ModifiedCentenePolicy CP MP.57

Lung Transplantation Medical Necessity Criteria

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Defines medical necessity criteria and coding guidance for lung transplantation requests for Centene members, based on ISHLT 2021 consensus guidance; affects clinicians and transplant program reviewers evaluating transplant eligibility.

Policy Summary

PayerCentene

PolicyLung Transplantation Medical Necessity Criteria

Policy CodePolicy CP MP.57

Change TypeMaterial revisions to clinical thresholds and eligibility

Effective Date

Next Review Date

Key ActionObtain prior authorization and submit documentation demonstrating absence of absolute contraindications, renal function (GFR), HIV control (if applicable), and failure of maximal medical therapy.

SourceLink

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ModifiedCentenePolicy CP MP.57

Lung Transplantation Medical Necessity Criteria

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Policy Summary

PayerCentene

PolicyLung Transplantation Medical Necessity Criteria

Policy CodePolicy CP MP.57

Change TypeMaterial revisions to clinical thresholds and eligibility

Effective Date

Next Review Date

SourceLink

POLICY UPDATE CHANGES

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

Expanded HIV-related criteria (I.C.9) including requirement for CD4 >200 cells/mm3 and ART and timing relative to transplantation.

Updated adult and pediatric disease-specific thresholds (e.g., FEV1 cutoffs) to align with ISHLT 2021 guidance, including changing FEV1 <25% to FEV1 <30% in some criteria.

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

ISHLT 2021Primary guideline source

GFR 40Renal function cutoff (I.C.2.)

FEV1 <30%Updated pulmonary function

CPT 32850–32856Referenced procedure codes

~25References cited

Medical Necessity Criteria for Lung Transplantation

General candidacy and disease-specific criteria

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

General candidacy

No absolute contraindications
- HIV-specific requirements to overcome contraindication: If HIV-positive, member must be on effective antiretroviral therapy (ART), have absence of active AIDS-defining opportunistic infection or malignancy, and have a CD4 cell count >200 cells/mm3 for at least three months prior to transplantation.
  HIV criteria

Disease-specific indications (adult and pediatric)

Interstitial lung disease (ILD) examples: Any of the following despite appropriate treatment: absolute decline in FVC >10% in past 6 months; absolute decline in DLCO >10% in past 6 months; absolute decline in FVC >5% with radiographic progression in past 6 months; desaturation to <88% on 6-minute walk test (6MWT) or 50 m decline in 6MWT distance in past 6 months; pulmonary hypertension on right heart catheterization or echocardiography (absent diastolic dysfunction).
See policy for full ILD detail
Cystic fibrosis (CF) / bronchiectasis examples: Any of the following despite optimal management (including trial of elexacaftor/tezacaftor/ivacaftor if eligible): FEV1 <30% predicted; or FEV1 <50% predicted and rapidly declining or with complications such as hypoxemia, hypercapnia, pulmonary hypertension, frequent IV-antibiotic-requiring exacerbations, massive hemoptysis (>240 mL) requiring bronchial artery embolization, or pneumothorax; hospitalization for respiratory decline.
Includes pediatric variants
COPD examples: Qualifying features include severe airflow limitation or progression (examples in policy): FEV1 thresholds (e.g., very low FEV1 such as ~20% predicted in some criteria), BODE score 7–10, history of severe exacerbations, chronic hypercapnia, frequent/prolonged hospitalizations (e.g., >28 days in prior year), pulmonary hypertension, recurrent massive hemoptysis, or chronic respiratory failure requiring increasing oxygen or ventilatory support.
See policy for complete COPD criteria
Pulmonary vascular disease / PAH examples: Moderate to severe pulmonary hypertension; ESC/ERS high-risk classification or REVEAL risk score >10 despite appropriate PAH therapy (including IV/SC prostacyclin); progressive hypoxemia; life‑threatening hemoptysis; and other features described in policy (pediatric PAH guidance included).
Includes pediatric guidance
LAM, primary lung failure, ARDS, and other indications: LAM with progression despite mTOR inhibitor therapy and severely abnormal lung function (e.g., FEV1 <30% predicted), hypoxemia at rest, exertional dyspnea (NYHA III–IV), or pulmonary hypertension; primary graft failure, refractory pneumothorax; ARDS with persistent need for mechanical ventilation and/or ECLS without expectation of recovery and irreversible lung destruction; pulmonary vein stenosis refractory to intervention; alveolar capillary dysplasia; pulmonary veno-occlusive disease and other specified rare conditions.
See policy for full list of disease categories and thresholds

The policy lists absolute contraindications that exclude a member from lung transplant candidacy. These include uncontrolled or high‑recurrence‑risk malignancy; acute liver failure or cirrhosis with portal hypertension/synthetic dysfunction (unless being considered for multi‑organ transplant); acute renal failure on dialysis with low recovery likelihood; recent stroke, acute coronary syndrome or myocardial infarction within 30 days; septic shock; active extrapulmonary or disseminated infection including active tuberculosis; HIV with detectable viral load (with specific exceptions when virologically controlled); progressive cognitive impairment; inability to adhere to the post‑transplant regimen even with caregiver support; active substance use or dependence without documented risk‑reduction/abstinence; and other severe uncontrolled medical conditions expected to limit survival after transplant.

Transplantation is not medically necessary when any of the listed absolute contraindications is present or when the member has not demonstrated failure of maximal medical therapy (including pulmonary rehabilitation when applicable) and has not met the required disease‑specific severity or progression thresholds described in the policy.

Coverage determinations using this clinical policy are made consistent with the member's benefit documents. Decisions are subject to all terms, conditions, exclusions and limitations of the coverage documents and to applicable state and federal requirements; state Medicaid provisions take precedence when they conflict with this clinical policy.

Procedure and Billing Codes

Referenced CPT/HCPCS codesmixed

32850	Donor pneumonectomy(s)
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; unilateral lung
32856	Backbench standard preparation of cadaver donor allograft; bilateral lung
S2060	Lobar transplantation
S2152	Solid organ(s) procurement/transplantation bundled services

inv-06: Glomerular filtration rate (GFR)

Operational GFR cutoffGFR >= 40 mL/min/1.73 m2 required for candidacy unless being considered for multi-organ transplant

Previous threshold (for context)Earlier version used GFR 30 mL/min/1.73 m2; updated in latest revision

Location in policyCriterion I.C.2 (absolute contraindications section) — updated glomerular filtration rate requirement

inv-07: FEV1 threshold (selected criteria)

Updated FEV1 thresholdFEV1 <30% predicted used as a qualifying pulmonary function threshold in selected adult and pediatric disease-specific criteria

Disease contexts referencedApplied in cystic fibrosis/bronchiectasis and LAM examples, where FEV1 <30% predicted despite optimal management qualifies

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior Authorization Required — Prior authorization is required for lung transplantation procedures. Providers must submit a prior authorization request with complete clinical documentation to support medical necessity before scheduling transplant-related services.

Affected services include lung transplantation surgical CPT codes (e.g., 32850, 32851, 32852, 32853, 32854, 32855, 32856) and related procurement/solid organ transplant codes (e.g., S2060, S2152).

Denial Risk

Denial Risk for Noncompliance with Coverage Documents or Regulations

Denial Risk if Coverage or Regulatory Requirements Not Met — Coverage decisions are subject to the member's benefit terms, exclusions, limitations, and applicable state and federal law. Requests that do not comply with the Health Plan's administrative policies, state Medicaid provisions, Medicare NCDs/LCDs, or other regulatory requirements may be denied.

Clinical Background

Lung transplantation is an accepted therapy for selected patients with end‑stage pulmonary disease and may be performed as single, double, or lobar transplants. Indications span a range of severe lung disorders in adults and children, and candidacy evaluation follows disease‑specific functional and clinical thresholds.

Definitions and Guideline Sources

inv-18: Maximal medical therapy

Maximal medical therapy definitionIncludes guideline-directed medical management for the underlying lung disease and pulmonary rehabilitation when applicable

Cystic fibrosis specificsFor CF, maximal therapy includes a trial of elexacaftor/tezacaftor/ivacaftor if the member is eligible

Documentation requirementMembers must have failed maximal medical therapy (including pulmonary rehabilitation when applicable) prior to transplant consideration

inv-19: ISHLT guidance

Primary guideline sourceInternational Society for Heart and Lung Transplantation (ISHLT) 2021 consensus document for selection of lung transplant candidates

Policy sourcingPolicy criteria are derived from and aligned to the ISHLT 2021 consensus guidance

Policy Summary

PayerCentene

PolicyLung Transplantation Medical Necessity Criteria

Policy CodePolicy CP MP.57

Change TypeMaterial revisions to clinical thresholds and eligibility

Effective Date

Next Review Date

SourceLink

On This Page

Alignment notePulmonary function thresholds were aligned with ISHLT 2021 guidance and changed in some criteria from FEV1 <25% to FEV1 <30%

inv-08: 6-minute walk test desaturation

6MWT desaturation criterionDesaturation to <88% on 6-minute walk test (6MWT) qualifies as a disease-specific threshold

Alternate 6MWT metricA decline of 50 m in 6MWT distance over the past six months is an additional qualifying threshold

Policy placementUsed within interstitial lung disease and other disease-specific criteria as an objective functional threshold

Verify the member's coverage documents (Evidence of Coverage / Certificate of Coverage / policy) prior to authorization.

For Medicare members, review applicable NCDs, LCDs, and Medicare Coverage Articles; for Medicaid members, state Medicaid rules take precedence where they conflict.

Documentation Required

Required Supporting Documentation

Required Supporting Documentation — Providers must supply documentation that demonstrates the member meets all medical necessity criteria and lacks any absolute contraindications. Documentation should clearly show prior maximal medical therapy (including pulmonary rehabilitation when applicable), disease-specific objective measures, and absence or mitigation of contraindications.

Clinical records documenting failure of maximal medical therapy, including pulmonary rehabilitation when applicable, and guideline-directed therapy.
Objective disease measures as applicable (examples): FEV1, FVC, DLCO trends, six-minute walk distance and desaturation, right heart catheterization or echocardiography evidence of pulmonary hypertension, hospitalizations for respiratory decline, exacerbation frequency, imaging demonstrating progression.
Documentation addressing contraindications: cancer history and risk of recurrence, renal/hepatic function (e.g., GFR), active infections (including TB, extrapulmonary/disseminated infections), recent major cardiovascular events, sepsis/septic shock history, HIV status including viral load and CD4 counts and evidence of effective ART when indicated, substance use history with evidence of abstinence or documented risk-reduction plan, cognitive and adherence assessments, nutritional status.
If multi-organ transplant is being considered, include relevant multi-organ evaluation notes and rationale.

Documentation Required

Documentation and Administrative Compliance

Documentation and Administrative Compliance — Providers must follow Health Plan administrative policies and submit documentation in the format and timeframe required by the plan. The clinical policy is intended to guide medical necessity determinations and does not guarantee payment.

Adhere to Health Plan prior authorization submission procedures and timelines.
Provide all requested records promptly during review; failure to provide requested information may delay or result in denial.
Ensure consent, credentialing, and facility requirements are met per plan policy and applicable regulatory standards.
If discrepancies exist between this clinical policy effective date and applicable legal/regulatory requirements, applicable laws and regulations govern.
Retain copies of all submitted documentation; unauthorized distribution of the clinical policy content is prohibited.

Reference citationLeard LE, Valapour M, et al. J Heart Lung Transplant. 2021;40(11):1349–1379 (ISHLT 2021 consensus)