CurrentFidelis CarePolicy CP.MP.102

Pancreas Transplantation

Defines medical necessity criteria, contraindications, and coding guidance for pancreas transplantation (PTA, SPK, PAK), autologous islet cell transplant as adjunct to pancreatectomy, and retransplantation after one failed primary transplant for members/enrollees of Centene-affiliated health plans.

Policy Summary

PayerFidelis Care

PolicyPancreas Transplantation

Policy CodePolicy CP.MP.102

Change TypeRevised / Clarified

Effective Date

Next Review Date

Key ActionProvide chart notes, ED visit notes, or hospitalization records documenting recurrent severe metabolic complications and documentation of endocrinologist management for at least 12 months.

SourceLink

POLICY UPDATE CHANGES

Added note to see CP.MP.250 for Lantidra (donislecel) related criteria.

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

1Autologous islet autotransplant indication

1Retransplant allowed after one failed primary

3Not supported indications (retransplants ≥2, allogeneic islet, SPK for amputees)

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Coverage Summary

Overview: This policy defines medical necessity criteria, contraindications, and coding guidance for pancreas transplantation procedures for Centene-affiliated health plans. The covered transplant types include Pancreas Transplant Alone (PTA), Simultaneous Pancreas-Kidney (SPK), and Pancreas After Kidney (PAK), as well as autologous islet cell transplantation when performed as an adjunct to total or near-total pancreatectomy for severe, refractory pancreatitis. Coverage stance: covered_with_criteria. Status: CURRENT.

Key thresholds & quick facts

Stable creatinine clearance (PAK)>= 30 mL/min

SPK renal function requirementGFR < 20 mL/min or CrCl < 20 mL/min, or dialysis dependent

Contraindication – low GFRGFR < 40 mL/min/1.73 m2 (unless multiorgan transplant)

Proteinuria exclusion (PAK)greater than 500 mg/day

HIV CD4 requirement> 200 cells/mm3 (with other HIV conditions met)

PTA diabetes typeDiabetes mellitus type I requiring insulin

PAK kidney stability criteriaSuccessful kidney transplant without significant chronic rejection

Medical Necessity Criteria

Contraindications (absolute/exclusionary)

Not Supported / Not Medically Necessary Indications

Coding

CPT Codes that support coverage criteriaCPTCovered

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
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 (includes imaging/guidance and interpretation)
0585T	Islet cell transplant, includes portal vein catheterization and infusion, laparoscopic
0586T	Islet cell transplant, includes portal vein catheterization and infusion, open

HCPCSHCPCSCovered

S2065

Simultaneous pancreas kidney transplantation

Provider Actions / Authorization & Documentation

Prior Authorization

Prior authorization required per plan policy

Requests for pancreas transplantation procedures must meet policy criteria and be authorized per Health Plan procedures (policy is guidance for medical necessity determinations).

Documentation Required

Document metabolic complications and prior management

Provide chart notes, ED visit notes, or hospitalization records documenting recurrent severe metabolic complications (e.g., severe hypoglycemia unawareness, recurring severe hypoglycemic attacks, marked hyperglycemia, recurring severe ketoacidosis) and documentation of endocrinologist management for at least 12 months.

Chart notes documenting recurrent severe metabolic complications
Emergency department visit notes or hospitalization records for those events
Documentation of endocrinologist management for at least 12 months

Background, Evidence & Definitions

Background: Pancreas transplantation (PTA, SPK, PAK) can restore glucose-regulated endogenous insulin secretion, decrease progression of diabetic complications, and improve quality of life—particularly in type 1 diabetes and select other indications. SPK is an established option for patients with advanced chronic kidney disease or end-stage renal disease and represents the majority of pancreas transplants performed in the U.S.

Autologous islet autotransplantation: During total or near-total pancreatectomy for severe, refractory chronic pancreatitis, islet β cells may be isolated and autotransplanted (typically via the portal vein) into the recipient’s liver; this autologous islet procedure is covered as an adjunct to pancreatectomy.

Common indications and linkage: PTA, SPK, and PAK are primarily performed for patients with type 1 diabetes with recurrent, severe metabolic complications or incapacitating problems with exogenous insulin therapy; SPK is for those meeting PTA criteria plus end-stage renal disease criteria (uremia with dialysis or expected dialysis and GFR/CrCl thresholds). Note: Allogeneic islet cellular therapy (e.g., Lantidra/donislecel) is addressed under a separate policy (see CP.MP.250) and is not covered under the allogeneic islet provisions of this policy.

Evidence metrics

1-year patient survivalover 95%

5-year patient survivalover 83%

Medicare Determinations

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

Revision History

01/26material_revisionLatest

01/26 annual review: specified 'type I' for diabetes criterion, added CPT code 50328, added recurring severe hypoglycemic attacks, adjusted myocardial infarction timing, and other wording clarifications. Multiple prior iterative revisions included removal of C‑peptide and BMI requirements, additions of exocrine pancreatic insufficiency, refinements to contraindications and management requirements (02/24, 02/23, etc.). See detail for specifics and coding implications under policy CP.MP.102. Note: this entry represents the material annual review and wording/coding updates made on 01/26.

01/26material_revision_detailLatest

Detail: Under I.A.1 specified 'type I' diabetes; under I.B.1.a replaced 'require' with 'required' and clarified department/ documentation wording; added I.C.1.a.ii 'Recurring severe hypoglycemic attacks'; revised myocardial infarction timing to within six months; added CPT code 50328; moved contraindications to I.C.; specified proteinuria threshold 'greater than 500 mg/day' for PAK definition; other editorial clarifications (per revision log).

Term	Definition
ESRD	End-stage renal disease defined by presence of uremia and requirement for dialysis or expected need for dialysis within 12 months