Medical Policy: 07.03.09
Original Effective Date: November 2009
Reviewed: December 2014
Revised: December 2014
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
The purpose of pancreas transplant is normalization of the diabetic patient's blood glucose level, thereby preventing eventual microvascular complications. The only effective treatment to restore normal glucose metabolism in patients who are insulin-dependent is beta cell replacement achieved by replacing the pancreas or replacing the pancreatic islet cells. Replacement of the pancreas may be performed alone, following a kidney transplant, or simultaneously with a kidney transplant.
Pancreas transplant alone (PTA) is indicated for patients with uncontrolled insulin-dependent diabetes yet adequate renal function. The purpose of the transplant is to control the blood glucose levels and prevent diabetes-related complications such as retinopathy, neuropathy, or end-stage renal disease.
Simultaneous pancreas-kidney transplants (SPK) and pancreas after kidney transplants (PAK) are performed to correct complications of insulin-dependent diabetes and renal failure in patients who are dependent on dialysis. Patients with insulin-dependent diabetes and impending or established end-stage renal disease who have minimal complications of diabetes are generally considered good candidates for kidney transplant. Kidney transplant is usually recommended for patients with advanced chronic kidney disease as they are highly predisposed to progress to end stage renal disease in a relatively short period of time.
The last four decades have seen a significant and progressive improvement in outcomes for pancreas transplantation. Improvements in immunosuppression, surgical technique and post-transplant management have all contributed to better graft survival. However, despite refinements in surgical technique, technical failure is defined by the International Pancreas Transplant Registry as graft loss secondary to vascular thrombosis, bleeding, anastomotic leaks or infection/pancreatitis and is responsible for more than 50% of all pancreas grafts lost in the first 6 months following transplantation. Thrombosis accounts for more than one-half of these technical failures, and may be influenced by donor and recipient factors, preservation and ischemic injury, immunological issues and surgical technique.
The decision to retransplant the pancreas after an early graft failure is complex. Prior to proceeding with retransplantation, a careful analysis of the factors contributing to the technical failure must be undertaken and reversible risk factors must be addressed. Surgical issues leading to thrombosis such as improper suturing of the vascular anastomosis, poor positioning of the allograft or inadequate hemostasis may be the primary cause of graft thrombosis. However, there may be no obvious surgical cause for graft loss identified. Reconfirming the tissue typing with the original donor and evaluating the patient for hypercoagulable state should be considered prior to attempting retransplantation in order to guide anticoagulation and immunosuppression management for the second graft.
Following appropriate evaluation for the causes of graft thrombosis, repeat pancreas transplantation may be considered, although the optimal timing for retransplantation remains somewhat controversial. From a surgical perspective, retransplanting in the early post-pancreatectomy period may be preferable because extensive adhesions have not yet formed. This facilitates placing the new graft in the same anatomic site as the prior transplant. Some previous studies suggest that immediate retransplantation is associated with similar graft and patient survival as primary transplants, others indicate that this approach is associated with higher incidence of post-operative complications and rejection leading to premature loss of the second graft.
Although there are no standard guidelines regarding multiple pancreas transplants, each transplant 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.
Implantable Bioartificial Pancreas
Bioartifical pancreas devices are being investigated for the treatment of diabetes. The device actually contains islets of Langerhans, cells that produce insulin and glucagon, which are meant to function together much like a healthy pancreas. The islet cells are encapsulated with a semipermeable membrane, such as hydrogel or polymer and the device is implanted in the peritoneal cavity or under the skin. It responds to changing blood glucose levels by releasing hormones, chiefly insulin. Though many research groups are developing versions of an artificial pancreas system, current systems require at least one hormone delivery insertion site and at least one glucose sensor site. This complexity limits commercial viability and potential acceptance by patients. The risk of infection from the multiple insertion sites is also an issue. Based on peer reviewed medical literature current studies are mainly of animal trials and their safety and effectiveness have not been established. Therefore, bioartifical pancreas devices are considered investigational.
Prior approval is required. Submit a prior approval now.
See also Medical Policy 07.03.01 Pancreatic Islet Cell Transplant
Pancreas transplant alone (PTA) may be considered medically necessary in patients with insulin-dependent diabetes that is poorly controlled despite maximal medical management and adherence to treatment recommendations.
Pancreas transplant after a prior kidney transplant (PAK) may be considered medically necessary in patients with insulin-dependent diabetes.
Combined (simultaneous) pancreas-kidney transplant (SPK) may be considered medically necessary in insulin-dependent diabetics with impending or established renal failure.
Pancreas transplant alone (PTA), pancreas after kidney (PAK) or simultaneous pancreas-kidney (SPK) retransplantation after a failure of the primary graft may be considered medically necessary provided the individual meets the criteria for transplant.
Implantable bioartificial pancreas transplant devices are considered investigational.
Based on peer reviewed medical literature current studies regarding implantable bioartifical pancreas transplant devices are mainly of animal trials and their safety and effectiveness have not been established. Therefore, implantable bioartifical pancreas devices are considered investigational.
Except as defined above, candidates for pancreas should meet the following general criteria:
- Absence of active infection
- Absence of non-curable chronic extrapulmonary infection including chronic active viral hepatitis B, hepatitis C, and human immunodeficiency virus
- Documentation of patient compliance with medical management
The evaluation of a transplant candidate who has a history of cancer must consider the prognosis and risk of recurrence from available information including tumor type and stage, response to therapy, and time since therapy was completed. Although evidence is limited, patients in whom cancer is thought to be cured should not be excluded from consideration for transplant. UNOS has not addressed malignancy in current policies.
The United Network for Organ Sharing (UNOS) believes that asymptomatic HIV-positive patients should not necessarily be excluded for candidacy for organ transplantation, stating, "A potential candidate for organ transplantation whose test for HIV is positive but who is in an asymptomatic state should not necessarily be excluded from candidacy for organ transplantation, but should be advised that he or she may be at increased risk of morbidity and mortality because of immunosuppressive therapy." In 2001, the Clinical Practice Committee of the American Society of Transplantation proposed that the presence of AIDS could be considered a contraindication to kidney transplant unless the following criteria were present. These criteria may be extrapolated to other potential organ transplants:
- CD4 count ≥ 200 cells/mm-3 for > 6 months
- HIV-1 RNA undetectable
- On stable anti-retroviral therapy > 3 months
- No other complications from AIDS (e.g., opportunistic infection including aspergillus, tuberculosis, coccidioses mycosis, resistant fungal infections, Kaposi's sarcoma, or other neoplasm)
- Meeting all other criteria for organ transplantation
It is likely that each individual transplant center will have explicit patient selection criteria for HIV-positive patients.
Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
- 48554; Transplantation of pancreatic allograft
- 50360 Renal allotransplantation, implantation of graft; without recipient nephrectomy
- 50365 Renal allotransplantation, implantation of graft; with recipient nephrectomy
- Aguera ML, Navarro MD, Perez-Calderon R et al. Simultaneous pancreas-kidney transplant: a single-center long-term outcome. J Nephrol. 2007 Mar-Apr; 20(2):173-6.
- Bunnapradist S, Cho YW, Cecka JM et al Kidney allograft and patient survival in type 1 diabetic recipients of cadaveric kidney alone versus simultaneous pancreas/kidney transplants: a multivariate analysis of the UNOS database. J Am Soc Nephrol. 2003 Jan;14(1):208-13.
- Humar A, Ramcharan T, Kandaswamy R et al. Pancreas after kidney transplants. Am J Surg. 2001 Aug;182(2):155-61.
- Humar A, Kandaswamy R, Drangstveit MB et al. Surgical risks and outcome of pancreas retransplants. Surgery. 2000 Jun;127(6):634-40.
- Johnson SR, Cherikh WS, Kauffman HM et al. Retransplantation after post-transplant lymphoproliferative disorders: an OPTN/UNOS database analysis. Am J Transplant. 2006 Nov;6(11):2743-9.
- Kizilel S, Garfinkel M, Opara E. The bioartificial pancreas: progress and challenges. Diabetes Technol Ther. 2005 Dec;7(6):968-85.
- Lipshutz GS, Wilkinson AH. Pancreas-kidney and pancreas transplantation for the treatment of diabetes mellitus. Endocrinol Metab Clin North Am. 2007 Dec;36(4):1015-38.
- Sutherland DE, Gruessner AC. Long-term results after pancreas transplantation. Transplant Proc 2007;39(7):2323-5.
- Scalea JR, Burler 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):1789-94.
- Hirshberg B. The cardinal features of recurrent autoimmunity in simultaneous pancreas-kidney transplant recipients. Curr Diab Rep 2010; 10(5):321-2.
- Fridell JA, Mangus RS, Hollinger EF et al. The case for pancreas after kidney transplantation. Clin Transplant 2009; 23(4):447-53.
- 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):437-46.
- Schenker P, Vonend O, Kruger B et al. Long-term results of pancreas transplantation in patients older than 50 years. Transpl Int. 2011 Feb; 24(2):136-42. doi: 10.1111/j.1432-2277.2010.01172.x. Epub 2010 Oct 13.
- Afaneh C, Rich BS, Aull MJ et al. Pancreas transplantation: does age increase morbidity? J transplant. 2011; 2011:596801. Epub 2011 Jun 4.
- 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 (IPTR). Rev Diabet Stud. 2011 Spring; 8(1):6-16. Epub 2011 May 10.
- Sampaio MS, Kuo HT, Bunnapradist S. Outcomes of simultaneous pancreas-kidney transplantation in type 2 diabetic recipients. Clin J AM Soc Nephrol. 2011 May;6(5):1198-206. Epub 2011 Mar 24.
- UpToDate. Pancreas and Islet Transplantation in Diabetes Mellitus. R. Paul Robertson, M.D.. Topic last updated April 30, 2013.
- United Network for Organ Sharing (UNOS): Pancreas Allocation Policy. September 1, 2013.
- CMS. National Coverage Determination for Pancreas Transplants (260.3).
- UpToDate. Patient Selection for an Immunologic Issues Relating to Kidney-Pancreas Transplantation in Diabetes Mellitus. Topic last updated November 20, 2014. Also available at www.uptodate.com
- Medscape. Pancreas Transplantation. Updated June 12, 2013. Also available at http://emedicine.medscape.com/article/429408
- Medscape. Kidney-Pancreas Transplantation. Updated September 18, 2013. Also available at http://emedicine.medscape.com/article/1830202
- American Diabetes Association. Pancreas Transplantation. Also available at www.diabetes.org
- National Kidney Foundation: Pancreas Transplant. Also available at www.kidney.org
- Organ Procurement and Transplant Network (OPTN). Allocation of Pancreas, Kidney-Pancreas and Islets. Also available at http://optn.transplant.hrsa.gov
- Gruessner Angelika C, 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 (IPTR). Journal of the Society of Biomedical Diabetes Research, April 2011. Published online May 10, 2011. Doi:10.1900/RDS.2011.8.6
- E.F. Hollinger, J.A. Powelson, et. al. Immediate Retransplantation for Pancreas Allograft Thrombosis, American Journal of Transplantation 2009; 9:740-745.
- National Guideline Clearinghouse. Clinical Practice Guideline for Diabetes Mellitus Type 1. May 2012. Also available at http://www.guideline/gov
- National Institute of Health (NIH). Microencapsulation of Pancreatic Islets for use in Bioartificial Pancreas.
Date Reason Action
April 2011 Annual review Policy renewed
March 2012 Annual review Policy renewed
March 2013 Annual review Policy renewed
January 2014 Annual review Policy renewed
December 2014 Annual review Policy revised
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*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.