Lung Transplantation
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Defines medical necessity, selection criteria, contraindications, coding, and investigational status for lung transplantation for Aetna members and describes disease-specific criteria for candidate selection.
No material clinical or coverage changes in this revision.
Coverage Criteria for Lung Transplantation
Medical Necessity — qualifying conditions
Covered when ANY of the following qualifying conditions are present and the member meets the transplanting institution's selection criteria (or the general selection criteria if institution criteria are absent) and has no contraindications.
Not an all-inclusive list
Disease-specific selection criteria — Cystic Fibrosis
Covered when ALL of the following are met:
Disease-specific selection criteria — Emphysema (including alpha-1)
Covered when ALL of the following are met:
BODE index indicates ~2 years or less survival at >=7
Disease-specific selection criteria — Pulmonary fibrosis / Pulmonary hypertension / Sarcoidosis / Eisenmenger
Covered when member meets general selection criteria plus any of the disease-specific thresholds below:
NYHA Class III defined as marked limitation of activity
General selection criteria
When the transplanting institution has no selection criteria, ALL of the following must be met:
All must be met and no contraindications present
Candidate indications and selection
Clinical indications and candidate considerations described in the document:
References: indications and rationale
See LVRS guidance for selection
Preservation and donor acceptance criteria (trial-based)
Donor lung preservation and selection using normothermic perfusion devices:
OCS Lung reduced PGD3 in INSPIRE and enabled extended-criteria utilization in EXPAND
Criteria for considering OCS/EVLP-assessed donor lungs
Use of OCS/EVLP-assessed donor lungs may be considered when the following apply (examples from trials):
From EXPAND eligibility criteria
From EXPAND protocol
Open air leak/lung contusion were reasons for rejection in trials
Intraoperative ECMO vs CPB
Intraoperative circulatory support choice considerations:
Evidence primarily from retrospective single-center studies and meta-analyses
Covered with clinical context and evidence limitations
Evidence summaries and clinical positioning from studies
Findings from single-center series (see cited studies)
Biologic variability and platform differences noted
Evidence limited to retrospective cohorts
Xenotransplantation of lungs (for example, porcine‑to‑human grafts) is currently considered experimental and investigational and is not a clinically applicable option for lung transplantation due to unresolved immunologic barriers and lack of durable function in preclinical models.
The policy therefore excludes xenotransplantation from clinically applicable coverage and treats it as investigational in the procedural listing.
Donor lungs with an open air leak or severe contusion should not be used with OCS Lung and are excluded from OCS‑assisted transplantation because perfusate leakage into the airways compromises oxygenation and functional assessment.
In preclinical OCS studies, acellular perfusion produced high vascular resistance, edema, and worsening compliance, which limited acellular OCS perfusion to 6 hours on that system; these findings suggest caution when considering prolonged acellular preservation strategies.
In an animal model using the OCS Lung system, whole blood perfusate maintained physiologic stability out to 24 hours, whereas acellular perfusion was limited to 6 hours due to prohibitive increases in vascular resistance, pulmonary edema, and falling compliance.
These preclinical data indicate a practical limit to acellular perfusion duration on OCS and highlight that extended acellular preservation has demonstrated physiologic deterioration in experimental models.
Clinical guideline resources (UpToDate reviews cited) do not currently list dd‑cfDNA testing as a routine management tool for lung transplant recipients, and the policy classifies AlloSure as investigational for rejection surveillance; study publications of dd‑cfDNA report thresholds such as 0.5% for high negative predictive value and thresholds near 0.85–1.0% for detection of rejection in observational cohorts.
When dd‑cfDNA is used in practice or research, interpretation should be paired with contemporaneous clinical and pathologic data and documented in the medical record.
Related therapies and technologies discussed in the policy include alemtuzumab (listed as experimental/investigational for induction or treatment of acute cellular rejection), antithymocyte globulin (ATG / Thymoglobulin) (described as medically necessary for treatment of acute cellular rejection), and AlloSure (donor‑derived cell‑free DNA) testing (listed as investigational).
Ex‑vivo lung perfusion (EVLP) and the TransMedics Organ Care System (OCS Lung) are described as preservation/assessment technologies under evaluation; EVLP and related CPT codes (0494T–0496T) are listed as investigational in the coding section.
The policy notes that traditional cold static (hypothermic) storage has been the standard for donation preservation but may be insufficient to evaluate or enable use of suboptimal or extended‑criteria donor lungs without additional assessment or reconditioning.
Normothermic perfusion strategies such as EVLP or portable systems (eg, OCS Lung) are described as techniques to preserve, assess, and potentially recondition donor lungs outside the body and may increase donor utilization compared with cold static storage in selected settings, but their role and impact on resources and outcomes remain under evaluation.
The evidence supporting EVLP/OCS is limited and heterogeneous: clinical series and early trials demonstrate that EVLP can convert a proportion of marginal donor lungs to transplantable status, but EVLP/OCS use has been associated with increased perioperative resource use in some studies and there remain device‑ and protocol‑specific limitations (for example, open air leak or severe contusion precluding use and acellular perfusion duration constraints in preclinical models).
Authors emphasize that many findings are from observational series or early randomized trials and that prospective, multicenter randomized data with longer follow‑up are needed to define which patients and donor lungs benefit most from EVLP/OCS assessment and to clarify impacts on outcomes and costs.
Coding and Billing
| 32850 | Donor pneumonectomy(s) (including cold preservation), from cadaver donor. |
| 32851 | Lung transplant, single; without cardiopulmonary bypass. |
| 32852 | Lung transplant, single; with cardiopulmonary bypass. |
| 32853 | Lung transplant, double (bilateral sequential or en bloc); without cardiopulmonary bypass. |
| 32854 | Lung transplant, double (bilateral sequential or en bloc); with cardiopulmonary bypass. |
| 34714 | Open femoral artery exposure with creation of conduit for delivery of endovascular prosthesis or for establishment of cardiopulmonary bypass, unilateral (List separately in addition to code for primary procedure). |
| 0494T | Surgical preparation and cannulation of marginal (extended) cadaver donor lung(s) to ex vivo organ perfusion system, including decannulation, separation from the perfusion system, and cold preservation of the allograft prior to implantation, when performed. |
| 0495T | Initiation and monitoring marginal (extended) cadaver donor lung(s) organ perfusion system by physician or qualified health care professional, including physiological and laboratory assessment (eg, pulmonary artery flow, pulmonary artery pressure, left atrial pressure, pulmonary vascular resistance, mean/peak and plateau airway pressure, dynamic compliance and perfusate gas analysis), including bronchoscopy and X ray when performed; first two hours in sterile field. |
| 0496T | Initiation and monitoring marginal (extended) cadaver donor lung(s) organ perfusion system by physician or qualified health care professional, including physiological and laboratory assessment (eg, pulmonary artery flow, pulmonary artery pressure, left atrial pressure, pulmonary vascular resistance, mean/peak and plateau airway pressure, dynamic compliance and perfusate gas analysis), including bronchoscopy and X ray when performed; each additional hour (List separately in addition to code for primary procedure). |
| J0202 | Injection, alemtuzumab, 1 mg. |
| C34.00 - C34.92 | Malignant neoplasm of bronchus and lung [good surgical candidates]. |
| E84.0 - E84.9 | Cystic fibrosis. |
| E88.01 | Alpha-1-antitrypsin deficiency. |
| I27.0 | Primary pulmonary hypertension. |
| I27.83 | Eisenmenger's syndrome. |
| J43.0 - J43.9 | Emphysema. |
| T86.810 - T86.819 | Complications of lung transplant. |
| A00.0 - B99.9 | Infectious and parasitic diseases (acute or chronic active infection not adequately treated). |
| I21.01 - I22.9 | ST elevation (STEMI) and non-ST (NSTEMI) myocardial infarction (MI in last 6 months). |
| I25.1 - I25.9 | Atherosclerotic heart disease of native coronary artery [significant]. |
| No codes listed |
Provider Actions, Authorization, and Documentation
Provider actions — none specified
None specified in this section of the document.
Bulletin scope and legal note
This bulletin contains a partial, general description of plan or program benefits and does not constitute a contract. It is intended to assist in administering plan benefits; treating providers remain responsible for medical advice and treatment. Participating providers are independent contractors and not employees or agents of Aetna.
Step therapy — not applicable
No explicit step-therapy sequences are specified in this policy section.
Selection criteria and required documentation
When institutional transplant selection criteria are absent, the member must meet the consolidated general selection criteria listed (e.g., absence of active infection, adequate cardiac status, adequate functional status, adequate liver and kidney function, limited life expectancy < 2 years, abstinence from substance dependency, controlled psychiatric conditions, controlled HIV per specified thresholds). These selection criteria must be documented. Contraindications that should trigger denial include active or inadequately treated infection, recent malignancy or complications from AIDS, uncontrolled cardiac disease (e.g., MI in last 6 months), uncontrolled psychiatric/substance dependency, refractory uncontrolled hypertension, and other conditions listed in the ICD-10 contraindicated codes.
- Document institution selection criteria when available; if absent, document that ALL listed general selection criteria are met.
- Document absence of contraindications (e.g., active infection, recent malignancy, uncontrolled cardiac disease, uncontrolled psychiatric disorder, refractory hypertension).
- Use ICD-10 contraindicated codes listed in the policy when submitting claims/documentation.
Authorization and billing — verification required
Prior authorization requirements are referenced elsewhere in the policy for listed transplant procedures and codes; providers should verify plan-specific prior authorization rules before scheduling transplantation-related services. Certain CPT/HCPCS codes for transplantation and related services are identified in the policy — when selection criteria are met, these codes may be billed; experimental or investigational items (e.g., alemtuzumab for induction, AlloSure dd‑cfDNA testing for post-transplant monitoring, ex‑vivo lung perfusion, TransMedics OCS Lung) are noted as experimental/investigational and may not be eligible for coverage.
- Verify prior authorization for transplant procedures and donor/organ preservation services per payer rules.
- Experimental/investigational items listed (eg, AlloSure, EVLP, TransMedics OCS Lung, alemtuzumab) are identified in this policy as not established — check coverage before ordering or billing.
Documentation expectations for advanced preservation/monitoring technologies
When using technologies or diagnostics discussed in the background (OCS Lung, EVLP, AlloSure, anti‑fibrotic continuation, ATG), document the clinical rationale, trial or registry participation if applicable, donor lung quality and preservation method, paired or serial dd-cfDNA measures when used for surveillance, and any institutional protocols guiding use. For EVLP/OCS use, document donor assessment findings, reasons for using EVLP/OCS (eg, extended-criteria donor), and explicit documentation if open air leak or severe contusion contraindications were evaluated.
- Document trial or registry enrollment (eg, INSPIRE, EXPAND) when applicable.
- For AlloSure/dd‑cfDNA, document paired baseline and serial measurements and clinical context for interpretation.
- For EVLP/OCS, document donor lung quality, reason for EVLP/OCS selection, intra‑procedure assessment parameters, and exclusion for open air leak or severe contusion.
Authorization/resource expectation for EVLP/OCS Lung
Authorization/resource expectations for EVLP and OCS Lung: these techniques may be used in trial or specialized center contexts; they can affect operative and post‑operative resource needs (eg, higher early PGD rates, increased ECMO and ICU use reported in some series). Providers should anticipate and document higher resource utilization when EVLP is employed and confirm coverage/authorization in advance.
- Document anticipated increased ECMO/ICU use and costs when EVLP is planned.
- Confirm plan-specific resource authorization for EVLP/OCS prior to procedure scheduling.
EVLP/OCS device regulatory status and documentation
EVLP devices and OCS Lung have evolving regulatory and trial status. As of cited evidence, two EVLP systems (XVIVO XPS and TransMedics OCS) have FDA approval/clearance for specific indications; some uses remain investigational or studied in clinical trials. Document device used and regulatory/clinical-trial context.
- Identify device (eg, XVIVO XPS, TransMedics OCS) and whether use is within FDA‑approved indication or a clinical trial.
- If used outside approved indications, document investigational status and trial participation.
Administrative and coverage verification — provider responsibilities
The bulletin is a partial, general description of plan benefits and is not a contract. Providers must verify member benefits, prior authorization requirements, and coverage determinations with Aetna. Treating providers retain responsibility for clinical care; policies may be updated and are subject to change.
- Verify member-specific benefits and prior authorization requirements before delivering services.
- This bulletin does not guarantee coverage — check plan documents and preauthorization portals.
Candidate Selection and Indications
Candidate selection — meet institution criteria or general selection criteria
Candidates must meet the transplanting institution's selection criteria; if the institution has no selection criteria, the general selection criteria apply.
Short-term mechanical ventilation (<2 weeks) or bridge with ambulatory ECMO does not by itself rule out candidacy
Candidate indications — clinical indications and considerations
Clinical indications and candidate considerations:
Single-LTX generally favored for fibrosis
Double-LTX commonly used for CF and COPD when infection present
Candidate and procedure-type considerations (registry and series data)
Patient selection and procedure-type considerations from registry and series data:
Case series and pooled analyses support consideration in select patients
UNOS registry analysis
EVLP candidate contexts — use for marginal or DCD donor lungs
EVLP may be used to evaluate marginal or DCD donor lungs prior to acceptance for transplantation.
Meta-analyses and systematic reviews summarize mixed but promising results
ATG candidate features
ATG candidate considerations from observational data:
Evidence observational; randomized data lacking
Contraindications to Transplant and Related Procedures
Single-lung transplantation is contraindicated for recipients with chronic pulmonary infections such as bronchiectasis, chronic bronchitis, and cystic fibrosis; requests may be denied when such contraindications are present. Additional contraindications that commonly trigger denial include active or inadequately treated infection, recent or active pulmonary malignancy (primary or metastatic), multi-system disease, refractory uncontrolled hypertension, significant cardiac disease (eg, recent MI), uncontrolled psychiatric/substance-abuse disorders, and other comorbidities that make the patient a poor surgical candidate.
Obesity greater than 20% above ideal body weight, cachexia (less than 80% of ideal body weight), prolonged mechanical ventilation or immobility are described as features of poor candidacy for transplantation and may lead to non-acceptance.
When assessing donor lungs for OCS/EVLP use, an open air leak from lung contusion or surgical laceration is a specific contraindication to OCS Lung assessment and will result in rejection of the organ for transplantation.
This policy duplicates some contraindication language elsewhere in the document to emphasize denial risk: active or inadequately treated infection, recent or active malignancy, multi-system disease, uncontrolled psychiatric/substance-abuse problems, and significant cardiac disease can each preclude consideration for lung transplantation.
Clinical Policy Bulletins are informational and do not themselves establish plan benefits; specific coverage and authorization decisions remain subject to the member’s plan terms and medical review.
Patients who are obese (>20% above ideal body weight), cachectic (<80% ideal body weight), mechanically ventilated, or otherwise immobile are considered poor candidates for lung transplantation and may be excluded from listing or from proceeding to transplant unless the transplant center documents net clinical benefit.
These clinical features are described in the candidate selection background and are used by programs when determining suitability for transplant evaluation and listing.
Donor lungs with an open air leak from lung contusion or surgical laceration are a contraindication to assessment and use with the OCS Lung device because perfusate leak into the airways (bloody froth) compromises oxygenation and leads to organ rejection.
Cases of severe lung contusion producing perfusate leakage were explicitly reported as reasons for rejecting lungs after OCS assessment in clinical experience series.
General contraindications summarized elsewhere in the policy include active or inadequately treated infection (pulmonary or non‑pulmonary), recent or active pulmonary malignancy, multi‑system disease not confined to the lung, refractory uncontrolled hypertension, recent myocardial infarction, and uncontrolled psychiatric or substance-abuse disorders; these are reiterated throughout the document as exclusion criteria for transplant candidacy.
Providers and programs should refer to the full policy and the member’s plan terms for a complete list of contraindications and to support authorization or denial decisions.
The policy sections addressing immunosuppressive therapies and surveillance do not state any absolute or relative contraindications for use of anti‑thymocyte globulin (ATG) or for donor‑derived cell‑free DNA (dd‑cfDNA) testing. ATG is described as medically necessary for treatment of acute cellular rejection, while alemtuzumab is listed as investigational; AlloSure (dd‑cfDNA) is listed as experimental/investigational in the policy’s procedural table.
Although no contraindications to ATG or dd‑cfDNA are specified in these excerpts, clinicians must weigh individual infection risk and immunologic status when considering cytolytic therapy and interpret dd‑cfDNA results in the context of concurrent clinical and biopsy data.
Pre-Transplant Evaluation and Testing
EVALUATION REQUIREMENTS — cardiac, liver, kidney assessment and other pre-transplant evaluations
Before listing or transplant, perform and document comprehensive pre-transplant evaluations including cardiac assessment (stress test or catheterization if symptomatic), liver and kidney function, and exclusion of significant coronary disease.
- Cardiac evaluation to exclude significant coronary artery disease; catheterization if symptoms present.
- Document liver (bilirubin) and kidney (creatinine clearance) results as specified in general selection criteria.
EVALUATION REQUIREMENTS — GERD assessment options (EGD, pH probe, impedance, gastric emptying, esophagram)
When considering anti-reflux intervention, document objective GERD testing such as EGD, pH probe, impedance testing, gastric emptying study, or esophagram as used in the cited studies.
- Record which objective test(s) confirmed GERD and include results in the medical record when anti-reflux surgery is considered.
EVALUATION REQUIREMENTS — EVLP/OCS physiologic stability assessment (PaO2:FiO2) required for extended-criteria/DCD donor lungs
For extended-criteria or DCD donor lungs, document EVLP/OCS assessment of physiologic stability including PaO2:FiO2 prior to acceptance; trials required PaO2:FiO2 >300 mm Hg on device assessment for transplantation in some protocols.
- Record PaO2:FiO2 measurements and EVLP/OCS variable stability before accepting extended-criteria donor lungs.
- Include surgeon acceptance documentation in the transplant record.
EVALUATION REQUIREMENTS — cardiac/liver/kidney assessment duplicate (fallback)
Cardiac, liver, and kidney assessment requirements described earlier apply across candidate evaluation; ensure documentation of these assessments per general selection criteria.
- Repeat and document cardiac, hepatic, and renal evaluations as part of pre-transplant workup.
EVALUATION REQUIREMENTS — dd-cfDNA interpretation requires paired clinical-pathologic data and serial measures
dd-cfDNA (AlloSure) interpretation should be accompanied by contemporaneous clinical and pathologic data and serial measurements; document paired biopsy findings and clinical context when using dd-cfDNA for surveillance.
- Document biopsy results, symptoms, and other clinical data alongside dd-cfDNA values.
- Record serial dd-cfDNA measurements and the thresholds applied (eg, 0.85% or 1.0%).
EVALUATION REQUIREMENTS — cardiac/liver/kidney assessment duplicate (fallback)
Cardiac, liver, and kidney assessment requirements reiterated: confirm and document these evaluations according to the general selection criteria prior to listing or transplant.
- Ensure documentation addresses bilirubin, creatinine clearance, cardiac testing, and functional status.
Transplant Center and Program Requirements
CENTER REQUIREMENTS — use transplanting institution selection criteria and document experience
Transplanting institutions must use their selection criteria when available and document their experience and institutional protocols; if the institution lacks criteria, providers must document that the member meets the policy's general selection criteria.
- Provide documentation of institutional selection criteria or explicit documentation that all general selection criteria are met.
- Document institutional experience with lung transplantation and multidisciplinary perioperative care.
CENTER REQUIREMENTS — institutional selection criteria and documented experience (duplicate)
Reiterate that institutional selection criteria and documented program experience should be used when available; record multidisciplinary team capabilities and case experience in the medical record.
- Document center protocols, team composition, and experience relevant to complex perioperative management.
CENTER REQUIREMENTS — programs using OCS/EVLP should have protocols and resources to manage increased perioperative needs
Programs using OCS or EVLP should have formal protocols and resources to manage increased perioperative needs (for example, ECMO capability and ICU capacity) and should document these capabilities and justification for device use.
- Document institutional ECMO capability, ICU resources, and protocols for managing EVLP/OCS-assessed transplants.
- Record participation in registries or trials and plans for follow-up data collection.
CENTER REQUIREMENTS — institutional criteria/documentation duplicate (fallback)
If institutional criteria are absent, repeat the requirement that providers must document that the member meets all general selection criteria before transplant listing or authorization.
- Ensure documentation explicitly addresses each element of the general selection criteria.
CENTER REQUIREMENTS — no explicit accreditation/volume requirements stated
Studies cited derive from multi-center transplant programs using center-specific surveillance algorithms; the policy does not specify accreditation or minimum volume requirements for transplant centers.
- Providers should note that no explicit accreditation or volume thresholds are stated in the policy.
- Document institutional surveillance algorithms and post-transplant follow-up plans.
Post-Transplant Care, Monitoring, and Interventions
Supplemental Coding Thresholds and Device Notes
| No codes listed |
Background and Evidence Summary
Background: Lung transplantation is a therapeutic option for selected patients with end‑stage pulmonary disease. Procedure types include single‑lung, double‑lung, and lobar transplantation; single‑lung transplantation is often used for end‑stage pulmonary fibrosis, while double‑lung transplantation is typically performed for cystic fibrosis, COPD/emphysema with chronic airway infection, and other indications where single‑lung transplant would be contraindicated.
Lobar lung transplantation (from living or cadaver donors) is described as an option—particularly for pediatric recipients or patients who would not survive waiting for cadaveric organs—and has demonstrated comparable intermediate outcomes to cadaver lobar transplantation in available evidence.
Definitions and Abbreviations
Policy Revision History
Policy became effective.
Policy underwent most recent review.
Next scheduled policy review date.
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