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    v1.0.30
    OpenPayerPolicy UpdatesTransplantAmbetter Georgia Lantidra Coverage Update | OpenPa…
    Ask Trek AI about this page
    CurrentAmbetter GeorgiaPolicy CP.MP.250

    Lantidra (donislecel): Allogeneic Pancreatic Islet Cellular Therapy

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    Medical-necessity coverage for Lantidra in adults with type 1 diabetes who cannot approach target HbA1c because of recurrent severe hypoglycemia despite intensive diabetes management and education; concomitant immunosuppression and specified clinical criteria are required.

    Policy Summary
    PayerAmbetter Georgia
    PolicyLantidra (donislecel): Allogeneic Pancreatic Islet Cellular Therapy
    Policy CodePolicy CP.MP.250
    Change TypeAnnual reviewprior maximum-age requirement removed
    Effective DateOct 1, 2026
    Last ReviewJul 1, 2026
    Next Review DateN/A
    Key ActionDocument the member’s age, type 1 diabetes, recurrent severe hypoglycemia, inability to approach target HbA1c despite intensive management and education, planned immunosuppression, planned infusion count, and absence of contraindications.
    SourceLink
    POLICY UPDATE CHANGES

    The policy underwent an annual review with updated background information and no change to the coverage criteria.

    The coding and policy description were reviewed and references were reviewed and updated.

    The prior maximum-age requirement was removed from the eligibility criteria.

    ≥18 yearsMinimum member age
    3Maximum Lantidra infusions
    30

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    Study participants
    21Insulin-free ≥1 year

    Lantidra Coverage Criteria

    Lantidra coverage criteria

    Covered when ALL of the following are met:

    Lantidra medical necessity

    • Eligibility and clinical criteria

      • Adult age: Member/enrollee is at least 18 years of age.≥18 years
      • Diagnosis: Member/enrollee has a diagnosis of type 1 diabetes.
      • Severe hypoglycemia and glycemic control: Member/enrollee is unable to approach target HbA1c due to current repeated episodes of severe hypoglycemia, despite intensive diabetes management and education.Target HbA1c not approached; repeated severe hypoglycemia despite intensive management and education
      • Immunosuppression: Therapy will be used in conjunction with concomitant immunosuppression.Concomitant immunosuppression required
      • Infusion limit: No more than three infusions will be given.≤3 infusions
      • No contraindicating condition: Member/enrollee does not have concomitant diseases or conditions, including pregnancy, that contraindicate the procedure for Lantidra infusion or immunosuppression.No contraindicating concomitant disease or condition, including pregnancy

    Coverage excludes members with concomitant diseases or conditions, including pregnancy, that contraindicate the Lantidra infusion procedure or immunosuppression.

    Coding and Coverage Parameters

    Referenced billing codeHCPCS
    J3590Unclassified biologics
    Member age
    Minimum ageAt least 18 years of age
    Eligibility populationAdult members/enrollees
    Age requirementMembers/enrollees under 18 years do not meet this criterion
    Maximum number of infusions
    Maximum number of infusionsNo more than three infusions
    Treatment planThe planned Lantidra treatment must include three or fewer infusions
    Coverage criterion

    Documentation and Denial Considerations

    Documentation Required

    Clinical Eligibility Documentation

    Submit clinical records establishing that the member/enrollee meets every medical-necessity requirement for Lantidra (donislecel), including the diagnosis, treatment history, planned therapy, and absence of contraindicating conditions.

    • Age: Member/enrollee is ≥ 18 years of age.
    • Diagnosis: Type 1 diabetes.
    • Clinical history: Unable to approach target HbA1c because of current repeated episodes of severe hypoglycemia despite intensive diabetes management and education.
    • Planned treatment: Lantidra will be administered with concomitant immunosuppression, with no more than three infusions planned.
    • Safety assessment: No concomitant disease or condition, including pregnancy, contraindicates Lantidra infusion or immunosuppression.
    Denial Risk

    Clinical Background

    Type 1 diabetes is an autoimmune disease involving destruction of pancreatic beta cells and lifelong insulin deficiency. Lantidra (donislecel) is derived from deceased-donor pancreatic islet cells and is infused into the hepatic portal vein, where the cells may engraft and produce insulin. It is intended for adults who cannot approach target HbA1c because of recurrent severe hypoglycemia despite intensive diabetes management and education. Immunosuppressive therapy is required before and long term after infusion to prevent rejection and preserve transplanted islet-cell viability.

    Key Definitions

    Lantidra (donislecel)
    Therapy typeAllogeneic pancreatic islet cellular therapy
    Cell sourceDerived from deceased-donor pancreatic islet cells
    Cell characteristicsIncludes insulin-producing beta cells
    AdministrationAdministered by infusion into the hepatic portal vein
    Recurrent severe hypoglycemia
    Clinical eventA severe low-blood-glucose event
    PatternThe event occurs repeatedly

    Pancreatic Islet Therapy Candidate Criteria

    Pancreatic islet therapy candidate criteria

    Candidate is eligible when ALL of the following are met:

    Pancreatic islet cellular therapy candidate

    • Candidate eligibility

      • Age: Member/enrollee is at least 18 years of age.≥18 years
      • Type 1 diabetes: Member/enrollee has a diagnosis of type 1 diabetes.
      • Recurrent severe hypoglycemia: Member/enrollee is unable to approach target HbA1c due to current repeated episodes of severe hypoglycemia, despite intensive diabetes management and education.

    Contraindications

    Lantidra infusion and the required immunosuppression are contraindicated when the member has a concomitant disease or condition that makes either treatment inappropriate. This includes pregnancy. Members with such conditions do not meet the medical-necessity criteria for coverage.

    Evaluation Requirements

    Documentation Required

    Complete required clinical evaluation

    Before treatment, document recurrent severe hypoglycemia and the inability to approach target HbA1c despite intensive diabetes management and education. Evaluate for concomitant diseases or conditions, including pregnancy, that could contraindicate the Lantidra infusion procedure or immunosuppression.

    • Confirm recurrent severe hypoglycemia despite intensive diabetes management and education.
    • Document inability to approach target HbA1c.
    • Assess for contraindicating concomitant diseases or conditions, including pregnancy.

    Post-Transplant Immunosuppression

    Immunosuppression after pancreatic islet cellular therapy
    Before infusionRecipients must receive immunosuppressive therapy before receiving Lantidra
    After infusionImmunosuppressive therapy must continue long term after the infusion
    PurposePrevent rejection of the transplanted islet cells
    Treatment objectiveMaintain the viability of the transplanted islet cells
    Policy Summary
    PayerAmbetter Georgia
    PolicyLantidra (donislecel): Allogeneic Pancreatic Islet Cellular Therapy
    Policy CodePolicy CP.MP.250
    Change TypeAnnual reviewprior maximum-age requirement removed
    Effective DateOct 1, 2026
    Last ReviewJul 1, 2026
    Next Review DateN/A
    Key ActionDocument the member’s age, type 1 diabetes, recurrent severe hypoglycemia, inability to approach target HbA1c despite intensive management and education, planned immunosuppression, planned infusion count, and absence of contraindications.
    SourceLink
    On This Page
    Lantidra Coverage CriteriaCoding and Coverage ParametersDocumentation and Denial ConsiderationsClinical BackgroundKey DefinitionsPancreatic Islet Therapy Candidate CriteriaContraindicationsEvaluation RequirementsPost-Transplant Immunosuppression
    More than three planned infusions does not meet the medical-necessity requirement
    Glycemic control
    Glycemic targetUnable to approach target HbA1c
    Hypoglycemia requirementCurrent repeated episodes of severe hypoglycemia
    Management historySevere hypoglycemia persists despite intensive diabetes management and education

    Failure to Meet Medical-Necessity Criteria

    Coverage may be denied when any required medical-necessity criterion is not met or is not supported by the submitted documentation.

    • Member/enrollee is younger than 18 years of age or does not have type 1 diabetes.
    • The required history of repeated severe hypoglycemia despite intensive diabetes management and education, with inability to approach target HbA1c, is absent or not established.
    • Therapy will not be used with concomitant immunosuppression, or more than three infusions are planned.
    • A concomitant disease or condition, including pregnancy, contraindicates Lantidra infusion or immunosuppression.
    Clinical impactThe repeated events impair the member's ability to approach target HbA1c despite intensive diabetes management and education
    Target HbA1c not approached; repeated severe hypoglycemia despite intensive management and education
  1. Immunosuppression: Lantidra therapy will be used in conjunction with concomitant immunosuppression.Concomitant immunosuppression required
  2. Infusion limit: The treatment plan includes no more than three infusions.≤3 infusions
  3. No contraindication: The member/enrollee does not have concomitant diseases or conditions, including pregnancy, that contraindicate the procedure for Lantidra infusion or immunosuppression.No contraindicating concomitant disease or condition, including pregnancy