Aetna Heart-Lung Transplant Coverage & Prior Auth

Coverage and Medical Necessity Criteria

Medical necessity criteria

Covered when ALL of the following are met

Primary indication: Severe refractory heart failure plus end-stage lung disease or irreversible pulmonary hypertensionNYHA III or IV as example

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

Selection criteria (recipient factors): Absence of chronic high-dose steroid therapy; absence of acute or chronic active infections that are not effectively treated; absence of active malignancy unless completely resected or judged to have low likelihood of recurrence; adequate functional status (active rehabilitation; mechanically ventilated or immobile persons are generally poor candidates unless bridged with ambulatory ECMO); adequate liver and kidney function (bilirubin < 2.5 mg/dL; creatinine clearance > 50 ml/min/kg); life expectancy > 2 years in the absence of cardiopulmonary disease; no active alcohol or chemical dependency; no uncontrolled or untreated psychiatric disorders that interfere with compliance; HIV, if present, under adequate control (CD4 > 200 cells/mm3 for >6 months, undetectable HIV-1 RNA, on stable antiretroviral therapy >3 months, and no AIDS-related complications)see detailed thresholds

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

Absolute contraindications: Irreversible end‑organ disease (e.g., renal, hepatic); active malignancy or infections; systemic diseases (autoimmune, vascular, amyloidosis); chronic gastrointestinal disease (e.g., bleeding peptic ulcer, diverticulitis, active or recurrent pancreatitis); progressive neuromuscular disease; use of tobacco products (ongoing tobacco use); untreated or unstable cerebrovascular disease; uncontrolled psychiatric disorders; multi‑system diseases that significantly affect outcomes; other conditions where risks of transplantation exceed benefitsN/A

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

Covered CPT CodesCPTCovered

33930-33945

Heart/lung transplant

Covered HCPCS CodesHCPCSCovered

S2054	Transplantation of multivisceral organs
S2055	Harvesting of donor multivisceral organs, with preparation and maintenance of allografts; from cadaver donor
S2060	Lobar lung transplantation
S2061	Donor lobectomy (lung) for transplantation, living donor

Covered ICD-10 CodesICD-10Covered

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

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inv-09: Liver and kidney function — bilirubin and creatinine clearance thresholds

Total bilirubin threshold< 2.5 mg/dL

Creatinine clearance threshold> 50 ml/min/kg

ContextAdequate liver and kidney function required as part of candidate selection

inv-10: Life expectancy (without cardiopulmonary disease) — > 2 years

Life expectancy requirement> 2 years (in the absence of cardiopulmonary disease)

ContextRequired as part of recipient physiologic and comorbidity assessment

Candidate Selection Criteria

Candidate selection criteria

Candidate must meet institution selection criteria or the following Aetna criteria:

Clinical indication: Severe refractory heart failure plus end-stage lung disease or irreversible pulmonary hypertensionNYHA III or IV or equivalent severity

Policy examples include cystic fibrosis with severe heart failure, Eisenmenger's complex, irreversible primary pulmonary hypertension, connective tissue disease with severe pulmonary fibrosis

Physiologic and comorbidity requirements: Absence of chronic high-dose steroids; absence of acute or chronic active infections that are not effectively treated; absence of active malignancy unless completely resected or deemed low recurrence risk; adequate functional status with active rehabilitation (mechanically ventilated or immobile persons are generally poor candidates though ambulatory ECMO bridge is not an absolute exclusion); adequate liver and kidney function (bilirubin < 2.5 mg/dL; creatinine clearance > 50 ml/min/kg); life expectancy > 2 years absent cardiopulmonary disease; abstinence from smoking for at least 3 months; no active alcohol or chemical dependency; no uncontrolled psychiatric disorders; controlled HIV if present (CD4 >200 cells/mm3 for >6 months, undetectable viral load, on stable ART >3 months, and no AIDS complications)

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

Documentation Required

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

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.

Note

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.

Transplant Center Requirements

Step Therapy

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

inv-27: Post-transplant surveillance and management — clinical guidance only in background about complications and chronic rejection

Primary post‑op complications (early)Acute isolated lung rejection, multi-organ failure, bacterial pneumonia (within first postoperative month)

Late post‑op complicationsViral pneumonia, fungal infection, tuberculosis, chronic obliterative bronchiolitis (chronic rejection)

Clinical guidance roleBackground discussion only — anticipatory management and surveillance recommended but no explicit coverage rules provided

inv-28: Reference literature — references for indications, outcomes, techniques, and considerations (35+ refs)

Scope of referencesLiterature covers indications, outcomes, techniques, and considerations for heart‑lung transplantation

Number of citations

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

inv-22: NYHA classification — NYHA functional class I–IV definitions

NYHA Class ICardiac disease without limitation of physical activity; ordinary activity does not cause symptoms

NYHA Class IISlight limitation of physical activity; comfortable at rest; ordinary activity causes symptoms

NYHA Class IIIMarked limitation of physical activity; comfortable at rest; less than ordinary activity causes symptoms

NYHA Class IVInability to carry on any physical activity without discomfort; symptoms may be present at rest

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.

OpenPayer

Heart-Lung Transplantation