Summary & Overview

CPT 0245U: ThyGeNEXT® Thyroid Oncogene Panel, NGS Molecular Test

CPT code 0245U designates the ThyGeNEXT® Thyroid Oncogene Panel, a proprietary molecular diagnostic assay that uses next generation sequencing (NGS) and RNA expression analysis to evaluate indeterminate thyroid fine needle aspiration (FNA) specimens for malignancy risk. As a PLA code, 0245U maps to a single manufacturer-specific test by Interpace Diagnostics and is used to capture reporting and reimbursement for this specific thyroid oncogene panel nationally.

Key payers covered in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. The publication summarizes coverage landscape and coding considerations for these major national payers and Medicare, highlighting how proprietary PLA codes are documented and billed across commercial and federal programs.

Readers will learn the clinical context for use of the panel, the service setting and specimen pathway, and what the code represents operationally. The report outlines expected benchmarks for code adoption, typical laboratory and site-of-service workflows, and policy considerations relevant to proprietary molecular tests. Data not available in the input is noted where applicable.

AetnaBlue Cross Blue ShieldCigna HealthUnitedHealthcareMedicare0245UCPTProprietary Laboratory AnalysesMolecular DiagnosticsThyroid FNANext Generation SequencingOncogene PanelLaboratory TestPLA

Billing Code Overview

CPT code 0245U is a Proprietary Laboratory Analyses (PLA) code that describes the ThyGeNEXT® Thyroid Oncogene Panel by Interpace Diagnostics. The test uses next generation sequencing (NGS) to analyze 10 genes, detect 37 RNA fusions, and measure expression of four mRNA markers to evaluate the risk that an indeterminate thyroid fine needle aspiration (FNA) specimen is malignant.

Service type: Molecular diagnostic laboratory test using next generation sequencing (NGS) and RNA expression analysis
Typical site of service: Clinical laboratory processing specimens collected from outpatient or ambulatory settings, typically following a thyroid fine needle aspiration (FNA)

Clinical & Coding Specifications

Clinical Context

A 48-year-old woman presents with a thyroid nodule found on routine neck palpation and confirmed by ultrasound. Fine needle aspiration (FNA) cytology yields an indeterminate result (e.g., Bethesda III or IV) where malignancy cannot be excluded. Her endocrinologist orders molecular testing using ThyGeNEXT® Thyroid Oncogene Panel to clarify malignancy risk and guide management between surveillance, repeat FNA, or diagnostic lobectomy. The specimen is prepared from residual FNA material and sent to a qualified reference laboratory. Turnaround includes NGS-based DNA mutation analysis, RNA fusion detection, and mRNA expression marker assessment. Results are incorporated into the patient’s chart, discussed in clinic, and used to inform surgical referral or conservative management.

Coding Specifications

Modifier	Description	When to Use
`00`	Default/No modifier	Use when no specific modifier applies to the billed PLA service
`22`	Increased procedural service	Rarely applicable; use if substantially greater lab work is documented beyond standard test complexity

Taxonomy Code	Specialty	Notes
207RC0000X	Endocrinology	Ordering clinicians who manage thyroid nodules and interpret molecular results
207L00000X	Clinical Laboratory	Laboratories performing molecular diagnostics and reporting PLA tests
207Q00000X	Pathology	Pathologists who correlate cytology and molecular findings
207LP0200X	Molecular Diagnostic Laboratory	Specialty labs performing NGS and fusion testing
2080P0200X	General Surgery	Surgeons who may receive results to plan thyroid surgery

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`E04.1`	Nontoxic single thyroid nodule	Common indication for FNA and subsequent molecular testing to assess malignancy risk
`E04.9`	Nontoxic goiter, unspecified	Palpable or imaging-detected nodules within a goiter may be evaluated with FNA and molecular panels
`R22.1`	Localized swelling, mass and lump, neck	Symptom prompting evaluation and FNA with possible ThyGeNEXT testing
`R91.8`	Other nonspecific abnormal finding of lung field (placeholder)	Data not clinically relevant to thyroid; excluded from routine use — included here only if documented concurrently
`E07.1`	Medullary thyroid carcinoma	Specific thyroid cancer subtype for which molecular profiling can influence diagnosis and management when suspected

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`10021`	Fine needle aspiration without imaging guidance	Represents the initial FNA tissue acquisition that may provide material for ThyGeNEXT testing when no imaging guidance is used
`10022`	Fine needle aspiration with imaging guidance	Represents FNA acquisition with ultrasound guidance; commonly performed to obtain robust samples for molecular analysis
`88305`	Level IV surgical pathology, gross and microscopic examination	Cytopathology or pathology review of FNA material that may accompany molecular testing and provide cytologic diagnosis
`81210`	EGFR (epidermal growth factor receptor) mutation analysis (example molecular test)	Example of molecular testing CPT family; conceptually related though not specific to thyroid panel — illustrates molecular test billing alongside PLA codes
`81479`	Unlisted molecular pathology procedure	Historically used for novel molecular tests before PLA assignment; related as antecedent coding approach to proprietary tests