Coverage Policy Manual
Policy #: 1998105
Category: Surgery
Initiated: August 2017
Last Review: September 2024
  Transplant, Lung and Lobar Lung
Description:
Solid organ transplantation offers a treatment option for patients with different types of endstage 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 the Organ Procurement and Transplantation Network (OPTN) and United Network of Organ Sharing.
 
In 2023, 46,630 transplants were performed in the United States procured from more than 16,000 deceased donors and 6900 living donors (UNOS, 2024). Lung transplants were the fourth most common procedure with 3,026 transplants performed from both deceased and living donors in 2023.
 
End-stage lung disease may derive from different etiologies. The most common indications for lung transplantation are chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, cystic fibrosis, alpha 1-antitrypsin deficiency, and idiopathic pulmonary arterial hypertension. Before consideration for transplant, patients should be receiving maximal medical therapy, including oxygen supplementation, or surgical options, such as lung volume reduction surgery for chronic obstructive pulmonary disease. Lung or lobar lung transplantation is an option for patients with end-stage lung disease despite these measures.
 
A lung transplant refers to single-lung or double-lung replacement. In a single-lung transplant, only one lung from a deceased donor is provided to the recipient. In a double-lung transplant, both the recipient's lungs are removed and replaced by the donor's lungs. In a lobar transplant, a lobe of the donor's lung is excised, sized appropriately for the recipient's thoracic dimensions, and transplanted. Donors for lobar transplant have primarily been living related donors, with one lobe obtained from each of two donors (generally friends or family members) in cases for which a bilateral transplantation is required. There are also cases of cadaver lobe transplants.
 
Potential recipients who are 12 years of age and older are ranked according to the Lung Allocation Score (OPTN, 2024). A score may range between 0 and 100 and incorporates predicted survival after transplantation and predicted survival on the waiting list; the Lung Allocation Score takes into consideration the patient's disease and clinical parameters. The waiting list incorporates the Lung Allocation Score, geography, and blood type classifications. Children younger than 12 years old receive priority for lung allocation. Under this system, children younger than 12 years old with respiratory lung failure and/or pulmonary hypertension who meet criteria are considered "priority 1", and all other candidates in the age group are considered "priority 2". A lung review board has the authority to adjust scores on appeal for adults and children.
 
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.
 
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 36 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.
 
Lung transplantation meets primary coverage criteria for effectiveness and is covered for adult members with irreversible, end stage pulmonary disease with a high risk of death in 2-3 years due to:
 
    • Non-bronchiectatic chronic obstructive pulmonary disease (emphysema, chronic bronchitis, bronchiolitis obliterans, chronic obstructive pulmonary disease;  
    • Bilateral bronchiectasis    
    • idiopathic pulmonary fibrosis;
    • Systemic disease with pulmonary fibrosis (scleroderma, rheumatoid arthritis, sarcoidosis, pulmonary fibrosis post-chemotherapy);
    • Pulmonary hypertension without congenital heart disease;
    • Pulmonary hypertension secondary to congenital heart disease (Eisenmenger’s Syndrome);
    • Combined pulmonary and other organ failure (i.e., advanced liver disease, advanced kidney failure;
    • Lymphangioleiomyomatosis; or
    • Graft failure of an initial lung/lobar transplant, due to either technical reasons or chronic rejection.
 
Lung transplantation meets primary coverage criteria for effectiveness and is covered for children with irreversible lung disease due to:
 
    • Primary pulmonary hypertension;
    • Pulmonary hypertension associated with structural heart disease;
    • Pulmonary venous stenosis;
    • Pulmonary hypertension associated with parenchymal lung disease (i.e., congenital cystic emphysematous lung diseases); Congenital abnormalities of lung development or of lung adaptation to extrauterine life (e.g., congenital diaphragmatic hernia, congenital surfactant protein B deficiency);
    • Bronchiolitis obliterans;
    • Bronchopulmonary dysplasia;
    • Alpha-1 antitrypsin deficiency   
    • Cystic fibrosis (both lungs to be transplanted)
    • Pulmonary fibrosis; or
    • Graft failure of an initial lung/lobar transplant, due to either technical reasons or chronic rejection.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary
Coverage Criteria
 
Lung transplantation, for any disease, including those listed above, does not meet primary coverage criteria if there is:
 
    • Dysfunction of major organs other than the lung, particularly renal dysfunction-creatine clearance of less than 50 mg/ml/min-because of the impact of immunosuppressive drugs on renal function;
    • Significant untreatable coronary artery disease or left ventricular dysfunction;
    • Infection with HIV;
    • Hepatitis B antigen positivity;
    • Hepatitis C with biopsy proven histologic evidence of liver disease is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For contracts without primary coverage criteria, lung transplantation, for any disease, including those listed above, if there is:
 
    • Dysfunction of major organs other than the lung, particularly renal dysfunction-creatine clearance of less than 50 mg/ml/min-because of the impact of immunosuppressive drugs on renal function;
    • Significant untreatable coronary artery disease or left ventricular dysfunction;
    • Infection with HIV;
    • Hepatitis B antigen positivity;
    • Hepatitis C with biopsy proven histologic evidence of liver disease is considered investigational. Investigational services are exclusion in the member benefit contract.
 
Effective Prior to May 2019
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage
Criteria
Lung transplantation meets primary coverage criteria for effectiveness and is covered for adult members with irreversible, end stage pulmonary disease with a high risk of death in 2-3 years due to:
 
  • Non-bronchiectatic chronic obstructive pulmonary disease (emphysema, chronic bronchitis, bronchiolitis obliterans, chronic obstructive pulmonary disease;
  • Bilateral bronchiectasis   
  • idiopathic pulmonary fibrosis;
  • Systemic disease with pulmonary fibrosis (scleroderma, rheumatoid arthritis, sarcoidosis, pulmonary fibrosis post-chemotherapy);
  • Pulmonary hypertension without congenital heart disease;
  • Pulmonary hypertension secondary to congenital heart disease (Eisenmenger’s Syndrome);
  • Combined pulmonary and other organ failure (i.e., advanced liver disease, advanced kidney failure;
  • Lymphangioleiomyomatosis; or
  • Graft failure of an initial lung/lobar transplant, due to either technical reasons or chronic rejection. Lung transplantation meets primary coverage criteria for effectiveness and is covered for children with irreversible lung disease due to:
  • Primary pulmonary hypertension;
  • Pulmonary hypertension associated with structural heart disease;
  • Pulmonary venous stenosis;
  • Pulmonary hypertension associated with parenchymal lung disease (i.e., congenital cystic emphysematous lung diseases); Congenital abnormalities of lung development or of lung adaptation to extrauterine life (e.g., congenital diaphragmatic hernia, congenital surfactant protein B deficiency);
  • Bronchiolitis obliterans;
  • Bronchopulmonary dysplasia;
  • Alpha-1 antitrypsin deficiency   
  • Cystic fibrosis (both lungs to be transplanted)
  • Pulmonary fibrosis; or
  • Graft failure of an initial lung/lobar transplant, due to either technical reasons or chronic rejection.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary
Coverage Criteria
  • Lung transplantation, for any disease, including those listed above, if there is:
  • Dysfunction of major organs other than the lung, particularly renal dysfunction-creatine clearance of less than 50 mg/ml/min-because of the impact of immunosuppressive drugs on renal function;
  • Significant untreatable coronary artery disease or left ventricular dysfunction;
  • Infection with HIV;
  • Hepatitis B antigen positivity;
  • Hepatitis C with biopsy proven histologic evidence of liver disease is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For contracts without primary coverage criteria, lung transplantation, for any disease, including those listed above, if there is:
  • Dysfunction of major organs other than the lung, particularly renal dysfunction-creatine clearance of less than 50 mg/ml/min-because of the impact of immunosuppressive drugs on renal function;
  • Significant untreatable coronary artery disease or left ventricular dysfunction;
  • Infection with HIV;
  • Hepatitis B antigen positivity;
  • Hepatitis C with biopsy proven histologic evidence of liver disease is considered investigational. Investigational services are exclusion in the member benefit contract.
 
Effective Prior to July 2016
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Lung transplantation meets primary coverage criteria for effectiveness and is covered for adult members with irreversible, end stage pulmonary disease with a high risk of death in 2-3 years due to:
        • Non-bronchiectatic chronic obstructive pulmonary disease (emphysema, chronic bronchitis, bronchiolitis obliterans, chronic obstructive pulmonary disease;
        • Idiopathic pulmonary fibrosis;
        • Systemic disease with pulmonary fibrosis (scleroderma, rheumatoid arthritis, sarcoidosis, pulmonary fibrosis post-chemotherapy);
        • Pulmonary hypertension without congenital heart disease;
        • Pulmonary hypertension secondary to congenital heart disease (Eisenmenger’s Syndrome);
        • Combined pulmonary and other organ failure (i.e., advanced liver disease, advanced kidney failure;
        • Lymphangioleiomyomatosis; and
        • Graft failure of an initial lung/lobar transplant, due to either technical reasons or chronic rejection.
 
Lung transplantation meets primary coverage criteria for effectiveness and is covered for children with irreversible lung disease due to:
        • Primary pulmonary hypertension;
        • Pulmonary hypertension associated with structural heart disease;
        • Pulmonary venous stenosis;
        • Pulmonary hypertension associated with parenchymal lung disease (i.e., congenital cystic emphysematous lung diseases);
        • Congenital abnormalities of lung development or of lung adaptation to extrauterine life (e.g., congenital diaphragmatic hernia, congenital surfactant protein B deficiency);
        • Bronchiolitis obliterans;
        • Bronchopulmonary dysplasia;
        • Pulmonary fibrosis; and
        • Graft failure of an initial lung/lobar transplant, due to either technical reasons or chronic rejection.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
  
Lung transplantation, for any disease, including those listed above, if there is:
        • Dysfunction of major organs other than the lung, particularly renal dysfunction-creatine clearance of less than 50 mg/ml/min-because of the impact of immunosuppressive drugs on renal function;
        • Significant untreatable coronary artery disease or left ventricular dysfunction;
        • Infection with HIV;
        • Hepatitis B antigen positivity;
        • Hepatitis C with biopsy proven histologic evidence of liver disease
is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For contracts without primary coverage criteria, lung transplantation, for any disease, including those listed above, if there is:
        • Dysfunction of major organs other than the lung, particularly renal dysfunction-creatine clearance of less than 50 mg/ml/min-because of the impact of immunosuppressive drugs on renal function;
        • Significant untreatable coronary artery disease or left ventricular dysfunction;
        • Infection with HIV;
        • Hepatitis B antigen positivity;
        • Hepatitis C with biopsy proven histologic evidence of liver disease
is considered investigational.  Investigational services are an exclusion in the member benefit contract.
 
Effective prior to August 2012
Lung transplantation meets primary coverage criteria for effectiveness and is covered for adult members with irreversible, end stage pulmonary disease with a high risk of death in 2-3 years due to:
    • Non-bronchiectatic chronic obstructive pulmonary disease (emphysema, chronic bronchitis, bronchiolitis obliterans, chronic obstructive pulmonary disease;
    • Idiopathic pulmonary fibrosis;
    • Systemic disease with pulmonary fibrosis (scleroderma, rheumatoid arthritis, sarcoidosis, pulmonary fibrosis post-chemotherapy);
    • Pulmonary hypertension without congenital heart disease;
    • Pulmonary hypertension secondary to congenital heart disease (Eisenmenger’s Syndrome);
    • Combined pulmonary and other organ failure (i.e., advanced liver disease, advanced kidney failure;
    • Lymphangioleiomyomatosis; and
    • Graft failure of an initial lung/lobar transplant, due to either technical reasons or chronic rejection.
 
Lung transplantation meets primary coverage criteria for effectiveness and is covered for children with irreversible lung disease due to:
    • Primary pulmonary hypertension;
    • Pulmonary hypertension associated with structural heart disease;
    • Pulmonary venous stenosis;
    • Pulmonary hypertension associated with parenchymal lung disease (i.e., congenital cystic emphysematous lung diseases);
    • Congenital abnormalities of lung development or of lung adaptation to extrauterine life (e.g., congenital diaphragmatic hernia, congenital surfactant protein B deficiency);
    • Bronchiolitis obliterans;
    • Bronchopulmonary dysplasia;
    • Pulmonary fibrosis; and
    • Graft failure of an initial lung/lobar transplant, due to either technical reasons or chronic rejection.
 
Lung transplantation, for any disease, including those listed above, if there is:
    • Dysfunction of major organs other than the lung, particularly renal dysfunction-creatine clearance of less than 50 mg/ml/min-because of the impact of immunosuppressive drugs on renal function;
    • Significant untreatable coronary artery disease or left ventricular dysfunction;
    • Infection with HIV;
    • 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;
    • Hepatitis B antigen positivity;
    • Hepatitis C with biopsy proven histologic evidence of liver disease
is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For contracts without primary coverage criteria, lung transplantation, for any disease, including those listed above, if there is:
    • Dysfunction of major organs other than the lung, particularly renal dysfunction-creatine clearance of less than 50 mg/ml/min-because of the impact of immunosuppressive drugs on renal function;
    • Significant untreatable coronary artery disease or left ventricular dysfunction;
    • Infection with HIV;
    • 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;
    • Hepatitis B antigen positivity;
    • Hepatitis C with biopsy proven histologic evidence of liver disease
is considered investigational.  Investigational services are an exclusion in the member benefit contract.
Rationale:
2002 Update
A literature search based on the MEDLINE database was conducted for the period of 1995 to October 2002. No published data were identified that would change policy statement. This update focuses on lung transplant registry data from the Scientific Registry of Transplant Recipients for the period of January 1, 1997, to June 30, 2001.  Note that deaths and retransplants are counted as graft failures. The total number of lung transplant procedures may be greater than the number of transplant recipients due to retransplants.
 
Adults (Age 18+)
For 2,160 lung transplant recipients, the 1-year adult transplant recipient survival rate is 77.9%, and the 3-year adult transplant recipient survival rate is 59.9%. For 2,207 lung transplant procedures, the 1-year lung graft survival rate is 75.7%, and the 3-year lung graft survival rate is 58.5%.
 
Pediatric (Age <18)
For 93 lung transplant recipients, the 1-year pediatric transplant recipient survival rate is 77.2%, and the 3-year pediatric transplant survival rate is 59.9%. For 96 lung transplant procedures, the 1-year lung graft survival rate is 82.2%, and the 3-year lung graft survival rate is 43.8%.
 
2006 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.
 
2008 Update
Review of MEDLINE from 2006 through December 2008 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."
 
2013 Update
A literature search of the MEDLINE database was conducted through July 2013. There was no new literature identified that would prompt a change in the coverage statement. A few relative studies were identified and are summarized below.
 
In 2012, Benden and colleagues reviewed pediatric lung transplants that have been reported to the international registry (Benden, 2012). Pediatric patients are defined as those younger than 18 years of age. The authors noted an increase in the number of pediatric lung transplants in recent years; there were 126 transplants in 2010 compared to 73 in 2000. In contrast to adult patients, the most common indication for pediatric patients was cystic fibrosis, accounting for 54% of lung transplants in 6-11 year-olds and 72% of lung transplants in 12-17 year-olds that occurred between 1990 and June 2011. Survival has improved in the recent era, and 5-year survival is not significantly different from adult recipients. The half-life, estimated time at which 50% of recipients have died, was 4.7 years for children and 5.3 years for adults. For children receiving allografts between 2002 and June 2010, the 5-year survival rate was 54% and 7-year survival was 44%. Patients aged 1 to 11 years had a significantly better survival rate than those between the ages of 12 and 17 years (half-life of 6.2 years and 4.3 years, respectively). In the first year after lung transplantation, non-CMV infection and graft failure were the 2 leading causes of death. Bronchiolitis obliterans syndrome was the major cause of death beyond 3 years after transplantation.
 
Also, in 2012, Shields and colleagues reported on infections in 596 consecutive lung transplant recipients treated at a single center occurring in the first 90 days after transplantation (Shields, 2012). A total of 109 patients (18%) developed 138 Staphylococcus aureus infections. The most common type of infection was pneumonia (66 of 138, 48%) followed by tracheobronchitis (36 of 138, 26%) and bacteremia (17 of 138, 12%). Thirteen of 109 (12%) of patients with S aureus infection died within 90 days of the onset of infection. The 1-year mortality rate was higher for patients with S aureus pneumonia (19 of 66, 29%) but not S aureus tracheobronchitis (8 of 36, 22%) compared with uninfected patients (85 of 487, 17%).
 
2014 Update
 
A literature search conducted through July 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
In 2013, Lobo et al reported on 13 lung transplant patients with Mycobacterium abscessus in cystic fibrosis (Lobo, 2013). Survival rates were 77%, 64%, and 50% after transplant at 1, 3, and 5 years, respectively. These results were not significantly different when compared to 154 cystic fibrosis patients treated with lung transplantation who did not have M abscessus (p=0.8).
 
Castleberry et al reported on a retrospective cohort study of lung transplantation with concurrent coronary bypass (CAB) or preoperative percutaneous coronary intervention (PCI) (Castleberry, 2013). Of 898 lung transplants performed during the period between 1997 and 2010, 49 patients also had concurrent CAB and 38 patients had preoperative PCI. All of the intervention groups, including revascularization, had similar rates of perioperative mortality, overall unadjusted survival and adjusted hazard ratio for cumulative risk of death. Postoperative major adverse cardiac event rates were also similar among groups, although postoperative length of stay, intensive care unit time and need for ventilator support increased in patients receiving concurrent CAB with lung transplantation.
 
Retransplantation
In 2013, Kilic et al evaluated data on 390 adult lung retransplantation patients from the UNOS database (Kilic, 2013). Patients received lung retransplantation during the period May 2005 to December 2010 which was after the LAS selection criteria were implemented. Patients with reduced functional status were found to have poorer outcomes than patients with better functional status prior to retransplantation. Using the Karnofsky scale to stratify patients into functional status groups, the authors found the overall 1-year survival of 56% for patients requiring total assistance before retransplantation was significantly lower than the overall 1-year survival of 82% for patients who only required some assistance before retransplantation (p<0.001). The 1-year mortality rate after risk adjustment was also increased significantly for patients requiring total assistance prior to retransplantation (odds ratio, 3.72; p=0.02). While additional patient selection criteria may be useful for lung retransplantation, current LAS criteria are now used.
 
2015 Update
 
A literature search conducted through December 2014 did not reveal any new information that would prompt a change in the coverage statement.
 
2018 Update
A literature search was conducted through June 2018.  There was no new information identified that would prompt a change in the coverage statement.  The key identified literature is summarized below.
 
LUNG TRANSPLANTATION
The Registry of the International Society for Heart and Lung Transplantation contains data from 49,453
adult recipients who received lung transplantation (including lung retransplantation) through June 30, 2015, at 134 transplant centers (RISHLT, 2015). A total of 55,795 lung transplants were performed, of which 53,522 (95.9%) were primary transplants and 2273 (4.1%) were retransplants. The overall median survival of patients who underwent lung transplantation was 5.8 years. Estimated unadjusted survival rates were 89% at 3 months, 80% at 1 year, 65% at 5 years, and 32% at 10 years. Patients who survived a year after primary transplantation had a median survival of 8.0 years. In the first 30 days after transplantation, the major reported causes of mortality were graft failure (24.5%) and non-cytomegalovirus (non-CMV) infections (19.1%) while non-CMV infections became the major cause of death for the remainder of the first year. Beyond the first year, the most common reported causes of mortality were obstructive bronchiolitis/bronchiolitis obliterans syndrome (OB/BOS), graft failure, and non-CMV infections. Beyond 10 years post-transplant, the major causes of mortality were OB/BOS (21.5%), non-CMV infection (16.5%), and nonlymphoma malignancy (13.7%).
 
The International Society for Heart and Lung Transplantation Registry contains a total of 2229 pediatric lung transplants performed through 2014 (ISHLTR, 2014). Most transplants (73%) were done in older children between the ages of 11 and 17 years. Median survival in children who underwent lung transplantation was 5.4 years, similar to survival in adults (mean survival, 5.7 years). However, median survival in children was lower (2.2 years) than in adults (5.6 years) for single-lung transplants.
 
LOBAR LUNG TRANSPLANTATION
Eberlein et al reported on a systematic review of studies on lobar lung transplantation from deceased donors (Eberlein, 2017). Reviewers identified 9 studies comparing outcomes after lobar lung or lung transplant, all of which were single-center retrospective cohort studies. Seven studies were conducted in Europe and one in Australia and one in North America. One-year survival reported in individual studies ranged from 50% to 100% after lobar lung transplant and from 72% to 88% after conventional lung transplant. In a pooled analysis of data from 8 studies, lobar lung transplant recipients (n=284) had a significantly higher risk of 1-year mortality than lung transplant recipients (n=2777) (relative risk [RR], 1.85; 95% CI, 1.52 to 2.25; p<0.001; I2=0%).
 
LUNG OR LOBAR RETRANSPLANTATION
The Organ Procurement and Transplantation Network has reported data on lung transplants performed between 2008 and 2015 (OPTN, 2015). Patient survival rates after repeat transplants were lower than primary transplants, but a substantial number of patients survived. For example, 1-year patient survival was 87.9% (95% CI, 87.2% to 88.7%) after a primary lung transplant and 76% (95% CI, 70.9% to 80.2%) after a repeat transplant. Five-year patient survival rates were 55.9% (54.7% to 57.2%) after a primary lung transplant and 33.8% (28.5 to 39.1%) after repeat transplant.
 
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through June 2019. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Paraskeva et al analyzed survival rates of adolescent lung transplant recipients using data from the International Society for Heart and Lung Transplantation Registry (Paraskeva, 2018). Patients between 10 and 24 years old represented 9% of the registry data (n=2319) and they were compared with both old and young cohorts. Overall survival in the adolescent cohort was 65% at 3 years, which was similar to that observed in adults between 50 and 65 years of age, but significantly lower than 3-year survival rate among the pediatric subgroup (73%; p=0.006) or adults 25 to 34 years old (75%; p<0.001) and 35 to 49 years old (71%; p<0.001). Within the adolescent group, patients between 15 and 19 years of age had the poorest survival rates at 3 years (59%) compared with 10- to 14-year old patients (73%) and 20- to 24-year old year patients (66%,) (both p<0.001). The registry study was biased toward inclusion of North American data and potential data entry errors or missing data. There were no data reported on the cause of mortality, differences in regimens, or rates of graft dysfunction between the groups.
 
Biswas Roy et al published a single-center retrospective study comparing survival outcomes in 29 patients who received retransplantation for chronic lung allograft dysfunction with 390 patients receiving a primary lung transplant at the same center (Biswas Roy, 2018). Patients receiving retransplantation had significantly higher use of extracorporeal membrane oxygenation support for severe primary graft dysfunction (p=0.019) and underwent cardiopulmonary bypass and re-exploration for bleeding (p=0.019) more frequently than patients receiving primary transplantation (p=0.029). At 1-year follow-up, 89.7% of primary transplant patients were living, as were 89.2% of retransplantation patients. At 5-year follow-up, a greater percentage of the retransplantation group had survived, compared with the primary transplantation group (64.3% vs 58.2%), although the difference was not statistically significant. While high LAS and extended hospital length of stay were both identified as independent mortality risk factors, retransplantation was not (hazard ratio, 1.58; 95% CI, 0.31 to 8.08; p=0.58). Study limitations included its single-center, retrospective design, the potential selection bias for younger patients, and the small size of the retransplantation group. Further, follow-up data at 3 and 5 years were incomplete for some patients and patients who were refused retransplantation were not considered in the analyses. However, for appropriately selected patients, retransplantation after chronic lung allograft dysfunction resulted in 1- and 5-year survival rates comparable to those seen after primary lung transplantation.
 
Potential Contraindications
HIV Infection
Currently Organ Procurement and Transplantation Network policy permits HIV-positive transplant candidates (OPTN, 2018).
 
The British HIV Association and the British Transplantation Society updated their guidelines on kidney transplantation in patients with HIV disease (Working Party of the British Transplantation Society, 2017).
 
These criteria may be extrapolated to other organs:
 
    • Adherent with treatment, particularly antiretroviral therapy
    • Cluster of Differentiation 4 count greater than 100 cells/mL (ideally >200 cells/mL) for at least 3 months
    • Undetectable HIV viremia (<50 HIV-1 RNA copies/mL) for at least 6 months
    • No opportunistic infections for at least 6 months
    • No history of progressive multifocal leukoencephalopathy, chronic intestinal cryptosporidiosis, or lymphoma.
 
Practice Guidelines and Position Statements
 
International Society for Heart and Lung Transplantation
Initial Transplant
 
The International Society for Heart and Lung Transplantation published consensus-based guidelines on selection of lung transplant candidates (Orens, 2006). The guidelines stated that:
 
“Lung transplantation is now a generally accepted therapy for the management of a wide range of severe lung disorders, with evidence supporting quality of life and survival benefit for lung transplant recipients. 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.…”
 
In 2014, these recommendations were updated for pulmonary vascular disease (Wells, 2015). The Society recommended including a transplant list for patients with New York Heart Association class III or IV disease, despite 3 months or more of combination therapy. Additional clinical indications included a cardiac index of less than 2 L/min/m2, a mean right atrial pressure of greater than 15 mm Hg, and a 6-minute walk distance of fewer than 350 meters. Also, recommended for transplant listing were significant hemoptysis, pericardial effusion, or signs of progressive right heart failure. Other common indications for lung transplant include interstitial lung disease, idiopathic pulmonary fibrosis, cystic fibrosis, and chronic obstructive pulmonary disease.
 
Retransplant
Lung retransplantation was addressed briefly, with the consensus statement noting that “criteria for candidate selection for lung retransplantation generally mirror the criteria used for selection for initial lung transplantation.”
 
American Thoracic Society et al
Evidence-based recommendations from the American Thoracic Society and 3 international cardiac societies were published in 2011 (Raghu, 2011). For appropriately selected patients with idiopathic pulmonary fibrosis, the group et al recommended lung transplantation (strong recommendation, low-quality evidence)
 
2020 Update
A literature search was conducted through June 2020.  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 June 2021. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Yu et al compared double-lung with single-lung transplantations for outcomes of survival, pulmonary function, surgical indicators, and complications in a meta-analysis of 30 studies (n=1980 recipients of single-lung transplants and n=2112 recipients of double-lung transplants) (Yu, 2019). Overall survival, in-hospital mortality, and postoperative complications besides bronchiolitis obliterans syndrome were similar between the 2 groups. Recipients of double-lung transplants had lower rates of bronchiolitis obliterans syndrome, better postoperative lung function, improved long-term survival, while recipients of single-lung transplants spent less time in surgery, postoperative intensive care unit, and postoperative hospital stay.
 
Current Organ Procurement and Transplantation Network policy permits human immunodeficiency virus (HIV)-positive transplant candidates. The 2020 US Public Health Service guideline also allows for transplantations in HIV-positive recipients with proper screenings and effective regimens for HIV infections (Jones, 2020).
 
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through June 2022. No new literature was identified that would prompt a change in the coverage statement.
 
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through June 2023. 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 published updated consensus-based guidelines on the selection of lung transplant candidates (Leard, 2021). The guidelines states that:
 
    • "Lung transplantation should be considered for adults with chronic, end-stage lung disease who meet all the following general criteria:
    1. High (>50%) risk of death from lung disease within 2 years if lung transplantation is not performed.
    2. High (>80%) likelihood of 5-year post-transplant survival from a general medical perspective provided that there is adequate graft function."
 
The guideline also notes risk factors to be considered in the evaluation of transplant candidates, along with pediatric and disease-specific considerations.
 
The 2021 guideline update briefly addressed lung retransplantation, with the consensus statement noting that "The outcomes after re-transplants are inferior compared to first lung transplants, particularly if the re-transplant is done within the first year after the original transplant or for patients with restrictive allograft syndrome (RAS) [...] In the pre-transplant evaluation of such patients, particular emphasis should be focused on understanding the possible reasons for the graft failure, such as alloimmunization, poor adherence, gastroesophageal reflux, or repeated infections" (Leard, 2021).
 
Evidence-based recommendations from the American Thoracic Society and 3 international cardiac societies were published in 2011 for the diagnosis and management of patients with idiopathic fibrosis (Raghu, 2011). For appropriately selected patients with idiopathic pulmonary fibrosis, the international guideline panel recommended lung transplantation (strong recommendation, low-quality evidence). An updated to this document was published in 2015 in which the committee did not make a recommendation regarding single versus bilateral lung transplantation in patients with idiopathic fibrosis (Raghu, 2015). The committee stated that "it is unclear whether single or bilateral lung transplantation is preferential for long-term outcomes".
 
2024 Update
Annual policy review completed with a literature search using the MEDLINE database through June 2024. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
In 2022, the US Public Health Service published updated guidance for testing transplant candidates aged less than 12 years of age (Free, 2022). They recommended that children less than 12 years of age who have received postnatal infectious disease testing are exempt from repeat pretransplant HIV, HBV, and HCV testing during hospital admission for transplant surgery.
 
In 2022, the American Thoracic Society along with the 3 other international cardiac societies published updated guidance on diagnosis and management of idiopathic pulmonary fibrosis and progressive pulmonary fibrosis (Raghu, 2022). In terms of treatment considerations, the committee stated that "patients at increased risk of mortality should be referred for lung transplantation at diagnosis".
CPT/HCPCS:
32850Donor pneumonectomy(s) (including cold preservation), from cadaver donor
32851Lung transplant, single; without cardiopulmonary bypass
32852Lung transplant, single; with cardiopulmonary bypass
32853Lung transplant, double (bilateral sequential or en bloc); without cardiopulmonary bypass
32854Lung transplant, double (bilateral sequential or en bloc); with cardiopulmonary bypass
32855Backbench standard preparation of cadaver donor lung allograft prior to transplantation, including dissection of allograft from surrounding soft tissues to prepare pulmonary venous/atrial cuff, pulmonary artery, and bronchus; unilateral
32856Backbench standard preparation of cadaver donor lung allograft prior to transplantation, including dissection of allograft from surrounding soft tissues to prepare pulmonary venous/atrial cuff, pulmonary artery, and bronchus; bilateral
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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.

Living donor patient survival rates. United Network for Organ Sharing 1995.

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Raghu G, Rochwerg B, Zhang Y, et al.(2015) An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline: Treatment of Idiopathic Pulmonary Fibrosis. An Update of the 2011 Clinical Practice Guideline. Am J Respir Crit Care Med. Jul 15 2015; 192(2): e3-19. PMID 26177183

Shields RK, Clancy CJ, Minces LR et al.(2012) Staphylococcus aureus infections in the early period after lung transplantation: Epidemiology, risk factors, and outcomes. J Heart Lung Transplant 2012; 31(11):1199-206.

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