Capital Bluecross Islet Transplantation Coverage Update

Coverage Criteria

Autologous islet transplantation (medically necessary)

Covered when ALL of the following are met

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

Supported by case series and systematic reviews showing decreased incidence of diabetes after pancreatectomy and acceptable safety profile.

Allogeneic islet transplantation (investigational/limited)

Not covered/Investigational when ANY of the following apply

Allogeneic islet transplantation with donislecel-jujn: Allogeneic islet transplantation using an FDA-approved cellular therapy product (donislecel-jujn) is considered investigational for the treatment of type 1 diabetes in general and investigational in all other situations except the narrowly defined FDA indication; insufficient evidence to support general health outcome improvement.

FDA approval exists for a specific subset, but policy considers allogeneic use investigational except as described; additional well-designed studies required.

Evidence basis for coverage

Document references clinical evidence and guidance supporting islet transplantation in specific contexts (autologous after pancreatectomy; allogeneic for type 1 diabetes) and cites regulatory materials.

Evidence and Guidance: Multiple systematic reviews, case series, consensus guidelines, and FDA regulatory materials are cited supporting use in specific clinical scenarios: autologous islet autotransplantation to reduce post-pancreatectomy diabetes and allogeneic islet transplantation (donislecel-jujn) for a narrowly defined adult type 1 diabetes population with current repeated severe hypoglycemia despite intensive management.

See cited references, FDA approval letter, and package insert for details

Donislecel-jujn (Lantidra) is not supported for individuals with liver disease, those with renal failure, or members who have previously received a renal transplant. These exclusions reflect the policy guidance that there is no evidence to support use of donislecel-jujn in these populations and that risks related to infusion and long-term immunosuppression warrant limiting use in these settings.

There is no evidence of benefit for donislecel-jujn in individuals whose diabetes is adequately controlled with insulin therapy. Likewise, the therapy is not supported for people with hypoglycemic unawareness who can prevent current repeated severe hypoglycemic events (neuroglycopenia requiring third‑party intervention) using intensive diabetes management, devices, and education.

The policy references the Centers for Medicare & Medicaid Services National Coverage Determination for islet cell transplantation in the context of a clinical trial (NCD 260.3.1), indicating that CMS coverage considerations for trial‑based islet transplantation are relevant to interpretation of this policy.

Allogeneic islet transplantation using donislecel-jujn is considered investigational and therefore generally not medically necessary in most situations due to insufficient evidence of improved net health outcomes; the policy allows a narrowly defined FDA indication but otherwise treats allogeneic use as investigational.

Some sections of the policy history and administrative updates document coding and operational changes but do not contain explicit statements declaring additional therapies or situations as not medically necessary; the record notes no explicit not medically necessary statements in those administrative chunks.

Coding

Investigational: therefore, not covered for allogeneic islet transplantationCPTNot Covered

48999
0584T
S2102

Covered when medically necessaryCPTCovered

48160

Relevant diagnosis codesICD-10

K86.0	Alcohol-induced chronic pancreatitis
K86.1	Other chronic pancreatitis

Additional codes listed in references/coding sectionmixed

0585T
0586T
C9399
G0341
G0342
G0343
J3590

Policy coding mentions and additionsmixed

0584T	New 2020 code added to policy
0585T	New 2020 code added to policy
0586T	New 2020 code added to policy
J3590	Added into the coding table (miscellaneous injectable code)
C9399	Added into the coding table (miscellaneous durable code)

Referenced drug/biologicNDC

donislecel-jujn (Lantidra)

Product referenced with FDA approval and package insert

Current repeated episodes — temporal coding note

Definition"Current repeated episodes" indicates risk within 1 year of the intended transplantation (events >1 year prior are not considered).

ContextThis temporal definition applies to assessment of severe hypoglycemic episodes when evaluating candidacy for allogeneic islet transplantation (donislecel-jujn).

ImplicationEvents occurring more than 1 year before the intended transplant are not counted as "current repeated episodes" for policy eligibility.

Policy coding update — new codes added in 2020 and 2025

SummaryPolicy updated with new procedure and related codes added in 2020 and additional miscellaneous codes added later (see coding table).

Provider Actions / Billing & Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for islet transplantation services and related cellular therapy products. Claims for islet transplantation (autologous or allogeneic) and associated drug billing must have prior authorization documented before service.

Affected procedure codes include, but may not be limited to: 48160, 48999, 0584T, 0585T, 0586T, S2102
Affected drug and miscellaneous codes added: J3590, C9399, and applicable NDCs for Lantidra
Autologous pancreas islet transplantation may be prior authorized when performed as an adjunct to total or near-total pancreatectomy for chronic pancreatitis; allogeneic islet transplantation (including donislecel-jujn/Lantidra) requires prior authorization and is investigational for most indications per policy

Documentation Required

Regulatory & Product Documentation

Documentation of regulatory status and product information must be included with claims and medical records. For donislecel-jujn (Lantidra), include the FDA approval/labeling reference and the product package insert information when submitting for authorization and payment.

Background

Autologous islet transplantation involves isolation of pancreatic islet cells from the patient’s resected pancreas during a total or near‑total pancreatectomy, followed by infusion of the isolated islets—typically into the portal venous system—to preserve beta‑cell function and reduce the incidence of post‑pancreatectomy diabetes. Evidence from case series and systematic reviews supports reduced post‑surgical diabetes incidence and acceptable safety when performed as an adjunct to pancreatectomy for chronic pancreatitis.

Definitions

Allogeneic

TermAllogeneic transplantation

DefinitionGrafting or transplantation of tissue from one individual into another of the same species.

Clinical relevanceRefers to donor-derived islet procedures (e.g., Lantidra) that typically require immunosuppression and regulatory oversight.

Autologous

TermAutologous

DefinitionOriginating within an individual (self-donation).

Clinical relevanceAutologous islet transplantation uses the patient’s own islets, typically during pancreatectomy, and does not require long-term donor immunosuppression.

Candidate Selection Criteria

Autologous candidates

Candidate selection information present in document

Autologous candidate: Patients undergoing total or near total pancreatectomy for chronic pancreatitis who would benefit from islet autotransplantation to decrease the incidence of post-surgical diabetes.

Selection informed by case series and systematic reviews; procedure typically performed during pancreatectomy and not associated with serious added complications.

Allogeneic (donor-derived) candidates per FDA label

Allogeneic candidate considerations

Donislecel-jujn candidate: Adults with type 1 diabetes who are unable to approach target HbA1c because of current repeated severe hypoglycemia despite intensive diabetes management and education, and who will receive concomitant immunosuppression.Current repeated episodes = within 1 year

Only adults were enrolled in pivotal studies; insufficient data for >=65 years and pregnancy risks not assessed; requires consideration of risks of infusion and long-term immunosuppression.

Contraindications

Prior portal vein thrombosis limits the ability to perform repeated intraportal islet infusions; repeat infusions are not recommended if the patient has experienced prior portal thrombosis unless the thrombosis was confined to second‑ or third‑order portal vein branches where limited repeat infusion may be considered.

The policy explicitly states that donislecel-jujn is not supported for individuals with liver disease, those with renal failure, or patients who have previously undergone a renal transplant, and therefore these conditions act as contraindications to coverage for the allogeneic product under this policy.

Administrative and coding history sections document updates and background information but do not list specific absolute or relative contraindications; in other words, certain administrative chunks contain policy history and coding changes but do not provide explicit contraindication statements beyond those stated elsewhere in the policy.

Evaluation Requirements

Documentation Required

Confirm intensive diabetes management failed and recent repeated severe hypoglycemia (within 1 year)

Patients considered for donislecel-jujn must have documented intensive diabetes management and education and continue to experience current repeated severe hypoglycemia (events within 1 year) despite optimization of therapy.

Document that repeated severe hypoglycemic events occurred within 1 year of intended transplantation.
Include records of intensive diabetes management efforts (insulin, devices, education) that failed to prevent these events.

Documentation Required

Document pre‑transplant evaluation using established protocols and glycemic predictors

Pre-transplant evaluation should follow available protocols and evidence-based predictors (for example, UIC protocol and glycemic predictors of insulin independence) to document candidate selection and expected outcomes.

Document adherence to recognized evaluation protocols (e.g., UIC protocol) and relevant predictive measures for insulin independence.
Include cited literature or protocol references in the medical record to support candidate selection decisions.

Center Requirements

Documentation Required

Comply with FDA CBER regulations for donor-derived islet therapies (21 CFR 1270/1271)

Allogeneic islet cells and donor-derived cellular therapies are regulated by FDA CBER under 21 CFR parts 1270 and 1271; providers must be aware of these regulatory requirements when handling, documenting, and billing donor-derived products.

Comply with FDA CBER regulations (21 CFR parts 1270 and 1271) for allogeneic islet cell handling and documentation.
Ensure regulatory documentation is available in the medical record and with claims as appropriate.

Note

No FACT accreditation or center volume requirements specified in policy

The policy does not specify FACT accreditation or minimum center volume requirements; do not assume accreditation or volume standards are required by this policy when assembling documentation for authorization or claims.

No explicit FACT-accreditation or center volume requirements are listed in the policy.
Providers need not indicate FACT accreditation solely to meet this policy, but should include any center qualifications that support care quality in prior authorization documentation.

Post-Transplant Coverage & Monitoring

Immunosuppressive therapy and monitoring

RequirementAllogeneic islet transplantation with donislecel-jujn requires concomitant long-term immunosuppression per clinical studies and the FDA label.

RisksThere are risks associated with the infusion procedure and long-term immunosuppression; these must be considered in coverage decisions.

Follow-up and outcomes monitoring

Follow-upPost-transplant follow-up and outcomes are cited in long-term follow-up studies and FDA materials (references and clinical trial listings).

Coverage durationSpecific coverage durations for follow-up monitoring are not specified in the policy text.

DocumentationRegulatory status and product-specific information (FDA approval and package insert) should be documented with claims and medical records when relevant.