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    v1.0.28
    OpenPayerPolicy UpdatesHematology/OncologyIndependent Health clonoSEQ MRD Coverage Prior Aut…
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    CurrentIndependent HealthPolicy M20240726022

    Measurable Residual Disease Assessment for Hematological Cancers - clonoSEQ

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    Defines medical necessity and coverage criteria for clonoSEQ NGS-based MRD testing in members with B-cell ALL, CLL, and multiple myeloma across Independent Health lines of business; affects ordering providers and billing for covered plans.

    Policy Summary
    PayerIndependent Health
    PolicyMeasurable Residual Disease Assessment for Hematological Cancers - clonoSEQ
    Policy CodePolicy M20240726022
    Change TypeNo material change
    Effective DateSep 1, 2024
    Last ReviewNov 1, 2024
    Next Review DateN/A
    Key ActionObtain preauthorization for initial and subsequent clonoSEQ MRD testing.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    10-4MRD detection threshold
    B-ALL, CLL, MMCancer types covered

    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.

    81479Billing code
    RequiredPreauthorization

    Coverage Criteria for clonoSEQ MRD Testing

    Clinical indications (Covered)

    clonoSEQ MRD assessment is considered medically appropriate as an alternative test at an MRD detection threshold of 10-4 when ONE or more of the following diagnoses apply:

    Covered diagnoses: Patient has one or more of the following diagnoses: B-cell acute lymphoblastic leukemia (B-ALL); chronic lymphocytic leukemia (CLL); or multiple myeloma (MM).MRD detection at 10^-4

    clonoSEQ used as an alternative NGS-based MRD assay to detect MRD at a 10^-4 threshold

    Contextual qualifiers: Testing must target MRD detection at a threshold of 10-4 (ratio of clonal cells to total nucleated cells).
    Authorization requirement: Preauthorization is required for initial and subsequent clonoSEQ testing requests.

    Provider Requirements and Actions

    Prior Authorization

    Prior Authorization Required

    Prior authorization is required for clonoSEQ MRD testing. This applies to both initial and all subsequent testing requests. Failure to obtain preauthorization may result in claim denial.

    • Preauthorization required for initial and subsequent clonoSEQ requests.
    • Obtain prior authorization before specimen submission or billing.
    Documentation Required

    Specimen and Baseline Documentation

    Specimen source and baseline documentation must be provided with the request. Bone marrow is preferred (especially for B‑cell ALL/LBL); a 2–5 mL sample from the first bone marrow aspirate is usually sufficient to achieve adequate sensitivity. Peripheral blood is acceptable for CLL when indicated. If available, submit a baseline (pre‑treatment) sample or documentation that a baseline characterization of the leukemic clone was performed, as some techniques and serial monitoring require a baseline to track the clone.

    • Preferred specimen: first pull bone marrow aspirate (2–5 mL) to avoid hemodilution; peripheral blood acceptable for CLL.

    Coding and MRD Threshold

    Covered CPT Codes (specified billing guidance)CPTCovered
    81479Unlisted molecular pathology procedure (billing guidance for MediSource, MediSource Connect, Essential Plan and Child Health Plus)
    inv-03: MRD detection threshold — key value
    MRD detection threshold10^-4 (ratio of total clonal cells to total nucleated cells)
    ContextThreshold used to determine medical appropriateness of clonoSEQ as an alternative NGS MRD assay
    Applicable indicationsPatients with leukemia, lymphoma, or multiple myeloma when testing targets MRD at 10^-4

    Definitions

    inv-09: B-ALL — definition
    TermB-cell acute lymphoblastic leukemia (B-ALL)
    DefinitionAn aggressive leukemia of B‑cell lineage characterized by excess lymphoblasts or lymphocytes in bone marrow and peripheral blood, classified by B‑cell lineage; may spread to lymph nodes, spleen, liver, CNS, testicles, and other organs.
    RelevanceIncluded among diagnoses for which clonoSEQ MRD assessment at 10^-4 is considered medically appropriate
    inv-10: CLL — definition
    TermChronic lymphocytic leukemia (CLL)
    DefinitionA chronic lymphoproliferative disorder characterized by progressive accumulation of functionally incompetent lymphocytes, usually monoclonal in origin.

    Background

    Measurable/Minimal Residual Disease (MRD) refers to the presence of residual malignant cells below the detection limits of conventional morphologic methods or standard immunophenotyping and functions as an important prognostic biomarker to guide post‑therapy risk stratification and treatment decisions. MRD assessment can be performed by multiparameter flow cytometry (MFC), quantitative PCR (qPCR), or next‑generation sequencing (NGS) such as the clonoSEQ assay.

    The clonoSEQ test is an NGS‑based assay that characterizes tumor‑specific immunoglobulin or T‑cell receptor sequences to monitor changes in disease burden during and after treatment. clonoSEQ is used with bone marrow samples for B‑cell acute lymphoblastic leukemia (B‑ALL) and multiple myeloma (MM), and with bone marrow or peripheral blood samples for chronic lymphocytic leukemia (CLL), consistent with specimen preferences for achieving adequate sensitivity.

    Bone marrow is generally the preferred specimen—particularly for B‑lineage ALL/LBL—and a 2–5 mL first pull bone marrow aspirate typically provides sufficient cells to reach the assay’s sensitivity. Timing of MRD assessment commonly includes at the end of induction and at the end of consolidation, with additional or more frequent serial monitoring guided by regimen, risk features, or evidence of molecular relapse.

    Independent Health’s policy defines clonoSEQ NGS MRD assessment as a medically appropriate alternative test to detect MRD at a threshold of 10-4 for members with B‑ALL, CLL, or MM, when performed according to the clinical and documentation requirements in this policy.

    Policy Summary
    PayerIndependent Health
    PolicyMeasurable Residual Disease Assessment for Hematological Cancers - clonoSEQ
    Policy CodePolicy M20240726022
    Change TypeNo material change
    Effective DateSep 1, 2024
    Last ReviewNov 1, 2024
    Next Review DateN/A
    Key ActionObtain preauthorization for initial and subsequent clonoSEQ MRD testing.
    SourceLink
    On This Page
    Coverage Criteria for clonoSEQ MRD TestingProvider Requirements and ActionsCoding and MRD ThresholdDefinitionsBackground
  1. Include baseline sample or documentation of baseline clone characterization when required for subsequent MRD comparisons.
  2. Document specimen source (BM or PB), date/time of collection, and relationship to therapy (e.g., post‑induction, end of consolidation).
    3. Denial Risk

    Denial Risk if Preauthorization Not Obtained

    Lack of prior authorization may lead to claim denial. Verify member eligibility and obtain authorization before ordering testing to avoid denial risk.

    • Authorization denial risk: claims submitted without required preauthorization are at risk for denial.
    • Confirm authorization validity for both initial and repeat clonoSEQ testing.
    Billing Rule

    Billing / Coding Guidance

    Billing code guidance for specified lines of business: use CPT 81479 for MediSource, MediSource Connect, Essential Plan and Child Health Plus claims for clonoSEQ MRD assessment.

    • Use CPT 81479 for MediSource, MediSource Connect, Essential Plan and Child Health Plus.
    Specimen notePeripheral blood is an acceptable specimen for clonoSEQ in CLL (per clinical context).
    inv-11: MM — definition
    TermMultiple myeloma (MM)
    DefinitionA clonal plasma cell proliferative disorder characterized by neoplastic proliferation of plasma cells producing a monoclonal immunoglobulin; plasma cells proliferate in bone marrow and can cause skeletal destruction, osteolytic lesions, osteopenia, and pathologic fractures.
    RelevanceIncluded among diagnoses for which clonoSEQ MRD assessment at 10^-4 is considered medically appropriate
    inv-12: MRD — definition
    TermMinimal/Measurable Residual Disease (MRD)
    DefinitionThe presence of leukemic or plasma cells below the threshold of detection by conventional morphologic methods or standard immunophenotyping.
    Testing implicationclonoSEQ assesses MRD by NGS and is considered medically appropriate to detect MRD at a threshold of 10^-4.