Summary & Overview
CPT 0585U: Labcorp Plasma Complete cfDNA 521-Gene Solid Tumor Profile
CPT code 0585U designates a proprietary genomic profiling assay — Labcorp® Plasma Complete™ — that analyzes circulating cell–free DNA (cfDNA) from blood plasma to detect somatic alterations across 521 genes relevant to solid organ cancers. As a PLA code, 0585U is specific to a single manufacturer's test, signaling its role in precision oncology diagnostics and enabling payers and providers to identify and track utilization of this specific assay nationally. Key payers covered 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 services associated with CPT code 0585U, payer coverage context, and what to expect in terms of the test’s capabilities (sequence variants, amplifications, rearrangements, and microsatellite instability reporting). The publication outlines common billing modifiers associated with molecular lab services, typical sites of service, and notes where input data were unavailable. This material is intended to inform billing staff, policy analysts, and clinical leaders about the code’s clinical scope, payer landscape, and areas where further local policy verification may be required.
Billing Code Overview
CPT code 0585U is a Proprietary Laboratory Analyses (PLA) code that applies exclusively to Labcorp® Plasma Complete™ from Labcorp. The test evaluates circulating cell–free DNA (cfDNA) in a blood plasma sample to detect mutations related to solid organ cancers. It analyzes 521 genes to identify sequence variants, gene amplifications, rearrangements, and microsatellite instability, and the report highlights mutations with potential clinical actionability.
Service type: Proprietary laboratory molecular diagnostic test (cfDNA genomic profiling)
Typical site of service: Clinical laboratory or outpatient phlebotomy collection site
Clinical & Coding Specifications
Clinical Context
A typical patient is an adult with a known or suspected solid-organ malignancy who requires comprehensive circulating tumor DNA analysis to guide treatment selection, detect actionable genomic alterations, or to evaluate for minimal residual disease or resistance mutations. The clinician (medical oncologist or surgical oncologist) orders 0585U (Labcorp® Plasma Complete™) after initial tissue diagnosis, at disease progression, or when tissue biopsy is infeasible. A phlebotomy draw of peripheral blood is obtained in an outpatient infusion center, oncology clinic, or hospital laboratory. The sample is sent to the performing laboratory (Labcorp) for cfDNA extraction and next-generation sequencing of 521 genes to report sequence variants, copy number changes, gene rearrangements, and microsatellite instability. Results are returned to the ordering provider and incorporated into tumor board review or individual treatment planning, including selection of targeted therapies, clinical trial matching, or detection of emergent resistance alterations.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Default operator modifier used when no other modifier applies | Apply when submitting the PLA code 0585U with no special circumstances requiring modifier reporting |