Clinical Policy: Pancreas Transplantation Form

# Clinical Policy: Pancreas Transplantation
Reference Number: CP.MP.102  
Date of Last Revision: 01/26  

[Revision Log](Revision Log)  
[Coding Implications](Coding Implications)  

See [Important Reminder](Important Reminder) at the end of this policy for important regulatory and legal information.  

## Description  
This policy describes the medical necessity requirements for pancreas transplantation procedures. Multiple types of pancreas transplants are effective therapeutic options for arresting the progression of complications of diabetes mellitus and improving the quality of life for diabetic patients, including simultaneous pancreas kidney transplant (SPK), pancreas after kidney transplant (PAK), pancreas transplant alone (PTA), and islet cell transplant.¹  

Note: For criteria related to Lantidra, please see CP.MP.250 Lantidra (donislecel): Allogeneic Pancreatic Islet Cellular Therapy  

## Policy/Criteria  
  
   13. Chronic, non-healing wounds;  
   14. Significant comorbidities, such as advanced cardiopulmonary, cardiovascular, cerebrovascular, or peripheral vascular disease;  
   15. Other severe uncontrolled medical condition expected to limit survival after transplant;  

II. It is the policy of health plans affiliated with Centene Corporation that autologous islet cell transplants are considered **medically necessary** as an adjunct procedure to a total or near total pancreatectomy for severe, refractory pancreatitis.  

III. It is the policy of health plans affiliated with Centene Corporation that pancreas re-transplantations are considered **medically necessary** after one failed primary pancreas transplant.  

IV. It is the policy of health plans affiliated with Centene Corporation that current evidence does not support the use of pancreas transplant procedures for any of the following indications:  
   A. Re-transplantations after two or more failed primary pancreas transplantations;  
   B. Allogeneic islet cell transplantation or xenotransplantation;  
   C. SPK transplantation for patients with amputation due to peripheral obstructive vascular disease;  
   D. For the treatment of all other conditions than those specified above.  

## Background  
The American Diabetes Association defines diabetes mellitus as a group of metabolic diseases characterized by hyperglycemia that results from defects in insulin secretion, insulin action, or both.³ According to the Centers for Disease Control and Prevention estimations, approximately 38.4 million people or 11.6% of the United States population has diabetes with approximately 8.7 million undiagnosed cases.⁴ Chronic hyperglycemia existing in diabetic patients facilitates long term organ damage, especially to the eyes, nerves, and blood vessels.³  

The prevalent type 2 diabetes is caused by a resistance to insulin action and an inadequate compensatory insulin secretory response.³ Type 1 diabetes is caused by immune mediated destruction of the insulin secreting pancreatic β cells.⁵ Islet cell autoantibodies, insulin autoantibodies, autoantibodies to glutamic acid decarboxylase, zinc transporter 8 (ZnT8A), and autoantibodies to the tyrosine phosphatase IA-2 and IA-2β are serological markers of the pancreatic β cell destruction observed in type 1 diabetes.³,⁵,⁶  

Pancreas transplantation allows for the possibility to restore glucose regulated endogenous secretion, decrease the progression of diabetic complications, and improve quality of life in patients with diabetes.¹ Pancreas transplantation is the only proven method to restore normoglycemia in type 1 diabetic patients.⁸ Simultaneous pancreas kidney transplant (SPK), pancreas after kidney transplant (PAK), and pancreas transplant alone (PTA) are primarily performed on patients with type 1 diabetes.⁸ SPK is an established procedure for diabetic patients with advanced chronic kidney disease or end stage kidney disease and accounts for approximately 90% of pancreas transplants performed in the United States.⁹  

A 2011 study by Gruessner¹⁰ reviewed the outcomes of SPK, PAK, and PTA transplantations according to follow-up data collected by the International Pancreas Transplant Registry. Patient survival rates were reported to be over 95% after one year and over 83% at five years post-transplant. The highest graft survival rates were observed in SPK transplants at 86% for pancreas and 93% for kidney graft function one-year post-transplant. PAK procedures displayed graft function at 80%, while PTA had graft function at 78% one year after transplantation.¹⁰ The study demonstrated that pancreas transplantation offers excellent outcomes for patients with diabetes due to the improvement in patient survival and graft function shown in all three categories over the course of 24 years.¹⁰  

Patients undergoing pancreas transplantation, especially SPK transplant, require extensive immunosuppression regiments.¹ It is theorized that pancreas transplant recipients require higher levels of immunosuppression therapy than other solid organ transplants due to the immunogenicity of the pancreas and the autoimmune status of the recipient.¹¹  

During pancreatic islet autotransplantation, Islet β cells are transferred to the liver through the portal vein of the recipient.¹ Pancreatic islet autotransplantation is performed following a pancreatectomy in patients with severe chronic pancreatitis. Chronic pancreatitis is a debilitating disease which causes diarrhea, weight loss, poor quality of life, and severe abdominal pain that is difficult to alleviate with pharmacological treatment or other therapeutic measures.¹,¹² Due to the excessive pain observed in patients with chronic pancreatitis, pain control is a primary goal of pancreatectomy and pancreatic islet autotransplantation.¹²  

## Coding Implications  
This clinical policy references Current Procedural Terminology (CPT®). CPT® is a registered trademark of the American Medical Association. All CPT codes and descriptions are copyrighted 2025, American Medical Association. All rights reserved. CPT codes and CPT descriptions are from the current manuals and those included herein are not intended to be all-inclusive and are included for informational purposes only. Codes referenced in this clinical policy are for informational purposes only. Inclusion or exclusion of any codes does not guarantee coverage. Providers should reference the most up-to-date sources of professional coding guidance prior to the submission of claims for reimbursement of covered services.  

| CPT Codes | Description |
|-----------|-------------|
| 48160 | Pancreatectomy, total or subtotal, with autologous transplantation of pancreas of pancreatic islet cells |
| 48550 | Donor pancreatectomy (including cold preservation), with or without duodenal segment for transplantation |
| 48551 | Backbench standard preparation of cadaver donor pancreas allograft prior to transplantation, including dissection of allograft from surrounding soft tissues, splenectomy, duodenotomy, ligation of bile duct, ligation of mesenteric vessels, and Y-graft arterial anastomoses from iliac artery to superior mesenteric artery and to splenic artery |
| 48552 | Backbench reconstruction of cadaver donor pancreas allograft prior to transplantation, venous anastomosis, each |
| 48554 | Transplantation of pancreatic allograft |
| 48556 | Removal of transplanted pancreatic allograft |
| 50300 | Donor nephrectomy (including cold preservation); from cadaver donor, unilateral or bilateral |
| 50320 | Donor nephrectomy (including cold preservation); open, from living donor |
| 50323 | Backbench standard preparation of cadaver donor renal allograft prior to transplantation, including dissection and removal of perinephric fat, diaphragmatic and retroperitoneal attachments, excision of adrenal gland, and preparation of ureter(s), renal vein(s), and renal artery(s), ligating branches, as necessary |
| 50325 | Backbench standard preparation of living donor renal allograft (open or laparoscopic) prior to transplantation, including dissection and removal of perinephric fat and preparation of ureter(s), renal vein(s), and renal artery(s), ligating branches, as necessary |
| 50327 | Backbench reconstruction of cadaver or living donor renal allograft prior to transplantation; venous anastomosis, each |
| 50328 | Backbench reconstruction of cadaver or living donor renal allograft prior to transplantation; arterial anastomosis, each |
| 50340 | Recipient nephrectomy (separate procedure) |
| 50360 | Renal allotransplantation, implantation of graft; without recipient nephrectomy |
| 50365 | Renal allotransplantation, implantation of graft; with recipient nephrectomy |

| CPT Codes | Description |
|-----------|-------------|
| 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 |

| HCPCS Codes | Description |
|-------------|-------------|
| S2065 | Simultaneous pancreas kidney transplantation |

| Reviews, Revisions, and Approvals | Revision Date | Approval Date |
|----------------------------------|---------------|---------------|
| Policy developed. Reviewed by specialist 4/16. | 02/16 | 04/16 |
| Background updated to reflect current data. References reviewed and updated. Replaced “member” with “member/enrollee” in all instances. Under contraindication I.C. removed “malignancy metastasized to or extending beyond the margins of the kidney and/or pancreas” as this is inclusive to contraindication #1. | 02/21 | 02/21 |
| Removed contraindication of “severely limited functional status with poor rehabilitation potential.” Replaced “Psychiatric or psychological condition associated with the inability to cooperate or comply with medical therapy” and the contraindication regarding non-compliance with medical therapy with “Inability to adhere to the regimen necessary to preserve the transplant, even with caregiver support.” Changed “Review Date” in header to “Date of Last Revision,” and “Date” in the revision log header to “Revision Date.” | 08/21 | 08/21 |
| Annual review. References reviewed and updated. Updated description and background with no clinical significance. Removed requirement in I.A. that medical therapy does not exist or has failed. Updated all contraindications in criteria I.C. “Experimental/investigational” verbiage replaced in criteria IV. statement with descriptive language. Specialist reviewed. | 02/22 | 02/22 |
| Annual review. Removed criterion I.A. stating that medical treatment does not exist or has failed. Removed C-peptide values and BMI requirements from Criteria I.B.1 and I.B.2. Noted in I.B.1. that member/enrollees with requirements for insulin over one unit/kg should be closely evaluated as they may be less likely to benefit from pancreas transplant compared to those with lower insulin doses Added indication in I.B.2 for exocrine pancreatic insufficiency. Added indication I.B.3. for requirement for the procurement or transplantation of a pancreas as part of a multiple organ transplant for technical reasons: Changed “chronic” to “active” in infection contraindication in I.C.7. Removed acute renal failure contraindication. Criteria I.C.12. updated to exclude marijuana use when prescribed by a licensed practitioner and include required commitment to reducing substance use behaviors if urgent transplant timelines are present. Added chronic, non-healing wounds as contraindication in Criteria I.C.13. Added contraindication of significant comorbidities in Criteria I.C.14. Clarified in I.C.1.b that problems with insulin could be clinical or clinical and emotional. Added in I.C.2.c. that | 02/23 | 02/23 |
| Added note to policy to see CP.MP.250 Lantidra (donislecel): Allogeneic Pancreatic Islet Cellular Therapy for criteria related to Lantidra. | 08/23 | 08/23 |
| Annual review. Expanded criteria I.B. to I.B.a. through c. Updated description and background with no clinical significance. Coding reviewed. References reviewed and updated. Reviewed by external specialist | 02/24 | 02/24 |
| Annual review. In I.B.3. changed “myocardial infarction within 30 days” to “myocardial (within 6 months)” and reworded the information about “stroke or acute coronary syndrome”. Added I.C.1.ii “Recurring severe hypoglycemic attacks”. Background updated. Added CPT code 50328. References reviewed and updated. | 01/25 | 01/25 |
| Annual review. Under criteria I.A.1. specified “type I” and removed “(members/enrollees with requirements…)”. Under I.B.1.a. replaced “require” with “required” and “room” with “department”. Reworded criteria under I.B.1.b. with no impact on criteria. Under I.B.2.c. removed “(does not have to be…)” and added “or dialysis dependent”. Under I.B.3.c.ii. added “specified as greater than 500mg/day”. Moved contraindications under I.B. to I.C. References reviewed and updated. Reviewed by internal and external specialist. | 01/26 | 01/26 |

  

## Important Reminder  
This clinical policy has been developed by appropriately experienced and licensed health care professionals based on a review and consideration of currently available generally accepted standards of medical practice; peer-reviewed medical literature; government agency/program approval status; evidence-based guidelines and positions of leading national health professional organizations; views of physicians practicing in relevant clinical areas affected by this clinical policy; and other available clinical information. The Health Plan makes no representations and accepts no liability with respect to the content of any external information used or relied upon in developing this clinical policy. This clinical policy is consistent with standards of medical practice current at the time that this clinical policy was approved. “Health Plan” means a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan’s affiliates, as applicable.  

The purpose of this clinical policy is to provide a guide to medical necessity, which is a component of the guidelines used to assist in making coverage decisions and administering benefits. It does not constitute a contract or guarantee regarding payment or results. Coverage decisions and the administration of benefits are subject to all terms, conditions, exclusions and limitations of the coverage documents (e.g., evidence of coverage, certificate of coverage, policy, contract of insurance, etc.), as well as to state and federal requirements and applicable Health Plan-level administrative policies and procedures.  

This clinical policy is effective as of the date determined by the Health Plan. The date of posting may not be the effective date of this clinical policy. This clinical policy may be subject to applicable legal and regulatory requirements relating to provider notification. If there is a discrepancy between the effective date of this clinical policy and any applicable legal or regulatory requirement, the requirements of law and regulation shall govern. The Health Plan retains the right to change, amend or withdraw this clinical policy, and additional clinical policies may be developed and adopted as needed, at any time.  

This clinical policy does not constitute medical advice, medical treatment or medical care. It is not intended to dictate to providers how to practice medicine. Providers are expected to exercise professional medical judgment in providing the most appropriate care, and are solely responsible for the medical advice and treatment of members/enrollees. This clinical policy is not intended to recommend treatment for members/enrollees. Members/enrollees should consult with their treating physician in connection with diagnosis and treatment decisions.  

Providers referred to in this clinical policy are independent contractors who exercise independent judgment and over whom the Health Plan has no control or right of control. Providers are not agents or employees of the Health Plan.  

This clinical policy is the property of the Health Plan. Unauthorized copying, use, and distribution of this clinical policy or any information contained herein are strictly prohibited. Providers, members/enrollees and their representatives are bound to the terms and conditions expressed herein through the terms of their contracts. Where no such contract exists, providers, members/enrollees and their representatives agree to be bound by such terms and conditions by providing services to members/enrollees and/or submitting claims for payment for such services.  

Note: For Medicaid members/enrollees, when state Medicaid coverage provisions conflict with the coverage provisions in this clinical policy, state Medicaid coverage provisions take precedence. Please refer to the state Medicaid manual for any coverage provisions pertaining to this clinical policy.  

Note: For Medicare members/enrollees, to ensure consistency with the Medicare National Coverage Determinations (NCD) and Local Coverage Determinations (LCD), all applicable NCDs, LCD’s and Medicare Coverage Articles should be reviewed prior to applying the criteria set forth in this clinical policy. Refer to the CMS website at http://www.cms.gov for additional information.  

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