Coverage Policy Manual - Arkansas Blue Cross and Blue Shield

Coverage Policy Manual
Policy #:	1998106
Category:	Surgery
Initiated:	January 1993
Last Review:	December 2023

Transplant, Heart/Lung

Description:

Solid organ transplantation offers a treatment option for patients with different types of end-stage organ failure that can be lifesaving or provide significant improvements to a patient’s quality of life (Black, 2018). 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 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 (Christie, 2010).

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-, 5-, and 10-year patient survival rates for heart/lung transplants performed between 1982 and 2014 were estimated at 63%, 45%, and 32%, respectively (Yusen, 2016).

In 2022, 42,889 transplants were performed in the United States procured from 36,421 deceased donors and 6,468 living donors (UNOS, 2023). Of these 42,889 transplants, 51 individuals received heart/lung transplants in the US in 2022 (total 1,486 heart-lung transplants done to date in US). As of June 2023, 36 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.

The transplant community has developed guidelines for appropriate candidates for heart – lung transplantation. Arkansas BCBS coverage policy follows those guidelines.

Reimbursement for solid organ transplant (that has been pre-authorized if that is required) is made as a global fee limited to the lesser of billed charges or the average allowable charge authorized by the Blue Quality Centers for Transplant in the geographic region where the transplant is performed. This global payment includes all related transplant services including institutional, professional, ancillary, and organ procurement. The global period begins one day prior to the date of the transplant and continues for 41 days after the transplant. This covers the inpatient/outpatient stay and provides a per diem outlier payment if necessary. This global fee also includes the cost of complications arising from the original procedure when services are rendered within the global postoperative period for the particular transplant.

Policy/
Coverage:

Effective May 2019

Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria

*Note: A positive Hepatitis C status of organs for transplant is NOT a contraindication for transplant.

Heart-lung transplantation meets primary coverage criteria for effectiveness and is covered for patients with progressive end-stage pulmonary disease co-existing with advanced cardiac disease that is not amenable to standard medical or surgical treatment, and who have the capacity for full rehabilitation after transplantation.

Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria

Heart-lung transplantation for any patient with any of the 'Absolute Contraindications' listed below does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.

Absolute Contraindications (ANY of the following):

Active extrapulmonary infection;
Irreversible organ dysfunction (e.g., liver or kidney failure);
HIV seropositivity;
Insulin dependent diabetes mellitus with end-organ damage;
Current IV drug abuse or alcohol abuse;
Down’s syndrome;
History of non-compliance with medical regimens;
Heart or lung malignancy;
Recurrent pulmonary emboli;
Current smoking or recent (last 3-4 months) smoking; or
Psychiatric illness.

For contracts without primary coverage criteria, heart-lung transplantation for any patient with any of the 'Absolute Contraindications' listed above is considered investigational. Investigational services are specific exclusions in the member benefit certificate of coverage.

Effective Prior to May 2019

Except for those patients excluded under “Absolute Contraindications”, Heart – lung transplantation meets primary coverage criteria for effectiveness and is covered for patients with progressive end-stage pulmonary disease co-existing with advanced cardiac disease that is not amenable to standard medical or surgical treatment, and who have the capacity for full rehabilitation after transplantation.

Absolute Contraindications (ANY of the following):

Active extrapulmonary infection;
Irreversible organ dysfunction (e.g., liver or kidney failure);
HIV seropositivity;
Insulin dependent diabetes mellitus with end-organ damage;
Current IV drug abuse or alcohol abuse;
Down’s syndrome;
History of non-compliance with medical regimens;
Heart or lung malignancy;
Recurrent pulmonary emboli;
Current smoking or recent (last 3-4 months) smoking; or
Psychiatric illness.

Heart – lung transplantation for any patient with any of the 'Absolute Contraindications' listed above does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.

For contracts without primary coverage criteria, heart – lung transplantation for any patient with any of the 'Absolute Contraindications' listed above is considered investigational. Investigational services are specific exclusions in the member benefit certificate of coverage.

Effective August 2012- August 2014

Absolute Contraindications (ANY of the following):

Active extrapulmonary infection;
Irreversible organ dysfunction (e.g., liver or kidney failure);
HIV seropositivity;
Insulin dependent diabetes mellitus with end-organ damage;
Current IV drug abuse or alcohol abuse;
Down’s syndrome;
History of non-compliance with medical regimens;
Heart or lung malignancy;
Recurrent pulmonary emboli;
Current smoking or recent (last 3-4 months) smoking;
Neurologic disorders
Poorly controlled hypertension; or
Psychiatric illness.

Effective prior to August 2012

Absolute Contraindications (ANY of the following):

Active extrapulmonary infection;
Irreversible organ dysfunction (e.g., liver or kidney failure);
Active malignancy within the past two years with the exception of basal cell and squamous cell carcinoma of the skin. In addition, recent data on recurrence of tumors post transplant indicate that a waiting period of at least 5 years is prudent for extracapsular renal cell tumors, breast cancer that is stage 2 or higher, colon cancer staged higher than Dukes A, and melanoma, level III or higher;
HIV seropositivity;
Insulin dependent diabetes mellitus with end-organ damage;
Current IV drug abuse or alcohol abuse;
Down’s syndrome;
History of non-compliance with medical regimens;
Heart or lung malignancy;
Recurrent pulmonary emboli;
Current smoking or recent (last 3-4 months) smoking;
Neurologic disorders
Poorly controlled hypertension; or
Psychiatric illness.

Heart – lung transplantation for any patient with any of the 'Absolute Contraindications' listed above is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.

For contracts without primary coverage criteria, heart – lung transplantation for any patient with any of the 'Absolute Contraindications' listed above is considered investigational. Investigational services are an exclusion in the member certificate of coverage.

Rationale:

2002 Update

A literature search was performed on the MEDLINE database for the period of 1996 to October 2002. No published articles were identified that would change the policy statement. This update focuses on the heart-lung transplant registry data from the Scientific Registry of Transplant Recipients for the reporting period of January 1, 1997, to June 30, 2001. Note that a death and retransplant are reported as a graft failure. The registry notes that because different cohorts are followed for each time period, it is possible for 3-year survival rates to exceed 1-year survival rates.

Adult (18+)

For 87 adult transplant recipients, the 1-year adult patient survival rate (n=87) was 62.5%, and the 3-year adult patient survival rate (n= 93) was 46.2%. For adult transplant graft survival, the 1-year graft survival (n= 88) was 61%, and the 3-year graft survival was 44.3%.

2005 Update

A literature search based on the MEDLINE database was conducted for the period of 1995 to January 2006. No published data were identified that would change the policy statement. The literature continues to document short- and long-term survival of both adult and pediatric recipients. Three-year recipient and graft survival rates for adults and children are 77.9% and 59.9% and 77.2% and 59.9%, respectively. Data from the United Network for Organ Sharing (UNOS) reveal that the number of lung transplantations in the United States is increasing, from 890 in 199 to 1,053 in 2001. Other published literature focuses on the reports of case series of both cadaver and living lobar lung transplantation from individual programs.

2007 Update

Review of MEDLINE from 2006 through December 2007 found two studies which influence coverage of lung transplantation: A study of lung transplantation in patients with cystic fibrosis was published in the New England Journal of Medicine in 2007. The authors concluded, "Prolongation of life by means of lung transplantation should not be expected in children with cystic fibrosis. A prospective, randomized trial is needed to clarify whether and when patients derive a survival and quality-of-life benefit from lung transplantation." The registry of the international society for heart and lung transplantion published their 2007 report, and cystic fibrosis was the third most prevalent condition for which bilateral lung transplantation was performed in adults.

Retransplantation of the lung was reviewed in January 2008: "Outcomes after lung retransplantation have improved; however, retransplantation continues to pose an increased risk of death compared with the initial transplant procedure. Retransplantation early after the initial transplant poses a particularly high mortality risk."

2012 Update

This policy is being updated with results of a literature search through July 2012. A summary of the relevant material is included below.

Pediatric Considerations

In 2010, Aurora and colleagues reported on pediatric heart/lung transplants which have reported to the international registry (Aurora, 2010). They note that the numbers of pediatric heart/lung transplants have been declining in recent years. Survival has been trending higher in this group in recent years, with a 5-year survival rate of 49%, which is comparable to lung transplant survival rate.

Potential Contraindications

Individual transplant centers may differ in their guidelines, and individual patient characteristics may vary within a specific condition. In general, heart transplantation is contraindicated in patients who are not expected to survive the procedure, or in whom patient-oriented outcomes, such as morbidity or mortality, are not expected to change due to comorbid conditions unaffected by transplantation e.g., imminently terminal cancer or other disease. Further, consideration is given to conditions in which the necessary immunosuppression would lead to hastened demise, such as active untreated infection. However, stable chronic infections have not always been shown to reduce life expectancy in heart transplant patients.

Malignancy

Concerns regarding a potential recipient’s history of cancer were based on the observation of significantly increased incidence of cancer in kidney transplant patients (Kasiske, 2004). In fact, carcinogenesis is two to four times more common in both heart transplant and lung transplant patients, likely due to the higher doses of immunosuppression necessary for the prevention of allograft rejection, the majority of which are skin cancers (Christie, 2010; Taylor, 2005). The incidence of de novo cancer in heart transplant patients approaches 26% at 8 years post-transplant, the rate for lung transplant is 28% at 10 years. For renal transplant patients who had a malignancy treated prior to transplant, the incidence of recurrence ranged from zero to more than 25%, depending on the tumor type (Trofe, 2004) (Otley, 2005). However, it should be noted that the availability of alternate treatment strategies informs recommendations for a waiting period following high-risk malignancies: in renal transplant, a delay in transplantation is possible due to dialysis; end-stage cardiopulmonary failure patients may not have an option. A small study (n=33) of survivors of lymphoproliferative cancers who subsequently received cardiac transplant had 1-, 5-, and 10-year survival rates of 77%, 64%, and 50%, respectively (Taylor, 2000). By comparison, overall 1-, 5-, and 10-year survival rates are expected to be 88%, 74%, and 55%, respectively for the general transplant candidate. The evaluation of a candidate who has a history of cancer must consider the prognosis and risk of recurrence from available information including tumor type and stage, response to therapy, and time since therapy was completed. Although evidence is limited, patients in whom cancer is thought to be cured should not be excluded from consideration for transplant. United Network for Organ Sharing (UNOS) has not addressed malignancy in current policies.

HIV

Solid organ transplant for patients who are HIV-positive (HIV+) has been controversial, due to the long-term prognosis for human immunodeficiency virus (HIV) positivity and the impact of immunosuppression on HIV disease. Although HIV+ transplant recipients may be a research interest of some transplant centers, the minimal data regarding long-term outcome in these patients consist primarily of case reports and abstract presentations of liver and kidney recipients. Nevertheless, some transplant surgeons would argue that HIV positivity is no longer an absolute contraindication to transplant due to the advent of highly active antiretroviral therapy (HAART), which has markedly changed the natural history of the disease.

In March 2009, the Organ Procurement Transfer Network (OPTN) revised its policies on HIV status in recipients. It reiterates an earlier position that: “A potential candidate for organ transplantation whose test for HIV is positive but who is in an asymptomatic state should not necessarily be excluded from candidacy for organ transplantation, but should be advised that he or she may be at increased risk of morbidity and mortality because of immunosuppressive therapy” (OPTN, 2009).

In 2006, the British HIV Association and the British Transplantation Society Standards Committee published guidelines for kidney transplantation in patients with HIV disease (Bhagani, 2006). These criteria may be extrapolated to other organs:

CD4 count greater than 200 cells/ml for at least 6 months
Undetectable HIV viremia (less than 50 HIV-1 RNA copies/ml) for at least 6 months
Demonstrable adherence and a stable HAART regimen for at least 6 months
Absence of AIDS-defining illness following successful immune reconstitution after HAART.

However, concerns have been raised about the extrapolation of these criteria to lung transplants.

Other

Note: Considerations for heart transplantation and lung transplantation alone may also pertain to combined heart-lung transplantation. For example, cystic fibrosis accounts for the majority of pediatric candidates for heart-lung transplantation, and infection with Burkholderia species is associated with higher mortality in these patients. And, experience with kidney transplantation in patients infected with HIV in the era of HAART has opened discussion of transplantation of other solid organs in these patients. These topics are addressed more fully in the separate policies on heart transplantation and lung transplantation.

Practice Guidelines and Position Statements

A key publication is the 2006 guidelines from the Pulmonary Scientific Council of the International Society for Heart and Lung Transplantation (Orens, 2006). The consensus-based guidelines state that, “Lung transplantation is now a generally accepted therapy for the management of a wide range of severe lung disorders….However, the number of donor organs available remains far fewer than the number of patients with end-stage lung disease who might potentially benefit from the procedure. It is of primary importance, therefore, to optimize the use of this resource, such that the selection of patients who receive a transplant represents those with realistic prospects of favorable long-term outcomes. There is a clear ethical responsibility to respect these altruistic gifts from all donor families and to balance the medical resource requirement of one potential recipient against those of others in their society. These concepts apply equally to listing a candidate with the intention to transplant and potentially de-listing (perhaps only temporarily) a candidate whose health condition changes such that a successful outcome is no longer predicted.” Thus, for all patients, including those with end-stage cardiopulmonary disease and HIV infection, evaluation of a candidate for transplant needs to consider the probability of a successful transplant and the limited supply of organs available.

Summary

The literature, consisting of case series and registry data, demonstrates that heart/lung transplantation provides a survival benefit in appropriately selected patients, as compared to the exceedingly poor expected survival without transplant. It may be the only option for some patients with end-stage cardiopulmonary disease. Heart/lung transplant is contraindicated in patients in whom the procedure is expected to be futile due to comorbid disease or in whom post-transplantation care is expected to significantly worsen comorbid conditions.

2014 Update

A literature search conducted through November 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.

Pediatric Considerations

A 2014 analysis of data from the Organ Procurement and Transplantation Network (OPTN) reported on indications for pediatric heart/lung transplantation (Spahr, 2014). The number of pediatric heart/lung transplants has decreased in recent years, ie, 56 cases in 1993-1997; 21 cases in 2008-2013. The 3 most common indications for pediatric heart/lung transplant were primary pulmonary hypertension (n=55), congenital heart disease (n=37), and Eisenmenger syndrome (n=30). However, while 30 children received a heart/lung transplant for Eisenmenger syndrome through 2002, none have been performed for this indication since then. Pediatric heart/lung transplants have also been performed for other indications including alpha1 antitrypsin deficiency, pulmonary vascular disease, cystic fibrosis, and dilated cardiomyopathy.

2017 Update

A literature search conducted through November 2017 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.

Yusen and colleagues reported the survival of adult heart/lung transplant recipients using the ISHLT Database (Yusen, 2016). Among the 3775 primary heart/lung transplants performed during 1982 to 2014, the 3 months, 1 year, 3 years, 5 years and 10 years survival rates were 71%, 63%, 52%, 45%, and 32% respectively.The overall median survival during this period (1982-2014) was 3.4 years. Those who survived to 1 year had a conditional median survival of 10.3 years. Survival improved over time, with median survival of 2.1 years for the patients who received transplant during 1982 to 1993 (n=1596), 3.9 years for patients during 1994 to 2003 (n=1392), and 5.8 years for patients during 2004 to 2014 (n=843) (p<0.05 for all pairwise comparisons). Heart/lung transplant recipients in the 2004 to 2014 group had a median conditional survival beyond 10 years. Compared with lung-only transplantation (median conditional survival, 8.0 years), heart/lung transplant recipients had a better long-term survival (median conditional survival, 10.3 years).

Hill and colleagues compared survival following heart/lung transplantation with double-lung transplantation for idiopathic pulmonary arterial hypertension (IPAH) among adult transplant recipients in the Scientific Registry of Transplant Recipients (SRTR) database during 1987-2012 (Hill, 2015). Among the 928 IPAH patients, 667 underwent double-lung transplantation and 261 underwent heart/lung transplantation. Overall, the adjusted survival was similar between double-lung transplantation and heart/lung transplant recipients. However, for recipients who were hospitalized in the ICU, double-lung transplantation was associated with worse outcome compared to heart/lung transplantation recipients (hazard ratio [HR], 1.83; 95% confidence interval [CI], 1.02 to 3.28).

Jayarajan and colleagues compared the mortality at 1 month and 5 year posttransplant between heart/lung transplant recipients requiring pretransplant ventilation (n=22) or extracorporeal membrane oxygenation (ECMO) (n=15) and evenly matched controls (Jayarajan, 2014). Median survival was 10 days, 181 days, and 1547 days among patients with pretransplant ECMO, patients with mechanical ventilator and control group respectively. Patients with pretransplant ECMO had a worse survival than the control group at 30 days (20.0% vs 83.5%) and 5 years (20.0% vs 47.4%; p<0.001). Similarly patients requiring ventilation prior transplantation had worse survival at 1 month (77.3% vs 83.5%) and 5 years (26.5% vs 47.4%; p<0.001) compared with the control group. The use of ECMO (HR=3.82; 95% CI, 1.60 to 9.12; p=0.003) or mechanical ventilation (HR=2.01; 95% CI, 1.07 to 3.78; p=0.030) as a bridge to transplantation was independently associated with mortality on multivariate analysis. The findings of the study raises question whether combined heart/lung transplant should be carried out in patients requiring ECMO and suggests a need for further research to improve survival in this high risk group of patients.

Pediatric Considerations

Goldfarband colleague reported the survival of pediatric lung and heart/lung transplant recipients using the ISHLT database (Goldfarb, 2016). Among the 698 pediatric heart/lung transplant recipients, median survival was 3.0 years and conditional median survival was 7.8 years. There was no statistically significant difference in survival by indication, recipient age group or era (time period) of transplant for pediatric heart/lung transplant recipients.

Keeshan and colleagues assessed outcomes for pediatric heart/lung transplantation between children who had congenital heart disease (CHD) with and without Eisenmenger syndrome using the UNOS database of heart/lung transplantations performed during 1987-2011 (Keeshan, 2014). Among the 178 pediatric heart/lung transplantations performed during that period, 73 (41%) had cardiac etiologies and 69 (38%) had idiopathic pulmonary arterial hypertension (IPAH) as the primary diagnosis. Among the patients with cardiac etiologies, CHD was the most common diagnosis (n=65). Children with CHD without Eisenmenger syndrome (n=34) had a lower median survival (1.31 years) than children with CHD plus Eisenmenger syndrome (n=31; median survival, 4.80 years; p=0.05). On multivariable analysis, CHD without Eisenmenger syndrome (adjusted HR=1.69; 95% CI, 1.09 to 2.62), younger age (adjusted HR=1.04; 95% CI, 1.01 to 1.08), pretransplant mechanical ventilation (adjusted HR=1.75; 95% CI, 1.01 to 3.06), pretransplant ECMO (adjusted HR=3.07; 95% CI, 1.32 to 7.12), pretransplant panel reactive antibodies (adjusted HR=1.53; 95% CI, 1.06 to 2.20), and transplant era (adjusted HR=1.85; 95% CI, 1.16 to 2.94) were associated with graft failure.

Section Summary: Initial Heart/Lung Transplant

Data from transplantation registries have found increasing patient survival rates after initial heart/lung transplant among adult and pediatric patients over time (eg, 5-year survival rate, 78%). Net benefit of heart transplantation compared to lung-only transplantation is also evident, especially among patients with idiopathic pulmonary arterial hypertension.

Malignancy

Pretransplant malignancy is considered a relative contraindication for heart transplantation considering this has the potential to reduce life expectancy and could prohibit immune suppression after transplantation. However, with improved cancer survival over the years and use of cardiotoxic chemotherapy and radiotherapy, the need for heart transplantation has increased in this population, Mistiaen and colleagues conducted a systematic review to study the posttransplant outcome of pretransplant malignancy patients. Most selected studies were small case series (median sample size, 17 patients; range, 7-1117 patients) (Mistiaen, 2015). Mean patient age varied from 6 to 52 years. Hematologic malignancy and breast cancer were the most common type of pretransplant malignancies. Dilated, congestive, or idiopathic cardiomyopathy was mostly the common reason for transplantation in 4 case series, chemotherapy related cardiomyopathy was the most important reason for transplantation in the other series. Hospital mortality varied between 0% and 33%, with small sample size potentially explaining the observed variation, One large series reported similar short-term and long-term posttransplant survival of chemotherapy related (N=232) and other nonischemic cardiomyopathy (N=8890) patients (Oliveria, 2012). The 1-, 3-, and 5-year survival rates of were 86%, 79%, and 71% for patients with chemotherapy-related cardiomyopathy compared with 87%, 81%, and 74% for other transplant patients. Similar findings were observed for 1-year survival in smaller series. Two-, 5-, and 10-year survival rates among pretransplant malignancy patients were also comparable with other transplant patients. In addition to the nonmalignancy related factors such as cardiac, pulmonary, and renal dysfunction, 2 malignancy related factors were identified as independent predictors of 5-year survival. Malignancy-free interval (the interval between treatment of cancer and heart transplantation) of less than 1 year was associated with lower 5- year survival compared with a longer interval (<60% vs >75%). Patients with prior hematologic malignancies had an increased posttransplant mortality in 3 small series. Recurrence of malignancy was more frequent among patients with a shorter disease-free interval, 63%, 26%, and 6% among patients with less than 1 year, 1 to 5 years, and more than 5 years of disease-free interval, respectively (Sigurdardottir, 2012). Yoosabai and colleagues conducted a retrospective review among 23,171 heart transplant recipient in the OPTN/UNOS database to identify whether pretransplant malignancy increases the risk of posttransplant malignancy (Yoosabai, 2015). Posttransplant malignancy was diagnosed in 2673 (11.5%) recipients during the study period. A history of any pretransplant malignancy was associated with increased risk of overall posttransplant malignancy (subhazard ratio [SHR], 1.51; p<0.01), skin (SHR=1.55, p<0.01), and solid organ malignancies (SHR=1.54, p<0.01) on multivariate analysis.

ONGOING AND UNPUBLISHED CLINICAL TRIALS

A search of ClinicalTrials.gov in November, 2017 did not identify any ongoing or unpublished trials that would likely influence this review.

2018 Update

A literature search was conducted through November 2018. There was no new information identified that would prompt a change in the coverage statement.

2021 Update

Annual policy review completed with a literature search using the MEDLINE database through November 2021. No new literature was identified that would prompt a change in the coverage statement.

2022 Update

Annual policy review completed with a literature search using the MEDLINE database through November 2022. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.

In 2021, the International Society for Heart and Lung Transplantation updated its consensus-based guidelines on the selection of lung transplant recipients (Leard, 2021). These guidelines made the following statements about lung transplantation:

"Lung transplantation should be considered for adults with chronic, end-stage lung disease who meet all the following general criteria:

High (>50%) risk of death from lung disease within 2 years if lung transplantation is not performed
High (>80%) likelihood of 5-year post-transplant survival from a general medical perspective provided that there is adequate graft function."

For combined heart/lung transplant, the guidelines state:

"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 guideline goes on to state: "The primary indication for heart-lung transplant is pulmonary hypertension, either secondary to idiopathic pulmonary arterial hypertension or congenital heart disease (CHD)."

The guidelines also mentioned:"..candidates free from complex CHD or left ventricular compromise can achieve comparable outcomes with isolated bilateral lung transplant. Similarly, patients with advanced lung disease and cardiac pathology amenable to surgical repair may be candidates for lung transplant concurrent with the appropriate corrective cardiac procedure."

2023 Update

Annual policy review completed with a literature search using the MEDLINE database through November 2023. No new literature was identified that would prompt a change in the coverage statement.

CPT/HCPCS:

References:

Aguero F, Castel MA, Cocchi S, et al.(2016) An Update on Heart Transplantation in Human Immunodeficiency Virus-Infected Patients. Am J Transplant. 2016;16(1):21-28.

Aurora P, Edwards LB, Kucheryavaya AY et al.(2010) The Registry of the International Society for Heart and Lung Transplantation: thirteenth official pediatric lung and heart-lung transplantation report--2010. J Heart Lung Transplant 2010; 29(10):1129-41.

Bhagani S, Sweny P, Brook G.(2006) Guidelines for kidney transplantation in patients with HIV disease. HIV Med 2006; 7(3):133-9.

Goldfarb SB, Levvey BJ, Edwards LB, et al.(2016) The Registry of the International Society for Heart and Lung Transplantation: Nineteenth Pediatric Lung and Heart-Lung Transplantation Report-2016; Focus Theme: Primary Diagnostic Indications for Transplant. The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation. 2016;35(10):1196-1205.

Green I.(1994) Health Technology Assessment Report: Institutional and patient criteria for heart – lung transplantation. National Center for Health Technology Research and Health Care Technology Assessment, May 1994.

Grover FL, Fullerton DA, Zamora MR, et al.(1997) The past, present, and future of lung transplantation. Am J Surg 1997; 523-533.

Hill C, Maxwell B, Boulate D, et al.(2015) Heart-lung vs. double-lung transplantation for idiopathic pulmonary arterial hypertension. Clinical transplantation. 2015;29(12):1067-1075.

Jayarajan SN, Taghavi S, Komaroff E, et al.(2014) Impact of extracorporeal membrane oxygenation or mechanical ventilation as bridge to combined heart-lung transplantation on short-term and long-term survival. Transplantation. 2014;97(1):111-115.

Kasiske BL, Snyder JJ, Gilbertson DT et al.(2004) Cancer after kidney transplantation in the United States. Am J Transplant 2004; 4(6):905-13.

Kawut SM, Lederer DJ, Keshavjee S, et al.(2008) Outcomes in lung retransplantation in the modern era. Am J Resp & Crit Care Med, 2008; 177:114-120.

Keeshan BC, Goldfarb SB, Lin KY, et al.(2014) Impact of congenital heart disease on outcomes of pediatric heartlung transplantation. Pediatr Transplant. 2014;18(2):204-210.

Leard LE, Holm AM, Valapour M, et al.(2021) Consensus document for the selection of lung transplant candidates: An update from the International Society for Heart and Lung Transplantation. J Heart Lung Transplant. Nov 2021; 40(11): 1349-1379. PMID 34419372

Liou TG, Adler FR, Cox DR, et al.(2007) Lung transplantation and survival in children with cystic fibrosis. New Engl J Med, 2007; 357:2143-2152.

Mistiaen WP.(2015) Heart transplantation in patients with previous malignancy. An overview. Acta Cardiol. 2015;70(2):123-130.

Oliveira GH, Hardaway BW, Kucheryavaya AY, et al.(2012) Characteristics and survival of patients with chemotherapy-induced cardiomyopathy undergoing heart transplantation. J Heart Lung Transplant. 2012;31(8):805-810.

Orens JB, Estenne M, Arcasoy S et al.(2006) International guidelines for the selection of lung transplant candidates: 2006 update--a consensus report from the Pulmonary Scientific Council of the International Society for Heart and Lung Transplantation. J Heart Lung Transplant 2006; 25(7):745-55.

Otley CC, Hirose R, Salasche SJ.(2005) Skin cancer as a contraindication to organ transplantation. Am J Transplant 2005; 5(9):2079-84.

Sigurdardottir V, Bjortuft O, Eiskjaer H, et al.(2012) Long-term follow-up of lung and heart transplant recipients with pre-transplant malignancies. J Heart Lung Transplant. 2012;31(12):1276-1280.

Spahr JE, West SC.(2014) Heart-lung transplantation: pediatric indications and outcomes. J Thorac Dis. Aug 2014;6(8):1129-1137. PMID 25132980

Taylor DO, Edwards LB, Boucek MM et al.(2005) Registry of the International Society for Heart and Lung Transplantation: twenty-second official adult heart transplant report--2005. J Heart Lung Transplant 2005; 24(8):945-55.

Taylor DO, Farhoud HH, Kfoury G et al.(2000) Cardiac transplantation in survivors of lymphoma: a multi-institutional survey. Transplantation 2000; 69(10):2112-5.

Trofe J, Buell JF, Woodle ES et al.(2004) Recurrence risk after organ transplantation in patients with a history of Hodgkin disease or non-Hodgkin lymphoma. Transplantation 2004; 78(7):972-7.

Trulock EP, Christie JD, Edwards LB, et al.(2007) Registry of the International Society for Heart and Lung Transplantation: Twenty-fourth official adult lung and heart-lung transplantation report - 2007. J of Heart & Lung Transpl, 2007; 26:782-795.

Weill D, Benden C, Corris PA, et al.(2015) 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.

Yoosabai A, Mehta A, Kang W, et al.(2015) Pretransplant malignancy as a risk factor for posttransplant malignancy after heart transplantation. Transplantation. 2015;99(2):345-350.

Yusen RD, Edwards LB, Kucheryavaya AY, et al.(2014) The registry of the International Society for Heart and Lung Transplantation: thirty-first adult lung and heart-lung transplant report--2014; focus theme: retransplantation. J Heart Lung Transplant. Oct 2014;33(10):1009-1024. PMID 25242125

Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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