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    v1.0.31
    OpenPayerPolicy UpdatesGenetic & Molecular TestingRegence MRD Testing Coverage Update | OpenPayer
    Ask Trek AI about this page
    CurrentRegencePolicy M-GT88

    Minimal Residual Disease (MRD) Testing for Cancer

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    Medicare Advantage coverage of minimal residual disease testing for solid tumors and hematologic malignancies, subject to applicable CMS requirements, FDA authorization or clearance, contractor jurisdiction, technical assessment status, and specific cancer indications.

    Policy Summary
    PayerRegence
    PolicyMinimal Residual Disease (MRD) Testing for Cancer
    Policy CodePolicy M-GT88
    Change TypeNo material change
    Effective DateJan 1, 202748d
    Last ReviewSep 1, 2026
    Next Review DateAug 1, 2027
    Key ActionSubmit the specific test name or gene, performing laboratory name and location, applicable procedure codes, medical-necessity rationale, and relevant medical records.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    2FDA-authorized or cleared MRD test examples

    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.

    16
    Solid-tumor combinations listed
    10Hematologic malignancy categories listed
    5Tests listed as not covered
    4MolDX jurisdiction groupings

    Coverage Criteria

    National Coverage Determination pathway

    Covered under NCD 90.2 when all applicable requirements are met.

    NCD 90.2 requirements

    • The member currently has cancer, and the requested test is a somatic cancer test, including an MRD test, that is FDA approved or cleared for its intended use.Currently has cancer

      NCD 90.2 applies only to next-generation sequencing testing and individuals who currently have cancer.

    • Applicable patient-specific cancer criterion

      • The cancer is recurrent, relapsed, refractory, or metastatic.
      • The cancer is advanced stage III or IV, when applicable.

    MolDX jurisdiction and technical assessment

    Covered in a MolDX jurisdiction when all applicable requirements are met.

    MolDX requirements

    • The test is performed under the Medicare contractor jurisdiction applicable to the laboratory location.

      The contractor with jurisdiction over the area where testing is performed controls the applicable LCD and article.

    • The test has completed the required technical assessment confirming the analytical validity, clinical validity, and clinical utility criteria established in the applicable MolDX policy.
    • The requested cancer indication is listed as covered in the applicable MolDX Billing and Coding article.

      Use of a test for an indication other than one listed as covered is considered not medically necessary.

    Listed covered indications

    Examples of tests and indications identified as potentially medically necessary. Coverage remains subject to the applicable NCD, MolDX, and test-specific requirements.

    Covered test and indication examples

    • FDA-authorized or cleared examples

      • clonoSEQ is used for B-cell acute lymphoblastic leukemia, chronic lymphocytic leukemia, or multiple myeloma.
      • Signatera is used for muscle-invasive bladder cancer.

    • Solid-tumor examples

      • Guardant Reveal is used for colorectal cancer.
      • Guardant360 Response is used to monitor response to immune checkpoint inhibitors for inoperable or metastatic cancers.

    The following tests are not covered: Haystack MRD, Heme-STAMP MRD, Labcorp Plasma Detect, Precise MRD, and Tempus xM.

    Medicare and member benefit plans exclude investigational or experimental services, cosmetic services, and services that are not medically reasonable and necessary under Title XVIII of the Social Security Act.

    In a MolDX jurisdiction, use of a MolDX test for an indication other than one listed as covered in the applicable Billing and Coding article is considered not medically necessary.

    The following tests are considered not medically necessary: Haystack MRD, Heme-STAMP MRD, Labcorp Plasma Detect, Precise MRD, and Tempus xM.

    Coding and Procedure Codes

    MRD and related molecular pathology codesCPT
    0040UBCR/ABL1 (t(9;22)) (eg, chronic myelogenous leukemia) translocation analysis, major breakpoint, quantitative.
    0171UTargeted genomic sequence analysis panel, acute myeloid leukemia, myelodysplastic syndrome, and myeloproliferative neoplasms, DNA analysis, 23 genes, interrogation for sequence variants, rearrangements and minimal residual disease, reported as presence/absence.
    0306UOncology (minimal residual disease [MRD]), next-generation targeted sequencing analysis, cell-free DNA, initial (baseline) assessment to determine a patient specific panel for future comparisons to evaluate for MRD.
    0307UOncology (minimal residual disease [MRD]), next-generation targeted sequencing analysis of a patient-specific panel, cell-free DNA, subsequent assessment with comparison to previously analyzed patient specimens to evaluate for MRD.
    0340UOncology (pan-cancer), analysis of minimal residual disease (MRD) from plasma, with assays personalized to each patient based on prior next-generation sequencing of the patient's tumor and germline DNA, reported as absence or presence of MRD, with disease-burden correlation, if appropriate.
    0356UOncology (oropharyngeal or anal), evaluation of 17 DNA biomarkers using droplet digital PCR (ddPCR), cell-free DNA, algorithm reported as a prognostic risk score for cancer recurrence.
    0422UOncology (pan-solid tumor), analysis of DNA biomarker response to anti-cancer therapy using cell-free circulating DNA, biomarker comparison to a previous baseline pre-treatment cell-free circulating DNA analysis using next-generation sequencing, algorithm reported as a quantitative change from baseline, including specific alterations, if appropriate.
    0467UOncology (bladder), DNA, next generation sequencing (NGS) of 60 genes and whole genome aneuploidy, urine, algorithms reported as minimal residual disease (MRD) status positive or negative and quantitative disease burden.
    0470UOncology (oropharyngeal), detection of minimal residual disease by next-generation sequencing (NGS) based quantitative evaluation of 8 DNA targets, cell-free HPV 16 and 18 DNA from plasma.
    0560UOncology (minimal residual disease [MRD]), genomic sequence analysis, cell-free DNA, whole blood and tumor tissue, baseline assessment for design and construction of a personalized variant panel to evaluate current MRD and for comparison to subsequent MRD assessments.
    1–10 of 28
    1/3
    Molecular and MRD laboratory procedure codesCPT
    0688UOncology (colorectal cancer), analysis of minimal residual disease (MRD), next-generation sequencing (NGS), circulating tumor DNA (ctDNA) analysis in whole blood and tumor for baseline assessment to evaluate current MRD status and for comparisons to subsequent MRD assessments.
    0689UOncology (colorectal cancer), analysis of minimal residual disease (MRD) using patient-specific assays, reported as amount of circulating tumor DNA (ctDNA) detection and trend over time.
    0693UOncology (head and neck), circulating tumor DNA (ctDNA), tumor-informed next-generation sequencing (NGS) analysis for 699 genes of patient-specific somatic variants identified from primary tumor tissue, postoperative lymphatic exudate specimen, algorithm reported as presence or absence of ctDNA.
    81206BCR/ABL1 (t(9;22)) (eg, chronic myelogenous leukemia) translocation analysis; major breakpoint, qualitative or quantitative.
    81207BCR/ABL1 (t(9;22)) (eg, chronic myelogenous leukemia) translocation analysis; minor breakpoint, qualitative or quantitative.
    81208BCR/ABL1 (t(9;22)) (eg, chronic myelogenous leukemia) translocation analysis; other breakpoint, qualitative or quantitative.
    81261IGH@ (Immunoglobulin heavy chain locus) (eg, leukemias and lymphomas, B-cell), gene rearrangement analysis to detect abnormal clonal population(s); amplified methodology (eg, polymerase chain reaction).
    81264IGK@ (Immunoglobulin kappa light chain locus) (eg, leukemia and lymphoma, B-cell), gene rearrangement analysis, evaluation to detect abnormal clonal population(s).
    81315NPM1 (nucleophosmin) (eg, acute myeloid leukemia) gene analysis, exon 12 variants.
    81342TRG@ (T cell antigen receptor, gamma) (eg, leukemia and lymphoma), gene rearrangement analysis, evaluation to detect abnormal clonal population(s).
    1–10 of 11
    1/2

    Provider Documentation and Coverage Risk

    Documentation Required

    Required Test and Medical-Necessity Information

    Submit the information required to determine medical necessity and potential Medicare coverage for the genetic or molecular diagnostic test.

    • Specific name of the test, or the gene for single-gene testing
    • Name and location of the performing laboratory
    • Applicable CPT and/or HCPCS code(s)
    • Brief explanation of how the results are necessary to guide treatment decisions relevant to the member’s medical condition
    Documentation Required

    Supporting Clinical Records

    Include medical records relevant to the testing being performed, including documentation from the referring physician and prior testing and treatment history.

    • History and physical examination by the referring physician
    • Conventional testing and outcomes

    Policy Background

    Minimal residual disease (MRD), also called measurable residual disease, refers to residual cancer cells in blood or bone marrow after treatment for solid tumors or hematologic malignancies. MRD testing may use flow cytometry, polymerase chain reaction (PCR), or next-generation sequencing to detect persistent or recurrent cancer.

    Key Definitions

    Minimal residual disease (MRD)
    TermMinimal residual disease (MRD)
    DefinitionResidual cells in blood or bone marrow following treatment.
    Applies toSolid tumor cancers or hematologic malignancies.
    Without active cancer
    TermWithout active cancer
    DefinitionNo clinical, radiographical, or other biological evidence that tumor cells remain post treatment.
    Treatment statusThe patient is no longer being subjected to therapeutic interventions for cancer.

    Covered Cancer Indications

    FDA-approved or cleared MRD testing

    Coverage may be available when the FDA-authorized or cleared test and indication meet all applicable NCD 90.2 requirements.

    FDA-authorized or cleared MRD testing

    • Covered indication

      • clonoSEQ is used for B-cell acute lymphoblastic leukemia, chronic lymphocytic leukemia, or multiple myeloma.
      • Signatera is used for muscle-invasive bladder cancer.
    • The member currently has cancer and the test is a somatic cancer test, including an MRD test, that is FDA approved or cleared for its intended use.

    • Applicable patient-specific cancer criterion

    Testing Eligibility Requirements

    Many MRD testing pathways require baseline testing of tumor tissue or blood before subsequent monitoring. Patient-specific assays may also require prior tumor and/or germline DNA sequencing or a previously analyzed patient specimen so that later results can be compared with the established patient-specific profile.

    Not Covered Tests

    The following tests are listed as not covered: Haystack MRD, Heme-STAMP MRD, and Labcorp Plasma Detect.

    Policy Summary
    PayerRegence
    PolicyMinimal Residual Disease (MRD) Testing for Cancer
    Policy CodePolicy M-GT88
    Change TypeNo material change
    Effective DateJan 1, 202748d
    Last ReviewSep 1, 2026
    Next Review DateAug 1, 2027
    Key ActionSubmit the specific test name or gene, performing laboratory name and location, applicable procedure codes, medical-necessity rationale, and relevant medical records.
    SourceLink
    On This Page
    Coverage CriteriaCoding and Procedure CodesProvider Documentation and Coverage RiskPolicy BackgroundKey DefinitionsCovered Cancer IndicationsTesting Eligibility RequirementsNot Covered Tests
  1. NavDx is used for HPV-driven oropharyngeal or anal squamous cell cancers.
  2. NeXT Personal is used for non-small cell lung cancer, breast cancer, or monitoring response to immune checkpoint inhibitors for stage IV metastatic solid tumors.
  3. Oncodetect is used for colorectal cancer.
  4. Pathlight is used for advanced breast cancer.
  5. RaDaR is used for HPV-negative head and neck squamous cell carcinoma or advanced breast cancer.
  6. Signatera is used for colorectal, muscle-invasive bladder, breast, ovarian, or non-small cell lung cancer, or to monitor response to immune checkpoint inhibitors for advanced cancers.
  7. TrueMRD is used for muscle-invasive bladder cancer.

  8. Hematologic malignancy examples

    • clonoSEQ is used for acute lymphoblastic leukemia, multiple myeloma, chronic lymphocytic leukemia, diffuse large B-cell lymphoma, or mantle cell lymphoma.
    • BCR-ABL1 testing is used for chronic myeloid or chronic myelogenous leukemia or acute lymphoblastic leukemia.
    • NPM1 or PML-RARA testing is used for acute promyelocytic leukemia.
    • RUNX1-RUNX1T1, CBFB-MYH11, or NPM1 testing is used for acute myeloid leukemia when the corresponding gene variant is present.
    • Immunoglobulin or T-cell receptor gene testing for IGH, IGK, TRB, or TRG is used for lymphoma or leukemia.
  9. Conservative treatment provided, if applicable
    10. Denial Risk

    NCD 90.2 Eligibility Not Met

    NCD 90.2 applies only to NGS testing for individuals who currently have cancer. Somatic cancer tests, including MRD tests, must be FDA approved or cleared for the intended use and meet additional patient-specific criteria.

    • Coverage under NCD 90.2 requires current cancer; individuals without clinical, radiographical, or other biological evidence that tumor cells remain after treatment and who are no longer receiving therapeutic interventions for cancer do not meet this requirement
    • The cancer must be recurrent, relapsed, refractory, metastatic, or advanced stage III or IV
    • FDA-approved or cleared MRD indications include clonoSEQ® for B-ALL, CLL, or multiple myeloma, and Signatera™ for muscle-invasive bladder cancer; consult the FDA for current information
    Denial Risk

    Test or Indication Outside MolDX Coverage

    Coverage is limited to tests that have completed a MolDX technical assessment and to the specific indications listed as covered in the applicable MolDX Billing and Coding article. Use for another indication is considered not medically necessary.

    • Confirm the test’s technical-assessment status and intended use in the DEX® Diagnostics Exchange Registry
    • Use the MolDX LCD and Billing and Coding article for the contractor with jurisdiction over the laboratory’s service area
    • Applicable guidance includes L38814 with A58454 for solid tumors and A58996 for hematologic malignancies in AK, ID, OR, WA, UT, AZ, MT, ND, SD, WY, CA, and NV
    • Other jurisdictional guidance includes L38779 with A58376/A58988; L38835 with A58468/A59004; and L38822 with A58434/A58998
    • Research may be needed for tests or indications not addressed in the applicable LCD and article
    Denial Risk

    Explicitly Noncovered Tests

    The following tests have completed a technical assessment and are listed as not covered; they are therefore considered not medically necessary.

    • Haystack MRD®
    • Heme-STAMP MRD
    • Labcorp® Plasma Detect™
    • Precise MRD
    • Tempus xM
    Denial Risk

    Inactive Cancer or Unsupported Indication

    Do not submit MRD testing for individuals without active cancer or for a test and indication lacking the required FDA authorization, clearance, or MolDX coverage support. The indication must match the covered intended use in the applicable guidance.

    • Active cancer excludes patients with no clinical, radiographical, or other biological evidence that tumor cells remain post-treatment and who are no longer receiving therapeutic interventions for cancer
    • For NCD 90.2, the somatic cancer test must be FDA approved or cleared for its intended use
    • For MolDX coverage, the test must have completed technical assessment and the indication must be listed as covered in the applicable Billing and Coding article
    Technical assessment (TA)
    TermTechnical assessment (TA)
    PurposeConfirms the analytical validity, clinical validity, and clinical utility criteria set in the applicable policy.
    Coverage relevanceTests that have completed a TA and are covered for specific indications are listed in the applicable Billing and Coding articles.
    The cancer is recurrent, relapsed, refractory, or metastatic.
  10. The cancer is advanced stage III or IV, when applicable.

    11. Listed solid-tumor indications

    Coverage is limited to the listed test-indication combinations and applicable MolDX requirements.

    Listed solid-tumor test and indication combinations

    • Guardant Reveal for colorectal cancer.
    • Guardant360 Response for monitoring response to immune checkpoint inhibitors for inoperable or metastatic cancers.
    • NavDx for HPV-driven oropharyngeal or anal squamous cell cancers.
    • NeXT Personal for non-small cell lung cancer.
    • NeXT Personal for breast cancer.
    • NeXT Personal for monitoring response to immune checkpoint inhibitors for stage IV metastatic solid tumors.
    • Oncodetect for colorectal cancer.
    • Pathlight for advanced breast cancer.
    • RaDaR for HPV-negative head and neck squamous cell carcinoma.
    • RaDaR for advanced breast cancer.
    • Signatera for colorectal cancer.
    • Signatera for muscle-invasive bladder cancer.
    • Signatera for breast cancer.
    • Signatera for ovarian cancer.
    • Signatera for non-small cell lung cancer.
    • Signatera for monitoring response to immune checkpoint inhibitors for advanced cancers.
    • TrueMRD for muscle-invasive bladder cancer.

    Listed hematologic malignancy indications

    Coverage is limited to the listed hematologic malignancy and molecular-target combinations.

    Listed hematologic malignancy and molecular-target combinations

    • clonoSEQ for acute lymphoblastic leukemia, multiple myeloma, chronic lymphocytic leukemia, diffuse large B-cell lymphoma, or mantle cell lymphoma.
    • BCR-ABL1 testing for chronic myeloid or chronic myelogenous leukemia or acute lymphoblastic leukemia.
    • NPM1 or PML-RARA testing for acute promyelocytic leukemia.
    • RUNX1-RUNX1T1, CBFB-MYH11, or NPM1 testing for acute myeloid leukemia when the corresponding gene variant is present.
    • IGH, IGK, TRB, or TRG immunoglobulin or T-cell receptor gene testing for lymphoma or leukemia.