meridian lung transplantation Coverage Update

Coverage Criteria for Lung Transplantation

General coverage criteria

Covered when ALL of the following are met

Overall transplant eligibility: Member has chronic, end-stage lung disease who failed maximal medical or surgical therapy; high (>50%) risk of death within two years without transplant; high (>80%) likelihood of five-year post-transplant survival from a general medical perspective provided there is adequate graft function; does not have any absolute contraindications.

Maximal medical therapy includes pulmonary rehabilitation when applicable.

Disease-specific coverage criteria

Disease-specific qualifying criteria (examples; list not exhaustive)

Interstitial lung disease: One of: absolute decline in FVC ≥10% in the past six months despite appropriate treatment; absolute decline in DLCO ≥10% in the past six months despite appropriate treatment; absolute decline in FVC ≥5% with radiographic progression in the past six months despite appropriate treatment; desaturation to <88% on six-minute-walk test or >50 m decline in 6MWT distance in the past six months; pulmonary hypertension on right heart catheterization or echocardiography (in absence of diastolic dysfunction); hospitalization for respiratory decline, pneumothorax, or acute exacerbation.

Cystic fibrosis/bronchiectasis (adult): One of: FEV1 <25% predicted despite optimal management including a trial of elexacaftor/tezacaftor/ivacaftor if eligible; OR both of the following: (a) FEV1 <30% predicted OR FEV1 <40% predicted with any of: 6MWD <400 m; PaCO2 >50 mmHg; hypoxemia at rest or with exertion; pulmonary hypertension (PA systolic pressure >50 mmHg on echocardiogram or RV dysfunction); worsening nutrition despite supplementation; ≥2 exacerbations/year requiring IV antibiotics; massive hemoptysis (>240 mL) requiring bronchial artery embolization; pneumothorax.

COPD: One of: BODE score 7–10; FEV1 <20% predicted; history of severe exacerbations; chronic hypercapnia; or moderate to severe pulmonary hypertension.

Pulmonary vascular disease/PAH: One of: ESC/ERS high risk or REVEAL risk score >10 on appropriate PAH therapy including IV/SC prostacyclin analogues; progressive hypoxemia; progressive liver or kidney dysfunction due to PAH; life‑threatening hemoptysis.

Other specific indications: Eisenmenger syndrome with pulmonary hypertension despite therapy; LAM with progression despite mTOR inhibitor therapy plus severely abnormal lung function (e.g., FEV1 <30%), NYHA III/IV dyspnea, resting hypoxemia, pulmonary hypertension, or refractory pneumothorax; primary lung graft failure or bronchiolitis obliterans; end-stage emphysema due to alpha-1 antitrypsin deficiency.

Pediatric disease-specific examples: Cystic fibrosis with progressive lung disease despite optimal therapy, FEV1 <30% predicted, or increasingly frequent hospitalizations; pediatric pulmonary vascular disease with EPPVDN high risk, 6MWT <350 m, uncontrolled syncope, hemoptysis, right‑sided heart failure, or failure to respond to vasodilator therapy; surfactant dysfunction disorders with unrelenting respiratory failure; bronchopulmonary dysplasia with specified severity criteria.

Pediatric thresholds and indications referenced separately.

Candidate selection

Candidate selection requires meeting general and disease-specific criteria and absence of absolute contraindications.

Candidate requirements: Adult (≥18) or pediatric (<18) disease-specific criteria met; failed maximal medical or surgical therapy (including pulmonary rehabilitation when applicable); high risk of death within two years without transplant; anticipated post-transplant survival from a general medical perspective; absence of any absolute contraindication; documented tobacco/nicotine abstinence if history of use.

Pediatric-specific thresholds provided for CF, PAH, pulmonary vascular disease, surfactant disorders, and bronchopulmonary dysplasia.

Candidate selection updates

Policy criteria were updated in multiple sections aligning with ISHLT 2021 guidance; candidate requirements include abstinence from nicotine/tobacco and substance-use commitments when urgent timelines exist.

Guideline alignment: Candidate selection and listing criteria updated to reflect ISHLT 2021 guidance across multiple sections; the policy removed the prior criterion requiring >80% likelihood of surviving at least 90 days after transplant and clarified multiple I.C. and I.D. subsections.

See policy review and revision history.

Nicotine/tobacco abstinence: Nicotine and tobacco abstinence contraindication clarified: if there is a history of nicotine or tobacco use, documentation of abstinence from all tobacco and nicotine products (including nicotine replacement therapy) for ≥ six months prior to transplant is required unless urgent timelines and exceptions apply.≥ six months

Serial testing may be used to verify abstinence.

Substance-use updates: Marijuana use prescribed by a licensed practitioner is not automatically disqualifying; criteria I.C.14 was updated to exclude prescribed marijuana and to allow candidates with substance‑use issues to commit to reducing behaviors when urgent transplant timelines are present.

Contraindications

Absolute contraindications — presence of ANY of the following makes transplant not medically appropriate

Absolute contraindications: Malignancy with high risk of recurrence or death related to cancer; GFR <40 mL/min/1.73 m2 unless being considered for multi‑organ transplant; acute renal failure with rising creatinine or on dialysis with low likelihood of recovery; acute liver failure or cirrhosis with portal hypertension or synthetic dysfunction unless multi‑organ transplant is considered; stroke, acute coronary syndrome, or myocardial infarction within 30 days; septic shock; active extrapulmonary or disseminated infection; active tuberculosis; HIV with detectable viral load; progressive cognitive impairment; inability to adhere to regimen necessary to preserve the transplant even with caregiver support; other severe uncontrolled medical condition expected to limit survival after transplant; active substance use or dependence including current tobacco use, vaping, marijuana use (unless prescribed by a licensed practitioner), or IV drug use without convincing evidence of risk reduction behaviors (exceptions for urgent timelines with commitment to reducing behaviors).

Serial blood and urine testing may be used to verify abstinence from substances of concern; documentation of tobacco/nicotine abstinence ≥ six months required if history of use.

Active substance use or dependence is treated as an absolute contraindication to lung transplantation unless there is convincing evidence of sustained risk reduction or an urgent transplant timeline with a documented commitment to reduce use. The policy lists current tobacco use, vaping, marijuana use (unless prescribed by a licensed practitioner), and IV drug use among disqualifying substance-use behaviors. Serial blood and urine testing may be used to verify abstinence for substances of concern. For candidates with a history of nicotine or tobacco use, the policy requires documentation of abstinence from all tobacco and nicotine products (including nicotine replacement therapy) for ≥ six months prior to transplant listing unless otherwise addressed by urgent exception criteria.

The policy explicitly notes that marijuana use prescribed by a licensed practitioner is not automatically disqualifying and is excluded from the list of disqualifying substance-use criteria when specified. However, when transplant timelines are urgent, candidates with substance-use concerns (including prescribed marijuana users when relevant to behavior assessment) must demonstrate a commitment to reducing substance-use behaviors as part of the evaluation and listing process per the updated I.C.14 language.

Presence of any listed absolute contraindication renders lung transplantation not medically necessary. Absolute contraindications include, but are not limited to: malignancy with a high risk of recurrence or death related to cancer; GFR < 40 mL/min/1.73 m2 unless being considered for multi‑organ transplant; acute renal failure with low likelihood of recovery; acute liver failure or cirrhosis with portal hypertension or synthetic dysfunction unless multi‑organ transplant; recent stroke/acute coronary syndrome/MI within 30 days; septic shock; active extrapulmonary or disseminated infection; active tuberculosis; HIV with detectable viral load; progressive cognitive impairment; inability to adhere to the required regimen even with caregiver support; other severe uncontrolled medical conditions expected to limit survival after transplant; and active substance use or dependence (including current tobacco use, vaping, marijuana use unless prescribed, or IV drug use) without convincing evidence of risk reduction behaviors. Requests may be denied when any of these contraindications are present.

The policy was updated to align with ISHLT 2021 guidance and includes multiple substantive clarifications: candidate selection and listing criteria were revised across several sections; the prior criterion requiring a >80% likelihood of surviving at least 90 days post‑transplant was removed; nicotine and tobacco abstinence requirements were clarified; language now specifies that maximal medical therapy (including pulmonary rehabilitation when applicable) or surgical therapy should be attempted prior to transplant; marijuana prescribed by a licensed practitioner is excluded from automatic disqualification while candidates with substance‑use issues must commit to behavior reduction when urgent timelines exist; and CPT codes 32850, 32855, and 32856 were added to the coding set. These updates also added a pediatric indication for end‑stage emphysema due to alpha‑1 antitrypsin deficiency.

6MWT desaturation criteria — Inv-25: key thresholds

6MWT desaturation thresholdDesaturation to <88% on six-minute walk test (6MWT)

6MWT distance decline>50 meter decline in 6MWT distance in the past six months

Pediatric 6MWT distance6MWT distance <400 meters considered in pediatric/CF criteria

BODE score — Inv-26: transplant criterion

BODE score definitionComposite index including BMI, airflow obstruction, dyspnea, and exercise capacity

Adult COPD criterionBODE score 7–10 qualifies for transplant consideration in adults with COPD

Components usedScore incorporates BMI, FEV1, dyspnea scale, and 6MWT/exercise capacity

FEV1 thresholds — Inv-12: adult and conditional thresholds

FEV1 — adult cystic fibrosis primary thresholdFEV1 <25% predicted despite optimal medical management (including CFTR modulator if eligible)

FEV1 — alternate adult thresholdsFEV1 <30% predicted, or FEV1 <40% predicted with additional features (e.g., 6MWD <400 m, PaCO2 >50 mmHg, hypoxemia, pulmonary hypertension)

Rapid decline considerationFEV1 <50% predicted considered when there is a rapid decline in lung function

GFR — Inv-14: contraindication threshold

GFR absolute contraindication thresholdGlomerular filtration rate <40 mL/min/1.73 m2 is an absolute contraindication unless being considered for multi-organ transplant

Multi-organ transplant exceptionGFR <40 mL/min/1.73 m2 may be acceptable if candidate is being considered for multi-organ transplant

Documentation implicationPresence of GFR below threshold makes transplant not medically appropriate unless multi-organ approach planned

Survival likelihood criterion — Inv-15: removal notice

Removed survival likelihood criterionThe prior criterion 'High (> 80%) likelihood of surviving at least 90 days after lung transplantation.' was removed from the policy

Policy update sourceRemoval and other updates were made to align with ISHLT 2021 guidance

Implication for evaluationsThis specific short-term (>90 day) survival requirement is no longer part of the criteria set; other survival expectations (e.g., five‑year likelihood) remain referenced elsewhere

Candidate Selection and Updates

Candidate selection

Candidate selection requires meeting general and disease-specific criteria and absence of absolute contraindications.

Candidate requirements: Adult (≥18) or pediatric (<18) disease-specific criteria are met; failed maximal medical or surgical therapy (including pulmonary rehabilitation when applicable); high (>50%) risk of death within two years without transplant; anticipated post-transplant survival from a general medical perspective; absence of any absolute contraindication; documented tobacco/nicotine abstinence if history of use.

Ensure documentation of disease-specific objective measures (FVC, DLCO, FEV1, 6MWT, hemodynamics) as part of evaluation.

Candidate selection updates

Policy updates affecting candidate criteria per ISHLT 2021 and other revisions.

Pediatric alpha-1 indication: Pediatric indication for end-stage emphysema due to alpha-1 antitrypsin deficiency was added to the policy.

See pediatric-specific sections for applicable thresholds and evaluation criteria.

Absolute Contraindications

This policy lists absolute contraindications that, if present, make lung transplantation not medically appropriate. Key contraindications include malignancy with high risk of recurrence or death related to cancer; glomerular filtration rate (GFR) < 40 mL/min/1.73 m2 unless the candidate is being considered for a multi‑organ transplant; acute renal failure with rising creatinine or dialysis and low likelihood of recovery; acute liver failure or cirrhosis with portal hypertension or synthetic dysfunction unless considered for multi‑organ transplant; recent stroke, acute coronary syndrome, or myocardial infarction within 30 days; septic shock; and active extrapulmonary or disseminated infection including active tuberculosis and HIV with detectable viral load.

Denial Risk

Absolute contraindications — presence of any listed condition will make transplant not medically appropriate

Presence of any listed absolute contraindication makes lung transplantation not medically appropriate. The policy lists specific absolute contraindications that will result in denial of transplant coverage, including malignancy with high recurrence risk; GFR <40 mL/min/1.73 m2 (unless multi‑organ transplant); acute renal failure with low likelihood of recovery; acute liver failure or cirrhosis with portal hypertension or synthetic dysfunction (unless multi‑organ); recent stroke/ACS/MI within 30 days; septic shock; active extrapulmonary or disseminated infection; active tuberculosis; HIV with detectable viral load; progressive cognitive impairment; inability to adhere to the transplant regimen despite caregiver support; other severe uncontrolled medical conditions expected to limit post‑transplant survival; and active substance use or dependence (including current tobacco use, vaping, marijuana use unless prescribed by a licensed practitioner, or IV drug use) without convincing evidence of risk‑reduction behaviors. If there is a history of nicotine or tobacco use, document abstinence from all tobacco and nicotine products (including nicotine replacement therapy) for ≥ six months prior to transplant. Serial blood and urine testing may be used to verify abstinence from substances of concern.

Pre-Transplant Evaluation Requirements

Documentation Required

Evaluation requirements — objective physiologic and functional data

Provide objective evidence of disease progression and physiologic impairment: serial pulmonary function tests (FVC, DLCO, FEV1) showing qualifying declines, six‑minute walk test results (including desaturation to <88% or >50 m decline in distance), and hemodynamic evidence of pulmonary hypertension by right heart catheterization or echocardiography when indicated. Include hospitalizations for respiratory decline and other disease‑specific evaluation elements.

Document absolute declines: FVC ≥10% or DLCO ≥10% in 6 months, or FVC ≥5% with radiographic progression (interstitial lung disease examples).
Report 6MWT desaturation (<88%) or >50 m decline in 6 months and 6MWD <400 m where applicable.
Provide evidence of pulmonary hypertension on RHC or echocardiography.

Step Therapy

Failed maximal medical or surgical therapy required before transplant

Document that the member has failed maximal medical therapy (including pulmonary rehabilitation when applicable) or surgical therapy prior to consideration for lung transplant listing.

Provider Actions, Authorization, and Documentation

Prior Authorization

Pre‑authorization required; reference CPT/HCPCS codes

Obtain pre‑authorization for lung transplant procedures and use the referenced CPT and HCPCS codes for claims and review. Codes referenced in the policy are informational; verify coding guidance prior to claim submission.

Referenced codes include CPT 32850, 32851, 32852, 32853, 32854, 32855, 32856 and HCPCS S2060, S2152.

Prior Authorization

Prior authorization implied; new CPT codes added

Note that prior authorization is implied for lung transplantation services and that CPT codes 32850, 32855, and 32856 were added to the policy's coding set.

Confirm the added CPT codes (32850, 32855, 32856) are included in prior‑authorization submissions and billing plans.

Coding and Procedure Codes

Referenced procedure and HCPCS codesmixed

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.
32855	Backbench standard preparation of cadaver donor lung allograft prior to transplantation, including dissection of allograft from surrounding soft tissues to.
32856	Backbench standard preparation of cadaver donor lung allograft prior to transplantation, including dissection of allograft from surrounding soft tissues to.
S2060	Lobar lung transplantation.
S2152	Solid organ(s), complete or segmental, single organ or combination of organs; deceased or living donor(s), procurement, transplantation, and related complications; global definition including drugs, supplies, hospitalization, and follow-up.

Covered CPT Codes (added)CPTCovered

32850	added CPT code (document lists as added)
32855	added CPT code (document lists as added)
32856	added CPT code (document lists as added)

6-Minute Walk Test (6MWT)

6MWT desaturation thresholdDesaturation to <88% on 6MWT supports transplant evaluation.

6MWT distance—pediatricSix‑minute walk distance <400 meters is referenced for pediatric evaluation thresholds in disease‑specific criteria.

Change over timeA decline of >50 meters in 6MWT distance over the prior six months supports consideration for transplant evaluation.

BODE score

BODE score rangeBODE score of 7–10 is specified as a transplant consideration criterion for adults with COPD.

ComponentsIncludes BMI, airflow obstruction (FEV1), dyspnea, and exercise capacity.

Post-Transplant Services and Benefit Considerations

Global transplant services and related care

HCPCS S2152 definitionHCPCS S2152 describes global transplant services: procurement, transplantation, related complications, and includes drugs, supplies, hospitalization, and outpatient follow‑up.

Coding implicationS2152 represents a global definition that can encompass the perioperative and post‑transplant care elements associated with solid organ transplantation.

Use in claimsReference S2152 when considering billing for comprehensive transplant services and related care components.

Post-transplant services per benefit design

Benefit design governs coveragePost‑transplant services and coverage are subject to the member's benefit terms and plan documents; this policy does not override contractual terms.

State Medicaid precedence

Background

Lung transplantation is an accepted therapy for selected patients with end‑stage pulmonary disease and may be performed as single, double (bilateral), or lobar transplants. Common adult indications include chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, cystic fibrosis, pulmonary arterial hypertension, and sarcoidosis. Pediatric indications (now clarified in the policy) include pulmonary vascular disease, bronchiolitis obliterans, bronchopulmonary dysplasia, graft failure from viral pneumonitis, cystic fibrosis, and end‑stage emphysema due to alpha‑1 antitrypsin deficiency.

Alpha-1 antitrypsin deficiency

Pediatric alpha‑1 indication addedPediatric indication for end‑stage emphysema due to alpha‑1 antitrypsin deficiency was added to the policy.

DefinitionAlpha‑1 antitrypsin deficiency is a genetic cause of early emphysema referenced in the policy as an indication for lung transplant in select pediatric cases.

ReferencesPolicy references pediatric lung transplant literature and alpha‑1 antitrypsin deficiency sources supporting this indication.

Transplant Center Requirements

Note

Use experienced transplant centers; follow center accreditation guidance

Use transplant centers experienced in lung transplantation for evaluations and procedures; the policy references center practice and coding implications though specific accreditation requirements are not specified in this portion of the document.

Refer to full policy and professional guidance (e.g., ISHLT/OPNT) for center accreditation and experience requirements.

Policy Revision History

2023-02 (02/23)revisionLatest

Added pediatric indication for end-stage emphysema due to alpha-1 antitrypsin deficiency; updated I.C.14 to exclude medically‑prescribed marijuana from disqualifying substance‑use criteria and require commitment to reducing substance‑use behaviors when urgent transplant timelines exist; removed ICD‑10 codes; references reviewed and updated.

2022-02 (02/22)revision

Updated multiple sections to align with ISHLT 2021 guidance and removed the criterion 'High (> 80%) likelihood of surviving at least 90 days after lung transplantation'; clarified nicotine and tobacco abstinence contraindication; added CPT codes 32850, 32855, and 32856.

Clinical Policy: Lung Transplantation

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