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 |
22 | Increased procedural services | Use when the laboratory provides additional, separately billable analytic or interpretive work beyond the typical scope documented and supported by medical record |
52 | Reduced services | Use when the test is partially completed or only a subset of the usual assay was performed and documented |
53 | Discontinued procedure | Use if specimen collection or testing was started but aborted and billing reflects a discontinued service, with documentation |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
| 208000000X | Hematology & Oncology | Medical oncologists frequently order cfDNA testing for systemic treatment decisions |
| 207Q00000X | Surgical Oncology | Surgical oncologists may order testing when planning resection or when tissue is limited |
| 261QA1900X | Clinical Laboratory | Pathology/laboratory physicians oversee test performance and interpretation |
| 207L00000X | Radiation Oncology | Radiation oncologists may use results for multidisciplinary planning |
| 363LP0800X | Molecular Genetics | Molecular geneticists or genetic counselors may be involved in result interpretation and counseling |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
C50.919 | Malignant neoplasm of unspecified site of right female breast | Breast cancer patients commonly undergo cfDNA testing to detect actionable alterations or resistance mutations |
C34.90 | Malignant neoplasm of unspecified part of unspecified bronchus or lung | Lung cancer is a frequent indication for broad cfDNA panels to identify EGFR, ALK, ROS1, and other targetable alterations |
C18.9 | Malignant neoplasm of colon, unspecified | Colorectal cancers may be evaluated for microsatellite instability and actionable mutations via plasma cfDNA |
C16.9 | Malignant neoplasm of stomach, unspecified | Gastrointestinal malignancies utilize cfDNA panels for identification of targetable alterations when tissue is limited |
C71.9 | Malignant neoplasm of brain, unspecified | CNS tumor patients with extracranial metastatic disease or when tissue biopsy poses high risk may have plasma cfDNA testing considered |
C80.1 | Malignant (primary) neoplasm, unspecified | Used when a solid organ malignancy is suspected but primary site or histology is not yet fully specified |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
36415 | Collection of venous blood by venipuncture | Commonly performed immediately prior to sending a blood sample for 0585U cfDNA testing |
88381 | In situ hybridization (per specimen) | May be used on tissue specimens as a complementary test to clarify gene rearrangements identified in plasma cfDNA |
81225 | Tumor profiling by sequencing; KRAS (this represents an example somatic gene test) | Targeted tissue or blood-based gene tests are often ordered in conjunction with broad NGS panels like 0585U for confirmation or insurance requirements |
G0452 | Pharmacogenomic testing for therapeutic decision making (example) | Other molecular or genomic tests for therapy guidance commonly appear in the workflow around plasma-based NGS testing |