Islet Transplantation
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Governs coverage determinations for autologous and allogeneic pancreatic islet transplantation, including FDA-approved allogeneic islet cellular therapy (donislecel-jujn/Lantidra); applies to Capital Bluecross products with benefit variations.
Added Lantidra into this policy.
Added J3590 and C9399 into the coding table.
Updated Policy Guideline and regulatory status.
Coverage Criteria
Autologous islet transplantation (medically necessary)
Covered when ALL of the following are met for autologous transplantation
Procedure performed in the context of total or near‑total pancreatectomy to reduce post‑pancreatectomy diabetes; evidence from case series and systematic reviews supports meaningful improvement in net health outcome.
Allogeneic islet transplantation (investigational)
Allogeneic islet transplantation stance
Policy states investigational due to insufficient evidence of net health outcome despite FDA approval language.
Investigational/not covered beyond the specific FDA‑referenced indication.
Policy update / coding inclusion
Policy updated to include Lantidra and coding changes; prior policy statements and detailed coverage criteria are referenced elsewhere.
See cross‑references, FDA approval letter, and package insert cited in references for additional regulatory and indication details.
Donislecel-jujn (Lantidra) is not supported for individuals with liver disease, renal failure, or for those who have received a renal transplant. This exclusion is based on policy guidelines noting a lack of evidence to support use of the allogeneic product in these populations and potential procedure- and immunosuppression-related risks.
No additional explicit exclusions are stated in the referenced policy history and references. The citations and policy history update entries do not list further patient-level exclusion criteria beyond those described elsewhere in the policy guidance.
There is no evidence of benefit for donislecel-jujn in individuals whose diabetes is well-controlled with insulin therapy or in those with hypoglycemic unawareness who can prevent current repeated severe hypoglycemic events using intensive diabetes management (including insulin, devices, and education). Such patients are not appropriate candidates for the allogeneic islet product per the policy guideline.
Within the provided reference material there are no explicit statements
Coding and Billing
| S2102 | Investigational: therefore, not covered for allogeneic islet transplantation (listed) |
| 0584T | Investigational: therefore, not covered for allogeneic islet transplantation (listed) |
| 0585T | Investigational: therefore, not covered for allogeneic islet transplantation (listed) |
| 0586T | Investigational: therefore, not covered for allogeneic islet transplantation (listed) |
| C9399 | Investigational: therefore, not covered for allogeneic islet transplantation (listed) |
| G0341 | Investigational: therefore, not covered for allogeneic islet transplantation (listed) |
| G0342 | Investigational: therefore, not covered for allogeneic islet transplantation (listed) |
| G0343 | Investigational: therefore, not covered for allogeneic islet transplantation (listed) |
| J3590 | Investigational: therefore, not covered for allogeneic islet transplantation (listed) |
| 48160 | Covered when medically necessary: islet cell autotransplantation (listed as Procedure Codes 48160) |
| K86.0 | Alcohol-induced chronic pancreatitis |
| K86.1 | Other chronic pancreatitis |
| 0584T | Code added to policy in 2020 (procedural T-code) |
| 0585T | Code added to policy in 2020 (procedural T-code) |
| 0586T | Code added to policy in 2020 (procedural T-code) |
| J3590 | Added into the coding table (unspecified drug code) |
| C9399 | Added into the coding table (other drugs and biologicals, not otherwise classified) |
Provider Actions / Requirements
Prior authorization varies by product
Services described in this policy may require prior authorization and applicability depends on the specific Capital BlueCross product or program; consult the member's benefit plan (including FEP PPO references) for PA requirements.
Policy updated — Lantidra and code additions
The policy was updated to add the FDA‑approved product Lantidra (donislecel-jujn) and the billing codes J3590 and C9399 were added to the coding table; inclusion of these codes implies prior authorization and coding changes should be applied per the policy history.
Do not offer donislecel to patients controlled on insulin or responsive to intensive management
Donislecel-jujn (Lantidra) has no demonstrated benefit for individuals whose diabetes is well-controlled with insulin therapy or for those with hypoglycemic unawareness who can prevent repeated severe hypoglycemic events using intensive diabetes management; such patients are not appropriate candidates.
- No evidence of benefit for patients controlled on insulin therapy.
- Not supported for patients who prevent severe hypoglycemia with intensive management.
Coding presence does not equal coverage
Listing a billing code in the policy does not guarantee coverage; coverage is determined by the member's benefit plan and medical necessity at claim adjudication.
- Identification of a code does not denote coverage.
- Final claim processing depends on member benefit and medical necessity determinations.
Document regulatory and trial references for donislecel
Policy references include the FDA approval letter and package insert for donislecel (Lantidra) and multiple clinical trial listings; documentation for allogeneic islet products should reference indication and adherence to regulatory guidance where applicable.
- FDA donislecel (Lantidra) approval letter and package insert are cited.
- ClinicalTrials.gov entries and other references are included in the policy references.
Investigational status — donislecel (Lantidra)
Allogeneic islet transplantation using donislecel-jujn (Lantidra) is considered investigational for treatment of type 1 diabetes and investigational in all other situations; investigational services are not covered and may be denied.
- Donislecel-jujn is investigational for type 1 diabetes.
- Donislecel-jujn is investigational in all other situations.
Regulatory status may influence coverage decisions
Regulatory status and FDA approval are referenced in the policy and may affect coverage determinations, but no explicit automatic denial triggers are listed in these sections.
- FDA approval of donislecel (Lantidra) is cited in references.
- Policy notes regulatory updates without listing explicit denial triggers.
Background
Autologous islet transplantation harvests islets from the patient’s resected pancreas during total or near-total pancreatectomy and infuses them—typically into the portal venous system—to reduce the incidence or severity of post‑pancreatectomy diabetes. This autologous approach is described as an adjunct to total or near‑total pancreatectomy and is considered medically necessary for selected patients with chronic pancreatitis who meet the procedure criteria.
Definitions
Candidate Selection Criteria
Candidate criteria (documented statements)
Candidate selection information present in document
Supported by case series and systematic reviews cited in the evidence summary.
Policy nevertheless considers donislecel investigational for type 1 diabetes due to insufficient evidence for net health outcome.
Candidate selection (literature references)
Research and clinical series describe candidate selection for total pancreatectomy with islet autotransplantation primarily in chronic pancreatitis.
References include multiple observational series and analyses of predictors of metabolic outcomes after autologous islet transplantation.
Contraindications
Prior portal vein thrombosis is a procedural concern: the policy notes that repeated intraportal islet infusions are not recommended in patients who have experienced prior portal thrombosis unless the prior thrombosis was limited to second‑ or third‑order portal vein branches. This caution reflects procedural risk considerations when planning intraportal islet infusion.
Evaluation Requirements
Confirm center and accreditation requirements with payer
No detailed evaluation or center accreditation requirements are specified in these document sections; confirm any site-specific credentialing or volume requirements with the payer prior to referral.
- Policy history and cross-references updated, but center requirements are not detailed here.
- Contact payer for product‑ or program‑specific site requirements.
Center Requirements
Post-Transplant Coverage Considerations
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