Pancreas/Pancreas-Kidney/Pancreatic Islet Cell Transplantation
DESCRIPTION
Pancreas transplantation is intended for insulin dependent diabetics to restore endogenous insulin secretion and normal glucose metabolism. Control of metabolic glucose is intended to prevent, halt, or reverse the secondary complications of insulin dependent diabetes mellitus (IDDM). Pancreas transplantation is not generally viewed as life-saving treatment, however, in a small subset of individuals who experience life-threatening complications from IDDM, pancreas transplantation may be considered life saving.
Transplant candidates include: 1) IDDM cases with renal failure receiving a cadaveric simultaneous pancreas / kidney transplant (SPK); 2) IDDM cases receiving a cadaveric pancreas transplant at some time after the kidney transplant from either a cadaveric or living-related donor (pancreas after kidney, i.e., PAK); and 3) non-uremic IDDM cases with severely disabling and potentially life-threatening diabetic problems, receiving a pancreas alone (PTA).
Individuals with chronic pancreatitis can experience intractable pain that can only be relieved only with a total or near total pancreatectomy, although this treatment will cause the individual to be an insulin dependent diabetic. Autologous islet transplantation has been considered as a technique to prevent this associated morbidity. A suspension of isolated islet cells taken from the resected pancreas specimen is injected into the portal vein of the liver, where the cells function as a free graft.
POLICY
Combined pancreas-kidney transplantation for the treatment of diabetics considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Pancreas transplantation alone for treatment of insulin dependent diabetes mellitus (IDDM) is considered medically necessary if the medical appropriateness criteria are met. (See Additional Information for definitions.) (See Medical Appropriateness below.)
Pancreas re-transplantation for the treatment of a failed primary pancreas transplant is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Autologous pancreatic islet cell transplantation as an adjunct to a total or near total pancreatectomy is considered medically necessary.
Repeated laboratory tests and procedures to address changes in condition and for continued transplant listing are considered medically necessary.
Multiple laboratory tests and work-up procedures for the sole purpose of repeat evaluation at multiple transplant centers will be considered not medically necessary.
Allogeneic pancreatic islet cell transplantation is considered investigational.
Pancreas re-transplantation after 2 or more failed pancreas transplants is considered investigational.
MEDICAL APPROPRIATENESS
BCBST approval is required prior to transplantation.
Pancreas transplantation is considered medically appropriate if ALL the following criteria are met:
ANY ONE of the following:
Combined pancreas-kidney transplantation for the treatment of diabetics with uremia
Pancreas transplantation alone for treatment of insulin dependent diabetes mellitus (IDDM) with ANY ONE of the following:
Severely disabling and potentially life-threatening metabolic complications due to labile diabetes as evidenced by documentation in chart notes or hospitalization for diabetic ketoacidosis
Hypoglycemia unawareness that persists despite optimal medical management, as evidenced by documentation in chart notes or emergency room visits
Pancreas re-transplantation after a failed primary pancreas transplant
ALL of the following:
Clinical information submitted for determination of medical appropriateness criteria is dated within the last 7 months
Adequate cardiopulmonary status
No active infection
No history of malignancy within 5 years of transplantation; excluding non-melanomatous skin cancers
Documentation of compliance with present medical management
No untreated, serious psychiatric illness per psychiatric evaluation
Full psychosocial evaluation including social and family support systems
No active drug or alcohol abuse (free of addiction for at least 6 consecutive months)
Willingness and ability to give signed consent and to comply with regular follow-up requirements
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
Severe metabolic complications include conditions such as ketoacidosis, hypoglycemic events, and infection. Hypoglycemia unawareness includes profound hypoglycemia without the usual warning signs such as palpitations, sweating, tremors, dizziness, tingling, and / or blurred vision.
There is inadequate data to permit scientific conclusion regarding the health outcomes associated with pancreas re-transplantation after two or more failed pancreas transplants or for allogeneic pancreatic islet cell transplantation.
The center responsible for the organ harvesting must comply with the United Network for Organ Sharing (UNOS) guidelines.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (2:2011). Allogeneic Pancreas Transplant (7.03.02). Retrieved June 7, 2011 from BlueWeb. (24 articles and/or guidelines reviewed)
BlueCross BlueShield Association. Medical Policy Reference Manual. (6:2010). Islet Transplantation (7.03.12). Retrieved March 7, 2011 from BlueWeb. (21 articles and/or guidelines reviewed)
Canadian Agency for Drugs and Technologies in Health. Technology report. (2007, March). Pancreas transplantation to restore glucose control: review of clinical and economic evidence. Retrieved May 5, 2009 from http://www.cadth.ca/media/pdf/I3005_Pancreatic_Transplantation_tr_e.pdf.
Complete Guide to Medicare Coverage Issues [Computer software]. (2011, April). Islet cell transplantation in the context of a clinical trial (NCD 260.3.1, p. 2-211). Ingenix.
Complete Guide to Medicare Coverage Issues [Computer software]. (2011, April). Pancreas transplants (NCD 260.3, p. 2-210). Ingenix.
Lipshutz, G.S. & Wilkinson, A.H. (2007). Pancreas-kidney and pancreas transplantation for the treatment of diabetes mellitus. Endocrinology and Metabolism Clinics of North America, 36 (4), 1015-1038.
Milanetti, F., Abinun, M., Voltarelli, J. C., & Burt, R. K. (2010). Autologous hematopoietic stem cell transplantation for childhood autoimmune disease. Pediatric Clinics of North America, 57 (1).
National Institute for Health and Clinical Excellence. (2008, April). Allogeneic pancreatic islet cell transplantation for type 1 diabetes mellitus. Retrieved June 6, 2011 from http://www.nice.org.uk/nicemedia/live/11963/40436/40436.pdf.
National Institute for Health and Clinical Excellence. (2008, September). Interventional procedure overview of autologous pancreatic islet cell transplantation for improved glycaemic control after pancreatectomy. Retrieved June 6, 2011 from http://www.nice.org.uk/nicemedia/live/11920/42043/42043.pdf.
Townsend, C. M., Jr., Beauchamp, R. D., Evers, B. M., & Mattox, K. L. (Eds.). (2008). Sabiston Textbook of Surgery (18th ed.). Philadelphia: Saunders Elsevier.
Vrochides, D. Paraskevas, St., & Papanikolaou, V. (2009). Transplantation for type 1 diabetes mellitus. Whole organ or islet? Hippokratia, 13 (1), 6-8.
Winifred S. Hayes, Inc. Medical Technology Directory. (2008, January). Simultaneous pancreas-kidney transplantation in diabetic patients. Retrieved May 8, 2009 from www.Hayesinc.com/subscribers. (39 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 5/1985
MOST RECENT REVIEW DATE: 8/11/2011
ID_BT
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
This document has been classified as public information.