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. |
TC | Technical component | Use when billing only the laboratory technical component (sequencing, bioinformatics pipeline) separate from professional interpretation. |
QK | Clinical laboratory improvement amendment (CLIA) waived test performed at an independent lab | Use per payer policy when applicable for test facility reporting; rarely applicable for high-complexity NGS. |
QX | Ordering physician is certified to perform the test (modifier for CLIA) | Use if specific payer requires provider-level CLIA certification reporting for the ordering clinician. |
QY | Laboratory performed under CLIA certificate of the physician owner | Use per payer policy when the performing lab is certified under the physician's CLIA certificate. |
62 | Two surgeons/physicians | Not typical for the assay itself but may apply when two physicians share responsibility for a biopsy procedure that supplied the specimen. |
78 | Unplanned return to OR | Use only if a surgical complication from specimen procurement required a return to the operating room; unrelated to the molecular test reporting. |
52 | Reduced services | Use if the laboratory performed a reduced or partial panel compared with the full validated assay (rare; document reason). |
53 | Discontinued procedure | Use if specimen collection or test was initiated but discontinued and payer policy permits billing with this modifier. |
22 | Increased procedural services | Use when the laboratory documents and bills for significantly increased work or complexity beyond the usual service, if payer allows for PLA codes. |
80 | Assistant surgeon | Use only when an assistant surgeon participated in obtaining the tissue specimen; not applied to the lab test itself. |
AS | Physician assistant, nurse practitioner, or clinical nurse specialist services | Use if an APP performed the specimen collection when payer requires this modifier for professional services. |
QZ | CLIA waived test performed by hospital lab (not in original list) | Data not available in the input. |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
| 208800000X | Hematology & Oncology | Medical oncologists order molecular profiling for targeted therapy selection and trial eligibility. |
| 207R00000X | Anatomic Pathology | Pathologists coordinate specimen handling and may request molecular testing and interpret results. |
| 207L00000X | Molecular Genetic Pathology | Specialists who supervise molecular diagnostics and interpret complex NGS reports. |
| 363LP0800X | Laboratory Director | Clinical laboratory directors overseeing test validation and reporting. |
| 208M00000X | Surgical Oncology | Surgeons obtain tumor tissue via biopsy or resection that supplies the FFPE specimen. |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
C34.90 | Malignant neoplasm of unspecified part of unspecified bronchus or lung | Common indication for comprehensive NGS to identify actionable mutations in non–small cell lung cancer. |
C18.9 | Malignant neoplasm of colon, unspecified | Colorectal cancers are frequently tested for MSI and tumor mutation burden and for actionable alterations. |
C50.919 | Malignant neoplasm of unspecified site of unspecified female breast | Breast cancers may undergo multigene profiling for therapeutic targets and resistance mechanisms. |
C71.9 | Malignant neoplasm of brain, unspecified | Central nervous system tumors may be profiled to detect targetable alterations for treatment or trial enrollment. |
C61 | Malignant neoplasm of prostate | Advanced prostate cancers may be assessed for genomic alterations, including copy number changes and rearrangements. |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
88305 | Level IV surgical pathology, gross and microscopic examination | Performed on the FFPE specimen to render histologic diagnosis before molecular testing; often billed by the pathology lab. |
88342 | Immunohistochemistry, per specimen; initial single antibody stain | May be performed on the same FFPE block to characterize tumor markers prior to or alongside genomic profiling. |
36415 | Collection of venous blood by venipuncture | Used to obtain the matched normal specimen (blood) required for tumor-normal comparison. |
84999 | Unlisted chemistry procedure | Occasionally used for ancillary biomarker testing not represented by specific codes; payer policies vary. |
0000U | Data not available in the input | Data not available in the input. |