Summary & Overview
CPT 0473U: xT CDx Comprehensive Tumor Genomic Profiling
CPT code 0473U designates the Tempus AI Inc. xT CDx proprietary laboratory assay, a comprehensive next‑generation sequencing (NGS) test that profiles 648 genes from FFPE solid tumor specimens with matched normal comparison to detect sequence variants, insertions/deletions, copy number changes, and rearrangements, while also reporting microsatellite instability and tumor mutation burden. As a PLA code, 0473U applies only to this single manufacturer’s test and is used to identify a specific laboratory-developed proprietary service in claims and coverage reviews. Nationally, such high‑content tumor profiling matters for precision oncology decision‑making and payer coverage strategies as NGS tests inform targeted therapy selection and eligibility for biomarker‑driven treatments.
Key payers addressed in the analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise overview of the clinical purpose and method of the assay, typical sites of service and billing considerations, and what elements are commonly reviewed by payers when adjudicating coverage for proprietary NGS assays. The publication summarizes payer coverage patterns, relevant policy features and billing implications at a national level, and clarifies where input data was not available for this code. Data not available in the input: associated taxonomies, ICD‑10 diagnoses, related codes, and service line details.
Billing Code Overview
CPT code 0473U is a Proprietary Laboratory Analyses (PLA) code assigned to the xT CDx test from Tempus AI Inc. This next‑generation sequencing (NGS) assay analyzes DNA from a formalin‑fixed paraffin‑embedded (FFPE) solid tumor specimen and compares tumor DNA to a matched normal specimen (blood or saliva) to detect sequence variants, insertions and deletions, copy number variants, and rearrangements. The test also evaluates microsatellite instability and calculates tumor mutation burden, providing a comprehensive genomic profile of the tumor.
Service type: Comprehensive tumor genomic profiling using next‑generation sequencing (NGS)
Typical site of service: Clinical laboratory (specimen collected in ambulatory clinics, hospitals, or oncology centers and analyzed in a specialized molecular diagnostics laboratory)
Clinical & Coding Specifications
Clinical Context
A 62-year-old patient with a newly diagnosed metastatic solid tumor (for example, non-small cell lung cancer or colorectal adenocarcinoma) undergoes tissue biopsy. Formalin-fixed paraffin-embedded (FFPE) tumor tissue is submitted to Tempus AI Inc. for comprehensive genomic profiling using the xT CDx assay. A matched normal specimen (blood or saliva) is collected to permit tumor-normal comparison. The laboratory performs next-generation sequencing of 648 cancer-related genes to detect sequence variants, insertions/deletions, copy number variants, and rearrangements, and reports tumor mutation burden and microsatellite instability status. Results are returned to the treating oncologist to inform targeted therapy selection, clinical trial eligibility, and prognostic assessment. Billing is reported using PLA code 0473U specific to Tempus xT CDx. Typical site of service is an outpatient pathology or molecular diagnostic laboratory; specimen collection occurs in an outpatient clinic, infusion center, or hospital procedural area. Turnaround time and the requirement for matched normal specimen are documented in the lab requisition and test report.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
26 | Professional component | Use when billing only the professional interpretive component of the molecular test separate from the technical laboratory processing when allowed by payer. |