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    OpenPayerBilling CodesProprietary Laboratory AnalysesCPT cpt-0558u-igocheck-bf7-elisa-colorectal-cancer-monitoring
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    CPT 0558U: Serum BF7 Antigen ELISA for Colorectal Cancer

    CPT code 0558U is a Proprietary Laboratory Analyses (PLA) code for the IGoCheck™ test from Milagen Inc., a blood-based enzyme-linked immunosorbent assay (ELISA) that measures serum BF7 antigen to assess colorectal cancer response or progression; this laboratory diagnostic service is performed by the manufacturer’s designated laboratory and is typically billed as an outpatient clinical laboratory service with specimen collection occurring in ambulatory clinics or phlebotomy centers.

    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 62-year-old patient with a history of stage II colorectal adenocarcinoma undergoing systemic therapy presents for routine surveillance. The oncology clinic orders the proprietary blood-based assay IGoCheck™ (0558U) to measure serum BF7 antigen levels via ELISA to assess tumor response to current therapy and to detect biochemical signs of progression. A venipuncture is performed in the outpatient oncology infusion center or hospital outpatient lab; serum is processed per the test kit instructions and sent to Milagen Inc. (or the designated performing laboratory). Results are reported as quantitative BF7 antigen concentration with interpretive comments indicating rising, stable, or falling levels to inform the treating oncologist’s assessment of response to therapy. Typical workflow steps: order placed by oncologist, specimen collection in outpatient infusion center or clinical laboratory, specimen processing and shipment to the performing lab, assay run by the proprietary laboratory, and report routed back to the ordering provider for integration into treatment planning.

    Related CPT Codes

    CPT CodeDescriptionRelationship to This Procedure
    36415Collection of venous blood by venipunctureVenous blood collection commonly performed prior to sending serum for the 0558U assay.
    80053Comprehensive metabolic panelRoutine concurrent chemistry testing often ordered alongside tumor marker monitoring for overall clinical assessment.
    86304Antibody; qualitative or semi-quantitativeRepresents immunoassay methodology; 0558U uses ELISA immunoassay techniques for BF7 antigen measurement (note: 0558U is a PLA code for the specific proprietary assay).
    88360Immunohistochemistry; initial single antibody stainMay be used in tissue-based correlated testing when tissue pathology is re-evaluated in parallel with serum markers.
    G0338Oncology care coordination (example of supportive services)Represents related oncology management services that contextualize laboratory surveillance results in care planning.

    Related Modifiers

    8 rows

    ModifierDescriptionWhen to Use
    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…
    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…
    91Modifier 91 — “Repeat Clinical Diagnostic Laboratory Test” — is appended when the exact same CPT laboratory test is performed more than once for the same patient on the same day because serial,…- Use modifier 91 when the exact same CPT laboratory test is performed more than once on the same patient on the same date because serial or repeated testing is medically necessary to monitor…

    Related Provider Taxonomies

    8 rows

    Taxonomy Code
    207R00000X
    207L00000X
    207Q00000X
    363LF0000X
    225400000X
    2086S0102X
    3418M1130X
    363LP0200X

    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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