![]() | Medical Policy |
Subject: Heart/Lung Transplantation | |
Document #: TRANS.00026 | Publish Date: 01/30/2025 |
Status: Revised | Last Review Date: 11/14/2024 |
Description/Scope |
This document addresses 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:
Position Statement |
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:
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:
*Steinman, Theodore, et al. Guidelines for the Referral and Management of Patients Eligible for Solid Organ Transplantation. Transplantation. 2001; 71(9):1189-1204.
Rationale |
Heart/lung transplantation is a standard treatment for individuals who meet the Medical Necessity criteria listed in this document. Combined heart/lung transplants are reserved for candidates in whom either a heart transplant or a lung transplant alone would not improve the individual’s condition and chances of survival. As of September 2024, United Network of Organ Sharing (UNOS) reported 39 candidates currently on the active waiting list for heart-lung transplant. A total of 45 combined heart-lung transplants occurred in 2021, 2 of the heart-lung transplants were performed in children. According to the 2022 Annual Report of the U.S. Organ Procurement Transplant Network (OPTN) and the Scientific Registry of Transplant Recipients (SRTR), multiorgan transplant has increased more rapidly than heart transplant alone. From 2011 to 2022, heart-lung increased 87.5% (from 24 to 45), while heart-alone transplant increased by only 69.4%. Heart-lung continues to have lower survival compared with other heart transplant combinations. Five-year survival for heart-lung transplant is 64.8%. The decrease in survival for heart-lung transplant occurs during the first month of transplant, by 3 months post-transplant 25.0% of other multiorgan recipients had died, and by 6 months, 14.8% of heart-lung recipients had died.
In 2018, the American Heart Association (AHA)/American College of Cardiology (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).
Valapour and colleagues, (2021) reported in the OPTN/ SRTR that lung transplants declined in 2020, this coincided with the COVID-19 pandemic. In 2022, they reported that for the first time since the pandemic, the annual number of lung transplants performed in the United States increased. There were 2743 lung transplants performed representing an increase of 174 lung transplants from 2569 in 2021. The number did not reach pre-pandemic volumes. The number of new adult candidates added to the waiting list continues to increase annually, with 3161 candidates added in 2022.
The Pulmonary Transplantation Council of the International Society for Heart and Lung Transplantation (ISHLT) issued a 2021 updated consensus document for the selection of heart-lung transplant candidates. The authors include the following information (Leard, 2021):
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.
The primary indication for heart-lung transplantation is pulmonary hypertension, either secondary to idiopathic pulmonary arterial hypertension or congenital heart disease (CHD). Criteria for heart-lung transplant listing described in a previous version of this document 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.
Additionally, the committee consensus update addressed use of lung transplantation in individuals with acute respiratory distress syndrome (ARDS) and COVID-19. The committee concluded:
Case reports describing bilateral lung transplant for COVID-19 associated ARDS have started to emerge since January 2020. Experts in the field recommend waiting at least 4-6 weeks after the onset of respiratory failure due to COVID-19 prior to considering lung transplant. While it seems likely that these cases should be evaluated like other patients with post-viral ARDS, it is too early to make conclusive recommendations at this time.
Mi (2024) performed a meta-analysis that summarized the clinical experience of individuals with COVID-19 ARDS versus pulmonary fibrosis that received lung transplantation and compared the outcomes. Eight studies included 478 COVID lung transplant recipients and 163 non-COVID-19 lung transplants. The pooled hospital mortality and follow up survival rates was 0.00% and 87.4%, respectively. Compared to non-COVID-19 lung transplant recipients, the COVID-19 lung transplant recipients were associated with higher rates of primary graft dysfunction (p<0.001).
Potential lung transplant recipients are ranked according to the 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. Specific factors in the scoring system include the severity of the candidate’s illness, the ability to cope with transplant surgery, and predicted lifespan after the transplant. Waitlist urgency is defined as what is expected to happen to a candidate, given their characteristics, in the next year if a transplant is not received. Post-transplant survival is defined as what is expected to happen to a candidate, given their characteristics, in the first year after a transplant (UNOS, 2020).
In 2021, the OPTN Lung Transplant Committee updated how lung transplants were allocated in the United States. UNOS made changes to the updated cohort for calculation of the LAS approved by the OPTN Board of Directors, the update improved the predication of candidates’ expected survival on the waitlist and post-transplant to improve equity in lung allocation. In 2023, the OPTN published a new policy for matching lung transplant candidates with organs from deceased donors. The new “continuous distribution” methodology states that all of the factors in the organ match are included in a single weighted score, calculated for each lung transplant candidate, and each potential lung from a donor. This new document states:
Statistical modeling suggests this will reduce the number of lung candidates who die awaiting a lung transplant, but it will increase transplant access for a number of candidates. This includes candidates who are:
All lung transplant candidates aged 12 and older will receive a lung Composite Allocation Score (lung CAS) that replaces the LAS. For candidates younger than age 12, the two existing priority rankings will still be utilized. With the CAS, candidates receive varying numbers of points based on a set of different attributes. The attributes are weighted. The categories of attributes include the following:
In recent years, the discussion of heart transplantation as a treatment for cardiomyopathy caused by amyloidosis has gathered interest. Cardiac amyloidosis causes restrictive cardiomyopathy, progressive heart failure, and death. Heart transplantation outcomes have been poorer in individuals with cardiac amyloidosis due to the systemic nature of the condition. Light chain suppressive therapies for light chain amyloidosis (AL) may improve outcomes. Barrett and colleagues (2020) reported a retrospective (2004-2017), single center study of heart transplantation outcomes in 31 individuals with cardiac amyloidosis (13 with AL, and 18 with transthyretin [ATTR] amyloidosis). Screening included evaluation for extracardiac amyloidosis with organ specific biopsies, and extracardiac amyloid deposits constituted an absolute contraindication. In individuals with vascular or mucosal amyloid positive gastrointestinal biopsy, transplantation candidacy was evaluated by clinical symptoms. Individuals were considered for transplantation if there was no evidence of dysmotility, bleeding, or malabsorption. Pre-transplantation response to light chain reducing therapies in AL amyloidosis was not an absolute requirement for transplantation. Post-transplantation immunosuppression regimens were followed. Autologous stem cell transplants were performed in select participants with AL amyloidosis once they achieved clinical stability following the transplant, but no sooner than 6 months post-heart transplantation. The results demonstrated that post-transplantation outcomes were similar between the AL and ATTR groups, including post-transplantation infection and organ rejection. Two participants had difficulty with post-transplantation hemostasis, and 5 developed post-transplantation renal dysfunction that required renal replacement therapy. One participant with gastrointestinal amyloid deposits developed a post-operative ileus, which resolved. Of the 2 participants with renal amyloidosis, 1 developed progressive renal dysfunction that required dialysis 7 years after transplantation. There were 4 deaths after transplantation, but none determined to be due to amyloidosis or amyloidosis therapy complications. There were no differences in mortality between the 31 participants and the 599 individuals without amyloidosis. The authors concluded that in carefully selected individuals with AL and ATTR cardiac amyloidosis, the results were similar in both post-transplantation outcomes and survival compared to individuals without amyloidosis who received transplantation for all other conditions. These results are promising; however, the study was limited by its small size and single center transplant practices. Treatment practices and transplant eligibility policies can vary between institutions and could lead to different results, therefore larger studies are needed to confirm the outcomes.
In 2023, the ACC published the “Expert Consensus Decision Pathway on Comprehensive Multidisciplinary Care for the Patient With Cardiac Amyloidosis.” The consensus supports heart transplant in some individuals with cardiac amyloidosis:
In select patients with ATTR-CM and AL-CM with advanced/stage D HF, heart transplantation may be an option, and the current adult donor allocation system provides priority as Status 4 to amyloid CM, given the lack of durable (MCS) support options. The traditional signs of advanced HF apply in patients with cardiac amyloidosis and should be recognized as triggers for a discussion of prognosis and advanced HF therapies that incorporates the patient’s goals, values, and preferences.
In March 2023, the OPTN also changed the policy to expand the eligibility to pediatric heart status 1A and 1B candidates, who are registered on the waiting list prior to turning age 2, to accept incompatible blood type (ABOi) donors.
In 2024 the AHA, ACC, American Medical Society for Sports Medicine (AMSSM), Heart Rhythm Society (HRS), Pediatric and Electrophysiology Society (PES) and the Society for Cardiovascular Magnetic Resonance (SCMR) published updated Guidelines for the Management of Hypertrophic Cardiomyopathy (Ommen, 2024). The update states:
In patients with nonobstructive HCM and advanced HF (NYHA functional class III to class IV despite GDMT), CPET should be performed to quantify the degree of functional limitation and aid in selection of patients for heart transplantation or mechanical circulatory support.
In patients with nonobstructive HCM and advanced HF (NYHA functional class III to class IV despite GDMT) or with life-threatening ventricular arrhythmias refractory to maximal GDMT, assessment for HT in accordance with current listing criteria is recommended.
In patients with nonobstructive HCM and advanced HF (NYHA functional class III to class IV despite GDMT) who are candidates for heart transplantation, continuous-flow LVAD therapy is reasonable as a bridge to HT.
In patients with HCM and recurrent, poorly tolerated life-threatening ventricular tachyarrhythmias refractory to maximal antiarrhythmic drug therapy and ablation, HT is indicated in accordance with current listing criteria.
The ACC acknowledges that no single test can identify which individuals may be candidates for advanced HF therapies; multiple factors including the history, physical examination, laboratory testing, and imaging studies must be considered together to identify those at greatest risk of future decompensation and those who will derive the greatest benefit.
The ISHLT published updated Guidelines for the Evaluation and Care of Cardiac Transplant Candidates in 2024. This update replaced previous documents (Listing Criteria for Heart Transplantation: ISHLT Guidelines for the Care of Cardiac Transplant Candidates 2006, and 2016 ISHLT Listing Criteria for Heart Transplantation: A 10-year Update). The 2024 guidelines highlight that clinical signs or symptoms of advanced HF predict a worse prognosis; therefore, recognition of these clinical indicators should prompt referral and evaluation for HT (Peled, 2024), see TRANS.00033 for detailed information.
Background/Overview |
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.
Definitions |
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:
Coding |
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:
CPT |
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00580 | Anesthesia for heart transplant or heart/lung transplant |
33930 | Donor cardiectomy-pneumonectomy (including cold preservation) |
33933 | Backbench standard preparation of cadaver donor heart/lung allograft prior to transplantation, including dissection of allograft from surrounding soft tissues to prepare aorta, superior vena cava, inferior vena cava, and trachea for implantation |
33935 | Heart-lung transplant with recipient cardiectomy-pneumonectomy |
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ICD-10 Procedure |
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02YA0Z0 | Transplantation of heart, allogeneic, open approach |
02YA0Z1 | Transplantation of heart, syngeneic, open approach |
0BYM0Z0 | Transplantation of bilateral lungs, allogeneic, open approach |
0BYM0Z1 | Transplantation of bilateral lungs, syngeneic, open approach |
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ICD-10 Diagnosis |
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| All diagnoses |
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.
References |
Peer Reviewed Publications:
Government Agency, Medical Society, and Other Authoritative Publications:
Websites for Additional Information |
Index |
Heart/Lung Transplantation
Transplantation, Heart/Lung
Document History |
Status | Date | Action |
Revised | 11/14/2024 | Medical Policy & Technology Assessment Committee review (MPTAC). Revised Absolute contraindications list to replace “noncompliance” with “nonadherence” and “patient” with “individual.” Revised Rationale, Background, References, and Websites sections. |
Revised | 11/09/2023 | MPTAC. Revised reference in Position Statement section. Updated Description, Background/Overview, References, and Website sections. |
Reviewed | 11/10/2022 | MPTAC review. Updated Rationale, Background, References and Websites sections. |
Reviewed | 11/11/2021 | MPTAC review. Updated Rationale, References and Websites sections. |
Reviewed | 11/05/2020 | MPTAC review. Updated Rationale, Background, References and Websites sections. |
Reviewed | 11/07/2019 | MPTAC review. Updated Rationale, References and Websites sections. |
Reviewed | 01/24/2019 | MPTAC review. Updated References and Websites sections. |
Reviewed | 03/22/2018 | MPTAC review. Updated References and Websites sections. |
Reviewed | 02/27/2018 | MPTAC review. The document header wording updated from “Current Effective Date” to “Publish Date”. Updated Rationale, References and Websites sections. |
Reviewed | 02/02/2017 | MPTAC review. Updated formatting in Position Statement section. Updated References and Websites sections. |
Revised | 02/04/2016 | MPTAC review. Reformatted investigational and not medically statement. Defined abbreviation in investigational and not medically necessary absolute contraindication section. Updated Rationale, Background and References sections. Removed ICD-9 codes from Coding section. |
Reviewed | 02/05/2015 | MPTAC review. Updated Description, Rationale, References and Websites sections. |
Reviewed | 02/13/2014 | MPTAC review. Updated Description, Definitions, References and Web Sites sections. |
Reviewed | 02/14/2013 | MPTAC review. Rationale, Definitions, and Websites Updated. |
Reviewed | 02/16/2012 | MPTAC review. Updated Rationale, References and Websites |
Reviewed | 02/17/2011 | Medical Policy & Technology Assessment Committee (MPTAC) review. Updated Rationale, References and Websites. |
Reviewed | 02/25/2010 | MPTAC review. References updated. |
Reviewed | 02/26/2009 | MPTAC review. References updated. |
Reviewed | 02/21/2008 | MPTAC review. Updated references. The phrase “investigational/not medically necessary” was clarified to read “investigational and not medically necessary” at the November 29, 2007 MPTAC meeting. |
Revised | 03/08/2007 | (MPTAC) review. Criteria clarified. References, web sites and coding updated. |
Reviewed | 03/23/2006 | MPTAC review. References were updated. |
Revised | 04/28/2005 | MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization. |
Pre-Merger Organizations | Last Review Date | Document Number | Title |
Anthem, Inc. | 11/15/2001 | TRANS.00006H Archived | Heart/Lung Transplant |
WellPoint Health Networks, Inc. | 09/23/2004 | 7.04.01 | Heart/Lung Transplantation |
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