Medical Policy: 07.03.09
Original Effective Date: November 2009
Reviewed: November 2015
Revised: November 2015
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.
Retransplantation
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.
Summary
Based on the medical literature 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.
Prior approval is required. Submit a prior approval now.
See also Medical Policy 07.03.01 Pancreatic Islet Cell Transplant
See also Medical Policy 01.01.26 Artificial Pancreas Device System
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 transplant after prior kidney transplant (PAK), or combined (simultaneous) pancreas-kidney transplant (SPK) performed for any other conditions not listed above will be considered not medically necessary.
Retransplantation
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
Except as defined above, candidates for pancreas should meet the following general criteria:
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:
It is likely that each individual transplant center will have explicit patient selection criteria for HIV-positive patients.
Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
partial, general description of plan or program benefits and do not
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and, therefore, cannot guarantee any results or outcomes.
Participating providers are independent contractors in private
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affiliates. Treating providers are solely responsible for medical
advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.