CurrentCentenePolicy CP.MP.102

Clinical Policy: Pancreas Transplantation

Defines medical necessity criteria, contraindications, covered procedures (PTA, SPK, PAK), autologous islet cell transplant as adjunct to total/near-total pancreatectomy, retransplantation after one failed primary, and non-covered indications for Centene-affiliated health plans.

Policy Summary

PayerCentene

PolicyClinical Policy: Pancreas Transplantation

Policy CodePolicy CP.MP.102

Change TypeRevisions, additions, clarifications

Effective Date

Next Review Date

Key ActionProviders must document recurrent, severe, and potentially life‑threatening metabolic complications with chart notes, ED visits, or hospitalizations, and document clinical/emotional problems with insulin therapy and endocrinology management for at least 12 months.

SourceLink

POLICY UPDATE CHANGES

Specified Type I diabetes in I.A.1; added/updated multiple contraindications and clarified substance-use, HIV, and infection language; added requirement of endocrinologist management for ≥12 months for PTA; added CPT 50328; removed prior C‑peptide and BMI requirements in earlier revisions.

Autologous islet cell transplants considered medically necessary as adjunct to total or near-total pancreatectomy for severe, refractory pancreatitis.

Current evidence does not support allogeneic islet cell transplantation or xenotransplantation.

3Primary covered transplant types (PTA, SPK, PAK)

1Autologous islet autotransplant indication

Listed contraindications

Coverage Summary

Overview: This coverage policy (Policy Number CP.MP.102) defines medical necessity criteria, contraindications, and covered pancreas transplant procedures for Centene-affiliated health plans. Subject: Pancreas Transplantation. Status: CURRENT. Effective / Last review dates: Last review 01/26/2025 (effective date not specified in source). Scope: the policy specifies criteria for pancreas transplant alone (PTA), simultaneous pancreas-kidney (SPK), and pancreas after kidney (PAK); autologous islet autotransplantation as an adjunct to total/near-total pancreatectomy; and retransplantation after one failed primary transplant. Headline statistics (descriptive): registry data report >95% one-year patient survival and >83% five-year patient survival; one-year graft survival for SPK was reported as 86% for pancreas and 93% for kidney.

Key Thresholds

Duration of endocrinologist management for PTA>= 12 months

GFR threshold for SPK (eligibility)< 20 mL/min

Creatinine clearance threshold for SPK (eligibility)< 20 mL/min

Stable creatinine clearance for PAK>= 30 mL/min

Significant proteinuria exclusion for PAK> 500 mg/day

GFR contraindication threshold< 40 mL/min/1.73 m2 (unless multiorgan transplant)

Medical Necessity Criteria

Medically Necessary — Autologous Islet Cell Transplant

Autologous islet cell transplants are considered medically necessary when ALL of the following are met:

ALL of the following

Performed as an adjunct procedure to a total or near total pancreatectomy
Indication: severe, refractory pancreatitis

Not Supported / Not Medically Necessary

Current evidence does not support pancreas transplant procedures for any of the following (IV):

ANY of the following

Coding

CPT Codes that support coverage criteriaCPTCovered

48160	Pancreatectomy, total or subtotal, with autologous transplantation 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
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
50325	Backbench standard preparation of living donor renal allograft prior to transplantation

1–10 of 15

1/2

CPT Codes that do not support coverage criteriaCPTNot Covered

0584T	Islet cell transplant, includes portal vein catheterization and infusion; percutaneous (does not support coverage criteria)
0585T	Islet cell transplant, includes portal vein catheterization and infusion; laparoscopic (does not support coverage criteria)
0586T	Islet cell transplant, includes portal vein catheterization and infusion; open (does not support coverage criteria)

HCPCS Codes referencedHCPCS

S2065

Simultaneous pancreas kidney transplantation

Provider Actions & Documentation Requirements

Documentation Required

Document metabolic complications and treatment history

Providers must document recurrent, severe, and potentially life‑threatening metabolic complications with chart notes, emergency department visits, or hospitalizations, and document clinical/emotional problems with insulin therapy and endocrinology management for at least 12 months.

Documentation Required

Document renal status for SPK/PAK

Providers must document ESRD criteria (presence of uremia, requirement for dialysis or expected need within 12 months), GFR/CrCl values, dialysis dependence, and for PAK demonstrate a successful kidney transplant without significant chronic rejection and stable kidney function (CrCl ≥ 30 mL/min and proteinuria not greater than 500 mg/day).

Background, Evidence & Definitions

Background: Pancreas transplantation (including PTA, SPK, and PAK) can restore endogenous, glucose‑regulated insulin secretion, decrease progression of diabetic complications, and improve quality of life, and is the only proven method to restore normoglycemia in type I diabetes. SPK is an established option for diabetic patients with advanced chronic kidney disease or end‑stage kidney disease and accounts for approximately 90% of pancreas transplants in the United States. Autologous islet autotransplantation is performed after total or near‑total pancreatectomy for patients with severe, refractory chronic pancreatitis to preserve islet function and help with postoperative glycemic control while addressing pain from chronic pancreatitis.

Registry Survival Statistics

One-year patient survival (registry)>95% (one year)

Five-year patient survival (registry)>83% (five years)

One-year graft survival — SPK pancreas86% (one year)

One-year graft survival — SPK kidney93% (one year)

Medicare Determinations

NCD Number	Name	Effective Date	Type
260.3	Pancreas transplants	2006-04-26	NCD

Revision History

01/26/2025material_revisionLatest

01/2025clarification

Under I.B.3 changed myocardial infarction timeframe wording and reworded stroke/acute coronary syndrome language; added I.C.1.a.ii 'Recurring severe hypoglycemic attacks'; added CPT code 50328.

02/2024annual_revision

Policy Summary

PayerCentene

PolicyClinical Policy: Pancreas Transplantation

Policy CodePolicy CP.MP.102

Change TypeRevisions, additions, clarifications

Effective Date

Next Review Date

SourceLink

On This Page

Re-transplantations after two or more failed primary pancreas transplantations

Allogeneic islet cell transplantation or xenotransplantation

SPK transplantation for patients with amputation due to peripheral obstructive vascular disease

For the treatment of all other conditions than those specified above

Documentation Required

Document contraindications and substance-use status

Providers must document absence of listed contraindications. For active substance use or dependence, provide evidence of risk‑reduction behaviors; if urgent transplant timelines are present, a commitment to reducing behaviors is acceptable. Serial blood and urine testing may be used to verify abstinence from substances of concern.

Serial blood and urine testing may be used to verify abstinence.

Term	Definition
ESRD	End-stage renal disease defined by presence of uremia and requiring dialysis or expected to require dialysis within 12 months.

Expanded criteria I.B.; added note referencing CP.MP.250 Lantidra for allogeneic islet therapy criteria; coding reviewed and references updated.

02/2023annual_revision

Removed C‑peptide values and BMI requirements from Criteria I.B.1 and I.B.2; added exocrine pancreatic insufficiency indication (I.B.2) and requirement for procurement/transplant as part of multiple organ transplant (I.B.3); changed infection contraindication from 'chronic' to 'active'; updated substance-use language to exclude prescribed marijuana and allow commitment to reduce behaviors if urgent timelines exist; added chronic non‑healing wounds and significant comorbidities as contraindications; clarified problems with insulin may be clinical or clinical and emotional.

02/2022annual_review

Background updated; removed prior requirement that medical therapy does not exist or has failed; updated all contraindications and replaced 'experimental/investigational' language in section IV.

02/2021revision

Removed several prior contraindications and replaced language about inability to comply with 'Inability to adhere to the regimen necessary to preserve the transplant, even with caregiver support'; editorial updates and formatting changes.

04/2016policy_development

Policy developed and reviewed by specialist; initial background and criteria established describing PTAs, SPK, PAK, and islet cell transplant roles.

coding_additions

CPT codes supporting coverage criteria include 48160, 48550, 48551, 48552, 48554, 48556, 50300, 50320, 50323, 50325, 50327, 50328, 50340, 50360, 50365; CPT codes that do not support coverage include 0584T, 0585T, 0586T; HCPCS S2065 referenced.

section_added

Policy section II added: Autologous islet cell transplants considered medically necessary as adjunct to total or near-total pancreatectomy for severe, refractory pancreatitis.

section_added

Policy section IV clarified: Current evidence does not support allogeneic islet cell transplantation or xenotransplantation and other listed unsupported indications.