CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Islet Cell Transplant

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.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyIslet Cell Transplant

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateJun 1, 2006

Next Review DateN/A

Key ActionBill Medicare clinical trial services with modifier Q0 for investigational study services (use Q1 for routine clinical service).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Autologous coveredAutologous coverage stance

Medicare trial-onlyAllogeneic Medicare

Not medically necessaryAllogeneic Commercial

48160Key procedure code

Coverage Criteria

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Autologous criteria: Autologous pancreas islet transplantation is considered medically necessary as an adjunct to a total or near-total pancreatectomy in members with chronic pancreatitis.

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

Allogeneic Medicare trial criteria: Allogeneic pancreatic islet cell transplantation is covered for BlueCHiP for Medicare members only as part of an approved clinical trial; claims must follow CMS and study billing rules (including required study modifiers).

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)

Commercial allogeneic stance: Allogeneic islet transplantation is considered not medically necessary for the treatment of type 1 diabetes for Commercial products because the evidence is insufficient to determine the effects on health outcomes.

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.

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

Covered CPT Codes (Autologous) / DiagnosisCPT|ICD-10Covered

48160	Pancreatectomy, total or subtotal, with autologous transplantation of pancreas or pancreatic islet cells
K86.1	Other Chronic Pancreatitis

Islet transplant procedure HCPCS/CPT/Therapy codesG-code|CPT|HCPCS|mixed

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

Study billing modifiersModifier

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.

Note

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.

Denial Risk

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 Rule

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)

Note

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

Autologous islet transplantation — definition key/value

DefinitionAutologous islet transplantation: islet cells are isolated from the patient’s resected pancreas during total or near-total pancreatectomy, then infused into the patient’s portal vein so implanted beta cells produce insulin.

Typical usePerformed as an adjunct to total or near-total pancreatectomy to treat intractable pain from chronic pancreatitis and to reduce incidence of post-pancreatectomy diabetes.

Regulatory noteIslet cells are regulated by the FDA under 21 CFR parts 1270 and 1271 as human cells and tissues intended for implantation/transplantation/infusion.

Allogeneic islet transplantation — definition key/value

DefinitionAllogeneic islet transplantation: islet cells are harvested from a deceased donor pancreas, processed, and injected into a recipient’s portal vein; multiple donor pancreases (up to three) may be required to achieve insulin independence.

Patient selectionGenerally reserved for patients with frequent and severe metabolic complications who have failed to achieve control with insulin-based management; may be performed in radiology settings.

ImmunosuppressionSuccess improved with modified immunosuppression regimens (eg, the 'Edmonton protocol').

NCD (CMS) — National Coverage Determination definition reference

DefinitionNational Coverage Determination (NCD) for Islet Cell Transplantation in the Context of a Clinical Trial: CMS NCD (260.3.1) limits Medicare coverage of islet cell transplantation to patients participating in NIH-sponsored clinical trials; transplants performed outside approved trials are not covered.

Year / sourceCMS NCD cited in references (Centers for Medicare & Medicaid).

ImplicationClaims for Medicare members must follow CMS and study billing rules when covered under the NCD (clinical trial context).

NICE guidance — NICE interventional procedure guidance definition/reference

DefinitionNICE guidance: National Institute for Health and Care Excellence interventional procedure guidance for autologous and allogeneic pancreatic islet cell transplantation (IPG257 for allogeneic; IPG274 for autologous) referenced in policy.

ReferencesNICE IPG257 and IPG274 cited in the policy references list (2008).

PurposeProvides UK interventional procedure guidance on use of pancreatic islet cell transplantation for type 1 diabetes and post-pancreatectomy glycaemic control.

Candidate Criteria

Autologous candidates

Candidates for autologous islet transplantation

Autologous candidate: Individuals with chronic pancreatitis undergoing total or near-total pancreatectomy to treat intractable pain, for whom autologous islet transplantation is performed as an adjunct to the pancreatectomy.

Procedure aims to reduce incidence of post‑pancreatectomy diabetes; evidence from case series and systematic reviews supports meaningful improvement in net health outcome.

Evaluation Requirements & Evidence

Documentation Required

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.

Post-Transplant Coverage Notes

Islet cell transplantation — Medicare covers islet transplantation only in context of NIH-sponsored clinical trials per CMS NCD

Medicare coverage ruleMedicare covers pancreatic islet transplantation only for patients with type 1 diabetes participating in a clinical trial sponsored by the National Institutes of Health (per CMS NCD).

Outside trial coveragePartial pancreatic tissue transplantation or islet transplantation performed outside a clinical trial are not covered by Medicare.

Billing implicationClaims for covered Medicare clinical trial services must follow CMS and study billing rules and use appropriate study billing modifiers as required.