Loading...

    Explore
    • Policy Monitoring
    • Live Policy Feed
    • Billing Codes
    • NPI Medicare & Medicaid
    • Healthcare Providers
    • Health Insurance Payers
    • States
    • Service Lines
    • Taxonomy Codes
    Lookup tools
    • Billing Code Lookup
    • CPT Modifier Lookup
    • Provider Taxonomy Code Lookup
    • Healthcare Provider & Facility Lookup
    • Health Insurance Payer Lookup
    • Payer Contact Directory

    Policy & Benchmark Tools

    • Prior Authorization Lookup
    • Coverage Criteria Lookup
    • Timely Filing Lookup
    • Billing Code Reimbursement Rates
    • Payer Comparison Dashboard
    • Facility Comparison Dashboard
    • All tools

    Company

    • About OpenPayer
    • Data Sources
    • Trek Health
    OpenPayerby Trek Health
    LinkedInYouTube

    © 2026 Trek Health. All rights reserved.

    OpenPayer is built and maintained by Trek Health.

    v1.0.28
    OpenPayerPolicy UpdatesEndocrinologyAmbetter Nevada Lantidra Coverage Update | OpenPay…
    Ask Trek AI about this page
    CurrentAmbetter NevadaPolicy CP.MP.250

    Lantidra (donislecel): Allogeneic Pancreatic Islet Cellular Therapy

    Customize your policy alerts

    Sign up for Ambetter Nevada Policy CP.MP.250 alerts

    Get alerted when Policy CP.MP.250 changes without checking for updates manually.

    Monitor payer policy activity

    Receive email alerts as soon as relevant payer policies are published or updated.

    Defines medical necessity criteria and coverage considerations for Lantidra (donislecel) for treating adults with type 1 diabetes who cannot reach target HbA1c due to recurrent severe hypoglycemia; applies to Ambetter Nevada (Centene-affiliated) health plans.

    Policy Summary
    PayerAmbetter Nevada
    PolicyLantidra (donislecel): Allogeneic Pancreatic Islet Cellular Therapy
    Policy CodePolicy CP.MP.250
    Change TypeNo material change
    Effective Date
    Last ReviewJul 25, 2025
    Next Review DateJul 25, 2025
    Key ActionObtain prior authorization documenting that all medical necessity criteria are met before approval of Lantidra infusions.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    ≥18minimum eligible age
    up to 3maximum infusions allowed

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    30
    total enrollees (studies)
    21insulin-independent ≥1 yr
    J3590HCPCS referenced

    Coverage / Medical Necessity Criteria

    Medical Necessity Criteria

    Covered when ALL of the following are met:

    Initial coverage criteria for Lantidra: Member/enrollee is ≥ 18 years of age; diagnosis of type 1 diabetes; member is unable to approach target HbA1c due to current repeated episodes of severe hypoglycemia despite intensive diabetes management and education; therapy will be used in conjunction with concomitant immunosuppression; no more than three infusions will be given; member/enrollee does not have concomitant diseases or conditions, including pregnancy, that contraindicate the procedure for Lantidra infusion or immunosuppression.

    Members with concomitant diseases or conditions that would contraindicate Lantidra infusion or the required concomitant immunosuppression are excluded from coverage. This includes, but is not limited to, pregnancy and any other medical condition that prevents safe administration of intrahepatic portal infusion or long‑term immunosuppressive therapy. Prior authorization will require documentation that no contraindicating comorbid condition or pregnancy is present before approval.

    If the medical necessity criteria are not met, the request should be considered not medically necessary and routed accordingly. Examples include when the member is younger than 18 years, does not have a documented diagnosis of type 1 diabetes, is not experiencing repeated episodes of severe hypoglycemia despite intensive diabetes management and education, will not receive the required concomitant immunosuppression, or the request is for > three infusions. In these situations, deny coverage for Lantidra and direct the provider to continue or optimize intensive diabetes management and education; alternative referrals (endocrinology, diabetes education programs) should be used as appropriate.

    Coding and Quantity Limits

    Referenced HCPCS CodesHCPCS
    J3590Unclassified biologics
    Maximum number of infusions
    Maximum number of infusionsNo more than three infusions will be given.
    Policy locationListed as criterion E in the medical necessity criteria.
    Implication for authorizationPrior authorization required and requests for >3 infusions may be denied.

    Provider Requirements, Authorization & Documentation

    Prior Authorization

    Prior Authorization Required

    Prior authorization is required. Requests must document that all medical necessity criteria are met before approval.

    • Prior authorization required prior to scheduling infusion
    • Include documentation addressing each medical necessity criterion (age, diagnosis, hypoglycemia history, prior management, planned immunosuppression, infusion number limit)
    Documentation Required

    Prior Management Requirement

    Member must have failed or be unable to achieve target HbA1c due to recurrent severe hypoglycemia despite intensive diabetes management and education. The member must be ≥ 18 years of age, have a diagnosis of type 1 diabetes, and be unable to reach target HbA1c because of repeated episodes of severe hypoglycemia. Therapy is intended to be used with concomitant immunosuppression and is limited to no more than three infusions.

    • Age ≥ 18 years

    Key Definitions

    Lantidra (donislecel) — product description
    Product name (generic)Lantidra (donislecel)
    DefinitionAn FDA‑approved allogeneic pancreatic islet cellular therapy produced from deceased donor pancreatic islet cells (including beta cells) intended to restore insulin production in adults with type 1 diabetes who have recurrent severe hypoglycemia and cannot achieve target HbA1c.
    AdministrationInfused into the hepatic portal vein so infused islet cells can produce insulin and regulate blood glucose.
    Adjunct therapy requirementMust be used in conjunction with concomitant immunosuppression to maintain graft viability.
    Intensive diabetes management — definition and components
    DefinitionCoordinated frequent blood glucose monitoring and insulin replacement tailored to meals and activity, combined with diabetes education.

    Background and Clinical Context

    Type 1 diabetes is a chronic autoimmune condition characterized by destruction of pancreatic beta cells leading to insulin deficiency. Standard care centers on intensive diabetes management—frequent blood glucose monitoring, individualized insulin replacement, and diabetes education—to achieve target HbA1c while minimizing hypoglycemia. Lantidra (donislecel) is an allogeneic pancreatic islet cell therapy intended for adults with type 1 diabetes who cannot approach target HbA1c because of recurrent severe hypoglycemia; treatment requires concomitant immunosuppression and is limited to no more than three infusions.

    Policy Summary
    PayerAmbetter Nevada
    PolicyLantidra (donislecel): Allogeneic Pancreatic Islet Cellular Therapy
    Policy CodePolicy CP.MP.250
    Change TypeNo material change
    Effective Date
    Last ReviewJul 25, 2025
    Next Review DateJul 25, 2025
    Key ActionObtain prior authorization documenting that all medical necessity criteria are met before approval of Lantidra infusions.
    SourceLink
    On This Page
    Coverage / Medical Necessity CriteriaCoding and Quantity LimitsProvider Requirements, Authorization & DocumentationKey DefinitionsBackground and Clinical Context
  1. Documented diagnosis of type 1 diabetes
  2. Documented intensive diabetes management and education attempts
  3. Evidence that recurrent severe hypoglycemia prevents achieving target HbA1c
  4. Plan for concomitant immunosuppression
  5. Infusion limit: ≤ 3 total infusions
    6. Denial Risk

    Triggers for Denial

    Common reasons for denial include missing or inadequate documentation of prior management and hypoglycemia history, ineligible age or diagnosis, lack of plan for immunosuppression, exceeding infusion limits, or contraindicating comorbid conditions (including pregnancy). Provide clear, dated clinical notes and relevant objective data to avoid denial.

    • Age < 18 years — not eligible
    • Diagnosis other than type 1 diabetes — not eligible
    • Insufficient documentation of recurrent severe hypoglycemia (e.g., unspecified episodes, no dates or clinical details)
    • No evidence of prior intensive diabetes management or education
    • No plan for concomitant immunosuppression
    • Request for > 3 infusions
    • Presence of contraindicating conditions (e.g., pregnancy, active infection, other contraindications to infusion or immunosuppression)
    Role in policyConsidered the standard of care for type 1 diabetes; Lantidra is considered only after intensive diabetes management fails to prevent recurrent severe hypoglycemia.
    Clinical challenge addressedUsed when patients cannot manage hyperglycemia without causing hypoglycemia or have hypoglycemia unawareness despite intensive management and education.