ModifiedKaiser PermanentePolicy N/A

Mechanical Circulatory Support Devices as Bridge to Cardiac Transplant

Criteria and clinical guidance for referral, evaluation, and medical necessity review of mechanical circulatory support (MCS) devices — including total artificial hearts, implanted VADs, and percutaneous LVADs — when used as a bridge to heart transplantation for Kaiser Permanente Washington members and providers.

Policy Summary

PayerKaiser Permanente

PolicyMechanical Circulatory Support Devices as Bridge to Cardiac Transplant

Policy CodePolicy N/A

Change TypeRevised: expanded coverage to destination therapyremoved retired NCD

Effective DateN/A

Next Review DateMar 1, 2026

Key ActionObtain prior authorization after documenting 45 of the last 60 days of optimal medical management and submit the last two Cardiology/Cardiovascular Surgery consult notes.

SourceLink

POLICY UPDATE CHANGES

Updated policy expands coverage to destination therapy, streamlines criteria into a single section, and clarifies device details.

Removed Artificial Hearts and Related Devices (20.9) NCD from coverage sources due to the retirement of this NCD.

Added statement for medical director to consult with cardiology re Impella (PLVAD) as needed.

1-4INTERMACS profiles

45/60OMM duration

≤12/≤14Peak VO2 thresholds

>3.0 mg/dL

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Coverage Criteria — Bridge to Transplant and Device Eligibility

Bridge-to-Transplant Medical Necessity Criteria

Covered when ALL of the following are met:

Overall prerequisites

Transplant listing or indication: Patient has been approved by Kaiser Permanente and is currently listed by UNOS as a candidate for heart transplant OR is being evaluated as a transplant candidate for NYHA class III–IV heart failure symptoms and/or intractable ventricular arrhythmia
INTERMACS profile: INTERMACS Profile 1, 2, 3, or 4Profiles 1–4
See INTERMACS definitions (Appendix)

Objective indicators of failing support (one or more required)

Hemodynamics: Systemic mean arterial pressure < 60 mmHg OR systolic BP < 80 mmHg; Cardiac index < 2.2 L/min/m2; Pulmonary capillary wedge pressure (or PA diastolic) > 20 mmHg
Exercise testing: Cardiopulmonary exercise testing abnormalities: VO2 ≤ 12 mL/kg/min on beta‑blocker OR VO2 ≤ 14 mL/kg/min off beta‑blocker OR VO2 < 19 mL/kg/min adjusted for lean body mass if BMI > 30 OR < 50% of age‑predicted maximum; OR VE/VCO2 > 35 on submaximal CPET (RER < 1.05)VO2 and VE/VCO2 thresholds listed
Other indicators: Inability to wean from other mechanical or inotropic support OR refractory life‑threatening arrhythmias

Implantable LVAD and Artificial Heart - Medically Necessary

Covered when ALL of the following are met per applicable policy statements:

Implantable LVAD/Artificial Heart coverage: Patient meets the applicable policy statements for implantable LVAD or total/artificial heart (meets end‑stage heart failure criteria and other selection criteria per policy) and is an appropriate candidate for the implanted device or total artificial heart

MTAC determined LVAD use for end‑stage heart failure meets MTAC; artificial hearts considered medically necessary when applicable policy criteria are met

Percutaneous Cardiac Support - Not Medically Necessary for End Stage HF

Not considered meeting MTAC criteria for End Stage Heart Failure:

Percutaneous cardiac support systems: Use of percutaneous cardiac support systems (e.g., Impella, TandemHeart) for treatment of end‑stage heart failure does not meet Kaiser Permanente Medical Technology Assessment Criteria and is not considered medically necessary for that indication

Randomized trials show hemodynamic improvement but no survival benefit; associated with increased device‑related bleeding and limb ischemia; Impella devices are FDA‑cleared for temporary use (up to 6 hours) with reported use longer in select cases

Renal dysfunction is an exclusion that can trigger denial for mechanical circulatory support when it is unlikely to be reversible. Specifically, creatinine > 3.0 mg/dL is listed as an exclusion unless the patient is being evaluated and listed for a combined heart–kidney transplant. Other end‑organ failure thresholds identified alongside renal dysfunction include severe hepatic failure (e.g., bilirubin > 5.0 mg/dL) and combinations of comorbidities that together make MCS plus transplantation unreasonable. Documented active infection, profound leukocytosis or coagulation/platelet disorders are additional exclusion-related considerations that should be clearly addressed in the medical record when requesting authorization.

Presence of a mechanical prosthetic aortic valve or uncorrected severe valvular disease (for example, severe aortic insufficiency) requires special consideration at the time of MCS implantation because additional surgical intervention may be necessary. Evidence of right ventricular dysfunction should prompt evaluation for the need for biventricular support rather than isolated left‑sided support. These valvular and right‑sided heart issues factor into transplant candidacy and may interact with the exclusion guidance (e.g., co‑morbid conditions or reversible organ dysfunction) used to determine appropriateness for device implantation.

Percutaneous cardiac support systems are not considered to meet the Kaiser Permanente Medical Technology Assessment Criteria (MTAC) for the treatment of End Stage Heart Failure. Consequently, use of these percutaneous systems for that indication is excluded from meeting MTAC and is not considered medically necessary under this policy.

The AbioCor permanent total artificial heart lacked published empirical studies of safety and efficacy. A small manufacturer feasibility series submitted to the FDA reported substantial adverse events and limited discharge outcomes. MTAC concluded that the AbioCor implantable replacement heart does not meet Kaiser Permanente Medical Technology Assessment Criteria, while other temporary systems (e.g., SynCardia CardioWest) were considered differently in later reviews.

Randomized and comparative evidence for percutaneous LVADs such as the Impella Recover LP 2.5 shows improved hemodynamics versus intra‑aortic balloon pump (IABP) but no demonstrable improvement in 30‑day survival in the identified trials. The small RCTs and pooled analyses reported increased device‑related complications, notably bleeding and limb ischemia, and were underpowered for clinical outcomes; these safety signals contributed to the determination that percutaneous LVADs do not meet MTAC for end‑stage heart failure.

Procedure and Clinical Thresholds

Medically necessary procedure 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; arterial access only.
33991	Insertion of ventricular assist device, percutaneous including radiological supervision and interpretation; both arterial and venous access, with transseptal puncture.
33995	Insertion of ventricular assist device, percutaneous, including radiological supervision and interpretation; right heart, venous access only.
33928	Implantation of a total replacement heart system (artificial heart) with recipient cardiectomy.

1–10 of 11

1/2

Peak VO2 thresholds

Peak VO2 on beta-blockerVO2 ≤ 12 mL/kg/min

Peak VO2 off beta-blockerVO2 ≤ 14 mL/kg/min

BMI-adjusted VO2 thresholdVO2 < 19 mL/kg/min when adjusted for lean body mass in patients with BMI > 30 kg/m2

Age-predicted maxLess than 50% of age-predicted maximum on CPET

Pulmonary vascular resistance / transpulmonary gradient

Pulmonary vascular resistance (PVR)PVR > 4–6 Wood units is discussed as a concern (not an absolute contraindication)

Transpulmonary gradient (TPG)

Prior Authorization, Documentation, and Operational Requirements

Prior Authorization

Prior Authorization Required for VAD and Artificial Heart Procedures

Prior authorization is required for all durable ventricular assist device (VAD) and implantable/artificial heart procedures. This includes CPT-coded insertion, removal, replacement, and pump exchange procedures for implantable intracorporeal and extracorporeal VADs. Submit a prior authorization request before scheduling to ensure medical necessity review and coverage determination.

Prior authorization required for insertion, removal, replacement, and pump exchange of VADs and artificial hearts (implantable and extracorporeal).
Include relevant CPT codes in the PA request (e.g., 33975, 33976, 33979, 33981, 33982, 33983, 33990, 33991, 33995).
If requesting Impella (percutaneous LVAD/PLVAD) cases, medical director should consult with cardiology as needed to determine appropriateness.

Denial Risk

Exclusion-Related Denial Triggers

Clinical Background and Rationale

Mechanical circulatory support (MCS) is used to sustain patients with end‑stage heart failure who have failed maximal medical therapy while awaiting heart transplantation or as destination therapy. The policy criteria require that patients have been on optimal medical management for at least 45 of the last 60 days and meet qualifying clinical profiles (INTERMACS 1–4) or objective indicators of failing support (hemodynamic instability, low peak VO2, inability to wean from inotropes/mechanical support, or refractory arrhythmia). MCS devices offer hemodynamic support that can reverse end‑organ dysfunction in some patients and enable transplant listing, but they also carry substantive risks (infection, bleeding, thromboembolism, device malfunction) that must be balanced against potential benefits when assessing candidacy for implant and transplant.

Device and Term Definitions

Total Artificial Heart (TAH) / Artificial Hearts

DefinitionImplantable devices that replace both ventricles, providing total cardiac replacement

ExamplesAbioCor; SynCardia (CardioWest)

Clinical useUsed as bridge to transplant or, in select non-transplant candidates, as replacement therapy per applicable criteria

Percutaneous LVAD (PLVAD)

DefinitionShort-term percutaneous mechanical support devices inserted via vascular access to provide temporary circulatory support

Typical indicationsCardiogenic shock, high-risk revascularization, or bridge to recovery/surgical device or transplant