Islet Transplantation for Chronic Pancreatitis
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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.
No material clinical or coverage changes in this revision.
Coverage Criteria
Autologous Pancreas Islet Transplantation (Initial)
Covered when ALL of the following are met
Allogeneic Islet Transplantation (Medicare Advantage)
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)
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
| 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 |
| 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 |
| S2102 | Islet cell tissue transplant from pancreas, allogeneic |
| 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.
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.
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.
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.
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
Candidate Criteria
Candidates
Candidate population described in policy/background
Refer to product labeling and clinical criteria for Lantidra.
Allogeneic Candidate Notes
Contraindications
This document does not list any explicit contraindications for islet transplantation in the excerpt provided.
Evaluation Requirements
Evaluation requirements: refer to member contract
Follow the Evidence of Coverage or Subscriber Agreement for evaluation steps and benefit applicability; no additional evaluation steps are specified in this excerpt.
Center Requirements
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
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