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    v1.0.31
    OpenPayerBilling CodesProprietary Laboratory AnalysesCPT cpt-0313u-pancreas-genomic-classifier-pancreaseq
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    CPT 0313U: PancreaSeq® Pancreatic Cyst Genomic Classifier

    CPT code 0313U is a Proprietary Laboratory Analyses (PLA) test for the PancreaSeq® Genomic Classifier from the University of Pittsburgh Medical Center Molecular and Genomic Pathology Laboratory that uses next-generation sequencing (NGS) of 74 genes plus gene expression (CEACAM5/CEA) analysis on pancreatic cyst fluid to generate an algorithmic probability score of low or high risk that a cyst harbors neoplastic genetic changes; service type: molecular pathology/genomic classifier testing; typical site of service: outpatient laboratory or hospital-based molecular diagnostics laboratory associated with specimen collection from image-identified pancreatic cysts.

    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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    Table of contents

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    Clinical & Coding Specifications

    Clinical Context

    A 58-year-old patient is referred to a gastroenterologist after cross-sectional imaging (CT or MRI) identifies a pancreatic cyst. The cyst is asymptomatic but has worrisome features such as a size >2 cm, a solid component, or a dilated main pancreatic duct. Endoscopic ultrasound (EUS) with fine-needle aspiration (FNA) is performed to obtain cyst fluid. Fluid is sent to the University of Pittsburgh Medical Center Molecular and Genomic Pathology Laboratory for the PancreaSeq® Genomic Classifier. The laboratory performs next-generation sequencing (NGS) of 74 genes plus measurement of carcinoembryonic antigen (CEA/CEACAM5) RNA expression and applies an algorithm to generate a probability score indicating low (negative) or high (positive) likelihood that the cyst harbors high-risk molecular alterations. Results are used by the multidisciplinary team (gastroenterology, surgery, and pathology) to support surveillance versus surgical resection decisions. Typical sites of service include outpatient endoscopy centers, hospital-based endoscopy suites, and reference molecular pathology laboratories. Specimen handling includes secure transport of cyst fluid, documented chain-of-custody, and laboratory accessioning under the specific proprietary test name PancreaSeq®.

    Related CPT Codes

    CPT CodeDescriptionRelationship to This Procedure
    0313UPancreaSeq® Genomic Classifier—NGS of 74 genes plus CEA RNA expression, algorithmic probability scoreProprietary test itself; bill when PancreaSeq® is performed by the University of Pittsburgh Medical Center Molecular and Genomic Pathology Laboratory
    43238Endoscopic ultrasound, with FNA; with single or multiple passesPerformed to obtain pancreatic cyst fluid that is submitted for PancreaSeq® testing
    47562Laparoscopic distal pancreatectomy with or without splenectomySurgical procedure that may be performed if PancreaSeq® indicates high probability of malignant transformation
    88342Immunohistochemistry or special interpretation, if applicableMay be billed when ancillary tissue-based markers are assessed in conjunction with molecular testing
    81479Unlisted molecular pathology procedureOccasionally used when specific PLA code is not applicable or additional molecular testing not covered by 0313U is required

    Related Modifiers

    11 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…
    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…
    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…
    59Modifier 59 indicates a distinct procedural service when two procedures that are not normally billed together are clinically and procedurally separate. The CPT definition (as reiterated by CMS)…- Use modifier -59 to report a distinct procedural service when documentation supports that the procedure reported is not normally billed together with another service on the same day because of a…
    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…
    23Modifier -23 (Unusual Anesthesia) is used on anesthesia service CPT codes when a procedure that normally requires no anesthesia or only local anesthesia must be performed under general anesthesia…- Use modifier -23 only on anesthesia CPT codes (00100–01999) when a procedure that normally requires no anesthesia or only local anesthesia must be performed under general anesthesia because of…

    Showing 1–10 of 11

    Related Provider Taxonomies

    8 rows

    Taxonomy Code
    207P00000X
    208000000X
    207RH0000X
    207Q00000X
    224ZR0403X
    3104A0625X
    2471Q0001X
    173C00000X

    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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