Aetna Lung Transplant Coverage & Prior Auth

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.

Qualifying conditions: Alpha1-antitrypsin deficiency; Bronchopulmonary dysplasia; Congenital heart disease (Eisenmenger's defect/complex); Cystic fibrosis; Graft-versus-host disease or failed primary lung graft; Lymphangioleiomyomatosis (LAM) with end-stage pulmonary disease; Obstructive lung disease (eg bronchiectasis, bronchiolitis obliterans, COPD, emphysema); Primary pulmonary hypertension; Restrictive lung disease (eg allergic alveolitis, asbestosis, collagen vascular disease, desquamative interstitial fibrosis, eosinophilic granuloma, idiopathic pulmonary fibrosis, post-chemotherapy, sarcoidosis, systemic sclerosis)

Not an all-inclusive list

Disease-specific selection criteria — Cystic Fibrosis

Covered when ALL of the following are met:

CF criteria: Member meets general selection criteria AND exhibits at least 2 of the following signs of clinical deterioration: cycling IV antibiotic therapy; decreasing FEV1; CO2 retention (pCO2 > 50 mm Hg); FEV1 < 30% predicted; increasing frequency of hospital admission; increasing severe exacerbations (eg requiring hospitalization); initiation of enteral/parenteral nutrition; nocturnal non-invasive ventilation; recurrent massive hemoptysis; worsening A-a gradient requiring higher FiO2; recurrent pneumothorax.>=2 signs

Disease-specific selection criteria — Emphysema (including alpha-1)

Covered when ALL of the following are met:

Emphysema criteria: Member meets general selection criteria AND both: (1) hospitalizations for COPD exacerbation associated with hypercapnia in the preceding year (pCO2 >= 50 mm Hg) with associated factors such as declining BMI, increasing oxygen requirements, reduced serum albumin, or presence of cor pulmonale (clinical diagnosis or any 2 of: enlarged pulmonary arteries on chest X-ray; mean PA pressure >25 mm Hg at rest or >30 mm Hg with exercise; pedal edema or JVD; RV hypertrophy or RA enlargement on ECG); AND (2) BODE index >= 7.pCO2>=50 mm Hg; BODE>=7

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:

Pulmonary fibrosis: One or more of: DLCO < 60% predicted; presence of cor pulmonale or pulmonary hypertension; total lung capacity (TLC) < 70% predicted.DLCO<60% or TLC<70%

Pulmonary hypertension: One or more of: NYHA Class III failing conventional vasodilators; NYHA Class III being considered for parenteral/subcutaneous vasodilator therapy; mean pulmonary artery pressure by right heart catheterization >25 mm Hg at rest or >30 mm Hg with exercise; pulmonary artery systolic pressure >= 50 mm Hg by echocardiogram or pulmonary angiography (valvular disease excluded by echo).PA pressure thresholds as stated

NYHA Class III defined as marked limitation of activity

Eisenmenger: Marked deterioration in functional capacity (NYHA III) OR pulmonary hypertension with mean PA pressure >25 mm Hg at rest or >30 mm Hg with exercise OR signs of right ventricular failure (progressive hepatomegaly, ascites).

General selection criteria

When the transplanting institution has no selection criteria, ALL of the following must be met:

General selection: Absence of acute or inadequately treated infection (pulmonary or non-pulmonary); adequate cardiac status (eg no significant coronary artery disease on angiography, EF > 40%, no MI in last 6 months; may require catheterization if symptoms); adequate functional status (active rehabilitation; mechanically ventilated or immobile persons are generally poor candidates though short-term mechanical ventilation <2 weeks or bridge with ambulatory ECMO does not itself rule out candidacy); adequate liver and kidney function (bilirubin < 2.5 mg/dL; creatinine clearance > 50 ml/min/kg); limited life expectancy < 2 years; no active alcohol/chemical dependency (abstinent >= 3 months if history); no uncontrolled/untreated psychiatric disorders interfering with compliance; controlled HIV (CD4 > 200 cells/mm3 for >6 months and HIV-1 RNA undetectable and on stable antiviral therapy >3 months).

All must be met and no contraindications present

Candidate indications and selection

Clinical indications and candidate considerations described in the document:

General candidate selection: Candidates include patients with end-stage pulmonary disease; single-LTX generally for end-stage pulmonary fibrosis; double-LTX for COPD and CF when cardiac function is preserved; lobar-LTX reserved for children/adolescents or those who will not survive waiting for cadaver lungs.

References: indications and rationale

Emphysema management: For end-stage emphysema, lung transplantation is preferred over lung volume reduction surgery (LVRS) when disease is diffuse, FEV1 is low, hypercapnia is present, or pulmonary hypertension exists; LVRS candidates have hyperinflation, heterogeneous disease, FEV1 > 20%, and normal PCO2.FEV1 thresholds noted in text

See LVRS guidance for selection

Preservation and donor acceptance criteria (trial-based)

Donor lung preservation and selection using normothermic perfusion devices:

OCS Lung/EVLP use for preservation: OCS Lung and EVLP may be used to preserve, assess, and potentially recondition donor lungs; INSPIRE required donors <65 years with PaO2:FiO2 > 300 mm Hg for standard-criteria enrollment; EXPAND used OCS to enable use of extended-criteria donors when OCS variables were stable and PaO2:FiO2 > 300 mm Hg prior to acceptance.PaO2:FiO2 >300 mm Hg for acceptance in trials

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):

Donor selection: Donor lungs meet one or more extended-criteria: PaO2:FiO2 <= 300 mm Hg; expected ischemic time > 6 hours; donor age >= 55 years; or donor after circulatory death (DCD).as listed

From EXPAND eligibility criteria

OCS/EVLP acceptance: OCS/EVLP variables are stable and PaO2:FiO2 > 300 mm Hg on assessment, and the transplant surgeon accepts the organ.PaO2:FiO2 > 300 mm Hg on OCS

From EXPAND protocol

Contraindications to OCS/EVLP acceptance: No open air leak or severe lung contusion or surgical laceration causing perfusate leak into airways.clinical exclusion

Intraoperative ECMO vs CPB

Intraoperative circulatory support choice considerations:

ECMO vs CPB considerations: When extracorporeal support is required intraoperatively, veno-arterial ECMO may be preferred to cardiopulmonary bypass (CPB) because observational studies report lower transfusion requirements, shorter ICU stays, and lower in-hospital mortality with ECMO compared with CPB.observational evidence

Evidence primarily from retrospective single-center studies and meta-analyses

Covered with clinical context and evidence limitations

Evidence summaries and clinical positioning from studies

ATG for CLAD: ATG has been used as second-line cytolytic therapy for CLAD with reported partial and complete responses in single-center series (eg, 23% complete responders, 40% partial responders in one series); responders tended to be younger and in earlier CLAD stages; observational evidence only and randomized trials are needed.

Findings from single-center series (see cited studies)

dd-cfDNA (AlloSure) monitoring: Donor-derived cell-free DNA testing (dd-cfDNA) has demonstrated elevated levels with ACR, AMR, and CLAD versus stable allografts across observational studies with reported thresholds (eg ~0.85%–1.0%) and high negative predictive values for ruling out events; interpretation should be paired with clinical and biopsy data.example thresholds ~0.85%–1.0%

Biologic variability and platform differences noted

Antifibrotic therapy before transplant: Small retrospective studies suggest continuation of antifibrotic therapy up to the time of transplant may be safe with respect to perioperative complications and 1-year survival, but evidence is limited and non-risk-adjusted; further prospective study recommended.

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

Covered CPT CodesCPTCovered

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).

Ex-vivo lung perfusion CPT Codes (not covered — investigational)CPTNot Covered

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).

HCPCS Codes Covered if selection criteria metHCPCSCovered

J7504	Lymphocyte immune globulin, antithymocyte globulin, equine, parenteral, 250 mg.
J7511	Lymphocyte immune globulin, antithymocyte globulin, rabbit, parenteral, 25 mg.

HCPCS Codes Not Covered (investigational)HCPCSNot Covered

J0202

Injection, alemtuzumab, 1 mg.

ICD-10 Codes Covered if selection criteria metICD-10Covered

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.

ICD-10 Codes Contraindicating Coverage (examples)ICD-10Not Covered

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].

Referenced devices/systems (no billing codes provided)mixed

No codes listed

Physiologic thresholds (FEV1, pCO2, BODE, DLCO, TLC)

FEV1 thresholdFEV1 < 30% predicted (criterion cited for cystic fibrosis)

Arterial CO2 (pCO2)pCO2 ≥ 50 mm Hg (hypercapnia associated with COPD/emphysema hospitalization criterion)

BODE indexBODE index ≥ 7 (indicating about 2 years or less survival; criterion for emphysema)

DLCODLCO < 60% predicted (disease-specific threshold for pulmonary fibrosis and sarcoidosis)

TLCTotal lung capacity (TLC) < 70% predicted (threshold for pulmonary fibrosis/sarcoidosis)

Donor PaO2:FiO2: INSPIRE enrollment criteria

INSPIRE donor PaO2:FiO2 enrollmentRequired PaO2:FiO2 > 300 mm Hg for eligible donors (standard-criteria enrollment)

Donor age for INSPIRE eligibilityDonors younger than 65 years (INSPIRE trial donor age criterion)

Study populationINSPIRE randomized trial enrolled 370 patients with 320 transplanted (context for enrollment criteria)

EXPAND acceptance PaO2:FiO2 during OCS assessment

OCS assessment acceptance PaO2:FiO2PaO2:FiO2 > 300 mm Hg on OCS/OCS-assessed evaluation was required prior to organ acceptance in EXPAND

ContextEXPAND used OCS to assess extended-criteria donors and required stability of OCS variables in addition to PaO2:FiO2 > 300 mm Hg

Trial findingEXPAND transplanted 87% of eligible OCS-perfused lungs (trial context for acceptance threshold)

EXPAND extended-criteria donor features

PaO2:FiO2 criterionDonor PaO2:FiO2 ≤ 300 mm Hg qualifies as an extended-criteria feature (one of several)

Ischemic timeExpected ischemic time > 6 hours listed as an extended-criteria feature

Other extended-criteria featuresDonor age ≥ 55 years or donation after circulatory death (DCD) status qualifies as extended-criteria

PaO2:FiO2 threshold for extended-criteria donors

PaO2:FiO2 threshold for extended criteriaPaO2:FiO2 ≤ 300 mm Hg defines the extended-criteria donor threshold

Use in trialsThis threshold was used to classify lungs as extended-criteria in the EXPAND study context

Acceptance caveatEven with initial PaO2:FiO2 ≤ 300 mm Hg, lungs were transplanted only if OCS variables stabilized and PaO2:FiO2 exceeded 300 mm Hg on assessment

Expected ischemic time threshold

Expected ischemic time threshold> 6 hours (listed as an extended-criteria feature in EXPAND)

Cold ischemic time considerationsEVLP/OCS may reduce cold ischemic time for DCD lungs (pilot data showed shorter cold ischemic time with portable EVLP)

Preclinical perfusion findingsWhole-blood perfusate maintained stability to 24 hours in animal models, suggesting potential to extend preservation beyond typical ischemic times

Donor age threshold

Donor age threshold>= 55 years (donor age criterion used to define extended-criteria donors in EXPAND)

ContextDonor age ≥55 was one of multiple criteria permitting evaluation with OCS for potential transplantation

Acceptance conditionAge ≥55 alone qualified for EXPAND inclusion but organ still required stability on OCS and surgeon acceptance

EVLP perfusion duration limits (preclinical/animal)

Whole-blood (WB) perfusate durabilityWB perfusate maintained stability to 24 hours in a swine OCS model (superior to RBC and acellular solutions)

Acellular perfusion limitAcellular perfusion on OCS was limited to 6 hours in animal model due to high vascular resistance, edema, and worsening compliance

Clinical implicationFindings suggest whole-blood perfusate may enable longer preservation times versus acellular solutions in preclinical studies

dd-cfDNA thresholds used in studies

Common dd-cfDNA thresholds in studiesReported thresholds include ~0.5%, 0.85% (optimal in some analyses), and 1.0% (used for ALAD surveillance)

Performance at 0.5%Threshold ~0.5% described as a rule-out threshold with high NPV in some cohorts

Study-specific optimal thresholdAn 'optimal' threshold of approximately 0.85% reported in pooled/observational analyses

dd-cfDNA rule-out NPVs reported

Rule-out NPV at <0.5%dd-cfDNA < 0.5% associated with NPV ~96% for ruling out acute rejection in one multicenter cohort

Rule-out NPV at <1.0%dd-cfDNA < 1.0% associated with NPV ~90% in some studies and useful to exclude ALAD during surveillance

Study contextNPV estimates vary by study and cohort; reported values derive from observational and multicenter surveillance series

BODE index component thresholds

FEV1 % predicted categoriesFEV1 % predicted scoring for BODE: ≥65; 50–64; 36–49; ≤35

6-Minute Walk Test categories6MWT (meters) scoring for BODE: ≥350; 250–349; 150–249; ≤149

MMRC dyspnea and BMI componentsMMRC categories 0–1,2,3,4; BMI >21 versus ≤21 used in BODE scoring

Overall index useBODE index combines BMI, airflow obstruction (FEV1), dyspnea (MMRC), and 6MWT to predict mortality risk in COPD

Provider Actions, Authorization, and Documentation

Note

Provider actions — none specified

None specified in this section of the document.

Documentation Required

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

Step therapy — not applicable

No explicit step-therapy sequences are specified in this policy section.

Documentation Required

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.

Prior Authorization

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 Required

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.

Prior Authorization

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.

Documentation Required

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.

Documentation Required

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.

Candidate requirements: Meet transplanting institution's selection criteria OR meet all general selection criteria; have a qualifying disease meeting disease-specific thresholds; and have no contraindications listed in the policy.

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:

Primary indications for single-LTX: End-stage pulmonary fibrosis and other interstitial lung diseases; primary pulmonary hypertension and Eisenmenger's syndrome may also be indications for single-LTX.

Single-LTX generally favored for fibrosis

Primary indications for double-LTX: Cystic fibrosis, emphysema, and alpha-1 antitrypsin deficiency and conditions with chronic airway infection are common indications for double-LTX; double-LTX often chosen when chronic airway infection is present to avoid spillover from native lung.

Double-LTX commonly used for CF and COPD when infection present

Pediatric indications include pulmonary vascular disease, bronchiolitis obliterans, bronchopulmonary dysplasia, graft failure from viral pneumonitis, and cystic fibrosis; lobar-LTX is used for children/adolescents who cannot wait for cadaver lungs.

Candidate and procedure-type considerations (registry and series data)

Patient selection and procedure-type considerations from registry and series data:

LTX after HSCT: Selected patients with severe, treatment-refractory bronchiolitis obliterans or other non-infectious pulmonary complications after hematopoietic stem cell transplantation may be considered for lung transplantation after failure of multiple immunosuppressive regimens.failure of multiple regimens

Case series and pooled analyses support consideration in select patients

Single vs Double LTX outcomes: Registry analyses report double-LTX associated with better graft survival than single-LTX for idiopathic pulmonary fibrosis but not for COPD; procedure choice should be diagnosis-specific.diagnosis-specific

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.

Indications for EVLP evaluation drawn from studies: Marginal donor lungs (abnormal radiographs, low PaO2:FiO2, high smoking history) and donation after circulatory death (DCD) lungs were evaluated with EVLP in multiple cohorts; EVLP increased usable lungs with reported conversion rates ranging 34%–100% and achieved similar post-transplant outcomes in pooled analyses, though some studies reported higher early graft injury and ICU/ECMO use.

Meta-analyses and systematic reviews summarize mixed but promising results

ATG candidate features

ATG candidate considerations from observational data:

Likely ATG responders: Patients with earlier-stage CLAD (stage 1–2) and younger age were more likely to achieve partial or complete response to ATG in single-center series; responses included partial response (improvement in FEV1 decline by 20%) and complete response (absolute improvement or stability in FEV1).

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

Documentation Required

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.

Documentation Required

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.

Documentation Required

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.

Documentation Required

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.

Documentation Required

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%).

Documentation Required

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

Documentation Required

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.

Documentation Required

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.

Documentation Required

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.

Documentation Required

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.

Note

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

Immunosuppression management; monitoring for rejection and infection (overview)

Lifelong immunosuppressionLung transplant recipients require lifelong systemic immunosuppression and monitoring for rejection and infection

ATG coverage roleAnti-thymocyte globulin (thymoglobulin) is considered medically necessary for treatment of acute cellular rejection

Surveillance needsPost-transplant monitoring should track complications (eg, rejection, infection, PGD) and outcomes over follow-up periods reported in studies (commonly at least 12 months)

Anti-reflux surgery (Nissen) for selected recipients with GERD

Indication for anti-reflux surgeryLaparoscopic Nissen fundoplication has been performed post-LTX in selected recipients with objective or symptomatic GERD

Objective GERD confirmationStudies used objective tests (eg, pH probe, impedance, EGD, esophagram) to confirm GERD before fundoplication

Reported outcomesFundoplication in selected LTX recipients improved reflux symptoms and in some series slowed progression of BOS or decline in lung function

Ex-vivo lung perfusion / OCS Lung preservation and assessment (post-transplant context)

Purpose of EVLP/OCS post-transplant contextOCS Lung and EVLP are used to preserve, assess, and potentially recondition donor lungs to increase donor utilization, particularly for extended-criteria or DCD lungs

Trial-based evidenceINSPIRE (OCS vs cold storage) demonstrated reduced PGD3 incidence in OCS arm; EXPAND used OCS to enable extended-criteria donor use with stability criteria

Documentation when usedWhen OCS/EVLP used, document device parameters, donor extended-criteria features, OCS/EVLP variable stability, and surgeon acceptance decision

Post-transplant monitoring and ICU care (PGD, ECMO, ICU stay, survival tracking)

PGD and ICU trackingPost-transplant outcomes such as PGD (including PGD grade-3 within 72 hrs), ECMO requirement, ICU/ITU stay and 30-day/12-month survival should be tracked (studies report these outcomes)

EVLP-associated resource useEVLP transplants have been associated with increased perioperative resource use including higher ECMO rates and longer intensive care stays in some studies

Survival tracking periodTrials report 30-day and 12-month survival as primary outcome timepoints (eg, INSPIRE, EXPAND) and recommend follow-up to evaluate longer-term outcomes including CLAD/BOS

rATG therapy for CLAD/acute rejection (observational evidence)

rATG response rates (single-center series)Reported response rates to rATG for CLAD: partial response ~40% and complete response ~23% in larger series; small series reported ~50% responders

Responder characteristicsResponders more likely to be younger and in earlier CLAD stages (stage 1–2) in observational reports

Adverse eventsrATG associated with serum sickness, cytokine release syndrome, and infectious complications in reported series

dd-cfDNA (AlloSure) testing — surveillance and thresholds

dd-cfDNA (AlloSure) surveillance usedd-cfDNA has been used for routine post-transplant surveillance (up to 3 years in some series) to detect rejection/ALAD

Operational thresholdsCommonly reported thresholds: <0.5% and <1.0% for rule-out (high NPV); ~0.85% reported as an optimal threshold in some analyses

Test interpretationClinical interpretation of dd-cfDNA should be paired with clinical-pathologic data and serial measurements due to biological and platform variability

Perioperative management regarding antifibrotic therapy

Perioperative antifibrotic management summaryContinuation of antifibrotic therapy up to time of lung transplantation appears likely safe in small retrospective series without consistent increases in major perioperative complications

Evidence limitationsAvailable studies are small, retrospective, and non–risk-adjusted; further prospective data recommended

Reported outcomesStudies report similar rates of perioperative bleeding, wound/anastomotic complications, primary graft dysfunction and 30-day/1-year survival between continued antifibrotic users and controls in pooled analyses

Definitions and Abbreviations

Lobar lung transplantation definition

Lobar lung transplantation definitionTransplantation using a lobe from a living-related or cadaver donor, often reserved for pediatric recipients or when waiting for cadaver lungs is not feasible

Typical indicationsUsed for children/adolescents or when a recipient will not survive waiting for cadaver lungs; sometimes used in CF and severe pulmonary hypertension

Comparative effectivenessLiving-donor lobar-LTX shows satisfactory intermediate survival and functional results comparable to cadaver lobar-LTX in available evidence

NYHA Class III definition

NYHA Class III definitionMarked limitation of physical activity; comfortable at rest; less than ordinary activity causes symptoms (fatigue, palpitation, dyspnea, or anginal pain)

RelevanceUsed as a criterion for pulmonary hypertension and Eisenmenger transplant candidacy

Clinical implicationNYHA III patients failing conventional therapies may be considered for transplant or parenteral/subcutaneous vasodilator therapy per policy criteria

Lobar-LTX definition

Lobar-LTX termTransplantation of a donor lung lobe (from living or cadaver donors) typically used for children/adolescents or when cadaver lungs are unavailable

Use casesCommon indications include CF and severe primary pulmonary hypertension in pediatric recipients

OutcomeNo significant difference in effectiveness between living-donor and cadaver lobar-LTX reported in available evidence

Ex-vivo lung perfusion (EVLP) / OCS Lung definition

EVLP / OCS Lung definitionNormothermic or near-normothermic perfusion techniques to preserve, assess, and potentially recondition donor lungs outside the body; OCS Lung is a portable system used in clinical trials

Clinical purposeUsed to evaluate and potentially recondition marginal or DCD donor lungs to expand the donor pool

Regulatory noteTwo EVLP systems (XVIVO XPS and OCS) have FDA approval for specific indications per review summaries

Extended-criteria donor lung definition

Extended-criteria donor lung definitionDonor lungs meeting one or more criteria such as PaO2:FiO2 ≤ 300 mm Hg; expected ischemic time > 6 hours; donor age ≥ 55 years; or DCD status

Purpose of classificationExtended-criteria designation used to identify lungs that may require OCS/EVLP assessment prior to acceptance

Trial contextDefinition derives from EXPAND trial eligibility criteria

EVLP definition (short)

EVLP (short) definitionA closed-circuit system that perfuses and ventilates donor lungs outside the body to evaluate and potentially recondition them prior to transplantation

Perfusate optionsPerfusates used include whole blood, RBC-based or acellular solutions; whole-blood perfusate maintained stability to 24 hours in preclinical models

LimitationsAcellular perfusion on OCS was limited to ~6 hours in an animal model due to rising vascular resistance and edema

Intraoperative ECMO definition

Intraoperative ECMO definitionVeno-arterial extracorporeal membrane oxygenation used during lung transplantation as an alternative to conventional cardiopulmonary bypass

Comparative benefitsObservational studies report ECMO associated with lower transfusion needs, shorter ICU stays, and lower in-hospital mortality versus CPB

Clinical implicationECMO increasingly used as preferred intraoperative support in many programs

EVLP (Ex-Vivo Lung Perfusion) — duplicate definition

EVLP definition (duplicate)Ex-vivo lung perfusion — technique to perfuse and ventilate donor lungs outside the body for assessment and potential reconditioning prior to transplantation

Clinical systemsCommercial systems include XVIVO XPS and TransMedics OCS; EVLP can be performed at dedicated facilities or using portable devices

Intended effectAims to increase usable donor lungs and potentially extend preservation times compared with cold static storage

CLAD definition

CLAD definitionChronic lung allograft dysfunction (CLAD) — progressive decline in allograft function after the first year post-transplant, includes phenotypes such as BOS and RAS

Clinical consequenceCLAD is the major factor limiting long-term survival after lung transplant

Relation to therapyCLAD is target condition for rescue therapies such as rATG in observational series

PR (partial response to ATG)

PR (Partial Response to ATG)Partial response defined as improvement in rate of FEV1 decline by 20% after ATG

ContextUsed to categorize response to rATG therapy in observational CLAD series

Proportion reportedIn one large series, ~40% achieved partial response to ATG

CR (complete response to ATG)

CR (Complete Response to ATG)Complete response defined as absolute improvement or stability in baseline FEV1 after ATG

Clinical significanceComplete responders had reduced risk of death or retransplant in observational data

Proportion reportedIn one series ~23% achieved complete response to ATG

dd-cfDNA definition and thresholds

dd-cfDNA definitionDonor-derived cell-free DNA (dd-cfDNA) — percentage of circulating donor DNA in recipient plasma used as a noninvasive marker of allograft injury

Reported thresholdsReported thresholds include ~0.5% (rule-out), ~0.85% (optimal in some analyses), and 1.0% (used for ALAD surveillance)

Performance characteristicsAUCs reported range from ~0.72 to 0.93 for various rejection endpoints; NPVs at <0.5% ≈96% and <1.0% ≈90% in some cohorts

BODE Index definition

BODE Index definitionBODE Index — multidimensional COPD capacity index combining Body-Mass Index, airflow obstruction (FEV1 % predicted), dyspnea (MMRC), and 6-minute walk distance to predict mortality

UseBODE score used as a selection threshold (eg, BODE ≥7) indicating high mortality risk and transplant consideration for emphysema

ComponentsFEV1 %, 6MWT distance, MMRC dyspnea scale, BMI (with reference scoring categories)

Definitions page linkage metadata

Definitions page linkagePolicy provides link to Definitions page for additional terms and glossary

Policy metadataPolicy Number: 0598; Effective: 03/12/2002; Last review: 09/07/2023; Next review: 06/27/2024

Supplemental resourcesAppendix includes BODE index and calculator link; trials and device registries referenced for EVLP/OCS

OpenPayer

Lung Transplantation

Coverage Criteria for Lung Transplantation

Coding and Billing

Provider Actions, Authorization, and Documentation

Candidate Selection and Indications

Contraindications to Transplant and Related Procedures

Pre-Transplant Evaluation and Testing

Transplant Center and Program Requirements

Post-Transplant Care, Monitoring, and Interventions

Supplemental Coding Thresholds and Device Notes

Background and Evidence Summary

Definitions and Abbreviations

Policy Revision History