MEDICAL POLICY

POLICY
RELATED POLICIES
POLICY GUIDELINES
DESCRIPTION
SCOPE
BENEFIT APPLICATION
RATIONALE
REFERENCES
CODING
APPENDIX
HISTORY

Solid Organ Transplants

Number 7.03.509

Effective Date February 10, 2014

Revision Date(s) 02/10/14; 01/14/13; 01/06/12; 01/11/11; 02/09/10; 03/10/09; 05/13/08; 05/08/07; 05/09/06; 05/10/05; 05/11/04; 01/01/04; 05/13/03; 07/01/02

Replaces 7.03.500, 7.03.502; 7.03.503; 7.03.504, 7.03.505; and 7.03.506

Policy

Kidney transplants, using a deceased or living donor, may be considered medically necessary for patients who have documented end-stage renal disease or imminent end-stage renal disease.

Kidney retransplant after a failed primary kidney transplant may be considered medically necessary.

Pancreas Transplants

  • A combined pancreas-kidney transplant may be considered medically necessary in diabetic patients.
  • Pancreas transplant after a prior kidney transplant may be considered medically necessary in patients with insulin dependent diabetes.
  • A pancreas transplant alone may be considered medically necessary in patients with severely disabling and potentially life-threatening complications due to hypoglycemia unawareness and labile diabetes.
  • Pancreas retransplants after a failed primary pancreas transplant may be considered medically necessary.
  • Pancreas retransplant after two or more prior failed pancreas transplants is considered investigational.

Liver transplants, using a deceased or living donor, may be considered medically necessary for patients with end-stage or imminent end-stage liver failure.

Lung transplants may be considered medically necessary for patients with end-stage pulmonary disease.

Lobar lung transplants may be considered medically necessary for children and adolescents with end-stage pulmonary disease.

Heart Transplants

A human heart transplant may be considered medically necessary for patients with end-stage heart failure.

  • “End stage heart failure” commonly reflects New York classification stage 3 or 4. (These are functional classifications, but describe scenarios that patients will be unlikely to return to normal level of function—without some fundamental change in the physiology, and because of the dysfunction of the organ system in question, other organ systems are showing signs of deterioration.)

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

Heart transplants requiring concurrent coronary artery bypass graft surgery of the donor heart are considered investigational.

Heart/Lung transplants may be considered medically necessary for patients with end-stage cardiac and pulmonary disease.

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

Solid organ transplants other than those addressed above are considered investigational.

Related Policies

7.03.11

Total Artificial Hearts and Implantable Ventricular Assist Devices

7.03.510

Isolated Small Bowel Transplant

8.01.505

Transcatheter Arterial Chemoembolization as a Treatment for Primary or Metastatic Liver Malignancies

8.02.02

Plasma Exchange

Policy Guidelines

A Company Medical Director or his/her designee will review all solid organ transplants for medical necessity against the criteria of the Transplant Center. If the member meets the criteria of the Transplant Center, the transplant may be considered medically necessary. This policy does not apply to Medicare Advantage.

Description

For purposes of this medical policy, solid organ transplants include kidney, pancreas, liver, lung and lobar lung, heart and heart/lung transplants.

Small bowel, small bowel/liver and multivisceral transplants are considered in a separate medical policy. (See Related Policies)

Scope

Medical policies are systematically developed guidelines that serve as a resource for Company staff when determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to the limits and conditions of the member benefit plan. Members and their providers should consult the member benefit booklet or contact a customer service representative to determine whether there are any benefit limitations applicable to this service or supply.*

Benefit Application

See contract language. There may be contract limitations on transplants.

Rationale

2006 Update

A literature search based on the MEDLINE database was performed for the periods of 2005 to April 2006. No published literature was identified that would prompt a change in the policy statement.

Ladowski and colleagues examined the issue of pre-existing malignancy disqualifying patients from solid organ transplantation because of concerns regarding recurrence. Two hundred and fourteen patients who underwent heart transplantation from July 1985 through June 2004 were studied retrospectively. Thirteen of these patients were previously treated for a malignancy before transplantation. Pre-transplant characteristics (age, sex, diabetes, and weight) and post-transplant outcomes (rejection, infection, and survival) were compared. The patients with pre-existing malignancies were younger (47 vs. 54 years), less heavy (73 vs 79 kg), and more likely to be female (54% vs 22%), compared with recipients without a pre-malignancy. Pulmonary vascular resistances, histories of tobacco use, and incidence of pre-transplant diabetes were not different between the 2 groups. The mean duration of follow-up was 2,760 days for the pre-malignancy group vs 2,215 days for the non-pre-malignancy group. Episodes of treated rejection and infection for the pre-malignancy group vs. the non-pre-malignancy group were similar at 1.8 episodes. None of the pre-malignancy patients had recurrence of their original cancer, and the long term survival for the 2 groups was essentially identical 63% at 10 years. The authors hope that this report will enable more patients with cured malignancies to benefit from transplantation.

Cevera and colleagues evaluated lower respiratory tract infections in solid organ transplantation patients to determine microbiologic diagnosis and clinical outcomes. They diagnosed 83 cases of pneumonia, 38 of which were community acquired and 45 were nosocomial. Those with bilateral infiltrates and those who did not experience any improvement after 3 days of treatment underwent bronchoscopy. Bacterial pneumonia was the most frequent diagnosis and mixed infection predominated in the nosocomial group (11/45 nosocomial vs. 1/38 in community). Fiberoptic bronchoscopy with bronchoalveolar lavage had higher diagnostic yield in nosocomial pneumonia (77% vs. 47%). Mortality differences between the 2 groups were 58% nosocomial vs. 8% community-acquired infections. They concluded that solid organ transplant patients with nosocomial pneumonia, or those who needed mechanical ventilation, had a high mortality rate and also benefited from fiberoptic diagnostic techniques.

2007 Update

Garrity, et al, examined the Organ Procurement and Transplantation Network/Scientific Registry of Transplant Recipients data on heart and lung transplantation in the United States from 1996 to 2005. The authors reported the number of heart transplants performed and the size of the heart waiting list continued to drop, reaching 2,126 and 1,334 from 1996 to 2005, respectively. Over the decade, post-transplant graft and patient survival improved, as did the chances for survival while on the heart waiting list. The number of deceased donor lung transplants increased by 78% since1996, reaching 1,407 in 2005 (up 22% from 2004). There were 3,170 registrants awaiting lung transplantation at the end of 2005, down 18% from 2004. Death rates for both candidates and recipients have been dropping, as has the time spent waiting for a lung transplant. Heart-lung transplantation has declined to a small (33 procedures in 2005) but important need in the United States.

Andreoni and Brayman reported kidney and pancreas transplantation in 2005 improved in quantity and outcome quality, despite the increasing average age of kidney graft recipients, with 56% aged 50 or older. Geography and ABO blood type contribute to the discrepancy in waiting time among the decreased donor candidates. Allocation policy changes are decreasing the median times to transplant for pediatric recipients. Overall, 6% more deceased donor kidney transplants were performed in 2005. The largest increase (39%) was in donations after cardiac death. The donations after cardiac death had equivalent outcomes to standard criteria donors. One- 3- and 5-year unadjusted fraft survival was 91%, 80% and 70% for non-expanded criteria donor transplants, 82%, 68% and 53% for expanded criteria donor-deceased donor grafts, and 95%, 88% and 80% for living donor kidney transplants. In 2005, 27% of patients were discharged without steroids compared to 3% in 1999. Acute rejection decreased to 11% in 2004. There was a slight increase in the number of simultaneous pancreas-kidney transplants (895), with fewer pancreas after kidney transplants (343 from 419 in 2004), and a stable number of pancreas alone transplants (129). Pancreas underutilization appears to be an ongoing issue.

2008 Update

A literature search of the MEDLINE database conducted from April 2007 through March 2008 did not identify any additional published studies that would prompt reconsideration of the policy statement, which remains unchanged.

2009 Update

Lung

Orens and colleagues found that in patients with cystic fibrosis there are no absolute contraindications based on either the type of the organism or the pattern of resistance. Alexander reported that infection with Burkholderia cenocepacia is associated with increased mortality in some transplant centers, a factor that may be taken into account when evaluating overall risk for transplant survival.

Liver

Recent literature continues to address expanded criteria for transplantation for hepatocellular carcinoma, predictors of recurrence, the role of neoadjuvant therapy in patients with hepatocellular carcinoma, expanded donor criteria, transplantation and retransplantation for hepatitis C, and living donor transplantation.

Cholangiocarcinoma

In a 2008 review , Heimbach considers the published outcomes of the combined protocol in the context of recent data on outcomes for surgical resection and concludes that outcomes of neoadjuvant chemoradiotherapy with subsequent liver transplantation for patients with early-stage hilar cholangiocarcinoma, which is unresectable, or arising in the setting of primary sclerosing cholangitis are comparable to transplantation for patients with hepatocellular carcinoma and other chronic liver diseases and superior to resection. (35) The author describes intraoperative challenges attributable to the neoadjuvant therapy including severe inflammatory changes and dense fibrosis and suggests that key principles to be considered by centers considering use of the combined protocol include a multidisciplinary approach, pretransplant staging, inclusion of only patients without lymph node metastasis, replacement of irradiated vessels (when possible) and monitoring for postoperative vascular complications. Wu et al describe an extensive surgical procedure combined with radiotherapy. (36) They retrospectively review their experience with surveillance and early detection of cholangiocarcinoma (CC) and en bloc total hepatectomy-pancreaticoduodenectomy-orthotopic liver transplantation (OLT-Whipple) in a small series of patients with early stage CC complicating primary sclerosing cholangitis. Surveillance involved endoscopic ultrasound and endoscopic retrograde cholangiopancreatography and cytological evaluation. Patients diagnosed with CC were treated with combined extra-beam radiotherapy, lesion-focused brachytherapy, and OLT-Whipple. CC was detected in 8 of the 42 patients followed up according the surveillance protocol between 1988 and 2001, and 6 patients underwent OLT-Whipple. One died at 55 months after transplant of an unrelated cause without tumor recurrence, and 5 are without recurrence at 5.7–10.1 years.

Hepatocellular Carcinoma

The evolution of selection criteria continues to be a focus in the literature. In their 2008 review, Schwartz and colleagues argue that selection based exclusively on the Milan criteria risks prognostic inaccuracy due to the diagnostic limitations of imaging procedures and the surrogate nature of size and number of tumors. They predict that evolution of allocation policy will involve the following: 1. the development of a reliable prognostic staging system to help with allocation of therapeutic alternatives; 2. new molecular markers that might improve prognostic accuracy; 3. aggressive multimodality neoadjuvant therapy to downstage and limit tumor progression before transplant and possibly provide information about tumor biology based on response to therapy; and, 4. prioritization for transplantation should consider response to neoadjuvant therapy, time on waiting list, suitability of alternative donor sources. (37) Two papers describe work on identifying predictors of survival and recurrence of disease. Ioannou and colleagues analyzed UNOS data pre- and post-adoption of the MELD allocation system finding a 6-fold increase in recipients with hepatocellular carcinoma and that survival in the MELD era was similar to survival to patients without hepatocellular carcinoma. The subgroup of patients with larger (3-5 cm) tumors, serum alpha-fetoprotein level >455 mg/mL, or a MELD score >20, however, had poor transplantation survival. (38) A predicting cancer recurrence scoring system was developed by Chan et al based on a retrospective review and analysis of liver transplants at 2 centers to determine factors associated with recurrence of hepatocellular carcinoma. Of 116 patients with findings of hepatocellular carcinoma in their explanted livers, 12 developed recurrent hepatocellular carcinoma. Four independent significant explant factors were identified by stepwise logistic regression: size of 1 tumor >4.5 cm, macroinvasion, and bilobar tumor were positive predictors of recurrence, and the presence of only well-differentiated hepatocellular carcinoma was a negative predictor. Points were assigned to each factor in relation to its odds ratio. The accuracy of the method was confirmed in two validation cohorts. (39)

Hepatitis C

Mukherjee and Sorrell, reviewing controversies in liver transplantation for hepatitis C, indicate that the greatest opportunity for hepatitis C virus (HCV) eradication is pretransplant before hepatic decompensation. Challenges of treatment post-transplantation include immunosuppressive drugs and abnormal hematologic, infectious, and liver function parameters. The authors list the following factors associated with poor outcomes in liver transplantation for recurrent HCV: high HCV-RNA level pretransplant, non-caucasian ethnicity, advanced donor age, T-cell depleting therapies, inappropriate treatment of Banff A1 ACR with steroid boluses, cytomegalovirus disease, and year of transplantation (worse with recent transplants). They cite the International Liver Transplantation Society Consensus on Retransplantation, which states that the following are associated with worse outcomes of retransplantation: total bilirubin level >10mg/dL, creatinine level >2 mg/dL, age >55 years, development of cirrhosis in the first post-transplant year, and donor age >40 years. (40)

Medicare Policy

Medicare covers adult liver transplantation for end-stage liver disease and for hepatocellular carcinoma. Adult transplantation is excluded for other malignancies. The following conditions must be met for coverage of hepatocellular carcinoma:

  • The patient is not a candidate for subtotal liver resection;
  • The patient's tumor(s) is less than or equal to 5 cm in diameter;
  • There is no identifiable extrahepatic spread of tumor to surrounding lymph nodes, lungs, abdominal organs or bone; and
  • Macrovascular involvement.

The coverage decision can be found at http://www.cms.hhs.gov/mcd/viewncd.asp?ncd_id=260.1&ncd_version=2&basket=ncd%3A260%2E1%3A2%3AAdult+Liver+Transplantation. (Last accessed January 27, 2014.)

2012 Update

Heart

A 2011 study by Jalowiec and colleagues compared clinical outcomes in sex-matched and sex-mismatched heart transplant recipients. (21) They retrospectively reviewed data from 347 heart transplant recipients; 237 (78.7%) received a heart from a same-sex donor, 40 (11.5%) cases involved a female donor and male recipient and 34 (9.8%) cases involved a male donor and female recipient. There was not a statistically significant difference in the mortality rate during the first month post-transplant between the sex-matched and either sex-mismatched group. In adjusted analyses, two of the other 9 study outcomes differed significantly among the 3 groups. The male donor-female recipient group had significantly more treated rejection episodes during the first year post-transplant and significantly more days of rehospitalization after the initial discharge than either of the other 2 groups. The incidence of steroid-induced diabetes, cardiac allograft vasculopathy, non-skin cancers, number of IV-treated infections post-transplant and initial hospital length of stay were not significantly different among groups.

The literature, consisting of case series and registry data, continues to demonstrate that heart transplantation provides a survival benefit in appropriately selected patients, compared to the exceedingly poor expected survival without transplantation. Despite an improvement in prognosis for many patients with advanced heart disease, heart transplant remains a viable treatment for those who have exhausted other medical or surgical remedies, yet remain in end-stage disease. Heart transplantation 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.

Pediatric Considerations

A retrospective review of pediatric cardiac transplantation patients was published by Auerbach and colleagues in 2011. A total of 191 patients who underwent primary heart transplantation at a single center in the United States were included; their mean age was 9.7 years (range= 0 to 23.6 years). Overall graft survival was 82% at 1 year and 68% at 5 years; the most common causes of graft loss were acute rejection and graft vasculopathy. Overall patient survival was 82% at one year and 72% at 5 years. In multivariate analysis, the authors found that congenital heart disease (HR= 1.6, 95% CI=1.02-2.64) and requiring mechanical ventilation at the time of transplantation (HR=1.6, 95% CI=1.13-3.10) were both significantly independently associated with an increased risk of graft loss. Renal dysfunction was a significant risk factor in univariate analysis, but was not included in the multivariate model due to the small study group. Limitations of the study include that it was retrospective and conducted in only one center.

Lung

Survival

The Registry of the International Society for Heart and Lung Transplantation (ISHLT) had reports from centers around the world of 3,272 lung transplants performed in 2009. The overall median survival of patients who underwent lung transplantation between 1994 and June 2010 was 5.5 years. In the first 30 days after transplantation and the first year, the major reported causes of mortality were graft failure and non- cytomegalovirus (CMV) infections. Beyond the first year, the most common reported causes of mortality were bronchiolitis obliterans and non-CMV infections. Over time, the proportion of patients who died from malignancies increased; malignancies accounted for 15% of all deaths between 5 and 10 years after transplant.

Pancreas

The Pancreas Allotransplantation for Diabetic Nephropathy and Mild Chronic Renal Failure Stage (PANCREAS) Study (NCT01067950) is currently recruiting participants at Nantes University in France. The stated objective of the study is to assess the superiority of isolated pancreas transplant to intensive insulin therapy in Type 1 diabetes patients with overt proteinuric nephropathy and mildly reduced renal function. This is to be an open-label, randomized trial. The primary combined endpoint is to be patient mortality and renal function impairment at five years. Secondary endpoints measuring safety and extrarenal diabetic complications are planned. If completed, this would represent the first RCT comparing pancreas transplant to insulin therapy.

Heart/Lung

Pediatric Considerations

In 2010, Aurora and colleagues reported on pediatric heart/lung transplants which have reported to the international registry. 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.

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.

Medicare National Coverage

Cardiac transplantation is covered under Medicare when performed in a facility that is approved by Medicare as meeting institutional coverage criteria, approximately 108 programs across the nation. The Centers for Medicare and Medicaid Services (CMS) has stated that under certain limited cases, exceptions to the criteria may be warranted if there is justification and if the facility ensures safety and efficacy objectives.

The AHA Council on Cardiovascular Disease in the Young; the Councils on Clinical Cardiology, Cardiovascular Nursing, and Cardiovascular Surgery and Anesthesia; and the Quality of Care and Outcomes Research Interdisciplinary Working Group stated in 2007 that, based on level B (non-randomized studies) or level C (consensus opinion of experts), heart transplantation is indicated for pediatric patients as therapy for the following indications:

  • Stage D heart failure (interpreted as abnormal cardiac structure and/or function, continuous infusion of intravenous inotropes, or prostaglandin E1 to maintain patency of a ductus arteriosus, mechanical ventilatory and/or mechanical circulatory support) associated with systemic ventricular dysfunction in patients with cardiomyopathies or previous repaired or palliated congenital heart disease
  • Stage C heart failure (interpreted as abnormal cardiac structure and/or function and past or present symptoms of heart failure) associated with pediatric heart disease and severe limitation of exercise and activity, in patients with cardiomyopathies or previously repaired or palliated congenital heart disease and heart failure associated with significant growth failure attributed to heart disease, pediatric heart disease with associated near sudden death and/or life-threatening arrhythmias untreatable with medications or an implantable defibrillator, or in pediatric restrictive cardiomyopathy disease associated with reactive pulmonary hypertension,
  • Feasible in the presence of other indications for heart transplantation, in patients with pediatric heart disease and an elevated pulmonary vascular resistance index >6 Woods units/m2 and/or a transpulmonary pressure gradient >15 mm Hg if administration of inotropic support or pulmonary vasodilators can decrease pulmonary vascular resistance to <6 Woods units/m2 or the transpulmonary gradient to <15 mm Hg.

2013 Update

Kidney – In 2012, Fournier and colleagues in France reported on long-term follow-up of individuals who had donated a kidney between 1952 and 2008. (30) Of a total of 398 donors at a single institution, 266 (67%) were alive, 44 (11%) were documented as having died and 88 (22%) were lost to follow-up. Among individuals who were known to have died, death occurred at a mean of 29.6 years after donation. Donor survival did not differ from that of the general population in France. Fifty-nine of 68 (87%) living individuals who had donated a kidney more than 30 years ago responded to a questionnaire. According to questionnaire responses, the mean serum creatinine level was 93.2 +/- 22.5 umol/L, no patient had an estimated GFR less than 30 mL/min per 1.73 m2 and none had ESRD.

Pancreas – In 2011, Sampaio and colleagues published an analysis of data from the United Network for Organ Sharing (UNOS) database. (31) The investigators compared outcomes in 6,141 patients with type 1 diabetes and 582 patients with type 2 diabetes who underwent SPK between 2000 and 2007. In adjusted analyses, outcomes were similar in the 2 groups. After adjusting for other factors such as body weight; dialysis time; and cardiovascular comorbidities, type 2 diabetes was not associated with an increased risk of pancreas or kidney graft survival, or mortality compared to type 1 diabetes.

Lung – A 2012 study reported on outcomes in patients with lung cancer who were lung transplant recipients. (12) Ahmad and colleagues identified 29 individuals in the UNOS database who underwent lung transplantation for advanced bronchoalveolar carcinoma (BAC). These patients represented 0.13% of the 21,553 lung transplantations during the study period. BAC and general lung transplant recipients had similar survival rates: the 30-day mortality rate was 7% versus 10% (p=0.44) and 5-year survival rate was 50% versus 57% (p=0.66), all respectively.

Heart – In 2012, Kilic and colleagues analyzed data from the UNOS on 5,330 patients age 60 and older (mean age 63.7 years) who underwent heart transplantation between 1995 and 2004. (33) A total of 3,492 individuals (65.5%) survived to 5 years. In multivariate analysis, statistically significant predictors of 5-year survival included younger age (OR: 0.97, 95% CI: 0.95 to 1.00), younger donor age (OR: 0.99, 95% CI: 0.99-1.00), white race (OR: 1.23, 95% CI: 1.02 to 1.49), shorter ischemic time (OR: 0.93, 95% CI: 0.87-0.99), and lower serum creatinine (OR: 0.92, 95% CI: 0.87 to 0.98). In addition, hypertension, diabetes, and mechanical ventilation each significantly decreased the odds of surviving to 5 years. Patients with 2 or more of these factors had a 12% lower rate of 5-years survival than those with none of them.

Heart/Lung – In 2012, the Registry of the International Society for Heart and Lung Transplantation (ISHLT) reported on pediatric heart/lung transplant data collected through June 2011. (34) In recent years, the number of heart/lung transplant procedures in children has decreased, and the number of lung transplants has increased. There have not been any heart/lung transplants in infants since 2007. Overall, survival rates after heart/lung transplants are comparable in children and adults (median half-life of 4.7 and 5.3 years, respectively). For pediatric heart/lung transplants that occurred between January 1990 and June 2010, the 5-year survival rate was 49%. The 2 leading causes of death in the first year after transplantation were non-cytomegalovirus infection and graft failure. Beyond 3 years post-transplant, the major cause of death was bronchiolitis obliterans syndrome.

2014 Update

Kidney-A 2013 study by Johnston and colleagues compared outcomes in 3,509 patients who underwent a preemptive second kidney transplant, defined as transplantation after fewer than 7 days of dialysis following graft failure, to outcomes in 14,075 patients who underwent a non-preemptive second kidney transplant. (35) Data from the U.S. Renal Data System (USRDS) were reviewed. In the first year after retransplantation, there was a significantly lower risk of acute rejection in patients receiving a preemptive second transplant (12%) compared to those with a non-preemptive second transplant (16%), p<0.0001. In a multivariate analysis adjusting for demographic differences between groups, there was a significantly lower risk of allograft failure by any cause including death after preemptive second transplants compared to non-preemptive second transplants (hazard ratio [HR]: 0.88, 95% CI: 0.81 to 0.96).

Pancreas- In 2013, Buron and colleagues reported on their experience with pancreas retransplantation in France and Geneva. (36) Between 1976 and 2008, 568 pancreas transplants were performed at 2 centers, including 37 repeat transplants. Patient survival after a repeat pancreas transplant was 100% after 1 year and 89% after 5 years. Graft survival was 64% at 1 year and 46% at 5 years. Among the 17 patients who underwent a second transplant in a later time period i.e., between 1995 and 2007, graft survival was 71% at 1 year and 59% at 5 years. In this more recently transplanted group, graft survival rates were similar to primary pancreas transplants, which was 79% at 1 year and 69% at 5 years.

Heart- In 2013, Saito et al. published a retrospective review of data on 593 heart transplants performed at their institution, 22 of these (4%) were re transplantations.(37) The mean interval between initial and repeat transplant was 5.1 years. The indications for a repeat transplant were acute rejection in 7 patients (32%), graft vascular disease in 10 patients (45%), and primary graft failure in 5 patients (23%). Thirty day mortality after cardiac retransplantation was 32% (7 of 22 patients). Among patients who survived the first 30 days (n=15), 1-, 5-, and 10-year survival rates were 93.3%, 79% and 59%, respectively. Comparable survival rates for patients undergoing primary cardiac transplants at the same institution (n=448) were 93%, 82%, and 63%, respectively. An interval of 1 year or less between the primary and repeat transplantation significantly increased the risk of mortality. Three of 9 patients (33.3%) with less than a year between the primary and retransplantation survived to 30 days. In comparison 12 of 13 patents (92%) with at least a year between primary and retransplantation were alive at 30 days after surgery.

Heart/Lung-Repeat heart-lung transplant procedures have been performed; only 1 published study was found that reported on outcomes after repeat heart-lung transplants. The study, published by Shuhaiber and colleagues in 2008, involved a review of data from the UNOS registry.(38) The authors identified 799 primary heart-lung and 19 repeat heart-lung transplants. According to Kaplan-Meier survival analysis, the observed median survival times were 2.08 years after primary transplant and 0.34 years after repeat transplants. In addition, the authors analyzed survival data in matched pairs of primary and repeat transplant patients, who were matched on a number of potentially confounding demographic and clinical characteristics. Matches were not available for 4 repeat transplant patients. For the 15 repeat transplant patients with primary transplant matches, survival time did not differ significantly in the 2 groups. Being on a ventilator was statistically significantly associated with decreased survival time. The main limitation of this analysis is the small number of repeat transplant procedures performed.

References

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  27. Jalowiec A, Grady KL, White-Williams C et al. First-year clinical outcomes in gender-mismatched heart transplant recipients. J Cardiovasc Nurs 2012 Nov-ec;27(6):519-27. doi 10.1097/JCN.0b013e31822ce6c9. Last accessed January 2, 2013.
  28. Christie JD, Edwards LB, Kucheryavaya AY et al. The Registry of the International Society for Heart and Lung Transplantation: twenty-eighth official adult lung and heart-lung transplant report. 2011. J Heart Lung Transplant 2011; 30(10):1104-22.
  29. Clinical Trial Registry of the U. S. National Institutes of Health. Pancreas Allotransplantation for Diabetic Nephropathy and Mild Chronic Renal Failure Stage (PANCREAS) trial. Available online at: http://clinicaltrials.gov/ct2/show/NCT01067950?term=pancreas+transplant&rank=4. Last accessed January 2, 2013.
  30. Fournier C, Pallet N, Cherqaoui Z et al. Very long-term follow-up of living kidney donors. Transpl Int 2012; 25(4):385-90.
  31. Sampaio MS, Kuo HT, Bunnapradist S. Outcomes of simultaneous pancreas-kidney transplantation in type 2 diabetic patients. Clin J Am Soc Nephrol 2011; 6(5):1198-206.
  32. Ahmad U, Wang Z, Bryant AS et al. Outcomes for lung transplantation for lung cancer in the United Network for Organ Sharing Registry. Ann Thorac Surg 2012; 94(3):935-40; discussion 40-1.
  33. Kilic A, Weiss ES, George TJ et al. What predicts long-term survival after heart transplantation? An analysis of 9,400 ten-year survivors. Ann Thorac Surg 2012; 93(3):699-704.
  34. Benden C, Edwards LB, Kucheryavaya AY et al. 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.
  35. Johnston O, Rose CL, Gill JS et al. Risks and benefits of preemptive second kidney transplantation. Transplantation 2013; 95(5):705-10.
  36. Buron F, Thaunat O, Demuylder-Mischler S et al. Pancreas Retransplantation: A Second Chance for Diabetic Patients? Transplantation 2013; 95(2):347-52.
  37. Saito A, Novick RJ, Kiaii B et al. Early and late outcomes after cardiac retransplantation. Can J Surg 2013; 56(1):21-6.
  38. Shuhaiber JH, Kim JB, Gibbons RD. Repeat heart-lung transplantation outcome in the United States. J Heart Lung Transplant 2008; 27(10):1122-7.
  39. Blue Cross and Blue Shield Association. Medical Policy Reference Manual, Policy No. 7.03.01, 7.03.02,7.03.06, 7.03.07, 7.03.08, 7.03.09, 2013.

Coding

Codes

Number

Description

CPT

32850

Donor pneumonectomy(s) (including cold preservation), from cadaver donor

 

32851

Lung transplant, single; without cardiopulmonary bypass

 

32852

with cardiopulmonary bypass

 

32853

Lung transplant, double (bilateral, sequential, or en bloc); without cardiopulmonary bypass

 

32854

with cardiopulmonary bypass

 

32855

Backbench 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

 

32856

bilateral

 

33930

Donor cardiectomy-pneumonectomy (including cold preservation)

 

33933

Backbench standard preparation of cadaver donor heart/lung allograft prior to transplantation, including dissection of allograft from surrounding soft tissues to prepare aorta, superior vena cava, inferior vena cava, and trachea for implantation

 

33935

Heart-lung transplant with recipient cardiectomy- pneumonectomy

 

33940

Donor cardiectomy (including cold preservation)

 

33944

Backbench standard preparation of cadaver donor heart allograft prior to transplantation, including dissection of allograft from surrounding soft tissues to prepare aorta, superior vena cava, inferior vena cava, pulmonary artery, and left atrium for implantation

 

33945

Heart transplant, with or without recipient cardiectomy

 

33960

Prolonged extracorporeal circulation for cardiopulmonary insufficiency; initial 24 hours

 

47133

Donor hepatectomy (including cold preservation), from cadaver donor

 

47135

Liver allotransplantation; orthoptic; partial or whole, from cadaver or living donor, any age

 

47136

heterotrophic, partial or whole, from cadaver or living donor, any age

 

47140

Donor hepatectomy (including cold preservation), from living donor; left lateral segments only (segments II and III)

 

47141

total left lobectomy (segments II, III, and IV)

 

47142

total right lobectomy (segments V, VI, VII and VIII)

 

47143

Backbench standard preparation of cadaver donor whole liver graft prior to allotransplantation, including cholecystectomy, if necessary, and dissection and removal of surrounding soft tissues to prepare the vena cava, portal vein, hepatic artery, and common bile duct for implantation; without trisegment or lobe split

 

47144

with trisegment split of whole liver graft into two partial liver grafts (i.e., left lateral segment (segments II and III) and right trisegment (segments I and IV through VIII))

 

47145

with lobe split of whole liver graft into two partial liver grafts (i.e., left lobe (segments II, III, and IV) and right lobe (segments I and V through VIII))

 

47146

Backbench reconstruction of cadaver or living donor liver graft prior to allotransplantation; venous anastomosis, each

 

47147

arterial anastomosis, each

 

48550

Donor pancreatectomy (including cold preservation), with or without duodenal segment for transplantation

 

48551

Backbench standard preparation of cadaver donor pancreas allograft prior to transplantation, including dissection of allograft from surrounding soft tissues, splenectomy, duodenotomy, ligation of bile duct, ligation of mesenteric vessels, and Y-graft arterial anastomoses from iliac artery to superior mesenteric artery and to splenic artery

 

48552

Backbench reconstruction of cadaver donor pancreas allograft prior to transplantation, venous anastomosis, each

 

48554

Transplantation of pancreatic allograft

 

50300

Donor nephrectomy (including cold preservation); from cadaver, unilateral or bilateral

 

50320

open from living donor

 

50323

Backbench standard preparation of cadaver donor renal allograft prior to transplantation, including dissection and removal of perinephric fat, diaphragmatic, and retroperitoneal attachments, excision of adrenal gland, and preparation of ureter(s), renal vein(s), and renal artery(s), ligating branches, as necessary

 

50325

Backbench standard preparation of living donor renal allograft (open or laparoscopic) prior to transplantation, including dissection and removal of perinephric fat, and preparation of ureter(s), renal vein(s), and renal artery(s), ligating branches, as necessary

 

50327

Backbench reconstruction of cadaver or living donor renal allograft prior to transplantation; venous anastomosis, each

 

50328

arterial anastomosis, each

 

50329

ureteral anastomosis, each

 

50340

Recipient nephrectomy (separate procedure)

 

50360

Renal allotransplantation; implantation of graft; without recipient nephrectomy

 

50365

with recipient nephrectomy

 

50547

Laparoscopic, surgical; donor nephrectomy (including cold preservation), from living donor

 

76776

Ultrasound, transplanted kidney, real time and duplex Doppler with image documentation

ICD-9-Procedure

39.61

Extracorporeal circulation auxiliary to open heart surgery

 

50.22

Partial hepatectomy

 

55.51

Nephroureterectomy

 

55.54

Bilateral nephrectomy

HCPCS

S2060

Lobar lung transplantation

 

S2061

Donor lobectomy (lung) for transplantation, living donor

 

S2065

Simultaneous pancreas kidney transplantation 

Type of Service

Surgery

 

Place of Service

Inpatient

 

Appendix

N/A

History

Date

Reason

07/01/02

Add to Surgery Section - New Policy. Replaces other transplant policies (PR.7.03.100, 102, 103, 104, 105, and 106)

05/13/03

Replace Policy - Scheduled review. References added and CPT code table updated.

01/01/04

Replace Policy - CPT code updates only.

05/11/04

Replace Policy - Policy reviewed by Nancy Aceto no changes needed at this time; new review date only. Appendices removed—no value.

09/01/04

Replace Policy - Policy renumbered from PR.7.03.109. No changes to dates.

05/10/05

Replace Policy - Scheduled review. References added. No change to policy statement.

02/06/06

Codes updated - No other changes.

05/09/06

Replace Policy - Scheduled review. References added; no change to policy statement.

05/26/06

Scope and Disclaimer Updates - No other changes.

02/26/07

Codes Updated - No other changes.

05/08/07

Replace Policy - Policy updated with literature review; reference added. No change in policy statement.

05/21/07

References Updated - Policy updated with information on Medicare coverage of heart transplants.

05/13/08

Replace Policy - Policy updated with literature search. Policy statement to include using a cadaver or living donor under kidney transplants as a medically necessary indication. Also to include “imminent end-stage liver failure” for patients under liver transplants as medically necessary.

03/10/09

Replace Policy - Policy updated with literature search; references added. No change to policy statement.

02/09/10

Replace Policy - Policy updated with literature search. No change to policy statement.

01/11/11

Replace Policy - Policy updated with literature search. No change to policy statement.

01/06/12

Replace Policy – Policy updated with literature search; references added. No change to policy statement.

12/03/12

Update title to Related Policy 7.03.11.

01/29/13

Replace policy. Policy updated with literature search. No change to policy statement. References updated.

02/12/13

Update Related Policies, change title for 8.02.02.

05/30/13

Update Related Policies. Change title for 7.03.510.

02/10/14

Replace policy. Retransplant policy statements added to kidney, heart, heart/lung. Literature updated. References 35-39 added. ICD-9 Diagnosis codes were listed for informational purposes only and have been removed from the policy.

03/11/14

Coding Update. Codes 33.50, 33.51, 33.52, 33.6, 37.5, 50.4, 50.51, 50.59, 52.80, 52.81, 52.82, 52.83, and 55.69 were removed per ICD-10 mapping project; these codes are not utilized for adjudication of policy.


Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit booklet or contact a member service representative to determine coverage for a specific medical service or supply. CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA).
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