ModifiedCommunity Health Plan WashingtonPolicy MC.CP.MP.57

Clinical Policy: Lung Transplantation

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Medical necessity criteria and coding guidance for lung transplantation for Medicare-affiliated members/enrollees, based on ISHLT 2021 consensus guidance and payer-specific adaptations. Applies to evaluation and coverage decisions for lung transplant requests.

Policy Summary

PayerCommunity Health Plan Washington

PolicyClinical Policy: Lung Transplantation

Policy CodePolicy MC.CP.MP.57

Change TypeCriteria revisions and additions

Effective Date

Next Review Date

Key ActionObtain prior authorization and document that all medical necessity criteria are met, including PFTs, 6MWT, and evidence of maximal medical therapy failure.

SourceLink

POLICY UPDATE CHANGES

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

Expanded qualifying criteria for members who are HIV positive to include CD4 >200 cells/mm3 for at least three months, absence of AIDS-defining opportunistic infection/malignancy, on effective ART, and no chronic wasting/severe malnutrition.

Updated cystic fibrosis FEV1 threshold from <25% to <30% predicted in Criteria I.D.2.a.1.

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

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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 TypeCriteria revisions and additions

Effective Date

Next Review Date

Key ActionObtain prior authorization and document that all medical necessity criteria are met, including PFTs, 6MWT, and evidence of maximal medical therapy failure.

SourceLink

POLICY UPDATE CHANGES

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

Updated cystic fibrosis FEV1 threshold from <25% to <30% predicted in Criteria I.D.2.a.1.

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

>50%risk of death within 2 years required

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

<40GFR absolute contraindication

<30%FEV1 threshold (CF adults)

<88%6MWT desaturation criterion

24+references included

Coverage and Medical Necessity Criteria

Initial eligibility criteria

Covered when ALL of the following are met:

Overall coverage gate: Member has chronic, end-stage lung disease who failed maximal medical and/or surgical therapy (including pulmonary rehabilitation and disease-specific optimized therapies) and is being considered for lung transplantation

Per policy introduction and evaluation requirements

Survival risk criteria: High (>50%) risk of death from lung disease within two years if transplant is not performed AND high (>80%) likelihood of five-year post-transplant survival from a general medical perspective with adequate graft function

Both conditions required (I.A and I.B)

No absolute contraindications

Enumerated absolute contraindications (examples): 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 considered for multi-organ transplant; Stroke, acute coronary syndrome, or myocardial infarction within 30 days; Septic shock; Active extrapulmonary or disseminated infection; Active tuberculosis infection; Progressive cognitive impairment; Inability to adhere to necessary regimen even with caregiver support; 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, or IV drug use) without convincing evidence of risk reduction; History of substance/tobacco/alcohol use without documentation of ≥6 months abstinence
Full list in policy I.C

Disease-specific eligibility: Member has one of the qualifying disease states with specified severity criteria

See adult and pediatric disease categories for required metrics (PFTs, functional tests, hemodynamics, exacerbation/hospitalization history, nutritional status)

Coverage for lung transplantation is available when the member meets the policy's overall medical necessity gates and does not have any listed absolute contraindication. Specifically, the member must have chronic, end-stage lung disease who has failed maximal medical (including pulmonary rehabilitation, as applicable) or surgical therapy, demonstrate high (>50%) risk of death within two years without transplant, and have a high (>80%) likelihood of five-year post-transplant survival from a general medical perspective with adequate graft function. The member must also not have any of the absolute contraindications enumerated in the policy (see contraindications section) for coverage to be considered.

Coverage determinations and the administration of benefits for lung transplantation are governed by the member's benefit documents and applicable legal and regulatory requirements. This clinical policy is a guide to medical necessity and does not guarantee payment. When there is a conflict with state Medicaid provisions or other regulatory requirements, the applicable state or federal provisions take precedence. Providers should consult the member's evidence of coverage and plan-specific administrative policies when requesting authorization.

Transplant Candidate Selection

Transplant candidate criteria

Candidate selection requires meeting the survival/contraindication gates AND the applicable disease-specific severity criteria:

Survival and contraindication gate: High risk of death without transplant (>50% within 2 years) AND high likelihood of five-year survival (>80%) AND absence of any absolute contraindications

Core candidate requirement (I.A–I.C)

Disease-specific severity requirements (Adults, age ≥18)

Interstitial lung disease (adult): Any of: 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 6MWT or >50 m decline in 6MWT in past 6 months; pulmonary hypertension on right heart cath or echocardiography; hospitalization for respiratory decline, pneumothorax, or acute exacerbation
See policy I.D.1.a.i–vi

Absolute and Relative Contraindications

Absolute contraindications that preclude coverage unless otherwise specified include, but are not limited to: 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); recent stroke, acute coronary syndrome, or myocardial infarction within 30 days; septic shock; active extrapulmonary or disseminated infection; active tuberculosis; uncontrolled HIV (unless meeting specified stability criteria including CD4 >200 cells/mm3 for ≥ three months, on effective ART, and absence of AIDS-defining illness); progressive cognitive impairment; inability to adhere to required regimens 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.

Pre-Transplant Evaluation and Documentation Requirements

Prior Authorization

EVALUATION REQUIREMENTS — Document failure of maximal medical/surgical therapy, pulmonary rehab, and disease‑optimized therapy

Document and submit evidence that the member has failed maximal medical and surgical therapy, including pulmonary rehabilitation when applicable, and disease‑specific optimized therapies (for example, trial of elexacaftor/tezacaftor/ivacaftor if eligible for cystic fibrosis) plus objective measures of disease severity (e.g., PFTs, 6MWT, right heart catheterization or echocardiography for pulmonary hypertension), nutritional assessment, and substance‑use abstinence verification when applicable. Prior authorization is required and will be decided only after these elements demonstrating that all medical necessity criteria are met are provided. Coverage decisions remain subject to the member’s benefit terms, applicable NCDs/LCDs, and Health Plan administrative policies.

Provide documentation of failure of maximal medical therapy, including pulmonary rehabilitation where applicable (Policy I and Evaluation Requirements).
For CF, document trial of CF modulators (e.g., elexacaftor/tezacaftor/ivacaftor) if the member is eligible (Policy I.D.2).
Include objective severity data: PFTs (FEV1/FVC/DLCO), 6MWT (desaturation <88% or >50 m decline), right heart cath or echocardiography for PAH, and recent hospitalizations or exacerbations (Policy disease‑specific nodes).
Supply nutritional assessment and documentation of substance‑use abstinence or serial testing as indicated (Policy I.C.13–14 and Evaluation Requirements).
Submit all required materials with the prior authorization request; plan‑specific authorization processes and benefit terms apply and may affect coverage determination (Policy prior auth and administrative notes).

Provider Responsibilities and Prior Authorization

Prior Authorization

Prior authorization required for lung transplantation and related services

Obtain prior authorization before scheduling lung transplantation procedures or submitting claims for the listed transplant CPT/HCPCS services; authorization decisions require submission of documentation that all medical necessity criteria are met.

Include clinical documentation demonstrating member meets all policy medical necessity criteria when requesting authorization
Referenced procedure codes include CPT 32850–32856 and HCPCS S2060, S2152

Prior Authorization

Submit PA per Health Plan procedures and benefit terms

Follow the Health Plan's specific prior authorization processes and benefit terms when requesting authorization; consult plan-level requirements for submission details and timing.

Verify the plan's effective date and any plan-specific administrative procedures
Confirm benefit coverage terms and any state/federal precedence applicable to the member

Billing Codes, Tests, and Key Clinical Thresholds

Covered CPT CodesCPTCovered

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, including dissection of allograft from surrounding soft tissues to prepare pulmonary venous/atrial cuff, pulmonary artery, and bronchus; unilateral.
32856	Backbench standard preparation of cadaver donor lung allograft prior to transplantation, including dissection of allograft from surrounding soft tissues to prepare pulmonary venous/atrial cuff, pulmonary artery, and bronchus; bilateral.

HCPCS CodesHCPCSCovered

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-07: 6-Minute Walk Test — desaturation threshold or >50 m decline within past 6 months

6MWT desaturation thresholdDesaturation to < 88% on six-minute walk test within the past 6 months

6MWT distance decline threshold> 50 meter decline in 6MWT distance within the past 6 months

Time windowDocumented within the past 6 months

inv-08: FEV1 (CF) — adult and pediatric FEV1 thresholds for cystic fibrosis transplant consideration

Adult CF FEV1 thresholdFEV1 < 30% predicted despite optimal medical management (including trial of elexacaftor/tezacaftor/ivacaftor if eligible)

Pediatric CF FEV1 threshold

Key Terms and Common Indications

inv-19: Common indications — list of conditions commonly leading to lung transplant

Chronic obstructive pulmonary disease (COPD)Common indication for lung transplant, frequently the most common adult indication

Idiopathic pulmonary fibrosis / interstitial lung disease (ILD)Includes progressive fibrosing ILD meeting severity criteria (FVC/DLCO declines, 6MWT desaturation, hospitalizations)

Cystic fibrosis and bronchiectasisCF and other bronchiectatic diseases with severe FEV1 decline or complications

Pulmonary arterial hypertension (PAH)Including advanced PAH meeting hemodynamic and functional severity criteria

Sarcoidosis and other pediatric-specific conditionsIncludes sarcoidosis and pediatric indications such as alveolar capillary dysplasia, pulmonary vein stenosis refractory to intervention, pulmonary veno-occlusive disease

Transplant Center and Surgical Requirements

Note

CENTER REQUIREMENT: Use accredited transplant centers following ISHLT guidance

Perform lung transplantation at appropriately accredited transplant centers and follow ISHLT guidance and standard transplant practice; document the center's accreditation and adherence to accepted standards when requested.

Transplant should be performed at accredited centers following ISHLT consensus guidance
Provide center accreditation or program information if requested during authorization or review

Post-Transplant Hospitalization, Follow-up, and Related Services

inv-25: Post-transplant services included in global HCPCS code S2152; related drugs and supplies noted

HCPCS S2152 global definitionSolid organ(s) procurement, transplantation, and related complications; includes drugs, supplies, hospitalization with outpatient follow-up, medical/surgical, diagnostic, emergency, and rehabilitative services in the global definition

Included servicesPre- and post-transplant care, hospitalization, follow-up, and related diagnostics are included in the global code definition

Related drugs and suppliesPost-transplant drugs and supplies are noted as included in the S2152 global definition, but specific immunosuppression regimens are not detailed in this policy section

Other HCPCS of interestHCPCS S2060 (lobar lung transplantation) is listed separately in coding guidance

Background and Scope

Lung transplantation (single, double, or lobar) is an accepted therapeutic option for selected patients with end-stage pulmonary disease. It is used to manage a range of severe lung disorders—such as chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, cystic fibrosis, pulmonary arterial hypertension, and a variety of pediatric pulmonary vascular and parenchymal diseases—when disease severity and survival benefit justify organ allocation. Candidate selection balances the expected survival benefit, organ scarcity, and the presence or absence of contraindications, and follows ISHLT consensus guidance and standard transplant center practices.

Policy Summary

PayerCommunity Health Plan Washington

PolicyClinical Policy: Lung Transplantation

Policy CodePolicy MC.CP.MP.57

Change TypeCriteria revisions and additions

Effective Date

Next Review Date

Key ActionObtain prior authorization and document that all medical necessity criteria are met, including PFTs, 6MWT, and evidence of maximal medical therapy failure.

SourceLink

On This Page

Cystic fibrosis or bronchiectasis (adult):

Any of: FEV1 criteria or complications as specified — examples include FEV1 <25% predicted despite optimal management including trial of elexacaftor/tezacaftor/ivacaftor if eligible; or complex criteria such as FEV1 <30% predicted, or FEV1 <40% predicted plus additional findings (6MWD <400 m, PaCO2 >50 mmHg, resting/exertional hypoxemia, pulmonary hypertension [PA systolic >50 mmHg or RV dysfunction], worsening nutrition, ≥2 IV-antibiotic-requiring exacerbations/year); massive hemoptysis requiring embolization; pneumothorax

See policy I.D.1.b and I.D.1.b.ii–vi

COPD (adult): Any of: BODE score 7–10; FEV1 <20% predicted; history of severe exacerbations; chronic hypercapnia; moderate to severe pulmonary hypertension

See policy I.D.1.c

Pulmonary vascular diseases/PAH (adult): Any of: ESC/ERS high risk or REVEAL risk score >10 on appropriate PAH therapy (including IV/SC prostacyclin), progressive hypoxemia, progressive but not end-stage liver or kidney dysfunction due to PAH, life-threatening hemoptysis

See policy I.D.1.d

LAM (adult): Disease progression despite mTOR inhibitor therapy plus one or more: severely abnormal lung function (e.g., FEV1 <30% predicted), NYHA class III–IV exertional dyspnea, resting hypoxemia, pulmonary hypertension, refractory pneumothorax

See policy I.D.1.e

Primary graft failure or ARDS (adult): Primary lung graft failure OR ARDS with persistent mechanical ventilation and/or ECLS without expectation of recovery and evidence of irreversible lung destruction

See policy I.D.1.f–g

Disease-specific severity requirements (Pediatric, age <18)

Cystic fibrosis (pediatric): Any of: FEV1 <30% predicted despite optimal management including trial of elexacaftor/tezacaftor/ivacaftor if eligible; or FEV1 <40% predicted or FEV1 <50% plus additional findings (6MWD <400 m, PaCO2 >50 mmHg, resting/exertional hypoxemia, pulmonary hypertension [PA systolic >50 mmHg or RV dysfunction], worsening nutrition, ≥2 IV-antibiotic-requiring exacerbations/year); massive hemoptysis; pneumothorax; FEV1 <50% and rapidly declining; any exacerbation requiring positive pressure ventilation
See policy I.D.2.a
Pulmonary vascular disease (pediatric): Any of: ESC/ERS high risk or REVEAL >10 on appropriate therapy; 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 improvement
See policy I.D.2.b
Interstitial lung disease (pediatric): Any of: absolute decline in FVC >10% in past six months; absolute decline in DLCO >10% in past six months; absolute decline in FVC >5% with radiographic progression; desaturation to <88% on 6MWT or >50 m decline in 6MWT; pulmonary hypertension on right heart cath or echocardiography; hospitalization for respiratory decline, pneumothorax, or acute exacerbation
See policy I.D.2.c and I.D.2.c.i–vi
Additional pediatric indications: Alveolar capillary dysplasia; pulmonary vein stenosis refractory to intervention; pulmonary veno-occlusive disease; other pediatric-specific conditions with analogous severity criteria
See policy I.D.2.g–j

Step Therapy

Maximal medical/surgical therapy must be documented prior to transplant

Provide documentation that the member has undergone and failed maximal medical and surgical therapy — including pulmonary rehabilitation when applicable — and that disease‑specific optimized treatments were attempted prior to transplant consideration.

For CF, document trial of elexacaftor/tezacaftor/ivacaftor if eligible and response
Include hospitalizations, exacerbation history, and objective decline metrics that demonstrate failure of therapy

Note

Provide any additional Health Plan‑specified documentation upon request

Provide any additional payer-requested items as part of the authorization or evaluation package as specified by the Health Plan; follow plan communications for required supplemental forms or checklists.

Respond to requests for additional clinical information in a timely manner
Follow any Health Plan‑specific submission format or required supplemental documentation

Documentation Required

Required procedure, diagnostic, and supporting clinical documentation

Submit procedure and diagnostic documentation consistent with the referenced CPT and HCPCS codes and include supporting clinical evidence that the member meets all medical necessity criteria (e.g., PFTs, 6MWT, right heart cath, imaging, nutrition and substance use documentation).

Include exact CPT/HCPCS codes (e.g., 32851–32854, 32855–32856, S2060, S2152) on authorization and claim submissions
Attach pertinent objective test results and clinical notes demonstrating criteria are met

Documentation Required

Follow Health Plan administrative policies and applicable NCD/LCD/Medicare guidance

Comply with Health Plan administrative policies and review applicable National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Medicare coverage guidance when treating Medicare members.

Verify any Medicare or state Medicaid requirements that may affect coverage decisions
Follow Health Plan-level administrative procedures and submission requirements

Denial Risk

Denial risk if ALL medical necessity criteria are not met

Requests will be denied if the member does not meet ALL medical necessity criteria, including the survival risk thresholds (>50% risk of death within 2 years and >80% likelihood of five‑year survival) or if any listed absolute contraindication is present.

Denial may occur for presence of any absolute contraindication (e.g., malignancy at high recurrence risk, GFR < 40 mL/min/1.73m2, active disseminated infection, recent MI/stroke within 30 days, uncontrolled substance use)
Ensure all criteria and required objective data are included to avoid denial

Note

Coverage determinations subject to plan terms, exclusions, and state/federal rules

Coverage decisions are subject to the terms, conditions, exclusions and limitations of the member's coverage documents and applicable state/federal requirements; plan documents govern benefit administration.

State Medicaid provisions take precedence where applicable
This policy is a guide to medical necessity and does not guarantee payment

FEV1 < 30% predicted (with other listed qualifying conditions)

Additional CF severity criteriaFEV1 < 40% predicted with physiologic or clinical complications (e.g., 6MWD <400 m, PaCO2 >50 mmHg, hypoxemia, pulmonary hypertension)

inv-09: GFR — glomerular filtration rate absolute contraindication threshold

GFR absolute contraindication thresholdGlomerular filtration rate < 40 mL/min/1.73m2 is an absolute contraindication unless being considered for multi-organ transplant

Multi-organ transplant exceptionGFR < 40 mL/min/1.73m2 may be acceptable when consideration is for multi-organ transplant

Operational change noteGFR threshold was revised (documented change in policy history) — see coding/revision notes

inv-20: Absolute contraindication (example) — examples of conditions that preclude transplant eligibility

Malignancy with high recurrence riskActive malignancy with high risk of recurrence or death related to cancer is an absolute contraindication

Recent major cardiovascular or neurologic eventStroke, acute coronary syndrome, or myocardial infarction within 30 days is an absolute contraindication

Active disseminated or extrapulmonary infectionActive extrapulmonary or disseminated infection, septic shock, or active tuberculosis precludes eligibility

Uncontrolled substance use or inadequate abstinenceActive substance use or dependence (including current tobacco use) without convincing evidence of risk reduction or <6 months abstinence is a contraindication