Summary & Overview

CPT 0368U: ColoScape cfDNA qPCR Panel for Colorectal Cancer Risk

CPT code 0368U identifies ColoScapeTM, a proprietary plasma-based molecular diagnostic from DiaCarta that analyzes circulating cell–free DNA (cfDNA) by quantitative PCR to detect eight gene mutations and seven methylation markers and returns an algorithmic risk score for colorectal cancer or advanced adenoma. As a PLA code, 0368U is specific to a single manufacturer and test and therefore has direct implications for lab billing, payer coverage policies, and precision oncology workflows nationwide. Major payers considered in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise overview of the clinical purpose and laboratory workflow for the test, a summary of payer coverage considerations and common billing modifiers, and benchmarks for coding and billing practice where available. The publication also outlines clinical context for cfDNA-based colorectal cancer screening and surveillance, plus practical notes on typical site-of-service and specimen requirements. Data not available in the input are identified as such elsewhere in the document.

AetnaBlue Cross Blue ShieldCigna HealthUnitedHealthcareMedicare0368UCPTProprietary Laboratory AnalysescfDNAcolorectal cancer screeningmolecular diagnosticsqPCRalgorithmic risk scorelaboratory billing

Billing Code Overview

CPT code 0368U is a Proprietary Laboratory Analyses (PLA) code that applies exclusively to the ColoScapeTM test from DiaCarta Clinical Lab, DiaCarta Inc. The assay evaluates a plasma specimen using quantitative polymerase chain reaction (qPCR) to detect eight gene mutations and seven gene methylation markers from circulating cell–free DNA (cfDNA). Results are processed through an algorithmic analysis that reports a risk score for colorectal cancer or advanced adenoma.

Service Type: Laboratory molecular diagnostic test — cfDNA qPCR panel with algorithmic risk scoring

Typical Site of Service: Clinical diagnostic laboratory or reference lab processing a blood (plasma) specimen

Clinical & Coding Specifications

Clinical Context

A 62-year-old average-risk patient presents to a primary care clinic for colorectal cancer screening discussion. The patient declined colonoscopy and stool-based testing or has had incomplete colonoscopy due to poor prep. The clinician orders a plasma-based molecular screening test, ColoScape™ (0368U), to evaluate circulating cell–free DNA (cfDNA) for eight gene mutations and seven methylation markers. A phlebotomy appointment at an outpatient laboratory or hospital outpatient facility is scheduled; a blood specimen (plasma) is collected, processed, and sent to DiaCarta Clinical Lab, DiaCarta Inc. The laboratory performs quantitative polymerase chain reaction (qPCR) analysis and runs an algorithmic risk score to report the likelihood of colorectal cancer or advanced adenoma. Results are returned to the ordering clinician, who integrates the risk score with clinical history to determine need for diagnostic colonoscopy or surveillance planning.

Coding Specifications

Modifier	Description	When to Use
`00`	Modifier not otherwise specified (placeholder)	Use per payer or internal reporting when a specific modifier is required by the billing system and no other modifier applies.
`22`

Taxonomy Code	Specialty	Notes
207Q00000X	Clinical Molecular Genetics Laboratory	Laboratories performing molecular diagnostic testing and interpretation for cfDNA assays.
208D00000X	Pathology	Pathologists overseeing molecular testing, result validation, and clinical reporting.
261QM0800X	General Internal Medicine	Ordering clinicians who manage screening and follow-up for colorectal cancer risk.
207L00000X	Clinical Laboratory	Facilities and laboratories responsible for specimen processing and qPCR analysis.
207S00000X	Anatomic and Clinical Pathology	Specialists involved in laboratory oversight and quality control of diagnostic assays.

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`Z12.11`	Encounter for screening for malignant neoplasm of colon	Common indication for ordering `0368U` as a colorectal cancer screening option.
`Z80.0`	Family history of malignant neoplasm of digestive organs	Family history prompting earlier or alternative screening strategies including cfDNA testing.
`K57.30`	Diverticulosis of large intestine without perforation or abscess	Gastrointestinal conditions that may complicate colonoscopy and lead clinicians to consider alternative noninvasive tests like `0368U`.
`K92.2`	Gastrointestinal hemorrhage, unspecified	Symptom prompting evaluation for colorectal pathology; cfDNA testing may be used adjunctively but diagnostic colonoscopy is standard.
`R19.5`	Other fecal abnormalities	Abnormal stool findings that may lead to further noninvasive molecular screening prior to colonoscopy.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`36415`	Collection of venous blood by venipuncture	Performed to obtain the plasma specimen used for the `0368U` cfDNA assay.
`84153`	Prostate specific antigen (PSA); total	Not directly related; included as an example of other single-analyte tumor screening labs occasionally ordered in preventive care workflows.
`G0463`	Hospital outpatient clinic visit for primary care services	Represents the clinic visit where screening options and order for `0368U` may be placed.
`88342`	Immunohistochemistry or special stains, per specimen; initial multiplex	May be performed on tissue if `0368U` risk score leads to diagnostic colonoscopy with biopsy and subsequent pathology testing.
`81599`	Unlisted multianalyte algorithmic pathology test	Alternative reporting pathway when no PLA or specific code exists; not used when `0368U` is reported for ColoScape™.