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    v1.0.28
    OpenPayerBilling CodesProprietary Laboratory AnalysesCPT cpt-0069u-mir-31now-mir-31-3p-expression-colon-cancer
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    CPT 0069U: miR-31-3p Expression Test for Colon Cancer

    CPT code 0069U is a Proprietary Laboratory Analyses (PLA) code for the miR–31now™ test by GoPath Laboratories that measures miR‑31‑3p expression in formalin‑fixed, paraffin‑embedded colon cancer tissue and uses an algorithm to assign an expression score to guide therapy selection; this represents a molecular diagnostic tumor profiling service typically performed by a clinical reference laboratory and reported for specimens received from ambulatory clinics, hospital outpatient departments, or cancer centers.

    For related coverage guidance, see recent payer policy updates: RTM Testing of Homocysteine Metabolism-Related Conditions, Multimarker Serum Testing Related to Ovarian Cancer, B-Hemolytic Streptococcus Testing.

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    Clinical & Coding Specifications

    Clinical Context

    A typical patient is a 60-year-old individual with a histologically confirmed stage II–III colon adenocarcinoma who has undergone surgical resection of the primary tumor. Tumor tissue fixed in formalin and embedded in paraffin (FFPE) is submitted to GoPath Laboratories for the miR–31now™ test. The laboratory extracts RNA from the FFPE block, measures miR–31–3p expression, and applies the proprietary algorithm to generate an expression score. The report is used by the treating medical oncologist to inform selection of systemic therapy, particularly in the context of decisions about anti–EGFR therapy versus alternative regimens for metastatic or recurrent disease. Typical workflow steps include: specimen accessioning, histology review to confirm tumor content, RNA extraction and assay run, algorithmic scoring, and result reporting to the ordering oncologist. Typical site of service is a clinical molecular diagnostics laboratory supporting outpatient oncology care; specimen collection originates from hospital outpatient surgical pathology or an ambulatory surgical setting.

    Related CPT Codes

    CPT CodeDescriptionRelationship to This Procedure
    88305Level IV surgical pathology, gross and microscopic examinationUsed by pathology to evaluate the resected colon specimen and select tumor blocks for molecular testing.
    88342Immunohistochemistry, each antibody stainMay be performed on FFPE tissue to confirm tumor phenotype prior to molecular testing in the diagnostic workflow.
    81599Unlisted molecular pathology procedureHistorically used for proprietary molecular tests before PLA codes; related conceptually but replaced by unique PLA code 0069U.
    0001UExample PLA molecular biomarker code (placeholder)Laboratories often perform panels or other PLA assays in conjunction with single-marker PLA tests; included to represent companion molecular testing workflows.
    81275KRAS gene analysis, codons 12,13Common companion molecular test for colon cancer that informs anti–EGFR therapy decisions alongside miR–31 testing.

    Related Modifiers

    8 rows

    ModifierDescriptionWhen to Use
    26Modifier 26 (Professional Component) identifies and bills only the professional portion of a split service — the physician’s interpretation, report, and medical judgment — when the technical…- Use CPT Modifier -26 when you are billing only the professional component (PC) of a split‑bill eligible service—i.e., you performed the physician interpretation, medical judgment and prepared a…
    52Modifier ‑52 (Reduced Services) indicates that a service or procedure was partially reduced or omitted at the provider’s discretion, allowing reporting of the basic procedure number with a qualifier…- Use modifier -52 when a physician or qualified health professional electively reduces or omits part of a procedure or service (for example, performing fewer required views or omitting a portion of…
    53Modifier 53 (Discontinued Procedure) signals that a surgical or diagnostic service was begun by the physician but terminated because of extenuating circumstances that threatened the patient’s…- Use modifier -53 when a physician/qualified healthcare professional has started a surgical or diagnostic procedure (e.g., anesthesia administered, incision or scope insertion) and then discontinues…
    56Modifier ‑56 indicates the reporting provider furnished only the preoperative management for a surgical procedure and did not perform the intraoperative or postoperative care. It is used in…- Use Modifier -56 when a provider performs only the preoperative management in a split‑care situation (one physician manages preop care while a different physician performs the intraoperative…
    62Modifier 62 indicates that two surgeons function as co‑surgeons, each performing distinct parts of the same primary surgical procedure. It is appended to the primary procedure code (and any…- Use modifier -62 when two surgeons act as co‑surgeons (both primary surgeons) on a single definitive primary procedure, each performing distinct parts of the same surgical procedure (append -62 to…
    78CPT modifier -78 indicates an unplanned, related return to the operating or procedure room by the same provider during the global postoperative period. It is appended when treatment for a…- Use modifier -78 when an unplanned, related complication during the original procedure’s global postoperative period requires the patient to return to a formal operating or procedure room and the…
    80CPT® Modifier 80 (Assistant Surgeon) is appended to a surgical CPT code when a physician (MD or DO) provides full, continuous assistance throughout the operative procedure. It is intended only for…- Use CPT Modifier -80 when a physician (MD or DO) serves as an assistant surgeon and provides full, continuous assistance throughout the entire operative procedure; append -80 to the surgical CPT…
    82Modifier 82 is appended to a surgical CPT code to indicate that an attending physician acted as an assistant because a qualified resident surgeon was unavailable. In teaching hospitals it documents…- When to use: Append modifier 82 in teaching-hospital settings to indicate a physician served as an assistant surgeon because a qualified resident surgeon was unavailable (includes situations where…

    Related Provider Taxonomies

    8 rows

    Taxonomy CodeSpecialtyNotes
    207RH0000XHematology (Internal Medicine) PhysicianAn internist with additional training who specializes in diseases of the blood, spleen and lymph. This specialist treats conditions such as anemia, cl…
    363A00000XPhysician AssistantA physician assistant is a person who has successfully completed an accredited education program for physician assistant, is licensed by the state and…
    207L00000XAnesthesiology PhysicianAn anesthesiologist is trained to provide pain relief and maintenance, or restoration, of a stable condition during and immediately following an opera…
    208000000XPediatrics PhysicianA pediatrician is concerned with the physical, emotional and social health of children from birth to young adulthood. Care encompasses a broad spectru…
    315D00000XInpatient HospiceA provider organization, or distinct part of the organization, which renders an interdisciplinary program providing palliative care, chiefly medical r…
    207R00000XInternal Medicine PhysicianA physician who provides long-term, comprehensive care in the office and the hospital, managing both common and complex illness of adolescents, adults…
    207XP3100XPediatric Orthopaedic Surgery PhysicianAn orthopedic surgeon who has additional training and experience in diagnosing, treating and managing musculoskeletal problems in infants, children an…
    246ZG0701XGraphics Methods Specialist/TechnologistNone

    Related Payer Policy Updates

    Specialty: Genetic & Molecular Testing1 / 3

    2 rows

    PolicyPayerEffective Date
    RTM Testing of Homocysteine Metabolism-Related ConditionsOscar Health2026-10-01
    Multimarker Serum Testing Related to Ovarian CancerBlue Cross Blue Shield - Rhode Island2026-09-01

    Related Codes

    CPT-0001U-PRECISETYPE-HEA-MULTIPLEX-RBC-ANTIGEN-GENOTYPING

    CPT 0001U: PreciseType HEA Erythrocyte Antigen Genotyping

    CPT-0002U-POLYPDX-URINE-METABOLOMIC-ASSAY-ADENOMATOUS-POLYP-RISK

    CPT 0002U: PolypDX™ Urine Metabolomic Risk Assay

    CPT-0003U-OVAR-A-NEXT-GENERATION-OVARIAN-CANCER-RISK-ASSAY

    CPT 0003U: Overa (MIA2G) Ovarian Cancer Risk Assay

    CPT-0005U-PROSTATE-EXOSOMEDX-INTELLISCORE-GENE-EXPRESSION-URINE-TEST

    CPT 0005U: ExosomeDx Prostate (IntelliScore) urine gene expression test

    CPT-0007U-TOXPROTECT-URINE-DRUG-SCREEN-WITH-DNA-AUTHENTICATION

    CPT 0007U: ToxProtect Urine Drug Screen With DNA Authentication

    CPT-0008U-H-PYLORI-ANTIBIOTIC-RESISTANCE-SEQUENCING-PANEL

    CPT 0008U: H. pylori Antibiotic Resistance Gene Panel

    CPT-0009U-DEPARRAY-HER2-FISH-TUMOR-CELL-ISOLATION

    CPT 0009U: DEPArray HER2 Tumor‑Cell Isolation with FISH Analysis

    CPT-0010U-BACTERIAL-TYPING-WHOLE-GENOME-SEQUENCING-MAYO-CLINIC

    CPT 0010U: Bacterial Typing by Whole Genome Sequencing, Mayo Clinic

    CPT-0011U-CORDANT-CORE-ALGORITHMIC-ORAL-FLUID-DRUG-TEST

    CPT 0011U: Oral Fluid Drug Test with Algorithmic Steady‑State Comparison

    CPT-0016U-BCR-ABL1-MAJOR-MINOR-FUSION-TRANSCRIPT-TESTING

    CPT 0016U: BCR–ABL1 Major and Minor Breakpoint Fusion Transcripts

    Showing 1–10 of 536

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    Frequently Asked Questions

    References

    1. 1.CPT® Codes and Descriptions. AAPC. Retrieved Aug 11, 2026.Maintains the CPT code set's official descriptions and guidelines, licensed from the American Medical Association, used as the definitional source for CPT codes on this page.
    2. 2.HCPCS Quarterly Update. Centers for Medicare & Medicaid Services (CMS). Retrieved Aug 11, 2026.CMS's quarterly release of HCPCS Level II codes and short/long descriptors, the source for HCPCS code definitions and update history.
    3. 3.ICD-10-CM Full Code List. Centers for Medicare & Medicaid Services (CMS). Retrieved Aug 11, 2026.CMS's complete ICD-10-CM diagnosis code list, used to cross-reference diagnosis codes associated with this procedure or service.
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