heart EXCOR)

Specific pediatric VADs are medically necessary as a bridge to transplant when device‑specific HDE/PMA criteria are met:

HeartAssist 5 pediatric criteria: Age 5–16; body surface area (BSA) ≥ 0.7 m2 and < 1.5 m2; NYHA Class IV end‑stage heart failure refractory to medical therapy; listed candidate for cardiac transplantation; and none of the following contraindications: primary coagulopathy/platelet disorders, anatomical anomalies preventing outflow graft connection to the ascending aorta, unresolved right ventricular failure.

All criteria must be met per HDE

Berlin Heart EXCOR pediatric criteria: Child with severe isolated left ventricular or biventricular dysfunction who is a candidate for cardiac transplant and requires circulatory support, in accordance with FDA labeling/requirements.

All criteria per device labeling

Percutaneous VADs

Specified percutaneous VAD systems are medically necessary for cardiogenic shock and selected high‑risk PCI indications:

Cardiogenic shock: TandemHeart PTVA, Impella 2.5, Impella CP, Impella 5.0, Impella 5.5 (with SmartAssist) and Impella RP (for right‑sided failure) are medically necessary for the treatment of cardiogenic shock when used consistent with FDA indications and labeling.

Any of listed devices for shock; align with device‑specific duration limits

High‑risk PCI uses: Impella 2.5, Impella CP, and Impella CP with SmartAssist are medically necessary during high‑risk PCI for EITHER: PCI on an unprotected left main or last patent coronary vessel with LVEF ≤ 35%; OR PCI for three‑vessel disease with LVEF ≤ 30%.

Either high‑risk PCI condition suffices

Impella RP is medically necessary for up to 14 days in a child or adult with BSA ≥ 1.5 m2 for acute right heart failure or decompensation following LVAD implantation, myocardial infarction, heart transplant, or open‑heart surgery.up to 14 days; BSA ≥ 1.5 m2

Duration and BSA thresholds specified per HDE/PMA

Total Artificial Heart (SynCardia)

SynCardia temporary Total Artificial Heart (TAH) and Freedom Driver System coverage stance:

SynCardia medical necessity: SynCardia temporary TAH is medically necessary as a bridge to transplantation in transplant‑eligible individuals at risk of imminent death from biventricular failure. The SynCardia Freedom Driver System is medically necessary in an individual who is clinically stable when discharge is planned following a medically necessary SynCardia implant.

Both items covered when device‑specific conditions met

SynCardia not medically necessary: SynCardia temporary TAH or SynCardia Freedom Driver System is not medically necessary for any indication other than the specified bridge‑to‑transplant uses.

Exclusive limitation

General coverage stance for VAD use

Covered when ALL of the following are met

FDA device‑specific inclusion/exclusion: Patient meets the FDA‑defined, device‑specific inclusion and exclusion criteria for the selected VAD (adult or pediatric).

See device IFU/PMA/HDE for exact criteria.

Indications: Device use is for one of the following: bridge to recovery in acute cardiogenic shock or myocarditis, bridge to transplantation, or destination therapy for selected end‑stage heart failure patients not eligible for transplant.

Patients must meet device‑specific FDA criteria.

Support duration and device type alignment: Device selection must match the intended duration of support and the device's labeled use (temporary percutaneous/short‑term devices versus implantable long‑term devices).

Examples: some percutaneous devices intended ≤6 hours (predicate 510(k)s), Impella 2.5/CP ≤4 days, Impella 5.0/LD ≤6 days, Impella 5.5 and Impella RP up to 14 days; CentriMag RVAD HDE up to 30 days.

Indicated clinical scenarios (per FDA approvals)

Coverage considerations are tied to FDA indications and available evidence; devices are used for short‑term support in specified settings.

FDA‑indicated uses: Device use must be consistent with FDA‑approved indications: treatment of cardiogenic shock (post‑AMI, post‑open heart surgery, cardiomyopathy/myocarditis) or temporary support for high‑risk PCI per device labeling; documentation should match the intended short‑term duration limits noted in approvals/summaries.as per device labeling (see device‑specific duration limits)

Supports coverage when documentation matches FDA indications and limits

Evidence summary and comparative outcomes

Evidence‑based expectations and comparative considerations

Comparative effectiveness: Randomized trials and meta‑analyses have not consistently demonstrated a mortality benefit of pVADs over intra‑aortic balloon pump (IABP); pVADs can improve hemodynamics and procedural metrics but are associated with increased bleeding and other adverse events; clinical judgment is required when selecting device type and timing.N/A

Evidence is limited and mixed; document rationale for device selection

TAH (SynCardia/CardioWest) bridge-to-transplant coverage criteria

Covered when ALL of the following are met (per pivotal trial inclusion and policy coding statements):

TAH candidate criteria: Patient is a candidate for heart transplantation per institutional criteria (NYHA Class IV; failing maximal medical therapy) AND meets anatomic/size constraints (BSA approximately 1.7–2.5 m2 or sternum‑to‑vertebra distance ≥10 cm) AND has qualifying hemodynamic compromise (eg, cardiac index ≤2.0 L/min/m2 with systolic arterial pressure ≤90 mm Hg or central venous pressure ≥18 mm Hg, or need for high‑dose inotropes, IABP, or cardiopulmonary bypass) AND does not have exclusionary conditions (pulmonary vascular resistance ≥640 dyn·sec·cm−5, dialysis within prior 7 days, serum creatinine ≥5 mg/dL, cirrhosis with total bilirubin ≥5 mg/dL, cytotoxic antibody ≥10%).see individual node texts

Reflects inclusion/exclusion criteria from multicenter controlled clinical trial supporting FDA approval.

Contraindications (updated wording)

Policy updates and contraindication changes

Contraindication wording update: Contraindication verbiage was changed to 'incurable systemic malignancy'.

Replaces prior wording 'malignancy that is expected to significantly limit future survival'.

Device-specific coverage statements

Policy status changes for specific devices

SynCardia Freedom Driver System: A not medically necessary policy statement was added for the SynCardia Freedom Driver System on 1/15/2025; concurrently the Freedom Driver System was removed from the experimental/investigational listing in the prior annual review.

Documented policy change per revision history

Percutaneous ventricular assist devices (pVADs) are covered only for the specific FDA‑labeled uses described in this policy. A pVAD used for any indication other than cardiogenic shock or the defined high‑risk PCI scenarios (unprotected left main/last patent vessel with LVEF ≤ 35% or three‑vessel disease with LVEF ≤ 30%) is considered not medically necessary. Permanently implantable aortic counterpulsation VADs are considered experimental/investigational and not covered for any indication because no FDA‑approved implantable aortic counterpulsation device exists.

Device Instructions for Use (IFU) list contraindications that may preclude coverage. Examples include inability or unwillingness to tolerate systemic anticoagulation (noted for CentriMag and Berlin Heart EXCOR), pediatric age or BSA below device‑specific thresholds, unresolved right ventricular failure for certain LVADs, and prior surgeries or anatomic conditions that prevent safe implantation or graft anastomosis.

The FDA‑stated contraindications for specific devices are explicit and should be checked prior to authorization. For Impella left‑side systems the IFU contraindications include mural thrombus in the left ventricle, presence of a mechanical aortic valve, severe aortic stenosis or significant aortic insufficiency, severe peripheral arterial disease that would prevent catheter placement, significant right heart failure, combined cardiorespiratory failure, septal defects, left ventricular rupture, and cardiac tamponade. For right‑sided devices such as Impella RP, contraindications include disorders of the pulmonary artery wall preventing placement, mechanical or severe tricuspid/pulmonic valvular disease, mural thrombus of the right atrium or vena cava, anatomic impediments to pump insertion, and presence of vena cava filters without adequate femoral access.

Permanently implantable aortic counterpulsation ventricular assist devices are considered investigational/experimental. No such device has FDA approval and published peer‑reviewed evidence on safety and effectiveness is sparse, so proposals for permanently implantable aortic counterpulsation systems lack sufficient support for coverage.

Because no FDA‑approved permanently implantable aortic counterpulsation device exists and the evidence base is limited, procedures to report insertion, replacement, programming/interrogation, relocation, or removal of permanently implantable aortic counterpulsation systems are considered experimental/investigational and not covered. Where such services are reported, unlisted cardiac procedure codes (e.g., 33999) may be subject to denial as not medically necessary.

A prior policy statement that referenced use of VADs as part of an ECMO circuit has been removed from the policy language. This change is reflected in the policy revisions effective 1/15/2025 and means the policy no longer contains a separate statement addressing VAD use specifically in the context of ECMO circuits.

A VAD is considered not medically necessary when a patient has contraindications to permanent (implantable) placement. Examples listed in the policy include persistent or recurrent major systemic infections, systemic illnesses or comorbidities expected to substantially worsen device outcomes, and lack of sufficient caregiver support; these conditions are evaluated against device IFU contraindications and may preclude coverage.

The SynCardia temporary Total Artificial Heart is covered as a bridge to transplantation for transplant‑eligible patients at imminent risk of death from biventricular failure, and the SynCardia Freedom Driver System is covered to support discharge after a medically necessary SynCardia implant. Use of the SynCardia temporary TAH or the SynCardia Freedom Driver System for any indication outside these specified bridge‑to‑transplant or discharge‑support scenarios is considered not medically necessary.

Devices that have been withdrawn from distribution or that are subject to unresolved FDA safety communications may trigger additional review or be considered not medically necessary. The policy cites examples such as the Medtronic HVAD distribution stop and other manufacturer safety communications; providers should expect denial risk or heightened review when devices with known safety actions are proposed for use.

Use of pVADs outside the FDA‑labeled settings (for example outside the specified cardiogenic shock or high‑risk PCI indications) or support prolonged beyond device‑labeled durations is not supported by the current evidence and is considered not medically necessary. Device‑specific duration limits (e.g., Impella 2.5/CP ≤ 4 days, Impella 5.0/LD ≤ 6 days, Impella 5.5 and Impella RP up to 14 days, and some devices intended only for ≤ 6 hours per 510(k)/label) must be observed in documentation submitted for authorization.

Routine initial use of pVADs as the first‑line mechanical management for cardiogenic shock or high‑risk PCI is not supported by randomized trial data. Trials and meta‑analyses have not consistently demonstrated a mortality benefit over intra‑aortic balloon pump (IABP) and have shown increased adverse events (for example bleeding and vascular complications), so routine first‑line use in place of established therapies is not supported by the evidence.

When reporting insertion or replacement of a permanently implantable aortic counterpulsation device and related programming/interrogation or relocation procedures, use of unlisted cardiac procedure codes (e.g., 33999) is referenced in the policy; however, these services are considered experimental/investigational and are not covered under the policy.

On 1/15/2025 a not medically necessary policy statement specifically naming the SynCardia Freedom Driver System was added to the policy. This update indicates that billing for the Freedom Driver System for indications outside the specified covered discharge‑support use will be subject to not medically necessary determinations.

Coding and Product Identifiers

Devices and referenced device models (device names)mixed

CentriMag	CentriMag Blood Pump (device name referenced as medically necessary in specific temporary indications)
HeartAssist 5 Pediatric VAD	HeartAssist 5 Pediatric VAD (HDE) bridge to transplantation in children meeting criteria
Berlin Heart EXCOR Pediatric VAD	Berlin Heart EXCOR Pediatric VAD bridge to transplantation in pediatric candidates
TandemHeart PTVA System	TandemHeart PTVA System — percutaneous VAD considered medically necessary for cardiogenic shock
Impella 2.5 / CP / 5.0 / 5.5 / RP	Impella systems — specified models considered medically necessary for cardiogenic shock; certain models for high-risk PCI
SynCardia temporary Total Artificial Heart	SynCardia temporary TAH considered medically necessary as a bridge to transplantation
SynCardia Freedom Driver System	SynCardia Freedom Driver System considered medically necessary to support discharge post-implant
Abiomed BVS 5000 / AB 5000	Abiomed BVS 5000 / AB 5000 circulatory support system — FDA PMA indicated uses noted
HVAD / HeartWare VAS	HeartWare (HVAD) VAS — device discussed with safety communications and distribution status noted

FDA 510(k) device identifiers mentionedmixed

K052570	TandemHeart Transseptal Cannula Set-EF 510(k)
K061369	TandemHeart Escort Controller 510(k)

PMA / HDE identifiers mentionedmixed

H070004	CentriMag HDE approval
H030003	HeartAssist 5 Pediatric VAD HDE approval
H100004	Berlin Heart EXCOR Pediatric HDE approval
P160035	Berlin Heart EXCOR PMA approval (device)
P160054	HeartMate 3 PMA approval
P060040	HeartMate II PMA approval

510(k) clearances mentionedmixed

K020271	CentriMag 510(k)
K090051	PediMag 510(k)

FDA 510(k)/PMA/HDE identifiers citedmixed

K052570	TandemHeart Transseptal Cannula Set-EF 510(k)
K061369	TandemHeart Escort Controller 510(k)
K063723	Impella Recover LP 2.5 510(k)
K112892	Impella 2.5 Plus (Impella CP) 510(k)
K083111	Impella 5.0 Catheters 510(k)
P140003	Impella 2.5 PMA / base PMA
P140003/S008	Impella CP added to PMA
P140003/S004/S005	PMA supplement expanding cardiogenic shock indication
P140003/S018	PMA supplement expanding indications
P140003/S027	PMA supplement removing 'depressed LVEF' reference

1–10 of 13

1/2

Considered medically necessary VAD/Ventricular assist CPT codesCPTCovered

33975	Insertion of ventricular assist device; extracorporeal, single ventricle.
33976	Insertion of ventricular assist device; extracorporeal, biventricular.
33979	Insertion of ventricular assist device, implantable, intracorporeal, single ventricle.
33981	Replacement of extracorporeal ventricular assist device, single or biventricular, pump(s), single or each pump.
33982	Replacement of ventricular assist device pump(s); implantable intracorporeal, single ventricle, without cardiopulmonary bypass.
33983	Replacement of ventricular assist device pump(s); implantable intracorporeal, single ventricle, with cardiopulmonary bypass.
33990	Insertion of ventricular assist device, percutaneous including radiological supervision and interpretation; left heart, arterial access only.
33991	Insertion of ventricular assist device, percutaneous including radiological supervision and interpretation; left heart, both arterial and venous access, with transseptal puncture.
33993	Repositioning of percutaneous right or left heart ventricular assist device with imaging guidance at separate and distinct session from insertion.

Total artificial heart and accessory codesmixedCovered

33927	Implantation of a total replacement heart system (artificial heart) with recipient cardiectomy.
33928	Removal and replacement of total replacement heart system (artificial heart).
33999	Unlisted procedure, cardiac surgery.
L8698	Miscellaneous component, supply or accessory for use with total artificial heart system.
E1399	Durable medical equipment, miscellaneous (used to report SynCardia Freedom Driver System).

Implantable aortic counterpulsation VAD (experimental)CPTExperimental

33999

Unlisted procedure, cardiac surgery (used for implantable aortic counterpulsation VAD procedures — considered experimental/investigational).

FDA product codes referencedmixed

OJE	FDA Humanitarian Device Exemption product code listed
DSQ	FDA PMA product code listed
OZD	FDA PMA product code listed
LOZ	FDA PMA product code listed
DWF	FDA 510(k) product code listed
DWA	FDA 510(k) product code listed
KFM	FDA 510(k) product code listed

LVEF and peak VO2 thresholds for implantable VAD

Left ventricular ejection fraction (LVEF)< 25%

Peak oxygen consumption (peak VO2)≤ 14 mL/kg/min

Context for thresholdsUsed to define implantable VAD candidacy for non-transplant candidates with NYHA Class IV end-stage LV failure

CentriMag duration

CentriMag as RVAD (HDE)Device may be used up to 30 days for cardiogenic shock due to acute right ventricular failure

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for mechanical circulatory support devices, including VADs, TAH, and related implantation, removal/replacement procedures and supplies. Submit requests in accordance with the applicable coverage policy and include the covered procedure and supply codes. Claims submitted without covered codes per the policy will be denied.

Prior auth required for implantation, removal/replacement, and related supplies (see coding).
Include applicable covered CPT/HCPCS/ICD-10 codes on authorization request.

Documentation Required

Document Device, Indication, and Intended Duration

Prior authorization requests must document the specific device model, the clinical indication for use, and the intended duration of support (short-term vs bridge-to-transplant vs destination therapy). For short-term percutaneous devices, indicate expected duration consistent with FDA labeling (e.g., ≤4 days for Impella 2.5/CP, ≤6 days for Impella 5.0/LD, ≤14 days for Impella 5.5 or RP when indicated).

Background and Evidence Context

Ventricular assist devices and other mechanical circulatory support systems decrease myocardial work while maintaining systemic perfusion and can be extracorporeal, paracorporeal, or implantable. They are used for short‑term stabilization (e.g., percutaneous devices for hours–days or CentriMag for up to 30 days) and for longer‑term support including bridge to transplant or destination therapy. The SynCardia temporary Total Artificial Heart fully replaces both ventricles and is FDA‑approved as a bridge to transplantation in eligible patients; clinical trial data demonstrated higher rates of survival to transplant and improved post‑transplant survival compared with control groups in the pivotal experience.

Definitions and Abbreviations

VAD / Mechanical circulatory support

DefinitionDevices that provide ventricular support (LVAD, RVAD, BiVAD) by reducing ventricular work and maintaining systemic circulation

Forms of MCSMay be extracorporeal, paracorporeal, implantable with percutaneous power, or fully implantable; continuous or pulsatile

UsesUsed as bridge to recovery, bridge to transplant, or destination therapy depending on duration and indication

Total Artificial Heart (TAH) definition

DefinitionAn implanted or temporary device that replaces both ventricles and all four cardiac valves and is used as a bridge to transplantation in transplant-eligible patients

Regulatory statusSynCardia TAH received FDA PMA as a bridge-to-transplant device intended for in-hospital use

OpenPayer

Mechanical circulatory assist devices (VADs, pVADs, TAH) — Coverage Policy

Coverage Criteria for Mechanical Circulatory Support

Coding and Product Identifiers

Provider Actions, Prior Authorization, and Documentation

Background and Evidence Context

Definitions and Abbreviations