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Date Printed: June 23, 2017: 06:23 PM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

02-40000-21

Original Effective Date: 06/15/03

Reviewed: 09/25/14

Revised: 10/15/14

Subject: Pancreatic Islet Cell Transplantation

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

Position
Statement
Billing/Coding Reimbursement Program
Exceptions
Definitions Related
Guidelines
Other References Updates    

DESCRIPTION:

Autologous islet transplantation, performed in conjunction with pancreatectomy, is proposed to reduce the likelihood of insulin-dependent diabetes. In autologous islet transplantation, during the pancreatectomy procedure, islet cells are isolated from the resected pancreas using enzymes, and a suspension of the cells is injected into the portal vein of the liver. Once implanted, the beta cells in these islets begin to make and release insulin.

Allogeneic islet cell transplantation is being investigated as a treatment or cure for those with type 1 diabetes.In allogeneic islet cell transplantation, cells are harvested from the deceased donor’s pancreas, processed, and injected into the recipient’s portal vein. Up to 3 donor organs may be required to achieve insulin independence.

Chronic pancreatitis

Primary risk factors for chronic pancreatitis include toxic-metabolic, idiopathic, genetic, autoimmune, recurrent and severe acute pancreatitis, or obstructive (the TIGAR-O classification system). Those 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 individual will be rendered an insulin-dependent diabetic. Autologous islet transplantation has been investigated as a technique to prevent this serious morbidity.

Type 1 diabetes

Allogeneic islet cell transplantation has been used for type 1 diabetes to restore normoglycemia and reduce or eliminate the long-term complications of diabetes such as retinopathy, neuropathy, nephropathy, and cardiovascular disease. Islet cell transplantation potentially offers an alternative to whole-organ pancreas transplantation. However, a limitation of islet cell transplantation is that two or more donor organs are usually required for successful transplantation, although experimentation with single-donor transplantation is occurring. A pancreas that is rejected for whole-organ transplant is typically used for islet transplantation. Therefore, islet cell transplantation has generally been reserved for those with frequent and severe metabolic complications who have consistently failed to achieve control with insulin-based management. Long-term follow-up data are needed in order to evaluate the effects of islet cell transplantation regarding freedom from exogenous insulin administration and impacts on reduced secondary complications of diabetes.

Regulatory Status

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 premarket approval. Islet cells 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) regulation.

POSITION STATEMENT:

REQUIRED: Certificate of Medical Necessity

NOTE: The attached Certificate of Medical Necessity should be completed and submitted (by transplant facility) with the request for transplant services, in order to facilitate medical review. To access the certificate of medical necessity, click on the link below, complete the required fields, and print.

Autologous pancreas islet cell transplantation meets the definition of medical necessity as an adjunct to a total or near total pancreatectomy in inividuals with chronic pancreatitis.

Allogeneic pancreas islet cell transplantation is considered experimental or investigational for all other indications, and specifically for the treatment of type 1 diabetes. There is insufficient published scientific evidence to support effectiveness and safety.

BILLING/CODING INFORMATION:

CPT Coding:

48160

Pancreatectomy, total or subtotal, with autologous transplantation of pancreas or pancreatic islets

HCPCS Coding:

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 tissue transplant from pancreas; allogeneic (investigational)

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

The following National Coverage Determinations (NCDs) were reviewed on the last guideline reviewed date: Pancreas Transplants (260.3) and Islet Cell Transplantation in the Context of a Clinical Trial (260.3.1), located at cms.gov.

DEFINITIONS:

Islets of Langerhans (islet cells): groups of specialized cells in the pancreas that secrete insulin and glucagon.

RELATED GUIDELINES:

Pancreas Transplantation, 02-40000-17

OTHER:

None applicable.

REFERENCES:

  1. Agency for Healthcare Research and Quality Evidence Report/Technology Assessment #98. Islet Transplantation in Patients with Type 1 Diabetes Mellitus, (07/04).
  2. American Diabetes Association. Living with Diabetes: Islet Transplantation. Accessed at http://www.diabetes.org/ on 01/31/13.
  3. American Medical Association CPT Coding (current edition).
  4. Bellin MD, Balamurugan AN, Pruett TL, Sutherland DE. No islets left behind: islet autotransplantation for surgery-induced diabetes. Curr Diab Rep. 2012 Oct;12(5):580-6.
  5. Bellin MD, Beilman GJ, Dunn TB, Pruett TL, Chinnakotla S, Wilhelm JJ, Ngo A, Radosevich DM, Freeman ML, Schwarzenberg SJ, Balamurugan AN, Hering BJ, Sutherland DE. Islet autotransplantation to preserve beta cell mass in selected patients with chronic pancreatitis and diabetes mellitus undergoing total pancreatectomy. Pancreas. 2013 Mar;42(2):317-21.
  6. Bhatt S, Fung JJ, Lu L, Qian S. Tolerance-Inducing Strategies in Islet Transplantation. International Journal of Endocrinology, 2012.
  7. Blue Cross Blue Shield Association Medical Policy Reference Manual. 7.03.12. Autologous Islet Cell Transplantation, (May 2014).
  8. Centers for Medicare and Medicaid Services (CMS) Publication 100-03 Medicare National Coverage Determinations, Transmittal 18, Change Request 3385, (10/01/04).
  9. Centers for Medicare and Medicaid Services (CMS), National Coverage Determination (NCD) for Islet Cell Transplantation in the Context of a Clinical Trial, Publication 100-3, Manual Section 260.3.1; 10/01/04. (Accessed 08/18/14).
  10. Centers for Medicare and Medicaid Services (CMS). National Coverage Determination (NCD) 260.3: Pancreas Transplants (04/26/06).
  11. ClinicalTrials.gov. NCT00214786: Pancreatic Islet Cell Transplantation. Baylor Research Institute (last updated August 28, 2008).
  12. ClinicalTrials.gov. NCT00468403: LEA29Y (Belatacept) Emory Edmonton Protocol (LEEP). National Institute of Allergy and Infectious Diseases (NIAID) (last updated January 28, 2013).
  13. Dong M, Parsaik AK, Erwin PJ, Farnell MB, Murad MH, Kudva YC. Systematic review and meta-analysis: islet autotransplantation after pancreatectomy for minimizing diabetes. Clin Endocrinol (Oxf). 2011 Dec;75(6):771-9.
  14. ECRI Health Technology Forecast; “Early results encouraging for islet cell transplantation in diabetic patients”, (12/05/05).
  15. ECRI Health Technology Forecast; “Islet cell transplantation for type 1 diabetes”, 10/05/06.
  16. ECRI Health Technology Forecast; “Promising diabetes treatment lacks long-term durability”, 10/06/06.
  17. ECRI Hotline Response article; “Islet Cell Transplantation for Type 1 Diabetes Mellitus”, (12/04).
  18. ECRI Institute Health Technology Forecast: Porcine-derived islet cell transplantation trial shows benefit in diabetes trial. July 24, 2008.
  19. ECRI Target Database; “Islet cell transplantation for type 1 diabetes”, (02/00; updated 03/05).
  20. ECRI, Windows on Medical Technology; “Islet Cell Transplantation for Type 1 Diabetes Mellitus”, (10/05).
  21. Farnell MB. Islet cell autotransplantation and chronic pancreatitis--still options. HPB (Oxford). 2011 Sep;13(9):596.
  22. Florida Medicare Medical Review Policy, Pancreas Transplantation, (retired 09/03/04).
  23. Halban PA, German MS, Kahn SE, Weir GC. Current Status of Islet Cell Replacement and Regeneration Therapy. J Clin Endocrinol Metab, March 2010, 95(3):1034–1043.
  24. HAYES Medical Technology Directory, “Islet Cell Transplantation for the Treatment of Type 1 Diabetes” 08/01/04; updated 08/24/07.
  25. Hering BJ, Kandaswammy R, Ansite JD, et al. Single-donor, marginal-dose islet transplantation in patients with type 1 diabetes.” JAMA 2005; 293(7): 830-835.
  26. Leitão CB, Tharavanij T, Cure P, Pileggi A, Baidal DA, Ricordi C, Alejandro R. Restoration of hypoglycemia awareness after islet transplantation. Diabetes Care. 2008 Nov; 31 (11): 2113-5. Epub 2008 Aug 12.
  27. National Diabetes Information Clearinghouse (NDIC). National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Pancreatic islet transplantation NIH Publication No. 07-4693. March 2007. Accessed 01/31/13 at: http://www.diabetes.niddk.nih.gov/dm/pubs/pancreaticislet/#2.
  28. National Institute for Health and Clinical Excellence. Allogeneic pancreatic islet cell transplantation for type 1 diabetes mellitus. IPG257. April 2008. (Accessed 08/19/14).
  29. National Institute of Diabetes and Digestive, and Kidney Diseases; “Centers Report Islet Transplant Results in Patients with Type 1 Diabetes”, 09/07/04.
  30. National Institute for Health and Clinical Excellence. Autologous pancreatic islet cell transplantation for improved glycaemic control after pancreatectomy. IPG274. September 2008. (Accessed 08/19/14).
  31. Organ Procurement and Transplant Network (OPTN). Policy 3.8 Pancreas Allocation. March 2009.
  32. 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 under Contract No. 290-02-0026). AHRQ Publication No. 04-E017-2. Rockville, MD: Agency for Healthcare Research and Quality. April 2004.
  33. Schmulewitz N. Total Pancreatectomy With Autologous Islet Cell Transplantation in Children: Making a Difference. Clinical Gastroenterology and Hepatology 2011;9:725–726.
  34. St. Anthony’s ICD-9-CM Code Book (current edition).
  35. Sutherland DER, et al. Total Pancreatectomy (TP) and Islet Autotransplantation (IAT) for Chronic Pancreatitis (CP). J Am Coll Surg. 2012 Apr;214(4):409-24; discussion 424-6.
  36. The National Diabetes Information Clearinghouse (NDIC). National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). “Pancreatic Islet Transplantation”, (11/03).
  37. U. S. Department of Health and Human Services National Institute of Health. The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Pancreatic Islet Cell Transplantation. Publication No. 07-4693. March 2007.
  38. U.S. Department of Health and Human Services. Food and Drug Administration. Center for Biologics Evaluation and Research. Considerations for Allogeneic Pancreatic Islet Cell Products. September 2009. Accessed 01/31/13 at: http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/UCM182441.pdf.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 09/25/14.

GUIDELINE UPDATE INFORMATION:

06/15/03

Medical Coverage Guideline Developed.

06/15/04

Scheduled review, no revisions.

10/01/04

4th Quarter HCPCS coding update; added procedure codes G0341, G0342, and G0343.

03/15/05

Scheduled review with revisions consisting of adding investigational statement for allogeneic islet cell transplantation for the treatment of type 1 diabetes.

01/01/06

Annual HCPCS coding update: add 0141T, 0142T, and 0143T.

03/15/06

Scheduled review; no change in coverage statement.

03/15/07

Scheduled review; no change in coverage statement.

06/15/07

Reformatted guideline.

03/15/08

Scheduled review; no change in position statement. Update references.

03/15/09

Scheduled review; no change in position statement. Update references.

03/15/10

Scheduled review; no change in position statement. Update references.

10/15/10

Revision; related ICD-10 codes added.

01/01/12

Annual HCPCS coding update. Deleted 0141T, 0142T and 0143T.

03/15/12

Scheduled review. Position statement maintained; updated description section and references.

03/15/13

Scheduled review. Maintain position statement and update references.

05/11/14

Revision: Program Exceptions section updated.

10/15/14

Scheduled review. Position statement maintained. Revised description and program exceptions. Updated references.

Date Printed: June 23, 2017: 06:23 PM