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    v1.0.31
    OpenPayerBilling CodesProprietary Laboratory AnalysesCPT cpt-0398u-esopredict-barretts-esophagus-risk-assay
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    CPT 0398U: ESOPREDICT® Barrett’s Esophagus Risk Classifier Assay

    CPT code 0398U is a Proprietary Laboratory Analyses (PLA) test for the ESOPREDICT® Barrett’s Esophagus Risk Classifier Assay by Capsulomics Inc. d/b/a Previse that assesses methylation status of specified genes from esophageal cells obtained from a formalin–fixed paraffin–embedded (FFPE) biopsy specimen and uses an algorithmic analysis to report a risk score for progression to high-grade dysplasia or esophageal cancer; service type: laboratory molecular diagnostic assay; typical site of service: clinical laboratory or pathology/lab associated with endoscopic biopsy processing.

    For related coverage guidance, see recent payer policy updates: Minimal Residual Disease (MRD) Testing for Cancer, Biomarker Testing Mandate, Prenatal (Fetal) Diagnostic Testing.

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    Clinical & Coding Specifications

    Clinical Context

    A 58-year-old patient with a long-standing history of gastroesophageal reflux disease (GERD) undergoes endoscopic surveillance after prior biopsy-proven Barrett’s esophagus. An endoscopic biopsy of the distal esophagus is fixed in formalin and embedded in paraffin (FFPE) by the pathology lab. Tissue sections are sent to a CAP/CLIA-certified reference laboratory performing the ESOPREDICT® Barrett’s Esophagus Risk Classifier Assay (0398U). The laboratory performs methylation analysis on targeted genes from the FFPE specimen and runs an algorithmic risk model to generate a risk score for progression to high-grade dysplasia or esophageal adenocarcinoma. Results are transmitted to the ordering gastroenterologist and incorporated into the patient’s longitudinal risk stratification and surveillance planning. Typical sites of service include ambulatory surgery centers, hospital outpatient departments, and independent clinical laboratories that receive FFPE biopsy specimens. The service type is laboratory-based molecular diagnostic testing performed by a proprietary assay; the specimen collection was performed during an upper endoscopy by a gastroenterology provider and the analytic testing and reporting are performed by the manufacturer-specific laboratory.

    Related CPT Codes

    CPT CodeDescriptionRelationship to This Procedure
    43235Esophagogastroduodenoscopy, flexible, transoral; diagnostic, with or without collection of specimen by brushing or washingPerforms diagnostic upper endoscopy and may include biopsy collection that yields the FFPE specimen used for 0398U.
    43239Esophagogastroduodenoscopy with biopsy, single or multipleCommon procedural code for obtaining mucosal biopsies of the esophagus; provides the tissue required for the methylation assay reported with 0398U.
    88305Level IV surgical pathology, gross and microscopic examinationInitial histopathologic evaluation of the endoscopic biopsy; often accompanies the workflow prior to sending tissue for specialized molecular testing.
    88172Cytopathology, smears, or other preparatory procedures for cytologic examination (when applicable)Used if additional cytology preparations are performed from biopsy or brushings prior to molecular testing.
    86152Antibody or antigens; immunoassay for tumor markers (example)Represents ancillary laboratory testing that may be ordered in parallel; not specific to methylation assay but may appear in the diagnostic workup.

    Related Modifiers

    7 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…
    22Modifier –22 (Increased Procedural Services) is used when a reported procedure is substantially more extensive than normally required. The CPT Manual and CMS state it may be appended only when the…- When to use: Append modifier -22 to a procedural CPT code when the service performed is substantially more extensive than the usual service described by that code — i.e., the procedure required…
    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…
    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…

    Related Provider Taxonomies

    8 rows

    Taxonomy Code
    208000000X
    207L00000X
    363L00000X
    163WW0000X
    207QP0002X
    310500000X
    2080I0007X
    207RC0200X

    Related Payer Policy Updates

    Specialty: Genetic & Molecular Testing1 / 3

    10 rows

    PolicyPayerEffective Date
    Minimal Residual Disease (MRD) Testing for Cancerregence2027-01-01
    Biomarker Testing MandateBlue Cross Blue Shield - Rhode Island2027-01-01
    Prenatal (Fetal) Diagnostic TestingBlue Cross Blue Shield - Rhode Island2027-01-01
    Oral Cancer Screening and TestingOscar Health2027-01-01
    RTM Testing for Alpha-1 Antitrypsin DeficiencyOscar Health2027-01-01
    Cytochrome P450 Genotype-Guided Treatment Strategy Corporate Medical Policybcbsvermont2027-01-01
    Polygenic Risk ScoreBlue Cross Blue Shield - Rhode Island2026-12-01
    Gene Expression Profiling for Cutaneous MelanomaBlue Cross Blue Shield - Rhode Island2026-12-01
    Genetic Testing for Macular Degenerationregence2026-11-01
    Pharmacogenetic Panel Testing (for Ohio Only)Colorado Rocky Mountain Health Plans2026-11-01

    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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