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    v1.0.31
    OpenPayerBilling CodesProprietary Laboratory AnalysesCPT cpt-0101u-colon-cancer-17-gene-sequencing-panel-colonext
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    CPT 0101U: ColoNext® 17-Gene Hereditary Colon Cancer Panel

    CPT code 0101U is a Proprietary Laboratory Analyses (PLA) code for the ColoNext® test from Ambry Genetics®, a genomic sequencing panel that analyzes 17 genes associated with hereditary colon cancer disorders; the service is a targeted germline genomic sequencing analysis performed by a proprietary laboratory, typically provided as a diagnostic and hereditary risk assessment service in outpatient, clinical laboratory, or genetic counseling settings.

    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 typical patient is an adult with a personal or family history suggestive of hereditary colorectal cancer syndrome (for example, early-onset colorectal cancer, multiple colorectal adenomas, or a known pathogenic variant in a first-degree relative). A colorectal surgeon, gastroenterologist, or genetic counselor orders the ColoNext® genomic sequencing panel to evaluate germline variants across 17 genes associated with hereditary colon cancer (e.g., APC, MLH1, MSH2, MSH6, PMS2, EPCAM). A phlebotomy encounter or saliva kit collection is performed in an outpatient clinic, hospital outpatient laboratory, or genetics laboratory where the specimen is shipped to Ambry Genetics® for testing. Results are returned to the ordering clinician; a genetic counselor typically reviews positive or uncertain results with the patient to discuss implications for surveillance, cascade testing of relatives, and potential referral for surgical or medical management. Billing is submitted under Proprietary Laboratory Analyses code 0101U with applicable modifiers to indicate component, provider, or unusual circumstances.

    Related CPT Codes

    CPT CodeDescriptionRelationship to This Procedure
    0101UColoNext®; genomic sequencing panel for 17 genes associated with hereditary colon cancerPrimary Proprietary Laboratory Analysis code for this test.
    84163Beta‑2‑microglobulin; blood testMay be ordered as part of an oncologic laboratory workup in parallel with genetic risk assessment.
    88360Morphometric analysis; tumor cell percentage estimationMay be performed on tumor tissue when somatic testing or tumor profiling is considered alongside germline testing.
    36415Collection of venous blood by venipunctureFrequently performed to obtain the specimen sent to the reference laboratory for 0101U.
    99000Handling and/or conveyance of specimen for transfer from patient to lab (historical/unlisted)May apply where additional specimen handling or transport services are billed; local payer rules determine acceptability.

    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…
    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…
    76Modifier -76, Repeat Procedure or Service by Same Physician or Other Qualified Health Care Professional, is appended when the same provider performs an identical, medically necessary procedure or…- Use modifier -76 when the same physician or other qualified health care professional performs an identical procedure or service a second (or subsequent) time on the same date of service and the…
    77Modifier 77 indicates that a previously performed procedure or service was legitimately repeated by a different physician or other qualified health care professional. The AMA’s CPT definition…- Use modifier 77 when a basic procedure or service already performed is repeated by a different physician or other qualified health care professional (for example, a second provider independently…
    90Modifier ‑90 (Reference/Outside Laboratory) indicates that a laboratory test was performed by an entity other than the treating or reporting provider. The American Medical Association defines…- Use CPT modifier -90 when a laboratory test is performed by an outside/reference laboratory (an entity other than the treating or reporting physician or qualified professional) and the claim needs…

    Related Provider Taxonomies

    8 rows

    Taxonomy Code
    207L00000X
    207K00000X
    2080P0206X
    208D00000X
    367A00000X
    207QS1201X
    173C00000X
    207WX0110X

    Related ICD-10-CM Codes

    26 rows

    ICD-10-CM CodeDescription
    C18.9Malignant neoplasm of colon, unspecified
    C19Malignant neoplasm of rectosigmoid junction
    C20Malignant neoplasm of rectum
    D12.0Benign neoplasm of cecum
    D12.2Benign neoplasm of ascending colon
    D12.6Benign neoplasm of colon, unspecified
    E78.5Hyperlipidemia, unspecified
    K50.90Crohn's disease, unspecified, without complications
    K51.90Ulcerative colitis, unspecified, without complications
    K57.30Diverticulosis of large intestine without perforation or abscess without bleeding

    Showing 1–10 of 26

    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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