Summary & Overview
CPT 0558U: IGoCheck™ BF7 ELISA for Colorectal Cancer Monitoring
CPT code 0558U is a Proprietary Laboratory Analyses (PLA) code assigned specifically to IGoCheck™, a blood-based ELISA that quantifies the BF7 antigen to monitor colorectal cancer response to therapy. As a PLA code, 0558U applies only to the single manufacturer and test indicated, which matters for coverage, billing clarity, and claims processing nationwide. Its designation signals a unique, proprietary diagnostic tool rather than a generic assay.
Major national payers considered in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find an overview of clinical context for serial biomarker monitoring in colorectal cancer, the laboratory service setting and typical use cases for this ELISA, and practical billing considerations tied to a PLA code. The publication summarizes benchmark information where available, outlines payer coverage themes, and flags policy or coding issues relevant to proprietary laboratory tests. It is intended to inform clinical program managers, laboratory billing teams, and policy analysts about the clinical purpose of the test, payer landscape, and the types of documentation and coding attention PLA codes commonly require.
Data not available in the input for specific modifiers, taxonomies, ICD-10 pairings, and related codes.
Billing Code Overview
CPT code 0558U is a Proprietary Laboratory Analyses (PLA) code for the IGoCheck™ test from Milagen Inc. The test is a blood-based enzyme-linked immunosorbent assay (ELISA) that measures the BF7 antigen protein level in patient serum. Results are used to assess colorectal cancer response to therapy and to detect signs of progression or regression.
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Service type: Laboratory biomarker assay for oncology monitoring
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Typical site of service: Clinical laboratory or hospital laboratory with blood draw performed in an outpatient clinic, phlebotomy center, or hospital outpatient setting
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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.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Default/No modifier | Use when no specific reporting modifier is applicable and full service is provided. |