Islet Cell Transplant
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Coverage criteria for autologous and allogeneic pancreatic islet cell transplantation for BlueCHiP for Medicare and Commercial products; defines when procedures and codes are covered or not covered.
No material clinical or coverage changes in this revision.
Coverage Criteria
Autologous Islet Transplantation (Medically Necessary)
Covered when ALL of the following are met
Performed in the context of total or near-total pancreatectomies to treat intractable pain from chronic pancreatitis; evidence shows decreased incidence of diabetes after pancreatectomy and acceptable safety (case series and systematic reviews).
Allogeneic Islet Transplantation (BlueCHiP for Medicare — Clinical Trial Only)
Covered when ALL of the following are met
Refer to Clinical Trials BlueCHiP for Medicare and CMS NCD for specifics; follow CMS billing modifier requirements for investigational and routine clinical services in approved studies.
Allogeneic Islet Transplantation (Commercial — Not Medically Necessary)
Codes for islet transplant are listed as not medically necessary for Commercial products.
Medicare coverage for islet transplantation is limited. Partial pancreatic tissue transplantation or islet transplantation performed outside an approved clinical trial are not covered by Medicare; allogeneic pancreatic islet cell transplantation is covered for BlueCHiP for Medicare members only as part of an approved clinical trial. Refer to CMS National Coverage Determinations and the Clinical Trials BlueCHiP for Medicare policy for trial-specific requirements and billing rules.
If services are determined to be not medically necessary or are non‑covered benefits, the member may be financially responsible unless the member has been informed and provided prior written agreement to accept liability. Benefits and eligibility are governed by the member’s subscriber agreement or employer agreement; contact the provider call center for member‑specific benefit determinations.
For Commercial products, allogeneic islet transplantation is considered not medically necessary for the treatment of type 1 diabetes because the evidence is insufficient to determine effects on health outcomes. The policy lists specific allogeneic procedure codes as not medically necessary for Commercial members (see Coding section).
Providers must confirm coverage before providing services. If a service is determined to be not medically necessary or a non‑covered benefit and the member has not provided prior written agreement accepting financial responsibility, the provider may be liable for charges. Always verify benefits in the member’s Evidence of Coverage and follow participation agreement terms when obtaining member consent for non‑covered services.
Coding and Billing Codes
| 48160 | Pancreatectomy, total or subtotal, with autologous transplantation of pancreas or pancreatic islet cells |
| K86.1 | Other Chronic Pancreatitis |
| 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 |
| 0584T | Islet cell transplant, includes portal vein catheterization and infusion, including all imaging, including guidance, and radiological supervision and interpretation, when performed; percutaneous (effective 1/1/2020) |
| 0585T | Islet cell transplant, includes portal vein catheterization and infusion, including all imaging, including guidance, and radiological supervision and interpretation, when performed; laparoscopic (effective 1/1/2020) |
| 0586T | Islet cell transplant, includes portal vein catheterization and infusion, including all imaging, including guidance, and radiological supervision and interpretation, when performed; open (effective 1/1/2020) |
| S2012 | Islet cell tissue transplant from pancreas, allogeneic |
| 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 |
| Modifier Q1 | Routine clinical service provided in a clinical research study that is in an approved clinical research study |
Provider Actions & Billing Rules
Prior Authorization
Not applicable. Prior authorization is not required under this medical policy. Providers should consult the member's Evidence of Coverage or Subscriber Agreement for any contract-specific requirements.
Prior authorization determination
Benefits and eligibility for islet cell transplant are determined by the member's subscriber agreement, Evidence of Coverage, or employer contract. For member-specific benefit confirmation or to determine whether prior authorization is required under a particular contract, contact the provider call center.
Member financial responsibility when NMN or non-covered
If services are determined to be not medically necessary or are non-covered benefits under the member's plan, the member may be financially responsible for the services only if you have informed the member in advance and they have agreed in writing to accept financial responsibility. Review your participation agreement(s) for applicable provisions.
Billing modifiers for CMS approved clinical studies
BlueCHiP for Medicare: Claims for services rendered as part of a CMS‑approved clinical study must be billed with the appropriate modifier. Use modifier Q0 for investigational clinical services provided in an approved research study (claims filed without Q0 will deny as not covered). Use modifier Q1 for routine clinical services in an approved clinical research study. Follow the Clinical Trials BlueCHiP for Medicare billing procedures when treating Medicare members in CMS‑approved studies.
- Modifier Q0 — Investigational clinical service provided in an approved research study (required for BlueCHiP for Medicare; omission will deny as not covered)
- Modifier Q1 — Routine clinical service provided in an approved clinical research study
- 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
- Covered CPT for chronic pancreatitis: 48160 Pancreatectomy, total or subtotal, with autologous transplantation of pancreas or pancreatic islet cells (with ICD-10 K86.1)
Provider reminder — consult member documents
Provider note: Benefits vary between groups/contracts. Refer to the appropriate Evidence of Coverage or Subscriber Agreement for applicable not medically necessary, not covered, transplant surgery, or investigational/experimental benefit provisions.
Background
Autologous islet transplantation is performed in patients undergoing total or near‑total pancreatectomy for chronic pancreatitis to treat intractable pain. In this context, islet cells are isolated from the resected pancreas and transplanted back into the patient to reduce the likelihood of post‑pancreatectomy insulin‑dependent diabetes; available case series and systematic reviews indicate a significant reduction in incidence of diabetes and acceptable safety when performed as an adjunct to pancreatectomy.
Definitions
Candidate Criteria
Autologous candidates
Candidates for autologous islet transplantation
Procedure aims to reduce incidence of post‑pancreatectomy diabetes; evidence from case series and systematic reviews supports meaningful improvement in net health outcome.
Contraindications
No specific contraindications are listed in this policy section.
Evaluation Requirements & Evidence
Document evidence supporting autologous transplants
Evidence supporting autologous islet transplantation includes case series and systematic reviews showing decreased incidence of diabetes and acceptable safety in patients undergoing pancreatectomy.
- Use this evidence summary when documenting medical necessity for autologous transplants.
Center Requirements
Follow CMS/Medicare clinical trial and center requirements
Centers performing islet transplantation must follow CMS and Medicare coverage requirements for clinical trials and referenced Clinical Trials BlueCHiP for Medicare guidance.
- Follow CMS NCDs and the Clinical Trials BlueCHiP for Medicare policy for billing and coverage rules.
Post-Transplant Coverage Notes
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