|MP 7.03.02||Allogeneic Pancreas Transplant|
Original Policy Date
Last Review Status/Date
Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract. Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage. Medical technology is constantly changing, and we reserve the right to review and update our policies periodically.
Achievement of insulin independence with resultant decreased morbidity and increased quality of life is the primary health outcome of pancreas transplantation. While pancreas transplantation is generally not considered a life-saving treatment, in a small subset of patients who experience life-threatening complications from diabetes, pancreas transplantation could be considered life-saving. Pancreas transplant alone (PTA) has also been investigated in patients following total pancreatectomy for chronic pancreatitis. In addition to the immune rejection issues common to all allograft transplants, autoimmune destruction of beta cells has been observed in the transplanted pancreas, presumably from the same mechanism responsible for type 1 diabetes.(2)
Pancreas transplantation occurs in several different scenarios such as: (1) a diabetic patient with renal failure who may receive a cadaveric simultaneous pancreas/kidney (SPK) transplant; (2) a diabetic patient who may receive a cadaveric or living-related pancreas transplant after a kidney transplantation (pancreas after kidney [PAK]); or (3) a nonuremic diabetic patient with specific severely disabling and potentially life-threatening diabetic problems who may receive a PTA. The total number of adult pancreas transplants (pancreas and pancreas/kidney) in the United States peaked at 1484 in 2004; the number has since declined.3 In 2013, 214 PTAs and 651 SPKs were performed in the United States.
According to International Registry data, the proportion of pancreas transplant recipients worldwide who have type 2 diabetes has increased over time, from 2% in 1995 to 7% in 2010.(1) In 2010, approximately 8% of SPK, 5% of PAK, and 1% of PTA were performed in patients with type 2 diabetes.
The approach to retransplantation varies according to the cause of failure. Surgical/technical complications such as venous thrombosis are the leading cause of pancreatic graft loss among diabetic patients. Graft loss from chronic rejection may result in sensitization, increasing both the difficulty of finding a cross-matched donor and the risk of rejection of a subsequent transplant. Each center has its own guidelines based on experience; some transplant centers may wait to allow reconstitution of the immune system before initiating retransplant with an augmented immunosuppression protocol.
A combined pancreas-kidney transplant may be considered medically necessary in insulin-dependent diabetic patients with uremia.
Pancreas transplant after a prior kidney transplant may be considered medically necessary in patients with insulin dependent diabetes.
Pancreas transplant alone may be considered medically necessary in patients with severely disabling and potentially life-threatening complications due to hypoglycemia unawareness and labile insulin dependent diabetes that persists in spite of optimal medical management.
Pancreas retransplant after a failed primary pancreas transplant may be considered medically necessary in patients who meet criteria for pancreas transplantation.
Pancreas transplant is considered investigational in all other situations.
Potential contraindications subject to the judgment of the transplant center:
- Known current malignancy, including metastatic cancer
- Recent malignancy with high risk of recurrence
- Untreated systemic infection making immunosuppression unsafe, including chronic infection
- Other irreversible end-stage disease not attributed to kidney or pancreatic disease
- History of cancer with a moderate risk of recurrence
- Systemic disease that could be exacerbated by immunosuppression
- Psychosocial conditions or chemical dependency affecting ability to adhere to therapy
Candidates for pancreas transplant alone should additionally meet 1 of the following severity of illness criteria:
- Documentation of severe hypoglycemia unawareness as evidenced by chart notes or emergency room visits; OR
- Documentation of potentially life-threatening labile diabetes as evidenced by chart notes or hospitalization for diabetic ketoacidosis.
In addition, the vast majority of pancreas transplant patients will have type 1 diabetes mellitus. Those transplant candidates with type 2 diabetes mellitus, in addition to being insulin-dependent, should also not be obese (body mass index [BMI] should be 32 or less). According to International registry data, in 2010, 7% of pancreas transplant recipients had type 2 diabetes. (1)
Although there are no standard guidelines regarding multiple pancreas transplants, the following information may aid in case review:
- If there is early graft loss resulting from technical factors (e.g., venous thrombosis), a retransplant may generally be performed without substantial additional risk.
- Long-term graft losses may result from chronic rejection, which is associated with increased risk of infection following long-term immunosuppression, and sensitization, which increases the difficulty of finding a negative cross-match. Some transplant centers may wait to allow reconstitution of the immune system before initiating retransplant with an augmented immunosuppression protocol.
BlueCard/National Account Issues
Transplant requests should be reviewed by the Plan medical director or his or her designee. Only patients accepted for transplantation by an approved transplantation center and actively listed for transplant should be considered for precertification or prior approval. Guidelines should be followed for transplant network or consortiums, if applicable.
Pancreas transplants should be considered for coverage under the transplant benefit.
What is covered under the scope of the human organ transplant (HOT) benefit needs to be considered. Typically, the following are covered under the HOT benefit:
- hospitalization of the recipient for medically recognized transplants from a donor to a transplant recipient;
- evaluation tests requiring hospitalization to determine the suitability of both potential and actual donors, when such tests cannot be safely and effectively performed on an outpatient basis;
- hospital room, board, and general nursing in semi-private rooms;
- special care units, such as coronary and intensive care;
- hospital ancillary services;
- physicians’ services for surgery, technical assistance, administration of anesthetics, and medical care;
- acquisition, preparation, transportation, and storage of organ;
- diagnostic services;
- drugs that require a prescription by federal law.
Expenses incurred in the evaluation and procurement of organs and tissues are benefits when billed by the hospital. Included in these expenses may be specific charges for participation with registries for organ procurement, operating rooms, supplies, use of hospital equipment, and transportation of the tissue or organ to be evaluated.
Administration of products with a specific transplant benefit needs to be defined as to:
- when the benefit begins (at the time of admission for the transplant or once the patient is determined eligible for a transplant, which may include tests or office visits prior to transplant);
- when the benefit ends (at the time of discharge from the hospital or at the end of required follow-up, including the immunosuppressive drugs administered on an outpatient basis).
Coverage usually is not provided for:
- HOT services, for which the cost is covered/funded by governmental, foundation, or charitable grants;
- organs sold rather than donated to the recipient;
- an artificial organ.
This policy was created in 1996 and updated regularly with searches of the MEDLINE database. Most recently, the literature was reviewed through January 6, 2015. Much of the published literature consists of case series reported by single centers and registry data. The extant randomized controlled trials compare immunosuppression regimens and surgical techniques and therefore do not address the comparison of pancreas transplantation with insulin therapy, or simultaneous pancreas/kidney (SPK) transplant to insulin therapy and hemodialysis.
This policy is based in part on a 1998 TEC Assessment, which focused on pancreas graft survival and health outcomes associated with both pancreas transplant alone (PTA) and pancreas after kidney transplant (PAK).(4) A 2001 TEC Assessment focused on the issue of pancreas retransplant.(5) The assessments and subsequent evidence offer the following observations and conclusions.
Pancreas After Kidney Transplant
PAK transplantation allows the uremic patient the benefits of a living-related kidney graft, if available and the benefits of a subsequent pancreas transplant that is likely to result in improved quality of life compared with a kidney transplant alone. Uremic patients for whom a cadaveric kidney graft is available, but a pancreas graft is not simultaneously available benefit similarly from a later pancreas transplant.
Based on International Pancreas Registry data reported in 2011, the patient survival rate after PAK was 83% at 5 years posttransplant.(1)
In 2009, Fridell et al reported a retrospective review (N=203) of a single center’s experience with PAK and SPK since 2003, when current induction/tacrolimus immunosuppressive strategies became standard.(6) Of the cases studied, 61 (30%) were PAK and 142 (70%) were SPK. One-year patient survival rates were 98% and 95% (PAK and SPK, respectively; p=0.44). Pancreas graft survival rates at 1 year were 95% and 90%, respectively (p=0.28). The authors concluded that in the modern immunosuppressive era, PAK should be considered as an acceptable alternative to SPK in candidates with an available living kidney donor.
In 2012, Bazarbachi et al reviewed a single center’s experience with PAK and SPK.(7) Between 2002 and 2010, 172 pancreas transplants were performed in diabetic patients; 123 SPK and 49 PAK. The median length of time between kidney and pancreas transplantation in the PAK group was 4.8 years. Graft and patient survival rates were similar in the 2 groups. Death-censored pancreas graft survival rates for SPK and PAK were 94% and 90% at 1 year, 92% and 90% at 3 years, and 85% and 85% at 5 years (all, p=0.93, respectively). Patient survival rates (calculated beginning at the time of pancreas transplantation) in the SPK versus PAK groups were, respectively, 98% and 100% after 1 year, 96% and 100% after 3 years, and 94% and 100% after 5 years (all p=0.09).
Kleinclauss et al (2009) retrospectively examined data from diabetic kidney transplant recipients (N=307) from a single center and compared renal graft survival rates in those who subsequently received a pancreatic transplant with those who did not.(8) The comparative group was analyzed separately depending on whether patients were medically eligible for pancreas transplant, but chose not to proceed for financial or personal reasons, or were ineligible for medical reasons. The ineligible (n=57) group
differed significantly at baseline from both the PAK group (n=175) and the eligible group (n=75) with respect to age, type of diabetes, and dialysis experience; kidney graft survival rates in this group were lower compared with both of the other groups, with 1-, 5-, and 10-year rates of 75%, 54%, and 22%, respectively (p<0.001) and 1-, 5-, and 10-year kidney graft survival rates in PAK patients with those in the eligible group: 98%, 82%, and 67% versus 100%, 84%, and 62%, respectively, and concluded that the subsequent transplant of a pancreas after a living donor kidney transplant does not adversely affect patient or kidney graft survival rates.
According to International Registry data through 2005, recent 5-year graft survival rates for SPK transplants were 72% for the pancreas and 80% for the kidney.(9) Ten-year graft survival rates reached almost 60% for SPK transplants. The U.S.-based Organ Procurement and Transplant Network (OPTN) reported a 5-year survival rate of 85.5% (95% confidence interval [CI], 84.3% to 86.7%) for SPK procedures performed between 1997 and 2000.(3)
Pancreas transplant has been found to improve mortality in patients with type 1 diabetes. In 2014, van Dellen et al in the U.K. reported a retrospective analysis of data on 148 SPK patients and a wait-list control group of 120 patients.(10) All patients had uncomplicated type 1 (insulin dependent) diabetes. (The study also included 33 patients who had PAK and 11 PTA patients.) Overall mortality (mortality at any time point) was 30% (30/120 patients) on the waiting list and 9% (20/193 patients) in transplanted patients; the difference between groups was statistically significant (Fisher exact test; p<0.001). One-year mortality was 13% (n=16) on the waiting list and 4% (n=8) in the transplant group (Fisher exact test; p<0.001).
There are some data on outcomes in patients with type 2 compared with type 1 diabetes. In 2011, Sampaio et al published an analysis of data from the United Network for Organ Sharing (UNOS) database.(11) The investigators compared outcomes in 6141 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 between 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 failure or mortality compared with type 1 diabetes.
Pancreas Transplant Alone
PTA graft survival has improved in recent years. According to International Registry data 1-year graft function increased from 51.5% in 1987-1993 to 77.8% in 2006-2010 (p<0.001).(1) One-year immunologic graft loss remained higher (6%) after PTA than PAK (3.7%) or SPK (1.8%). In carefully selected patients with insulin dependent diabetes mellitus (IDDM) and severely disabling and potentially life-threatening complications due to hypoglycemia unawareness and persistent labile diabetes despite optimal medical management, benefits of PTA were judged to outweigh the risk of performing pancreas transplantation with subsequent immunosuppression.
Most patients undergoing PTA are those with either hypoglycemic unawareness or labile diabetes. However, other exceptional circumstances may exist where nonuremic IDDM patients have significant morbidity risks due to secondary complications of diabetes (eg, peripheral neuropathy) that exceed those of the transplant surgery and subsequent chronic immunosuppression. Because virtually no published evidence regarding outcomes of medical management in this very small group of exceptional diabetic patients exists, it is not possible to generalize about which circumstances represent appropriate indications for pancreas transplantation alone. Case-by-case consideration of each patient’s clinical situation may be the best option for determining the balance of risks and benefits.
Noting that nephrotoxic immunosuppression may exacerbate diabetic renal injury after PTA, Scalea et al (2008) reported a single institutional review of 123 patients who received 131 PTA for development of renal failure.(12) Mean graft survival was 3.3 years (range, 0-11.3), and 21 patients were lost to follow-up. At mean follow-up of 3.7 years, mean estimated glomerular filtration rate was 88.9 mL/min/1.73 m² pretransplantation versus 55.6 mL/min/1.73 m² posttransplantation. All but 16 patients had a decrease in estimated glomerular filtration rate. Thirteen developed end-stage renal disease, which required kidney transplantation at a mean of 4.4 years. The authors suggested that patients should be made aware of the risk and only the most appropriate patients offered PTA. Future updates of this policy will continue to follow this clinical topic.
OPTN reported data on transplants performed between 1997 and 2004.(3) Patient survival rates after repeat transplants were similar to survival rates after primary transplants. For example, 1-year survival was 94% (95% CI, 93% to 95%) after a primary pancreas transplant and 96% (95% CI, 93% to 99%) after a repeat pancreas transplant. The numbers of patients transplanted were not reported, but OPTN data stated that 1217 patients were alive 1 year after primary transplant and 256 after repeat transplants. Three-year patient survival was 90% (95% CI, 88% to 91%) after primary transplants and 90% (95% CI, 86% to 94%) after repeat transplants. One-year graft survival was 78% (95% CI, 76% to 81%) after primary pancreas transplant and 70% (95% CI, 65% to 76%) after repeat transplant.
Data are similar for patients receiving combined kidney/pancreas transplants, but follow-up data are only available on a small number of patients who had repeat kidney/pancreas transplants so estimates of survival rates in this group are imprecise. Three-year patient survival was 90% (95% CI, 89% to 91%) after primary combined transplant and 80% (95% CI, 64% to 96%) after a repeat combined transplant. The number of patients who were living 3 years after transplant was 2907 after a primary combined procedure and 26 after a repeat combined procedure.
Several centers have published outcomes after pancreas retransplantation. In 2014, Seal et al reported on 96 consecutive PTA patients treated at a single center in Canada; 78 were initial transplants, and 18 were retransplants.13 Pancreas graft survival was similar for primary transplants and retransplants at 1 year (88% vs 100%, p=0.88) and 3 years (85% in both groups, p=0.99). Patient survival rates were also similar in the 2 groups at 1 year (96% and 100%, p=0.95) and 3 years (93% and 100%, p=0.93). In 2013, Buron et al reported on their experience with pancreas retransplantation in France and Geneva.(14) 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, ie, 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.
Pancreas Transplant in HIV-Positive Transplant Recipients
Current OPTN policy on Identification of Transmissible Diseases states: “OPTN permits HIV test-positive individuals as organ candidates if permitted by the transplant hospital.”(15)
In 2006, the British HIV Association and the British Transplantation Society Standards Committee published guidelines for kidney transplantation in patients with HIV disease.(16) As described earlier, these criteria may be extrapolated to other organs. The guidelines recommend that any patient with end-stage organ disease and life expectancy of at least 5 years is considered appropriate for transplantation under the following conditions:
- CD4 count greater than 200 cells/microliter for at least 6 months
- Undetectable HIV viremia (<50 HIV-1 RNA copies/mL) for at least 6 months
- Demonstrable adherence and a stable HAART [highly active antiretroviral therapy] regimen for at least 6 months
- Absence of AIDS-defining illness following successful immune reconstitution after HAART.
Recipient age older than 50 years has in the past been considered a relative contraindication for pancreas transplant. In the past 5 to 10 years, several analyses of outcomes by patient age group have been published and there is now general agreement among experts that age should not be a contraindication; however, age-related comorbidities are important to consider when selecting patients for transplantation.
In the largest study of pancreas outcomes by recipient age, Siskind et al (2014) used data from the UNOS database.(17) Investigators included all adult patients who received SPK or PTA between 1996 and 2012 (N=20,854). This included 3160 patients between the ages of 50 and 59 years, and 280 patients, 60 years or older. Overall, Kaplan-Meier survival analysis found statistically significant differences in patient survival (p<0.001) and graft survival (p<0.001) among age categories. Graft survival was lowest in the 18-to-29 age group at 1, 5, and 10 years, which the authors noted might be due to early immunologic graft rejection as a result of more robust immune responses. However, 10- and 15-year graft survival was lowest in the 60 and older age group. Patient survival rates decreased with increasing age, and the
differential between survival in older and younger ages increased with longer follow-up intervals. Lower survival rates in patients 50 and older could be due in part to comorbidities at the time of transplantation. Also, as patients age, they are more likely to die from other causes. Still, patient survival at 5 and 10 years was relatively high, as shown in Table 1.
Table 1: Patient Survival by Age Group(17)
Age 18-29, %
Age 30-39, %
Age 40-49, %
Age 50-59, %
Age 60+, %
Among previous studies on pancreas outcomes in older patients, Shah et al (2013) reviewed data on 405 patients who underwent PTA between 2003 and 2011.(18) One-year patient survival was 100% for patients younger than age 30 years, 98% for patients age 30 to 39 years, 94% for patients 40 to 49 years, 95% for patients 50 to 59 years, and 93% for patients age 60 or older. There was not a statistically significant difference in patient survival by age (p=0.38). Findings were similar for 1-year graft survival; there was not a statistically significant difference in outcomes by age of transplant recipients (p=0.10).
A 2011 study by Afaneh et al reviewed data on 17 individuals at least 50 years old and 119 individuals younger than 50 years who had a pancreas transplant at a single institution in the United States.(19) The 2 groups had similar rates of surgical complications, acute rejection, and nonsurgical infections. Overall patient survival was similar. Three- and 5-year survival rates were 93% and 90%, respectively, in the younger group, and 92% and 82%, respectively, in the older group. Schenker et al (2011) in Germany compared outcomes in 69 individuals at least 50 years old and 329 individuals younger than 50 years who had received pancreas transplants.(20) Mean duration of follow-up was 7.7 years. One-, 5-, and 10-year patient and graft survival rates were similar in the 2 groups. For example, 5-year patient survival was 89% in both groups. Five-year pancreas graft survival was 76% in the older group and 72% in the younger group. The authors of both studies, as well as the authors of a commentary accompanying the Schenker article,(21) agreed that individuals age 50 years and older are suitable candidates for pancreas transplantation.
Summary of Evidence
The literature, consisting primarily of case series and registry data, demonstrate graft survival rates comparable with other solid organ transplants, as well as attendant risks associated with the immunosuppressive therapy necessary to prevent allograft rejection. No randomized controlled trials have compared any form of pancreas transplant with insulin therapy. Pancreas transplant may be considered medically necessary in patients who are undergoing, or have undergone, kidney transplantation for renal
failure. It may also be considered medically necessary as a stand-alone treatment in patients with hypoglycemia unawareness and labile diabetes, despite optimal medical therapy and in whom severe complications have developed.
Practice Guidelines and Position Statements
In 2014, the Board of Directors of the Organ Procurement and Transplantation Network issued an updated comprehensive list of transplant related policies.(22)
Each candidate registered on the pancreas waiting list must meet one of the following requirements:
- Be diagnosed with diabetes
- Have pancreatic exocrine insufficiency
- Require the procurement or transplantation of a pancreas as part of a multiple organ transplant for technical reasons
The policy also delineated pancreas, kidney-pancreas, and islet allocation, classifications, and rankings.
U.S. Preventive Services Task Force Recommendations
Medicare National Coverage
Allogeneic pancreas transplant is covered under Medicare when performed in a facility that is approved by Medicare as meeting institutional coverage criteria.(23) The Centers for Medicare and Medicaid Services has made the following national coverage decision regarding pancreas transplant for Medicare recipients.
Pancreas transplantation is performed to induce an insulin-independent, euglycemic state in diabetic patients. The procedure is generally limited to those patients with severe secondary complications of diabetes, including kidney failure. However, pancreas transplantation is sometimes performed on patients with labile diabetes and hypoglycemic unawareness.
B. Nationally Covered Indications
Effective for services performed on or after July 1, 1999, whole organ pancreas transplantation is nationally covered by Medicare when performed simultaneous with or after a kidney transplant. If the pancreas transplant occurs after the kidney transplant, immunosuppressive therapy begins with the date of discharge from the inpatient stay for the pancreas transplant.
Effective for services performed on or after April 26, 2006, pancreas transplants alone (PA) are reasonable and necessary for Medicare beneficiaries in the following limited circumstances(24):
1. PA will be limited to those facilities that are Medicare-approved for kidney transplantation.
Patients must have a diagnosis of type I diabetes:
Patient with diabetes must be beta cell autoantibody positive; or
2. Patient must demonstrate insulinopenia defined as a fasting C-peptide level that is less than or equal to 110% of the lower limit of normal of the laboratory's measurement method. Fasting C-peptide levels will only be considered valid with a concurrently obtained fasting glucose ≤225 mg/dL;
3. Patients must have a history of medically-uncontrollable labile (brittle) insulin-dependent diabetes mellitus with documented recurrent, severe, acutely life-threatening metabolic complications that require hospitalization. Aforementioned complications include frequent hypoglycemia unawareness or recurring severe ketoacidosis, or recurring severe hypoglycemic attacks;
4. Patients must have been optimally and intensively managed by an endocrinologist for at least 12 months with the most medically-recognized advanced insulin formulations and delivery systems;
5. Patients must have the emotional and mental capacity to understand the significant risks associated with surgery and to effectively manage the lifelong need for immunosuppression; and,
6. Patients must otherwise be a suitable candidate for transplantation.
C. Nationally Noncovered Indications
The following procedure is not considered reasonable and necessary within the meaning of section 1862(a)(1)(A) of the Social Security Act:
Transplantation of partial pancreatic tissue or islet cells (except in the context of a clinical trial [see section 260.3.1 of the National Coverage Determinations Manual]).
- Gruessner AC. 2011 update on pancreas transplantation: Comprehensive trend analysis of 25,000 cases followed up over the course of twenty-four years at the International Pancreas Transplant Registry. Rev Diabet Stud. 2011;8(1):6-16.
- Hirshberg B. The cardinal features of recurrent autoimmunity in simultaneous pancreas-kidney transplant recipients. Curr Diab Rep. 2010;10(5):321-322.
- Organ Procurement and Transplantation Network (OPTN).
http://optn.transplant.hrsa.gov/ContentDocuments/OPTN_Policies.pdf. Accessed December 1, 2014.
- Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Pancreas Transplantation. TEC Assessments. 1998;Volume 13, Tab 7.
- Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Pancreas Retransplantation. TEC Assessments. 2001;Volume 16, Tab 23.
- Fridell JA, Mangus RS, Hollinger EF, et al. The case for pancreas after kidney transplantation. Clin Transplant. 2009;23(4):447-453.
- Bazerbachi F, Selzner M, Marquez MA, et al. Pancreas-After-Kidney Versus Synchronous Pancreas-Kidney Transplantation: Comparison of Intermediate-Term Results. Transplantation. Nov 21 2012. PMID 23183776
- Kleinclauss F, Fauda M, Sutherland DE, et al. Pancreas after living donor kidney transplants in diabetic patients: impact on long-term kidney graft function. Clin Transplant. 2009;23(4):437-446.
- Gruessner AC, Sutherland DE, Gruessner RW. Long-term outcome after pancreas transplantation. Curr Opin Organ Transplant. 2012;17(1):100-105.
- van Dellen D, Worthington J, Mitu-Pretorian OM, et al. Mortality in diabetes: pancreas transplantation is associated with significant survival benefit. Nephrol Dial Transplant. May 2013;28(5):1315-1322. PMID 23512107
- 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):1198-1206.
- Scalea JR, Butler CC, Munivenkatappa RB, et al. Pancreas transplant alone as an independent risk factor for the development of renal failure: a retrospective study. Transplantation. 2008;86(12):1789-1794. PMID
- Seal J, Selzner M, Laurence J, et al. Outcomes of Pancreas Retransplantation After Simultaneous Kidney-Pancreas Transplantation Are Comparable to Pancreas After Kidney Transplantation Alone. Transplantation. Aug 21 2014. PMID 25148379
- Buron F, Thaunat O, Demuylder-Mischler S, et al. Pancreas Retransplantation: A Second Chance for Diabetic Patients? Transplantation. Jan 27 2013;95(2):347-352. PMID 23222920
- Organ Procurement and Transplantation Network (OPTN). Identification of Transmissible Diseases, effective date 12/04/2014. http://optn.transplant.hrsa.gov/ContentDocuments/OPTN_Policies.pdf. Accessed December 1, 2014.
- Bhagani S, Sweny P, Brook G. Guidelines for kidney transplantation in patients with HIV disease. HIV Med. 2006;7(3):133-139.
- Siskind E, Maloney C, Akerman M, et al. An analysis of pancreas transplantation outcomes based on age groupings--an update of the UNOS database. Clin Transplant. Sep 2014;28(9):990-994. PMID 24954160
- Shah AP, Mangus RS, Powelson JA, et al. Impact of recipient age on whole organ pancreas transplantation. Clin Transplant. Jan-Feb 2013;27(1):E49-55. PMID 23228216
- Afaneh C, Rich BS, Aull MJ, et al. Pancreas transplantation: does age increase morbidity? J Transplant. 2011;2011:596801. PMID 21766007
- Schenker P, Vonend O, Kruger B, et al. Long-term results of pancreas transplantation in patients older than 50 years. Transplant Int. 2011;24(2):136-142.
- Gruessner AC, Sutherland DE. Access to pancreas transplantation should not be restricted because of age. Transplant Int. 2011;24(2):134-135.
- Organ Procurement and Transplantation Network (OPTN). Policies and Bylaws: Deceased Donor Organ Procurement. http://optn.transplant.hrsa.gov/PoliciesandBylaws2/policies/pdfs/policy_7.pdf. Accessed December 1, 2014.
- Centers for Medicare and Medicaid Services (CMS). Medicare approved pancreas and kidney/pancreas transplant centers. http://www.cms.gov/CertificationandComplianc/Downloads/ApprovedTransplantPrograms.pdf. Accessed December 1, 2014.
- Centers for Medicare and Medicaid Services (CMS). National Coverage Determination (NCD) for pancreas Transplants (260.3). Effective 4/26/2006. http://www.cms.gov/medicare-coverage-database/overview-and-quicksearch.aspx?clickon=search. Accessed December 1, 2014.
|CPT||48550||Donor pancreatectomy (including cold preservation), with or without duodenal segment for transplantation|
|48551||Backbench standard preservation of cadaver donor pancreas allograft prior to transplantation, including dissection of allograft from surrounding 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|
|ICD-Procedure||52.80||Pancreatic transplant, not otherwise specified|
|52.81||Reimplantation of pancreatic tissue|
|52.82||Homotransplant of pancreas|
|52.83||Heterotransplant of pancreas|
|ICD-9 Diagnosis||250.11, 250.13, 250.21, 250.23, 250.31 and 250.33||Codes for type 1 diabetes mellitus with ketoacidosis, hyperosmolarity or other coma|
|250.41 and 250.43||Codes for type 1 diabetes mellitus with renal complications|
|250.81 and 250.83||Codes for type 1 diabetes mellitus with other specified manifestations|
|250.91 and 250.93||Codes for type 1 diabetes mellitus with unspecified complication|
|996.86||Complication of transplanted organ; pancreas|
|HCPCS||S2065||Simultaneous pancreas kidney transplantation|
|ICD-10-CM (effective 10/1/15)||E10.10-E10.11||Type I diabetes mellitus with ketoacidosis, code range|
|E10.21-E10.29||Type I diabetes mellitus with kidney complications, code range|
|E10.641-E10.649||Type I diabetes mellitus with hypoglycemia, code range|
|E10.69||Type I diabetes mellitus other specified complications|
|E10.8||Type I diabetes mellitus with unspecified complications|
|T86.890-T86.899||Complications of other transplanted tissue, code range|
|Z90.5||Acquired absence of kidney|
|ICD-10-PCS (effective 10/1/15)||FYG0Z0, 0FYG0Z1||Surgical, hepatobiliary system & pancreas, transplantation, open, code by qualifier (allogeneic or syngeneic)|
|0FSG0ZZ, 0FSG4ZZ||Surgical, hepatobiliary system & pancreas, reposition, code by approach (open or percutaneous endoscopic)|
|Type of Service||Surgery|
|Place of Service||Inpatient|
Pancreas After Kidney Transplant
Pancreas Transplant Alone
|12/01/96||Add to Surgery section||New policy|
|04/01/98||Replace policy||Policy updated; new indications|
|02/15/02||Replace policy||Policy updated and revised based on 2002 TEC Assessment; policy statement revised to indicate that a single pancreas retransplantation may be medically necessary|
|10/9/03||Replace policy||Policy updated; no change to policy statement|
|02/25/04||Replace policy||Policy revised; policy statement revised to indicate that transplant in HIV+ patients is investigational (previously only addressed in Policy Guidelines)|
|03/15/05||Replace policy||Policy updated with literature search; no change in policy statement. Reference number 4 added|
|04/1/05||Replace policy||Policy revised; HIV+ deleted as an investigational indication for transplant; additional information provided in Rationale section|
|9/27/05||Replace policy||Policy corrected; HIV positivity statement removed from policy section and CPT coding updated|
|03/7/06||Replace policy||Policy updated with literature search; no change in policy statement|
|02/14/08||Replace policy||Policy updated with literature search; references 9 and 10 added; policy statement regarding “2 or more prior failed pancreas transplants” was removed; no other change in policy statements.|
|04/24/09||Replace policy||Policy updated with literature search; reference number 11 added; no change in policy statement|
|2/10/11||Replace policy||Policy updated with literature review; rationale section rewritten; not medically necessary indications regarding malignancy, infection and terminal conditions added to policy statement; relative contraindications clarified in guidelines; reference numbers 1, 2, 5-7, 9 – 13, 18 – 21 and 24 added, reference 22 updated.|
|02/09/12||Replace policy||Policy updated with literature review. “Not medically necessary” statement removed. Contraindications combined (absolute and relative) and moved to Policy Guidelines section. Wording of contraindications changed to be consistent with other solid organ transplant policies. Note on proportion of pancreas transplant recipients with type 2 diabetes added to Policy Guidelines. Reference numbers 3, 9, 12, 21-23 added; other references renumbered or removed.|
|06/14/12||Replace policy-correction only||In Policy Guidelines, corrected 4th potential contraindication to read: kidney or pancreatic disease|
|2/14/13||Replace policy||Policy updated with literature review. No change to policy statements. References 7, 14 and 21 added; other references renumbered or removed.|
|2/13/14||Replace policy||Policy updated with literature review through January 6, 2014. Statement on retransplantation modified to state that it applies to patients who meet criteria for pancreas transplant. References 2, 11 and 17 added; other references renumbered or removed.|
|2/12/15||Replace policy||Policy updated with literature review through January 6, 2015. References 13, 17, and 22 added. Statement added that pancreas transplant investigational in all other situations.|