CPT 0334U Guardant360 TissueNext Reimbursement | OpenPayer

Summary & Overview

CPT 0334U: Guardant360 TissueNext NGS Tumor DNA Profiling

CPT code 0334U denotes a proprietary next-generation sequencing (NGS) tumor profiling test — Guardant360 TissueNext™ — designed to evaluate DNA from formalin-fixed paraffin-embedded (FFPE) solid tumor tissue across 84+ genes for structural variants and other actionable mutations. As a PLA code, 0334U is unique to a single manufacturer's test and identifies a high-complexity genomic assay that can influence oncology treatment selection and precision medicine workflows nationally. Key payers reviewed include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise explanation of the clinical scope of the test, typical sites of service, and the billing context for a PLA-designated CPT code. The publication also presents benchmarks for coverage and reimbursement policy where available, summarizes payer policy themes relevant to proprietary NGS tumor assays, and outlines the clinical context linking comprehensive tumor DNA profiling to treatment decision-making. Data not available in the input for associated taxonomies, specific ICD-10 diagnoses, and related service-line coding are noted as unavailable in corresponding sections.

AetnaBlue Cross Blue ShieldCigna HealthUnitedHealthcareMedicare0334UCPTProprietary Laboratory AnalysesNGStumor profilingoncologyFFPEgenomic testingprecision medicine

Billing Code Overview

CPT code 0334U is a Proprietary Laboratory Analyses (PLA) code that applies exclusively to the Guardant360 TissueNext™ test from Guardant Health Inc. The test uses next-generation sequencing (NGS) to analyze formalin-fixed paraffin-embedded (FFPE) solid tumor tissue for DNA alterations across 84 or more genes, including structural variants and other genomic changes that may inform treatment decisions.

Service type: Laboratory — NGS-based tumor genomic profiling

Typical site of service: Clinical laboratory or hospital outpatient pathology/laboratory setting, where FFPE tumor tissue specimens are processed for DNA sequencing.

Clinical & Coding Specifications

Clinical Context

A 62-year-old patient with a newly diagnosed metastatic non-small cell lung carcinoma (NSCLC) undergoes tissue-based comprehensive genomic profiling to guide targeted therapy selection. A formalin-fixed paraffin-embedded (FFPE) tumor block from a core needle biopsy of the lung mass is submitted to a reference laboratory for Guardant360 TissueNext™ testing. The clinical workflow includes: initial oncology consultation and indication for molecular profiling, pathology confirmation of adequate tumor content and specimen processing (FFPE), test requisition and consent for proprietary laboratory analysis, shipment of the specimen to Guardant Health, laboratory NGS processing and analysis of ≥84 cancer-related genes for single-nucleotide variants, insertions/deletions, copy number alterations, structural variants and tumor mutation burden, and delivery of a clinical report to the treating oncologist. Results inform targeted therapy selection, clinical trial eligibility, and potential companion diagnostic interpretation. Typical site of service is an outpatient hospital or independent pathology/laboratory setting where surgical pathology and specimen handling occur; billing is for a laboratory-based PLA test rather than a physician-performed procedure.

Coding Specifications

Modifier	Description	When to Use
`00`	Default/No modifier required	Used when no specific modifier applies to the laboratory test billing.

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Taxonomy Code	Specialty	Notes
2085R0200X	Clinical Pathology	Pathologists oversee test interpretation and sign-out.
207L00000X	Molecular Genetic Pathology	Laboratory specialists performing NGS assay design, validation, and interpretation.
207Q00000X	Medical Oncology	Ordering clinicians who use results for systemic therapy decisions.
363L00000X	Clinical Laboratory	Laboratory directors and managers responsible for test processing and CLIA compliance.
208800000X	Anatomic Pathology	Anatomic pathologists responsible for specimen adequacy assessment and FFPE block preparation.

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`C34.90`	Malignant neoplasm of unspecified part of unspecified bronchus or lung	Common indication for comprehensive tumor genomic profiling to identify actionable mutations in lung cancer.
`C50.911`	Malignant neoplasm of unspecified site of right female breast	Breast cancers may undergo NGS profiling for targeted therapy selection and clinical trial eligibility.
`C71.9`	Malignant neoplasm of brain, unspecified	Brain tumor specimens may be profiled to detect actionable alterations where tissue is available.
`C78.7`	Secondary malignant neoplasm of liver and intrahepatic bile duct	Metastatic lesions often profiled when primary tumor genotype is unknown or to guide treatment of metastases.
`C80.1`	Malignant (primary) neoplasm, unspecified	Used when a malignancy requires broad genomic profiling but primary site or histology is not fully specified.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`88305`	Level IV surgical pathology, gross and microscopic examination	Performed by pathology to evaluate the tissue specimen, ensure tumor is present, and prepare FFPE blocks prior to NGS testing.
`88342`	Immunohistochemistry, each separate antigen antibody stain	May be performed as ancillary testing to characterize tumor subtype prior to or alongside molecular profiling.
`88360`	Morphometric analysis (e.g., percent tumor nuclei)	Used to document tumor cellularity in the FFPE specimen to confirm adequacy for NGS testing.
`88172`	Cytopathology, cell block, using immunocytochemistry (when applicable)	Applied when cytology specimens are processed as cell blocks and forwarded for molecular testing.
`G0480`	Molecular pathology procedure level 8 (or local molecular pathology codes where applicable)	Represents alternate molecular testing codes that may be billed when institution-performed broad NGS panels are used in conjunction with or instead of a proprietary PLA test.
`99600`	Specimen handling/transportation (institution-specific ancillary code)	Billed in some institutional settings to capture special handling or shipping of high-complexity specimens to reference labs.

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