Heart-Lung Transplant
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Medical coverage policy for combined heart and lung transplantation and retransplantation for individuals with end-stage cardiac and pulmonary disease; applies to Blue Cross Blue Shield - Iowa members and providers requesting prior approval.
No material clinical or coverage changes in this revision.
Coverage Criteria for Heart-Lung Transplant
inv-01: Initial Transplant — Covered when ALL of the following are met
Covered when ALL of the following are met
Prior approval required
inv-02: Retransplantation — Covered when ALL of the following are met
Covered when ALL of the following are met
Prior approval required
inv-03: Investigational Indications — 1 top-level node
Evidence insufficient for other indications
inv-04: Initial combined heart/lung transplant — Covered when ALL of the following are met
Covered when ALL of the following are met
Documented candidacy per transplant evaluation
Consideration of less-extensive surgical alternatives should be documented
Follow-up and monitoring plan required
inv-05: Combined heart/lung retransplant — Covered when ALL of the following are met
Covered when ALL of the following are met
Prior approval required; center-level assessment
Rationale documented
Long-term outcomes monitoring recommended
inv-06: Initial transplant candidacy criteria — Covered when ALL of the following are met
Covered when ALL of the following are met
ISHLT guidance; primary indications often pulmonary hypertension or congenital heart disease
Decision individualized; ISHLT advises against arbitrary waiting periods
inv-07: Contraindications and special infection/immunodeficiency considerations — Exclude or consider carefully when ANY of the following contraindications exist
Exclude or consider carefully when ANY of the following contraindications exist
Individual transplant center judgment applies
OPTN/ISHLT–aligned considerations; individual assessment required
inv-08: Retransplantation — Retransplantation considerations
Retransplantation considerations
Low procedural volumes limit evidence; individual center-level considerations required
Heart-lung transplantation is considered investigational for any indication that does not meet the policy's listed medical necessity criteria. The evidence is judged insufficient to demonstrate a net health outcome benefit for other indications.
Pretransplant bridging with extracorporeal membrane oxygenation (ECMO) or mechanical ventilation is associated with substantially worse survival after combined heart/lung transplantation. Published series report markedly lower short- and long-term survival for patients bridged with ECMO or ventilator support, and these findings raise concern about proceeding with transplant in these high-risk candidates.
Transplantation should not be performed in patients who are not expected to survive the procedure or in whom significant comorbid conditions mean that patient-oriented outcomes (mortality, morbidity, functional status) will not improve with transplantation (for example, imminently terminal cancer). Consideration is also required where necessary immunosuppression would hasten demise (eg, active untreated infection).
The policy references evaluation and literature regarding candidates with prior malignancy and HIV but does not list explicit exclusions in the cited excerpts. Assessment of prior cancer should document tumor type, stage, response to therapy, disease-free interval, and a negative metastatic workup to characterize recurrence risk. HIV infection may be considered when patients are adherent to antiretroviral therapy and meet virologic and immunologic criteria described in the literature.
Procedures are contraindicated and considered unsafe for individuals with active, untreated systemic infection or other contraindications listed in the policy (for example, known current malignancy or recent malignancy with high recurrence risk). These conditions make the required immunosuppression unsafe and may preclude transplantation.
Transplantation is considered not medically necessary when expected patient-oriented outcomes will not improve because of comorbid conditions (for example, imminently terminal cancer) or when active untreated infection would render immunosuppression unsafe.
No additional explicit 'not medically necessary' conditions are stated in the provided excerpts beyond those already identified as contraindications or circumstances where transplantation would not alter expected outcomes.
Candidate Selection and Prioritization
inv-41: Prioritization of Candidates — Candidate prioritization and severity considerations
Candidate prioritization and severity considerations
OPTN/UNOS criteria and appeal processes apply
inv-42: Candidate selection — focus on individuals with end-stage disease affecting both heart and lungs and insufficient alternatives
Candidate selection should focus on individuals with end-stage disease affecting both heart and lungs and for whom alternatives are insufficient.
Documentation of insufficient alternatives required
inv-43: Society-based candidacy — Candidate selection per society guidance
Candidate selection per society guidance
Primary indication often pulmonary hypertension or congenital heart disease
Medical Contraindications
Known current malignancy, recent malignancy with high recurrence risk, untreated systemic infection, and other irreversible end-stage diseases not attributable to heart or lung disease are listed as potential contraindications that may preclude transplant candidacy.
High-risk pretransplant factors linked to poorer posttransplant survival include pretransplant ECMO support and mechanical ventilation; certain pediatric age groups (infants and ages 1–11) also have higher posttransplant mortality in published series.
Known current malignancy or recent malignancy with a high risk of recurrence is considered a contraindication unless evaluation demonstrates an acceptably low recurrence risk; untreated systemic infection and other irreversible end-stage diseases unrelated to heart or lung disease are additional contraindications.
Candidates with active, untreated systemic infections are excluded from transplantation because immunosuppression would be unsafe; stable chronic infections require individualized assessment by the transplant center.
Other irreversible end-stage diseases not due to heart or lung disease, and systemic diseases that could be worsened by immunosuppression, are listed as contraindications that may preclude transplantation.
Psychosocial conditions or chemical dependency that impair adherence to therapy are recognized as potential contraindications and may lead to denial of transplant candidacy.
Pretransplant Evaluation Requirements
Prior Authorization Required
Prior approval is required for all initial and repeat (retransplant) solid-organ transplants. Providers must obtain authorization before scheduling the transplant procedure.
- Prior approval required for initial transplant and retransplant
- Benefit and coding verification prior to submission
Indication, Alternatives, and Transplant Selection
Document and confirm the indication for transplant, including severity and progression of disease, prior therapies tried, and why transplant is appropriate. For some indications, preference should be given to the least extensive transplant that will address the condition (for example, single- vs bilateral-lung transplant when clinically appropriate). Consider and document alternatives — particularly prior to combined-organ transplant procedures — and explain why alternatives are insufficient.
- Confirmation of indication
- Preference for less extensive transplant in some indications
- Consider alternatives prior to combined transplant
Comprehensive Pretransplant Evaluation
Comprehensive evaluation is required to determine end-stage cardiac and/or pulmonary disease and suitability for transplantation. Evaluation should include documentation of disease severity (use of NYHA functional class where applicable), assessment of comorbidities, psychosocial evaluation, cancer screening and documentation of cancer-free intervals where relevant, infectious disease evaluation, and planned follow-up for outcomes. Listing and candidacy requirements must be documented in the medical record prior to listing.
- Listing and candidacy requirements must be documented prior to listing
- Cancer evaluation documentation (history of malignancy, staging, disease-free interval)
- Postoperative monitoring documentation and planned follow-up for outcomes
High-risk Bridging Support
Patients on high-risk bridging therapies (e.g., extracorporeal membrane oxygenation [ECMO] or invasive mechanical ventilation) require explicit documentation of indication for bridging, duration, and candidacy for transplant while on support. Providers should note that these high-risk statuses may affect eligibility and outcome expectations.
- High-risk bridging (ECMO/ventilation) must be documented
- Impact of bridging on candidacy should be addressed
Contraindications, Coding, and Benefit Verification
Contraindications identified during evaluation (active, uncontrolled infection; active substance abuse; uncontrolled psychiatric illness; recent or active malignancy without appropriate disease-free interval; severe irreversible non‑transplantable comorbidities) may lead to denial of coverage. Coding errors or missing required documentation (e.g., lack of prior authorization, incomplete cancer or outcomes documentation, improper codes for transplant vs related procedures) can result in claim denial. Verify member benefits, prior authorization, and applicable procedure and diagnosis coding before submission.
- Contraindications may cause denial
- Coding-related denial risk
- Benefit and coding verification
Provider Actions, Prior Authorization, and Billing
Obtain prior authorization for initial and repeat transplant
Obtain prior approval before initial or repeat combined heart-lung transplantation; initial heart-lung transplantation is considered medically necessary only for carefully selected individuals who meet the listed criteria.
- Prior approval required for both initial transplant and retransplant
Confirm indication and alternatives during prior authorization
Ensure prior authorization confirms the patient has end-stage cardiac and pulmonary disease and that combined heart/lung transplantation is being considered instead of alternatives such as medical management or isolated lung transplantation.
- Documentation should show why combined transplant is indicated over single/double lung transplant or medical therapy
Show listing criteria and additional-organ dysfunction
Demonstrate that the candidate meets lung transplant listing criteria and has significant dysfunction of one or more additional organs (or meets non-pulmonary organ listing criteria with significant pulmonary dysfunction) as part of prior authorization.
- Reference ISHLT criteria showing lung listing thresholds and additional-organ dysfunction
Follow prior authorization process and use CPT 33935
Follow payer prior authorization processes and report the procedure using CPT code 33935; heart-lung transplantation is a surgically intensive inpatient service and policies are reviewed annually.
- Use CPT 33935 for heart-lung transplant reporting
- Follow usual transplant program prior authorization procedures
Document consideration of single/double lung transplant alternatives
Document consideration of less-extensive options—single or double lung transplant with maximal medical therapy for heart failure—when applicable, since these approaches may be favored for many indications.
- If less-extensive transplant is chosen, document rationale comparing expected outcomes
Document consideration of less-extensive surgical alternatives
Prior to approval, document that alternatives such as double-lung transplant, single-lung transplant, or medical management were considered and why combined heart/lung transplant was selected.
- Include comparative rationale and supporting clinical data in the record
Consider all management alternatives before combined transplant
Document consideration of medical management and isolated lung transplant options (single or double) before electing combined heart/lung transplantation.
No specified step therapy requirements
No step therapy sequencing requirements are specified in the policy excerpts; do not assume mandatory prior procedures before requesting authorization.
Verify benefits and coding before submission
Verify member benefits and applicable contract language prior to requesting authorization; consult the Codes table for billing details.
- Confirm member coverage and any exclusions or limitations under the contract
Document postoperative surveillance and long-term follow-up
Document postoperative monitoring plans and long-term follow-up, including surveillance for graft failure, overall survival, graft function, and infections with follow-up extending to 3–5 years or longer.
- Include schedule and measures for monitoring graft function and infections
Provide detailed cancer evaluation documentation
When the candidate has a history of malignancy, document tumor type, stage, response to therapy, time since therapy, a negative metastatic workup, and assessment of recurrence risk to support candidacy.
- Provide evidence of disease-free interval and negative metastatic workup
- Include oncology consultation or records of response to therapy
Use correct billing and place-of-service codes
Use appropriate CPT, HCPCS, Revenue, and ICD diagnosis codes and indicate inpatient place of service when submitting claims for heart-lung transplantation.
- Report CPT 33935 for the heart-lung transplant procedure
- Set Type of Service = Surgery; Place of Service = Inpatient
Known contraindications may trigger denial
Be aware that active current malignancy, recent high-risk malignancy, untreated systemic infection, other irreversible end-stage disease, systemic disease exacerbated by immunosuppression, or psychosocial/substance-use issues affecting adherence are potential contraindications that may result in denial.
- Include documentation addressing any listed contraindications and center judgment for risk assessment
High-risk bridging (ECMO/mechanical ventilation) may affect candidacy
Document pretransplant use of ECMO or mechanical ventilation and recognize these bridging therapies are associated with substantially worse survival and may affect candidacy or lead to denial in high-risk cases.
- Provide objective survival data and justification if patient required ECMO/ventilation pretransplant
Do not list patients unlikely to benefit or survive — risk of denial
Transplantation should not be pursued for patients not expected to survive the procedure or for whom comorbid conditions will prevent meaningful improvement; such scenarios may lead to denial.
- Document assessment of overall prognosis and expected patient-oriented outcome improvement
Use CPT 33935 to prevent coding-related denials
Ensure correct CPT/HCPCS coding on claims; use CPT code 33935 for heart-lung transplant procedures to avoid coding-related denials.
- Incorrect or inappropriate coding may result in claim denial
Coding and Billing
| 33935 | Heart-lung transplant with recipient cardiectomy-pneumonectomy. |
| No code(s) | HCPCS: No code(s) listed |
Definitions and Key Terms
Transplant Center Requirements
Center judgment governs contraindication assessment
Transplant center judgment is used to assess potential contraindications; no specific accreditation or minimum volume requirements are specified in these excerpts.
- Follow individual transplant center guidelines and applicable federal regulations
Comply with CFR Title 21 (parts 1270, 1271) for organs/tissues
Comply with federal regulations for human cells and tissues used in transplantation per Code of Federal Regulations Title 21, parts 1270 and 1271.
- Ensure tissue handling and related processes meet CFR Title 21 requirements
Rely on center judgment for candidate suitability
Apply transplant center judgment to evaluate contraindications and candidate suitability; the policy does not specify center accreditation or volume thresholds.
No specific center accreditation or volume requirements stated
Transplant centers should use their clinical judgment to assess contraindications and candidate fitness; the policy provides no specific accreditation or volume criteria.
Post-Transplant Care and Surveillance
Background
Combined heart/lung transplantation is a surgical option intended to prolong survival and improve function for patients with end-stage cardiac and pulmonary disease. Common primary indications include pulmonary hypertension and congenital heart disease; recipients require lifelong immunosuppression and are prioritized by severity through established allocation systems.
Policy Revision History
Policy reviewed and renewed during the October 2025 annual review.
Policy reviewed and renewed during the October 2024 annual review.
Policy revised following the October 2023 annual review.
Policy revised following the November 2022 annual review.
Policy revised following the November 2021 annual review.
Policy renewed following the November 2020 annual review.
Policy renewed following the November 2019 annual review.
Policy renewed following the November 2018 annual review.
Policy renewed following the November 2017 annual review.
Policy revised following the November 2016 annual review.
Policy renewed following the November 2015 annual review.
Policy revised following the December 2014 annual review.
Policy renewed following the February 2014 annual review.
Policy renewed following the March 2013 annual review.
Policy renewed following the March 2012 annual review.
Policy renewed following the April 2011 annual review.
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