CurrentCentenePolicy CP MP.57

Clinical Policy: Lung Transplantation

Defines medical necessity criteria, contraindications, disease-specific indications, and coding implications for lung transplantation for non-Medicare Centene-affiliated health plans, aligned to ISHLT 2021 consensus guidance and subsequent Centene revisions.

Policy Summary

PayerCentene

PolicyClinical Policy: Lung Transplantation

Policy CodePolicy CP MP.57

Change TypeRevisions (criteria updates, coding additions)

Effective Date

Next Review Date

Key ActionProvider must document trials of maximal medical and, if applicable, surgical therapy including pulmonary rehabilitation and trials of eligible modulators where applicable.

POLICY UPDATE CHANGES

Updated glomerular filtration rate from 30 to 40 mL/min/1.73m2 in Criteria I.C.2.

Expanded HIV-related criteria to include qualifying conditions (effective ART, absence of active AIDS-defining infection/malignancy, CD4 >200 for ≥3 months).

Revised adult and pediatric criteria to align with ISHLT 2021 consensus document and added pediatric indications (including end-stage emphysema due to alpha-1 antitrypsin deficiency).

Clarified substance use and nicotine/tobacco abstinence requirements, including allowance for commitment to reducing behaviors if urgent transplant timelines are present.

Added CPT codes 32850, 32855, and 32856 to referenced coding list.

MultipleCovered Indications

NumerousAbsolute Contraindications

Coverage Summary

This policy (CP MP.57) defines medical necessity criteria for lung transplantation for non‑Medicare Centene‑affiliated health plans and is CURRENT as of the last revision (02/25). It is aligned to the ISHLT 2021 Consensus Document for the Selection of Lung Transplant Candidates and is intended to guide coverage decisions for single, double, and lobar lung transplantation in members/enrollees who have failed maximal medical and/or surgical therapy.

Common adult indications include end‑stage pulmonary diseases such as COPD, idiopathic pulmonary fibrosis, pulmonary arterial hypertension, cystic fibrosis, and alpha‑1 antitrypsin deficiency; pediatric indications include pulmonary vascular disease and bronchiolitis obliterans (with pediatric additions such as end‑stage emphysema due to alpha‑1 antitrypsin deficiency).

This policy incorporates Centene updates through 2023–2025 (including coding and criteria clarifications) and applies to non‑Medicare plans affiliated with Centene; Medicare‑specific criteria are addressed separately (see MC.CP MP.57).

Key clinical thresholds

GFR< 40 mL/min/1.73 m2 is a contraindication unless multi-organ transplant considered

CD4 count> 200 cells/mm3 for at least 3 months prior to transplant (HIV+ candidates)

DLCO declineAbsolute decline ≥ 10% in past 6 months

FVC declineAbsolute decline ≥ 10% in past 6 months, or > 5% with radiographic progression

6MWT desaturationDesaturation to ≤ 88% on 6MWT or > 50 m decline in 6MWT distance in past 6 months

FEV1 thresholdsFEV1 < 30% predicted (CF criteria) or FEV1 ≤ 40% with additional criteria; COPD consideration with FEV1 < 20% predicted; FEV1 <50% with rapid decline may qualify

PaCO2> 50 mmHg (in CF/bronchiectasis criteria)

6MWD< 400 meters (in certain CF criteria)

BODE scoreBODE score 7 to 10 indicates consideration

Hemoptysis volume> 240 mL (massive hemoptysis requiring bronchial artery embolization)

BMI concernBMI < 18 kg/m2 associated with worsening nutritional status despite interventions

Medical Necessity Criteria

General medical necessity (Non-Medicare plans)

Transplantation is medically necessary when ALL of the following are met:

ALL of the following

Member/enrollee has chronic, end-stage lung disease who have failed maximal medical and/or surgical therapy (including pulmonary rehabilitation when applicable).
Member/enrollee meets disease-specific indication criteria (see Disease-specific indications tree).
Member/enrollee does not have any absolute contraindications (see Absolute contraindications tree).
From a general medical perspective, there is >80% likelihood of five-year post-transplant survival provided there is adequate graft function.
This is a policy expectation; assessment performed by transplant program

Provider Actions / Documentation & Billing

Documentation Required

Document failure of maximal medical/surgical therapy

Provider must document trials of maximal medical and, if applicable, surgical therapy including pulmonary rehabilitation and trials of eligible modulators (e.g., elexacaftor/tezacaftor/ivacaftor) where applicable.

Documentation Required

Document abstinence/substance use risk reduction

Provider must document abstinence from nicotine/tobacco/alcohol/illicit drugs for ≥ six months prior to transplant. If urgent transplant timelines are present, a documented commitment to reducing behaviors is acceptable; serial blood and urine testing may be used to verify abstinence.

Coding

Referenced CPT codes for lung transplant and related proceduresCPT

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 allograft to transplantation, including dissection of allograft from surrounding soft tissues
32856	Backbench standard preparation of cadaver donor lung allograft to transplantation, including dissection of allograft from surrounding soft tissues

Referenced HCPCS codesHCPCS

S2060	Lobar transplantation, lung
S2152	Solid organ(s) procurement, transplantation, and related complications; includes global defined services

Background & Evidence

Lung transplantation is an accepted therapy for selected patients with end‑stage pulmonary disease; selection guidance in this policy is based on the ISHLT 2021 consensus and Centene’s periodic updates to align adult and pediatric criteria with that document.

Pediatric indications commonly include pulmonary vascular disease and bronchiolitis obliterans, and Centene has explicitly added pediatric considerations such as end‑stage emphysema due to alpha‑1 antitrypsin deficiency consistent with ISHLT alignment and recent revisions.

This policy has been updated across 2023–2025 to reflect ISHLT 2021 alignment and Centene revisions (including clarifications on renal function, HIV‑related qualifying criteria, and substance use/abstinence documentation) and is reviewed annually with coding and criteria changes recorded in the revision history.

Source	Description
ISHLT 2021 Consensus Document (Leard et al., J Heart Lung Transplant. 2021)	Primary guideline source for candidate selection and criteria used to develop this policy (selection of lung transplant candidates; expert synthesis of current literature).
UpToDate	Supplementary clinical summaries and disease-based guidance referenced for management and transplant considerations (UpToDate topics on lung transplantation and disease-specific management).
Registry reports and peer-reviewed literature	Supplementary evidence including ISHLT Registry reports and peer-reviewed studies cited in references to support outcomes, indications, and risks used in policy development.

Definitions

Term	Definition
6MWT	Six-minute walk test
DLCO	Diffusing capacity for carbon monoxide
FEV1	Forced expiratory volume in one second
FVC	Forced vital capacity
BODE score	Composite index including BMI, airflow obstruction, dyspnea, and exercise capacity

Revision History

08/23revised

Revised adult and pediatric criteria to align with ISHLT 2021 consensus document and added pediatric indications (including end-stage emphysema due to alpha-1 antitrypsin deficiency). (Revised adult and pediatric criteria to align with ISHLT 2021 consensus document; Approval Date = 08/23.)

02/23revised

Clarified nicotine and tobacco abstinence contraindication; annual review and updated Criteria I.C.14 to exclude marijuana use when prescribed by a licensed practitioner and include required commitment to reducing substance use behaviors if urgent transplant timelines are present. (Annual review. Criteria I.C.14. updated to exclude marijuana use when prescribed by a licensed practitioner and include required commitment to reducing substance use behaviors if urgent transplant timelines are present; Approval Date = 02/23.)

04/24

Absolute contraindications

Member/enrollee does NOT have ANY of the following:

ANY of the following

Acute liver failure, or cirrhosis with portal hypertension or synthetic dysfunction unless considered for multi-organ transplant.
Stroke, acute coronary syndrome, or myocardial infarction (excluding demand ischemia) within 30 days.
Septic shock.
Active extrapulmonary or disseminated infection.
Active tuberculosis infection.
Acute renal failure with rising creatinine on dialysis and low likelihood of recovery.
GFR threshold: Glomerular filtration rate < 40 mL/min/1.73 m2 unless being considered for multi-organ transplant.< 40 mL/min/1.73 m2
HIV infection considerations
- Member/enrollee is currently on effective antiretroviral therapy (ART).
- Absence of active AIDS-defining opportunistic infection or malignancy.
- CD4 cell count > 200 cells/mm3 for at least three months before transplantation.CD4 > 200 cells/mm3 for ≥3 months
Progressive cognitive impairment.
Inability to adhere to regimen necessary to preserve transplant, even with caregiver support.
Other severe, uncontrolled medical condition expected to limit survival after transplant.
Substance use contraindications (absolute unless exceptions noted): Active substance use or dependence (including current tobacco use, vaping, marijuana use [unless prescribed by a licensed practitioner], or intravenous drug use) without convincing evidence of risk reduction behaviors.
Note: If urgent transplant timelines are present, a commitment to reducing behaviors is acceptable; serial blood and urine testing may be used to verify abstinence.
History of nicotine, tobacco, alcohol, or illicit drug use without documentation of abstinence from all (including nicotine replacement therapy) for ≥ six months prior to transplant.≥ 6 months abstinence

Disease-specific indications

Member/enrollee has one of the listed disease states plus accompanying criteria (not exhaustive list).

ANY of the following

Interstitial lung disease (ILD)
- Absolute decline in DLCO ≥ 10% in past 6 months.DLCO decline ≥10% in 6 months
- Absolute decline in FVC ≥ 10% in past 6 months.FVC decline ≥10% in 6 months
- Absolute decline in FVC > 5% with radiographic progression in past 6 months.FVC decline >5% with radiographic progression
- Desaturation to 88% on six-minute walk test (6MWT) or >50 m decline in 6MWT distance in past 6 months.6MWT desaturation ≤88% or >50 m decline
- Pulmonary hypertension on right heart catheterization or 2D echocardiography (in absence of diastolic dysfunction).
- Hospitalization for respiratory decline, pneumothorax, or acute exacerbation.
Cystic fibrosis (CF) / bronchiectasis
- FEV1 < 30% predicted.FEV1 <30%
- ALL of the following
  - PaCO2 > 50 mmHg.PaCO2 >50 mmHg
  - 6MWD < 400 meters.6MWD <400 m
  - Hypoxemia at rest or with exertion.
  - Worsening nutritional status despite supplementation.
Chronic obstructive pulmonary disease (COPD)
- BODE score 7 to 10.BODE 7-10
- FEV1 < 20% predicted.FEV1 <20%
- History of severe exacerbations.
- Chronic hypercapnia.
- Hospitalization because of respiratory decline, pneumothorax, or acute exacerbation.
- Chronic respiratory failure with hypoxemia or hypercapnia, increasing oxygen requirements, or need for long-term noninvasive ventilation therapy.
Pulmonary vascular diseases / PAH
- Moderate to severe pulmonary hypertension.
- ESC/ERS high risk or REVEAL risk score >10 on appropriate PAH therapy including IV or SC prostacyclin analogues.REVEAL >10 or ESC/ERS high risk
- Progressive hypoxemia.
- Progressive but not end-stage liver or kidney dysfunction due to PAH.
- Life-threatening hemoptysis.
Lymphangioleiomyomatosis (LAM)
- Severely abnormal lung function (e.g., FEV1 < 30% predicted).FEV1 <30%
- Exertional dyspnea (NYHA class III or IV).NYHA III-IV
- Hypoxemia at rest.
- Pulmonary hypertension.
- Refractory pneumothorax.
Primary lung failure / other anatomic indications
- Refractory pneumothorax.
- Pulmonary vein stenosis refractory to intervention.
- Alveolar capillary dysplasia.
- Pulmonary veno-occlusive disease.
Acute respiratory distress syndrome (ARDS): Persistent requirement for mechanical ventilatory support and/or extracorporeal life support (ECLS) without expectation of clinical recovery and with evidence of irreversible destruction.
Pediatric-specific criteria (age <18)
- Cystic fibrosis with FEV1 <30% predicted despite optimal management including trial of modulators if eligible.FEV1 <30% (pediatric)
- End-stage emphysema due to alpha-1 antitrypsin deficiency (added pediatric indication).
- Pulmonary vascular disease meeting pediatric high-risk criteria (e.g., EPPVDN high risk on therapy without improvement).EPPVDN high risk