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.
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 |