Medical Policy

This document addresses combined heart and lung (heart-lung) transplantation criteria for individuals who have both cardiac (heart) and lung disease. A heart-lung transplant refers to the harvesting of one or both lungs and the heart from a single cadaver donor, which is then implanted into a single recipient in a coordinated surgical procedure.

Note: Please see the following related documents for additional information:

• TRANS.00009 Lung and Lobar Transplantation
• TRANS.00033 Heart Transplantation

Medically Necessary:

Heart-lung transplantation is considered medically necessary when the following clinical indications and the general individual selection criteria listed below are met.

Clinical Indications - Individuals must meet one of the following criteria:

1. Irreversible primary pulmonary hypertension with heart failure; or
2. Secondary pulmonary hypertension and resulting heart failure due to pulmonary fibrosis, cystic fibrosis, chronic obstructive pulmonary disease or emphysema; or
3. Eisenmenger's complex or other types of congenital heart disease with irreversible pulmonary hypertension and heart failure.

Investigational and Not Medically Necessary:

A heart-lung transplantation is considered investigational and not medically necessary when the above criteria are not met.

Note: For multi-organ transplant requests, criteria must be met for each organ requested. In those situations, an individual may present with concurrent medical conditions which would be considered an exclusion or a comorbidity that would preclude a successful outcome, but would be treated with the other organ transplant. Such cases will be reviewed on an individual basis for coverage determination to assess the member’s candidacy for transplantation.

General Individual Selection Criteria

In addition to having one of the clinical indications above, the member must not have a contraindication, as defined by the American Society of Transplantation (AST) in Guidelines for the Referral and Management of Patients Eligible for Solid Organ Transplantation (2001) listed below.

Absolute Contraindications - for Transplant Recipients* include, but are not limited to, the following:

1. Metastatic cancer;
2. Ongoing or recurring infections that are not effectively treated;
3. Serious cardiac or other ongoing insufficiencies that create an inability to tolerate transplant surgery;
4. Serious conditions that are unlikely to be improved by transplantation as life expectancy can be finitely measured;
5. Active, systemic lupus erythematosus or sarcoid with multisystem involvement;
6. Any systemic condition with a high probability of recurrence in the transplanted heart;
7. Demonstrated individual nonadherence, which places the organ at risk by not adhering to medical recommendations;
8. Potential complications from immunosuppressive medications are unacceptable to the individual;
9. Acquired immune deficiency syndrome (AIDS) (diagnosis based on Centers for Disease Control and Prevention [CDC] definition of CD4 count, 200cells/mm³) unless the following are noted:
   1. CD4 count greater than 200 cells/mm³ for greater than 6 months;
   2. HIV-1 RNA undetectable;
   3. On stable anti-retroviral therapy greater than 3 months;
   4. No other complications from AIDS (for example, opportunistic infection, including aspergillus, tuberculosis, coccidioidomycosis, resistant fungal infections, Kaposi’s sarcoma or other neoplasm);
   5. Meeting all other criteria for heart-lung transplantation.

*Steinman, Theodore, et al. Guidelines for the Referral and Management of Patients Eligible for Solid Organ Transplantation. Transplantation. 2001; 71(9):1189-1204.

Summary:

Combined heart-lung transplantation can be considered medically necessary for individuals with end-stage cardiopulmonary disease when isolated heart or lung transplantation alone would not improve survival or function. Evidence shows that, while the number of heart-lung transplants has increased modestly in recent years, outcomes remain less favorable and long-term survival is lower compared to other transplant types. Primary indications include pulmonary hypertension (PH), particularly idiopathic PH or PH related to congenital heart disease, as well as select cases of cystic fibrosis and other complex conditions. Advances in medical therapy and improvements in lung transplantation have reduced the frequency of heart-lung transplants, but it remains an important option for carefully selected candidates. Professional guidance includes recommendations from the American Heart Association (AHA)/American College of Cardiology (ACC) for congenital heart disease, consensus updates from the International Society for Heart and Lung Transplantation (ISHLT)on candidate selection, the American Society of Transplantation (AST) regarding malignancy, and the American Thoracic Society (ATS) guideline addressing pediatric pulmonary hypertension

Background:

For detailed discussions of indications for isolated heart or lung transplantation, see the following documents:

• TRANS.00009 Lung and Lobar Transplantation
• TRANS.00033 Heart Transplantation

Combined Heart-lung transplantation is a standard treatment for select individuals who either a heart transplant or a lung transplant alone would not improve their condition and chances of survival. As of September 2025, United Network of Organ Sharing (UNOS) reported 38 candidates currently on the active waiting list for heart-lung transplant, compared with approximately 3,850 candidates for heart transplant alone and 933 for lung transplant alone, highlighting the rarity of the combined procedure.  

The 2023 U.S. Organ Procurement Transplant Network (OPTN) Data Report states that multiorgan transplants constituted 13.5% of heart transplants in adults, an increase from 6% in 2012. Although the number of heart-lung transplants continued to increase, they were less than 2% of all heart transplants and were 9.6% of all multiorgan transplants in 2023. Only 53 adult heart-lung transplants were performed in the United States in 2023. Survival in heart-lung transplant recipients remained the lowest of all multiorgan categories, at 86.6% at 1 year and 64.2% at 5 years.

In 2018, the AHA/ ACC published guidelines for the management of adults with congenital heart disease (CHD). Typically, CHD is treated with simultaneous heart-lung transplantation for conditions that result in irreversible pulmonary hypertension such as Eisenmenger syndrome (Stout, 2019).

The Pulmonary Transplantation Council of the ISHLT issued a 2021 updated consensus document for the selection of heart-lung transplant candidates (Leard, 2021; reaffirmed 2024). The document  includes the following consensus statements:

Candidates should meet the criteria for lung transplant listing and have significant dysfunction of one or more additional organs, or meet the listing criteria for a non-pulmonary organ transplant and have significant pulmonary dysfunction.

Criteria for heart-lung transplant listing include the presence of New York Heart Association (NYHA) functional class IV symptoms despite maximal medical management, a cardiac index below 2 l/min/m², and a mean right atrial pressure above 15 mmHg; however, the decision about whether to list a patient for heart-lung transplant remains difficult.

Heart-lung and other multi-organ transplantation should be limited to centers with experience in such procedures and where specialists are available to manage each of the transplanted organs.

Evidence from a systematic review (El-Andari, 2025) indicates that combined heart-lung transplantation for the treatment of end-stage heart and lung disease is now performed far less frequently, reflecting advances in disease-specific medical therapies and evolving transplant practices. The review included 29 articles, the authors reported that cases of heart-lung transplant were more common before 2000 for the indications of CF, Eisenmenger’s syndrome, and PAH. While Eisenmenger’s syndrome and some congenital heart conditions remain indications for transplant, the management of CF and PAH have changed significantly. With improved medical therapy, fewer individuals with CF are being referred for transplantation, often later in life, and are now being managed with double lung transplantation. Similarly, PAH therapies have improved in recent years, and in individuals requiring transplantation, lung transplantation has become the preferred intervention instead of heart-lung transplant as was traditionally the case. This is due to the findings that right ventricular function may recover following isolated lung transplantation and that double lung transplantation results in comparable or improved outcomes with PAH. Additionally, double lung transplantation allows for use of the heart for transplantation in another recipient. Outcomes may also be related to improvements in ECMO technology and understanding who should receive ECMO prior to lung transplantation. The most commonly reported contemporary indications continue to be PAH and congenital heart disease. Among individuals with septal defects and Eisenmenger Syndrome, the type of septal defect is associated with differing outcomes depending on the type of transplant. Among 442 adults with Eisenmenger Syndrome who underwent thoracic transplantation, those with atrial septal defects had improved outcomes following double lung transplantation, while individuals with ventricular septal defects had improved outcomes following heart-lung transplant. This has helped guide the use of donor organs and optimal selection of transplantation procedures. Candidate selection for heart-lung transplantation is more stringent than for isolated lung transplantation, including younger recipient and donor age and strict size-matching requirements. While the frequency of heart-lung transplantation has declined in favor of medical therapy or isolated heart or lung transplantation, it remains a valuable treatment for a subset of individuals with end-stage cardiopulmonary disease not amenable to alternative management strategies. As clinical understanding of end-stage heart and lung disease has evolved, the management has been refined and become more targeted. While heart-lung transplantation is used less frequently compared to previous years, indications for heart and lung transplantation continue to be prevalent. Recent evidence demonstrates improving short- and long-term survival outcomes.

Combined heart-lung transplantation is intended to prolong survival and improve function in individuals with end-stage cardiopulmonary or pulmonary disease. The technique involves a coordinated triple operative procedure, consisting of procurement of a single donor heart-lung block, excision of the heart and lungs of the recipient, and implantation of the new donor heart and lungs into the recipient.

The limiting factor for heart-lung transplantation is the short supply of donor organs. The procurement and distribution of heart-lung organs for transplantations in the United States is under the discretion of the SUNOS. A national database of transplant candidates, donors, recipients, and donor-recipient matching and histocompatibility is maintained by UNOS.

In 2021 the American Society of Transplant Surgeons (ASTS) Statement Concerning Eligibility for Solid Organ Transplant Candidacy noted:

The ASTS advocates transplanting as many of these patients, as quickly as possible, while also making the most responsible use of our nation’s organ supply. Limiting a transplanted organ’s life expectancy due to placing it with a patient, or in a situation, in which it cannot be adequately supported can deprive another waitlisted patient of a better outcome with the same organ.

To this end, we feel that any medically eligible patient, with sufficient support in place to allow for their adequate care following surgery, should be supported in their pursuit of transplantation.

When a patient presents to a transplant center for evaluation, the center makes a judgement concerning the patient’s medical fitness to undergo the procedure, and also the patient’s expected ability to capably care for themselves and a new organ.

If the patient has cognitive, physical, or financial limitations that would preclude them from being able to adequately care for themselves, then appropriate social supports or other compensatory mechanisms which would remediate the situation should be identified. If these can be found, then the patient’s candidacy for transplantation should be supported. If, however, they cannot be identified, proceeding with transplantation could threaten both the patient’s health and safety, and the longevity of a donated organ. In such a case, further evaluation should be deferred until the limiting issue can be corrected.

As such it is the recommendation of the ASTS that no patient will be discriminated against or precluded from transplant listing solely due to the presence of a disability or handicap whether physical or psychological. However, if these disabilities lead to a clinical reality where the patient will suffer a great risk of morbidity or mortality from the transplant surgery itself, or the subsequent placement on lifelong immunosuppression, then transplantation would not be recommended. This decision would be made due to the clinical risk benefit analysis for the specific patient, and not on any external factors.

Additionally, the ASTS recommends that transplant candidates with a history of skin cancer, hematological malignancies, and solid organ malignancies are based on tumor grade and stage, see TRANS.00033 for detailed information.

Heart-lung transplantation remains a treatment option for carefully selected individuals with end-stage heart and lung diseases.

End-stage heart failure: In people with heart failure, the body does not receive an adequate supply of oxygen. As a result, they can feel weak, fatigued or short of breath. Everyday activities such as walking, climbing stairs, carrying groceries and yard work can become quite difficult. In end-stage heart failure, the heart is so weakened the individual will die without a heart transplant.

Heart-lung transplant: Removal of an individual’s heart and lungs and replacing it with a heart and lungs from a single donor.

Lung Allocation Score (LAS): The UNOS LAS is a numerical score used to prioritize awaiting candidates 12 years of age or older for lung transplant in the United States. This system is intended to ensure fair and equitable allocation of organs based on urgency rather than waiting time. A higher score signals a more urgent need for transplant.

New York Heart Association (NYHA) definitions:

• Class III. Individuals with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea (difficulty breathing) or anginal (chest) pain.
• Class IV. Individuals with cardiac disease resulting in inability to carry on any physical activity without discomfort and/ or dyspnea. Symptoms of heart failure or anginal (chest) pain may be present even at rest. If any physical activity is undertaken, cardiac symptoms are increased.

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member’s contract benefits in effect at the time for service to determine coverage or non-coverage of these services as it applies to an individual member.

When services may be Medically Necessary, when criteria are met:

When services are Investigational and Not Medically Necessary:
For the procedure codes listed above when criteria are not met, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

Peer Reviewed Publications:

1. Barlow CW, Robbins RC, Moon MR, et al. Heart-lung versus double-lung transplantation for suppurative lung disease. J Thorac Cardiovasc Surg. 2000; 119(3):466-476.
2. Boucek MM, Edwards LB, Keck BM, et al. Registry for the International Society for Heart and Lung Transplantation: seventh official pediatric report - 2004. J Heart Lung Transplant. 2004; 23(8):933-947.
3. Boucek MM, Faro A, Novick RJ, et al. The Registry of the International Society for Heart and Lung Transplantation. Fourth official pediatric report - 2000; J Heart Lung Transplant. 2001; 20(1):39-52.
4. El-Andari R, Fialka NM, Alam A, et al. En bloc heart-lung transplantation: past and present. a systematic review. Clin Transplant. 2025; 39(8):e70270.
5. Ganesh JS, Rogers CA, Bonser RS, et al. Steering Group of the UK Cardiothoracic Transplant Audit. Outcome of heart-lung and bilateral sequential lung transplantation for cystic fibrosis: a UK national study. Eur Respir J. 2005; 25(6):964-969.
6. Klepetko W, Mayer E, Sandoval J, et al. Interventional and surgical modalities of treatment for pulmonary arterial hypertension. J Am Coll Cardiol. 2004 Jan 16; 43(12 Suppl S):73S-80S.
7. Miyoshi S, Mochizuki Y, Nagai S, et al. Physiologic aspects in human lung transplantation. Ann Thorac Cardiovasc Surg. 2005; 11(2):73-79.
8. Moffatt-Bruce SD, Karamichalis J, Robbins RC, et al. Are heart-lung transplant recipients protected from developing bronchiolitis obliterans syndrome? Ann Thorac Surg. 2006; 81(1):286-291.
9. Pierson RN 3rd, Barr ML, McCullough KP, et al. Thoracic organ transplantation. Am J Transplant. 2004; 4(Suppl 9):93-105.
10. Ro PS, Spray TL, Bridges ND. Outcome of infants listed for lung or heart/lung transplantation. J Heart Lung Transplant. 1999; 18(12):1232-1237.
11. Trulock EP. Lung transplantation for primary pulmonary hypertension. Clin Chest Med. 2001; 22(3):583-593.
12. Trulock EP, Edwards LB, Taylor DO, et al. The Registry of the International Society for Heart and Lung Transplantation: twenty-first official adult lung and heart-lung transplant report - 2004. J Heart Lung Transplant. 2004; 23(7):804-815.

Government Agency, Medical Society, and Other Authoritative Publications:

1. American Society of Transplant Surgeons. ASTS Statement Concerning Eligibility for Solid Organ Transplant Candidacy. Available at: https://www.asts.org/docs/default-source/position-statements/asts-statement-concerning-eligibility-for-solid-organ-transplant-candidacy.pdf?sfvrsn=1a6b4ed3_3. Accessed on September 23, 2025.
2. Hunt SA, Abraham WT, Chin MH, et al. 2009 focused update incorporated into the ACC/AHA 2005 Guidelines for the Diagnosis and Management of Chronic Heart Failure in the Adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2009; 119(14):e391-e479.
3. Leard LE, Holm AM, Valapour M, et al. Consensus statement. Consensus document for the selection of lung transplant candidates: an update from the International Society for Heart and Lung Transplantation. J Heart Jung Transplant. 2021; 40(11):1349-1379.
4. Organ Procurement and Transplantation Network (OPTN) and Scientific Registry of Transplant Recipients (SRTR). OPTN/SRTR 2021 Annual Data Report. U.S. Department of Health and Human Services, Health Resources and Services Administration; 2023. Available at: http://srtr.transplant.hrsa.gov/annual_reports/Default.aspx. Accessed September 23, 2025.
5. Organ Procurement and Transplantation Network (OPTN) and Scientific Registry of Transplant Recipients (SRTR). OPTN/SRTR 2023 Annual Data Report. U.S. Department of Health and Human Services, Health Resources and Services Administration; 2024. Available at: https://srtr.transplant.hrsa.gov/ADR/Chapter?name=Heart&year=2023. Accessed on September 23, 2025.
6. Steinman TL, Becker BN, Frost AE, et al. Clinical Practice Committee, American Society of Transplantation. Guidelines for the referral and management of patients eligible for solid organ transplantation. Transplantation. 2001; 71(9):1189-1204.
7. Stout KK, Daniels CJ, Valente AM, Van Hare GF. Clinical practice guideline. 2018 AHA/ACC Guideline for the management of adults with congenital heart disease. J Amer Coll Cardiol. 2019; 73(12):e81-e192.
8. United Network for Organ Sharing (UNOS). Policy 6 Organ Distribution: allocation of hearts and heart-lungs. Updated September 3, 2024. Available at: https://optn.transplant.hrsa.gov/professionals/by-organ/heart-lung/. Accessed on September 23, 2025.
9. United States Organ Procurement and Transplantation Network and the Scientific Registry of Transplant Recipients. OPTN/SRTR 2022 Annual data report: heart. Updated 2023.
10. Weill D, Benden C, Corris PA, et al. A consensus document for the selection of lung transplant candidates: 2014-an update from the Pulmonary Transplantation Council of the International Society for Heart and Lung Transplantation. J Heart Lung Transplant. 2015; 34(1):1-15.

1. American Lung Association. Available at: https://www.lung.org. Accessed on September 23, 2025.
2. Scientific Registry of Transplant Recipients. Available at: https://www.srtr.org/. Accessed on September 23, 2025.
3. The International Society for Heart & Lung Transplantation. Available at: http://www.ishlt.org. Accessed on September 23, 2025.
4. The Organ Procurement and Transplantation Network. Available at: http://optn.transplant.hrsa.gov/. Accessed on September 23, 2025.
5. United Network for Organ Sharing. Available at: http://www.unos.org/. Accessed on September 23, 2025.

Heart-lung Transplantation
Transplantation, Heart-lung

This Medical Policy provides assistance in understanding Healthy Blue’s standard Medicaid benefit plan. When evaluating coverage for a specific member benefit, reference to federal and state law, as well as contractual requirements may be necessary, since these may differ from our standard benefit plan. In the event of a conflict with standard plan benefits, federal, state and/or contractual requirements will govern. Before using this policy, please check all federal, state and/or contractual requirements applicable to the specific benefit plan coverage. Healthy Blue reserves the right to modify its Policies and Guidelines as necessary and in accordance with legal and contractual requirements. This Medical Policy is provided for informational purposes. It does not constitute medical advice. Healthy Blue may also use tools and criteria developed by third parties, to assist us in administering health benefits. Healthy Blue’s Policies and Guidelines are intended to be used in accordance with the independent professional medical judgment of a qualified health care provider and do not constitute the practice of medicine or medical advice.

No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, mechanical, photocopying, or otherwise, without permission from the health plan.

© CPT Only – American Medical Association