DraftBlue Cross Blue Shield - Rhode IslandPolicy N/A

Islet Transplantation for Chronic Pancreatitis

Policy governing coverage of autologous and allogeneic pancreatic islet transplantation as an adjunct to pancreatectomy for chronic pancreatitis and, for commercial products, FDA-approved allogeneic cellular therapy for type 1 diabetes. Affects Medicare Advantage and commercial members of Blue Cross & Blue Shield of Rhode Island.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyIslet Transplantation for Chronic Pancreatitis

Policy CodePolicy N/A

Change TypeNo material change

Effective Date01|01|2026

Next Review DateN/A

Key ActionUse modifier Q0 on Medicare Advantage clinical study claims or risk denial; confirm member benefits with the Evidence of Coverage before scheduling.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

48160, G0341-3Key codes referenced

Lantidra coveredCommercial stance

Clinical trial onlyMedicare stance

June 2023FDA approval

Coverage Criteria

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Autologous Pancreas Islet Transplantation (Initial)

Covered when ALL of the following are met

Allogeneic Islet Transplantation (Medicare Advantage)

Allogeneic islet transplantation - Medicare Advantage: Allogeneic pancreatic islet cell transplantation is covered for Medicare Advantage Plan individuals only as part of an approved clinical trial.

Refer to Related Policies and CMS NCD/LCD; partial pancreatic tissue transplantation or islet transplantation performed outside a clinical trial are not covered under Medicare Advantage.

Allogeneic Islet Transplantation (Commercial)

Allogeneic islet transplantation - Commercial: Allogeneic islet transplantation using an FDA‑approved cellular therapy product (donislecel‑jujn [Lantidra]) is considered medically necessary for Commercial Products.

Commercial product coverage differs from Medicare Advantage and follows FDA‑approved indications.

For Medicare Advantage Plan members, partial pancreatic tissue transplantation and islet transplantation performed outside of an approved clinical trial are not covered. This exclusion applies to allogeneic islet procedures performed outside NIH- or CMS-approved study settings.

Islet transplantation outside an approved clinical trial is not covered under Medicare Advantage for individuals with type 1 diabetes. Coverage for pancreatic islet transplantation for Medicare Advantage members is limited to participation in an approved clinical trial.

Coding and Billing

Covered CPT CodesCPTCovered

48160

Pancreatectomy, total or subtotal, with autologous transplantation of pancreas or pancreatic islet cells

Medicare Advantage Allowed HCPCS/G-codes (clinical study context)HCPCSCovered

G0341	Percutaneous islet cell transplant, includes portal vein catheterization and infusion
G0342	Laparoscopy for islet cell transplant, includes portal vein catheterization and infusion
G0343	Laparotomy for islet cell transplant, includes portal vein catheterization and infusion

Invalid codes for Medicare Advantage (use corresponding G-codes)CPTNot 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

Covered CPT Codes for Commercial ProductsCPTCovered

48160	Pancreatectomy, total or subtotal, with autologous transplantation of pancreas or pancreatic islet cells
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 S-codeHCPCS

S2102

Islet cell tissue transplant from pancreas, allogeneic

Modifiers for clinical research billing (Medicare Advantage)Modifier

Modifier Q0	Investigational clinical service provided in a clinical research study that is in an approved research study (Medicare Advantage Plan claims filed without the Q0 modifier will deny as not covered)
Modifier Q1	Routine clinical service provided in a clinical research study that is in an approved clinical research study

Provider Actions and Billing Guidance

Prior Authorization

Prior authorization is not applicable for this policy.

Documentation Required

Benefits and Contract Documentation

Benefits and coverage for transplant surgery vary by contract. Providers must refer to the member's Evidence of Coverage (EOC) or Subscriber Agreement for plan-specific transplant surgery benefits and limitations.

Billing Rule

Medicare Advantage Billing and Modifier Requirements

For Medicare Advantage and commercial products, submit the listed CPT and G‑codes as applicable. Medicare Advantage claims for services rendered as part of a CMS‑approved clinical study must be billed with the appropriate modifier (Q0 for investigational clinical service or Q1 for routine clinical service). Claims filed to Medicare Advantage without required modifiers (for CMS study services) will deny as not covered. Use G0341–G0343 for covered islet cell transplant procedures; do not file invalid T-codes (0584T–0586T) or S2102 for Medicare Advantage — file the appropriate G code instead.

Covered CPT: 48160
Allowed CMS study HCPCS: G0341, G0342, G0343
Required study modifiers (Medicare Advantage): Q0, Q1
Invalid for Medicare Advantage (use G codes instead): 0584T, 0585T, 0586T, S2102

Note

Benefits & Eligibility and Member Financial Responsibility

For member‑specific benefits and eligibility, contact the provider call center. If services are determined to be not medically necessary or are non‑covered under the member's contract, the member may be financially responsible unless they provided prior written agreement to accept liability.

Denial Risk

Modifier Requirement and Denial Risk

Claims for Medicare Advantage clinical study services billed without the required Q0/Q1 modifier(s) will deny as not covered.

Background and Scope

Autologous pancreas islet transplantation is performed in conjunction with a total or near-total pancreatectomy for chronic pancreatitis. The procedure isolates the patient’s own islet cells from the resected pancreas and transplants them—typically by infusion into the portal vein—to reduce the likelihood of postoperative insulin-dependent diabetes. As an autologous approach, the goal is to preserve endocrine function while treating the underlying pancreatic disease.

Definitions

Autologous islet transplantation

DefinitionIslet cells isolated from the patient’s resected pancreas using enzymes and a suspension of these cells is injected into the portal vein of the patient’s liver during the pancreatectomy procedure.

PurposePerformed at the time of total or near-total pancreatectomy to reduce the likelihood of insulin-dependent diabetes by preserving beta-cell insulin production.

Procedure siteInjection/infusion into the portal vein of the patient’s liver.

Clinical contextTypically offered to individuals undergoing pancreatectomy for chronic pancreatitis as an adjunct to surgery.

Allogeneic islet transplantation

DefinitionIslet cells harvested from a deceased donor’s pancreas, processed, and injected into the recipient’s portal vein.

RegulationAllogeneic islet cells are regulated by the FDA under 21 CFR parts 1270 and 1271 through the Center for Biologics Evaluation and Research.

Approved productDonislecel-jujn (Lantidra), a deceased donor-derived allogeneic pancreatic islet cellular therapy, approved by the FDA in June 2023 for certain adults with type 1 diabetes.

Typical candidatesReserved for individuals with frequent and severe metabolic complications who have failed to achieve control with insulin-based management.

Candidate Criteria

Candidates

Candidate population described in policy/background

Candidates for autologous islet transplantation: Individuals undergoing total or near total pancreatectomy for chronic pancreatitis; autologous islet transplant is performed in conjunction with pancreatectomy to reduce the likelihood of insulin‑dependent diabetes.

Candidates for allogeneic islet transplantation (commercial): Adults with type 1 diabetes who are unable to approach target hemoglobin A1c because of repeated episodes of severe hypoglycemia despite intensive diabetes management and education (per FDA indication for donislecel‑jujn [Lantidra]).

Refer to product labeling and clinical criteria for Lantidra.

Allogeneic Candidate Notes

Center Requirements

Note

Center requirements and CMS clinical study billing rules

Refer to CMS regulations and transplant‑specific requirements for Medicare Advantage center qualifications; billing for CMS‑approved clinical study procedures must follow the Clinical Trials Medicare Advantage billing procedures referenced in policy.

Use G‑codes (G0341–G0343) for Medicare Advantage clinical study cases as specified.
Follow Clinical Trials Medicare Advantage Plan billing procedures when treating study participants.

Post-Transplant Coverage and Procedures

Islet cell transplant procedures and associated portal vein catheterization/infusion

Key CPT for autologous transplant48160 - Pancreatectomy, total or subtotal, with autologous transplantation of pancreas or pancreatic islet cells.

Medicare Advantage - allowed G-codes (clinical study)G0341 (percutaneous), G0342 (laparoscopy), G0343 (laparotomy) - each includes portal vein catheterization and infusion; claims as part of a CMS-approved clinical study must be billed with appropriate modifier (Q0/Q1).

Commercial CPT/T codes0584T (percutaneous), 0585T (laparoscopic), 0586T (open) - covered for Commercial Products and describe islet cell transplant with portal vein catheterization and infusion.

HCPCS S-codeS2102 - Islet cell tissue transplant from pancreas, allogeneic (listed in both Medicare Advantage and Commercial sections).

Medicare invalid CPTs0584T, 0585T, 0586T are invalid for Medicare Advantage and should be filed with corresponding G-codes (G0341-G0343).