Centene Lung Transplant Coverage Update

Coverage Criteria — Lung Transplantation

Initial transplant eligibility

Covered when ALL of the following are met for non-Medicare Centene plans:

Core eligibility preconditions

Absolute contraindications absent: Does not have any absolute contraindications (listed separately).N/A
See absolute contraindications node

Disease-specific criteria: Member meets at least one disease-specific indication and its associated objective thresholds (examples include interstitial lung disease with specified declines in FVC/DLCO or 6MWT desaturation, cystic fibrosis with FEV1 thresholds or combinations of physiologic impairments, COPD with BODE 7-10 or FEV1 <20%, pulmonary vascular disease meeting ESC/ERS high risk or REVEAL >10 on therapy, LAM with progression despite mTOR therapy, primary graft failure, ARDS with irreversible destruction and ongoing ECLS/ventilatory support).See disease nodes

Multiple disease-specific branches provided in policy

Absolute contraindications

Absolute contraindications (must NOT be present):

Absolute contraindications list: Any of: malignancy with high risk of recurrence or death related to cancer; glomerular filtration rate <30 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 being considered for multi-organ transplant; stroke, acute coronary syndrome, or myocardial infarction within 30 days; septic shock; active extrapulmonary or disseminated infection; active tuberculosis; HIV infection with detectable viral load unless CD4 >200 cells/mm3, absence of active AIDS-defining opportunistic infection or malignancy, and current effective antiretroviral therapy; progressive cognitive impairment; inability to adhere to the required post-transplant 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 smoking, or IV drug use.N/A

Presence of any listed item is an absolute contraindication

This policy applies to non-Medicare health plans affiliated with Centene Corporation and defines medical necessity criteria for lung transplantation for members with chronic, end-stage lung disease who have failed maximal medical or surgical therapy (including pulmonary rehabilitation when applicable). For Medicare-specific clinical criteria, reference policy MC.CP.MP.57.

Lung transplantation is not medically necessary when the candidate fails to meet the core eligibility preconditions (including evidence of failed maximal medical/surgical therapy and required prognostic thresholds), has any listed absolute contraindication, or has not completed required evaluation and documentation demonstrating objective physiologic measures and disease-specific thresholds.

Disease-Specific Candidate Criteria

Disease-specific candidate criteria

Candidate selection criteria by disease category (one or more must be met per policy):

Interstitial lung disease (adult): Any of: absolute decline in FVC >10% in the past 6 months despite treatment; absolute decline in DLCO >10% in the past 6 months despite treatment; absolute decline in FVC >5% with radiographic progression in the past 6 months despite treatment; desaturation to <88% on six-minute walk test or >50 m decline in 6MWT distance in the past 6 months; pulmonary hypertension on right heart catheterization or echocardiography (in the absence of diastolic dysfunction); hospitalization for respiratory decline, pneumothorax, or acute exacerbation.see text

Adults and pediatrics have similar ILD thresholds

Cystic fibrosis / bronchiectasis (adult): Any of: FEV1 <30% predicted despite optimal management including trial of elexacaftor/tezacaftor/ivacaftor if eligible; or both of the following: (1) any of: FEV1 <30% predicted; FEV1 <40% predicted plus one or more of: 6MWD <400 m; PaCO2 >50 mmHg; hypoxemia at rest or with exertion; pulmonary hypertension (PA systolic >50 mmHg on echocardiogram or RV dysfunction); worsening nutrition despite supplementation; ≥2 exacerbations/year requiring IV antibiotics; massive hemoptysis (>240 mL) requiring bronchial artery embolization; pneumothorax; any exacerbation requiring positive pressure ventilation; (2) rapid decline in lung function or progressive symptoms, frequent hospitalization, mechanical ventilation, chronic respiratory failure, or WHO functional class IV.

Contraindications

Absolute contraindications that must not be present include: malignancy with high risk of recurrence or cancer-related death; glomerular filtration rate < 30 mL/min/1.73 m2 unless the candidate is being considered for multi-organ transplant; acute renal failure with rising creatinine or ongoing dialysis and low likelihood of recovery; acute liver failure or cirrhosis with portal hypertension or synthetic dysfunction unless multi-organ transplant is planned; stroke, acute coronary syndrome, or myocardial infarction within the prior 30 days; septic shock; active extrapulmonary or disseminated infection, including active tuberculosis; uncontrolled HIV infection unless all of the following are met: CD4 > 200 cells/mm3, absence of active AIDS-defining opportunistic infection or malignancy, and current effective antiretroviral therapy; progressive cognitive impairment; inability to adhere to the post-transplant regimen even with caregiver support; other severe uncontrolled medical conditions expected to limit survival after transplant; and active substance use or dependence (including current tobacco use, vaping, marijuana smoking, or IV drug use).

Pre-Approval Evaluation Requirements

Prior Authorization

Prior Authorization and Documentation Requirements

Prior authorization is required and governed by the member's plan rules; providers must obtain approval before scheduling transplant-related services. Documentation submitted for pre-approval must include objective physiologic measures and testing (e.g., pulmonary function tests, right heart catheterization results, six-minute walk distance, arterial blood gas measurements) and evidence of maximal medical and, where applicable, surgical therapy including pulmonary rehabilitation. Failure to provide necessary documentation may delay or result in denial of the request.

Prior authorization governed by plan rules
Include objective physiologic measures and testing (PFTs, RHC, 6MWD, ABG)
Document trials of maximal medical/surgical therapy and rehabilitation

Denial Risk

Absolute Contraindications — Denial Risk

Requests must demonstrate the member does not have any absolute contraindications. Presence of any absolute contraindication (for example: active high-risk malignancy, uncontrolled extrapulmonary or disseminated infection, active tuberculosis, acute liver failure with portal hypertension or synthetic dysfunction unless considered for multi-organ transplant, acute renal failure with low likelihood of recovery, recent stroke/acute coronary syndrome/MI within 30 days, septic shock, HIV with detectable viral load without required immune criteria met) places the request at high risk for denial. If an absolute contraindication exists, include documentation supporting evaluation of risk or rationale for multi-organ transplant consideration when applicable.

Provider Actions and Administrative Requirements

Prior Authorization

Prior authorization required for listed transplant procedure codes

Prior authorization is required for lung transplant procedures and related donor/preparation CPT/HCPCS codes listed in the policy; providers must submit supporting clinical criteria and documentation with requests.

CPT codes: 32850, 32851, 32852, 32853, 32854, 32855, 32856
HCPCS: S2060, S2152

Note

Prior authorization subject to plan administrative rules

This clinical policy is a guide to medical necessity; prior authorization requirements themselves are governed by the Health Plan's administrative policies and the member's coverage documents, not by this policy alone.

Follow the Health Plan's prior authorization and coverage documents for administrative requirements

Coding and Billing

Referenced Procedure CodesCPT | HCPCS

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.
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; procurement, transplantation, and related complications; global definition including drugs, supplies, hospitalization, and follow-up.

inv-06: 6-Minute Walk Test, desaturation

Desaturation thresholdSix-minute walk test desaturation to <88%

Significant decline over timeDecrease in 6MWT distance >50 meters over 6 months as an alternative objective criterion

Operational notePre-approval evaluation must document 6MWT distance and oxygen saturation; desaturation or documented >50 m decline over 6 months supports disease severity criteria

inv-07: FEV1 thresholds (CF adults/pediatrics)

Adult cystic fibrosis FEV1 threshold (revised)FEV1 <30% predicted (policy change from prior <25% threshold)

Adult alternate CF criteriaFEV1 <40% predicted plus additional impairments (e.g., 6MWD <400 m, PaCO2 >50 mmHg, hypoxemia, PA systolic >50 mmHg, RV dysfunction)

Transplant Center Requirements

Note

Follow ISHLT guidance and transplant center/coding standards

Transplant evaluation and center practices should follow ISHLT guidance; providers should also adhere to transplant center standards and professional coding guidance when preparing evaluations and claims.

Follow ISHLT 2021 consensus recommendations for candidate selection
Reference current professional coding guidance when billing transplant services

Note

References OPTN/ISHLT; confirm center certification and volume requirements

The policy references OPTN policies and ISHLT candidate selection guidance as sources informing center requirements; specific center certification, volume, or FACT accreditation requirements are not specified in this section and should be confirmed with the transplant center and relevant regulatory bodies.

Policy cites OPTN and ISHLT guidance but does not list exact certification/volume/FACT standards here
Confirm center-specific certification and volume requirements directly with the transplant center or regulatory authority

Post-Transplant Coverage Considerations

inv-28: Transplant procurement, hospitalization, follow-up, and related services (HCPCS S2152)

HCPCS S2152 definitionS2152: Solid organ(s), complete or segmental, single organ or combination of organs; procurement, transplantation, and related complications; including drugs, supplies, hospitalization with outpatient follow-up, and related services (global definition).

Scope of servicesGlobal transplant episode may include procurement, hospitalization, follow-up care, medical/surgical, diagnostic, emergency, and rehabilitative services per S2152 description

Coding guidance noteProviders should reference S2152 for comprehensive billing of transplant procurement, transplantation, and related complications as described in the policy coding section

Background

Lung transplantation is performed to treat end-stage lung disease when other medical or surgical therapies have failed. Common adult indications include chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis and other interstitial lung diseases, cystic fibrosis, pulmonary arterial hypertension, and sarcoidosis; pediatric indications include disorders such as pulmonary vascular disease, bronchiolitis obliterans, bronchopulmonary dysplasia, graft failure due to viral pneumonitis, and cystic fibrosis. Transplant selection uses objective physiologic measures and disease-specific thresholds (for example, declines in FVC or DLCO, desaturation on six-minute walk testing, FEV1 thresholds in cystic fibrosis, and high BODE or REVEAL risk scores) to identify candidates for whom transplant is medically necessary.

Definitions and Reference Thresholds

inv-19: maximal medical (including pulmonary rehabilitation)

DefinitionMaximal medical therapy: failure of appropriate medical (and when applicable, surgical) therapies, including pulmonary rehabilitation when indicated, prior to considering transplantation

Documentation expectationClinical records must show trial and inadequate response to guideline-directed medical therapies and pulmonary rehabilitation as applicable

Role in authorizationEvidence of failed maximal medical therapy is required for medical necessity determination and prior authorization review

inv-20: Desaturation to <88% on six-minute walk test

Threshold definitionDesaturation defined as measured oxygen saturation <88% during six-minute walk test

Associated documentation