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    v1.0.28
    OpenPayerPolicy UpdatesHematology/OncologyCentene Donor Lymphocyte Infusion Coverage | OpenP…
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    CurrentCentenePolicy CP.MP.101

    Donor Lymphocyte Infusion

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    Medical necessity and coverage criteria for donor lymphocyte infusion following allogeneic hematopoietic stem cell transplantation for relapsed or high-risk hematologic malignancies, applicable to non-Medicare Centene health plans.

    Policy Summary
    PayerCentene
    PolicyDonor Lymphocyte Infusion
    Policy CodePolicy CP.MP.101
    Change TypeNo material changes
    Effective Date
    Last ReviewFeb 25, 2024
    Next Review Date
    Key ActionObtain prior authorization where applicable and provide documentation supporting prior allogeneic HSCT and indication for relapse or high risk of relapse.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    40-60%GvHD after DLI
    70-80%

    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.

    CML remission rate
    15-20%AML remission induction
    22-52%MM response rate
    2-5%Bone marrow aplasia

    Coverage Criteria for Donor Lymphocyte Infusion (DLI)

    inv-01: Initial therapy/Indications

    Covered when ALL of the following are met:

    Primary coverage criteria: Member has previously undergone allogeneic hematopoietic stem cell transplantation (HSCT); DLI is being requested for treatment of relapsed or refractory hematologic malignancy OR to decrease risk of relapse in a patient at high risk (e.g., mixed chimerism or detection of minimal residual disease); donor lymphocytes are from the original stem cell donor.

    Applies to non-Medicare Centene health plans per policy.

    inv-02: Contraindications / Unsupported Indications

    Not covered / current evidence does not support when ANY of the following are present:

    Contraindications and not supported indications: Presence of grade 2 or higher acute graft-versus-host disease (GvHD); genetic modification or ex vivo manipulation of donor lymphocytes; use of DLI for sole purpose of increasing donor chimerism when there is no risk of relapse.

    Policy states current evidence does not support these uses.

    DLI should not be used solely to increase donor chimerism when there is no accompanying risk of relapse. The policy explicitly states that DLI is intended to treat relapsed or refractory hematologic malignancy or to decrease relapse risk in high‑risk patients; using DLI only to convert mixed to full donor chimerism without evidence of relapse risk is discouraged because it may exacerbate graft‑versus‑host disease (GvHD) and provides uncertain benefit.

    Current evidence does not support DLI when any of the following are present: grade 2 or higher acute graft‑versus‑host disease (GvHD), or when donor lymphocytes have undergone genetic modification or ex vivo manipulation. The policy lists these situations as contraindications or not supported indications and states that such uses are not recommended outside of a clinical trial because benefits have not been established to outweigh risks.

    Regimens and Clinical Contexts Where DLI May Be Used

    RegimenIndicationCoverage statusSupporting evidence / notes
    Donor lymphocyte infusion (DLI)
    Relapsed chronic myeloid leukemia (CML)
    covered
    Multiple studies demonstrate complete remission rates of 70–80% in relapsed CML following DLI; originally described by Kolb et al. and supported by subsequent reviews.
    RegimenIndicationCoverage statusSupporting evidence / notes
    Donor lymphocyte infusion (DLI) often combined with chemotherapy
    Relapsed acute myeloid leukemia (AML)
    covered_with_criteria
    DLI has lower single-agent efficacy in relapsed AML (approx. 15–20% remission rate); clinical reports indicate combination with chemotherapy is often necessary to elicit an anti-tumor effect.
    RegimenIndicationCoverage statusSupporting evidence / notes
    Donor lymphocyte infusion (DLI)
    Relapsed multiple myeloma
    covered_with_criteria
    DLI can stimulate a graft‑versus‑myeloma effect with reported response rates varying widely (approximately 22–52%); some reports describe conversion to full chimerism associated with response in select cases.

    Line of Therapy and Salvage Use

    inv-13: salvage

    Salvage or post-HSCT use: DLI is used after allogeneic HSCT for relapsed or refractory disease or as pre-emptive therapy in high-risk patients; specific line (first-line vs salvage) depends on clinical scenario and disease, with DLI commonly used as salvage for relapse.

    Policy does not specify strict line numbering; clinical judgment applies.

    Biomarker and Disease Activity Requirements

    inv-14: Minimal residual disease (MRD) — detection by molecular or immunophenotypic methods
    DefinitionMinimal residual disease (MRD) detection by molecular or immunophenotypic methods (used to identify incipient relapse and consider pre-emptive DLI).
    Use in policyMRD detection can trigger consideration of pre-emptive DLI in patients at high risk of relapse following allogeneic HSCT.
    MethodsDetected by molecular assays or immunophenotypic techniques per clinical laboratory evaluation.
    Clinical contextMRD detection often accompanies mixed chimerism as a rationale for administering DLI to prevent overt relapse.

    Provider Actions, Prior Authorization, and Documentation

    Prior Authorization

    Prior authorization required for DLI and related procedure codes

    Prior authorization is required, when applicable, for donor lymphocyte infusion (DLI) procedures and associated codes — e.g., CPT 38242 (Allogeneic lymphocyte infusions) and other referenced procedure codes — per applicable plan coverage rules.

    • Referenced procedure codes in policy: 38215, 38242, 86950, S2150.
    • Providers should obtain prior authorization according to the member's non‑Medicare plan before scheduling DLI.
    Step Therapy

    Sequencing: combine DLI and chemotherapy per clinical judgment (no formal step‑therapy)

    DLI is frequently used in combination with cytotoxic chemotherapy in certain malignancies (notably relapsed AML) to elicit an anti‑tumor response; the policy does not mandate a formal step‑therapy sequence, so clinical judgment and local operational workflows should guide timing and coordination with systemic therapy.

    • Clinical reports note DLI is often combined with chemotherapy for relapsed AML to achieve remission.

    Procedure and Billing Codes

    Referenced procedure codesmixed
    38215Transplant preparation of hematopoietic progenitor cells; cell concentration in plasma, mononuclear or buffy coat layer.
    38242Allogeneic lymphocyte infusions.
    86950Leukocyte transfusion.
    S2150Bone marrow or blood-derived stem cells (peripheral or umbilical), allogeneic or autologous, harvesting, transplantation, and related complications; including: pheresis and cell preparation/storage; marrow ablative therapy; supplies, hospitalization with outpatient follow-up; medical/surgical, diagnostic, emergency, and rehabilitative services; and the number of days of pre-and posttransplant care in the global definition.

    Background on Donor Lymphocyte Infusion

    Donor lymphocyte infusion (DLI) is an adoptive immunotherapy in which donor T lymphocytes from the original stem cell donor are infused into a patient after allogeneic hematopoietic stem cell transplantation (HSCT) to induce a graft‑versus‑tumor (GvT) effect. It is used therapeutically for relapsed or progressive hematologic malignancies and pre‑emptively in high‑risk patients (for example, those with mixed chimerism or detectable minimal residual disease). Major risks include graft‑versus‑host disease (GvHD) and bone marrow aplasia.

    Key Definitions

    inv-11: Mixed chimerism — Presence of <90% donor cells detected after HSCT
    DefinitionMixed chimerism: presence of <90% donor cells detected after hematopoietic stem cell transplantation (HSCT).
    Clinical implicationMixed chimerism identifies patients at increased risk of relapse and may prompt consideration of pre-emptive DLI.
    Relationship to DLIConversion from mixed to full chimerism has been associated with graft-versus-tumor responses after DLI in reported series.
    MeasurementDetermined by chimerism testing of peripheral blood or marrow to quantify percent donor cells post-engraftment.
    inv-12: Full/complete chimerism — 100% donor cells detected, indicating complete hematopoietic replacement
    DefinitionFull/complete chimerism: 100% donor cells detected, indicating complete hematopoietic replacement after HSCT.
    Policy Summary
    PayerCentene
    PolicyDonor Lymphocyte Infusion
    Policy CodePolicy CP.MP.101
    Change TypeNo material changes
    Effective Date
    Last ReviewFeb 25, 2024
    Next Review Date
    Key ActionObtain prior authorization where applicable and provide documentation supporting prior allogeneic HSCT and indication for relapse or high risk of relapse.
    SourceLink
    On This Page
    Coverage Criteria for Donor Lymphocyte Infusion (DLI)Regimens and Clinical Contexts Where DLI May Be UsedLine of Therapy and Salvage UseBiomarker and Disease Activity RequirementsProvider Actions, Prior Authorization, and DocumentationProcedure and Billing CodesBackground on Donor Lymphocyte InfusionKey Definitions
  1. Policy states formal step‑therapy sequencing is not specified.
    2. Documentation Required

    Required documentation to support DLI prior authorization

    Documentary support must be submitted with prior authorization requests to confirm prior allogeneic HSCT, the indication (relapsed/refractory disease or high risk of relapse), and that donor lymphocytes are from the original stem cell donor.

    • Evidence of prior allogeneic hematopoietic stem cell transplantation (HSCT).
    • Clinical rationale: treatment of relapsed/refractory hematologic malignancy OR pre‑emptive use for high relapse risk (e.g., mixed chimerism or detection of minimal residual disease).
    • Verification that donor lymphocytes originate from the original stem cell donor.
    Denial Risk

    Denial triggers: unsupported indications and contraindications

    Requests for DLI will be denied when the indication is among those the policy identifies as not supported — for example, presence of grade 2 or higher acute graft‑versus‑host disease (GvHD), or when donor lymphocytes have been genetically modified or ex vivo manipulated.

    • Use of DLI for sole purpose of increasing donor chimerism without risk of relapse is not supported.
    • DLI is not supported in the presence of grade 2 or higher acute GvHD.
    • DLI using genetically modified or ex vivo‑manipulated donor lymphocytes is not supported.
    Clinical relevanceAchievement of full chimerism after DLI can reflect an effective graft-versus-tumor effect and has been reported with clinical responses.
    Role in monitoringUsed as an endpoint in assessing engraftment and response to interventions such as DLI in post-transplant patients.