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Medical Policy: 07.03.01
Original Effective Date: October 2004
Reviewed: November 2007
Revised:
This policy applies to all products unless specific contract
limitations, exclusions or exceptions apply. Please refer to the member's coverage
manual for benefit availability. Managed care guidelines related to referral authorization,
and precertification of inpatient hospitalization, home health, home infusion and
hospice services apply.
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.
Policy:
Prior Approval is recommended for all transplant services. Contact:
Transplant Nurse Case Managers
1-800-552-3993 phone
1-515-235-4449 fax
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. Limited data are available documenting the effects of islet transplantation on long-term diabetic consequences. Clinical trials remain underway.
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Procedure Codes and Billing
Guidelines:
- To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes.
- CPT 48160; Pancreatectomy, total or subtotal, with autologous transplantation of pancreas or pancreatic islet cells.
- CPT 0141T; Pancreatic islet cell transplantation through portal vein, percutaneous
- CPT 0142T; Pancreatic islet cell transplantation through portal vein, open
- CPT 0143T; Laparoscopy, surgical, pancreatic islet cell transplantation through portal vein
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Selected References:
- The Medical Policy Reference Manual (MPRM) developed by the Blue Cross and Blue Shield Association Health Management Systems, based on Technology Evaluation Center (TEC) criteria.
- 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).
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New information or technology that would be relevant for Wellmark to consider when this policy is next reviewed may be submitted to:
Wellmark Blue Cross and Blue Shield
Medical Policy Analyst
Station 304
636 Grand Ave
Des Moines, Iowa 50309
*Current Procedural Terminology © 2008 American Medical Association. All Rights Reserved.
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.
Participating providers are independent contractors in private
practice and are neither employees nor agents of Wellmark or its
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.
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