ModifiedFidelis CarePolicy MC.CP.MP.57

Lung Transplantation (Medicare)

Defines medical necessity criteria for lung transplantation for Medicare health plans affiliated with Centene, based primarily on ISHLT 2021 consensus guidance, including candidate selection, absolute contraindications, disease-specific indications for adults and pediatrics, and coding implications.

Policy Summary

PayerFidelis Care

PolicyLung Transplantation (Medicare)

Policy CodePolicy MC.CP.MP.57

Change TypeMODIFIED (criteria and thresholds updated)

Effective Date

Next Review Date

Key ActionProvide records demonstrating failed maximal medical or surgical therapy and disease‑specific objective measures, and document absence of absolute contraindications including HIV and substance‑use criteria as specified.

SourceLink

POLICY UPDATE CHANGES

Updated GFR threshold in Criteria I.C.2. (revisions alternated between <30 and <40 mL/min/1.73m2; current policy lists GFR <40 mL/min/1.73m2 as an absolute contraindication unless multi‑organ transplant).

Expanded HIV criteria in I.C.9 to specify CD4 >200 cells/mm3 for at least three months prior to transplant, absence of AIDS-defining conditions, current effective ART, and absence of chronic wasting/severe malnutrition.

Revised FEV1 threshold in criteria for CF/bronchiectasis (I.D.2.a.1.) from <25% to <30% predicted in applicable populations.

Added pediatric-specific qualifying disease states: alveolar capillary dysplasia, pulmonary vein stenosis refractory to intervention, and pulmonary veno-occlusive disease.

Clarified and expanded substance use criteria: active substance use/dependence is a contraindication without convincing risk‑reduction evidence; documentation of abstinence (≥6 months) or commitment to risk reduction and serial testing may be used when urgent timelines apply.

Coverage Summary

This policy defines medical necessity criteria for lung transplantation for Medicare health plans affiliated with Centene, aligned primarily with the ISHLT 2021 consensus guidance and subsequent updates. It applies to Medicare members/enrollees and describes candidate selection, disease-specific qualifying indications, required objective measures, and documentation and coding implications.

High-level coverage stance: covered_with_criteria. Target population: Medicare members/enrollees being evaluated for lung transplantation who meet the specified medical necessity criteria including disease severity thresholds and absence of absolute contraindications.

Numeric thresholds and requirements

Risk of death without transplant> 50% within 2 years

Likelihood of 5-year post-transplant survival> 80% likelihood provided adequate graft function

GFR contraindicationGlomerular filtration rate < 40 mL/min/1.73m2 (absolute contraindication unless multi-organ transplant)

CD4 count for HIV> 200 cells/mm3 for at least 3 months before transplantation

6MWT desaturationDesaturation to < 88% on six-minute walk test or > 50 m decline in 6MWT distance in past 6 months

FEV1 thresholds (CF/bronchiectasis)Adult: FEV1 <25% predicted OR FEV1 <30% predicted OR FEV1 <40% predicted with additional criteria; Pediatric: FEV1 <30% predicted or FEV1 <40–50% with qualifiers

BODE scoreBODE score 7–10

Pulmonary arterial systolic pressure> 50 mmHg (echocardiogram) for qualifying pulmonary hypertension criteria

PaCO2> 50 mmHg

Six-minute walk distance< 400 meters (qualifier for certain FEV1/CF criteria)

Massive hemoptysis> 240 mL (requiring bronchial artery embolization)

Abstinence from substance useDocumented abstinence ≥ 6 months prior to transplant (or convincing evidence of risk-reduction behaviors; serial testing may be used)

Medically Necessary Criteria for Lung Transplantation

Medically Necessary Criteria for Lung Transplantation (General)

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

Top-level requirements

General candidate requirements: Member/enrollee has chronic, end-stage lung disease who have failed maximal medical (including pulmonary rehabilitation, as applicable) or surgical therapy
Risk thresholds: High (> 50%) risk of death from lung disease within two years if lung transplantation is not performed> 50% within 2 years
Post-transplant survival expectation: High (> 80%) likelihood of five-year post-transplant survival from a general medical perspective provided there is adequate graft function

Not Covered / Experimental (Guidance)

Providers should confirm absence of the policy-listed absolute contraindications before considering lung transplantation. The policy specifies that candidates must NOT have any of the listed absolute contraindications, including malignancy with high risk of recurrence or death related to cancer, glomerular filtration rate < 40 mL/min/1.73m2 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 planned, recent major cardiac events (stroke, acute coronary syndrome, or myocardial infarction within 30 days), septic shock, active extrapulmonary or disseminated infection, and active tuberculosis infection.

The policy also details conditions related to HIV and substance use that affect candidacy rather than being automatic exclusions: HIV-positive candidates may qualify only if they meet all HIV-specific criteria (for example, CD4 > 200 cells/mm3 for at least three months, absence of AIDS-defining conditions, effective ART, and no chronic wasting/severe malnutrition), and active substance use or dependence is a contraindication unless there is convincing evidence of risk-reduction behaviors (with allowance for urgent transplant timelines where a commitment to reduce behaviors is acceptable and serial testing may verify abstinence).

Coding (Procedure Codes)

Procedural CPT/HCPCS codes referenced (informational)mixed

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 global procedure code (deceased or living donor)

Provider Actions and Requirements

Prior Authorization

Prior authorization required per health plan policy

Requests for lung transplantation require evaluation against this medical necessity policy and prior authorization as determined by the Health Plan. The policy functions as the medical necessity guide; prior authorization decisions are made by the Health Plan and requests must be reviewed against these criteria.

Documentation Required

Document failure of maximal medical/surgical therapy

Provide records demonstrating failed maximal medical (including pulmonary rehabilitation where applicable) or surgical therapy and include disease-specific objective measures to document severity and progression.

Forced expiratory volume in one second (FEV1) — include predicted percentage and trend/decline
Forced vital capacity (FVC) — include predicted percentage and trend/decline

Background and Evidence

This policy is based on the International Society for Heart and Lung Transplantation (ISHLT) 2021 consensus document for selection of lung transplant candidates and has been updated with more recent guidance and literature as noted in the policy references. The guidance emphasizes that donor lungs are a limited societal resource and candidate selection should prioritize survival benefit.

The policy background recognizes common adult indications for lung transplantation such as COPD, idiopathic pulmonary fibrosis, cystic fibrosis, pulmonary arterial hypertension, and other severe lung diseases, and identifies common pediatric indications including pulmonary vascular disease and bronchiolitis obliterans, among others. It aligns with ISHLT and supporting literature and reflects revisions described in the policy history.

Evidence / Guidelines

Primary guideline sourceISHLT Consensus Document 2021 (Leard et al.)

Supporting guideline(s)ISHLT Guidelines 2024 and other transplant literature (references listed: e.g., ISHLT 2024 evaluation/care guidelines, UpToDate reviews, transplant registry reports)

Definitions

Definitions (term / value pairs)

6MWT (Six-minute walk test)Standard exercise test measuring distance walked in six minutes; desaturation <88% or >50 m decline in 6 months is a transplant criterion

FEV1 (Forced expiratory volume in 1 second)Volume of air exhaled in first second of forced expiration; thresholds used (e.g., <20–30% predicted depending on disease and age) to assess transplant candidacy

FVC (Forced vital capacity)Total volume exhaled during forced expiratory maneuver; >10% absolute decline in 6 months (or >5% with radiographic progression) is a criterion for ILD

DLCO (Diffusing capacity for carbon monoxide)Measure of gas transfer across alveolar membrane; >10% absolute decline in 6 months is a criterion for ILD

BODE scoreComposite score including BMI, airflow obstruction (FEV1), dyspnea, and exercise capacity; score 7–10 indicates high risk and qualifies for transplant evaluation in COPD

Revision History

08/23revision

Annual review: Updated I.C.2. GFR threshold changed from <40 to <30 mL/min/1.73m2; expanded I.C.9 with qualifying HIV criteria; updated I.D.2.a.1 FEV1 threshold from <25% to <30%; background updated (no impact to criteria).

04/24revision

Annual review: Updated I.C.2. GFR threshold from <40 to <30 mL/min/1.73m2; expanded I.C.9 with qualifying HIV criteria; updated I.D.2.a.1 FEV1 threshold from <25% to <30%; background updated (no impact to criteria).

02/25revisionLatest

Policy Summary

PayerFidelis Care

PolicyLung Transplantation (Medicare)

Policy CodePolicy MC.CP.MP.57

Change TypeMODIFIED (criteria and thresholds updated)

Effective Date

Next Review Date

SourceLink

On This Page

NO absolute contraindications

Absolute contraindications list
- Malignancy with high risk of recurrence or death related to cancer
- GFR: Glomerular filtration rate < 40 mL/min/1.73m2 unless being considered for multi-organ transplantGFR < 40 mL/min/1.73m2
  Except if being considered for multi-organ transplant
- Acute renal failure with rising creatinine or on dialysis and low likelihood of recovery
- Liver failure: Acute liver failure, or cirrhosis with portal hypertension or synthetic dysfunction unless being considered for multi-organ transplant
- Recent cardiovascular event: Stroke, acute coronary syndrome, or myocardial infarction (excluding demand ischemia) within 30 days30 days
- Septic shock
- Active disseminated infection: Active extrapulmonary or disseminated infection
- Active tuberculosis infection
- HIV infection
  - HIV: CD4 count: CD4 cell count >200 cells/mm3 for at least three months before transplantation> 200 cells/mm3 for >=3 months
  - HIV: AIDS-defining conditions: Absence of AIDS-defining opportunistic infection or malignancy
  - HIV: ART: Member/enrollee is currently on effective antiretroviral therapy (ART)
  - HIV: 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 uncontrolled conditions: 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 intravenous drug use) without convincing evidence of risk reduction behaviors
  Unless urgent transplant timelines are present, in which case a commitment to reducing behaviors is acceptable; serial blood and urine testing may be used to verify abstinence
- History of substance use without documented 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 transplant>= 6 months documented abstinence

Qualifying disease states (one of below; disease-specific additional criteria required)

Adult members/enrollees, age ≥ 18 — Interstitial lung disease
- ILD: FVC decline >10%: Absolute decline in forced vital capacity (FVC) > 10% in the past six months despite appropriate treatment> 10% in 6 months
- ILD: DLCO decline >10%: Absolute decline in diffusing capacity of the lung for carbon monoxide (DLCO) > 10% in the past six months despite appropriate treatment> 10% in 6 months
- ILD: FVC decline >5% with radiographic progression: Absolute decline in forced vital capacity (FVC) > 5% with radiographic progression in the past six months despite appropriate treatment> 5% with radiographic progression
- ILD: 6MWT desaturation: Desaturation to < 88% on six-minute-walk test (6MWT) or > 50 m decline in 6MWT distance in the past six months< 88% or > 50 m decline
- ILD: pulmonary hypertension: Pulmonary hypertension on right heart catheterization or two dimensional echocardiography (in the absence of diastolic dysfunction)
- ILD: hospitalization: Hospitalization because of respiratory decline, pneumothorax, or acute exacerbation
Adult — Cystic fibrosis (CF) or other bronchiectasis
- CF: FEV1 <25%: FEV1 < 25% predicted despite optimal medical management including a trial of elexacaftor/tezacaftor/ivacaftor if eligibleFEV1 < 25%
- CF: Either - severe criteria
  - Either: severe FEV1 criteria
    FEV1 <30%: FEV1 < 30% predictedFEV1 < 30%
    FEV1 <40% plus features
    6MWD <400m: Six-minute walk distance < 400 meters
Adult — COPD
- BODE score of 7 to 10BODE 7-10
- FEV1 severe: FEV1 < 20% predictedFEV1 < 20%
- Severe exacerbations history: History of severe exacerbations
- Chronic hypercapnia
- Pulmonary hypertension COPD: Moderate to severe pulmonary hypertension
Adult — Pulmonary vascular diseases (PAH)
- PAH risk scores: ESC/ERS high risk or REVEAL risk score >10 on appropriate PAH therapy, including IV or SC prostacyclin analoguesREVEAL > 10 or ESC/ERS high risk
- PAH progressive hypoxemia: Progressive hypoxemia
- PAH end-organ dysfunction: Progressive, but not end stage, liver, or kidney dysfunction due to PAH
- PAH hemoptysis: Life-threatening hemoptysis
Adult — Lymphangioleiomyomatosis (LAM)
- LAM: severely abnormal lung function: Severely abnormal lung function (e.g., FEV1 <30% predicted)FEV1 < 30%
- LAM: exertional dyspnea: Exertional dyspnea (NYHA class III or IV)NYHA III-IV
- LAM: hypoxemia: Hypoxemia at rest
- LAM: pulmonary hypertension: Pulmonary hypertension
Adult — Primary lung graft failure or ARDS: Primary lung graft failure; OR ARDS with persistent requirement for mechanical ventilatory support and/or extracorporeal life support (ECLS) without expectation of clinical recovery and with evidence of irreversible lung destruction
Pediatric (<18) qualifying disease states (examples)
- Pediatric — Cystic fibrosis
  - Pediatric CF: FEV1 <30%: FEV1 < 30% predicted despite optimal medical management including a trial of elexacaftor/tezacaftor/ivacaftor if eligibleFEV1 < 30%
  - Pediatric CF: Both of the following
    Pediatric CF: FEV1 <40% or <50% with qualifiers: FEV1 < 40% predicted; OR FEV1 < 50% predicted and any of the following: six-minute walk distance < 400 meters; PaCO2 > 50 mmHg; hypoxemia at rest or with exertion; pulmonary hypertension (PA systolic pressure > 50 mmHg on echocardiogram or evidence of right ventricular dysfunction)FEV1 < 40% OR FEV1 <50% + qualifiers
    Pediatric CF: additional:

Documentation Required

Document contraindications and HIV criteria

Document absence of absolute contraindications and, for HIV-positive candidates, document HIV-specific qualifying criteria before transplantation.

CD4 cell count > 200 cells/mm3 for at least three months prior to transplantation
Absence of AIDS-defining opportunistic infection or malignancy
Currently on effective antiretroviral therapy (ART)
No chronic wasting or severe malnutrition documented

Documentation Required

Substance use abstinence verification

Provide documentation of abstinence from nicotine, tobacco, alcohol, or illicit drugs or evidence of risk-reduction behaviors. For candidates with urgent transplant timelines, a documented commitment to reduce behaviors may be acceptable; serial blood and urine testing may be used to verify abstinence when substances of concern are present.

Documented abstinence from substances (including nicotine replacement) for ≥ six months prior to transplant OR
If urgent timelines apply, documented commitment to reduce/stop use with plan for monitoring
Serial blood and urine testing results as applicable to verify abstinence

Billing Rule

Use referenced CPT/HCPCS codes for transplant procedures

When billing for transplant-related procedures, submit appropriate CPT/HCPCS codes per coding guidance. Codes referenced are informational and do not guarantee coverage; providers should reference current coding guidance prior to claim submission.

32850
32851
32852
32853
32854
32855
32856
S2060
S2152
Note: Codes are included for informational purposes only and inclusion does not guarantee coverage.

Annual review: Updated glomerular filtration rate in Criteria I.C.2. from <30 to <40 mL/min/1.73m2 (absolute contraindication unless multi-organ transplant); updated I.C.9.a to specify CD4 cell count timeframe (at least three months prior to transplantation) and added I.C.9.d regarding chronic wasting/severe malnutrition; expanded Criteria I.C.13 on active substance use/dependence and added I.C.14 on documentation of abstinence; added pediatric indications including alveolar capillary dysplasia, pulmonary vein stenosis refractory to intervention, and pulmonary veno-occlusive disease; minor grammatical updates and background/references reviewed.

Adult — CF/bronchiectasis alternative criteria: Any of: rapid decline in lung function (>30% relative decline in FEV1 over 12 months), frequent hospitalization (particularly if > 28 days hospitalized in preceding year), any exacerbation requiring mechanical ventilation, chronic respiratory failure with hypoxemia or hypercapnia (increasing O2 needs or needing long-term noninvasive ventilation), pulmonary hypertension (PA systolic pressure >50 mmHg or RV dysfunction), worsening nutritional status with BMI <18 kg/m2 despite interventions, recurrent massive hemoptysis despite embolization, WHO Functional Class IVVarious thresholds as listed

Pediatric — Interstitial lung disease: Absolute decline in FVC > 10% in past six months despite appropriate treatment; Absolute decline in DLCO > 10% in past six months despite appropriate treatment; Absolute decline in FVC > 5% with radiographic progression in past six months despite appropriate treatment; Desaturation to < 88% on 6MWT or > 50 m decline in 6MWT distance in past six months; Pulmonary hypertension on right heart catheterization or echocardiography (absent diastolic dysfunction); Hospitalization for respiratory decline, pneumothorax, or acute exacerbation