CurrentEmblemHealthPolicy MG.MM.TR.02C10

Pancreatic Islet Cell Transplantation

Defines medical necessity criteria, limitations/exclusions, applicable procedure and diagnosis codes for pancreatic islet cell transplantation in members with chronic pancreatitis requiring pancreatectomy. Directs referrals for whole-organ pancreas transplant to the EmblemHealth Transplant Program.

Policy Summary

PayerEmblemHealth

PolicyPancreatic Islet Cell Transplantation

Policy CodePolicy MG.MM.TR.02C10

Change TypeNo material change

Effective Date

Next Review Date

Key ActionTreating physician or primary care provider must submit clinical evidence that the member meets criteria (severe refractory pain and pancreatectomy adjunct) for preauthorization or post-payment review.

SourceLink

POLICY UPDATE CHANGES

No material changes to clinical coverage criteria or policy terms.

2Required Clinical Criteria

2Excluded Transplant Types

5Procedure Codes Listed

4Diagnosis Codes Listed

Coverage Summary

Status: CURRENT. Policy subject: Pancreatic islet cell transplantation (autologous). EmblemHealth considers autologous pancreatic islet cell transplantation covered with criteria for members with chronic pancreatitis who meet the specified medical necessity criteria. Autologous islet transplantation is covered when the patient meets the required criteria (severe pain refractory to medical management and transplantation performed adjunctive to total/near-total pancreatectomy). Allogeneic and xenotransplantation approaches are not covered under this indication and are addressed as investigational/not medically necessary in the policy background and limitations.

Key policy values

Policy numberMG.MM.TR.02C10

StatusCURRENT

SubjectPancreatic islet cell transplantation (autologous)

Last review dateJanuary 23, 2026

Medicare NCD referenceNCD 260.3.1 (Islet Cell Transplantation in the Context of a Clinical Trial)

Medical Necessity Criteria

Medically Necessary - Autologous Pancreatic Islet Cell Transplantation

Members with chronic pancreatitis are eligible for autologous pancreatic islet cell transplantation when the following criteria are met; both:

ALL of the following

Severe pain refractory to medical management.
Transplantation is adjunctive to total/near-total pancreatectomy.

Not Medically Necessary / Limitations

The following transplantation types are not considered medically necessary for the treatment of Type 1 diabetes due to insufficient evidence of therapeutic value:

ANY of the following

Allogeneic islet cell transplantation.
Islet cell xenotransplantation.

Applicable Codes

Applicable Procedure CodesCPT/HCPCS (unlisted codes listed as Category I or temporary codes)Covered

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.
48160	Pancreatectomy, total or subtotal, with autologous transplantation of pancreas or pancreatic islet cells.
48550	Donor pancreatectomy (including cold preservation), with or without duodenal segment for transplantation.

Applicable ICD-10 Diagnosis CodesICD-10Covered

K86.0	Alcohol-induced chronic pancreatitis.
K86.1	Other chronic pancreatitis.
Z90.410	Acquired total absence of pancreas.
Z90.411	Acquired partial absence of pancreas.

Provider Actions / Authorization

Prior Authorization

Preauthorization requirement implied

Requests for islet cell transplantation require submission of clinical evidence for review and are subject to EmblemHealth preauthorization/post-payment review processes.

0584T
0585T
0586T
48160

Documentation Required

Clinical documentation required for review

The treating physician or primary care provider must submit to EmblemHealth the clinical evidence that the member meets the criteria for the treatment or surgical procedure. Without this documentation and information, EmblemHealth will not be able to properly review the request — preauthorization or post-payment review.

Document that the member has severe pain refractory to medical management and that transplantation is adjunctive to total/near-total pancreatectomy.

Note

Pancreas transplant referrals

For whole organ (pancreas) transplant to treat Type 1 diabetes, members and providers must call the EmblemHealth Transplant Program for case management services at 1-800-447-0768.

Background & Definitions

Background: Autologous islet transplantation is performed as an adjunct to total or near-total pancreatectomy to salvage and transplant the patient's own beta cells into the portal vein of the liver to help prevent post-pancreatectomy diabetes. The procedure involves isolating islet cells from the individual's resected pancreatic specimen, creating a suspension with plasma, and infusing that suspension into the portal vein so the cells function as a free graft. By contrast, allogeneic islet transplantation (using donor human cells) and xenotransplantation (using porcine cells) require lifelong immunosuppression to prevent graft rejection and recurrence of autoimmune disease and are considered investigational / not medically necessary for treatment of Type 1 diabetes due to insufficient evidence.

Term	Definition
Autologous islet transplantation	Technique performed as an adjunct to total/near-total pancreatectomy using islet cells isolated from the individual's resected pancreas and infused into the portal vein to function as a free graft.
Allogeneic islet transplantation	Islet transplantation using donor (non-recipient) human cells requiring lifelong immunosuppression.
Xenotransplantation	Islet transplantation utilizing porcine cells.

Evidence & Guidance

Evidence and references: The policy references multiple guideline and registry sources, including MCG care guidelines, American Diabetes Association position statements, National Institute for Health and Clinical Excellence (NICE) guidance, and the CMS National Coverage Determination for islet cell transplantation in the context of a clinical trial. These sources and literature citations are cited in the policy and were accessed January 23, 2026.

Name	Number	Type	Effective Date
Islet Cell Transplantation in the Context of a Clinical Trial	NCD 260.3.1 (reference in document)	NCD	2004-10

Revision History

2026-01-23policy_reviewLatest

Policy reviewed: clinical criteria and limitations reaffirmed; no changes to clinical policy content (autologous islet transplantation criteria and exclusions for allogeneic/xenotransplantation).