Medical policy: Heart/Lung Transplant

Policy number: MP 9.014

Effective date: 2/1/2026

Policy

Heart/lung transplantation may be considered medically necessary for carefully selected individuals with end-stage cardiac and pulmonary disease including, but not limited to, one of the following conditions:

• Irreversible primary pulmonary hypertension with heart failure
• Non-specific severe pulmonary fibrosis with severe heart failure
• Eisenmenger complex with irreversible pulmonary hypertension and heart failure
• Cystic fibrosis with severe heart failure
• Chronic obstructive pulmonary disease with heart failure
• Emphysema with severe heart failure
• Pulmonary fibrosis with uncontrollable pulmonary hypertension or heart failure

Heart/lung retransplantation after a failed primary heart/lung transplant may be considered medically necessary in individuals who meet criteria for heart/lung transplantation.

Heart/lung transplantation is considered investigational in all other situations, as there is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.

Policy guidelines

Potential contraindications subject to the judgment of the transplant center include:

• Known current malignancy, including metastatic cancer
• Recent malignancy with high risk of recurrence
• Untreated systemic infection making immunosuppression unsafe, including chronic infection
• Other irreversible end-stage disease not attributed to heart or lung disease
• History of cancer with a moderate risk of recurrence
• Systemic disease that could be exacerbated by immunosuppression
• Psychosocial conditions or chemical dependency affecting ability to adhere to therapy

When the candidate is eligible to receive a heart in accordance with United Network for Organ Sharing (UNOS) guidelines for cardiac transplantation, the lung(s) shall be allocated to the heart/lung candidate from the same donor. When the candidate is eligible to receive a lung in accordance with the UNOS Lung Allocation System, the heart shall be allocated to the heart/lung candidate from the same donor "after the heart has been offered to all heart and heart-lung potential transplant recipients in allocation classifications 1 through 4". Candidates with allocation classifications 1 through 4 falls within adult status 1 or 2 or pediatric status 1A.

Specific criteria for prioritizing donor thoracic organs for transplant are provided by the Organ Procurement and Transplantation Network (OPTN) and implemented through a contract with UNOS. Donor thoracic organs are prioritized by UNOS on the basis of recipient medical urgency, distance from donor hospital, and pediatric status. Patients who are most severely ill (status 1A) are given highest priority.

The following factors are considered in assessing the severity of cardiac illness: reliance on continuous mechanical ventilation, infusion of intravenous inotropes, and/or dependency on mechanical circulatory support (e.g., total artificial heart, intra-aortic balloon pump, extracorporeal membrane oxygenator, ventricular assist device). Factors considered in assessing the severity of pulmonary illness include increased pulmonary artery systolic pressure, pulmonary arterial hypertension, and/or elevated pulmonary vascular resistance.

Additional criteria may be considered in pediatric patients, including diagnosis of an OPTN-approved congenital heart disease diagnosis, presence of ductal dependent pulmonary or systemic circulation, and diagnosis of hypertrophic or restrictive cardiomyopathy while less than 1 year old. Of note, pediatric heart transplant candidates who remain on the waiting list at the time of their 18th birthday without receiving a transplant continue to qualify for medical urgency status based on the pediatric criteria.

In both adult and pediatric patients, isolated cardiac or pulmonary transplantations are preferred to combined heart/lung transplantation when medical or surgical management, other than organ transplantation, is available.

Full OPTN guidelines are available online at: https://optn.transplant.hrsa.gov/governance/policies/ .

Individuals who are considered temporarily unsuitable to receive a thoracic organ transplant may be assigned an inactive status.

Cross-references:

• MP 1.026 Total Artificial Hearts and Implantable Ventricular Assist Devices
• P 9.007 Heart Transplant
• MP 9.015 Lung and Lobar Lung Transplant

Product variations

This policy is only applicable to certain programs and products administered by Capital Blue Cross and subject to benefit variations. Please see additional information below.

FEP PPO - Refer to FEP Medical Policy Manual.

Description/Background

Heart/lung transplantation involves a coordinated triple operative procedure consisting of procurement of a donor heart/lung block, excision of the heart and lungs of the recipient, and implantation of the heart and lungs into the recipient. Heart/lung transplantation refers to the transplantation of one or both lungs and heart from a single cadaver donor.

Solid organ transplantation offers a treatment option for individuals with different types of end-stage organ failure that can be lifesaving or provide significant improvements to a patient’s quality of life. Many advances have been made in the last several decades to reduce perioperative complications. Available data supports improvement in long-term survival as well as improved quality of life particularly for liver, kidney, pancreas, heart, and lung transplants. Allograft rejection remains a key early and late complication risk for any organ transplantation. Transplant recipients require life-long immunosuppression to prevent rejection. Patients are prioritized for transplant by mortality risk and severity of illness criteria developed by the Organ Procurement and Transplantation Network and United Network of Organ Sharing.

Most heart/lung transplant recipients have Eisenmenger syndrome (37%), followed by idiopathic pulmonary artery hypertension (28%) and cystic fibrosis (14%). Eisenmenger syndrome is a form of congenital heart disease in which systemic-to-pulmonary shunting leads to pulmonary vascular resistance. It is possible that pulmonary hypertension could lead to a reversal of the intracardiac shunting and inadequate peripheral oxygenation or cyanosis.

Heart/Lung Transplant

Combined heart/lung transplantation is intended to prolong survival and improve function in patients with end-stage cardiac and pulmonary diseases. Due to corrective surgical techniques and improved medical management of pulmonary hypertension, the total number of patients with Eisenmenger syndrome has seen a decline in recent years. Additionally, heart/lung transplants have not increased appreciably, but for other indications, it has become more common to transplant a single or double lung and maximize medical therapy for heart failure, rather than perform a combined transplant. For those indications, patient survival rates following heart/lung transplantations are similar to lung transplant rates.

Bronchiolitis obliterans syndrome is a major complication. One-, five-, and ten-year patient survival rates for heart/lung transplants performed between 1982 and 2014 were estimated at 63%, 45%, and 32%, respectively.

In 2023, 46,630 transplants were performed in the United States procured from more than 16,000 deceased donors and 6900 living donors. Of these transplants, fifty four individuals received heart/lung transplants in the US in 2023 (total 1537 heart-lung transplants done to date in US). As of June 2024, 41 patients were on the waiting list for heart/lung transplants.

Regulatory status

Solid organ transplants are a surgical procedure and, as such, are not subject to regulation by the U.S. Food and Drug Administration (FDA).

The FDA regulates human cells and tissues intended for implantation, transplantation, or infusion through the Center for Biologics Evaluation and Research, under Code of Federal Regulation Title 21, parts 1270 and 1271. Solid organs used for transplantation are subject to these regulations.

Rationale

Summary of evidence

For individuals who have end-stage cardiac and pulmonary disease who receive combined heart/lung transplant, the evidence includes a systematic review, case series, and registry data. Relevant outcomes are overall survival, symptoms, morbid events, and treatment-related morbidity and mortality. The available literature reports on outcomes after heart/lung transplantation. Given the exceedingly poor expected survival rates without transplantation, this evidence is sufficient to demonstrate that heart/lung transplantation provides a survival benefit in appropriately selected patients. A transplant may be the only option for some patients with end-stage cardiopulmonary disease. Heart/lung transplant is contraindicated for patients in whom the procedure is expected to be futile due to comorbid disease or for whom posttransplantation care is expected to worsen comorbid conditions significantly. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have a combined heart/lung transplant complicated by graft failure or severe dysfunction of the heart/lung and who receive a combined heart/lung retransplant, the evidence includes case series and registry data. Relevant outcomes are overall survival, symptoms, morbid events, and treatment-related morbidity and mortality. A very limited amount of data has suggested that, after controlling for confounding variables, survival rates after primary and repeat heart/lung transplants are similar. Findings are inconclusive due to the small number of cases of repeat heart/lung transplants reported in the published literature. Repeat heart/lung transplantation is, however, likely to improve outcomes in patients with a prior failed transplant who meet the clinical criteria for heart/lung transplantation. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

Definitions

Blue Distinction Centers for Transplant (BDCT) is a cooperative effort of the Blue Cross and Blue Shield Plans, the Blue Cross and Blue Shield Association, and participating medical institutions to provide patients who need transplants with access to leading centers through a coordinated, streamlined program of transplant management.

End-stage refers to the final phase of a disease process.

New York Heart Association (NYHA) functional class is used to assess the functional class of patients with heart failure:

• Class I – No limitation during ordinary activity
• Class II – Slight limitation by shortness of breath and/or fatigue during moderate exertion or stress
• Class III – Symptoms with minimal exertion that interfere with normal daily activity
• Class IV – Inability to carry out any physical activity

Disclaimer

Capital Blue Cross’ medical policies are used to determine coverage for specific medical technologies, procedures, equipment, and services. These medical policies do not constitute medical advice and are subject to change as required by law or applicable clinical evidence from independent treatment guidelines. Treating providers are solely responsible for medical advice and treatment of members. These policies are not a guarantee of coverage or payment. Payment of claims is subject to a determination regarding the member’s benefit program and eligibility on the date of service, and a determination that the services are medically necessary and appropriate. Final processing of a claim is based upon the terms of contract that applies to the member’s benefit program, including benefit limitations and exclusions. If a provider or a member has a question concerning this medical policy, please contact Capital Blue Cross’ Provider Services or Member Services.

Coding information

Note: This list of codes may not be all-inclusive, and codes are subject to change at any time. The identification of a code in this section does not denote coverage as coverage is determined by the terms of member benefit information. In addition, not all covered services are eligible for separate reimbursement.

Covered when medically necessary

References

1. Black CK, Termanini KM, Aguirre O, et al. Solid organ transplantation in the 21st century. Ann Transl Med. Oct 2018; 6(20): 409. PMID 30498736
2. Christie JD, Edwards LB, Kucheryavaya AY, et al. The Registry of the International Society for Heart and Lung Transplantation: twenty-seventh official adult lung and heart-lung transplant report--2010. J Heart Lung Transplant. Oct 2010; 29(10): 1104-18. PMID 20870165
3. Yusen RD, Edwards LB, Dipchand AI, et al. The Registry of the International Society for Heart and Lung Transplantation: Thirty-third Adult Lung and Heart-Lung Transplant Report-2016. J Heart Lung Transplant. Oct 2016; 35(10): 1170-1184. PMID 27772669
4. United Network for Organ Sharing (UNOS). Transplant trends. 2024.
5. Kalogeropoulos AP, Georgiopoulou VV, Giamouzis G, et al. Utility of the Seattle Heart Failure Model in patients with advanced heart failure. J Am Coll Cardiol. Jan 27 2009; 53(4): 334-42. PMID 19161882