Heart-Lung Transplantation
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Coverage and medical necessity criteria for heart-lung transplantation for Aetna members with severe refractory heart failure combined with end-stage lung disease or irreversible pulmonary hypertension, and related coding and background information for providers and transplant centers.
No material clinical or coverage changes in this revision.
Coverage and Medical Necessity Criteria
Medical necessity criteria
Covered when ALL of the following are met
Examples include COPD with severe heart failure; congenital heart disease with pulmonary hypertension not amenable to repair; cystic fibrosis with severe heart failure; Eisenmenger’s complex; irreversible primary pulmonary hypertension; connective tissue disease with severe pulmonary fibrosis and uncontrollable pulmonary hypertension; severe coronary artery disease or cardiomyopathy with irreversible pulmonary hypertension
Member must also meet the transplanting institution's selection criteria; bridge to transplant with ambulatory ECMO does not by itself rule out candidacy
Contraindications / Not medically necessary
Not medically necessary when ANY of the following absolute contraindications are present
Under established guidelines, obese (>20% of ideal body weight), cachectic (<80% of ideal body weight), mechanically ventilated or otherwise immobile patients are considered poor candidates and may be considered not medically necessary
Heart-lung transplantation is indicated when a patient has severe refractory heart failure plus end-stage lung disease or irreversible pulmonary hypertension and meets the selection criteria described in this policy. Examples include cystic fibrosis with severe heart failure, Eisenmenger’s complex, irreversible primary pulmonary hypertension, connective tissue disease with severe pulmonary fibrosis and uncontrollable pulmonary hypertension, and severe coronary artery disease or cardiomyopathy with irreversible pulmonary hypertension. Heart-lung transplantation is not medically necessary where lung transplantation alone would restore right ventricular function; every attempt should be made to preserve the heart.
This Clinical Policy Bulletin provides a partial, general description of plan or program benefits and is intended to assist in administering benefits. It does not constitute a contract, guarantee coverage, or provide medical advice. Coverage determinations remain subject to the terms of the member’s benefit plan and any applicable medical necessity criteria described herein; providers are responsible for confirming eligibility and benefit coverage.
Certain recipient factors are associated with poor outcomes and are considered ineligibility risks. Under established guidelines, patients who are obese (greater than 20% of ideal body weight), cachectic (less than 80% of ideal body weight), or who are mechanically ventilated or otherwise immobile are considered poor candidates for transplantation unless specific mitigating circumstances exist (for example, ambulatory ECMO as a bridge may be evaluated). These factors may render the procedure not medically necessary.
Coding and Diagnostic Criteria
| 33930-33945 | Heart/lung transplant |
| E84.0-E84.9 | Cystic fibrosis |
| I25.10-I25.9 | Chronic ischemic heart disease |
| I26.01-I127.9 | Pulmonary heart disease |
| I42.0-I43 | Cardiomyopathy |
| I50.1-I50.9 | Heart failure |
| J40-J47.9 | Chronic lower respiratory diseases |
| J84.10 | Pulmonary fibrosis, unspecified |
| J84.89 | Other specified interstitial pulmonary diseases |
| M32.0-M35.9 | Diffuse diseases of connective tissue |
| Q20.0-Q28.9 | Congenital malformations of the circulatory system |
Candidate Selection Criteria
Candidate selection criteria
Candidate must meet institution selection criteria or the following Aetna criteria:
Policy examples include cystic fibrosis with severe heart failure, Eisenmenger's complex, irreversible primary pulmonary hypertension, connective tissue disease with severe pulmonary fibrosis
Member must meet the transplanting institution's selection criteria if available
Contraindications
Absolute contraindications that generally render heart-lung transplantation not medically necessary include irreversible end‑organ disease (for example, renal or hepatic failure), active malignancy or active infection, and significant systemic diseases such as autoimmune or vascular disorders and amyloidosis. Chronic gastrointestinal conditions (for example, bleeding peptic ulcer, diverticulitis, active or recurrent pancreatitis), progressive neuromuscular disease, uncontrolled psychiatric disorders, and ongoing tobacco use are additional contraindications. The presence of significant multi‑system disease that is expected to adversely affect outcomes also argues against transplantation.
Pre-Transplant Evaluation Requirements
Comprehensive pre‑transplant evaluation required
Perform a comprehensive pre-transplant evaluation documenting severity of cardiac and pulmonary disease, and objective organ function measures (liver and kidney). Evaluation must address infection and malignancy status, functional status and rehabilitation potential, and HIV control if applicable.
- Assess heart failure severity (e.g., NYHA III–IV) and confirm end-stage lung disease or irreversible pulmonary hypertension [[see policy examples]].
- Document liver and kidney function: bilirubin < 2.5 mg/dL and creatinine clearance > 50 ml/min/kg.
- Evaluate for active or chronic infections and malignancy; ensure adequate functional/rehabilitation status and address HIV control if present (CD4 >200, undetectable viral load, stable ART >3 months).
Provider Actions and Prior Authorization
Prior authorization required for heart‑lung transplant procedures
Obtain prior authorization before performing heart‑lung transplantation procedures (covered CPT codes 33930–33945 and related HCPCS S2054, S2055, S2060, S2061) when the member meets selection criteria and no absolute contraindications are present.
- Submit documentation that selection criteria are met and contraindications are absent as part of the authorization request.
No separate prior authorization code list provided
No additional explicit prior authorization codes or separate prior authorization requirement language is provided in the policy beyond the listed transplant procedure codes and HCPCS codes.
- Refer to the procedure and HCPCS codes listed elsewhere in the policy for authorization submissions.
Required clinical documentation to support medical necessity
Include clinical documentation demonstrating severe refractory heart failure plus end‑stage lung disease or irreversible pulmonary hypertension and that the candidate meets listed selection criteria (NYHA class, organ function thresholds, absence/control of infection or malignancy, functional status, and HIV control when applicable).
- Document NYHA class (III or IV) or equivalent severity and examples/diagnoses supporting indication.
- Provide lab values showing bilirubin < 2.5 mg/dL and creatinine clearance > 50 ml/min/kg.
- If HIV positive, include CD4 > 200 cells/mm3 for >6 months, undetectable viral load, and evidence of stable antiretroviral therapy >3 months.
Policy history — no additional provider actions specified
Policy history and review dates are provided for reference; these chunks do not specify extra provider steps or documentation beyond the clinical and authorization requirements in the policy.
- Last review: 09/07/2023. Effective: 03/12/2002. Next review: 06/27/2024.
Absolute contraindications may cause denial of coverage
Be aware that the presence of absolute contraindications may render transplantation not medically necessary and can lead to coverage denial.
- Absolute contraindications include irreversible end‑organ disease (renal, hepatic), active malignancy or infection, systemic diseases (autoimmune/vascular/amyloidosis), chronic GI disease, progressive neuromuscular disease, uncontrolled psychiatric disorders, active substance dependence, and ongoing tobacco use.
- Obesity >20% of ideal body weight, cachexia <80% of ideal body weight, mechanical ventilation or immobility are considered poor candidates and may affect coverage decisions.
No specific provider actions listed in this section
No provider‑action requirements are specified in these policy chunks.
Transplant Center Requirements
Must meet transplanting institution’s selection criteria
Member must meet the transplanting institution’s selection criteria; if the institution has no criteria, ensure the patient meets all Aetna selection criteria before listing.
- When institutional criteria are absent, document that all Aetna criteria are met (clinical indication, organ function thresholds, functional status, absence/control of contraindications).
- Consider referral to an experienced transplant center that meets institutional selection standards.
Post-Transplant Surveillance and References
Background and Scope
Heart-lung transplantation is used for patients whose disease combines severe refractory heart failure and end-stage lung disease or irreversible pulmonary hypertension, where single-organ transplantation would not adequately restore cardiopulmonary function. The procedure is historically applied to conditions such as congenital heart disease with pulmonary hypertension, cystic fibrosis with severe cardiac involvement, primary pulmonary hypertension, and selected cases of connective tissue disease with severe pulmonary fibrosis. Donor organ availability limits procedure frequency, and post-operative complications include early events such as acute lung rejection and multi-organ failure, and later complications such as infection and chronic obliterative bronchiolitis.
The information in this bulletin is informational and does not replace the member’s benefit contract. It is not an explicit coverage guarantee or a substitute for individualized clinical judgment; providers should consult the member’s plan documents and authorizations for coverage specifics.
Definitions
Policy History and Review Dates
Policy effective date: 03/12/2002. Last review: 09/07/2023. Next scheduled review: 06/27/2024. This policy’s review history and revisions are documented in the policy history file.
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