Islet Transplantation for Chronic Pancreatitis Form

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 1 (401) 274-4848 WWW.BCBSRI.COM EFFECTIVE DATE: 01|01|2026 POLICY LAST REVIEWED: 10|01|2025 OVERVIEW Performed in conjunction with pancreatectomy for chronic pancreatitis, autologous islet transplantation is proposed to reduce the likelihood of insulin-dependent diabetes. Allogeneic islet cell transplantation with donislecel-jujn is also being investigated as a treatment or cure for patients with type 1 diabetes. MEDICAL CRITERIA Not applicable PRIOR AUTHORIZATION
Not applicable POLICY STATEMENT Autologous Pancreas Islet Transplantation: Medicare Advantage Plans and Commercial Products Autologous pancreas islet transplantation is considered medically necessary as an adjunct to a total or near total pancreatectomy in individuals with chronic pancreatitis.
Allogeneic Islet Transplantation: Medicare Advantage Plans Allogeneic Pancreatic islet cell transplantation is covered for Medicare Advantage Plan individuals only as part of an approved clinical trial. Refer to Related Policies section. Note: Blue Cross & Blue Shield of Rhode Island (BCBSRI) must follow Centers for Medicare and Medicaid Services (CMS) guidelines, such as national coverage determinations or local coverage determinations for all Medicare Advantage Plan policies. Therefore, Medicare Advantage Plan policies may differ from Commercial Products. In some instances, benefits for Medicare Advantage Plans may be greater than what is allowed by the CMS. Commercial Products Allogeneic islet transplantation using an FDA-approved cellular therapy product (donislecel-jujn [ie, Lantidra]) is considered medically necessary. COVERAGE Benefits vary between groups/contracts. Please refer to the appropriate Evidence of Coverage or Subscriber Agreement, for applicable/transplant surgery/ benefits/coverage. BACKGROUND Performed in conjunction with pancreatectomy, autologous islet transplantation is proposed to reduce the likelihood of insulin-dependent diabetes. Allogeneic islet cell transplantation is also being investigated as a treatment or cure for individuals with type 1 diabetes. Islet Transplantation Medical Coverage Policy | Islet Transplantation for Chronic Pancreatitis

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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 patient’s liver. Once implanted, the beta cells in these islets begin to make and release insulin.

Allogeneic islet transplantation potentially offers an alternative to whole-organ pancreas transplantation. In the case of allogeneic islet cell transplantation, cells are harvested from a deceased donor’s pancreas, processed, and injected into the recipient’s portal vein. Islet transplantation has generally been reserved for individuals with frequent and severe metabolic complications who have consistently failed to achieve control with insulin-based management. Allogeneic transplantation may be performed in the radiology department.
In 2000, a modified immunosuppression regimen increased the success of allogeneic islet transplantation. This regimen is known as the “Edmonton protocol.” The U.S. Food and Drug Administration (FDA) regulates human cells and tissues intended for implantation, transplantation, or infusion through the Center for Biologics Evaluation and Research, under Code of Federal Regulation Title 21, parts 1270 and1271. Allogeneic islet cells are included in these regulations. Donislecel- jujn (Lantidra™), a first-in-class deceased donor-derived allogeneic pancreatic islet cellular therapy product, was approved by the FDA in June 2023 for the treatment of type 1 diabetes in adults who are unable to approach target hemoglobin A1c due to repeated episodes of severe hypoglycemia despite intensive diabetes management and education.

Medicare Advantage Plans Medicare covers pancreatic islet transplantation in individuals with type 1 diabetes participating in a clinical trial sponsored by the National Institutes of Health. Partial pancreatic tissue transplantation or islet transplantation performed outside a clinical trial are not covered.

CODING Medicare Advantage Plans and Commercial Products The following CPT code(s) is covered: 48160 Pancreatectomy, total or subtotal, with autologous transplantation of pancreas or pancreatic islet cells

The HCPCS code(s) listed below are allowed for Medicare Advantage Plans as part of a CMS approved clinical study. Claims for services rendered as part of a CMS approved clinical study must be billed with an appropriate modifier:
Modifier Q0 – Investigational clinical service provided in a clinical research study that is in an approved
research study (Medicare Advantage Plan claims filed without the Q0 modifier will deny as not
covered)
Modifier Q1 – Routine clinical service provided in a clinical research study that is in an approved clinical
research study
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

Note: If you are treating a Medicare Advantage Plan member as part of a CMS approved study, please follow the procedures for correct billing and coding of services found in the policy for Clinical Trials Medicare Advantage Plans.

The following code(s) are invalid for Medicare Advantage Plans and should be filed with the appropriate “G’ code(s) above: 0584T Islet cell transplant, includes portal vein catheterization and infusion, including all imaging, including
guidance, and radiological supervision and interpretation, when performed; percutaneous
0585T Islet cell transplant, includes portal vein catheterization and infusion, including all imaging, including
guidance, and radiological supervision and interpretation, when performed; laparoscopic
0586T Islet cell transplant, includes portal vein catheterization and infusion, including all imaging, including
guidance, and radiological supervision and interpretation, when performed; open

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 3 (401) 274-4848 WWW.BCBSRI.COM

S2102 Islet cell tissue transplant from pancreas, allogeneic

Commercial Products The following CPT code(s) is covered
48160 Pancreatectomy, total or subtotal, with autologous transplantation of pancreas or pancreatic islet cells

The following code(s) are covered:
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 0584T Islet cell transplant, includes portal vein catheterization and infusion, including all imaging, including
guidance, and radiological supervision and interpretation, when performed; percutaneous
0585T Islet cell transplant, includes portal vein catheterization and infusion, including all imaging, including
guidance, and radiological supervision and interpretation, when performed; laparoscopic
0586T Islet cell transplant, includes portal vein catheterization and infusion, including all imaging, including
guidance, and radiological supervision and interpretation, when performed; open S2102 Islet cell tissue transplant from pancreas, allogeneic

RELATED POLICIES Clinical Trials Medicare Advantage Plans Medicare Advantage Plans National and Local Coverage Determinations

PUBLISHED Provider Update, January/November 2025 Provider Update, February 2024 Provider Update, October 2022 Provider Update, April 2021

REFERENCES

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500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 4 (401) 274-4848 WWW.BCBSRI.COM

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500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 5 (401) 274-4848 WWW.BCBSRI.COM

33. Takita M, Lara LF, Naziruddin B, et al. Effect of the Duration of Chronic Pancreatitis on Pancreas Islet Yield and Metabolic Outcome Following Islet Autotransplantation. J Gastrointest Surg. Jul 2015; 19(7): 1236-46. PMID 25933581
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36. Mokadem M, Noureddine L, Howard T, et al. Total pancreatectomy with islet cell transplantation vs intrathecal narcotic pump infusion for pain control in chronic pancreatitis. World J Gastroenterol. Apr 28 2016; 22(16): 4160-7. PMID 27122666
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500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 6 (401) 274-4848 WWW.BCBSRI.COM

53. ElSayed NA, Aleppo G, Bannuru RR, et al. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes-2024. Diabetes Care. Jan 01 2024; 47(Suppl 1): S158-S178. PMID 38078590
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55. Centers for Medicare & Medicaid. National Coverage Determination (NCD) for ISLET CELL Transplantation in the Context of a Clinical Trial (260.3.1). 2004; https://www.cms.gov/medicare- coverage-database/view/ncd.aspx?NCDId=286. Accessed July 5, 2024.

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    This medical policy is made available to you for informational purposes only. It is not a guarantee of payment or a substitute for your medical judgment in the treatment of your patients. Benefits and eligibility are determined by the member's subscriber agreement or member certificate and/or the employer agreement, and those documents will supersede the provisions of this medical policy. For information on member-specific benefits, call the provider call center. If you provide services to a member which are determined to not be medically necessary (or in some cases medically necessary services which are non-covered benefits), you may not charge the member for the services unless you have informed the member and they have agreed in writing in advance to continue with the treatment at their own expense. Please refer to your participation agreement(s) for the applicable provisions. This policy is current at the time of publication; however, medical practices, technology, and knowledge are constantly changing. BCBSRI reserves the right to review and revise this policy for any reason and at any time, with or without notice. Blue Cross & Blue Shield of Rhode Island is an independent licensee of the Blue Cross and Blue Shield Association. CLICK THE ENVELOPE ICON BELOW TO SUBMIT COMMENTS