BlueCross BlueShield of Tennessee Medical Policy Manual

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 pancreas transplant at some time after a kidney transplant (pancreas after kidney, i.e., PAK) from either a cadaveric or living-related donor; 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 be relieved only with a total or near total pancreatectomy, although this treatment will cause the individual to become 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

MEDICAL APPROPRIATENESS

BCBST approval is required prior to transplantation.

NOTE:  Potential contraindications are subject to the judgment of the transplant center

      • Clinical information submitted for determination of medical appropriateness criteria is dated within the last 7 months

      • Adequate cardiopulmonary status

      • No other irreversible end-stage disease not attributed to kidney disease

      • No untreated systemic infection making immunosuppression unsafe, including chronic infection

      • No known current malignancy

      • No history of malignancy with a moderate to high risk of recurrence

      • Documentation of compliance with present medical management

      • No major psychiatric history likely to result in non-adherence

      • No psychosocial conditions or chemical or alcohol dependency affecting ability to adhere to therapy

IMPORTANT REMINDERS

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.

SOURCES

BlueCross BlueShield Association. Medical Policy Reference Manual. (8:2017). Allogeneic Pancreas Transplant (7.03.02). Retrieved February 15, 2018 from BlueWeb. (27 articles and/or guidelines reviewed)

BlueCross BlueShield Association. Medical Policy Reference Manual. (8:2017). Islet Transplantation (7.03.12). Retrieved February 15, 2018 from BlueWeb. (17 articles and/or guidelines reviewed)

Bramis, K., Gordon-Weeks, A., Friend, P., Bastin, E., Burls, A., Silva, M., & Dennison, A. (2012). Systematic review of total pancreatectomy and islet autotransplantation for chronic pancreatitis. British Journal of Surgery, 99, 761-766. (Level 1 evidence)

Centers for Medicare & Medicaid Services. CMS.gov. NCD for pancreas transplants (260.3). Retrieved February 25, 2015 from http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId.

Kopp, W.H., Verhagen, M.J., Blok, J.J., Huurman, V.A., de Fijter, J.W., de Koning, E.J., et al. (2015). Thirty years of pancreas transplantation at Leiden University Medical Center: long-term follow-up in a large Eurotransplant center. Transplantation, 99 (9), e145-e151. Abstract retrieved March 14, 2017 from PubMed database.

National Health Services (NHS). (2016). Pancreas transplantation: patient selection. Retrieved March 14, 2017 from http://www.odt.nhs.uk/pdf/pancreas_selection_policy.pdf.

National Institute for Health and Care Excellence. (2015, August). Type 1 diabetes in adults: diagnosis and management. Retrieved March 22, 2016 from https://www.nice.org.uk/guidance/ng17.

National Institute of  Health. National Institute of Diabetes and Digestive and Kidney Diseases. (2016). Pancreatic islet transplantation. Retrieved March 23, 2016 from www.diabetes.niddk.nih.gov.

National Kidney Foundation. (2016). Kidney-pancreas transplant. Retrieved March 25, 2016 from www.kidney.org/atoz/content/kidpantx.

Organ Procurement and Transplantation Network. (2017). Policy 11: allocation of pancreas, kidney-pancreas, and islets. Retrieved March 14, 2017 from https://optn.transplant.hrsa.gov/governance/policies/.

Seal,J., Selzner, M., Laurence, J., Marquez, M., Bazerbachi, F., McGilvray, I., et al. (2015). Outcomes of pancreas transplantation after simultaneous kidney-pancreas transplantation are comparable to pancreas after kidney transplantation alone. Transplantation, 99 (3), 623-628. Abstract retrieved March 14, 2017 from PubMed database.

Winifred S. Hayes, Inc. Medical Technology Directory. (2013, March; last update search February 2017). Simultaneous pancreas-kidney (SPK) transplantation in diabetic patients. Retrieved March 14, 2017 from www.Hayesinc.com/subscribers . (128 articles and/or guidelines reviewed)

Winifred S. Hayes, Inc. Medical Technology Directory. (2015, December; last update search December 2017). Total pancreatectomy with islet autotransplantation for chronic pancreatitis. Retrieved February 15, 2018 from www.Hayesinc.com/subscribers. (45 articles and/or guidelines reviewed)

ORIGINAL EFFECTIVE DATE:  5/1985

MOST RECENT REVIEW DATE:  3/8/2018

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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.

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