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Autologous islet transplantation is a technique developed to prevent or delay the onset of insulin-dependent diabetes in patients who have undergone total or near-total pancreatectomy for the treatment of chronic pancreatitis. In this procedure, islet cells from the patient’s pancreas are transplanted to the patient’s liver. The pancreas is first removed and is sent to a special laboratory for islet preparation. Islet cells are then collected, placed in syringes, and transplanted into the patient via the portal vein system. Islets are injected slowly into the portal vein, and portal vein pressure is measured during the infusion. Once in the portal vein, the blood flow and pressure carry the islets to the liver where they encounter small diameter capillaries that can’t be traversed by the islets. The islets become engrafted in the liver.
Allogeneic islet cell transplantation is being investigated as a treatment for a subset of patients with type 1 diabetes who have a history of severe metabolic instability. During allogeneic islet transplantation, islet cells are first isolated from the pancreas of one or more cadaver donors and then transplanted into the patient via the portal vein system. Because allogeneic islet cells meet the definition of a drug under the federal Food, Drug, and Cosmetic Act, clinical trials are required to determine safety and effectiveness according to investigational new drug regulations. Currently, allogeneic pancreatic islet cell products are not approved by the U.S. Food and Drug Administration (FDA) outside the setting of a clinical trial.
I. Autologous islet transplantation may be considered MEDICALLY NECESSARY AND APPROPRIATE as an adjunct to a total or near total pancreatectomy in patients with chronic pancreatitis.
II. Allogeneic islet transplantation is considered EXPERIMENTAL/INVESTIGATIVE for the treatment of type I diabetes due to lack of evidence demonstrating an impact on improved health outcomes.
III. Autologous and allogeneic islet transplantation is considered EXPERIMENTAL/INVESTIGATIVE for all other indications.
0584T 0585T 0586T 48160 G0341 G0342 G0343 S2102
Link to Transplant Pre-Authorization Form: https://www.bluecrossmn.com/sites/default/files/DAM/2019-12/X16519R04_Transplant%20Request%20Form.pdf
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CPT® codes copyright American Medical Association® 2022. All rights reserved.
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