CurrentBlue Cross Blue Shield - MassachusettsPolicy 197

Heart Transplantation (Coverage Criteria)

Medical necessity and coverage criteria for heart transplantation and heart retransplantation for commercial members, including adult and pediatric candidate selection, exclusions, and prior authorization requirements.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyHeart Transplantation (Coverage Criteria)

Policy CodePolicy 197

Change TypeAnnual review — no material changes

Effective Date

Next Review Date

Key ActionObtain precertification/preauthorization for inpatient heart transplant services and include transplant team documentation for recently treated malignancy when applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4039heart transplants in US (2023)

3440waiting list (Jun 2024)

33945CPT code

Preauthinpatient services

addressedretransplant stance

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Adult Candidate Selection

Covered when ANY one of the following accepted indications for transplantation is met

Hemodynamic compromise indications

VO2 criterion: Maximal VO2 (oxygen consumption) <10 mL/kg/min with achievement of anaerobic metabolism<10 mL/kg/min
Objective measure of cardiac functional reserve
Inotropic dependence: Documented dependence on intravenous inotropic support to maintain adequate organ perfusion
Continuous IV inotrope requirement
Refractory cardiogenic shock
Hemodynamic instability despite therapy

Other accepted/probable indications: Other accepted or probable indications for adult transplantation include: severe ischemia consistently limiting routine activity not amenable to bypass or angioplasty; recurrent symptomatic ventricular arrhythmias refractory to all accepted therapies; maximal VO2 <14 mL/kg/min with major limitation of activities; instability of fluid balance or renal function not due to noncompliance; recurrent unstable ischemia not amenable to revascularization.see text

From adult probable indications

Pediatric Candidate Selection

Covered when ALL of the following pediatric conditions apply (examples listed — any one may suffice depending on clinical context)

Pediatric severe manifestations: Pediatric candidates include individuals with any of the following: continuous infusion of intravenous inotropic agents; persistent symptoms at rest requiring mechanical ventilatory support or mechanical circulatory support; cardiomyopathies or repaired/palliated congenital heart disease with growth failure attributable to the heart disease; severe exercise limitation (maximal VO2 <50% predicted for age/sex); near sudden death or life‑threatening arrhythmias untreatable with medication or implantable defibrillator; restrictive cardiomyopathy with reactive pulmonary hypertension; anatomical/physiologic conditions likely to worsen disease course in single‑ventricle infants; reactive pulmonary hypertension risking future fixed elevated PVR; or anatomical/physiologic conditions leading to transplant without systemic ventricular dysfunction.see text

Pediatric-specific criteria; any one listed condition may suffice depending on clinical context

Retransplantation

Covered when candidates meet standard transplant criteria

Retransplant criteria: Heart retransplantation after a failed primary heart transplant may be considered medically necessary in individuals who meet criteria for heart transplantation.

Retransplantation follows the same candidate selection criteria as primary transplant

Evidence-based stance

Summary of evidence: Evidence from retrospective studies and registry data indicates that heart transplant and heart retransplant provide a survival benefit for appropriately selected patients; transplantation is contraindicated when the procedure is expected to be futile or to worsen comorbid conditions.

Supported by registry and retrospective study data

Initial and Retransplant Coverage Rationale

Covered when ALL of the following clinical expectations are met:

General coverage rationale: Patient has end‑stage heart failure or graft failure with severe dysfunction despite appropriate medical management (medication, surgery, or devices) and is an appropriate candidate for transplantation; transplantation is not expected to be futile and post‑transplant care is not expected to significantly worsen comorbid conditions.N/A

Based on retrospective studies and registry data demonstrating survival benefit

Do not cover heart transplantation for patients with a recent malignancy with high risk of recurrence or a known current malignancy, including metastatic cancer. The transplant team must assess recurrence risk for previously treated malignancy; when applicable, providers must submit a statement from the transplant team explaining why the patient with a recently treated malignancy is an appropriate transplant candidate and addressing recurrence risk. Also excluded are patients with other irreversible end-stage disease not attributable to heart or lung disease, those with untreated systemic infection (including chronic infections that make immunosuppression unsafe), and patients with a history of cancer with moderate risk of recurrence or systemic disease that could be exacerbated by immunosuppression.

Patients for whom transplantation is expected to be futile due to comorbid disease or for whom post-transplantation care is expected to significantly worsen comorbid conditions are excluded from coverage. The policy treats such situations as contraindications because the evidence indicates transplantation is not expected to provide net clinical benefit when these risks render the procedure futile or likely to harm overall outcomes.

Heart transplantation is considered investigational in all other situations that do not meet the medical necessity criteria listed in this policy. If a patient’s presentation does not align with the accepted adult or pediatric indications, or the specific clinical expectations required for coverage, the procedure is not supported by the available evidence and is therefore investigational.

Heart transplantation is not medically necessary when it is expected to be futile because of comorbid disease or when post-transplant care would significantly worsen comorbid conditions. The policy’s evidence summary affirms that transplantation provides a survival benefit only for appropriately selected patients and is contraindicated when the procedure cannot reasonably be expected to improve net health outcomes.

Candidate Selection and Eligibility

Heart transplant candidate criteria

Selection criteria differ for adults and pediatrics; objective measures and severity guide candidacy.

Adult candidate nodes: Adult candidates meet accepted or probable indications such as VO2 thresholds (see <10 mL/kg/min with anaerobic metabolism or <14 mL/kg/min with major limitation), dependence on IV inotropes, refractory cardiogenic shock, refractory ischemia not amenable to revascularization, or recurrent symptomatic ventricular arrhythmias refractory to therapies.see adult criteria

Objective measures (VO2) and hemodynamic/clinical severity guide selection

Pediatric candidate nodes: Pediatric candidates include those on continuous IV inotropes, requiring mechanical ventilatory or circulatory support, with growth failure due to heart disease, severe exercise limitation (VO2 <50% predicted), untreatable life‑threatening arrhythmias, restrictive cardiomyopathy with reactive pulmonary hypertension, or anatomic/physiologic risks in single‑ventricle infants.see pediatric criteria

Pediatric‑specific objective and clinical indicators

Heart transplant and retransplant candidate criteria

Candidate selection considerations reflected in evidence summary and references:

Candidate selection: Patient has end‑stage heart failure or failing graft with severe symptoms despite other therapies; expected survival without transplant is exceedingly poor; retransplantation is considered when prior graft failure or severe dysfunction persists after other treatments are exhausted.N/A

Supported by registry, retrospective studies, and guideline/review references

Provider Actions and Prior Authorization

Prior Authorization

Preauthorization required for inpatient heart transplant

Precertification/preauthorization is required when heart transplantation is performed in the inpatient setting; outpatient preauthorization may be required depending on product and setting per policy guidance.

Inpatient heart transplant services: precertification/preauthorization IS REQUIRED for products if procedure is inpatient.
Check product-specific rules for outpatient preauthorization requirements.

Prior Authorization

Prior authorization required

Prior authorization is required for services described in this policy; note that ICD‑9 diagnosis codes were removed from the policy when this requirement was established.

Submit prior authorization before scheduling transplant-related inpatient services.
Policy history documents removal of ICD‑9 codes when prior authorization requirement was implemented.

Step Therapy

Step therapy not applicable

Step therapy does not apply to heart transplantation; candidate selection is based on clinical severity, hemodynamics, functional status, and refractory disease rather than medication trial sequencing.

Decisions are driven by objective measures (e.g., VO2 thresholds, inotrope dependence) and refractory status, not by prior medication trials.

Step Therapy

Therapy sequencing is clinical (not step therapy)

Heart transplant is considered when patients have severe heart dysfunction despite appropriate medical management (medication, surgery, or devices); sequencing of therapy is clinical rather than following a step‑therapy drug algorithm.

Transplantation is an option after failure of other appropriate medical, surgical, or device therapies.
Selection depends on expected survival benefit and severity of dysfunction.

Documentation Required

Submit transplant team statement for recent malignancy

If the candidate has a recently treated malignancy, submit a statement from the transplant team explaining why the patient is an appropriate transplant candidate and addressing the risk of recurrence.

Transplant team statement must explain rationale and recurrence risk assessment for the individual patient.
Include cancer treatment history and oncologic input as applicable.

Documentation Required

Include policy updates and evidence citations in support materials

Include supporting materials documenting the policy‑relevant evidence base and policy history (literature review updated through June 21, 2024) and cite registry/guideline sources when submitting for medical necessity review.

Provide literature or guideline citations (e.g., UNOS/OPTN/registry data) relevant to case selection.
Reference the policy literature review date (updated through June 21, 2024).

Denial Risk

Coverage exclusions that may cause denial

Heart transplantation is not covered when exclusions are present, including recent or active malignancy with high recurrence risk, untreated systemic infection, fixed pulmonary hypertension, psychosocial/chemical dependency affecting adherence, or other listed contraindications; presence of these exclusions can lead to denial.

Recent or active malignancy with high recurrence risk or known current malignancy (including metastatic).
Untreated systemic infection or systemic disease worsened by immunosuppression.
Fixed pulmonary hypertension (PVR >5 Wood units or TPG ≥16 mm Hg) and psychosocial/chemical dependency impairing adherence.

Denial Risk

Contraindications creating high denial risk (futility)

Transplantation is contraindicated and likely to be denied when the procedure is expected to be futile due to comorbid disease or when post‑transplant care is expected to significantly worsen comorbid conditions.

Patients with comorbid conditions rendering transplantation futile are excluded.
Consider expected post‑transplant course and whether immunosuppression would exacerbate comorbid disease.

Coding and Procedure Codes

Covered CPT CodesCPTCovered

33945

Heart transplant_with or without recipient cardiectomy

Included ICD-10-PCS CodesICD-10

O2YAOZO	Transplantation of Heart_Allogeneic_Open Approach
O2YAOZI	Transplantation of Heart_Syngeneic_Open Approach

inv-12: VO2max — <10 mL/kg/min (with anaerobic metabolism) or <14 mL/kg/min with major limitation

ThresholdMaximal VO2 <10 mL/kg/min with achievement of anaerobic metabolism

Alternative thresholdMaximal VO2 <14 mL/kg/min when there is major limitation of activities

Measurement contextVO2max is measured during maximal exercise as an objective criterion of cardiac functional reserve used in transplant selection

inv-13: Pulmonary vascular resistance (PVR) — >5 Wood units (fixed PVR is exclusion)

Threshold>5 Wood units (pulmonary vascular resistance)

Exclusion noteFixed PVR >5 Wood units despite treatment is an exclusion to transplantation

Clinical implicationFixed pulmonary hypertension may preclude orthotopic heart transplantation; combined heart-lung transplant may be considered

inv-14: Transpulmonary gradient (TPG) — >=16 mm Hg (fixed TPG is exclusion)

Threshold>=16 mm Hg (transpulmonary gradient)

Exclusion noteFixed TPG >=16 mm Hg despite treatment is an exclusion to transplantation

Clinical implicationFixed pulmonary hypertension (elevated TPG) indicates increased perioperative risk and may preclude transplant

Background and Definitions

Heart transplantation replaces a diseased heart with a donor heart for patients with refractory end-stage cardiac disease. Recipients require lifelong immunosuppression and ongoing surveillance. Selection and prioritization of candidates are guided by illness severity and mortality risk using standard transplant criteria and objective measures (for example, VO2max and hemodynamic parameters). Registry and observational data demonstrate a survival benefit for appropriately selected primary and repeat transplant recipients.

inv-24: VO2max definition — Maximal oxygen consumption measured during maximal exercise; objective criterion used in transplant selection

DefinitionMaximal oxygen consumption measured during maximal exercise

Clinical roleAn objective criterion of cardiac functional reserve used in transplant selection

Example thresholdsExamples include <10 mL/kg/min with anaerobic metabolism or <14 mL/kg/min with major activity limitation

inv-25: Heart retransplantation definition — Repeat heart transplantation in patients with prior transplant complicated by graft failure or severe dysfunction

DefinitionRepeat heart transplantation in patients with prior transplant complicated by graft failure or severe dysfunction

IndicationConsidered when prior graft failure or severe dysfunction persists after other medical or surgical remedies have been exhausted

EvidenceSupported by systematic reviews, retrospective studies, and registry data demonstrating survival benefit in appropriately selected patients

OpenPayer

Heart Transplantation (Coverage Criteria)

Coverage Criteria for Heart Transplantation

Candidate Selection and Eligibility

Contraindications

Evaluation and Documentation Requirements

Provider Actions and Prior Authorization

Coding and Procedure Codes

Post-Transplant Care and Coverage Considerations

Background and Definitions

Transplant Center and Team Requirements