CurrentKaiser PermanentePolicy N/A

Heart Transplantation — Referral and Evaluation Criteria

Defines referral, evaluation, indication, and contraindication criteria for heart transplant candidates for Kaiser Permanente Washington members; applies to providers referring patients for transplant evaluation.

Policy Summary

PayerKaiser Permanente

PolicyHeart Transplantation — Referral and Evaluation Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain authorization/verification for listed heart transplant procedure codes and include the last 6 months of clinical notes to support medical necessity.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

VO2VO2 thresholds

PVRPVR thresholds

BMIBMI exclusion

>70Age consideration

Coverage and Referral Criteria

inv-01: Referral for Transplant Evaluation

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Referral for Transplant Evaluation

Clinical evidence of end-stage disease
- VO2 criteria: VO2 maximum thresholds met per beta blocker status or BMI adjustments<=14 ml/kg/min (not on beta blocker) or <=12 ml/kg/min (on beta blocker) or <19 ml/kg/min adjusted for lean body mass if BMI >30 or <50% age predicted
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- VE/VCO2 >35 with sub-maximal CPET (RER <1.05)>35
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- Hemodynamics: Cardiac index < 2 L/min/m2<2 L/min/m2
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Support/therapy dependence: Unable to wean from mechanical or inotropic support
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Specific diagnoses: Specific cardiomyopathies or refractory life-threatening arrhythmias (e.g., amyloid cardiomyopathy: TTR; AL without significant extra-cardiac involvement)
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inv-02: Contraindications / Unsuitable Candidates

Not appropriate / contraindicated when ANY of the following absolute or significant relative contraindications exist

Contraindications / Unsuitable Candidates

Uncontrollable active infection
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Malignancy with recurrence risk: History of malignancy with moderate to high risk of recurrence unless assessed as low risk by oncology consultation
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Substance use: Active substance abuse or less than 6 months abstinence without evaluation by a substance abuse program6 months abstinence
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Tobacco use within the prior 6 months for thoracic organ candidates6 months
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Pulmonary vascular disease: Pulmonary hypertension not reversible by drug manipulation despite maximum tolerated medical therapyAdults: PVR >4-6 Wood units (transpulmonary gradient >15 mm Hg); Children: PVR >9 Wood units
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Severe organ dysfunction: Severe pulmonary or hepatic disease after optimal treatment, or kidney disease despite optimal therapyCreatinine clearance <34 ml/kg/min or GFR <30 ml/min
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Nutritional status: Cachexia or malnutrition, or obesity associated with poor outcomesBMI <19 kg/m2 or <80% ideal; BMI >35 kg/m2
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Age over 70 years (carefully selected patients over 70 may be considered only in exceptional cases)>70 years
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Other comorbidities: Any other comorbid condition that would limit life expectancy or quality of life, including active progressive CNS disease, severe symptomatic osteoporosis, active peptic ulcer disease, AL amyloidosis with significant extra-cardiac involvement, or diabetes with severe end-organ damage
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Adherence/social support concerns: Inadequate social support systems or evidence of non-adherence to medical treatment
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inv-03: Social and Behavioral Criteria

Additional candidate expectations

Behavioral and Social Criteria: Candidates must demonstrate adequate social support, documented adherence to medical treatment, have caregivers physically and cognitively able to assist with self-care and travel on short notice to the KP approved transplant Center of Excellence, and participate in substance abuse treatment programs with documented abstinence when applicable6 months abstinence for substance and tobacco for thoracic organs

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Specific medical conditions that are listed as contraindications to heart transplantation include severe irreversible end-organ diseases and other disorders likely to limit survival or recovery. Examples include severe pulmonary disease after optimal heart-failure treatment; severe hepatic disease after optimal treatment; kidney disease with creatinine clearance <34 ml/min or GFR <30 ml/min despite optimal therapy; active or progressive central nervous system disease (except fully recovered embolic stroke); and AL amyloidosis with significant extra-cardiac involvement. Additional conditions noted are active peptic ulcer disease, severe symptomatic osteoporosis, diabetes with severe end-organ damage, and any other comorbidity expected to limit life expectancy or quality of life.

Patients with pulmonary vascular disease that is not reversible with medical therapy are not appropriate candidates for transplant. The policy specifies pulmonary hypertension not reversible by drug manipulation despite maximum tolerated medical management and lists hemodynamic thresholds of Adults: PVR > 4–6 Wood units (or transpulmonary gradient > 15 mm Hg) and Children: PVR > 9 Wood units. In addition, severe end-organ dysfunction—such as advanced hepatic disease or renal failure meeting the thresholds above—constitutes a contraindication to transplant candidacy.

Heart Transplant Candidate Selection

inv-19: Heart candidate criteria

Candidate selection is based on clinical severity, physiologic thresholds, and social/behavioral eligibility.

Heart transplant candidate criteria: End-stage heart disease (NYHA class III/IV) not correctable by other therapies; objective physiologic thresholds (VO2, VE/VCO2, cardiac index); inability to wean from mechanical or inotropic support; specific cardiomyopathies (e.g., amyloid) or refractory life-threatening arrhythmiasSee VO2/VE-VCO2/Cardiac index/PVR/BMI thresholds in policy

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Physiologic thresholds (detail): VO2 max: ≤14 ml/kg/min (not on beta blocker); ≤12 ml/kg/min (on beta blocker); <19 ml/kg/min adjusted for lean body mass if BMI >30; <50% age predicted. VE/VCO2 >35 with sub-maximal CPET (RER <1.05). Cardiac index <2 L/min/m2.VO2 and VE/VCO2 and cardiac index values as listed

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Contraindications and Unsuitable Candidates

Absolute and significant relative contraindications that may preclude referral or listing include uncontrollable active infection; active substance abuse or insufficient documented abstinence and lack of program evaluation; tobacco use within the prior 6 months for thoracic organ candidates; and inadequate social support or inability of caregivers to participate in required follow-up. Severe irreversible organ dysfunction is also a contraindication, including pulmonary hypertension with elevated PVR as noted above, severe hepatic disease, and renal dysfunction meeting the specified creatinine clearance or GFR cutoffs. These conditions should be identified during evaluation and documented in the medical record.

Clinical Thresholds and Codes

Covered CPT CodesCPTCovered

33940	Donor cardiectomy (including cold preservation)
33944	Backbench standard preparation of cadaver donor heart allograft prior to transplantation, including dissection of allograft from surrounding soft tissues to prepare aorta, superior vena cava, inferior vena cava, pulmonary artery, and left atrium for implantation.
33945	Heart transplant, with or without recipient cardiectomy

inv-07: VO2 max — thresholds and adjustments

VO2 max threshold (no beta blocker)≤14 ml/kg/min

VO2 max threshold (on beta blocker)≤12 ml/kg/min

BMI adjustment (BMI >30)<19 ml/kg/min adjusted for lean body mass

Age‑predicted adjustmentLess than 50% of age predicted maximum

inv-08: VE/VCO2

VE/VCO2 cutoff>35

Test conditionApplies when cardiopulmonary exercise test is sub‑maximal (RER <1.05)

ContextUsed as an objective physiologic criterion for end‑stage heart disease in transplant referral

inv-09: Pulmonary vascular resistance (PVR)

Adult PVR threshold> 4–6 Wood units

Adult transpulmonary gradient> 15 mm Hg (alternate hemodynamic concern)

Pediatric PVR threshold> 9 Wood units (children)

inv-10: Renal function

GFR threshold after optimal HF treatmentGFR <30 ml/min

Creatinine clearance thresholdCreatinine clearance <34 ml/kg/min

ContextRenal dysfunction at these thresholds is listed as a contraindication to transplant unless addressed

inv-11: BMI cutoffs

Cachexia / low BMIBMI <19 kg/m2 or <80% ideal body weight

Obesity exclusionBMI >35 kg/m2 (or >140% ideal body weight)

Clinical implicationEither extreme (cachexia or obesity) is associated with poor outcomes and may contraindicate transplant

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Pre-authorization is required for listed heart transplant procedure codes. Use the Pre-authorization Code Check to confirm plan-specific authorization requirements prior to scheduling or billing.

Verify authorization requirements by plan before performing or billing transplant procedures
Affected CPT codes: 33940, 33944, 33945

Denial Risk

Active, Uncontrollable Infection

Candidates with an active, uncontrollable infection are contraindicated for transplant and should not be listed until the infection is resolved and controlled. Document absence of active infection in clinical records prior to referral or listing.

Active, uncontrolled systemic infection — contraindication until resolved
Document any recent infections and treatment status in submitted records

Prior Authorization

Prior Optimization Required

Patients must have exhausted or be unresponsive to optimal medical and surgical therapies prior to referral for transplant evaluation. Ensure documentation demonstrates prior optimization attempts and treatment response.

Evidence that maximal tolerated medical therapy was attempted
Documentation of surgical therapy attempts when applicable
Objective measures supporting refractory disease (e.g., VO2, cardiac index, VE/VCO2)

Documentation Required

Required Clinical Documentation

Include the following clinical documentation with all transplant service requests to support medical necessity and authorization decisions.

Last 6 months of clinical notes from the requesting provider and/or specialist
Documentation of prior medical and surgical therapies and responses
Infection status and relevant microbiology or treatment details
Substance use history and evidence of required abstinence (if applicable)
Tobacco use history and cessation documentation for prior 6 months (thoracic candidates)
Evidence of adequate social support and adherence history

Evaluation and Assessment Requirements

Documentation Required

Evaluation requires prior 6 months of notes and malignancy recurrence assessment

Provide complete clinical notes for the prior 6 months and document assessment of malignancy recurrence risk with oncology consultation when there is a history of cancer as part of the transplant evaluation.

Last 6 months of clinical notes from requesting provider/specialist
Assess malignancy recurrence risk with oncology for patients with prior malignancy

Transplant Center and Caregiver Requirements

Note

Confirm caregiver ability to travel to KP Transplant Center of Excellence

Ensure a caregiver is available and able to travel on short notice to a Kaiser Permanente–approved Transplant Center of Excellence for evaluation and urgent return for complications.

Caregiver(s) must be physically and cognitively able to assist with self‑care and available to travel on short notice to the KP approved transplant Center of Excellence

Background and Context

Heart transplantation is indicated for patients with irreversible end-stage heart disease who are at significant risk of death or have severely impaired quality of life and for whom other medical or surgical therapies are ineffective or not feasible. Candidate selection relies on clinical severity (for example, New York Heart Association functional class III–IV), objective physiologic thresholds such as low VO2 max, elevated VE/VCO2, and reduced cardiac index, and assessment of social and behavioral suitability. Historical outcomes for adult recipients have demonstrated substantive survival benefit at 1 and 5 years when appropriate selection criteria are applied.