328 Form

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Medical Policy Allogeneic Pancreas Transplant Table of Contents
• Policy: Commercial • Description • Information Pertaining to All Policies
• Authorization Information • Policy History • References
• Coding Information

Policy Number: 328 BCBSA Reference Number: 7.03.02 (For Plan internal use only)

Related Policies
• Artificial Pancreas Device Systems, #107
• Kidney Transplant, #196
• Islet Transplantation, #324

Policy
Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity

A combined pancreas-kidney transplant may be MEDICALLY NECESSARY in insulin dependent diabetic individuals with uremia.

Pancreas transplant after a prior kidney transplant may be MEDICALLY NECESSARY in individuals with insulin dependent diabetes.

Pancreas transplant alone may be MEDICALLY NECESSARY in individuals with severely disabling and potentially life-threatening complications due to hypoglycemia unawareness and labile insulin-dependent diabetes that persists in spite of optimal medical management.

Pancreas retransplant after a failed primary pancreas transplant may be MEDICALLY NECESSARY in individuals who meet criteria for pancreas transplantation.

In addition to the above information, we do not cover pancreas transplantation when any of the following conditions are present: • Known current malignancy, including metastatic cancer • Recent malignancy with high risk of recurrence

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o Note: the assessment of risk of recurrence for a previously treated malignancy is made by the transplant team; providers must submit a statement with an explanation of why the patient with a recently treated malignancy is an appropriate candidate for a transplant. • Untreated systemic infection making immunosuppression unsafe, including chronic infection • Other irreversible end-stage disease not attributed to kidney disease • History of cancer with a moderate risk of recurrence • Systemic disease that could be exacerbated by immunosuppression • Psychosocial conditions or chemical dependency affecting ability to adhere to therapy.

Policy Guidelines Candidates for pancreas transplant alone should additionally meet 1 of the following severity of illness criteria: • Documentation of severe hypoglycemia unawareness as evidenced by chart notes or emergency department visits, OR • Documentation of potentially life-threatening labile diabetes, as evidenced by chart notes or hospitalization for diabetic ketoacidosis.

Additionally, most pancreas transplant individuals will have type 1 diabetes. In 2022, individuals with type 2 diabetes accounted for 22.4% of all pancreas transplants, according to data from the Organ Procurement and Transplantation Network and the Scientific Registry of Transplant Recipients.1,

Pancreas transplant is considered INVESTIGATIONAL in all other situations.

Prior Authorization Information
Inpatient • For services described in this policy, precertification/preauthorization IS REQUIRED for all products if the procedure is performed inpatient.
Outpatient • For services described in this policy, see below for products where prior authorization might be required if the procedure is performed outpatient.

Outpatient Commercial Managed Care (HMO and POS) This procedure is performed in the inpatient setting. Commercial PPO and Indemnity This procedure is performed in the inpatient setting. CPT Codes / HCPCS Codes / ICD Codes Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage as it applies to an individual member.
Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable.

The above medical necessity criteria MUST be met for the following codes to be covered for Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity: CPT Codes CPT codes: Code Description 48554 Transplantation of pancreatic allograft

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HCPCS Codes HCPCS codes: Code Description S2065 Simultaneous pancreas kidney transplantation ICD-10 Procedure Codes ICD-10-PCS procedure codes: Code Description 0FYG0Z0 Transplantation of Pancreas, Allogeneic, Open Approach 0FSG0ZZ Reposition Pancreas, Open Approach 0FSG4ZZ Reposition Pancreas, Percutaneous Endoscopic Approach

Description Solid Organ Transplantation Solid organ transplantation offers a treatment option for patients with different types of end-stage organ failure that can be lifesaving or provide significant improvements to a patient’s quality of life.2, Many advances have been made in the last several decades to reduce perioperative complications. Available data supports improvement in long-term survival as well as improved quality of life particularly for liver, kidney, pancreas, heart, and lung transplants. Allograft rejection remains a key early and late complication risk for any organ transplantation. Transplant recipients require life-long immunosuppression to prevent rejection. Patients are prioritized for transplant by mortality risk and severity of illness criteria developed by the Organ Procurement and Transplantation Network and United Network of Organ Sharing.

Allogeneic Pancreas Transplant In 2024, 48,136 transplants were performed in the United States procured from more than 17,000 deceased donors and 7,000 living donors.3, Pancreas-kidney transplants were the fifth most common procedure, with 733 transplants performed in 2024. Pancreas-alone transplants were the sixth most common procedure, with 114 transplants performed in 2024.

Pancreas transplantation occurs in several different scenarios such as (1) a diabetic patient with renal failure who may receive a simultaneous cadaveric pancreas plus kidney transplant; (2) a diabetic patient who may receive a cadaveric or living-related pancreas transplant after a kidney transplantation (pancreas after kidney); or (3) a nonuremic diabetic patient with specific severely disabling and potentially life- threatening diabetic problems who may receive a pancreas transplant alone.

Data from the United Network for Organ Sharing and the International Pancreas Transplant Registry indicate that the proportion of simultaneous pancreas plus kidney transplant recipients worldwide who have type 2 diabetes has increased over time, from 6% of transplants between 2005 and 2009 to 9% of transplants between 2010 and 2014.4, Between 2010 and 2014, approximately 4% of pancreas after kidney transplants and 4% of pancreas alone transplants were performed in patients with type 2 diabetes. In 2022, patients with type 2 diabetes accounted for 22.4% of all pancreas transplants, according to data from the Organ Procurement and Transplantation Network and the Scientific Registry of Transplant Recipients.1,

Summary Description

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Transplantation of a healthy pancreas is a treatment for individuals with insulin-dependent diabetes. Pancreas transplantation can restore glucose control and prevent, halt, or reverse the secondary complications from diabetes.

Summary of Evidence For individuals who have insulin-dependent diabetes who receive a pancreas transplant after a kidney transplant, the evidence includes retrospective studies and registry studies. Relevant outcomes are overall survival (OS), change in disease status, and treatment-related mortality and morbidity. Data from national and international registries have found relatively high patient survival rates with a pancreas transplant after a kidney transplant (eg, a 3-year survival rate of 94.5%). Single-center retrospective studies have found similar patient survival and death-censored pancreas graft survival rates with a pancreas transplant after a kidney transplant or a simultaneous pancreas and kidney (SPK) transplant. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome. For individuals who have insulin-dependent diabetes with uremia who receive SPK transplants, the evidence includes retrospective studies and registry studies. Relevant outcomes are OS, change in disease status, and treatment-related mortality and morbidity. Data from national and international registries have found relatively high patient survival rates after SPK transplant. A retrospective analysis found a higher survival rate in patients with type 1 diabetes who had an SPK transplant versus those on a waiting list. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome. For individuals who have insulin-dependent diabetes and severe complications who receive pancreas transplant alone, the evidence includes registry studies. Relevant outcomes are OS, change in disease status, and treatment-related mortality and morbidity. Data from international and national registries have found that graft and patient survival rates after pancreas transplant alone have improved over time (eg, 3- year survival of 94.9%). The evidence is sufficient to determine that the technology results in an improvement in the net health outcome. For individuals who have had a prior pancreas transplant who still meet criteria for a pancreas transplant who receive pancreas retransplantation, the evidence includes retrospective studies and registry studies. Relevant outcomes are OS, change in disease status, and treatment-related mortality and morbidity. National data and specific transplant center data have generally found similar graft and patient survival rates after pancreas retransplantation compared with initial transplantation. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

Policy History Date Action 11/2025 Annual policy review. Policy updated with literature review through July 16, 2025; no references added. Policy statements unchanged. 10/2024 Annual policy review. Policy updated with literature review through June 24, 2024; references added. Policy Guidelines updated to remove obesity-related criteria. 10/2023 Annual policy review. Description, summary, and references updated. Policy statement unchanged. 10/2022 Annual policy review. No references added. Minor editorial refinements to policy statements; intent unchanged. 9/2021 Annual policy review. Description, summary, and references updated. Policy statements unchanged.

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1/2021 Medicare information removed. See MP #132 Medicare Advantage Management for local coverage determination and national coverage determination reference.
10/2020 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 10/2019 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 10/2018 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 9/2017 Annual policy review. New references added. 5/2015 Clarified coding language. 4/2015 Annual policy review. Clarified that pancreas transplant is investigational in all other situations. Effective 4/1/2015. 10/2014 Medical policy remediation: New indications for non-coverage. Coding information clarified. Effective 10/1/2014. 6/2014 Updated Coding section with ICD10 procedure and diagnosis codes, effective 10/2015. 4/2014 Annual policy review. Medically necessary indications clarified. Effective 4/1/2014.
Coding information clarified 11/2011- 4/2012 Medical policy ICD 10 remediation: Formatting, editing and coding updates. No changes to policy statements.
10/2011 Reviewed - Medical Policy Group - Gastroenterology, Nutrition and Organ Transplantation. No changes to policy statements. 5/2011 Annual policy review. Changes to policy statements. 11/2010 Reviewed - Medical Policy Group - Gastroenterology, Nutrition and Organ Transplantation. No changes to policy statements. 11/2009 Reviewed - Medical Policy Group - Gastroenterology, Nutrition and Organ Transplantation. No changes to policy statements. 6/2009 Annual policy review. No changes to policy statements. 11/2008 Reviewed - Medical Policy Group - Gastroenterology, Nutrition and Organ Transplantation. No changes to policy statements. 4/2008 Annual policy review. No changes to policy statements. Information Pertaining to All Blue Cross Blue Shield Medical Policies Click on any of the following terms to access the relevant information: Medical Policy Terms of Use Managed Care Guidelines Indemnity/PPO Guidelines Clinical Exception Process Medical Technology Assessment Guidelines

References

1. Kandaswamy R, Stock PG, Miller JM, et al. OPTN/SRTR 2022 Annual Data Report: Pancreas. Am J Transplant. Feb 2024; 24(2S1): S119-S175. PMID 38431358
2. Black CK, Termanini KM, Aguirre O, et al. Solid organ transplantation in the 21 st century. Ann Transl Med. Oct 2018; 6(20): 409. PMID 30498736
3. United Network for Organ Sharing (UNOS). Transplant trends. 2025; https://unos.org/data/. Accessed July 16, 2025.
4. Gruessner AC, Gruessner RW. Pancreas Transplantation of US and Non-US Cases from 2005 to 2014 as Reported to the United Network for Organ Sharing (UNOS) and the International Pancreas Transplant Registry (IPTR). Rev Diabet Stud. 2016; 13(1): 35-58. PMID 26982345

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5. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Pancreas Transplantation. TEC Assessments. 1998;Volume 13, Tab 7.
6. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Pancreas Retransplantation. TEC Assessments. 2001;Volume 16, Tab 23.
7. Parajuli S, Arunachalam A, Swanson KJ, et al. Outcomes after simultaneous kidney-pancreas versus pancreas after kidney transplantation in the current era. Clin Transplant. Dec 2019; 33(12): e13732. PMID 31628870
8. Bazerbachi F, Selzner M, Marquez MA, et al. Pancreas-after-kidney versus synchronous pancreas- kidney transplantation: comparison of intermediate-term results. Transplantation. Feb 15 2013; 95(3): 489-94. PMID 23183776
9. Fridell JA, Mangus RS, Hollinger EF, et al. The case for pancreas after kidney transplantation. Clin Transplant. 2009; 23(4): 447-53. PMID 19453642
10. Kleinclauss F, Fauda M, Sutherland DE, et al. Pancreas after living donor kidney transplants in diabetic patients: impact on long-term kidney graft function. Clin Transplant. 2009; 23(4): 437-46. PMID 19496790
11. Organ Procurement and Transplantation Network (OPTN). National Data. n.d.; https://optn.transplant.hrsa.gov/data/view-data-reports/national-data/. Accessed July 16, 2025.
12. Barlow AD, Saeb-Parsy K, Watson CJE. An analysis of the survival outcomes of simultaneous pancreas and kidney transplantation compared to live donor kidney transplantation in patients with type 1 diabetes: a UK Transplant Registry study. Transpl Int. Sep 2017; 30(9): 884-892. PMID 28319322
13. van Dellen D, Worthington J, Mitu-Pretorian OM, et al. Mortality in diabetes: pancreas transplantation is associated with significant survival benefit. Nephrol Dial Transplant. May 2013; 28(5): 1315-22. PMID 23512107
14. Sampaio MS, Kuo HT, Bunnapradist S. Outcomes of simultaneous pancreas-kidney transplantation in type 2 diabetic recipients. Clin J Am Soc Nephrol. May 2011; 6(5): 1198-206. PMID 21441123
15. Pugliese A, Reijonen HK, Nepom J, et al. Recurrence of autoimmunity in pancreas transplant patients: research update. Diabetes Manag (Lond). Mar 2011; 1(2): 229-238. PMID 21927622
16. Gruessner AC. 2011 update on pancreas transplantation: comprehensive trend analysis of 25,000 cases followed up over the course of twenty-four years at the International Pancreas Transplant Registry (IPTR). Rev Diabet Stud. 2011; 8(1): 6-16. PMID 21720668
17. Boggi U, Baronti W, Amorese G, et al. Treating Type 1 Diabetes by Pancreas Transplant Alone: A Cohort Study on Actual Long-term (10 Years) Efficacy and Safety. Transplantation. Jan 01 2022; 106(1): 147-157. PMID 33909390
18. Scalea JR, Butler CC, Munivenkatappa RB, et al. Pancreas transplant alone as an independent risk factor for the development of renal failure: a retrospective study. Transplantation. Dec 27 2008; 86(12): 1789-94. PMID 19104423
19. Parajuli S, Arunachalam A, Swanson KJ, et al. Pancreas Retransplant After Pancreas Graft Failure in Simultaneous Pancreas-kidney Transplants Is Associated With Better Kidney Graft Survival. Transplant Direct. Aug 2019; 5(8): e473. PMID 31576369
20. Gasteiger S, Cardini B, Göbel G, et al. Outcomes of pancreas retransplantation in patients with pancreas graft failure. Br J Surg. Dec 2018; 105(13): 1816-1824. PMID 30007018
21. Buron F, Thaunat O, Demuylder-Mischler S, et al. Pancreas retransplantation: a second chance for diabetic patients?. Transplantation. Jan 27 2013; 95(2): 347-52. PMID 23222920
22. Fridell JA, Mangus RS, Chen JM, et al. Late pancreas retransplantation. Clin Transplant. Jan 2015; 29(1): 1-8. PMID 25284041
23. Seal J, Selzner M, Laurence J, et al. Outcomes of pancreas retransplantation after simultaneous kidney-pancreas transplantation are comparable to pancreas after kidney transplantation alone. Transplantation. Mar 2015; 99(3): 623-8. PMID 25148379
24. Rudolph EN, Finger EB, Chandolias N, et al. Outcomes of pancreas retransplantation. Transplantation. Feb 2015; 99(2): 367-74. PMID 25594555
25. Organ Procurement and Transplantation Network (OPTN). OPTN Policies. Updated June 26, 2025; https://optn.transplant.hrsa.gov/media/1200/optn_policies.pdf. Accessed July 15, 2025.

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26. Blumberg EA, Rogers CC. Solid organ transplantation in the HIV-infected patient: Guidelines from the American Society of Transplantation Infectious Diseases Community of Practice. Clin Transplant. Sep 2019; 33(9): e13499. PMID 30773688
27. Siskind E, Maloney C, Akerman M, et al. An analysis of pancreas transplantation outcomes based on age groupings--an update of the UNOS database. Clin Transplant. Sep 2014; 28(9): 990-4. PMID 24954160
28. Shah AP, Mangus RS, Powelson JA, et al. Impact of recipient age on whole organ pancreas transplantation. Clin Transplant. 2013; 27(1): E49-55. PMID 23228216
29. Afaneh C, Rich BS, Aull MJ, et al. Pancreas transplantation: does age increase morbidity?. J Transplant. 2011; 2011: 596801. PMID 21766007
30. Schenker P, Vonend O, Krüger B, et al. Long-term results of pancreas transplantation in patients older than 50 years. Transpl Int. Feb 2011; 24(2): 136-42. PMID 21039944
31. Gruessner AC, Sutherland DE. Access to pancreas transplantation should not be restricted because of age: invited commentary on Schenker et al. Transpl Int. Feb 2011; 24(2): 134-5. PMID 21208293
32. Centers for Medicare & Medicaid Services (CMS). Organ transplant program. 2025; https://www.cms.gov/Medicare/Provider-Enrollment-and- Certification/CertificationandComplianc/Transplant. Accessed July 15, 2025.
33. Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD) for Pancreas Transplants (260.3). 2006; https://www.cms.gov/medicare-coverage-database/details/ncd- details.aspx?ncdid=107&ver=3. Accessed July 16, 2025.