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    OpenPayerPolicy UpdatesHematology/OncologyCommunity Health Plan Washington DLI Coverage Upda…
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    CurrentCommunity Health Plan WashingtonPolicy MC.CP.MP.101

    Clinical Policy: Donor Lymphocyte Infusion

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    Defines medical necessity criteria for donor lymphocyte infusion after allogeneic hematopoietic stem cell transplantation for Medicare health plans affiliated with Centene, including indications, contraindications, and coding implications.

    Policy Summary
    PayerCommunity Health Plan Washington
    PolicyDonor Lymphocyte Infusion
    Policy CodePolicy MC.CP.MP.101
    Change TypeNo material changes noted
    Effective Date
    Next Review Date
    Key ActionObtain prior authorization per plan rules and include documentation supporting prior allogeneic HSCT, relapse or high relapse risk, and donor identity.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    40-60%GvHD rate

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    70-80%
    CML CR rate
    15-20%AML remission rate
    2-5%Bone marrow aplasia
    0.01–8.8 x10^8Dose range

    Coverage Criteria for Donor Lymphocyte Infusion (DLI)

    inv-01: Medically necessary indications

    Covered when ALL of the following are met

    Medicare-covered DLI criteria: Member has previously undergone allogeneic hematopoietic stem cell transplantation (HSCT) from the original donor and DLI is being used to treat relapsed or refractory hematologic malignancy OR to decrease the risk of relapse of a hematologic malignancy.

    Applies to Medicare health plans affiliated with Centene Corporation.

    Chimerism consideration: DLI is not recommended for patients with full chimerism (100% donor cells) and should not be used solely to increase donor chimerism in the absence of relapse risk.

    Risk of graft-versus-host disease (GvHD) and uncertain benefit.

    inv-02: Unsupported or investigational uses

    Not supported / not medically necessary

    Not supported indications: Genetic modification or ex vivo manipulation of donor lymphocytes; DLI administered in the presence of higher than grade 2 acute graft-versus-host disease (GvHD); and other indications not specified as medically necessary.

    Current evidence does not support these uses; manipulation techniques are investigational and recommended only in clinical trials.

    Donor lymphocyte infusion (DLI) is medically necessary when ALL of the following are met: the member previously underwent an allogeneic hematopoietic stem cell transplantation (HSCT) from the original donor, and DLI is being used to treat relapsed or refractory hematologic malignancy or to decrease the risk of relapse of a hematologic malignancy. This policy applies to Medicare health plans affiliated with Centene Corporation and follows current evidence and guideline-based recommendations for post‑HSCT management of relapse risk and salvage therapy. DLI is not recommended for patients with full (100%) donor chimerism or for the sole purpose of increasing donor chimerism in the absence of relapse risk due to uncertain benefit and the risk of graft‑versus‑host disease (GvHD).

    Coverage determinations for DLI are made in the context of the member's applicable coverage documents and Health Plan administrative policies. Coverage decisions and the administration of benefits are subject to the terms, conditions, exclusions and limitations of the member's coverage documents (for example, evidence of coverage, certificate of coverage, policy or contract of insurance), as well as applicable state and federal requirements. This clinical policy is a guide to medical necessity and does not guarantee payment; providers are expected to exercise professional medical judgment and follow the conditions of the member's coverage.

    Uses of DLI beyond the specified post‑HSCT indications are not supported by current evidence. Specifically, genetic modification or ex vivo manipulation of donor lymphocytes (for example, enrichment, depletion, activation or other graft manipulation techniques) are considered investigational and should not be used outside of clinical trials. Additionally, DLI administered when a patient has acute GvHD greater than grade 2 or for indications other than treating relapsed/refractory hematologic malignancy or decreasing relapse risk is not supported and may be denied. These limitations reflect uncertain benefit and potential for serious harm, including exacerbation of GvHD.

    Clinical Regimens and Reported Outcomes

    IndicationRegimen / RationaleCoverage status
    Relapsed chronic myeloid leukemia (CML) after allogeneic HSCTDLI as single‑agent therapy; multiple studies report complete remission rates of 70–80% with durable responses in the majority of cases.Covered with criteria
    IndicationRegimen / RationaleCoverage status
    Relapsed acute myeloid leukemia (AML) after allogeneic HSCTDLI has lower remission induction rates (~15–20%) and is frequently combined with chemotherapy to elicit an anti‑tumor effect.Covered with criteria
    IndicationRegimen / RationaleCoverage status
    Relapsed multiple myeloma after allogeneic HSCTDLI can stimulate a graft‑versus‑myeloma effect; reported response rates vary (approximately 22–52%); NCCN notes DLI may be used on or off trial for patients who relapse after allogeneic grafting.Covered with criteria

    Procedure Codes and Dosing

    Referenced procedure codesCPT|HCPCS
    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; drugs, supplies, hospitalization with outpatient follow-up; medical/surgical, diagnostic, emergency, and rehabilitative services; and the number of days of pre- and post-transplant care in the global definition
    DLI cellular dose range — reported effective cellular dose range
    Reported effective cellular dose range0.01 to 8.8 × 10^8 T cells/kg
    Source of rangeDeol and Lum review summarizing multiple published reports
    Measurement unitsT cells per kilogram of recipient body weight

    Provider Obligations, Prior Authorization, and Documentation

    Prior Authorization

    Prior Authorization Required

    Prior authorization is required per plan rules for donor lymphocyte infusion (DLI). Providers must obtain any required prior authorization before scheduling or performing DLI; failure to obtain authorization may result in claim denial or delayed payment.

    • Affecting codes include procedure and transfusion codes (e.g., 38215, 38242, 86950, S2150) — verify plan-specific prior authorization requirements.
    • Authorization is subject to the member's benefit document, medical necessity criteria, and Health Plan administrative policies.
    Denial Risk

    DLI Not for Chimerism-Only Use

    DLI should not be used for the sole purpose of increasing donor chimerism in patients who are at low or no risk of disease relapse. Use of DLI for a "chimerism-only" indication (i.e., to convert mixed to full donor chimerism when there is no evidence of relapse risk or minimal residual disease) is discouraged and may be denied.

    Intended Line of Therapy

    inv-21: salvage

    Therapeutic context: DLI is used post-HSCT as salvage therapy for relapsed disease or as pre-emptive/prophylactic therapy in high relapse risk patients (e.g., mixed chimerism or detectable minimal residual disease).

    Effectiveness varies by disease; often most effective in relapsed CML and less effective in AML/ALL where combination with chemotherapy may be needed.

    Definitions and Terms

    Mixed chimerism
    DefinitionPresence of < 90% donor cells after HSCT.
    Clinical relevanceMay indicate increased risk of relapse and can prompt consideration of pre-emptive DLI in high-risk patients.
    Threshold used in policy< 90% donor cells denotes mixed chimerism (versus full chimerism at 100%).
    Full (complete) chimerism
    Definition100% donor cells detected after HSCT (complete hematopoietic replacement).
    Clinical implicationIndicates full (complete) chimerism; DLI is not recommended solely to convert to full chimerism absent relapse risk.
    Contrast

    Background on Donor Lymphocyte Infusion

    Donor lymphocyte infusion (DLI) is an adoptive immunotherapy in which lymphocytes from the original stem cell donor are infused into the transplant recipient to induce a graft‑versus‑tumor (GvT) immune effect. DLI may be used therapeutically to treat clinically relapsed hematologic malignancy after allogeneic HSCT or preemptively in patients at high risk of relapse (for example, those with mixed chimerism or detectable minimal residual disease). DLI is associated with substantial risks, most notably graft‑versus‑host disease (GvHD) and, less commonly, bone marrow aplasia; efficacy varies by disease and is generally greatest for chronic myeloid leukemia (CML) and lower for acute leukemias where combination therapy is often needed.

    Policy Summary
    PayerCommunity Health Plan Washington
    PolicyDonor Lymphocyte Infusion
    Policy CodePolicy MC.CP.MP.101
    Change TypeNo material changes noted
    Effective Date
    Next Review Date
    Key ActionObtain prior authorization per plan rules and include documentation supporting prior allogeneic HSCT, relapse or high relapse risk, and donor identity.
    SourceLink
    On This Page
    Coverage Criteria for Donor Lymphocyte Infusion (DLI)Clinical Regimens and Reported OutcomesProcedure Codes and DosingProvider Obligations, Prior Authorization, and DocumentationIntended Line of TherapyDefinitions and TermsBackground on Donor Lymphocyte Infusion
    • DLI is medically necessary post-allogeneic HSCT to treat relapsed/refractory hematologic malignancy or to decrease relapse risk; isolated chimerism conversion without relapse risk does not meet medical necessity.
    • Document clinical indicators of relapse risk (e.g., mixed chimerism plus rising MRD, cytogenetic or molecular relapse markers) when ordering DLI.
    Documentation Required

    Document Combination Therapy

    When DLI is given for diagnoses such as AML where combination therapy is commonly required, providers must document concurrent or prior therapies (for example chemotherapy regimens) and the clinical rationale for combining treatments. Documentation should include timing, agents used, response assessment, and plans for monitoring and managing complications such as graft‑versus‑host disease (GvHD) and marrow aplasia.

    • Specify prior or concurrent cytoreductive or induction chemotherapy details (agent, dose, dates) when DLI is part of a combined approach.
    • Provide evidence of therapeutic intent (salvage vs. pre-emptive), disease status, and response assessments to support medical necessity.
    Note

    Provider Responsibilities and Documentation

    Providers must follow Health Plan coverage documents and exercise professional judgment. Submission of a claim implies the provider agrees services met applicable coverage and billing requirements. Coverage decisions and administration of benefits are subject to terms, conditions, exclusions, and limitations of the member's coverage.

    • Retain and submit required clinical documentation to support medical necessity, including prior HSCT details, evidence of relapse or high relapse risk, MRD or chimerism testing results, and prior/concurrent therapies.
    • Be aware that the clinical policy is a guide; final coverage is determined by the member's benefit plan and applicable laws/regulations.
    Distinguished from mixed chimerism, which is defined as < 90% donor cells.
    Clinical policy — definition
    PurposeA clinical policy provides a guide to medical necessity used to assist in making coverage decisions and administering benefits.
    ScopeBased on review of accepted standards, peer-reviewed literature, guidelines, and expert opinion; does not constitute medical advice or guarantee payment.
    LimitationsCoverage decisions remain subject to the member's coverage documents, applicable law, and Health Plan administrative policies.
    AuthorityDeveloped by experienced licensed health care professionals and adopted by the Health Plan.