Coverage Policy Manual
Policy #: 1998105
Category: Surgery
Initiated: August 2017
Last Review: July 2018
  Transplant, Lung and Lobar Lung

Description: A lung transplant refers to single-lung or double-lung replacement. In a single-lung transplant, only one lung from a cadaver donor is provided to the recipient. In a double-lung transplant, the recipient's lungs are removed and replaced by the donor's lungs.  Lung transplants have been done successfully since the 1980's.  The number of donor lungs is considerably less than the number of potential recipients; for this reason transplant physicians and surgeons representing the International Society of Heart and Lung Transplantation, the American Society of Transplant Physicians, the American Thoracic Society, the European Respiratory Society, and the Thoracic Society of Australia and New Zealand have developed guidelines for the appropriate selection of patients.  These coverage guidelines reflect the recommendations of these transplant and lung societies.

In a lobar transplant, a lobe of the donor's lung is excised, sized appropriately for the recipient's thoracic dimensions and is transplanted. Donors for lobar transplant have been primarily living related donors, with one lobe obtained from each of two donors (e.g., mother and father) in cases where a bilateral transplant is required, there are also cases of cadaver lobe transplants.

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 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;
  • 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 21016
 
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.

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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Benden C, Edwards LB, Kucheryavaya AY et al.(2012) The registry of the International Society for Heart and Lung Transplantation: fifteenth pediatric lung and heart-lung transplantation report--2012. J Heart Lung Transplant 2012; 31(10):1087-95.

Bisson A, Bonnette P, El Kadi NB, et al.(1994) Bilateral pulmonary lobe transplantation: left lower and right middle and lower lobes. Ann Thor Surg 1994; 57:219-21.

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Cohen RG, Barr ML, Schenkel FA, et al.(1994) Living related donor lobectomy for bilateral lobar transplantation in patients with cystic fibrosis. Ann Thor Surg 1994; 57:1423-28.

Eberlein M, Reed RM, Chahla M, et al.(2017) Lobar lung transplantation from deceased donors: A systematic review. World J Transplant. Feb 24 2017;7(1):70-80. PMID 28280698

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