Coverage Policies

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

QualChoice maintains a national network of Centers of Excellence for members who require transplantation.

 

Transplants and transplant related services are covered only when performed at a transplant center previously approved by QualChoice.

1)    Islet cell transplantation is the infusion of pancreatic islet cells into the liver circulation in an effort to restore or preserve insulin production in persons who have lost or are at risk to lose that function.

2)    Islet cell transplantation from a donor is not covered.

3)    Islet cell auto-transplantation (auto-transplantation involves transplanting cells back into the same person from whom they were taken) requires pre-authorization.

Islet cell auto-transplantation is considered medically necessary in members who are undergoing total or near total resection of the pancreas for severe refractory chronic pancreatitis (K86.0-K86.1).

Codes Used In This BI:

48160 Pancreatectomy, total or subtotal, with autologous transplantation of pancreas or pancreatic islet cells
G0341 Percutaneous islet cell transplant, includes portal vein catheterization and infusion
G0342 Laparoscopy for islet cell transplant, includes portal vein catheterization and infusion
G0343 Laparotomy for islet cell transplant, includes portal vein catheterization and infusion
S2102 Islet cell transplant, allogeneic
 

Allogenic islet cell transplantation is considered experimental/ investigational in the treatment of Diabetes mellitus as there is insufficient documentation in the peer reviewed published medical literature of its effectiveness and safety Hayes C&D.

1)    Autologous islet cell transplantation is an alternative for persons undergoing total pancreatectomy for severe, refractory chronic pancreatitis. Near total or total pan-creatic resection can alleviate pain in patients with severe chronic inflammation. Autologous islet cell transplantation can preserve islet cell function in patients undergoing this procedure. The islet cell transplantation procedure involves the infusion of islet cells into the liver by portal embolization, where the cells function as a free graft. The liver`s dual vascular supply allows embolization of isolated pan-creatic islets by cannulating the umbilical vein, a tributary of the mesenteric venous system, or by transcutaneous, transhepatic cannulation of the portal vein itself. The terminal portal venule can be occluded without infracting the transplant site.

2)    Allogeneic islet cell transplantation is being investigated as an alternative means of restoring normoglycemia, without the attendant morbidity of the whole-organ procedure, and potentially with significantly less need for immunosuppression than pancreas transplantation. Experience with allogeneic islet cell transplantation has increased and incremental improvements in the islet cell isolation process have been achieved.  Islet cell transplantation has several advantages: (1) the cells can be delivered easily into the recipient`s portal circulation by umbilical vein cannulation without a major operation, and (2) allogeneic islets can be cryopreserved. Methods for treating allogeneic islet cells to reduce their immunogenicity are being studied.

3)    Although considerable knowledge regarding allogeneic islet cell transplantation has been accumulated, both in the techniques of islet isolation and in preventing damage to the transplant by rejection or autoimmunity, research has not progressed much beyond experimental models. Until recently, successful human islet transplantation has been exceedingly rare; human islet cell transplantations have been almost uniformly unsuccessful, if success is defined as restoration of normoglycemia with no dependence on exogenous insulin. With continued improvements, allogeneic islet cell transplantation could eventually replace both insulin therapy and whole-pancreas transplantation as the optimal treatment for type 1 diabetes. A number of immunologically privileged transplantation sites have been evaluated, including the anterior chamber of the eye, the brain, the pregnant uterus, the placenta, the testis, and the thymus. Several of these sites have been shown to provide at least partial sanctuary for allogeneic islets while allowing normal physiologic function. However, the technical considerations and potential morbidity of engraftment into these sites discourage their clinical use.

4)    Guidelines from the American Diabetes Association (Robertson, et al., 2004) have concluded that “islet cell transplantation is an experimental procedure, also requiring systemic immunosuppression, and should be performed only within the setting of controlled research studies.”

1)    Shapiro AM, Ryan EA, Lakey JR. Pancreatic islet transplantation in the treatment of diabetes mellitus. Best Pract Res Clin Endocrinol Metab. 2001;15(2):241-264.

2)    White SA, Kimber R, Veitch PS, et al. Surgical treatment of diabetes mellitus by islet cell and pancreas transplantation. Postgrad Med J. 2001;77(908):383-387.

3)    Robertson RP, Davis C, Larsen J, et al. Pancreas and islet transplantation for patients with diabetes. Diabetes Care. 2003;26 Suppl:S120.

4)    Guo B, Harstall C, Corabian P. Islet cell transplantation for the treatment of non-uremic type 1 diabetic patients with severe hypoglycemia. Health Technology Assessment. HTA 31. Edmonton, AB: Alberta Heritage Foundation for Medical Research (AHFMR); April 2003.

5)    Hayes, Islet cell transplantation for the treatment of Type 1 diabetes; August 2004

6)    Hering BJ, Kandaswamy R, Ansite JD, et al. Single-donor, marginal-dose islet transplantation in patients with type 1 diabetes. JAMA. 2005;293(7):830-835.

7)    Korsgren O, Nilsson B, Berne C, et al. Current status of clinical islet transplantation. Transplantation. 2005;79(10):1289-1293.

8)    Guo B, Harstall C, Corabian P. Islet cell transplantation for the treatment of non-uremic type 1 diabetic patients with severe hypoglycemia. Edmonton, AB: Alberta Heritage Foundation for Medical Research (AHFMR); 2003.

9)    National Institute for Clinical Excellence (NICE). Pancreatic islet cell transplantation. Interventional Procedure Guidance 13. London, UK: NICE; October 2003.

10) Rodriguez Rilo HL, Ahmad SA, D`Alessio D, et al. Total pancreatectomy and autologous islet cell transplantation as a means to treat severe chronic pancreatitis. J Gastrointest Surg. 2003;7;978-989.

11) Jie T, Hering BJ, Ansite JD, et al. Pancreatectomy and auto-islet transplant in patients with chronic pancreatitis [abstract]. Surgical Forum, Alimentary Tract Category. #2005-466. American College of Surgeons 91st Annual Clinical Congress, San Francisco, CA, October 16-20, 2005.

12) Clayton HA, Davies JE, Pollard CA, et al. Pancreatectomy with islet auto transplantation for the treatment of severe chronic pancreatitis: The first 40 patients at the Leicester General Hospital. Transplantation. 2003;76(1):92-98.

13) Ryan EA, Bigam D, Shapiro AM. Current indications for pancreas or islet transplant. Diabetes Obes Metab. 2006;8(1):1-7.

14) Balamurugan AN, Bottino R, Giannoukakis N, Smetanka C. Prospective and challenges of islet transplantation for the therapy of autoimmune diabetes. Pancreas. 2006;32(3):231-243.

15) American Diabetes Association; Islet cell transplant program for type 1 diabetes successful across international centers at: http://www.diabetes.org/for-media/2004-press-releases/edmonton.jsp