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Medical Policy: 07.03.01
Original Effective Date: October 2004
Reviewed: August 2011
Revised:
Benefit Application
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.
Description:
Pancreatic islets are small clusters of endocrine cells in the pancreas that include insulin-producing beta cells. Transplantation of islet cells has been investigated to treat patients with chronic pancreatitis, and more recently type 1 diabetes.
Patients with chronic pancreatitis may experience intractable pain that can only be relieved with a total or near-total pancreatectomy. However, the pain relief must be balanced against the certainty that the patient will be rendered an insulin-dependent diabetic. Autologous islet cell transplantation may be used to prevent this morbidity. During the pancreatectomy procedure a suspension of isolated islet cells is created from the resected pancreas specimen and injected into the portal vein of the liver, where the cells function as a free graft.
Allogeneic islet cell transplant has been used in patients with type 1 diabetes to restore normoglycemia in an effort to reduce or eliminate the long-term complications of diabetes such as retinopathy, neuropathy, nephropathy, and cardiovascular disease.
Islet cells are subject to regulation by the U.S. Food and Drug Administration (FDA), which classifies allogeneic islet cell transplantation as somatic cell therapy, requiring pre-market approval. Islets also meet the definition of a drug under the federal Food, Drug, and Cosmetic Act. Clinical studies to determine safety and effectiveness outcomes of allogeneic islet cell transplantation must be conducted under FDA investigational new drug (IND) regulations.
Limited data are available documenting the effects of islet transplantation on long-term diabetes complications.
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Prior Approval:
Not applicable
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Policy:
Autologous pancreatic islet cell transplantation may be considered medically necessary as an adjunct to a total or near-total pancreatectomy in patients with chronic pancreatitis.
Allogeneic pancreatic islet cell transplantation is considered investigational for the treatment of type 1 diabetes.
Although the published experience with autologous islet cell transplant is limited, the procedure appears to significantly decrease the incidence of diabetes after total or near total pancreatectomy in patients with chronic pancreatitis. In addition, this procedure is not associated with serious complications itself and is performed as an adjunct to the pancreatectomy procedure.
The techniques for allogeneic islet cell transplants are evolving; the impact on net health outcomes is still uncertain. Moreover, longer follow up with larger numbers of patients is needed before conclusions can be drawn about the safety of allogeneic islet transplantation and its impact on complications of diabetes mellitus, thus the procedure is considered investigational.
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Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes.
- 48160 Pancreatectomy, total or subtotal, with autologous transplantation of pancreas or pancreatic islet cells.
- 0141T Pancreatic islet cell transplantation through portal vein, percutaneous
- 0142T Pancreatic islet cell transplantation through portal vein, open
- 0143T Laparoscopy, surgical, pancreatic islet cell transplantation through portal vein
- G0341 Percutaneous islet cell transplant, includes portal vein catheterization and infu
- 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 tissue transplant from pancreas; allogeneic
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Selected References:
- Piper MA, Seidenfeld J, Aronson N. Islet Transplantation in Type 1 Diabetes Mellitus. Evidence Report/Technology Assessment No. 98 (Prepared by the Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center). AHRQ Publication No. 04-E017-2. Rockville, MD: Agency for Healthcare Research and Quality. April 2004.
- Wahoff DC, Papalois BE, Najarian JS, et al. Autologous islet transplantation to prevent diabetes after pancreatic resection. Ann Surg 1995; 222(4):562-79.
- Robertson RP, Lanz KJ, Sutherland DE, et al. Prevention of diabetes for up to 13 years by auto islet transplantation after pancreatectomy for chronic pancreatitis. Diabetes 2001; 50(1):47-50.
- TARGET [database online]. Plymouth Meeting (PA): ECRI; 2005 March. Islet cell transplantation for type 1 diabetes.
- Frank A, Deng S, Huang X et al. Transplantation for type 1 diabetes: comparison of vascularized whole-organ pancreas with isolated pancreatic islets. Ann Surg 2004 Oct; 240(4):631-40.
- Robertson RP. Islet transplantation as a treatment for diabetes-a work in progress. NEJM. 2004; 350(7):694-705.
- TARGET [database online]. Plymouth Meeting (PA): ECRI; 2005 March. (Updated 2005 June 27) Islet cell transplantation for type 1 diabetes.
- Frank A, Deng S, Huang X et al. Transplantation for type 1 diabetes: comparison of vascularized whole-organ pancreas with isolated pancreatic islets. Ann Surg 2004 Oct; 240(4):631-40.
- Robertson RP. Islet transplantation as a treatment for diabetes-a work in progress. NEJM. 2004; 350(7):694-705.
- ECRI. Islet cell transplantation for the treatment of Type 1 diabetes. Plymouth Meeting (PA): ECRI Health Technology Assessment Information Service; 2005 Oct. 80 p. (Windows on medical technology; no. 130).
- Robertson RP, Davis C, Larsen J, Stratta R, Sutherland DE, American Diabetes Association. Position statements: Pancreas and islet transplantation in type 1 diabetes. Diabetes Care. 2006 Apr;29(4):935.
- National Institutes of Health (US). Collaborative Islet Transplant Registry: Annual Report. Bethesda, MD: National Institute of Diabetes and Digestive Kidney Diseases. September 2008. Accessed March 16, 2009. Available at: http://www.citregistry.org/
- Jindal RM, Ricordi C, Shriver CD. Autologous pancreatic islet transplantation for severe trauma. N Engl J Med. 2010 Apr 22;362(16):1550.
- Halban PA, German MS Kahn SE et al. Current status of islet cell replacement and regeneration therapy. J Clin Endocrinol Metab. 2010 Mar;95(3):1034-43. Epub 2010 Jan 8.
- Gremizzi C, Vergani A, Paloschi V et al. Impact of pancreas transplantation of type 1 diabetes-related complications. Curr Opin Organ Transplant. 2010 Feb; 15(1):119-23.
- Thompson DM, Meloche M, Ao Z et al. Reduced progression of diabetic microvascular complications with islet cell transplantation compared with intensive medical therapy. Transplantation. 2011 Feb 15;91(3):373-8.
- Posselt AM, Szot GL, Frassetto LA et al. Islet transplantation in type 1 diabetic patients using calcineurin inhibitor-free immunosuppressive protocols based on R-cell adhesion or costimulation blockade. Transplantation. 2010 Dec 27;90(12):1595-601.
- Posselt AM, Bellin MD, Tavakol M et al. Islet transplantation in type 1 diabetes using an immunosuppressive protocol based on the anti-LFA-1 antibody efalizumab. Am J Transplant. 2010 Aug;10(8):1870-80.
- Aguayo-Mazzucato C, Bonner-Weir S. Stem cell therapy for type 1 diabetes mellitus. Nat Rev Endocrinol. 2010 Mar;6(3):139-48.
- de Vos P, Spasojevic M, Faas MM. Treatment of diabetes with encapsulated islets. Adv Exp Med Biol. 2010; 670:38-53.
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Policy History:
Date Reason Action
August 2011 Annual review Policy renewed
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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
constitute a contract. Wellmark does not provide health care services
and, therefore, cannot guarantee any results or outcomes.
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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 © 2010 American Medical Association. All Rights Reserved.
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