ModifiedCommunity Health Plan WashingtonPolicy MC.CP.MP.57

Clinical Policy: Lung Transplantation

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Defines medical necessity criteria and coding guidance for lung transplantation for Medicare members/enrollees, based on ISHLT 2021 consensus, and describes candidate selection, contraindications, and disease-specific indications.

Policy Summary

PayerCommunity Health Plan Washington

PolicyClinical Policy: Lung Transplantation

Policy CodePolicy MC.CP.MP.57

Change TypeMaterial revisions to clinical thresholds and eligibility

Effective Date

Next Review Date

Key ActionObtain prior authorization and submit documentation demonstrating all medical necessity criteria are met, including physiologic thresholds, GFR, HIV status, and required procedure codes.

SourceLink

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ModifiedCommunity Health Plan WashingtonPolicy MC.CP.MP.57

Clinical Policy: Lung Transplantation

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Policy Summary

PayerCommunity Health Plan Washington

PolicyClinical Policy: Lung Transplantation

Policy CodePolicy MC.CP.MP.57

Change TypeMaterial revisions to clinical thresholds and eligibility

Effective Date

Next Review Date

Key ActionObtain prior authorization and submit documentation demonstrating all medical necessity criteria are met, including physiologic thresholds, GFR, HIV status, and required procedure codes.

SourceLink

POLICY UPDATE CHANGES

Updated glomerular filtration rate criterion from < 30 to < 40 mL/min/1.73m2 (and prior iterations noted).

Expanded HIV-related criteria to include CD4 >200 cells/mm3 for at least three months and other qualifying conditions for transplant consideration.

Updated cystic fibrosis FEV1 threshold from <25% to <30% predicted for adults and pediatrics where applicable.

Added explicit criteria items for alveolar capillary dysplasia, pulmonary vein stenosis refractory to intervention, and pulmonary veno-occlusive disease as indications.

14absolute contraindications

>=50%risk of death (2yr)

>=80%5-yr survival likelihood

9procedure codes

ISHLT 2021primary guideline

Medical Necessity — Coverage Criteria for Lung Transplantation

Initial transplant medical necessity criteria

Covered when ALL of the following are met:

Member has chronic, end-stage lung disease who has failed maximal medical (including pulmonary rehabilitation, as applicable) or surgical therapy

High (>50%) risk of death from lung disease within two years if lung transplantation is not performed

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

Member does NOT have ANY of the listed absolute contraindications (I.C.1-14), including: malignancy with high risk of recurrence; GFR < 40 mL/min/1.73m2 unless being considered for multi-organ transplant; acute renal failure with rising creatinine or on 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/ACS/MI within 30 days; septic shock; active extrapulmonary or disseminated infection; active tuberculosis; uncontrolled HIV without meeting specified criteria; progressive cognitive impairment; inability to adhere to the regimen necessary to preserve the transplant; other severe uncontrolled medical conditions expected to limit survival after transplant; active substance use or dependence without evidence of risk reduction; and lack of documented abstinence for ≥ six months where required

Disease-specific indications by age group

Adults (age ≥ 18): Includes interstitial lung disease, cystic fibrosis/bronchiectasis, COPD, pulmonary vascular diseases (including PAH meeting high-risk/REVEAL/ESC-ERS criteria), LAM, primary graft failure, ARDS with irreversible lung destruction, and others with specified numeric thresholds (e.g., FVC or DLCO absolute declines, FEV1 thresholds including <25% or <30% for CF when specified, BODE 7–10, PaCO2 >50 mmHg, desaturation to <88% on 6MWT or >50 m decline, six-minute walk distance <400 m, pulmonary hypertension with PA systolic pressure >50 mmHg, WHO FC IV, recurrent massive hemoptysis, pneumothorax, frequent hospitalizations, etc.)
Pediatrics (age < 18): Pediatric-specific criteria analogous to adults including CF with FEV1 thresholds (e.g., <30% predicted or <40% with additional findings), pulmonary vascular disease meeting pediatric high-risk categories, interstitial lung disease with absolute declines in FVC or DLCO, desaturation on 6MWT, pulmonary hypertension, recurrent massive hemoptysis, pneumothorax, WHO FC IV, and other age-appropriate physiologic/clinical thresholds

Documentation demonstrates that the member meets all applicable evaluation requirements and disease-specific numeric thresholds referenced in policy (PFT trends, 6MWT results, hemodynamics/imaging, nutritional status, history of exacerbations/hospitalizations, and failed maximal therapy).

Absolute contraindications (I.C.1-14) that exclude a member from transplant eligibility include, among others: malignancy with high recurrence risk; glomerular filtration rate < 40 mL/min/1.73 m2 (unless multi-organ transplant is being considered); acute renal failure with rising creatinine or dialysis; acute liver failure or cirrhosis with portal hypertension or synthetic dysfunction (unless multi-organ transplant considered); recent stroke/acute coronary syndrome/myocardial infarction within 30 days; septic shock; active extrapulmonary or disseminated infection; active tuberculosis; uncontrolled HIV without meeting specified criteria; progressive cognitive impairment; inability to adhere to required regimen; other severe uncontrolled medical conditions expected to limit survival; and active substance use or dependence without documented risk reduction or documented abstinence for ≥ six months where required. These contraindications must be absent for coverage to be considered.

Coverage for lung transplantation is subject to the terms, conditions, exclusions and limitations of the member's coverage documents (for example, evidence of coverage, certificate of coverage, policy or contract of insurance). This clinical policy provides guidance on medical necessity used to assist coverage determinations but does not constitute a contract or guarantee of payment and is administered in accordance with applicable state and federal requirements and Health Plan administrative procedures.

Lung transplantation is not medically necessary when any of the following apply: the member has not failed maximal medical (including pulmonary rehabilitation, as applicable) or surgical therapy; the member does not meet the required risk/survival thresholds (i.e., high risk of death within two years >50% without transplant and high likelihood of five‑year post‑transplant survival >80% with adequate graft function); or the member has any of the listed absolute contraindications (I.C.1-14). Requests that do not meet these core criteria will not meet medical necessity.

Coding and Clinical Thresholds

Referenced procedure codesCPT

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), complete or segmental, single organ or combination of organs; deceased or living donor(s), procurement, transplantation, and related complications; including: drugs; supplies; hospitalization with outpatient follow-up; medical/surgical, diagnostic, emergency, and rehabilitative services, and the number of days of pre- and post-transplant care in the global definition.

inv-06: GFR — numeric contraindication threshold (mL/min/1.73m2)

Glomerular filtration rate (GFR)GFR < 40 mL/min/1.73 m2 is an absolute contraindication to lung transplant unless the member is being considered for multi‑organ transplant.

ExceptionMulti‑organ transplant consideration may override the GFR contraindication on a case‑by‑case basis as noted in policy.

Related contraindicationAcute renal failure with rising creatinine or on dialysis and low likelihood of recovery is a separate absolute exclusion.

inv-07: Risk of death without transplant — required high risk (> 50%) of death within two years

Required risk thresholdHigh (>50%) risk of death from lung disease within two years if transplantation is not performed.

Context

Candidate Selection and Eligibility

Candidate selection

Candidate selection criteria derived from ISHLT 2021 consensus for lung transplant candidates.

Eligibility core: failed maximal therapy, meets survival/risk thresholds, has no absolute contraindications, and has a qualifying disease-specific indication

HIV-positive candidate allowance: HIV infection is not an absolute contraindication provided all of the following are met: CD4 cell count >200 cells/mm3 for at least three months before transplantation; absence of AIDS-defining opportunistic infection or malignancy; currently on effective antiretroviral therapy (ART); and no chronic wasting or severe malnutrition

Adult disease-specific examples: Adult indications include: interstitial lung disease with absolute decline in FVC >10% or DLCO >10% in past 6 months, or FVC >5% with radiographic progression, desaturation to <88% on 6MWT or >50 m decline, pulmonary hypertension on RHC or echo, hospitalization for respiratory decline; cystic fibrosis/bronchiectasis with FEV1 thresholds (e.g., FEV1 <25% despite optimal therapy, or FEV1 <30% or <40% with additional criteria such as 6MWD <400 m, PaCO2 >50 mmHg, hypoxemia, PAH, worsening nutrition, frequent IV antibiotic exacerbations, massive hemoptysis, pneumothorax); COPD with BODE score 7–10, FEV1 <20% predicted, chronic hypercapnia or severe exacerbations; pulmonary vascular diseases meeting ESC/ERS high-risk or REVEAL >10 criteria; LAM with FEV1 <30% predicted or other progression criteria; primary graft failure; ARDS with irreversible lung destruction requiring persistent mechanical ventilation or ECLS

Absolute Contraindications

Patients with any of the absolute contraindications listed (I.C.1-14) are excluded from coverage as medically necessary for lung transplantation. These absolute contraindications include: malignancy with high risk of recurrence or death related to cancer; glomerular filtration rate < 40 mL/min/1.73 m2 (unless being considered for 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 multi-organ transplant considered); recent major cardiovascular events within 30 days (stroke, ACS, MI); septic shock; active extrapulmonary or disseminated infection; active tuberculosis; uncontrolled HIV (exceptions detailed below); progressive cognitive impairment; inability to adhere to post-transplant regimen despite caregiver support; other severe uncontrolled medical conditions expected to limit post-transplant survival; and active substance use or dependence without convincing evidence of risk reduction or documented abstinence where required.

HIV infection is specifically addressed: HIV is an absolute contraindication unless all of the following are met — CD4 cell count > 200 cells/mm3 for at least three months, absence of AIDS-defining opportunistic infection or malignancy, current effective antiretroviral therapy, and no chronic wasting or severe malnutrition. Documentation supporting these criteria is required to consider transplantation in HIV-positive candidates.

inv-20: Absolute contraindications — conditions that preclude transplant eligibility

Active infectionActive extrapulmonary or disseminated infection is an absolute contraindication to lung transplant.

Recent major cardiovascular events

Provider Requirements, Documentation, and Administrative Actions

Prior Authorization

Prior authorization required for lung transplant

Prior authorization is required for lung transplantation; requests must document that all medical necessity criteria are met and submit appropriate procedure codes for the service.

Document failure of maximal medical/surgical therapy, disease-specific physiologic thresholds, absence of absolute contraindications, and risk/survival thresholds.
Include applicable CPT/S codes (e.g., 32850–32856, S2060, S2152) on the prior authorization/submission.

Note

Use clinical policy to guide medical necessity

Clinical policy criteria guide medical necessity determinations used in coverage decisions; prior authorization decisions are informed by this policy and the Health Plan's administrative procedures.

Policy provides the medical necessity gateway used to assist in coverage decisions and benefit administration.
Health Plan-level administrative policies and procedures apply alongside the clinical policy.

Pre-Transplant Evaluation Requirements

Documentation Required

Pre-transplant evaluation and required disease-specific testing

Pre-transplant evaluation must include disease-specific testing and objective measures: pulmonary function testing with FEV1/FVC/DLCO trends, six-minute walk test with desaturation/distance, right heart catheterization or echocardiography for pulmonary hypertension, relevant labs (including GFR), imaging, nutritional assessment, and infectious disease workup.

Include PFT reports showing trends, 6MWT results (desaturation <88% or distance <400 m or >50 m decline when relevant), right heart catheterization data for pulmonary hypertension, and lab results such as GFR and HIV viral load/CD4 when applicable.
Attach imaging, hospitalization history, and documentation of failed medical/surgical therapy as part of the evaluation packet.

Clinical Background and Scope

Lung transplantation is an accepted therapy for select patients with end‑stage lung disease and may be performed as single, double, or lobar transplantation. Common adult indications include COPD, idiopathic pulmonary fibrosis (interstitial lung disease), cystic fibrosis, pulmonary arterial hypertension, and sarcoidosis; pediatric indications include pulmonary vascular disease, bronchiolitis obliterans, bronchopulmonary dysplasia, and graft failure from viral pneumonitis. Candidate selection follows ISHLT‑based criteria and requires demonstration of failed maximal therapy, appropriate physiologic thresholds, and absence of absolute contraindications.

Procurement, Transplantation, Hospitalization, and Post-Transplant Services

inv-26: Procurement, transplantation, hospitalization, and related post-transplant care — referenced within bundled CPT S2152; coverage subject to plan terms

Bundled transplant services (S2152)Procurement, transplantation, hospitalization, and related post‑transplant care are referenced within bundled CPT S2152.

Coverage subject to plan termsCoverage for procurement and related services is subject to the member's benefit plan terms, conditions, exclusions, and limitations.

Coding guidanceProviders should reference CPT and HCPCS codes included in the policy when submitting prior authorization and claims (see coding section).

inv-27: post-transplant services — governed by member's benefit plan and applicable regulations; consult Medicare/Medicaid guidance

Benefit plan governs servicesPost‑transplant services and coverage are governed by the member's benefit plan terms, conditions, exclusions, and limitations.

Transplant Center Requirements

Note

Center accreditation or adherence to recognized transplant program standards

Use transplant centers that meet recognized program standards or accreditation expectations as implied by ISHLT-based candidate selection criteria; document center accreditation or adherence to recognized transplant program standards where available.

Policy references ISHLT and OPTN standards; providers should document the center’s accreditation or program recognition when submitting requests.
If specific center requirements are requested by the Health Plan, provide documentation of accreditation or program participation.

Definitions and Disease-Specific Thresholds

inv-21: Indication thresholds — disease-specific numeric physiologic or functional cutoffs by diagnosis

Indication thresholds overviewDisease‑specific numeric physiologic or functional cutoffs (e.g., FEV1, FVC decline, DLCO decline, 6MWT desaturation/distance, BODE score, PA systolic pressure) are used to establish transplant indication.

Examples — pulmonary functionFEV1 thresholds vary by diagnosis (e.g., CF FEV1 <30% predicted; COPD FEV1 <20% predicted; progressive decline criteria are also specified).

Examples — functional/hemodynamic6MWT desaturation <88% or distance <400 m, PaCO2 >50 mmHg, and pulmonary artery systolic pressure >50 mmHg are among enumerated thresholds that may indicate need for transplant evaluation.

Policy Revision History

2025-02revisionLatest

Annual review updated the glomerular filtration rate criterion from <30 to <40 mL/min/1.73m2.

2024-04revision

Annual review updated I.C.2 GFR threshold (noted change involving <30 mL/min/1.73m2), expanded HIV qualifying criteria, and changed FEV1 threshold to <30% predicted.

2023-08revision

Policy Summary

PayerCommunity Health Plan Washington

PolicyClinical Policy: Lung Transplantation

Policy CodePolicy MC.CP.MP.57

Change TypeMaterial revisions to clinical thresholds and eligibility

Effective Date

Next Review Date

Key ActionObtain prior authorization and submit documentation demonstrating all medical necessity criteria are met, including physiologic thresholds, GFR, HIV status, and required procedure codes.

SourceLink

On This Page

This risk requirement is part of the core medical‑necessity gateway that must be met in addition to disease‑specific indications and absence of absolute contraindications.

Denial triggerRequests lacking documentation demonstrating >50% two‑year mortality risk will not meet medical necessity criteria.

inv-08: Five-year survival likelihood — required high likelihood (> 80%) of five-year post-transplant survival

Five‑year survival likelihoodHigh (>80%) likelihood of five‑year post‑transplant survival (from a general medical perspective) is required.

ConditionLikelihood assumes adequate graft function and is evaluated as part of overall candidate selection.

Relation to coverage decisionFailure to demonstrate anticipated ≥80% five‑year survival may result in denial for lack of medical necessity.

inv-09: FEV1 threshold for cystic fibrosis (adult/pediatric) — < 30% predicted

Adult FEV1 threshold (CF)FEV1 < 30% predicted (policy includes CF criteria with FEV1 thresholds; earlier item also references FEV1 <25% in specific CF pathways).

Pediatric FEV1 threshold (CF)Pediatric cystic fibrosis: FEV1 < 30% predicted despite optimal medical management (including modulator therapy if eligible).

Additional CF thresholdsPolicy lists multiple CF criteria including FEV1 <25% in some adult CF pathways and FEV1 <40% with additional risk features—see disease‑specific section for details.

inv-10: 6-minute walk test desaturation/distance — desaturation to <88% or distance <400 meters or >50 m decline

6MWT desaturation thresholdDesaturation to < 88% on the six‑minute walk test meets the indication threshold for transplant evaluation.

6MWT distance thresholdSix‑minute walk distance < 400 meters qualifies as a disease‑specific indication in multiple diagnostic pathways.

Significant declineA decline >50 meters in 6MWT distance (or rapid functional decline as defined in criteria) is noted as an indicator of disease progression prompting transplant consideration.

inv-11: Prior authorization required for transplant — documentation that all medical necessity criteria are met

Prior authorization requirementPrior authorization is required for lung transplantation and must include documentation that all medical necessity criteria are met and appropriate CPT/HCP S codes are submitted.

Supporting documentationSubmit disease‑specific parameters, GFR, HIV status, abstinence documentation, PFTs, 6MWT, imaging, hemodynamics, and other evaluation results as applicable.

Codes to referencePolicy references CPT codes such as 32850–32856 and HCPCS S2060, S2152 for documentation and claims submission guidance.

Pediatric disease-specific examples: Pediatric indications include cystic fibrosis with FEV1 <30% predicted or FEV1 <40–50% with additional findings (6MWD <400 m, PaCO2 >50 mmHg, hypoxemia, pulmonary hypertension, worsening nutrition, recurrent IV-antibiotic-requiring exacerbations, massive hemoptysis, pneumothorax), pulmonary vascular disease meeting pediatric high-risk (EPPVDN) categories, interstitial lung disease with absolute FVC or DLCO decline >10% in 6 months, desaturation on 6MWT, pulmonary hypertension on hemodynamics or echo, frequent hospitalizations, WHO FC IV, and other age-appropriate thresholds

Stroke, acute coronary syndrome, or myocardial infarction within 30 days is an absolute contraindication.

Septic shockSeptic shock is listed as an absolute contraindication to transplantation.

Active malignancy with high recurrence riskMalignancy with high risk of recurrence or death related to cancer precludes transplant eligibility.

Renal failure below GFR thresholdGFR < 40 mL/min/1.73 m2 unless being considered for multi‑organ transplant, and acute renal failure with rising creatinine or on dialysis with low likelihood of recovery, are absolute exclusions.

Step Therapy

Document failure of maximal therapy prior to listing

The member must have failed maximal medical therapy (including pulmonary rehabilitation when applicable) or prior surgical interventions before being listed for transplant; this failure must be documented in the record.

Document trials of optimal medical management, pulmonary rehabilitation (if applicable), and any prior relevant surgical therapies with dates and outcomes.
Include objective measures showing continued disease progression despite maximal therapy (PFT trends, 6MWT results, imaging, hospitalizations).

Note

Administrative submission and responsibility note

Providers must follow administrative requirements for submissions and comply with plan notices; the clinical policy is not a guarantee of payment and providers remain responsible for exercising clinical judgment.

Ensure prior authorization submissions follow the Health Plan's procedures and include all requested supporting documentation.
Be aware the policy does not replace provider clinical judgment and does not guarantee payment.

Documentation Required

Required documentation and coding to submit

Submit all applicable procedure codes and supporting clinical documentation with the request; reference the CPT and HCPCS S codes listed in the policy and include disease-specific data demonstrating criteria are met.

Include CPT codes 32850, 32851, 32852, 32853, 32854, 32855, 32856 and HCPCS S2060, S2152 as applicable on claims and authorization requests.
Attach supporting clinical documentation: PFTs (FEV1/FVC/DLCO), 6MWT results, imaging, hemodynamics, GFR, HIV labs (if applicable), abstinence verification, and history of failed therapies.

Documentation Required

Adhere to plan and regulatory documentation requirements

Follow the Health Plan coverage documents and applicable state and federal requirements; review Medicare NCDs/LCDs and state Medicaid manuals when applicable before applying the policy criteria.

For Medicare members, review all applicable NCDs, LCDs, and Medicare Coverage Articles on the CMS website prior to applying criteria.
For Medicaid members, state Medicaid coverage provisions take precedence where they conflict with this clinical policy; consult the state Medicaid manual.

Denial Risk

Denial triggers if core criteria or contraindications not met

Requests will be denied as not medically necessary if the member does not meet the core criteria: high risk of death within two years, high likelihood of five‑year post‑transplant survival, or has any listed absolute contraindication.

Verify and document risk thresholds (>50% two‑year mortality risk; >80% five‑year post‑transplant survival likelihood) and absence of any absolute contraindications (I.C.1–14).
Denials may occur if required objective measures or contraindication exclusions are not clearly demonstrated.

Denial Risk

Denial risk from coverage contract terms

Coverage and prior authorization are subject to all terms, conditions, exclusions and limitations of the member's coverage documents; failure to meet contract terms may result in denial or non‑payment.

Confirm member eligibility and benefit limitations in the evidence of coverage/certificate of coverage before proceeding.
Understand that the clinical policy guides but does not override coverage contract provisions or regulatory requirements.

Regulatory guidanceConsult applicable Medicare/Medicaid NCDs, LCDs, and state Medicaid manuals when applying coverage criteria for post‑transplant care.

No guarantee of paymentThe clinical policy guides medical necessity determinations but does not constitute a contract or guarantee regarding payment or results.

Policy developed with updates including prior change of GFR threshold to <30 mL/min/1.73m2, expansion of HIV qualifying criteria, and FEV1 threshold changed from <25% to <30% predicted.

addition

Added disease-specific indications for alveolar capillary dysplasia, pulmonary vein stenosis refractory to intervention, and pulmonary veno-occlusive disease.