Lung and Lobar Lung Transplant
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Policy governing medical necessity and prior approval for lung and lobar (including living-donor lobar) transplant and retransplant for individuals with end-stage pulmonary disease; applies to members under Blue Cross Blue Shield - Iowa/Wellmark.
No material clinical or coverage changes in this revision.
Coverage Criteria for Lung and Lobar Transplant
inv-01: Initial Transplant — Covered when ALL of the following are met
Covered when ALL of the following are met
See list of qualifying diseases and prior-therapy requirements; prior authorization is required.
inv-02: Retransplantation — Covered when ALL of the following are met
Covered when ALL of the following are met
Applies to prior lung or lobar transplant recipients who satisfy initial transplant criteria and require documentation of indication for retransplant.
inv-03: Initial transplant candidate coverage criteria — Covered when ALL of the following are met
Covered when ALL of the following are met
Candidates must have exhausted alternative therapies prior to transplant listing; see clinical guidance.
Testing per US Public Health Service and OPTN recommendations; centers should consider species-specific infection risk.
inv-04: Initial and retransplant candidate coverage criteria — Covered when ALL of the following are met (candidate selection/context)
Covered when ALL of the following are met (candidate selection/context):
Per ISHLT: consider >50% 2-year mortality without transplant and >80% likelihood of 5-year post-transplant survival from a general medical perspective.
Registry and case series show retransplantation can yield favorable outcomes in appropriately selected patients; selection should consider higher perioperative risks.
Documentation of attempts at guideline-directed medical therapy and optimization should be provided prior to listing.
inv-05: Initial Transplant Coverage Criteria — Covered when ALL of the following are met per ISHLT and specialty guidance
Covered when ALL of the following are met per ISHLT and specialty guidance:
Includes disease-specific and pediatric considerations per specialty society guidance.
inv-06: Retransplant Coverage Criteria — Retransplantation covered when ALL of the following are met and after careful evaluation
Retransplantation covered when ALL of the following are met and after careful evaluation:
Outcomes after retransplant are generally inferior to first transplants, particularly if retransplant within 1 year or for restrictive allograft syndrome; increased scrutiny recommended.
inv-07: Disease-specific guidance — Disease-specific guidance informing coverage decisions
Disease-specific guidance informing coverage decisions:
2011/2015/2022 ATS guidance: no clear long-term preference single vs bilateral in 2015 update.
See retransplantation criteria for required evaluation of graft failure causes.
Very low certainty evidence; guidance conditionally recommends transplantation in selected pediatric patients.
Lung and lobar lung (living or deceased) transplant and retransplant are considered investigational when the specific coverage criteria in this policy are not met. This investigational designation applies to all other indications not explicitly listed as medically necessary because available evidence is insufficient to demonstrate a net improvement in health outcomes.
Infection with certain Burkholderia species has been associated with increased posttransplant mortality and should be considered in risk assessment. Published studies report higher mortality for recipients infected or colonized with species such as Burkholderia cenocepacia (notably epidemic strains) and Burkholderia gladioli
Outcomes after lobar lung transplantation are less well characterized than for whole-lung transplants. Systematic reviews and single-center series show heterogeneity in reported outcomes, with 1-year survival in individual studies ranging from 50%–100% and pooled analyses indicating a higher risk of 1-year mortality after lobar versus whole-lung transplant. Some retrospective comparisons report inferior early postoperative outcomes for lobar recipients, although longer-term survival among those discharged may approach that of whole-lung recipients.
Retransplantation is associated with worse outcomes than primary transplantation in registry and guideline data and should be considered only after careful evaluation. Registry reports show lower 1- and 5-year survival after repeat transplant compared with primary transplant, and guideline statements note that outcomes are particularly inferior when retransplantation occurs within the first year after the original transplant or for patients with restrictive allograft syndrome. Failure to document and, where possible, address causes of prior graft failure (for example, alloimmunization, nonadherence, reflux, or recurrent infections) may be grounds for exclusion or denial.
Lobar transplantation performed to address donor–recipient size mismatch has been linked to higher early postoperative morbidity and mortality compared with conventional whole-lung transplantation. While some series report acceptable longer-term survival for patients who survive the initial postoperative period, the limited and heterogeneous data support cautious selection of candidates for lobar procedures and consideration of alternative strategies when feasible.
Coding and Allocation Scores
| No codes listed |
| 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. |
Provider Actions, Prior Authorization, and Documentation
Prior Authorization Required
Prior approval is required for lung or lobar (living or deceased) lung transplantation. Benefit determinations depend on the member's contract language and eligibility; providers must obtain prior authorization before scheduling transplant-related services.
- Prior approval required for transplant procedures
- Benefit determinations based on contract language; verify member benefits
Regulatory Documentation
Solid organ transplantation is a surgical procedure not regulated by the FDA; however, the FDA does regulate human cells and tissues intended for implantation, transplantation, or infusion under 21 CFR parts 1270 and 1271. Providers should ensure compliance with applicable HCT/P regulations and submit any required regulatory documentation with prior authorization requests.
- Solid organ transplants themselves are not FDA-regulated
- Human cells and tissues (HCT/P) used with transplants are regulated under 21 CFR parts 1270 and 1271
- Include applicable regulatory documentation with prior authorization submissions
Infection-Related Risk Considerations
Document infection history and any organism colonization that may increase posttransplant mortality risk. Certain infections (for example, Burkholderia cenocepacia and some other Burkholderia species) have been associated with higher posttransplant mortality and should be disclosed and considered during candidate evaluation.
- Report pretransplant infectious disease testing per US Public Health Service guidance (HIV, HBV, HCV) and local transplant center requirements
- Document presence and species of Burkholderia or other high-risk colonizing organisms
Registry Survival Differences
Registry data indicate survival after repeat (retransplant) procedures is inferior to primary transplants, with higher early postoperative mortality and lower 1- and 5-year survival rates. These differences should be documented and considered when evaluating retransplant candidates.
- 1-year survival: primary transplant ~87.2% vs repeat transplant ~76%
- 5-year survival: primary transplant ~53.4% vs repeat transplant ~32.9%
- Retransplant outcomes are poorer if performed within the first year after the original transplant or for patients with restrictive allograft physiology
Required Clinical Documentation
Prior authorization requests must include complete clinical documentation demonstrating the candidate meets selection criteria and has undergone guideline-directed pre-listing optimization. Documentation should address expected outcomes, prior therapies tried, infectious disease testing, and transplant-specific contraindications.
- Clinical rationale for transplant and expected posttransplant outcomes
- Evidence of maximal medical therapy and any prior surgical interventions
- Results of pretransplant infectious disease testing (HIV, HBV, HCV) per US Public Health Service guidance
- Documentation of absence of contraindications (e.g., active malignancy, untreated systemic infection, uncontrolled psychosocial issues)
- For retransplant candidates, documentation addressing reasons for prior graft failure (alloimmunization, adherence, reflux, repeated infections)
Pre-Listing Therapy Optimization
Candidates must have received maximal medical therapy and optimization before listing, including guideline-directed pharmacologic therapy, oxygen supplementation when indicated, and consideration of relevant surgical options (for example, lung volume reduction surgery in COPD). Prior authorization should confirm these optimization efforts.
- Document trials of maximal medical therapy and oxygen use
- Document consideration of and/or attempts at relevant surgical therapies (e.g., lung volume reduction surgery for COPD)
- Confirm referral to and evaluation by a transplant center
Conservative Therapy Prior to Approval
Before approval, demonstrate exhaustion of conservative therapies including maximal medical management, oxygen supplementation when indicated, and evaluation of alternative surgical procedures. Prior authorization reviewers will expect documentation that less invasive options were considered or attempted.
- Evidence of maximal medical therapy and adherence
- Documentation that alternative surgical options were considered or attempted
- Statement that the patient's condition is irreversible and progressively disabling despite conservative measures
Transplant Prior Authorization and Coding
Prior authorization submissions for transplant procedures involving CPT codes 32851–32854 and HCPCS codes S2060–S2061 must include supporting documentation described above. Providers should submit complete medical records, testing results, and transplant center evaluations to facilitate timely review.
Candidate Criteria and Indications
inv-44: Indications — Qualifying underlying diagnoses and prior therapy
Candidates must have irreversible, progressively disabling disease despite maximal therapy.
Documentation of maximal therapy is expected prior to listing and prior authorization.
inv-45: HIV-specific candidate criteria — HIV-positive candidates eligibility parameters
HIV-positive candidates may be eligible if meeting virologic and immunologic control parameters (guidance extrapolated from OPTN and British guidelines):
Based on British HIV Association/British Transplantation Society criteria and US Public Health Service testing guidance.
inv-46: Selection thresholds — Candidate selection notes for initial transplant and retransplant
Candidate selection notes for initial transplant and retransplant:
ISHLT 2021 selection threshold.
ISHLT 2021 selection threshold.
inv-47: Candidate selection — Candidate selection references and thresholds used to determine eligibility
Candidate selection references and thresholds used to determine eligibility:
Also consider disease-specific, pediatric, and center-specific factors when applying thresholds.
Contraindications to Lung or Lobar Transplant
Contraindications that commonly impact approval decisions include known current malignancy or recent malignancy with high risk of recurrence; untreated systemic infection or chronic infection that would make postoperative immunosuppression unsafe; and other irreversible, end-stage diseases not attributable to heart or lung disease. Significant psychosocial issues or active substance use disorders that impair adherence, colonization with highly resistant or highly virulent organisms, and severe coronary artery disease not amenable to revascularization are also recognized concerns that may preclude transplantation.
The transplant center’s clinical judgment is central in applying contraindications. The policy aligns with standard practice that listed contraindications are subject to center-level evaluation and may vary based on individual circumstances and center experience.
Known active, untreated systemic infections are considered contraindications because the required immunosuppression after transplant would substantially increase the risk of uncontrolled infection and poor outcomes.
Significant irreversible comorbid conditions that are not expected to improve with transplant (for example, advanced nonpulmonary end-stage organ failure) may be contraindications to lung transplant when they substantially limit expected benefit.
Psychosocial factors, including inadequate social support or active chemical dependency that compromises the candidate’s ability to adhere to complex posttransplant regimens, are potential contraindications and should be documented and addressed in the evaluation.
Colonization with highly resistant or highly virulent organisms (bacterial, fungal, or mycobacterial) can contraindicate transplantation because postoperative immunosuppression increases the risk of severe infection.
Coronary artery disease that is not amenable to revascularization or severe left ventricular dysfunction may preclude isolated lung transplantation and prompt consideration of combined heart–lung transplantation where appropriate.
Infection with certain Burkholderia species (notably epidemic strains of Burkholderia cenocepacia and Burkholderia gladioli) may be treated as a contraindication or reason for centers to deny or assign a higher-risk designation, based on evidence linking these infections to increased posttransplant mortality.
Registry data indicate that retransplantation carries higher perioperative mortality and lower long-term survival compared with primary transplantation. These findings support careful patient selection and documentation of the expected benefit prior to approval.
Relative contraindications to retransplantation include ongoing, unmodifiable causes of prior graft failure—such as persistent nonadherence, uncontrolled infection, or other recurrent behaviors—that would predict poor outcomes after another transplant. Guidelines emphasize documenting and attempting to remediate modifiable contributors to graft failure before considering retransplantation.
Evaluation and Documentation Requirements
Require exhaustion of maximal medical/surgical therapies
Candidates must have exhausted maximal medical and surgical therapies (including oxygen supplementation and lung volume reduction surgery when indicated) before transplant consideration.
Verify maximal therapy attempted before listing
Candidates should have exhausted maximal medical and surgical therapies (including oxygen supplementation and surgical options such as lung volume reduction) prior to transplant consideration.
Confirm documentation of maximal medical/surgical therapy
Ensure documentation shows candidates received maximal medical and surgical therapies (eg, oxygen supplementation, lung volume reduction) before transplant evaluation.
Require infectious disease testing and verification of maximal therapy
Pretransplant evaluation must include infectious disease testing (HIV, HBV, HCV) per US Public Health Service guidance and verification that maximal medical therapy and surgical options have been considered.
Use methodologically credible evidence in evaluation documentation
Evaluation should follow methodologically credible assessments and include available comparative or observational evidence where relevant; studies with duplicative populations were excluded in evidence review.
Document disease severity, prognosis, and retransplant considerations
Pre‑transplant evaluation must document disease severity, prognosis without transplant, expected post‑transplant survival, and for retransplant cases, detailed reasons for prior graft failure and attempts to remediate modifiable risks.
Transplant Center and Reporting Requirements
Follow UNOS/OPTN guidelines and center judgment
Individuals should meet UNOS/OPTN guidelines for listing and transplant center clinical judgment applies; centers must comply with CMS/OPTN program requirements and applicable allocation policies.
Ensure center compliance with HCT/P regulations
Transplant centers must comply with applicable HCT/P regulations for solid organs (21 CFR parts 1270 and 1271); centers and providers should document compliance.
Consider center experience and registry outcomes
Transplant center experience and reported outcomes are center‑ and registry‑specific; providers and payers should consider center experience and reported outcomes when selecting patients and making approval decisions.
Adhere to UNOS/OPTN allocation and listing policies
UNOS/OPTN listing and allocation policies apply; transplant center judgment remains central for listed contraindications and candidate selection.
Comply with CMS certification and OPTN allocation policies
Centers must follow applicable CMS transplant certification and OPTN allocation policies referenced in the policy when participating in transplant programs and reporting outcomes.
Post-Transplant Management, Surveillance, and Coding
Background and Epidemiology
Lung transplantation (single, bilateral, or lobar) is a treatment option for individuals with end-stage pulmonary disease that can improve survival and quality of life in carefully selected patients. Recipients require lifelong immunosuppression and are at increased risk for complications such as rejection, infection, and posttransplant malignancy. Candidates are prioritized using the Lung Allocation Score, and evidence supporting transplantation includes registry data and case series demonstrating survival benefit in appropriately selected populations.
Definitions and Key Terms
Policy Revision History
Policy effective date recorded in brief metadata.
ISHLT published updated consensus-based guidelines on selection of lung transplant candidates, informing candidate selection thresholds and retransplant considerations.
Document references international registry data (>50,000 individuals) and U.S. lung transplant volumes, informing evidence on survival and long-term follow-up needs.
Most recent policy action recorded: policy renewed Oct 2025.
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