CPT 0163U: BeScreened–CRC Blood Immunoassay for Colorectal Cancer Risk

CPT code 0163U denotes a Proprietary Laboratory Analyses (PLA) test — the BeScreened™–CRC assay from Beacon Biomedical Inc. The blood-based immunoassay measures proteins TDGF‑1, CEA, and ECM and uses a proprietary algorithm to generate a positive/negative result estimating colorectal cancer (CRC) risk and the potential need for colonoscopy. As a PLA code, 0163U applies to a single manufacturer’s test and is used for claims and policy determinations specific to that proprietary assay.

Key payers in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a national overview of the code’s clinical purpose, typical sites of service, and the service type. The publication summarizes how payers approach coverage and reimbursement for PLA-designated laboratory tests, highlights typical billing considerations and common modifiers used in practice, and provides clinical context on the role of blood-based immunoassays in CRC screening pathways. This summary is intended to inform coding, billing, and payer policy discussions relevant to adoption and claims processing of the BeScreened™–CRC assay under CPT code 0163U.

Billing Code Overview

CPT code 0163U is a Proprietary Laboratory Analyses (PLA) code for the BeScreened™–CRC test produced by Beacon Biomedical Inc. The test is an immunoassay performed on a blood sample that measures proteins TDGF‑1, CEA, and ECM, and applies an algorithm to report a positive or negative result indicating the likelihood of colorectal cancer (CRC) and the potential need for colonoscopy.

Service type: Laboratory — Proprietary molecular/immunoassay with algorithmic interpretation

Typical site of service: Clinical laboratory or outpatient phlebotomy collection site

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Clinical Context

A 58-year-old asymptomatic patient presents to their primary care clinic for routine preventive care and is due for colorectal cancer screening but prefers a blood-based option. The clinician orders the BeScreened™–CRC immunoassay (PLA code 0163U) from Beacon Biomedical Inc. Blood is drawn at an outpatient laboratory or ambulatory clinic (typical site of service: outpatient laboratory or physician office draw). The specimen is sent to the performing laboratory that runs the proprietary immunoassay measuring TDGF‑1, CEA, and ECM protein levels and applies the vendor algorithm to generate a positive or negative result indicating likelihood of colorectal cancer and recommendation for colonoscopy if positive. Results are reviewed by the ordering clinician; a positive result prompts referral to gastroenterology for diagnostic colonoscopy and possible biopsy, while a negative result may lead to continued routine screening per guideline intervals. Billing for the test uses PLA code 0163U and may include anatomic or technical/professional component modifiers if applicable to the billing arrangement.

Coding Specifications

Modifier	Description	When to Use
`26`	Professional component	Use when only the professional interpretation component is billed separately by the physician or pathologist reviewing results.

Taxonomy Code	Specialty	Notes
208000000X	Family Medicine	Ordering and longitudinal follow-up for primary care colorectal cancer screening.
207Q00000X	Internal Medicine	Primary care internists commonly order screening tests and manage results.
207L00000X	Gastroenterology	Specialist receiving positive results and performing diagnostic colonoscopy and biopsy.
213E00000X	Pathology	Pathologists may provide consultative interpretation when laboratory testing requires clinical interpretation.
363LF0000X	Clinical Laboratory	Performing laboratory personnel and laboratory director roles for test performance and billing.

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`Z12.11`	Encounter for screening for malignant neoplasm of colon	Standard screening indication for ordering a blood-based colorectal cancer screening test such as `0163U`.
`Z12.12`	Encounter for screening for malignant neoplasm of rectum	Alternate screening encounter code when screening focuses on rectal neoplasm detection.
`R19.5`	Other fecal abnormalities	May prompt additional noninvasive screening or alternative testing strategies in patients with stool abnormalities.
`R19.4`	Change in bowel habit	Symptom that may lead a clinician to order a diagnostic CRC screen despite being a blood-based assay typically used for screening.
`K50.90`	Crohn's disease, unspecified, without complications	Inflammatory bowel disease patients are higher risk and may have different screening pathways; positive blood-based tests may prompt endoscopic evaluation.
`K51.90`	Ulcerative colitis, unspecified, without complications	Similar to Crohn's, indicates increased colorectal cancer surveillance and may influence follow-up after `0163U` results.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`0163U`	BeScreened™–CRC immunoassay (proprietary PLA) measuring TDGF‑1, CEA, ECM with algorithmic result for CRC likelihood	Primary billed test described; reports positive/negative result indicating need for colonoscopy.
`88305`	Level IV pathology; surgical pathology, gross and microscopic examination	May be used for diagnostic tissue evaluation if colonoscopy with biopsy follows a positive `0163U` result.
`45378`	Colonoscopy, flexible; diagnostic, with or without collection of specimen(s) by brushing or washing	Common diagnostic procedure performed after a positive blood-based CRC screen.
`88307`	Surgical pathology, gross and microscopic examination for partial or total organ; more complex specimens	Used for more complex colorectal specimens requiring detailed pathology after biopsy or resection.
`83036`	Hemoglobin; glycosylated (A1C) - example of common lab workflow code (not directly related)	Represents common lab testing performed during preventive visits; not specific to CRC screening but sometimes ordered same encounter.
`G0105`	Colorectal cancer screening; colonoscopy on high risk patient (Medicare)	May be relevant in workflow when scheduling screening colonoscopy for higher-risk patients identified after positive `0163U` test.

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Summary & Overview