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    v1.0.30
    OpenPayerPolicy UpdatesHematology/OncologyArizona Complete Health Omisirge RegeneCyte Covera…
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    CurrentArizona Complete HealthPolicy CP.MP.249

    Allogeneic Hematopoietic Progenitor Cell Therapy (Omisirge, RegeneCyte)

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    Medical necessity criteria and coverage guidance for allogeneic hematopoietic progenitor cell therapies (Omisirge/omidubicel and RegeneCyte/HPC cord blood) for non-Medicare plans administered by the health plan.

    Policy Summary
    PayerArizona Complete Health
    PolicyAllogeneic Hematopoietic Progenitor Cell Therapy (Omisirge, RegeneCyte)
    Policy CodePolicy CP.MP.249
    Change TypeAdded RegeneCyte criteriarevised Omisirge indications
    Effective Date
    Next Review Date
    Key ActionObtain prior authorization with documentation of clinical criteria and planned transplantation and preparative regimen.
    SourceLink
    POLICY UPDATE CHANGES

    Added medically necessary criteria for RegeneCyte (HPC Cord Blood) as Criteria II.

    Updated Criteria I to include severe aplastic anemia as a medically necessary indication for Omisirge.

    Specified this policy applies to non-Medicare health plans and references a separate Medicare policy MC.CP.MP.249 for Medicare criteria.

    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.

    2therapies covered
    ≥12Omisirge min age (malignancy)
    ≥6Omisirge min age (aplastic anemia)
    FDA 2023–2025regulatory refs
    J3590, C9399billing codes

    Coverage Criteria

    Omisirge (omidubicel) - Covered Indications

    Omisirge is covered when ALL of the following applicable criteria are met for each indication group:

    Omisirge for hematologic malignancies: Member is >= 12 years of age AND is planned for an umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection AND request is for one administration post-myeloablative conditioning.
    Omisirge for severe aplastic anemia: Member is >= 6 years of age AND request is for one administration following reduced intensity conditioning.

    RegeneCyte (HPC Cord Blood) - Covered Indications

    RegeneCyte is covered when ALL of the following are met:

    RegeneCyte coverage: Member is planned for an unrelated donor hematopoietic progenitor cell transplantation procedure AND an appropriate preparative regimen for hematopoietic and immunologic reconstitution will be used in conjunction with the transplantation procedure AND member has a disorder affecting the hematopoietic system that is inherited, acquired, or a result from myeloablative treatment.

    This policy applies to non‑Medicare health plans administered by the plan. Medicare-specific criteria are not governed by this policy; providers must refer to MC.CP.MP.249 for Medicare members.

    Use of Omisirge (omidubicel) or RegeneCyte outside the specified age ranges, outside the listed clinical indications, or when not paired with the required transplantation procedure and described preparative regimen is not supported by this policy. Such uses may be considered not medically necessary and are subject to denial if documentation does not demonstrate the required age, indication, transplant plan, and appropriate conditioning or preparative regimen.

    Covered Preparative Regimens and Regimen Pairing

    Product / ContextRequired conditioning / preparative regimenCoverage note
    RegeneCyte (HPC cord blood) — unrelated donor transplantation
    An appropriate preparative regimen for hematopoietic and immunologic reconstitution must be used in conjunction with the unrelated donor hematopoietic progenitor cell transplantation procedure.
    Covered when all RegeneCyte criteria are met (planned for unrelated donor transplantation plus appropriate preparative regimen and qualifying hematopoietic disorder).

    Line of Therapy / Salvage Use

    salvage

    Transplant context: Used as part of planned umbilical cord blood transplantation (Omisirge) or unrelated donor hematopoietic progenitor cell transplantation (RegeneCyte); not specified by line (first/second) of therapy.

    Coding and Reimbursement

    Referenced billing codesHCPCS
    J3590Unclassified biologics.
    C9399Unclassified drugs or biologicals
    Referenced billing codes (duplicate group not expected)HCPCS
    No codes listed
    inv-06: Neutrophil recovery time (median) — Omisirge ~12 days; RegeneCyte studies median ~22-27 days
    Omisirge (omidubicel) median neutrophil recoveryApproximately 12 days (87% of subjects attained neutrophil recovery in an average of 12 days)
    RegeneCyte median neutrophil recovery (COBLT/Study 1)27 days (median time to neutrophil recovery was 27 days in Study 1)
    RegeneCyte median neutrophil recovery (Study 3)22 days (median time to neutrophil recovery was 22 days in Study 3)
    RegeneCyte median neutrophil recovery (Study 2)25 days (median time to neutrophil recovery was 25 days in Study 2)

    Provider Actions & Prior Authorization

    Prior Authorization

    Prior authorization required; allowable billing codes

    Prior authorization is required for requests for Omisirge (omidubicel) or RegeneCyte and must include documentation that the clinical criteria in this policy are met. Claims may reference unclassified biologics/drugs codes J3590 or C9399 per coding guidance.

    • Prior authorization submission must demonstrate the applicable coverage criteria for Omisirge or RegeneCyte.
    • Billing may utilize HCPCS codes J3590 or C9399 as noted in the policy.
    Note

    Include transplantation plan and preparative regimen in request

    Confirm the transplantation plan and preparative regimen when submitting authorization: Omisirge requires a planned umbilical cord blood transplantation (post-myeloablative or reduced intensity conditioning as specified) and RegeneCyte requires a planned unrelated donor hematopoietic progenitor cell transplantation with an appropriate preparative regimen.

    • For Omisirge — indicate whether the indication is hematologic malignancy (≥ 12 years; post‑myeloablative conditioning) or severe aplastic anemia (≥ 6 years; following reduced intensity conditioning).

    Background

    Allogeneic hematopoietic cell transplantation (HCT) is used to treat hematologic malignancies and other disorders of the hematopoietic system by infusing stem/progenitor cells from related or unrelated donors following a preparative (myeloablative or reduced‑intensity) conditioning regimen. Conditioning induces pancytopenia and places patients at high risk for infection and other complications; therapies that accelerate neutrophil recovery may reduce infectious complications and healthcare utilization.

    This policy defines medical necessity criteria for two allogeneic cord blood–derived hematopoietic progenitor cell products for non‑Medicare members: Omisirge (omidubicel) — indicated for use to accelerate neutrophil recovery when administered as a single post‑transplant administration in the specified age groups and transplant/conditioning contexts (hematologic malignancy after myeloablative conditioning, or severe aplastic anemia after reduced‑intensity conditioning) — and RegeneCyte (HPC Cord Blood) — indicated for planned unrelated donor hematopoietic progenitor cell transplantation when used with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with inherited, acquired, or treatment‑related hematopoietic disorders.

    Definitions

    inv-12: Myeloablative conditioning — Myeloablative conditioning (MAC) is a regimen expected to destroy hematopoietic cells in the bone marrow, producing extensive and typical...
    DefinitionMyeloablative conditioning (MAC) is a regimen of one or more agents anticipated to destroy hematopoietic cells in the bone marrow, producing extensive pancytopenia typically within one to three weeks.
    Clinical consequenceExtensive and typically irreversible pancytopenia occurs within one to three weeks after administration of a MAC regimen.
    Purpose/contextMAC is used as preparative therapy prior to allogeneic hematopoietic cell transplantation to ablate marrow stem cells and allow donor engraftment.
    inv-13: Products — Omisirge (omidubicel) is a nicotinamide-modified, cord blood–derived allogeneic hematopoietic progenitor cell therapy; RegeneCyte is an a...
    Omisirge (omidubicel)A nicotinamide‑modified, cord blood–derived allogeneic hematopoietic progenitor cell therapy approved to accelerate neutrophil recovery after umbilical cord blood transplantation.
    Policy Summary
    PayerArizona Complete Health
    PolicyAllogeneic Hematopoietic Progenitor Cell Therapy (Omisirge, RegeneCyte)
    Policy CodePolicy CP.MP.249
    Change TypeAdded RegeneCyte criteriarevised Omisirge indications
    Effective Date
    Next Review Date
    Key ActionObtain prior authorization with documentation of clinical criteria and planned transplantation and preparative regimen.
    SourceLink
    On This Page
    Coverage CriteriaCovered Preparative Regimens and Regimen PairingLine of Therapy / Salvage UseCoding and ReimbursementProvider Actions & Prior AuthorizationBackgroundDefinitions
  1. For RegeneCyte — document plan for unrelated donor transplantation and the preparative regimen for hematopoietic and immunologic reconstitution.
    2. Documentation Required

    Required documentation to support authorization

    Provide clinical documentation that supports the diagnosis, patient age, the planned transplantation type, and the conditioning/preparative regimen as applicable to the requested product.

    • Diagnosis supporting use (hematologic malignancy or severe aplastic anemia, or other hematopoietic disorder for RegeneCyte).
    • Patient age consistent with product criteria (Omisirge ≥ 12 years for malignancy; Omisirge ≥ 6 years for severe aplastic anemia).
    • Planned umbilical cord blood transplantation for Omisirge or unrelated donor hematopoietic progenitor cell transplantation for RegeneCyte.
    • Type of conditioning: myeloablative or reduced intensity as required by indication.
    • If applicable, include intent for one administration post-conditioning (Omisirge).
    • Include billing code intent (e.g., J3590 or C9399) for claims processing.
    Denial Risk

    Denial triggers — missing age, indication, or transplant/regimen documentation

    Requests lacking the specific age, indication, planned transplantation, or appropriate conditioning/preparative regimen required by this policy may be denied.

    • Use outside the specified age ranges or indications is not supported and may be considered not medically necessary.
    • Failure to document planned umbilical cord blood transplantation (Omisirge) or unrelated donor transplantation and preparative regimen (RegeneCyte) may trigger denial.
    RegeneCyteAn allogeneic hematopoietic stem/progenitor cell therapy derived from human umbilical cord blood, approved for unrelated donor hematopoietic progenitor cell transplantation with an appropriate preparative regimen.
    Intended use contextsOmisirge: intended for patients ≥12 years for malignancy post‑myeloablative conditioning and ≥6 years for severe aplastic anemia after reduced intensity conditioning; RegeneCyte: intended for disorders affecting the hematopoietic system (inherited, acquired, or post‑myeloablative treatment) in unrelated donor transplantation.