CurrentFidelis CarePolicy CP.MP.57

Cp.Mp.57 Lung Transplantation

Defines medical necessity criteria for lung transplantation for non-Medicare Centene-affiliated commercial and Medicaid plans, aligned to ISHLT 2021 consensus with separate adult and pediatric indications, absolute contraindications, and coding guidance for transplant procedure CPT/S codes.

Policy Summary

PayerFidelis Care

PolicyCp.Mp.57 Lung Transplantation

Policy CodePolicy CP.MP.57

Change TypeCriteria revisions and coding updates

Effective Date

Next Review Date

Key ActionDocument trials of maximal medical and/or surgical therapy, provide evidence supporting mortality and survival thresholds, and submit clinical evidence that required criteria and absence of absolute contraindications are met.

SourceLink

POLICY UPDATE CHANGES

Updated glomerular filtration rate threshold to GFR < 40 mL/min/1.73m2 as absolute contraindication.

Expanded HIV-related qualifying criteria to require CD4>200 cells/mm3 for at least 3 months, absence of AIDS-defining conditions, on effective ART, and no severe malnutrition.

Clarified active substance use and abstinence requirements; added allowance for commitment to reducing behaviors for urgent transplants with serial testing verification.

Revised adult and pediatric criteria to align with ISHLT 2021 consensus and added end-stage or refractory pulmonary alveolar proteinosis as indication.

Added CPT codes 32850, 32855, and 32856 to coding implications.

Added note to refer Medicare criteria to MC.CP.MP.57 and specified this policy governs non-Medicare plans.

9Adult disease categories listed

Pediatric disease/indication examples listed

12Absolute contraindications enumerated

9Procedure CPT/S codes referenced

Coverage Summary

Scope: This policy defines medical necessity criteria for lung transplantation for non‑Medicare Centene‑affiliated commercial and Medicaid plans and references CPT/S procedural codes for donor procurement, single/double/lobar transplants, and backbench preparation. It is aligned to the ISHLT 2021 Consensus Document for Selection of Lung Transplant Candidates.

Coverage stance: Covered with criteria — lung transplantation is medically necessary when the policy’s selection criteria are met, including failed maximal medical/surgical therapy, specified risk thresholds, and absence of absolute contraindications.

Subject: Lung Transplantation medical necessity criteria (single, double, and lobar transplants; adult and pediatric indications).

Policy number and status: CP.MP.57 — CURRENT.

Payer metadata: Governs non‑Medicare Centene‑affiliated commercial and Medicaid plans; Medicare-specific criteria are referenced separately (see MC.CP.MP.57).

Key thresholds referenced in policy: > 50% risk of death within 2 years without transplant, > 80% projected 5‑year post‑transplant survival, GFR < 40 mL/min/1.73 m2 as an absolute contraindication unless multi‑organ transplant is being considered, and HIV exceptions requiring CD4 > 200 cells/mm3 for ≥ 3 months plus effective ART and absence of AIDS‑defining conditions.

Key Clinical Thresholds

Risk of death without transplant> 50% within 2 years

Projected 5-year post-transplant survival> 80% likelihood

GFR contraindication threshold< 40 mL/min/1.73 m2 (absolute contraindication unless multi-organ transplant consideration)

CD4 count (HIV)> 200 cells/mm3 for at least 3 months

6-Minute Walk Test desaturationDesaturation to < 88% or > 50 m decline

FEV1 thresholds (CF/adult)FEV1 < 25% or specified criteria of <30%/<40% as listed

Pulmonary artery systolic pressure> 50 mmHg on echocardiogram

Medical Necessity for Lung Transplantation (Non‑Medicare plans)

Medical Necessity for Lung Transplantation (Non-Medicare plans)

Lung transplantation is medically necessary when ALL of the following are met:

Top-level requirements

Failed maximal therapy: Member has failed maximal medical or surgical therapy (including pulmonary rehabilitation, as applicable)
Includes appropriate medical and surgical therapies and pulmonary rehabilitation when applicable.
Risk without transplant: High (> 50%) risk of death from lung disease within two years if transplantation is not performed> 50% within 2 years
Projected post-transplant survival:

Provider Actions & Documentation Requirements

Prior Authorization

Prior authorization required for lung transplant requests

Prior authorization is required for all lung transplant requests. Submit prior authorization with complete clinical evidence demonstrating that the member meets all required medical necessity criteria (including failed maximal therapy, disease-specific thresholds, absence of absolute contraindications, and any required testing). Include relevant clinical notes, pulmonary function tests, imaging, right heart catheterization results (if applicable), transplant evaluation summaries, and documentation of abstinence or substance use testing when applicable.

Submit complete clinical evidence supporting ALL policy criteria
Include disease-specific testing (PFTs, 6MWT, DLCO), imaging, and hemodynamics
Include documentation of failed maximal medical/surgical therapy and transplant center evaluation
Include substantiation of absence of absolute contraindications or HIV-specific documentation when applicable

Referenced Procedure Codes

Referenced CPT codes for lung transplant 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 lung allograft prior to transplantation; unilateral.
32856	Backbench standard preparation of cadaver donor lung allograft prior to transplantation; bilateral.
S2060	Lobar lung transplantation.
S2152	Solid organ(s) procurement/transplantation and related complications; bundled global description.

Background and Evidence

Background: This policy uses the ISHLT 2021 consensus recommendations to guide selection of lung transplant candidates, emphasizing survival benefit and stewardship of limited donor lungs.

Applicability: The guidance applies to single, double, and lobar lung transplants and includes separate adult and pediatric indications and disease‑specific criteria.

Stewardship context: ISHLT recognizes donor lungs are a limited societal resource and candidate selection is based on expected survival benefit; the policy incorporates that stewardship principle to balance benefit and resource allocation.

Procedural scope: The policy includes coding guidance for donor pneumonectomy, single and double lung transplant, lobar transplant, and backbench preparation codes to support implementation.

Evidence: Primary guideline source is the ISHLT 2021 Consensus Document for the Selection of Lung Transplant Candidates.

Other guideline sources and evidence referenced include ISHLT and related transplant literature and clinical reviews such as UpToDate summaries and registry/consensus publications supporting candidate selection and outcomes.

Definitions

Maximal medical therapyIncludes appropriate medical and surgical therapies and pulmonary rehabilitation when applicable.

Contraindications and Not Eligible Situations

Absolute contraindications summary: The policy lists specific absolute contraindications that preclude lung transplantation unless stated exceptions apply. HIV infection with a detectable viral load is an absolute contraindication unless all HIV‑specific exceptions are met — specifically, CD4 > 200 cells/mm3 for at least three months, absence of active AIDS‑defining opportunistic infection or malignancy, the member is on effective antiretroviral therapy, and there is no chronic wasting or severe malnutrition.

Renal function rule and multi‑organ exception: A measured glomerular filtration rate < 40 mL/min/1.73 m2 is listed as an absolute contraindication, but this does not apply when consideration is being given to a planned multi‑organ transplant.

Substance‑use and abstinence requirements: Active substance use or dependence (including current tobacco use, vaping, non‑prescribed marijuana, or IV drug use) is an absolute contraindication unless there is convincing evidence of sustained risk‑reduction behaviors. The policy requires documented abstinence from nicotine, tobacco, alcohol, or illicit drugs for ≥ six months prior to transplant; for urgent transplant timelines, a documented commitment to reduce behaviors is acceptable with verification via serial blood and urine testing.

ABSOLUTE CONTRAINDICATIONS (including HIV exception)

ABSOLUTE CONTRAINDICATIONS sub-branch from the main criteria tree (focused on contraindications and HIV exception logic):

ABSOLUTE CONTRAINDICATIONS - member must NOT have ANY of the following

Revision History

04/24revised

Updated glomerular filtration rate threshold to GFR < 30 mL/min/1.73m2 as absolute contraindication (04/24 update cycle).

02/25revised

Updated glomerular filtration rate threshold from < 30 to GFR < 40 mL/min/1.73m2 as absolute contraindication (04/24-02/25 update cycle).

04/24revised

Expanded HIV-related qualifying criteria to require CD4 > 200 cells/mm3 for at least three months, absence of AIDS-defining conditions, on effective ART, and no severe malnutrition (04/24 update cycle).

Policy Summary

PayerFidelis Care

PolicyCp.Mp.57 Lung Transplantation

Policy CodePolicy CP.MP.57

Change TypeCriteria revisions and coding updates

Effective Date

Next Review Date

SourceLink

On This Page

High (> 80%) likelihood of five-year post-transplant survival from a general medical perspective provided there is adequate graft function

ABSOLUTE CONTRAINDICATIONS - member must NOT have ANY of the following

Malignancy with high risk of recurrence or death related to cancer
GFR threshold: Glomerular filtration rate < 40 mL/min/1.73m2 unless being considered for multi-organ transplant< 40 mL/min/1.73m2
Acute renal failure with rising creatinine on dialysis and low likelihood of recovery
Liver failure or cirrhosis: Acute liver failure, or cirrhosis with portal hypertension or synthetic dysfunction unless being considered for multi-organ transplant
Recent vascular/neurologic event: Stroke, acute coronary syndrome, or myocardial infarction (excluding demand ischemia) within 30 dayswithin 30 days
Septic shock
Active extrapulmonary infection: Active extrapulmonary or disseminated infection
Active TB: Active tuberculosis infection
HIV infection contraindication exceptions
- HIV criteria - CD4: CD4 cell count >200 cells/mm3 for at least three months before transplantationCD4 > 200 cells/mm3 for ≥ 3 months
- HIV criteria - AIDSdef: Absence of active AIDS-defining opportunistic infection or malignancy
- HIV criteria - ART: Member/enrollee is currently on effective antiretroviral therapy (ART)
- HIV criteria - nutrition: Member/enrollee does not have chronic wasting or severe malnutrition
Cognitive impairment: Progressive cognitive impairment
Adherence: Inability to adhere to the regimen necessary to preserve the transplant, even with caregiver support
Other severe uncontrolled condition: Other severe, uncontrolled medical condition expected to limit survival after transplant
Active substance use or dependence
- Urgent transplant exception for substance use: 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
History of substance use without abstinence: History of nicotine, tobacco, alcohol, or illicit drug use without documentation noting abstinence from all (including nicotine replacement therapy) for ≥ six months prior to transplantabstinence ≥ 6 months

Acceptable primary disease states

Adult - Interstitial lung disease
- ILD criteria list: Absolute decline in forced vital capacity (FVC) > 10% in the past six months despite appropriate treatmentFVC decline > 10% in 6 months
- ILD DLCO decline: Absolute decline in diffusing capacity for carbon monoxide (DLCO) > 10% in the past six months despite appropriate treatmentDLCO decline > 10% in 6 months
- ILD FVC radiographic progression: Absolute decline in FVC > 5% with radiographic progression in the past six months despite appropriate treatmentFVC decline > 5% + radiographic progression
- ILD desaturation: Desaturation to < 88% on six-minute-walk test (6MWT) or > 50 m decline in 6MWT distance in the past six months6MWT desaturation < 88% or > 50 m decline
- ILD pulmonary hypertension: Pulmonary hypertension on right heart catheterization or 2D echocardiography (in absence of diastolic dysfunction)
- ILD hospitalization: Hospitalization because of respiratory decline, pneumothorax, or acute exacerbation
- End-stage or refractory PAP criteria (one of the following)
  - PAP unresponsive to therapy: Unresponsive to standard therapies, such as whole lung lavage and GM-CSF augmentation
  - PAP fibrosis: Extensive pulmonary fibrosis develops
Adult - Cystic fibrosis or other bronchiectasis
- Group A - any of the following despite optimal management
  - CF FEV1 < 25%: FEV1 < 25% predicted despite optimal medical management including a trial of elexacaftor/tezacaftor/ivacaftor if eligibleFEV1 < 25%
  - CF complex criteria set
    CF physiologic criteria: Any of the following despite optimal medical management including a trial of elexacaftor/tezacaftor/ivacaftor if eligible: FEV1 < 30% predicted; or FEV1 < 40% predicted plus any of: 6MWD < 400 m, PaCO2 > 50 mmHg, hypoxemia, or pulmonary hypertension (PA systolic >50 mmHg)FEV1 < 30% OR FEV1 < 40% + additional findings
    CF other criteria:
Adult - Other disease categories
- COPD criteria: COPD: BODE score 7-10; FEV1 <20% predicted; history of severe exacerbations; chronic hypercapnia; moderate to severe pulmonary hypertensionBODE 7-10; FEV1 <20%
- Pulmonary vascular diseases: ESC/ERS high risk or REVEAL >10 on appropriate PAH therapy (including IV/SC prostacyclin), progressive hypoxemia, progressive but not end-stage liver/kidney dysfunction due to PAH, life-threatening hemoptysis, PAH in EPPVDN high risk category on optimal therapy without improvementREVEAL > 10 or ESC/ERS high risk
- LAM with disease progression despite mTOR inhibitor therapy and any of: severely abnormal lung function (e.g., FEV1 <30% predicted); exertional dyspnea (NYHA III/IV); hypoxemia at rest; pulmonary hypertension; refractory pneumothoraxFEV1 <30% example
Pediatric members (age < 18) - disease categories (examples)
- Pediatric - Cystic fibrosis: Pediatric CF: FEV1 <30% predicted despite optimal management including trial of elexacaftor/tezacaftor/ivacaftor if eligible; or the listed composite criteria (FEV1 <40% or FEV1 <50% with any of: 6MWD <400 m, PaCO2 >50 mmHg, hypoxemia, pulmonary hypertension) or FEV1 <50% rapidly declining; any exacerbation requiring positive pressure ventilationFEV1 <30% or FEV1 <40% with additional findings
- Pediatric - Pulmonary vascular disease: Pediatric pulmonary vascular disease criteria mirror adult PAH criteria including ESC/ERS high risk or REVEAL >10 on appropriate PAH therapy, progressive hypoxemia, progressive but not end-stage liver/kidney dysfunction due to PAH, life-threatening hemoptysis
- Pediatric - Interstitial lung disease: Pediatric ILD criteria mirror adult ILD: absolute declines in FVC or DLCO, desaturation on 6MWT, pulmonary hypertension, hospitalization for respiratory decline, and for PAP: unresponsive to standard therapies or extensive pulmonary fibrosis

Documentation/notes: Providers must document trials of maximal therapy, evidence supporting >50% 2-year mortality risk without transplant, and projected >80% 5-year post-transplant survival; document absence of absolute contraindications or meet HIV exceptions; substance use testing when indicated

See provider actions and thresholds

Documentation Required

Demonstrate failed maximal therapy and risk thresholds

Document trials of maximal medical and surgical therapy prior to transplant consideration and evidence that the candidate meets risk thresholds: >50% risk of death within 2 years without transplant, and >80% projected 5-year post-transplant survival from a general medical perspective (assuming adequate graft function). Provide objective data such as serial pulmonary function tests, six-minute walk tests, imaging, hospitalization history, and transplant center risk assessments supporting these thresholds.

Evidence of failed maximal medical therapy (e.g., optimized medical therapy, pulmonary rehabilitation, disease-specific drug trials when applicable)
Objective measures supporting >50% 2‑year mortality risk (e.g., rapid decline in FEV1, BODE score, REVEAL risk score, persistent hypoxemia/hypercapnia, frequent hospitalizations)
Documentation supporting >80% estimated 5‑year post‑transplant survival from transplant center assessment

Documentation Required

Document absence of absolute contraindications

Document the absence of any absolute contraindications. For candidates with HIV, include HIV‑specific documentation: CD4 count >200 cells/mm3 for at least three months prior to transplant, absence of active AIDS‑defining opportunistic infection or malignancy, current effective antiretroviral therapy (ART), and no chronic wasting or severe malnutrition. For substance use history, provide documentation of abstinence ≥6 months where applicable or, if urgent, a documented commitment to reduce risk behaviors.

Confirm no active extrapulmonary or disseminated infection, TB, uncontrolled malignancy with high recurrence risk, recent major cardiac or neurologic events, septic shock, or other absolute contraindications listed in policy
HIV-specific: CD4 >200 cells/mm3 for ≥3 months; no active AIDS‑defining conditions; on effective ART; no severe malnutrition
Documented abstinence from nicotine, tobacco, alcohol, or illicit drugs for ≥6 months prior to transplant when required; if urgent, document a concrete, time‑bound plan/commitment to reduce behaviors

Documentation Required

Substance use testing when indicated

When substance use is a concern, document testing and verification of abstinence as indicated. Serial blood and urine testing may be used to verify abstinence and to document risk‑reduction behaviors; for urgent transplant timelines, documentation of a committed, monitored reduction program may be acceptable.

Use serial blood/urine drug and nicotine testing as needed to verify abstinence
Document enrollment in or compliance with risk‑reduction or cessation programs when applicable
If urgent transplant is indicated, include documentation of an agreed plan for behavior reduction and monitoring

Billing Rule

Use referenced CPT/S codes for procedural billing

Use the referenced CPT/S codes for procedural billing. Report appropriate codes for donor procurement, implantation type (single, bilateral, lobar), and backbench preparation per coding guidance and facility billing practices. Ensure coding reflects the actual procedure performed and any donor‑specific or organ procurement services.

Report donor lung procurement and organ recovery codes as applicable
Report single lung transplant, bilateral lung transplant, or lobar transplant CPT codes corresponding to the procedure performed
Include codes for backbench preparation and any related intraoperative services per coding guidelines
Follow payer and facility-specific billing instructions for transplant-related services and modifiers

Absolute contraindicationConditions that preclude lung transplantation unless specified exceptions apply (e.g., multi-organ transplant consideration or HIV criteria met).

Malignancy with high risk of recurrence or death related to cancer

GFR threshold: Glomerular filtration rate < 40 mL/min/1.73m2 unless being considered for multi-organ transplant< 40 mL/min/1.73m2

Updated threshold; exception for multi-organ transplant consideration

Acute renal failure with rising creatinine on dialysis and low likelihood of recovery

Liver failure or cirrhosis: Acute liver failure, or cirrhosis with portal hypertension or synthetic dysfunction unless being considered for multi-organ transplant

Recent vascular/neurologic event: Stroke, acute coronary syndrome, or myocardial infarction (excluding demand ischemia) within 30 dayswithin 30 days

Active extrapulmonary infection: Active extrapulmonary or disseminated infection

Active TB: Active tuberculosis infection

HIV infection contraindication exceptions

HIV criteria - CD4: CD4 cell count >200 cells/mm3 for at least three months before transplantationCD4 > 200 cells/mm3 for ≥ 3 months
HIV criteria - AIDSdef: Absence of active AIDS-defining opportunistic infection or malignancy
HIV criteria - ART: Member/enrollee is currently on effective antiretroviral therapy (ART)
HIV criteria - nutrition: Member/enrollee does not have chronic wasting or severe malnutrition

Cognitive impairment: Progressive cognitive impairment

Adherence: Inability to adhere to the regimen necessary to preserve the transplant, even with caregiver support

Other severe uncontrolled condition: Other severe, uncontrolled medical condition expected to limit survival after transplant

Active substance use or dependence

Urgent transplant exception for substance use: 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

History of substance use without abstinence: History of nicotine, tobacco, alcohol, or illicit drug use without documentation noting abstinence from all (including nicotine replacement therapy) for ≥ six months prior to transplantabstinence ≥ 6 months

Note on HIV exception: HIV is an absolute contraindication if detectable viral load unless ALL of: CD4 >200 cells/mm3 for ≥3 months; absence of AIDS-defining opportunistic infection or malignancy; currently on effective ART; no chronic wasting or severe malnutritionCD4 >200 cells/mm3 for ≥3 months

If all four are present, HIV is not an absolute contraindication

02/25revised

Clarified HIV exceptions: CD4 > 200 cells/mm3 for ≥3 months, absence of active AIDS-defining opportunistic infection or malignancy, on effective ART, and no chronic wasting/severe malnutrition (04/24-02/25 update cycle).

04/24revised

Expanded and clarified active substance use and abstinence requirements; added documentation of abstinence ≥ 6 months and allowance for commitment to reducing behaviors for urgent transplants with serial testing verification (04/24 update cycle).

02/25revisedLatest

Further expanded I.C.13 and added I.C.14 documenting abstinence ≥ 6 months; codified serial blood and urine testing for verification when urgent transplant timelines permit (04/24-02/25 update cycle).

08/23-02/26revisedLatest

Revised adult and pediatric criteria to align with ISHLT 2021 consensus and added pediatric indications including alveolar capillary dysplasia, pulmonary vein stenosis, pulmonary veno-occlusive disease, and added end-stage or refractory pulmonary alveolar proteinosis as indication (multiple updates across I.D. sections; 04/24-02/25 update cycle referenced).

02/22added

Added CPT codes 32850, 32855, and 32856 to coding implications (administrative/coding update).

11/23clarified

Added note to refer Medicare criteria to MC.CP.MP.57 and specified this policy governs non-Medicare plans (administrative alignment).

Worsening nutritional status despite supplementation; Two exacerbations per year requiring IV antibiotics; Massive hemoptysis (>240 mL) requiring bronchial artery embolization; Pneumothorax

Group B - any of the following

CF rapid decline: Rapid decline in lung function or progressive symptoms (>30% relative decline in FEV1 over 12 months)>30% relative decline in 12 months
CF hospitalizations: Frequent hospitalization, particularly if > 28 days hospitalized in the preceding year> 28 days
CF mechanical ventilation: Any exacerbation requiring mechanical ventilation
CF chronic respiratory failure: Chronic respiratory failure with hypoxemia or hypercapnia, particularly for those with increasing oxygen requirements or needing long-term noninvasive ventilation therapy
CF pulmonary hypertension: Pulmonary hypertension (PA systolic pressure >50 mmHg on echocardiogram or evidence of right ventricular dysfunction)> 50 mmHg
CF worsening nutrition: Worsening nutritional status particularly with BMI <18 kg/m2 despite nutritional interventionsBMI < 18 kg/m2
CF recurrent hemoptysis: Recurrent massive hemoptysis despite bronchial artery embolization
CF WHO class: WHO Functional Class IV

Primary lung graft failure

ARDS with persistent requirement for mechanical ventilatory support and/or ECLS without expectation of clinical recovery and evidence of irreversible lung destruction

Additional pediatric indications: Pediatric - COPD with criteria similar to adult COPD where applicable; pediatric primary lung graft failure; pediatric LAM criteria as adults; pediatric ARDS with persistent ventilatory/ECLS requirement and irreversible lung destruction; alveolar capillary dysplasia; pulmonary vein stenosis refractory to intervention; pulmonary veno-occlusive disease